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Milbemycin Oxime

Detailed information about Milbemycin Oxime

Official label facts Owner quick guide first Marketing clearly labeled
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Pet Owner Quick Guide

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

Usually used for:

Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations ( Ctenocephalides felis ), and the treatment and control of adult hookworm ( Ancylostoma caninum ), adult roun...

What it does:

For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections. For prevention of heartworm disease caused by Dirofil...

When it's needed:

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats ha...

Call your vet sooner if you notice:

  • Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Commonly reported reactions:

  • (2 reports)
  • (2 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?
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Milbemycin Oxime

Milbemycin Oxime

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

Species: Both

Manufacturer: Elanco US Inc.

Quick Facts

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

Species: Both
Manufacturer: Elanco US Inc.
Form: Chewable Tablets, Flavored Tablets, Liquid (Solution), Tablet
Identifiers:
ANADA: 200629 NADA: 140915 NADA: 141084 NADA: 141163 NADA: 141204 NADA: 141321 NADA: 141333 NADA: 141338 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02
Source metadata:

Warnings / Contraindications

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

  • High: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..
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
29
Serious reports
15
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 0
2 Cat, Dog 0
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1

Species coverage: Cat (23) Dog (9)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Cat Serious - 1
Cat Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Non-serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Unknown - -
Cat Unknown - -
Cat Unknown - -
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: 27 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

Source metadata:

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.
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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, 11:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: INTERCEPTOR™ PLUS Interceptor™ MilbeGuard™ Milbemite™ Otic Solution Sentinel® Flavor Tabs® Sentinel® Flavor Tabs® and Capstar® Flea Management System™ Sentinel® Spectrum® Trifexis™
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Cat And Kitten, Cats and kittens, Dog, Dogs and puppies
Rx/OTC: RX
Form/route: Chewable Tablets, Flavored Tablets, Liquid (Solution), Tablet • Oral, Topical
Applications: NADA 141-321 • NADA 141-084 • NADA 141-204 • NADA 141-333 • ANADA 200-629 • NADA 141-338 • NADA 140-915 • NADA 141-163
Documents: 19 (FOI: 18) • SPL: 8 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 56 • Cat 56 • View
Case summaries: 12 (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
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

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
  • Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal.. (Contraindication, High)
Top reaction signals
Administration error NOS (1) Anaemia NOS (1) Ataxia (1) Cyst NOS (1) Diarrhoea (1) Disorientation (1) Emesis (multiple) (1) Hypoglycaemia (1) Inappropriate defecation (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - heartworm (1) Lack of efficacy (endoparasite) - hookworm (1) Lack of efficacy (endoparasite) - whipworm (1) Malaise (1) Medication error NOS (1) Muscle tremor (1)

Identifiers & Packages

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

Identifiers
ANADA: 200629 NADA: 140915 NADA: 141084 NADA: 141163 NADA: 141204 NADA: 141321 NADA: 141333 NADA: 141338 NDC Package: 0061-5350-01 NDC Package: 0061-5350-02 NDC Package: 0061-5351-01 NDC Package: 0061-5351-02 NDC Package: 0061-5352-01 NDC Package: 0061-5352-02 NDC Package: 0061-5353-01 NDC Package: 0061-5353-02 NDC Package: 0061-5354-01 NDC Package: 0061-5354-02 NDC Package: 0061-5355-01 NDC Package: 0061-5355-02 NDC Package: 0061-5356-01 NDC Package: 0061-5356-02 NDC Package: 0061-5357-01 NDC Package: 0061-5357-02
Package NDC Product NDC Form / Route Status
0061-5350-01 0061 -
0061-5350-02 0061 -
0061-5351-01 0061 -
0061-5351-02 0061 -
0061-5352-01 0061 -
0061-5352-02 0061 -
0061-5353-01 0061 -
0061-5353-02 0061 -
0061-5354-01 0061 -
0061-5354-02 0061 -
0061-5355-01 0061 -
0061-5355-02 0061 -
0061-5356-01 0061 -
0061-5356-02 0061 -
0061-5357-01 0061 -
0061-5357-02 0061 -
13744-510-10 13744 -
13744-511-10 13744 -
13744-512-10 13744 -
13744-513-10 13744 -

