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Roxee Medication Guide

Butorphanol Tartrate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

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

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

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

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

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Butorphanol Tartrate

Butorphanol Tartrate

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

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Butorphanol Tartrate

For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures. Species commonly shown: Both, Cat, Horse, Not For Meat Production.

Generic name
Butorphanol Tartrate
Brand names
Torbugesic-SA®, Dolorex®, Torphadine®, Butorphic™ Injection
Manufacturer
Multiple FDA sponsors
Species
Both, Cat, Horse
Dosage forms
Liquid (Solution)
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Torbugesic-SA® Dolorex® Torphadine® Butorphic™ Injection Butorphanol Tartrate Injection Butorphine™
Dosage forms
Liquid (Solution)

Indications / Uses

For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

Warnings / Contraindications

Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Death, Diarrhoea, Bradycardia, Injection site swelling.

FAQ

Both, Cat, Horse, Not For Meat Production, Horse

Yes. Roxee shows this as prescription-only.

Liquid (Solution)

Related Conditions

Pain (acute, chronic) Trauma (HBC, falls, bite wounds) Cough (acute/chronic) Tracheitis (non-kennel cough)

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 relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures

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:

  • Repeat at intervals of 6 to 12 hours as required
  • If necessary, increase dose to maximum of 0.05 milligram per pound of body weight
  • Treatment should not normally be required for longer than 7 days
  • For oral use in dogs only
  • If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight
  • Dose may be repeated within 3 to 4 hours
  • Treatment should not exceed 48 hours
  • Not for use in horses intended for food
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Biting -aggression (1 reports)

When to call the vet:

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

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Butorphanol Tartrate; use the official documents and your veterinarian's instructions for product-specific decisions.

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

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

Source: openFDA case USA-USFDACVM-2025-US-070810
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-070810
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Biting -aggression (1 reports), Behavioral disorder (unspecified) (1 reports), Basophilia (1 reports)

Body systems represented Signal grouping

Digestive (1), Skin & allergy (4), Neurologic (1), Behavior (3)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (16 reports), Cat (16 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (3), Pug (1), Ragdoll (1), Terrier - Bull - Staffordshire (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 Butorphanol Tartrate 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

Repeat at intervals of 6 to 12 hours as required, If necessary, increase dose to maximum of 0.05 milligram per pound of body weight, Treatment should not normally be required for longer than 7 days, For oral use in dogs only, If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight

Call sooner if Escalation

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

Bottom line: Use this Butorphanol Tartrate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-070810 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • Repeat at intervals of 6 to 12 hours as required
  • If necessary, increase dose to maximum of 0.05 milligram per pound of body weight
  • Treatment should not normally be required for longer than 7 days
  • For oral use in dogs only
  • If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Biting -aggression (1 reports)
Explore reported case details

Emergency warning signs:

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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Cat, Horse
Indication / use
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures
Form / route / dose
Form: Liquid (Solution)
Route: Intravenous, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
  • High: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Liquid (Solution)
Identifiers:
ANADA: 200239 ANADA: 200322 ANADA: 200332 ANADA: 200408 ANADA: 200446 NADA: 102990 NADA: 103390 NADA: 135780 NADA: 141047 NDC Package: 11695-7044-1 NDC Package: 11695-7044-2 NDC Package: 17033-097-01 NDC Package: 17033-097-05 NDC Package: 54771-2033-1 NDC Package: 54771-2033-2 NDC Package: 57926-722-66 NDC Package: 69043-064-02 NDC Package: 69043-064-05 NDC Package: 73377-107-01 NDC Package: 86136-137-31
Source metadata:

Warnings / Contraindications

Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
85
Matching reports
85
Active filters
0
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (12) Intentional misuse (11) Not eating (9) Abnormal radiograph finding (8) Other (79) Neurologic (28) Digestive (19) Skin & allergy (17)
Showing up to 50 matching reports. Narrow filters to inspect the remaining reports.

USA-USFDACVM-2026-US-014624

Received 2026-03-26 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5 Kilogram)
Age
Under 1 year (1 Month)
Sex
Male Intact
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014454

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
Facial pruritusMedication error NOS
Body systems
Skin & allergyOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014105

Received 2026-03-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Pug
Size / weight
25-49 lb (12.7 Kilogram)
Age
1-3 years (3.75 Year)
Sex
Male Neutered
Region
USA
Reactions
Neurogenic keratoconjunctivitis sicca (KCS)Corneal ulcerNasal cavity disorder NOSAbnormal Schirmer tear test
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014107

Received 2026-03-24 · MSK · MSK

Non-serious
Species
Cat
Breed
Ragdoll
Size / weight
10-24 lb (5.498 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Head tilt - neurological disorder (see also Head tilt - ear disorder)Ataxia
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013479

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (33.611 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Unknown
Region
USA
Reactions
Facial swelling (see also Skin)Hypersensitivity reactionEmesis (multiple)Bloody diarrhoeaAtaxiaElevated total bilirubinElevated alanine aminotransferase (ALT)Elevated blood urea nitrogen (BUN)Lethargy (see also Central nervous system depression in Neurological)Intentional misuse
Body systems
Skin & allergyOtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-012798

Received 2026-03-20 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (14.969 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
VocalisationRestlessnessIntentional misuse
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014481

