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Roxee Medication Guide

Atipamezole Hydrochloride

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 (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Mar 3, 2026, 11:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Atipamezole Hydrochloride

Atipamezole Hydrochloride

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Atipamezole Hydrochloride

For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. Species commonly shown: Both, Dog.

Generic name
Atipamezole Hydrochloride
Brand names
Antisedan®, REVERTIDINE™, Cropamezole™, CONTRASED™
Manufacturer
Multiple FDA sponsors
Species
Both, Dog
Dosage forms
Liquid (Solution), Sterile Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Antisedan® REVERTIDINE™ Cropamezole™ CONTRASED™ Atipamezole Hydrochloride Injection
Dosage forms
Liquid (Solution) Sterile Injectable Solution

Indications / Uses

For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Warnings / Contraindications

For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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.

  • For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, INEFFECTIVE, REVERSAL, Bradycardia, Death, Diarrhoea.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Sterile Injectable Solution

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:

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

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:

  • For intramuscular use only
  • Not recommended for use in pregnant or lactating animals, or animals intended for breeding
  • Atipamezole has not been evaluated in breeding animals
  • wobbly/unsteady walking (1 reports)
  • Death (1 reports)
  • Cough, productive (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 Atipamezole Hydrochloride; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-070810
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 21 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-070810
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 USA-USFDACVM-2025-US-070810
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

Unsteady walking (ataxia) (1 reports), Death (1 reports), Cough, productive (1 reports), Constipation (1 reports), Conjunctivitis (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (2), Neurologic (1), Behavior (3)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (20 reports), Dog (12 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (3), Pug (1), Terrier - Bull - Staffordshire (1), Domestic Mediumhair (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 Atipamezole Hydrochloride 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

For intramuscular use only, Not recommended for use in pregnant or lactating animals, or animals intended for breeding, Atipamezole has not been evaluated in breeding animals, wobbly/unsteady walking, Death

Call sooner if Escalation

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

Bottom line: Use this Atipamezole Hydrochloride 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 USA-USFDACVM-2025-US-070810 · 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: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • For intramuscular use only
  • Not recommended for use in pregnant or lactating animals, or animals intended for breeding
  • Atipamezole has not been evaluated in breeding animals
  • wobbly/unsteady walking
  • Death

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Death (1 reports)
  • Cough, productive (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
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
Form / route / dose
Form: Liquid (Solution), Sterile Injectable Solution
Route: Intramuscular
Confirm product label and patient-specific plan.
Warnings
  • High: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding.…
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 sponsors
Form: Liquid (Solution), Sterile Injectable Solution
Identifiers:
ANADA: 200624 ANADA: 200753 ANADA: 200772 ANADA: 200838 NADA: 141033 NDC Package: 11695-7020-1 NDC Package: 15914-008-01 NDC Package: 43744-021-01 NDC Package: 46066-109-13 NDC Package: 54771-6293-1 NDC Package: 64189-0001-0 NDC Package: 64189-0001-1 NDC Package: 68504-007-01 NDC Package: 69043-039-10 NDC Package: 71052-191-10 NDC Package: 71052-191-25 NDC Package: 71052-191-50 NDC Package: 86101-068-41 NDC Package: 86136-106-31 NDC Package: 86136-115-31
Source metadata:

Warnings / Contraindications

For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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.

  • High: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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.
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
45
Matching reports
4
Active filters
2
Selected filters
Reaction: Abnormal radiograph finding Clear Body system: Neurologic Clear
Reset
Drill into common report signals
Abnormal radiograph finding (7) Death (6) Dilated pupils (6) Lethargy (see also Central nervous system depression in Neurological) (6) Other (43) Neurologic (12) Digestive (11) Effectiveness (9)
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-013278

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.8 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-004494

Received 2026-02-03 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.804 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-075237

Received 2025-12-23 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.08 Kilogram)
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
FeverCough, productiveWeight lossBreathing difficultyAbnormal radiograph findingPulmonary disorder NOSLethargy (see also Central nervous system depression in Neurological)SedationKidney atrophyBilirubinuriaElevated mean corpuscular haemoglobin concentration (MCHC)Enlarged kidney(s)Elevated mean corpuscular volume (MCV)EosinopeniaLow serum alkaline phosphatase (ALP)NeutropeniaDiscoloured urineMonocytosisLymphopeniaElevated amylaseElevated alanine aminotransferase (ALT)Low creatinineHyponatremiaOther abnormal test result NOSElevated total bilirubinHyperglycaemiaLymphocytosisNeutrophiliaLeucocytosis NOSBasophilia
Body systems
OtherNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-070810

