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Medetomidine

Detailed information about Medetomidine

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:

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

What it does:

As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intu...

When it's needed:

Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. D...

Call your vet sooner if you notice:

  • Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Commonly reported reactions:

  • (2 reports)
  • (2 reports)
  • (2 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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Medetomidine

Medetomidine

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

Species: Both

Manufacturer: MSK

Quick Facts

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

Species: Both
Manufacturer: MSK
Form: Injectable Solution, Liquid, Liquid (Solution), Oromucosal Gel, Solution, Sterile Injectable Solution
Identifiers:
ANADA: 200573 ANADA: 200610 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 140999 NADA: 141267 NADA: 141456 NADA: 141551 NDC Package: 11695-6967-1 NDC Package: 15914-005-01 NDC Package: 17033-005-10 NDC Package: 17033-090-05 NDC Package: 46066-088-13 NDC Package: 54771-1050-1 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 58597-8373-6 NDC Package: 58597-8373-7
Source metadata:

Warnings / Contraindications

Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
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
32
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 2
2 Cat, Dog 2
2 Cat, Dog 2
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1
1 Dog 1

Species coverage: Cat (26) Dog (6)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat 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: 24 • 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, 11:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: DEXVETRA™ Dexdomitor® DexmedVet™ Dexmedesed® Dexmedetomidine Hydrochloride Domitor® Placadine™ SILEO® Zenalpha®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Injectable Solution, Liquid, Liquid (Solution), Oromucosal Gel, Solution, Sterile Injectable Solution, Sterile Solution • Intramuscular, Intravenous, Oromucosal
Applications: ANADA 200-699 • ANADA 200-824 • ANADA 200-752 • ANADA 200-735 • NADA 141-551 • ANADA 200-573 • NADA 141-456 • ANADA 200-610 • NADA 141-267 • NADA 140-999
NDC: Packages 11695-6967-1 64189-8502-0 64189-8502-1 68504-006-10 • Products 11695 64189 64189 68504
Documents: 14 (FOI: 12) • SPL: 10 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 20 • Cat 56 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: 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
  • Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Abnormal posture NOS (1) Acute renal failure (1) Anaphylaxis (1) Anaphylaxis (1) Anisocoria (1) Anorexia (1) Ataxia (1) Cardiac arrest (1) Crust (1) Death (1) Decreased body temperature (1) Decreased haematocrit (1) Decreased heart rate (1) Desquamation (1) Elevated alanine aminotransferase (ALT) (1) Elevated blood urea nitrogen (BUN) (1)

Identifiers & Packages

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

Identifiers
ANADA: 200573 ANADA: 200610 ANADA: 200699 ANADA: 200735 ANADA: 200752 ANADA: 200824 NADA: 140999 NADA: 141267 NADA: 141456 NADA: 141551 NDC Package: 11695-6967-1 NDC Package: 15914-005-01 NDC Package: 17033-005-10 NDC Package: 17033-090-05 NDC Package: 46066-088-13 NDC Package: 54771-1050-1 NDC Package: 54771-2805-1 NDC Package: 54771-2806-1 NDC Package: 58597-8373-6 NDC Package: 58597-8373-7 NDC Package: 58597-8373-8 NDC Package: 64189-8501-0 NDC Package: 64189-8501-1 NDC Package: 64189-8502-0
Package NDC Product NDC Form / Route Status
11695-6967-1 11695 -
15914-005-01 15914 -
17033-005-10 17033 -
17033-090-05 17033 -
46066-088-13 46066 -
54771-1050-1 54771 -
54771-2805-1 54771 -
54771-2806-1 54771 -
58597-8373-6 58597 -
58597-8373-7 58597 -
58597-8373-8 58597 -
64189-8501-0 64189 -
64189-8501-1 64189 -
64189-8502-0 64189 -
64189-8502-1 64189 -
68504-006-10 68504 -
69043-038-10 69043 -
71052-254-10 71052 -
71052-254-25 71052 -
71052-254-50 71052 -

