Meds A-Z
Atipamezole
Detailed information about Atipamezole
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
What it does:
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...
When it's needed:
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...
Call your vet sooner if you notice:
- 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.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Atipamezole
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200772 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200753 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (24) Cat (8)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-053925
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 9 • Secondary summaries: 0
- FOI Summary oA 200-772 Approved March 1, 2024.pdf · FOI
- CONTRASED™ · SPL
- FOI Summary oA 200-753 Approved July 11, 2023.pdf · FOI
- Cropamezole™ · SPL
- FOI Summary oA 200-624 Approved July 2, 2018.pdf · FOI
- REVERTIDINE™ · SPL
- ucm116099.pdf · FOI
- UCM487819.pdf · FOI
- Antisedan® · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15091 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/15345/CONTRASED%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14244 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/14481/Cropamezole%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3881 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/3416/REVERTIDINE%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/563 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/562 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1833/Antisedan%C2%AE · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
At a Glance
Quick facts and links to official labeling and safety signals.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
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.
- 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)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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 | - | |
| 71052-192-10 | 71052 | - | |
| 71052-192-25 | 71052 | - | |
| 71052-192-50 | 71052 | - | |
| 86136-106-31 | 86136 | - | |
| 86136-115-31 | 86136 | - | |
| 86197-002-01 | 86197 | - | |
| 86197-002-02 | 86197 | - | |
| 86197-003-01 | 86197 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-772 Approved March 1, 2024.pdf
• FOI summary • Official
• Nov. 26, 2024
FDA FOI summary for application 200772
-
FOI Summary oA 200-753 Approved July 11, 2023.pdf
• FOI summary • Official
• Aug. 1, 2023
FDA FOI summary for application 200753
-
FOI Summary oA 200-624 Approved July 2, 2018.pdf
• FOI summary • Official
• Aug. 2, 2018
FDA FOI summary for application 200624
-
UCM487819.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141033
-
ucm116099.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141033
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Injection site swelling, Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in… (Official, 2026-02-12)
- usage: For reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride or medetomidine hydrochloride. For the reversal of the sedative and analges… (Official, 2026-02-12)
- 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 |
|---|---|---|---|---|
|
CONTRASED™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Parnell Technologies Pty. Ltd. | ANADA 200-772 | Approved | Nov 26, 2024 |
|
Cropamezole™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-753 | Approved | Aug 1, 2023 |
|
REVERTIDINE™
RX
Atipamezole Hydrochloride
Sterile Injectable Solution
• Intramuscular
|
Modern Veterinary Therapeutics, LLC | ANADA 200-624 | Approved | Aug 2, 2018 |
|
Antisedan®
RX
Atipamezole Hydrochloride
Liquid (Solution)
• Intramuscular
|
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
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
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.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
- CONTRASED™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
- Cropamezole™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
- REVERTIDINE™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm116099.pdf
Summary
An additional indication for the reversal of the sedative and analgesic effects of DEXDOMITOR (dexmedetomidine hydrochloride). -
FOI UCM487819.pdf
Summary
ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs.
- Antisedan® (ZIP)
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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 56 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, Male, 5 year, 8.61 kilogram • Drug: MSK, Unknown • Reactions: Hyperthermia, Hyperactivity • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055972
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 5.00 Year
- Weight: 8.610 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Cat (unknown), Female, 4.05 kilogram • Drug: MSK, Unknown, Dose: 0.16 Milligram per kilogram • Reactions: Hyperglycaemia • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-054116
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Weight: 4.050 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Dose: 0.16 Milligram per kilogram
Dog, ['Crossbred Canine/dog', 'Retriever - Labrador', 'Poodle - Medium size'], Female, 3 year, 12.338 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy - NOS, Rubbing, Application site pain • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-056018
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 3.00 Year
- Weight: 12.338 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Domestic Shorthair, Male, 20 week, 3 kilogram • Drug: MSK, Unknown, Dose: 0.05 mL per animal • Reactions: Dysphoria, Sedation, Decreased blood urea nitrogen (BUN) or creatinine, Intentional misuse • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-053968
- Serious AE: Yes
- Treated For AE: No
- Sex: Male
- Age: 20.00 Week
- Weight: 3.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Dose: 0.05 mL per animal
Dog, Bulldog - French, Female, 10 year, 15.876 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.10 mL per dose, Frequency: 1 per day • Reactions: Vomiting, Regurgitation, Not eating, Tiredness (lethargy), Not urinating… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-053925
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 10.00 Year
- Weight: 15.876 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intramuscular
- Form: Injection
- Dose: 0.10 mL per dose
- Frequency: 1 per day
Cat, Domestic Shorthair, Female, 6 month, 3.45 kilogram • Drug: MSK, Intramuscular, Dose: 0.07 mL per animal • Reactions: Application site hair loss, Pyoderma • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-051014
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 6.00 Month
- Weight: 3.450 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intramuscular
- Dose: 0.07 mL per animal
Cat, Domestic Shorthair, Female, 11.5 year, 4 kilogram • Drug: MSK, Intramuscular, Dose: 0.10 mL per animal • Reactions: Hyperactivity, Restlessness, Pacing, Not eating, Mydriasis… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-049844
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 11.50 Year
- Weight: 4.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intramuscular
- Dose: 0.10 mL per animal
Dog, Dog (other), Male, 8 year, 7.711 kilogram • Drug: MSK, Solution, Unknown, Frequency: 1 per day • Reactions: Overdose, Tarry or black stool, Oral bleeding, Haematemesis, Dehiscence… • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-052403
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 8.00 Year
- Weight: 7.711 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
- Frequency: 1 per day
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.
Share Your Thoughts
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.