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Roxee Medication Guide

Medetomidine

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Liquid Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 16, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Medetomidine

Medetomidine

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

Both Liquid Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Medetomidine

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. Species commonly shown: Both, Dog, Not Breeding Animals, Dog, Restricted During Pregnancy.

Generic name
Medetomidine
Brand names
Domitor®, Placadine™, Medetomidine HCL, Medetomidine Hydrochloride
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Liquid, Sterile Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Domitor® Placadine™ Medetomidine HCL Medetomidine Hydrochloride Placadine
Dosage forms
Liquid Sterile Injectable Solution

Indications / Uses

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.

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.

  • 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

Top reported reactions (openFDA): Injection site swelling, Lack of efficacy - NOS, Licking at injection site, Vomiting, Diarrhoea, Injection site erythema.

FAQ

Both, Dog, Not Breeding Animals, Dog, Restricted During Pregnancy, Dog

Yes. Roxee shows this as prescription-only.

Liquid, Sterile Injectable Solution

Related Conditions

Shock (hypovolemic, septic, cardiogenic, anaphylactic)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

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...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • 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
  • 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
  • Vomiting (1 reports)
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or 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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Medetomidine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case GBR-USFDACVM-2025-GB-000009
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 32 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case GBR-USFDACVM-2025-GB-000009
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case GBR-USFDACVM-2025-GB-000009
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Hyperphosphataemia (1 reports), Hyperactivity (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (1), Behavior (1), Other (27)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (18 reports), Dog (14 reports)

Breed metadata in reports Metadata only

['Retriever - Labrador', 'Hound - Basset'] (1), ['Pit Bull', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Medetomidine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dog, 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, Do not use DEXDOMITOR in dogs or cats with cardiovascular disease, respiratory disorders, liver or k

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Medetomidine brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case GBR-USFDACVM-2025-GB-000009 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • 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
  • 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

Most reported reactions:

  • Vomiting (1 reports)
  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / 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 m…
Form / route / dose
Form: Liquid, Sterile Injectable Solution
Route: Intramuscular, Intravenous
Confirm product label and patient-specific plan.
Warnings
  • High: Do not use in dogs with cardiac diseases, dogs in shock, dogs which are severely debilitated, or dogs which are stresse…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Liquid, 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: 40074-0020-1 NDC Package: 40074-0020-2 NDC Package: 40074-0020-3 NDC Package: 46066-088-13 NDC Package: 54771-1050-1 NDC Package: 54771-2805-1
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.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
2
Matching reports
2
Active filters
1
Selected filters
Body system: Effectiveness Clear
Reset
Drill into common report signals
Breathing difficulty (1) Death by euthanasia (1) Generalised skin slough (1) Lack of efficacy (neoplasia, no remission) (1) Effectiveness (2) Other (2)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-068459

Received 2025-11-17 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Hound - Basset']
Size / weight
50-99 lb (25.401 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Generalised skin sloughPyodermaLack of efficacy (neoplasia, partial remission)Death by euthanasiaBreathing difficulty
Body systems
OtherEffectiveness
Outcomes
Euthanized

USA-USFDACVM-2025-US-066723

Received 2025-11-04 · MSK · MSK

Non-serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (24.948 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (neoplasia, no remission)Mast cell tumourMass NOS
Body systems
EffectivenessOther
Outcomes
Outcome Unknown

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
Grouped by Body System
Digestive (3) · Vomiting, Loss of appetite, Haemorrhagic diarrhoea Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Head shake - behavioural disorder Other (27) · Hyperphosphataemia, Hyperactivity, Generalised skin slough
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Neurologic 1 Cat 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Behavior 1 Cat 1
Digestive 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (18) Dog (14)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Neurologic Cat Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Behavior Cat Serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

CIS SILEO N141456G0022-2.pdf Owner handouts · Official label PI SILEO N141456G0022.pdf Official label / PI · Official label Placadine™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

1

Official label / PI

1

SPL

13

FOI

12

CIS SILEO N141456G0022-2.pdf

Owner handouts · Official label

Open original

PI SILEO N141456G0022.pdf

Official label / PI · Official label

Open original

Placadine™

SPL · SPL

Open original
FDA Structured Product Label

Placadine™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Modern Veterinary Therapeutics, LLC
ANADA
200-610
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular, Intravenous
Species
Dog
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.

Domitor®

SPL · SPL

Open original
FDA Structured Product Label

Domitor®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Orion Corp.
NADA
140-999
Status
RX
Form
Liquid
Route
Intravenous, Intramuscular
Species
Dog
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.

Medetomidine Hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine Hydrochloride. Use the source link for the full official labeling record.

MEDETOMIDINE HYDROCHLORIDE SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for MEDETOMIDINE HYDROCHLORIDE. Use the source link for the full official labeling record.

Medetomidine HCl SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine HCl. Use the source link for the full official labeling record.

Medetomidine HCl SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine HCl. Use the source link for the full official labeling record.

Medetomidine Hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine Hydrochloride. Use the source link for the full official labeling record.

Medetomidine Hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine Hydrochloride. Use the source link for the full official labeling record.

Medetomidine hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine hydrochloride. Use the source link for the full official labeling record.

Placadine SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Placadine. Use the source link for the full official labeling record.

Medetomidine HCL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine HCL. Use the source link for the full official labeling record.

Medetomidine Hydrochloride SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine Hydrochloride. Use the source link for the full official labeling record.

Medetomidine HCl SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Medetomidine HCl. Use the source link for the full official labeling record.

