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Alfaxalone

Detailed information about Alfaxalone

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

Induction of general anesthesia.

What to watch for:

  • Administer by intravenous injection only
  • When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available
  • trouble breathing (1 reports)
  • very low energy (1 reports)
  • Stomatitis (1 reports)

When to call the vet:

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

Regulatory restrictions are shown in Vet View.

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?
Safety & side effects

What to watch:

  • Administer by intravenous injection only
  • When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available
  • trouble breathing
  • very low energy
  • Stomatitis

Most reported reactions:

  • Trouble breathing (dyspnea) (1 reports)
  • Tiredness (lethargy) (1 reports)
  • Stomatitis (1 reports)

When to call your vet:

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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 15, 2026, 10:05 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Image coming soon
Alfaxalone

Alfaxalone

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: Injectable Solution
Identifiers:
NADA: 141342 NDC Package: 49480-003-01 NDC Package: 49480-003-02 NDC Package: 54771-6696-1 NDC Package: 54771-6696-2 NDC Package: 54771-6698-1 NDC Package: 54771-6698-2 NDC Product: 49480 NDC Product: 54771
Source metadata:

Warnings / Contraindications

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

  • High: Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
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
25
Species represented
2
Grouped by Body System
Digestive (3) · Nausea, Loss of appetite, Haemorrhagic diarrhoea Neurologic (2) · Tiredness (lethargy), Convulsion Behavior (1) · Behavioral disorder (unspecified) Other (26) · Trouble breathing (dyspnea), Tachycardia, Stomatitis
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (27) Dog (5)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (1)
  • Alfaxan® Multidose · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2239/Alfaxan%C2%AE%20Multidose
FOI (3)
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 15, 2026, 10:05 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Alfaxan® Multidose
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Injectable Solution • Intravenous
Applications: NADA 141-342
Documents: 3 (FOI: 3) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 18 • Cat 21 • View
Case summaries: 10 (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
  • Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. (Contraindication, High)
Top reaction signals
Trouble breathing (dyspnea) (1) Tiredness (lethargy) (1) Stomatitis (1) Regurgitation (1) Prolonged one stage prothrombin time (1) Prolonged activated partial thrombin time (1) Polyuria (1) Neutrophilia (1)

Identifiers & Packages

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

Identifiers
NADA: 141342 NDC Package: 49480-003-01 NDC Package: 49480-003-02 NDC Package: 54771-6696-1 NDC Package: 54771-6696-2 NDC Package: 54771-6698-1 NDC Package: 54771-6698-2 NDC Product: 49480 NDC Product: 54771
Package NDC Product NDC Form / Route Status
49480-003-01 49480 -
49480-003-02 49480 -
54771-6696-1 54771 -
54771-6696-2 54771 -
54771-6698-1 54771 -
54771-6698-2 54771 -

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 6 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients sh… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Death, Tachycardia, Cardiac arrest, Vocalisation, Vomiting, Paddling. (Official, 2026-02-12)
  • usage: Induction of general anesthesia. For induction of anesthesia followed by maintenance with an inhalant anesthetic Maintenance of general anesthesia following in… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Alfaxan® Multidose
RX
Alfaxalone
Injectable Solution • Intravenous
Label highlights
Official documents
Zoetis Inc. NADA 141-342 Approved Feb 16, 2024

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 10 milligrams (mg) alfaxalone.
Cats
Indication
Induction of general anesthesia.
Dosage
Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Indication
For induction of anesthesia followed by maintenance with an inhalant anesthetic
Dosage
Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Indication
Maintenance of general anesthesia following induction
Dosage
Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Dogs
Indication
Maintenance of general anesthesia following induction
Dosage
Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Indication
Induction of general anesthesia
Dosage
Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Indication
For induction of anesthesia followed by maintenance with an inhalant anesthetic
Dosage
Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.
Limitations
Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    This supplement provides for the addition of preservatives to the formulation and use of a multidose vial.