Enriched Documents

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

Data Sources & Revision History

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

Official 22 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy (endoparasite) - heartworm, Lethargy (see also Central nervous system depression in 'Neurological'… (Official, 2026-02-12)
  • usage: For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infe… (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
Trifexis™
RX
Milbemycin Oxime Spinosad
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-321 Approved May 17, 2021
Sentinel® Flavor Tabs®
RX
Lufenuron Milbemycin Oxime
Tablet • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-084 Approved Aug 3, 2020
Sentinel® Flavor Tabs® and Capstar® Flea Management System™
RX
Lufenuron Milbemycin Oxime Nitenpyram
Tablet • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-204 Approved Aug 3, 2020
Sentinel® Spectrum®
RX
Lufenuron Milbemycin Oxime Praziquantel
Chewable Tablets • Oral
Label highlights
Official documents
Intervet, Inc. NADA 141-333 Approved Aug 3, 2020
MilbeGuard™
RX
Milbemycin Oxime
Flavored Tablets • Oral
Label highlights
Official documents
Ceva Sante Animale ANADA 200-629 Approved Jan 7, 2019
INTERCEPTOR™ PLUS
RX
Milbemycin Oxime Praziquantel
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-338 Approved Jan 10, 2018
Interceptor™
RX
Milbemycin Oxime
Tablet • Oral
Label highlights
Official documents
Elanco US Inc. NADA 140-915 Approved Aug 3, 2017
Milbemite™ Otic Solution
RX
Milbemycin Oxime
Liquid (Solution) • Topical
Label highlights
Official documents
Elanco US Inc. NADA 141-163 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: Dog, No Use Class Stated Or Implied
Composition / specifications
The product is available in five tablet strengths:
140 mg spinosad and 2.3 mg milbemycin oxime
270 mg spinosad and 4.5 mg milbemycin oxime
560 mg spinosad and 9.3 mg milbemycin oxime
810 mg spinosad and 13.5 mg milbemycin oxime
1620 mg spinosad and 27 mg milbemycin oxime
Dogs and Puppies (8 Weeks and Older and 5 Lbs or Greater)
Indication
Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
Dosage
Given orally, once a month at a minimum dosage of 13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.
Indication
Trifexis™Chewable Tablets are indicated for the prevention of heartworm disease (Dirofilaria immitis).
Dosage
Given orally, once a month at a minimum dosage of 13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Treatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention. Use with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 2 Pounds • Dogs and puppies, excluding puppies under 4 weeks age
Composition / specifications
Tablets containing: 2.3 milligrams milbemycin oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 milligrams/230 milligrams, and 23 milligrams/460 milligrams.
Dogs and Puppies (4 Weeks and Older; 2 Lbs or Greater)
Indication
For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis, Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
SENTINEL FLAVOR TABS are given orally, once a month, at the recommended minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime and 4.55 mg/lb (10mg/kg) lufenuron.
Limitations
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

FDA page: Open in Animal Drugs @ FDA

Species: Dogs and puppies, excluding puppies under 4 weeks age
Composition / specifications
Flavored tablets containing: 2.3 milligrams milbemycin oxime and 46 milligrams lufenuron, 5.75 milligrams milbemycin oxime and 115 milligrams lufenuron, 11.5 milligrams milbemycin oxime and 230 milligrams lufenuron, or 23 milligrams milbemycin oxime and 460 milligrams lufenuron.
concurrent with
Tablet contains 11.4 or 57 milligrams nitenpyram.
Dogs
Indication
The concurrent use of flavored milbemycin oxime and lufenuron tablets with nitenpyram tablets is indicated to kill adult fleas and prevent flea eggs from hatching.
Dosage
0.5 milligram milbemycin oxime and 10 milligrams lufenuron per kilogram of body weight, once a month. used concurrently with One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly.
Limitations
The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets shall be 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 chewable tablet contains: 2.3 mg milbemycin oxime/46 mg lufenuron/22.8 mg praziquantel; 5.75 mg milbemycin oxime/115 mg lufenuron/57 mg praziquantel; 11.5 mg milbemycin oxime/230 mg lufenuron/114 mg praziquantel; 23.0 mg milbemycin oxime/460 mg lufenuron/228 mg praziquantel
Dogs
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Dipylidium caninum,Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Dosage