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
['Shih Tzu', 'Spitz - German Pomeranian']
Size / weight
Under 10 lb (3.402 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Seizure NOSDeathMedication error NOSNot eatingLeucocytosis NOSPain NOSElevated lactateHyperglycaemiaAbdominal discomfortAbnormal radiograph findingNeutrophiliaMonocytosisElevated triglyceride
Body systems
NeurologicOther
Outcomes
Died

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

Tracked signals
32
Reported cases
32
Serious reports
21
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss at application site, Alopecia local Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (24) · Death, Cough, productive, Corneal ulcer
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (20) Dog (12)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Serious - 1
Digestive Dog Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Digestive Dog Serious - 1
Behavior Cat Non-serious - 1
Other Cat Serious - 1
Behavior Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Behavior Cat Non-serious - 1
Other Cat Serious - 1
Skin & allergy Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog 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.

Atipamezole Hydrochloride Injection SPL · SPL CONTRASED™ SPL · SPL Cropamezole™ SPL · SPL

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

5

FOI

6

Atipamezole Hydrochloride Injection

SPL · SPL

Open original
FDA Structured Product Label

Atipamezole Hydrochloride Injection

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

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-838
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular
Composition / specifications
5.0 mg atipamezole hydrochloride/mL

Dogs

Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer 3,750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

CONTRASED™

SPL · SPL

Open original
FDA Structured Product Label

CONTRASED™

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

Sponsor
Parnell Technologies Pty. Ltd.
ANADA
200-772
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular
Species
Dog
Composition / specifications
5 mg/mL

Dogs

Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine hydrochloride or medetomidine hydrochloride. The atipamezole dose for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride is 3750 mcg/m2. The atipamezole dose for the reversal of IM dexmedetomidine hydrochloride or medetomidine hydrochloride is 5000 mcg/m2.

Cropamezole™

SPL · SPL

Open original
FDA Structured Product Label

Cropamezole™

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

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-753
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular
Species
Dog
Composition / specifications
5 mg/mL

Dogs

Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer 3750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

REVERTIDINE™

SPL · SPL

Open original
FDA Structured Product Label

REVERTIDINE™

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
200-624
Status
RX
Form
Sterile Injectable Solution
Route
Intramuscular
Species
Dog
Composition / specifications
5.0 mg/mL

Dogs

Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

REVERTIDINE™ is administered intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine or medetomidine. The atipamezole dose for the reversal of IV dexmedetomidine or medetomidine is 3750 mcg/m2.

The atipamezole dose for the reversal of IM dexmedetomidine or medetomidine is 5000 mcg/m2.

Limitations

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

Antisedan®

SPL · SPL

Open original
FDA Structured Product Label

Antisedan®

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
141-033
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Dog
Composition / specifications
Each milliliter of sterile injectable solution contains 5.0 milligrams of atipamezole hydrochloride.

Dogs

Indication
For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride.
Dosage
The atipamezole dose for the reversal of intravenous (IV) DEXDOMITOR (dexmedetomidine hydrochloride), or DOMITOR (medetomidine hydrochloride) is 3750 mcg/m2. The atipamezole dose for the reversal of intramuscular (IM) DEXDOMITOR (dexmedetomidine hydrochloride), or DOMITOR (medetomidine hydrochloride) is 5000 mcg/m2.
Limitations
For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOI Summary oA 200-838 Approved February 6, 2026.pdf

FOI · FOI

Open original

FOI Summary oA 200-772 Approved March 1, 2024.pdf

FOI · FOI

Open original

FOI Summary oA 200-753 Approved July 11, 2023.pdf

FOI · FOI

Open original

FOI Summary oA 200-624 Approved July 2, 2018.pdf

FOI · FOI

Open original

ucm116099.pdf

FOI · FOI

Open original

UCM487819.pdf

FOI · FOI

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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Mar 3, 2026, 11:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid (Solution), Sterile Injectable Solution • Intramuscular
Applications: ANADA 200-838 • ANADA 200-772 • ANADA 200-753 • ANADA 200-624 • NADA 141-033
Documents: 6 (FOI: 6) • SPL: 5 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 87 • Cat 126 • View
Case summaries: 45 (showing 8) • View
openFDA reports are unverified and do not prove causation.
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
  • For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Death (1) Cough, productive (1) Constipation (1) Conjunctivitis (1) Cardiac arrest (1) Burn (1) Bruising (1)