  • Summary
    This supplement provides for the approval of the revised labeling components to reflect the placement of alfaxalone into Schedule IV controlled substance classification..
  • Summary
    For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Induction of general anesthesia. For induction of anesthesia followed by maintenance with an inhalant anesthetic Maintenance of general anesthesia following induction

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Top Reported Reactions (openFDA)

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

Digestive
Nausea (1) • Cat Loss of appetite (1) • Cat Haemorrhagic diarrhoea (1) • Cat

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Cat Convulsion (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Dog Tachycardia (1) • Dog Stomatitis (1) • Cat Regurgitation (1) • Dog Prolonged one stage prothrombin time (1) • Cat
Show more (21)
Prolonged activated partial thrombin time (1) • Cat Polyuria (1) • Cat Neutrophilia (1) • Cat Lip disorder NOS (1) • Cat Intestinal stasis (1) • Cat Inappropriate defecation (1) • Cat Hypotension (1) • Dog Hyperthermia (1) • Cat Hiding (1) • Cat Haematemesis (1) • Cat Fever (1) • Cat Erythema (1) • Cat Elevated thyroxine (1) • Cat Desquamation (1) • Cat Dehydration (1) • Cat Death (1) • Cat Crust (1) • Cat Cardiac arrest (1) • Cat Anaemia NOS (1) • Cat Administration error NOS (1) • Cat Adipsia (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 13 year, 6.804 kilogram • Drug: MSK, Injection, Intramuscular, Dose: 0.40 Microgram per kilogram • Reactions: Nausea, Prolonged one stage prothrombin time, Prolonged activated partial thrombin time, Cardiac arrest, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-055853
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
  • Dose: 0.40 Microgram per kilogram
Reactions Reported:
Nausea Prolonged one stage prothrombin time Prolonged activated partial thrombin time Cardiac arrest Death
Outcomes: Died

Cat, Mixed (Cat), Mixed, 11 year • Drug: MSK, Intravenous, Dose: 0.50 Milligram per kilogram • Reactions: Ulceration NOS, Inappropriate defecation, Crust, Desquamation, Erythema… • Outcome: Recovered/Normal, Died, Outcome Unknown

  • Report ID: AUS-USFDACVM-2025-AU-000005
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Mixed
  • Age: 11.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Dose: 0.50 Milligram per kilogram
Reactions Reported:
Ulceration NOS Inappropriate defecation Crust Desquamation Erythema Death Tiredness (lethargy) Loss of appetite
Outcomes: Recovered/Normal, Died, Outcome Unknown

Dog, ['Chihuahua', 'Mixed (Dog)'], Female, 9 year, 5.534 kilogram • Drug: MSK, Solution, Intravenous, Dose: 1 mL per animal • Reactions: Tachycardia, Hypotension • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055949
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 5.534 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 1 mL per animal
Reactions Reported:
Tachycardia Hypotension
Outcomes: Recovered/Normal

Dog, Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog), Female, 6 year, 17.3 kilogram • Drug: MSK, Solution, Intravenous, Dose: 2 mL per animal • Reactions: Twitching, Convulsion • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-053470
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 17.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 2 mL per animal
Reactions Reported:
Twitching Convulsion
Outcomes: Recovered/Normal

Dog, ['Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)', 'Dog (unknown)'], Male, 12 year, 22.8 kilogram • Drug: MSK, Solution, Intravenous, Dose: 4.30 mL per animal • Reactions: Twitching, Convulsion • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-053259
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 22.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 4.30 mL per animal
Reactions Reported:
Twitching Convulsion
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 15 year • Drug: MSK, Unknown • Reactions: Inappropriate defecation, Hyperthermia, Dehydration, Weight loss, Adipsia… • Outcome: Ongoing

  • Report ID: GBR-USFDACVM-2025-GB-000057
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 15.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Inappropriate defecation Hyperthermia Dehydration Weight loss Adipsia Loss of appetite Polyuria Urine abnormalities NOS Elevated thyroxine Neutrophilia Anaemia NOS Nausea Stomatitis Lip disorder NOS Haemorrhagic diarrhoea Haematemesis
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Unknown • Reactions: Regurgitation • Outcome: Outcome Unknown

  • Report ID: GBR-USFDACVM-2025-GB-000058
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Regurgitation
Outcomes: Outcome Unknown

Dog, Dog (unknown), Unknown • Drug: MSK, Unknown • Reactions: Regurgitation, Death, Trouble breathing (dyspnea) • Outcome: Died

  • Report ID: GBR-USFDACVM-2025-GB-000059
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Regurgitation Death Trouble breathing (dyspnea)
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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