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Roxee Medication Guide

Alfaxalone

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 Injectable Solution Zoetis Inc. Official label facts Owner quick guide first
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Data freshness

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

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

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

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

Safety reports
Safety data refreshed
Jun 20, 2026, 8:54 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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Alfaxalone

Alfaxalone

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

Both Injectable Solution Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Alfaxalone

Induction of general anesthesia. For induction of anesthesia followed by maintenance with an inhalant anesthetic Maintenance of general anesthesia following induction Species commonly shown: Both, Dog, Cat.

Generic name
Alfaxalone
Brand names
Alfaxan® Multidose, ALFAXAN MULTIDOSE
Manufacturer
Zoetis Inc.
Species
Both, Dog, Cat
Dosage forms
Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Alfaxan® Multidose ALFAXAN MULTIDOSE
Dosage forms
Injectable Solution

Indications / Uses

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

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.

  • 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.

Side Effects

Top reported reactions (openFDA): Death, Tachycardia, Cardiac arrest, Vocalisation, Vomiting, Paddling.

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

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:

Induction of general anesthesia.

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:

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

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • 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 Alfaxalone; 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; 26 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), Trouble breathing (dyspnea) (1 reports), Loss of appetite (1 reports), Elevated triglyceride (1 reports), Elevated thyroxine (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (22 reports), Dog (10 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (2), ['Shih Tzu', 'Spitz - German Pomeranian'] (2), Persian (1), Cat (unknown) (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Alfaxalone 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

Administer by intravenous injection only, When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of, wobbly/unsteady walking, trouble breathing, Loss of appetite

Call sooner if Escalation

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

Bottom line: Use this Alfaxalone 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. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. FOI · document · documents
  7. FOI · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • 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
  • wobbly/unsteady walking
  • trouble breathing
  • Loss of appetite

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Trouble breathing (dyspnea) (1 reports)
  • Loss of appetite (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
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
Cat, Dog
Indication / use
Induction of general anesthesia.
Form / route / dose
Form: Injectable Solution
Route: Intravenous
Confirm product label and patient-specific plan.
Warnings
  • High: Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veter…
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: Zoetis Inc.
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.

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
11
Matching reports
0
Active filters
2
Selected filters
Reaction: Death Clear Body system: Behavior Clear
Reset
Drill into common report signals
Death (3) Not eating (3) Apnoea (2) Seizure NOS (2) Other (10) Neurologic (3) Behavior (2) Digestive (2)
No stored openFDA reports match the selected 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.

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

Tracked signals
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (1) · Loss of appetite Skin & allergy (1) · Hair loss at application site Neurologic (2) · Unsteady walking (ataxia), Convulsion Behavior (3) · Circling - behavioural disorder, Behavioral disorder (unspecified), Aggression Other (25) · Trouble breathing (dyspnea), Elevated triglyceride, Elevated thyroxine
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Dog 1
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (22) Dog (10)

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

Alfaxan® Multidose SPL · SPL ALFAXAN MULTIDOSE SPL SPL · Structured Product Label FOI Summary sN 141-342 Approved June 6, 2018 .pdf FOI · FOI

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

2

FOI

3

Alfaxan® Multidose

SPL · SPL

Open original
FDA Structured Product Label

Alfaxan® Multidose

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

Sponsor
Zoetis Inc.
NADA
141-342
Status
RX
Form
Injectable Solution
Route
Intravenous
Species
Dog • Cat
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.

ALFAXAN MULTIDOSE SPL

SPL · Structured Product Label

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

FOI Summary sN 141-342 Approved June 6, 2018 .pdf

FOI · FOI

Open original

UCM417729.pdf

FOI · FOI

Open original

UCM326904.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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: ALFAXAN MULTIDOSE
Manufacturer mapping: Zoetis Inc.
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
NDC: Packages 54771-6696-1 54771-6696-2 • Products 54771
Documents: 3 (FOI: 3) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 25 • Cat 29 • View
Case summaries: 11 (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
Unsteady walking (ataxia) (1) Trouble breathing (dyspnea) (1) Loss of appetite (1) Elevated triglyceride (1) Elevated thyroxine (1) Elevated lactate (1) Elevated creatinine (1) Desquamation (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.

  • ALFAXAN MULTIDOSE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM326904.pdf • FOI summary • Official • April 29, 2026
    FDA FOI summary for application 141342
  • UCM417729.pdf • FOI summary • Official • April 29, 2026
    FDA FOI summary for application 141342
  • FOI Summary sN 141-342 Approved June 6, 2018 .pdf • FOI summary • Official • April 29, 2026
    FDA FOI summary for application 141342