Identifiers & Packages

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

Identifiers
ANADA: 200624 ANADA: 200753 ANADA: 200772 ANADA: 200838 NADA: 141033 NDC Package: 11695-7020-1 NDC Package: 15914-008-01 NDC Package: 43744-021-01 NDC Package: 46066-109-13 NDC Package: 54771-6293-1 NDC Package: 64189-0001-0 NDC Package: 64189-0001-1 NDC Package: 68504-007-01 NDC Package: 69043-039-10 NDC Package: 71052-191-10 NDC Package: 71052-191-25 NDC Package: 71052-191-50 NDC Package: 86101-068-41 NDC Package: 86136-106-31 NDC Package: 86136-115-31 NDC Package: 86136-151-31 NDC Package: 86184-006-01 NDC Package: 86197-002-01 NDC Package: 86197-002-02
Package NDC Product NDC Form / Route Status
11695-7020-1 11695 -
15914-008-01 15914 -
43744-021-01 43744 -
46066-109-13 46066 -
54771-6293-1 54771 -
64189-0001-0 64189 -
64189-0001-1 64189 -
68504-007-01 68504 -
69043-039-10 69043 -
71052-191-10 71052 -
71052-191-25 71052 -
71052-191-50 71052 -
86101-068-41 86101 -
86136-106-31 86136 -
86136-115-31 86136 -
86136-151-31 86136 -
86184-006-01 86184 -
86197-002-01 86197 -
86197-002-02 86197 -
86225-019-06 86225 -

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 117 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in b… (Clinical, 2026-04-16)
  • contraindications: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in b… (Clinical, 2026-04-15)
  • contraindications: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in b… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, INEFFECTIVE, REVERSAL, Bradycardia, Death, Diarrhoea. (Clinical, 2026-04-11)
  • usage: For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analges… (Clinical, 2026-04-16)
  • usage: For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analges… (Clinical, 2026-04-15)
  • usage: For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analges… (Clinical, 2026-04-11)
  • contraindications: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in b… (Official, 2026-04-22)
  • contraindications: For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in b… (Official, 2026-02-12)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-06)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-05)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-04)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-03)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-02)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-08-01)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-07-31)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-07-30)
  • indications: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs. An addit… (Official, 2026-07-29)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-17 10:09 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-17 10:09 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-17 10:09 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-17 10:09 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-17 10:09 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-17 10:09 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 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
Atipamezole Hydrochloride Injection
RX
Atipamezole Hydrochloride
Sterile Injectable Solution • Intramuscular
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-838 Approved Mar 2, 2026
CONTRASED™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution • Intramuscular
Label highlights
Official documents
Parnell Technologies Pty. Ltd. ANADA 200-772 Approved Nov 26, 2024
Cropamezole™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution • Intramuscular
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-753 Approved Aug 1, 2023
REVERTIDINE™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution • Intramuscular
Label highlights
Official documents
Modern Veterinary Therapeutics, LLC ANADA 200-624 Approved Aug 2, 2018
Antisedan®
RX
Atipamezole Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Orion Corp. NADA 141-033 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.

Composition / specifications
5.0 mg atipamezole hydrochloride/mL
Dogs
Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer 3,750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
5 mg/mL
Dogs
Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine hydrochloride or medetomidine hydrochloride. The atipamezole dose for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride is 3750 mcg/m2. The atipamezole dose for the reversal of IM dexmedetomidine hydrochloride or medetomidine hydrochloride is 5000 mcg/m2.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
5 mg/mL
Dogs
Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

Administer 3750 mcg/m2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5000 mcg/m2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
5.0 mg/mL
Dogs
Indication

For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Dosage

REVERTIDINE™ is administered intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine or medetomidine. The atipamezole dose for the reversal of IV dexmedetomidine or medetomidine is 3750 mcg/m2.

The atipamezole dose for the reversal of IM dexmedetomidine or medetomidine is 5000 mcg/m2.

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
Each milliliter of sterile injectable solution contains 5.0 milligrams of atipamezole hydrochloride.
Dogs
Indication
For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride.
Dosage
The atipamezole dose for the reversal of intravenous (IV) DEXDOMITOR (dexmedetomidine hydrochloride), or DOMITOR (medetomidine hydrochloride) is 3750 mcg/m2. The atipamezole dose for the reversal of intramuscular (IM) DEXDOMITOR (dexmedetomidine hydrochloride), or DOMITOR (medetomidine hydrochloride) is 5000 mcg/m2.
Limitations
For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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

For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For intramuscular use only. Not recommended for use in pregnant or lactating animals, or animals intended for breeding. Atipamezole has not been evaluated in breeding 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.

Top Reported Reactions (openFDA)

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

Digestive
Loss of appetite (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Cat Alopecia local (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Cat Behavioral disorder (1) • Cat Anxiety (1) • Cat

Showing top 5 for Behavior.