SENTINEL SPECTRUM is given orally, once a month, at the minimum dosage of 0.23 mg/pound body weight (0.5 mg/kg) of milbemycin oxime, 4.55 mg/pound (10 mg/kg) of lufenuron, and 2.28 mg/pound (5 mg/kg) of praziquantel. For heartworm prevention, give once monthly beginning within 1 month of the dog’s first seasonal exposure to mosquitoes and continuing until at least 6 months after the dog’s last seasonal exposure.

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
2.3 mg, 5.75 mg, 11.5 mg, or 23.0 mg milbemycin oxime per tablet
Dogs
Indication

For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum(hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Limitations
Cats
Indication

For use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Dosage

MilbeGuard™ Flavored Tablets are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains:
2.3 mg milbemycin oxime/22.8 mg praziquantel
5.75 mg milbemycin oxime/57 mg praziquantel
11.5 mg milbemycin oxime/114 mg praziquantel
23 mg milbemycin oxime/228 mg praziquantel
Dogs (2 lbs or greater and 6 weeks or older)
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and Echinococcus granulosus) and Dipylidium caninum infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Dosage
Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.
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, Excluding Under 2 Pounds • Dogs and puppies, excluding puppies under 4 weeks age • Cat And Kitten, Excluding Under 1.5 Pounds Weight • Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams of milbemycin oxime.
Cats and Kittens (6 Weeks of Age or Greater and 1.5 Lbs. Body Weight or Greater)
Indication
For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections.
Dosage
INTERCEPTOR for Cats is given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).
Limitations
Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established.
Dogs and Puppies (4 Weeks of Age and Older and 2 Pounds of Body Weight and Greater)
Indication
For prevention of heartworm disease caused by Dirofilaria immitis. For control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonine and whipworm infections caused by Trichuris vulpis.
Dosage

INTERCEPTOR is given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Limitations
Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae.

FDA page: Open in Animal Drugs @ FDA

Species: Cat And Kitten, Excluding Under 4 Weeks Of Age
Composition / specifications
Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.
Cats and Kittens (4 Weeks of Age and Older)
Indication
For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
Dosage
One tube (aproximately .2 mL) administered topically into each external ear canal.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of MILBEMITE OTIC Solution in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents
  • Summary
    Indicated for the prevention of heartworm disease ( Dirofilaria immitis). Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations ( Ctenocephalides felis), and the treatment and control of adult hookworm ( Ancylostoma caninum), adult roundworm ( Toxocara canis and Toxascaris leonina) and adult whipworm ( Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Approval of this supplemental NADA will change the labeling for NADA 141-084.
    1. There are some minor revisions to clarify the currently approved text in the package insert.
    2. Use of the Client Information insert will be discontinued.
    3. The package insert is revised to include reference to the concurrent use of CAPSTAR® (nitenpyram) Tablets (NADA 141-175) to kill adult fleas. The information supporting approval for this concurrent use is documented in NADA 141-204.
    4. The unit dose cartons are revised to refer to concurrent use with CAPSTAR® Tablets.
    5. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEM™” package insert that provides specific information for using CAPSTAR® Tablets with SENTINEL® Flavor Tabs®.

  • Summary

    Supplement for the addition of a flavored tablet formulation with the same indications. The flavored tablets (in three tablet sizes) will replace the swallow tablets for dogs > 11 pounds. The swallow tablet will remain for dogs between 2-10 lbs.

  • Summary

    SENTINEL Tablets are indicated for use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm disease caused by Dirofilaria immitis, for the prevention and control of flea populations, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis, Toxascaris leonina (roundworm) and Trichuris vulpis (whipworm) infections.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For use in dogs 4 weeks and older to kill adult fleas and to prevent flea eggs from hatching.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the treatment and control of adult tapeworm (Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

  • Summary
    For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

    For use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the addition of the treatment and control of adult tapeworm (Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

  • Summary

     For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For the prevention of heartworm disease caused by Dirofilaria immitis in dogs and puppies four weeks of age or greater and 2 pounds of body weight or greater.

