Skip to main content

Need urgent help? Start triage first, then route to emergency care.

Meds A-Z

Sulfadimethoxine

Detailed information about Sulfadimethoxine

Official label facts Owner quick guide first Marketing clearly labeled
Showing simplified owner view. Switch to Vet View for full technical detail.

Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

As an aid in the prevention of coccidiosis caused by Eimeria tenella , E. necatrix , E. acervulina , E. maxima , E. brunetti , and E. mivati ; as an aid in the prevention of bacterial infections caused by Haemophilus gal...

What it does:

Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs. It i...

When it's needed:

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed vete...

Call your vet sooner if you notice:

  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Commonly reported reactions:

  • (2 reports)
  • (1 reports)
  • (1 reports)

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Talk to a Vet / Find a Vet Near You
Image coming soon
Sulfadimethoxine

Sulfadimethoxine

Drug type: Generic ingredient • Branded profile FDA branded products available

Species: Both

Manufacturer: Zoetis Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Zoetis Inc.
Form: Bolus, Injection, Liquid, Liquid (Solution), Liquid (Suspension), Medicated Feed
Identifiers:
ANADA: 200030 ANADA: 200031 ANADA: 200038 ANADA: 200165 ANADA: 200177 ANADA: 200192 ANADA: 200238 ANADA: 200251 ANADA: 200258 ANADA: 200376 ANADA: 200443 ANADA: 200523 NADA: 100929 NADA: 12087 NADA: 12554 NADA: 125933 NADA: 15102 NADA: 31205 NADA: 31715 NADA: 37700
Source metadata:

Warnings / Contraindications

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

  • High: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
10
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 0
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1

Species coverage: Dog (22) Cat (10)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Dog Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Non-serious - 1
Dog Serious - 1
Source metadata:

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 49 • Secondary summaries: 0

Secondary summaries

No source yet.