Data Sources & Change Log

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

Official 121 Clinical 3 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-14)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-12)
  • side_effects: Top reported reactions (openFDA): Death, Tachycardia, Cardiac arrest, Vocalisation, Vomiting, Paddling. (Clinical, 2026-04-11)
  • 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, 2026-04-12)
  • 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, 2026-04-12)
  • 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, 2026-04-11)
  • 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)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-22)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-22)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-21)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-20)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-13)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-12)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-12)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-11)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-11)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-10)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-09)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-08)
  • manufacturer_name: Zoetis Inc. (Official, 2026-06-07)
Recent Revisions
  • monitoring updated 2026-04-14 05:16 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-14 05:16 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-14 05:16 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-14 05:16 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-14 05:16 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-14 05:16 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-12 22:03 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 22:03 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 22:03 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-12 22:03 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-12 22:03 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-12 22:03 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-12 22:03 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-12 22:03 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-12 22:03 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields

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 Apr 29, 2026

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 • Cat
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

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
Loss of appetite (1) • Cat

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Convulsion (1) • Dog

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Cat Behavioral disorder (1) • Cat Aggression (1) • Cat

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Dog Elevated triglyceride (1) • Dog Elevated thyroxine (1) • Cat Elevated lactate (1) • Dog Elevated creatinine (1) • Cat
Show more (20)
Dilated pupils (1) • Cat Desquamation (1) • Cat Dehydration (1) • Cat Defect Unknown/Not Specified (1) • Cat Decreased haematocrit (1) • Cat Death (1) • Cat Cyanosis (1) • Dog Crust (1) • Cat Cardiac enlargement (1) • Cat Cardiac arrest (1) • Cat Bladder distension (1) • Cat Application site dry skin (1) • Dog Apnoea (1) • Dog Angioedema (1) • Dog Anaemia NOS (1) • Cat Administration error NOS (1) • Cat Adipsia (1) • Cat Abnormal ultrasound finding (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, 4 month, 2.4 kilogram • Drug: MSK, Parenteral • Reactions: Head shake - behavioural disorder, Unable to walk, Not drinking, Not eating, Unsteady walking (ataxia)… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074782
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Month
  • Weight: 2.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Head shake - behavioural disorder Unable to walk Not drinking Not eating Unsteady walking (ataxia) Circling - behavioural disorder Unsteady gait
Outcomes: Ongoing

Cat, Persian, Male, 10.83 year, 4.67 kilogram • Drug: MSK, Unknown • Reactions: Hair loss at application site, Defect Unknown/Not Specified • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074803
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.83 Year
  • Weight: 4.670 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Hair loss at application site Defect Unknown/Not Specified
Outcomes: Ongoing

Cat, Cat (unknown), Unknown • Drug: MSK, Unknown • Reactions: Aggression, Dilated pupils, Staring • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073972
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Aggression Dilated pupils Staring
Outcomes: Outcome Unknown

Dog, Bulldog - French, Female, 8 year, 12.927 kilogram • Drug: MSK, Solution, Intravenous, Dose: 2.59 mL per animal • Reactions: Tachycardia, Apnoea, Cyanosis, Cardiac arrest, Death… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-073109
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 12.927 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 2.59 mL per animal
Reactions Reported:
Tachycardia Apnoea Cyanosis Cardiac arrest Death Angioedema
Outcomes: Died

Dog, Dachshund (unspecified), Female, 12 year, 4.536 kilogram • Drug: MSK, Solution, Intravenous, Dose: 0.65 mL per animal • Reactions: Apnoea • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072789
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Dose: 0.65 mL per animal
Reactions Reported:
Apnoea
Outcomes: Ongoing

Dog, ['Shih Tzu', 'Spitz - German Pomeranian'], Female, 8 year, 3.4 kilogram • Drug: MSK, Unknown, Dose: 0.68 mL per animal • Reactions: Seizure NOS, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-072468
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 3.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.68 mL per animal
Reactions Reported:
Seizure NOS Death
Outcomes: Died

Dog, ['Shih Tzu', 'Spitz - German Pomeranian'], Female, 8 year, 3.402 kilogram • Drug: MSK, Unknown, Dose: 0.68 mL per animal • Reactions: Seizure NOS, Death, Medication error NOS, Not eating, Leucocytosis NOS… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-070810
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 3.402 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.68 mL per animal
Reactions Reported:
Seizure NOS Death Medication error NOS Not eating Leucocytosis NOS Pain NOS Elevated lactate Hyperglycaemia Abdominal discomfort Abnormal radiograph finding Neutrophilia Monocytosis Elevated triglyceride
Outcomes: Died

Cat, Domestic Shorthair, Male, 13 year, 6.2 kilogram • Drug: MSK, Solution, Intramuscular, Dose: 1.30 mL per animal • Reactions: Not eating, Vomiting, Cardiac enlargement, Splenomegaly, Abnormal ultrasound finding… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-069596
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 6.200 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Solution
  • Dose: 1.30 mL per animal
Reactions Reported:
Not eating Vomiting Cardiac enlargement Splenomegaly Abnormal ultrasound finding Haematuria Pyuria Non-regenerative anaemia Decreased haematocrit Hypokalaemia Bladder distension Dehydration Elevated creatinine Not urinating Intentional misuse Urinary tract disorder NOS
Outcomes: Ongoing

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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