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 17 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue.… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Injection site swelling, Lack of efficacy - NOS, Licking at injection site, Vomiting, Diarrhoea, Injection site erythema. (Official, 2026-02-12)
  • usage: As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring musc… (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
DEXVETRA™
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-699 Approved Jan 8, 2026
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-824 Approved Oct 1, 2025
DexmedVet™
RX
Dexmedetomidine hydrochloride
Sterile Injectable Solution • Intramuscular, Intravenous
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-752 Approved Aug 1, 2023
Dexmedetomidine Hydrochloride
RX
Dexmedetomidine hydrochloride
Injectable Solution • Intravenous, Intramuscular
Label highlights
Official documents
ZYVET AH, Inc. ANADA 200-735 Approved Feb 1, 2023
Zenalpha®
RX
Medetomidine hydrochloride Vatinoxan hydrochloride
Solution • Intramuscular
Label highlights
Official documents
Dechra, Ltd. NADA 141-551 Approved May 10, 2022
Dexmedesed®
RX
Dexmedetomidine hydrochloride
Sterile Solution • Intramuscular, Intravenous
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-573 Approved Dec 16, 2021
SILEO®
RX
Dexmedetomidine
Oromucosal Gel • Oromucosal
Label highlights
Official documents
Orion Corp. NADA 141-456 Approved May 17, 2021
Placadine™
RX
Medetomidine hydrochloride
Sterile Injectable Solution • Intramuscular, Intravenous
Label highlights
Official documents
Modern Veterinary Therapeutics, LLC ANADA 200-610 Approved Feb 23, 2021
Dexdomitor®
RX
Dexmedetomidine hydrochloride
Liquid (Solution) • Intravenous, Intramuscular
Label highlights
Official documents
Orion Corp. NADA 141-267 Approved Jun 1, 2016
Domitor®
RX
Medetomidine
Liquid • Intravenous, Intramuscular
Label highlights
Official documents
Orion Corp. NADA 140-999 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 • Cat, No Use Class Stated Or Implied
Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (mcg) per square meter (/m2) of body surface area by intravenous injection or 500 mcg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 mcg/kg by intramuscular injection

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.

Dosage

Administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

Limitations
Indication

For use as a preanesthetic to general anesthesia.

Dosage

Administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

Dosage

40 µg/killogram by intramuscular injection.

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
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.


Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.

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
0.5 mg/mL
Dogs
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

Limitations
Cats
Indication

For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia.

Dosage

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM)

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.5 mg medetomidine hydrochloride and 10 mg vatinoxan hydrochloride
Dog
Indication

For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures and minor surgical procedures.

Dosage

Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m2)BSA or use the dosing table provided in labeling.

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
0.5 mg/mL
<strong>Dogs</strong>
Indication
Dosage
For sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection
Limitations
<strong>Cats</strong>
Indication
For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats
Dosage
For sedation, analgesia, or preanesthesia administer 40 mcg/kg IM
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each mL contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride)
Dogs
Indication
For the treatment of noise aversion in dogs.
Dosage
Administer onto the oral mucosa between the dog’s cheek and gum at the dose of 125 micrograms per square meter.
Limitations
Federal law (USA) 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
1.0 mg medetomidine hydrochloride/mL
Dogs
Indication

As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.

Dosage

750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface.

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
Each mL contains 0.5 mg dexmedetomidine hydrochloride
Cats
Indication
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
40 mcg/kg by intramuscular (IM) injection.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Dogs
Indication
For use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures.
Dosage
Administer 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 of body surface area by intravenous (IV) injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.
Indication
For use as a preanesthetic to general anesthesia.
Dosage
Administer 125 mcg/m2 of body surface area or 375 mcg/m2 of body surface area by intramuscular injection. Note that the mcg/kg dosage decreases as body weight increases.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Not Breeding Animals • Dog, Restricted During Pregnancy
Composition / specifications
1.0 milligram medetomidine hydrochloride per milliliter.
Dogs
Indication
As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.
Dosage
750 micrograms intravenously or 1,000 micrograms intramuscularly per square meter of body surface.
Limitations
Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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

    For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for a new indication for use as a preanesthetic to general anesthesia in cats.
  • Summary
    The effect of the supplement is to add an indication for its use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures in cats.
  • Summary
    DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. DEXDOMITOR is also indicated for use as a preanesthetic to general anesthesia
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Domitor is indicated for use as a sedative and analgesic in dogs over 12 weeks of age, to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The IV route of administration is more efficacious for dental care.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. For use as a preanesthetic to general anesthesia.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stressed due to extreme heat, cold, or fatigue. Allow agitated dogs to rest quietly before administration. Do not repeat dosing in dogs not responding satisfactorily to treatment. Do not use in breeding or pregnant animals. 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. Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 20 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 (5) Diarrhea (4)
Skin & allergy
Injection site swelling (10)
Neurologic
Tiredness (lethargy) (4)
Effectiveness
Lack of efficacy - NOS (10)
Other
Licking at injection site (6) Injection site erythema (4) Injection site necrosis (4) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Anaphylaxis (1) Oedema NOS (1) Oedema NOS (1) Oedema NOS (1) Oedema NOS (1) Oedema NOS (1) Oedema NOS (1)
Cat
Digestive
Loss of appetite (4) Loss of appetite (1) Loss of appetite (1) Loss of appetite (1) Loss of appetite (1) Loss of appetite (1) Loss of appetite (1)
Neurologic
Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1) Tiredness (lethargy) (1)
Behavior
Behavioral disorder (unspecified) (3)
Other
Death (6) Hypothermia (5) Not eating (5) Dehydration (4) Wobbliness (4) Anaemia NOS (3) Crust (1) Crust (1) Crust (1) Crust (1) Crust (1) Crust (1) Death (1) Death (1) Death (1) Death (1) Death (1) Death (1) Desquamation (1) Desquamation (1) Desquamation (1) Desquamation (1) Desquamation (1) Desquamation (1) Erythema (1) Erythema (1) Erythema (1) Erythema (1) Erythema (1) Erythema (1) Inappropriate defecation (1) Inappropriate defecation (1) Inappropriate defecation (1) Inappropriate defecation (1) Inappropriate defecation (1) Inappropriate defecation (1) Ulceration NOS (1) Ulceration NOS (1) Ulceration NOS (1) Ulceration NOS (1) Ulceration NOS (1) Ulceration NOS (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.