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
Talk to a Vet / Find a Vet Near You
Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5% Albon Oral Suspension 5% Albon® Albon® S.R. (Sustained Release) Albon® Tablets Albon® or Agribon® Bactrovet Injectable Bactrovet Oral Suspension 12.5% Bactrovet Tablets 250 mg DI-METHOX® Di-Methox Injection 40% Medacide-SDM Injection 10% Primor® Tablets Rofenaid® & Ipropran Rofenaid® 40 Rofenaid® Plus Roxarsone Romet®-30 SulfaMed® Sulfadimethoxine 12.5% Oral Solution Sulfadimethoxine Concentrated Solution 12.5% Sulfadimethoxine Injection 40% Sulfadimethoxine Soluble Powder Sulfamed-G® Sulfasol Soluble Powder Sulforal®
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Beef, Beef And Dairy, Beef calves, Breeding, Broilers, Broilers up to 16 weeks, Cat, Catfish, Chicken, Chukar Partridges, Dairy, Dairy calves, Dairy heifers, Dog, Duck, Excluding turkeys producing eggs for human consumption, Growing, Horse, Meat type, No Use Class Stated Or Implied, Replacements, Replacements up to 16 weeks age, Salmonids, Under 16 weeks, Up to 16 weeks (112 days) of age
Rx/OTC: OTC, RX, VFD
Form/route: Bolus, Injection, Liquid, Liquid (Solution), Liquid (Suspension), Medicated Feed, Soluble Powder, Solution, Sustained Release Bolus, Tablet, Type A Medicated Article Intramuscular, Intravenous, Oral, Subcutaneous
Applications: NADA 40209 • ANADA 200-038 • NADA 43785 • NADA 15102 • NADA 125-933 • ANADA 200-523 • NADA 41245 • NADA 31715 • ANADA 200-031 • ANADA 200-165 • NADA 47089 • ANADA 200-376 • ANADA 200-030 • NADA 98569 • ANADA 200-238 • ANADA 200-251 • NADA 100-929 • ANADA 200-192 • ANADA 200-177 • NADA 46285 • NADA 31205 • ANADA 200-258 • NADA 93107 • NADA 12554 • NADA 37700 • NADA 12087 • NADA 41984 • ANADA 200-443
NDC: Packages 46066-081-11 46066-555-93 69043-025-89 86136-110-47 Products 46066 46066 69043 86136
Documents: 20 (FOI: 16) • SPL: 29 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 56 Cat 8 View
Case summaries: 10 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. (Contraindication, High)
Top reaction signals
Anaphylaxis (1) Ataxia (1) Blood in faeces (1) Blood in vomit (1) Dehydration (1) Disorientation (1) Ear canal inflammation (1) Ear infection NOS (1) Elevated blood urea nitrogen (BUN) (1) Elevated haematocrit (1) Emesis (multiple) (1) Foaming at the mouth (1) Gagging (1) Hives (see also Skin) (1) Hypersalivation (1) Hyperthermia (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200030 ANADA: 200031 ANADA: 200038 ANADA: 200165 ANADA: 200177 ANADA: 200192 ANADA: 200238 ANADA: 200251 ANADA: 200258 ANADA: 200376 ANADA: 200443 ANADA: 200523 NADA: 100929 NADA: 12087 NADA: 12554 NADA: 125933 NADA: 15102 NADA: 31205 NADA: 31715 NADA: 37700 NADA: 40209 NADA: 41245 NADA: 41984 NADA: 43785
Package NDC Product NDC Form / Route Status
13985-574-24 13985 -
13985-751-01 13985 -
15331-0103-1 15331 -
17033-415-01 17033 -
17033-428-03 17033 -
23243-0410-5 23243 -
23243-3700-7 23243 -
46066-081-11 46066 -
46066-552-04 46066 -
46066-555-93 46066 -
54771-1446-0 54771 -
54771-8431-1 54771 -
54771-8432-1 54771 -
54771-8433-1 54771 -
54771-8433-2 54771 -
54771-8435-1 54771 -
54771-8435-2 54771 -
54771-8449-1 54771 -
54771-8450-1 54771 -
54771-8450-2 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • ucm049548.pdf • FOI summary • Official • June 17, 2025
    FDA FOI summary for application 40209
  • A200038_Orig_05_25_1993.pdf • FOI summary • Official • July 3, 2024
    FDA FOI summary for application 200038
  • UCM452233.pdf • FOI summary • Official • Dec. 27, 2022
    FDA FOI summary for application 125933
  • UCM388201.pdf • FOI summary • Official • Dec. 16, 2022
    FDA FOI summary for application 200523
  • A200031_Orig_6_17_1992.pdf • FOI summary • Official • March 3, 2022
    FDA FOI summary for application 200031
  • A200165_Org_12_4_1996.pdf • FOI summary • Official • May 22, 2020
    FDA FOI summary for application 200165
  • ucm059308.pdf • FOI summary • Official • Oct. 2, 2018
    FDA FOI summary for application 200376
  • A200030 Orig_12_31_1992.pdf • FOI summary • Official • July 2, 2018
    FDA FOI summary for application 200030
  • A200251_Orig_8_03_1998.pdf • FOI summary • Official • July 19, 2017
    FDA FOI summary for application 200251
  • A200238_Orig_07_28_1998.pdf • FOI summary • Official • July 19, 2017
    FDA FOI summary for application 200238
  • N 100929_Orig_11_24_1989.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929
  • N100929_Supp_8_5_1996.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929
  • A200192_Org_3_24_1997.pdf • FOI summary • Official • May 22, 2017
    FDA FOI summary for application 200192
  • A200177_Org_3_13_1997.pdf • FOI summary • Official • May 19, 2017
    FDA FOI summary for application 200177
  • ucm061683.pdf • FOI summary • Official • Jan. 3, 2017
    FDA FOI summary for application 200258
  • UCM196111.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200443