Other
Death (1) • Dog Cough, productive (1) • Cat Corneal ulcer (1) • Dog Constipation (1) • Cat Conjunctivitis (1) • Dog
Show more (19)
Cardiac arrest (1) • Cat Burn (1) • Dog Bruising (1) • Dog Breathing difficulty (1) • Dog Bradycardia (1) • Cat Bilirubinuria (1) • Cat Basophilia (1) • Cat Balance problem (1) • Cat Azotaemia (1) • Cat Asystole (1) • Cat Anisocoria (1) • Cat Agitation (1) • Cat Abnormal urine odour (1) • Dog Abnormal Schirmer tear test (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal pupil light reflex (1) • Cat Abnormal movement NOS (1) • Cat Abnormal cytology (1) • Cat Abdominal discomfort (1) • Dog

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, Pug, Male, 3.75 year, 12.7 kilogram • Drug: MSK, Unknown • Reactions: Neurogenic keratoconjunctivitis sicca, Corneal ulcer, Nasal cavity disorder NOS, Abnormal Schirmer tear test • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014105
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.75 Year
  • Weight: 12.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Neurogenic keratoconjunctivitis sicca Corneal ulcer Nasal cavity disorder NOS Abnormal Schirmer tear test
Outcomes: Ongoing

Dog, Terrier - Bull - Staffordshire, Female, 2 year, 33.611 kilogram • Drug: MSK, Solution, Intramuscular • Reactions: Facial swelling (possible allergy), Hypersensitivity reaction, Vomiting, Bloody diarrhoea, Unsteady walking (ataxia)… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013479
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 33.611 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Solution
Reactions Reported:
Facial swelling (possible allergy) Hypersensitivity reaction Vomiting Bloody diarrhoea Unsteady walking (ataxia) Elevated total bilirubin Elevated alanine aminotransferase Elevated blood urea nitrogen Tiredness (lethargy) Intentional misuse
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 11 year, 5.33 kilogram • Drug: MSK, Unknown • Reactions: Dysphoria, Behavioral disorder (unspecified), Dilated pupils, Loss of appetite, Skin and tissue infection NOS… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-013633
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 5.330 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Dysphoria Behavioral disorder (unspecified) Dilated pupils Loss of appetite Skin and tissue infection NOS Tiredness (lethargy)
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 7 year, 4.354 kilogram • Drug: MSK, Intramuscular • Reactions: Drooling, Reluctant to move, Not eating, Dilated pupils, Not himself/herself… • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-014092
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 4.354 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
Reactions Reported:
Drooling Reluctant to move Not eating Dilated pupils Not himself/herself Hypothermia Tachypnoea Intentional misuse Leukopenia NOS Hypoglycaemia Elevated symmetrical dimethylarginine Azotaemia Low ionized calcium Obtunded Weak pulse Lateral recumbency Regurgitation Cardiac arrest Death
Outcomes: Died

Cat, Domestic Mediumhair, Male, 9 year, 6.8 kilogram • Drug: MSK, Unknown, Dose: 0.15 mL per animal • Reactions: Injection site cyst, Injection site sarcoma, Injection site lump, Injection site discharge NOS, Injection site irritation… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013278
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 6.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.15 mL per animal
Reactions Reported:
Injection site cyst Injection site sarcoma Injection site lump Injection site discharge NOS Injection site irritation Tiredness (lethargy) Elevated symmetrical dimethylarginine Hypoalbuminaemia Thrombocytosis Hyperkalaemia Abnormal radiograph finding Constipation Pain NOS Abnormal cytology Decreased appetite Licking at injection site
Outcomes: Ongoing

Cat, Domestic Longhair, Female, 2 year, 4.17 kilogram • Drug: MSK, Parenteral • Reactions: Not drinking, Oliguria, Neutrophilia, Reluctant to move, Behavioral disorder (unspecified)… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-011407
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 4.170 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Not drinking Oliguria Neutrophilia Reluctant to move Behavioral disorder (unspecified) Not eating Elevated temperature Hypophosphataemia Low creatinine Hypocalcaemia Low blood urea nitrogen
Outcomes: Recovered/Normal

Dog, ['Schnauzer - Miniature', 'Dog (unknown)'], Female, 5 year, 12.701 kilogram • Drug: MSK, Solution, Intravenous, Dose: 0.05 mL per animal • Reactions: Bradycardia, Hypotension, Premature ventricular contractions, Hypoventilation, Heart block NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-010196
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 12.701 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 0.05 mL per animal
Reactions Reported:
Bradycardia Hypotension Premature ventricular contractions Hypoventilation Heart block NOS Lack of efficacy - NOS Intentional misuse
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 13 year, 2.522 kilogram • Drug: MSK, Solution, Intramuscular, Dose: 0.10 mL per animal • Reactions: Death, Intentional misuse • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-009874
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 2.522 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Solution
  • Dose: 0.10 mL per animal
Reactions Reported:
Death Intentional misuse
Outcomes: Died

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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