FOI Summary oA 200-610 Approved May 25, 2017.pdf

FOI · FOI

Open original

UCM487850.pdf

FOI · FOI

Open original

FOI Summary oA 200-699 Approved March 11, 2021.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-824 Approved September 19, 2025.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-752 Approved July 6, 2023.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-735 Approved January 13, 2023.pdf

FOI · FOI summary

Open original

FOI Summary oN 141-551 Approved March 30, 2022.pdf

FOI · FOI summary

Open original

UCM436647.pdf

FOI · FOI summary

Open original

UCM475135.pdf

FOI · FOI summary

Open original

ucm062316.pdf

FOI · FOI summary

Open original

ucm062318.pdf

FOI · FOI summary

Open original

UCM504535.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

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
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: MEDETOMIDINE HYDROCHLORIDE Medetomidine HCL Medetomidine HCl Medetomidine Hydrochloride Medetomidine hydrochloride Placadine
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid, Sterile Injectable Solution • Intramuscular, Intravenous
Applications: ANADA 200-610 • NADA 140-999
NDC: Packages 15914-005-01 40074-0020-1 40074-0020-2 40074-0020-3 58597-8373-6 58597-8373-7 • Products 15914 40074 58597 64189 71052 73309
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 7 • Cat 0 • View
Case summaries: 2 (showing 2) • 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
Vomiting (1) Unsteady walking (ataxia) (1) Loss of appetite (1) Hyperphosphataemia (1) Hyperactivity (1) Head shake - behavioural disorder (1) Haemorrhagic diarrhoea (1) Generalised skin slough (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: 40074-0020-1 NDC Package: 40074-0020-2 NDC Package: 40074-0020-3 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
Package NDC Product NDC Form / Route Status
11695-6967-1 11695 -
15914-005-01 15914 -
17033-005-10 17033 -
17033-090-05 17033 -
40074-0020-1 40074 -
40074-0020-2 40074 -
40074-0020-3 40074 -
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 -

Enriched Documents

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

Data Sources & Change Log

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

Official 144 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Injection site swelling, Lack of efficacy - NOS, Licking at injection site, Vomiting, Diarrhoea, Injection site erythema. (Clinical, 2026-04-11)
  • 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, 2026-04-12)
  • 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, 2026-04-11)
  • 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)
  • indications: 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… (Official, 2026-06-22)
  • indications: 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… (Official, 2026-06-22)
  • indications: 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… (Official, 2026-06-21)
  • indications: 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… (Official, 2026-06-20)
  • indications: 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… (Official, 2026-06-13)
  • indications: 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… (Official, 2026-06-12)
  • indications: 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… (Official, 2026-06-12)
  • indications: 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… (Official, 2026-06-11)
  • indications: 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… (Official, 2026-06-11)
  • indications: 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… (Official, 2026-06-10)
  • indications: 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… (Official, 2026-06-09)
  • indications: 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… (Official, 2026-06-08)
  • indications: 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… (Official, 2026-06-07)
  • indications: 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… (Official, 2026-06-06)
  • indications: 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… (Official, 2026-06-05)
  • indications: 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… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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
Placadine™
RX
Medetomidine hydrochloride
Sterile Injectable Solution • Intramuscular, Intravenous
Label highlights
Official documents
Modern Veterinary Therapeutics, LLC ANADA 200-610 Approved Feb 23, 2021
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
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
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

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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Dog Loss of appetite (1) • Dog Haemorrhagic diarrhoea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Head shake - behavioural disorder (1) • Cat

Showing top 5 for Behavior.

Other
Hyperphosphataemia (1) • Cat Hyperactivity (1) • Dog Generalised skin slough (1) • Dog Fluid from nose (1) • Cat Excitation (1) • Cat
Show more (22)
Erythema (1) • Cat Elevated total bilirubin (1) • Cat Elevated symmetrical dimethylarginine (1) • Dog Elevated creatinine (1) • Cat Elevated blood urea nitrogen (1) • Dog Elevated alanine aminotransferase (1) • Cat Dysphoria (1) • Dog Discomfort NOS (1) • Dog Desquamation (1) • Cat Decreased heart rate (1) • Cat Decreased haematocrit (1) • Cat Decreased body temperature (1) • Cat Death by euthanasia (1) • Dog Death (1) • Cat Crust (1) • Cat Cardiac arrest (1) • Cat Breathing difficulty (1) • Dog Azotaemia (1) • Dog Anisocoria (1) • Cat Anaphylaxis (1) • Dog Acute renal failure (1) • Dog Abnormal posture NOS (1) • Cat

Showing top 5 for Other.

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, ['Retriever - Labrador', 'Hound - Basset'], Male, 13 year, 25.401 kilogram • Drug: MSK, Injection, Intravenous, Dose: 0.25 mL per dose, Frequency: 1 per day • Reactions: Generalised skin slough, Pyoderma, Lack of efficacy, Death by euthanasia, Breathing difficulty • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-068459
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 25.401 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Injection
  • Dose: 0.25 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Generalised skin slough Pyoderma Lack of efficacy Death by euthanasia Breathing difficulty
Outcomes: Euthanized

Dog, ['Pit Bull', 'Dog (unknown)'], Female, 5 year, 24.948 kilogram • Drug: MSK, Injection, Intravenous, Dose: 0.20 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Mast cell tumour, Mass NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-066723
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 24.948 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Injection
  • Dose: 0.20 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy Mast cell tumour Mass 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.

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This medication has not been reviewed by a veterinarian yet.