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 19 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Lack of efficacy (protozoa) - C… (Official, 2026-02-12)
  • usage: Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Rofenaid® 40
VFD
Ormetoprim Sulfadimethoxine
Type A Medicated Article Oral
Phibro Animal Health Corp. NADA 40209 Approved Jun 17, 2025
Di-Methox Injection 40%
RX
Sulfadimethoxine
Liquid (Solution) Intravenous
Huvepharma EOOD ANADA 200-038 Approved Jul 3, 2024
Albon Oral Suspension 5%
RX
Sulfadimethoxine
Liquid (Suspension) Oral
Zoetis Inc. NADA 43785 Approved May 22, 2023
Albon® Tablets
RX
Sulfadimethoxine
Tablet Oral
Zoetis Inc. NADA 15102 Approved May 22, 2023
Romet®-30
VFD
Ormetoprim Sulfadimethoxine
Type A Medicated Article Oral
Pharmaq AS NADA 125-933 Approved Dec 27, 2022
SulfaMed®
RX
Sulfadimethoxine
Injection Intravenous
Bimeda Animal Health Limited ANADA 200-523 Approved Dec 16, 2022
Albon®
RX
Sulfadimethoxine
Liquid Intravenous, Subcutaneous
Zoetis Inc. NADA 41245 Approved Dec 5, 2022
Albon® or Agribon®
RX
Sulfadimethoxine
Bolus Oral
Zoetis Inc. NADA 31715 Approved Nov 30, 2022
DI-METHOX®
RX
Sulfadimethoxine
Soluble Powder Oral
Huvepharma EOOD ANADA 200-031 Approved Mar 3, 2022
Sulfadimethoxine Concentrated Solution 12.5%
RX
Sulfadimethoxine
Liquid (Solution) Oral
Cronus Pharma Specialities India Private Ltd. ANADA 200-165 Approved May 22, 2020
Rofenaid® & Ipropran
OTC
Ipronidazole Ormetoprim Sulfadimethoxine
Roche Vitamins, Inc. NADA 47089 W Oct 21, 2019
Sulfamed-G®
RX
Sulfadimethoxine
Soluble Powder Oral
Bimeda Animal Health Limited ANADA 200-376 Approved Oct 2, 2018
DI-METHOX®
RX
Sulfadimethoxine
Solution Oral
Huvepharma EOOD ANADA 200-030 Approved Jul 2, 2018
Medacide-SDM Injection 10%
RX
Sulfadimethoxine
Liquid Subcutaneous, Intramuscular, Intravenous
Cronus Pharma Specialities India Private Ltd. NADA 98569 Approved Feb 1, 2018
Sulfasol Soluble Powder
RX
Sulfadimethoxine
Soluble Powder Oral
Med-Pharmex, Inc. ANADA 200-238 Approved Jul 19, 2017
Sulforal®
RX
Sulfadimethoxine
Liquid (Solution) Oral
Med-Pharmex, Inc. ANADA 200-251 Approved Jul 19, 2017
Primor® Tablets
RX
Ormetoprim Sulfadimethoxine
Tablet Oral
Zoetis Inc. NADA 100-929 Approved Jul 12, 2017
Sulfadimethoxine 12.5% Oral Solution
RX
Sulfadimethoxine
Liquid (Solution) Oral
Huvepharma EOOD ANADA 200-192 Approved May 22, 2017
Sulfadimethoxine Injection 40%
RX
Sulfadimethoxine
Liquid Intravenous
Huvepharma EOOD ANADA 200-177 Approved May 19, 2017
Albon®
RX
Sulfadimethoxine
Soluble Powder Oral
Zoetis Inc. NADA 46285 Approved Jan 3, 2017
ALBON® Concentrated Solution 12.5% AGRIBON® Concentrated Solution 12.5%
RX
Sulfadimethoxine
Solution Oral
Zoetis Inc. NADA 31205 Approved Jan 3, 2017
Sulfadimethoxine Soluble Powder
RX
Sulfadimethoxine
Liquid (Solution) Oral
Phibro Animal Health Corp. ANADA 200-258 Approved Jan 3, 2017
Albon® S.R. (Sustained Release)
RX
Sulfadimethoxine
Sustained Release Bolus Oral
Zoetis Inc. NADA 93107 Approved Jun 1, 2016
Bactrovet Injectable
RX
Sulfadimethoxine
Mallinckrodt Veterinary, Inc. NADA 12554 W Jun 1, 2016
Bactrovet Oral Suspension 12.5%
RX
Sulfadimethoxine
Liquid Oral
Intervet, Inc. NADA 37700 Approved Jun 1, 2016
Bactrovet Tablets 250 mg
RX
Sulfadimethoxine
Tablet Oral
Intervet, Inc. NADA 12087 Approved Jun 1, 2016
Rofenaid® Plus Roxarsone
OTC
Ormetoprim Roxarsone Sulfadimethoxine
Medicated Feed Oral
Zoetis Inc. NADA 41984 W Jun 1, 2016
Sulfadimethoxine Soluble Powder
RX
Sulfadimethoxine
Soluble Powder Oral
First Priority, Inc. ANADA 200-443 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Duck, Excluding Laying Eggs For Human Consumption • Breeding • Up to 16 weeks (112 days) of age • Broilers • Replacements • Excluding turkeys producing eggs for human consumption • Chukar Partridges, Up To 8 Weeks Of Age
Composition / specifications
Each pound of Type A medicated article contains 113.5 grams sulfadimethoxine (25%) and 68.1 grams ormetoprim (15%)
Chickens (broilers and replacements)
Indication