  • Summary
    Approval of this supplemental NADA will change NADA 140-915 by adding an additional species (cat) to the label. The supplemental application also provides for changes in the dosage and indications for the cat only. No changes are made in the dosage form, dosages or treatment regimen for the dog. The cat will have labeling separate from the dog approval.
  • Summary

    This supplement expands the indications to include the removal and control of adult roundworms Toxascaris leonina. 

  • Summary
    Approval of the supplemental NADA will change NADA No. 140-915 by adding indications for the use of INTERCEPTOR (milbemycin oxime) Flavor Tabs in puppies four weeks of age or greater and two pounds of body weight or greater (from greater than eight weeks of age). The supplemental application does not propose any changes in the formulation, dosage forms, manufacturing procedures, recommended dosages or monthly treatment regimen for INTERCEPTOR (milbemycin oxime) Flavor Tabs.
  • Summary

    For the removal and control of adult Toxocara canis (roundworm) and Trichuris vulpis (whipworm) infections in dogs over eight weeks of age.

  • Summary
    Interceptor tablets are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis and control of adult hookworm infections caused by Ancylostoma caninum in dogs.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides target animal safety study data to lower the age limitation of the product from 8 to 4 week old kittens and to allow a repeat treatment if necessary.
  • Summary
    MILBEMITE OTIC Solution is indicated for treatment of ear mite (Otodectes cyanotis) infestations in cats and kittens eight weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections. For prevention of heartworm disease caused by Dirofilaria immitis . For control of hookworm infections caused by Ancylostoma caninum , and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonine and whipworm infections caused by Trichuris vulpis . For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis , for prevention and control of flea populations, control of adult Ancylostoma caninum (hookworm), and removal and control of adult Toxocara canis , Toxascaris leonine (roundworm), and Trichuris vulpis (whipworm) infections. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas. The concurrent use of flavored milbemycin oxime and lufenuron tablets is indicated to kill adult fleas and prevent flea eggs from hatching.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not use in kittens less than 6 weeks of age or 1.5 pounds body weight. Administer once a month. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established. Do not use in puppies less than 4 weeks of age and less than 2 pounds of body weight. Administer once a month. First dose given within 1 month after first exposure to mosquitoes and continue regular use until at least 1 month after end of mosquito season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Prior to initiation of the INTERCEPTOR treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Administer tablets once a month, preferably on the same date each time. All dogs in a household should be treated to achieve maximum efficacy. Do not use in dogs less than 4 weeks of age and less than 2 pounds body weight To ensure adequate absorption, always administer sentinel® flavor tabs® to dogs immediately after or in conjunction with a normal meal..

Side Effects

No approved side-effect narrative is linked yet.

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

Top Reported Reactions (openFDA)