Cat, Mixed (Cat), Mixed, 11 year • Drug: MSK, Intravenous, Dose: 2 Microgram per kilogram • Reactions: Ulceration NOS, Inappropriate defecation, Crust, Desquamation, Erythema… • Outcome: Recovered/Normal, Died, Outcome Unknown

  • Report ID: AUS-USFDACVM-2025-AU-000005
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Mixed
  • Age: 11.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Dose: 2 Microgram per kilogram
Reactions Reported:
Ulceration NOS Inappropriate defecation Crust Desquamation Erythema Death Tiredness (lethargy) Loss of appetite
Outcomes: Recovered/Normal, Died, Outcome Unknown

Dog, ['Poodle (unspecified)', 'Spaniel (unspecified)'], Female, 4 year, 8.9 kilogram • Drug: MSK, Intravenous, Dose: 0.04 mL per animal • Reactions: Anaphylaxis, Oedema NOS • Outcome: Recovered/Normal

  • Report ID: AUS-USFDACVM-2025-AU-000003
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 8.900 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Dose: 0.04 mL per animal
Reactions Reported:
Anaphylaxis Oedema NOS
Outcomes: Recovered/Normal

Dog, ['Poodle - Toy', 'Chihuahua'], Unknown, 3 year, 1 kilogram • Drug: MSK, Unknown, Dose: 28 Microgram per kilogram • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-045387
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Age: 3.00 Year
  • Weight: 1.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 28 Microgram per kilogram
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, ['Retriever - Labrador', 'Corso Dog', 'Dog (unknown)'], Unknown • Drug: MSK, Unknown, Dose: 30 Microgram per kilogram • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-045388
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 30 Microgram per kilogram
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Dog, Collie - Border, Female, 13 month, 13 kilogram • Drug: MSK, Unknown, Dose: 5 Microgram per unknown • Reactions: Acute renal failure, Elevated creatinine, Elevated blood urea nitrogen, Elevated symmetrical dimethylarginine • Outcome: Recovered/Normal

  • Report ID: GBR-USFDACVM-2025-GB-000034
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 13.00 Month
  • Weight: 13.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 5 Microgram per unknown
Reactions Reported:
Acute renal failure Elevated creatinine Elevated blood urea nitrogen Elevated symmetrical dimethylarginine
Outcomes: Recovered/Normal

Dog, Dog (unknown), Female, 8.4 year, 28.032 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.30 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy - NOS, Whining • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-018508
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 8.40 Year
  • Weight: 28.032 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.30 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy - NOS Whining
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 18 month, 5.2 kilogram • Drug: MSK, Unknown, Dose: 0.16 mL per unknown • Reactions: Respiratory sound, Cardiac arrest, Death, Abnormal posture NOS • Outcome: Died

  • Report ID: GBR-USFDACVM-2025-GB-000009
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 18.00 Month
  • Weight: 5.200 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.16 mL per unknown
Reactions Reported:
Respiratory sound Cardiac arrest Death Abnormal posture NOS
Outcomes: Died

Cat, Domestic Mediumhair, Female, 11 year, 2.4 kilogram • Drug: MSK, Unknown • Reactions: Low blood pressure, Paddling, Decreased haematocrit, Low serum alkaline phosphatase, Elevated alanine aminotransferase… • Outcome: Ongoing

  • Report ID: FIN-USFDACVM-2024-FI-000004
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 2.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Low blood pressure Paddling Decreased haematocrit Low serum alkaline phosphatase Elevated alanine aminotransferase Anisocoria Unsteady walking (ataxia) Excitation Head shake - behavioural disorder Decreased heart rate
Outcomes: Ongoing

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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