As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations

Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

Turkeys
Indication
As an aid in the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis, and E. meleagrimitis and for the prevention of bacterial infections caused by P. multocida (fowl cholera).
Dosage
Sulfadimethoxine, 56.75 grams (0.00625 percent) per ton of feed plus ormetoprim, 34.05 grams (0.00375 percent) per ton of feed.
Limitations

Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.

Ducks (including breeding ducks)
Indication

As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks including breeding ducks.

Dosage

Sulfadimethoxine, 227 grams per ton of feed (0.025 percent), and ormetoprim, 136.2 grams per ton of feed (0.015 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.

Ducks
Indication

As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3, and 4), and severe challenge of P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 454 grams per ton of feed (0.05 percent), and ormetoprim, 272.4 grams per ton of feed (0.03 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.

Chukar partridges
Indication
For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.
Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations
Feed continuously to young birds up to 8 weeks of age as sole ration.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each mL contains 400 mg sulfadimethoxine
Cattle
Indication

For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine.

Dosage

To be administered in amounts to provide 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. Must be administered only by the intravenous route in cattle. Length of treatment depends on the clinical response. In most cases treatment for 3-5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.
Cats
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.

Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.
Dogs
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.






Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats
Indication

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Dosage

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Salmonids, Reared • Catfish, Reared
Composition / specifications
Type A medicated articles: 25 percent sulfadimethoxine and 5 percent ormetoprim.
Fresh-water reared salmonids
Indication

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.
Catfish
Indication

For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
400 mg/mL
Label highlights
Indication
For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine
Dosage
Intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Horse, Not For Meat Production • No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter.
Horses
Indication
For the treatment of respiratory disease caused by Streptococcus equi (strangles).
Dosage
It is administered by intravenous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.
Limitations
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs
Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.
Cats
Indication
For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine.
Dosage
It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
Limitations
Federal law restricts this drug to use by or on the order of a veterinarian.
Cattle
Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. Tissue damage may result from perivascular infiltration. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Cattle
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

Dosage
1.25 to 2.5 grams per 100 pounds body weight. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
107 g (3.77 oz.) pouch: each packet contains 3.34 oz. (94.6 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate. 535 g (18.87 oz.) pouch: each packet contains 16.8 oz. (473 g) of sulfadimethoxine in the form of the soluble salt and disodium edetate.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 (0.05 percent) grams of powder per gallon of water in drinking water or as a drench. Administer for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks (168 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. The oral solution is administered as a drench or diluted as directed to prepare drinking water.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broiler and replacements)
Indication

For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams/gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (growing)
Indication

For growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams/gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age.Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams/gallon (0.031-0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Replacements up to 16 weeks age • Broilers up to 16 weeks
Composition / specifications
107 g (3.77 oz) pouch: each packet contains 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 535 g (18.87 oz) pouch: each packet contains 16.8 oz (473 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate. 25 lb (11.34 kg) pail: 3 scoops contain 3.34 oz (94.6 g) Sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams of powder per gallon to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef cattle)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. Federal law prohibits the extralabel use of this product in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Beef calves • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12.5 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

The oral solution is administered as a drench or diluted as directed to prepare drinking water. Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams per gallon of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine containing 100 milligrams per milliliter.
Dogs
Indication
It is used or intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
Dosage
It is administered by subcutaneous, intramuscular or intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.
Limitations
For use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon. The powder is used to prepare a drench or drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. The powder is used to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
The oral solution contains 12 percent (3.75 gram per ounce) sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water for treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains 120 milligrams (100 milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 milligrams of ormetoprim), or 1200 milligrams (1,000 milligrams of sulfadimethoxine and 200 milligrams of ormetoprim).
Dogs
Indication
Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by Escherichia coli, Staphylococcus species, and Proteus mirabilis susceptible to ormetoprim-potentiated sulfadimethoxine.
Dosage
On the first day of treatment, administer 25 milligrams per pound (55 milligrams per kilogram) of body weight. Then follow with a daily dosage of 12.5 milligrams per pound (27.5 milligrams per kilogram) of body weight.
Limitations
Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Growing • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.
Turkeys (growing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication.Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) ofdrinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. 

Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Sulfadimethoxine injection containing 400 milligrams per milliliter
Cattle
Indication
For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.
Dosage
It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
Limitations
Tissue damage may result from perivascular infiltration. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt).
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Cattle (dairy calves, dairy heifers, and beef cattle)
Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each ounce of solution contains (3.75 grams (12.5 percent) sulfadimethoxine.
Chickens (broilers and replacements)
Indication

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Turkeys (growing)
Indication

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Limitations

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Cattle (dairy calves, dairy heifers, and beef)
Indication

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Limitations

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy calves • Dairy heifers • Meat type, up to 24 weeks age • Broilers • Replacements • Under 16 weeks
Composition / specifications
Each packet of powder contains the equivalent of 94.6 grams of sulfadimethoxine.
Chickens (broilers and replacements)
Indication
Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat)
Indication
Treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025 percent) grams per gallon of drinking water.
Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Administer as sole source of drinking water and sulfonamide medication. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

 Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Dosage
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).
Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, non-lactating
Composition / specifications
12.5-gram-sustained-release bolus.
Cattle (beef and nonlactating dairy)
Indication
Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella species sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus necrophorus.
Dosage
Administer one bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight.
Limitations
Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of the drug contains 50 milligrams of sulfadimethoxine.
Dogs
Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections in dogs and enteritis associated with coccidiosis.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.
Cats
Indication
It is intended for use in the treatment of sulfonamide susceptible bacterial infections.
Dosage
On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.
Limitations
For use only by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
No specifications are included in the CFR for this product.
Dogs
Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.
Cats
Indication
Treatment of sulfadimethoxine-susceptible bacterial infections.
Dosage
12.5 to 25 milligrams per pound body weight.
Limitations
Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Chicken, Broilers
Chickens (broilers)
Indication
As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bacterial infections due to H. gallinarium (infectious coryza), E. coli (colibacillosis), and P. multocida (fowl cholera); growth promotion and feed efficiency; improving pigmentation.
Dosage
Sulfadimethoxine, 113.5 grams (0.0125 percent) per ton of feed plus ormetoprim 68.1 grams (0.0075 percent) per ton of feed plus roxarsone, 22.7 grams (0.0025 percent) per ton of feed.
Limitations
Withdraw 5 days before slaughter. Feed as sole source of organic arsenic.