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

Dog
Digestive
Vomiting (27178) Diarrhea (4875) Vomiting (47) Vomiting (47) Vomiting (46) Vomiting (46) Vomiting (42) Vomiting (42) Diarrhea (30) Diarrhea (30) Diarrhea (29) Diarrhea (29) Diarrhea (26) Diarrhea (26)
Neurologic
Tiredness (lethargy) (7017) Tiredness (lethargy) (29) Tiredness (lethargy) (29) Tiredness (lethargy) (27) Tiredness (lethargy) (27) Tiredness (lethargy) (23) Tiredness (lethargy) (23) Seizure NOS (17) Seizure NOS (17) Seizure NOS (17) Seizure NOS (17) Seizure NOS (17) Seizure NOS (16)
Effectiveness
Lack of efficacy (endoparasite) - heartworm (12861) Lack of efficacy (endoparasite) - hookworm (3231) Lack of efficacy (endoparasite) - heartworm (80) Lack of efficacy (endoparasite) - heartworm (80) Lack of efficacy (endoparasite) - heartworm (80) Lack of efficacy (endoparasite) - heartworm (80) Lack of efficacy (endoparasite) - heartworm (74) Lack of efficacy (endoparasite) - heartworm (71) Lack of efficacy (endoparasite) - hookworm (47) Lack of efficacy (endoparasite) - hookworm (47) Lack of efficacy (endoparasite) - hookworm (46) Lack of efficacy (endoparasite) - hookworm (46) Lack of efficacy (endoparasite) - hookworm (44) Lack of efficacy (endoparasite) - hookworm (43) Lack of efficacy (ectoparasite) - flea (16) Lack of efficacy (ectoparasite) - flea (16) Lack of efficacy (ectoparasite) - flea (16) Lack of efficacy (ectoparasite) - flea (16) Lack of efficacy (ectoparasite) - flea (15)
Other
INEFFECTIVE, HOOKS (4592) INEFFECTIVE, HEARTWORM LARVAE (2699) Other abnormal test result NOS (2453) Other abnormal test result NOS (17) Other abnormal test result NOS (17) Other abnormal test result NOS (17) Other abnormal test result NOS (17) Other abnormal test result NOS (15) Other abnormal test result NOS (15) Death (12)
Cat
Digestive
Vomiting (59) Diarrhea (11) Vomiting (1) Vomiting (1) Vomiting (1) Vomiting (1) Vomiting (1) Vomiting (1)
Neurologic
Tiredness (lethargy) (56) Unsteady walking (ataxia) (20)
Behavior
Behavioral disorder (unspecified) (13)
Effectiveness
Lack of efficacy (ectoparasite) - ear mite (52)
Other
Accidental exposure (33) INEFFECTIVE, EAR MITES (28) Administration error NOS (1) Administration error NOS (1) Administration error NOS (1) Administration error NOS (1) Administration error NOS (1) Administration error NOS (1) Disorientation (1) Disorientation (1) Disorientation (1) Disorientation (1) Disorientation (1) Disorientation (1) Hypoglycaemia (1) Hypoglycaemia (1) Hypoglycaemia (1) Hypoglycaemia (1) Hypoglycaemia (1) Hypoglycaemia (1) Malaise (1) Malaise (1) Malaise (1) Malaise (1) Malaise (1) Malaise (1) Medication error NOS (1) Medication error NOS (1) Medication error NOS (1) Medication error NOS (1) Medication error NOS (1) Medication error NOS (1) Star-gazing (1) Star-gazing (1) Star-gazing (1) Star-gazing (1) Star-gazing (1) Star-gazing (1) Unwell (1) Unwell (1) Unwell (1) Unwell (1) Unwell (1) Unwell (1)

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, Havanese, Male, 12 year, 7.711 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Diarrhea, Inappropriate defecation • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055917
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 7.711 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Diarrhea Inappropriate defecation
Outcomes: Outcome Unknown

Dog, Bulldog - French, Female, 3 year, 15.42 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Cyst NOS, Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055991
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 15.420 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Cyst NOS Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 6 year, 17.69 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 11.50 Milligram per dose, Frequency: 30 per day • Reactions: Lack of efficacy (endoparasite) - whipworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056105
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 17.690 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 11.50 Milligram per dose
  • Frequency: 30 per day
Reactions Reported:
Lack of efficacy (endoparasite) - whipworm
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 2.75 year, 33.11 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055687
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.75 Year
  • Weight: 33.110 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Dog, Crossbred Canine/dog, Male, 8 year, 23.94 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 23 Milligram per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055799
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 23.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 23 Milligram per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Dog, ['Pit Bull', 'Dog (unknown)'], Male, 4.33 year, 23.59 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Weight loss, Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056117
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 4.33 Year
  • Weight: 23.590 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Weight loss Lack of efficacy (endoparasite) - hookworm
Outcomes: Outcome Unknown

Dog, ['Terrier - Yorkshire', 'Bichon Frise'], Female, 15 year, 4.536 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 5.75 Milligram per animal • Reactions: Diarrhea, Vomiting, Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055882
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 5.75 Milligram per animal
Reactions Reported:
Diarrhea Vomiting Vomiting
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 12 year, 6.35 kilogram • Drug: MSK, Tablet, Oral, Dose: 23 Milligram per animal, Frequency: 1 per month • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-051052
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 6.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 23 Milligram per animal
  • Frequency: 1 per month
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

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.

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