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Roxee Meds Catalog

Atipamezole Hydrochloride

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
Apr 22, 2026, 10:07 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM 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 May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
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Atipamezole Hydrochloride

Atipamezole Hydrochloride

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

Both Liquid (Solution) Rx required 100% storefront ready

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, No Use Class Stated Or Implied.

Generic name
Atipamezole Hydrochloride
Brand names
Antisedan®, REVERTIDINE™, Cropamezole™, CONTRASED™
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Liquid (Solution), Sterile Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
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, No Use Class Stated Or Implied

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
  • Loss of appetite (1 reports)
  • Elevated lactate (1 reports)
  • Elevated amylase (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?
Major cautions & emergency warning signs

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
  • Loss of appetite
  • Elevated lactate

Most reported reactions:

  • Loss of appetite (1 reports)
  • Elevated lactate (1 reports)
  • Elevated amylase (1 reports)

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

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.

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

Tracked signals
32
Reported cases
32
Serious reports
23
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Decreased appetite Skin & allergy (1) · Hair loss at application site Neurologic (1) · Depression Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Other (25) · Elevated lactate, Elevated blood urea nitrogen, Elevated amylase
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Cat (21) Dog (11)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM 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 May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM 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 42 • Cat 72 • View
Case summaries: 24 (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
Loss of appetite (1) Elevated lactate (1) Elevated amylase (1) Dysphoria (1) Drooling (1) Discoloured urine (1) Dilated pupils (1) Decreased heart rate (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 25 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, 2026-05-05)
  • 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, 2026-05-03)
  • 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, 2026-05-02)
  • 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, 2026-04-29)
  • 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, 2026-04-28)
  • 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, 2026-04-27)
  • 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, 2026-04-26)
  • 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, 2026-04-25)
  • 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, 2026-04-22)
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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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, No Use Class Stated Or Implied
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) • Cat Drooling (1) • Dog Decreased appetite (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Depression (1) • Cat

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Elevated lactate (1) • Dog Elevated blood urea nitrogen (1) • Cat Elevated amylase (1) • Cat Elevated alanine aminotransferase (1) • Cat Dysphoria (1) • Cat
Show more (20)
Discoloured urine (1) • Cat Dilated pupils (1) • Cat Decreased pulse oxygenation (1) • Cat Decreased heart rate (1) • Dog Decreased drinking (1) • Dog Decreased body temperature (1) • Cat Death by euthanasia (1) • Cat Death (1) • Cat Cough, productive (1) • Cat Conjunctivitis (1) • Dog Cardiac arrest (1) • Cat Burn (1) • Dog Bruising (1) • Dog Breathing difficulty (1) • Dog Bilirubinuria (1) • Cat Basophilia (1) • Cat Asystole (1) • Cat Agitation (1) • Cat Abnormal radiograph finding (1) • Dog 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.

Cat, Domestic Shorthair, Female, 7 month, 3.08 kilogram • Drug: MSK, Unknown • Reactions: Fever, Cough, productive, Weight loss, Breathing difficulty, Abnormal radiograph finding… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075237
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Month
  • Weight: 3.080 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Fever Cough, productive Weight loss Breathing difficulty Abnormal radiograph finding Pulmonary disorder NOS Tiredness (lethargy) Sedation Kidney atrophy Bilirubinuria Elevated mean corpuscular haemoglobin concentration Enlarged kidney Elevated mean corpuscular volume Eosinopenia Low serum alkaline phosphatase Neutropenia Discoloured urine Monocytosis Lymphopenia Elevated amylase Elevated alanine aminotransferase Low creatinine Hyponatremia Other abnormal test result NOS Elevated total bilirubin Hyperglycaemia Lymphocytosis Neutrophilia Leucocytosis NOS Basophilia
Outcomes: Recovered/Normal

Dog, Terrier - Bull - American Pit, Male, 7 year, 37 kilogram • Drug: MSK, Solution, Intramuscular, Dose: 0.40 mL per animal • Reactions: Loose stool, Vomiting, Decreased appetite, Decreased drinking, Medication error NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073901
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 37.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Solution
  • Dose: 0.40 mL per animal
Reactions Reported:
Loose stool Vomiting Decreased appetite Decreased drinking Medication error NOS Lack of efficacy - NOS
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 6 month, 3.084 kilogram • Drug: MSK, Unknown, Dose: 0.04 mL per animal • Reactions: Elevated temperature, Breathing difficulty, Quiet • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074179
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Month
  • Weight: 3.084 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.04 mL per animal
Reactions Reported:
Elevated temperature Breathing difficulty Quiet
Outcomes: Ongoing

Cat, Maine Coon, Male, 13 year, 6.58 kilogram • Drug: MSK, Unknown • Reactions: Twitching, Focal seizure, Death, Tiredness (lethargy) • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074994
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 6.580 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Twitching Focal seizure Death Tiredness (lethargy)
Outcomes: Died

Dog, Bulldog - French, Female, 11 year, 12.066 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.12 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Swollen limb, Wound, Local erythema, Bruising • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074617
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 12.066 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.12 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy Swollen limb Wound Local erythema Bruising
Outcomes: Outcome Unknown

Dog, Terrier - Bull - American Pit, Male, 2 year, 28.395 kilogram • Drug: MSK, Solution, Unknown, Dose: 0.30 mL per animal • Reactions: Localised rash, Warm feeling to the touch • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073898
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 28.395 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
  • Dose: 0.30 mL per animal
Reactions Reported:
Localised rash Warm feeling to the touch
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 9 year, 5.81 kilogram • Drug: MSK, Unknown, Dose: 5 Milligram per animal • Reactions: Hair loss at application site • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-072426
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 5.810 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 5 Milligram per animal
Reactions Reported:
Hair loss at application site
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 8 month, 3.175 kilogram • Drug: MSK, Solution, Intramuscular, Dose: 0.12 mL per animal • Reactions: Faint heart sound, Cardiac arrest, Intentional misuse, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-072148
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Month
  • Weight: 3.175 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Solution
  • Dose: 0.12 mL per animal
Reactions Reported:
Faint heart sound Cardiac arrest Intentional misuse Death
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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