FDA page: Open in Animal Drugs @ FDA

Species: Beef And Dairy • Growing • Broilers • Replacements
Composition / specifications
Each 107 gram packet contains 3.34 oz (94.6 g) of sulfadimethoxine in the form of soluble sodium salt and disodium edetate.
Chickens (broiler and replacement)
Indication
For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
Dosage
1.875 (0.05%) grams per gallon to prepare a drench or drinking water (contents of packet diluted to 50 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to chickens over 16 weeks (112 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Dosage

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Turkeys (meat-producing)
Indication
For the treatment of disease outbreaks of coccidiosis and fowl cholera.
Dosage
0.938 (0.025%) grams per gallon to prepare a drench or drinking water (contents of the packet diluted to 100 gallons of water). Treat for 6 consecutive days.
Limitations

Do not administer to turkeys over 24 weeks (168 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Indication

Treatment of disease outbreaks of coccidiosis and fowl cholera.

Dosage

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Limitations

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Cattle (dairy calves, dairy heifers, and beef)
Indication
For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine, and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Dosage
Administer 25 mg/lb the first day followed by 12.5 mg/lb/day for 4 consecutive days.
Limitations

During treatment period, make certain that animals maintain adequate water Intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Indication

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Dosage

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Limitations

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary
    This supplemental application provides for the addition of a new species (chukar partridges).
  • EA 040-209
  • FONSI 040-209
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Recommended in cattle for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum, sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum, sensitive to sulfadimethoxine.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement extends the claim to include control of enteric septicemia in catfish.
  • EA 125-933
  • FONSI 125-933
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Broiler and Replacement Chickens: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

    Meat Producing Turkeys: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera.

    Dairy Calves, Dairy Heifers and Beef: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Chickens: Coccidiosis, fowl cholera, and coryza.

    Turkeys: Coccidiosis and fowl cholera.

    Cattle: Shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For Broiler and Replacement Chickens Only: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. For Meat-producing Turkeys Only: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.
    For Dairy Calves, Dairy Heifers, and Beef Cattle: Use for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Broiler and Replacement Chickens: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. 

    Meat Producing Turkeys: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. 

    Dairy Calves, Dairy Heifers and Beef Cattle: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For Broiler and Replacement Chickens Only ⿿ Use for the treatment of disease outbreaks of coccidiosis, fowl cholera and infectious coryza. 

    For Meat Producing Turkeys Only ⿿ Use for the treatment of disease outbreaks of coccidiosis and fowl cholera. 

    For Dairy Calves, Dairy Heifers and Beef Cattle â¿¿ Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Broiler and Replacement Chickens: For the treatment of coccidiosis, fowl cholera and infectious coryza.

    Meat-Producing Turkeys: For the treatment of coccidiosis and fowl cholera.

    Dairy Calves, Dairy Heifers and Beef Cattle: For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacteria susceptible to sulfadimethoxine/ormetoprim. Primor® Tablets (NADA 100-929) is currently approved for use in dogs.

  • Summary

    Primor is to be used in the treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli susceptible to sulfadimethoxine/ormetoprim.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Broiler and Replacement Chickens- Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

    Meat-Producing Turkeys- Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

    Dairy Calves, Dairy Heifers and Beef Cattle- Use for the treatment of shipping fever complex, and bacterial pneumonia associated with Pasteurella Spp. sensitive to sulfadimethoxine; and calf diptheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella Spp. Sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Chickens: For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. Turkeys: For the treatment of disease outbreaks of coccidiosis and fowl cholera. Cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza in broiler and replacement chickens only; the treatment of coccidiosis and fowl cholera in meat-producing turkeys only; and the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine in dairy calves, dairy heifers and beef cattle.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Treatment of sulfadimethoxine-susceptible bacterial infections. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs. It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 56 and Cat 8 (view top reported reactions).

Top Reported Reactions (openFDA)

Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).

Dog
Digestive
Vomiting (52) Diarrhea (33)
Skin & allergy
Facial swelling (possible allergy) (17) Hives (1) Hives (1) Hives (1) Hives (1) Hives (1) Itchy rash (1) Itchy rash (1) Itchy rash (1) Itchy rash (1) Itchy rash (1) Itchy rash (1)
Neurologic
Tiredness (lethargy) (49)
Effectiveness
Lack of efficacy (protozoa) - Coccidia (18) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy - NOS (1)
Other
Death (17) Other abnormal test result NOS (17) Anaemia NOS (16) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Dehydration (1) Dehydration (1) Dehydration (1) Dehydration (1) Dehydration (1) Dehydration (1) Elevated blood urea nitrogen (1) Elevated blood urea nitrogen (1) Elevated blood urea nitrogen (1) Elevated blood urea nitrogen (1) Elevated blood urea nitrogen (1) Elevated blood urea nitrogen (1) Gagging (1) Gagging (1) Gagging (1) Gagging (1) Gagging (1) Gagging (1) Inappropriate urination (1) Inappropriate urination (1) Inappropriate urination (1) Inappropriate urination (1) Inappropriate urination (1) Inappropriate urination (1)
Cat
Digestive
Diarrhea (10)
Neurologic
Tiredness (lethargy) (6) Tiredness (lethargy) (5)
Effectiveness
Lack of efficacy (protozoa) - Coccidia (8) Lack of efficacy (endoparasite) - roundworm NOS (7)
Other
INEFFECTIVE, COCCIDIA (6) Death (5) Fever (5)

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Shepherd Dog - Australian, Male, 1.25 year, 11.57 kilogram • Drug: MSK, Unknown • Reactions: Shaking, Proteinuria, Elevated blood urea nitrogen, Lymphocytosis, Monocytosis… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054912
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 1.25 Year
  • Weight: 11.570 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Shaking Proteinuria Elevated blood urea nitrogen Lymphocytosis Monocytosis Neutropenia Low platelet count Urine abnormalities NOS Weight gain Gagging Inappropriate urination Reverse sneezing Lack of efficacy (endoparasite) - heartworm Vomiting Anaphylaxis Unable to stand Not eating Other abnormal test result NOS Dehydration Tiredness (lethargy)
Outcomes: Ongoing

Dog, Bulldog - French, Male, 14 week, 4.98 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy - NOS, Mucous stool, Itchy rash • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-051406
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Week
  • Weight: 4.980 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy - NOS Mucous stool Itchy rash
Outcomes: Outcome Unknown

Dog, Crossbred Canine/dog, Female, 2 year, 18.144 kilogram • Drug: MSK, Tablet, Oral • Reactions: Hives • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-050468
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 18.144 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Hives
Outcomes: Recovered/Normal

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Female, 1.67 year, 15 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (virus) - parvovirus, Blood in faeces, Not eating, Lack of efficacy (endoparasite) - tapeworm, Ear infection NOS… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054918
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.67 Year
  • Weight: 15.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (virus) - parvovirus Blood in faeces Not eating Lack of efficacy (endoparasite) - tapeworm Ear infection NOS Ear canal inflammation Low serum alkaline phosphatase Elevated haematocrit Lymphocytosis Tiredness (lethargy) Unwell Blood in vomit Hypoproteinaemia
Outcomes: Outcome Unknown

Dog, Havanese, Male, 2 month, 1.95 kilogram • Drug: MSK, Suspension, Oral, Dose: 1 dose per animal • Reactions: Nausea, Tiredness (lethargy), Inappetence, Vomiting, Underdose • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-045615
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Month
  • Weight: 1.950 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Suspension
  • Dose: 1 dose per animal
Reactions Reported:
Nausea Tiredness (lethargy) Inappetence Vomiting Underdose
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 2 year, 4.08 kilogram • Drug: MSK, Unknown • Reactions: Foaming at the mouth, Tremors, Stumbling gait • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-043481
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 4.080 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Foaming at the mouth Tremors Stumbling gait
Outcomes: Ongoing

Cat, Persian, Male, 7 year, 4.44 kilogram • Drug: MSK, Unknown • Reactions: Disorientation, Unsteady walking (ataxia), Hyperthermia • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-043490
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 4.440 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Disorientation Unsteady walking (ataxia) Hyperthermia
Outcomes: Outcome Unknown

Cat, Domestic Mediumhair, Male, 3 month, 1.814 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-008776
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Month
  • Weight: 1.814 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Outcome Unknown

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.