Received 2026-03-19 · MSK · MSK

Serious
Species
Dog
Breed
Poodle - Standard
Size / weight
25-49 lb (18.552 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
DroolingNauseaInjection site swelling
Body systems
DigestiveSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-013633

Received 2026-03-19 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.33 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
DysphoriaBehavioural disorder NOSDilated pupilsAnorexiaSkin and tissue infection NOSLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherBehaviorDigestiveNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013262

Received 2026-03-19 · MSK · MSK

Serious
Species
Cat
Breed
Persian
Size / weight
Under 10 lb (4.08 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Laboured breathingAnorexia
Body systems
OtherDigestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013265

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Corso Dog
Size / weight
50-99 lb (42.184 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Not eatingFeverInjection site lumpApplication site serous discharge
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012648

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Maine Coon
Size / weight
10-24 lb (8.591 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
OpisthotonusHorizontal nystagmusProlonged anaesthesiaIntentional misuse
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012640

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
Chihuahua
Size / weight
Under 10 lb (2.54 Kilogram)
Age
8+ years (8.25 Year)
Sex
Female Unknown
Region
USA
Reactions
Muscle tremorOpisthotonusRigidity of limbsStar-gazingProlonged anaesthesiaIntentional misuse
Body systems
NeurologicOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012565

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Cat
Breed
['Siberian', 'Crossbred Feline/cat']
Size / weight
10-24 lb (4.85 Kilogram)
Age
4-7 years (4.83 Year)
Sex
Female Neutered
Region
USA
Reactions
Application site discharge NOSApplication site reddeningApplication site hair lossApplication site lesion
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-011535

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (4.037 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Horizontal nystagmusOpisthotonusMuscle stiffnessSeizure NOSIntentional misuse
Body systems
OtherNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014083

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
American Pit Bull Terrier
Size / weight
50-99 lb (26.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Cardiac arrestDeath
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-014082

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.4 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Neutered
Region
USA
Reactions
Cardiac arrestDeath by euthanasiaNeurological symptoms NOS
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-014081

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)
Size / weight
50-99 lb (23.2 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Sudden death
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-013584

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (15.876 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
ItchingLicking
Body systems
Skin & allergyOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-011996

Received 2026-03-13 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (29.937 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site painAnorexiaFeverInjection site swellingInjection site abscessLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherDigestiveSkin & allergyNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-009874

Received 2026-03-05 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.522 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
DeathIntentional misuse
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-012200

Received 2026-03-04 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (33.566 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Intact
Region
USA
Reactions
FeverPantingElevated temperature
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-009973

Received 2026-02-27 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (34.019 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingWalking difficultyPantingSeizure NOSDeathIntentional misuse
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-010730

Received 2026-02-25 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
50-99 lb (25.265 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
SpondylosisGait abnormalityHead tilt - neurological disorder (see also Head tilt - ear disorder)Balance problemHorizontal nystagmusPacingStrokeDeath by euthanasiaBrain tumourUnable to walk
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-010994

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.874 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
Blood clotIntentional misuse
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-009390

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (30.617 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
Swollen limbInjection site inflammationLack of efficacy (neoplasia, no remission)
Body systems
OtherEffectiveness
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008346

Received 2026-02-23 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
MonocytosisLow creatinineGait abnormalityMuscle atrophy (see also Muscle wasting)Unkempt hair coatPlantigrade postureSedationGreasy skin
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-007819

Received 2026-02-19 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd (unspecified)
Size / weight
50-99 lb (28.576 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Bloody diarrhoeaVomitingDehydrationIncreased packed cell volume (PCV)DiarrhoeaWeight loss
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-010895

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.688 Kilogram)
Age
Under 1 year (8 Month)
Sex
Male Neutered
Region
USA
Reactions
Not sleepingHyperactivityBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-010894

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.495 Kilogram)
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
RestlessnessAgitationDifficulty standingStumbling gaitNot sleepingBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-007434

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.44 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Application site alopecia
Body systems
Skin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-008820

Received 2026-02-16 · MSK · MSK

Serious
Species
Cat
Breed
Siamese
Size / weight
10-24 lb (4.763 Kilogram)
Age
1-3 years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
AnaphylaxisVomitingBloody stoolLethargy (see also Central nervous system depression in Neurological)HypothermiaElevated alanine aminotransferase (ALT)Elevated blood urea nitrogen (BUN)HyperphosphataemiaLeukocytosis NOSElevated total bilirubin
Body systems
OtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-006579

Received 2026-02-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.495 Kilogram)
Age
Under 1 year (7 Month)
Sex
Female Neutered
Region
USA
Reactions
RestlessnessAgitationDifficulty standingStumbling gaitNot sleepingBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-006576

Received 2026-02-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.688 Kilogram)
Age
Under 1 year (8 Month)
Sex
Male Neutered
Region
USA
Reactions
Not sleepingHyperactivityBehavioural disorder NOS
Body systems
OtherBehavior
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-010643

Received 2026-02-12 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Golden
Size / weight
50-99 lb (30.844 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
Localised pain NOS (see other SOCs for specific pain)Limb non-weight bearingSwollen limbWhiningUncomfortablePain NOSReluctant to moveInappropriate urinationAbnormal urine odourInjection site bleedingAnorexiaInjection site itchingInjection site irritationInjection site self traumaLimpingInjection site discharge NOSSkin irritationReddening of the skinAlopecia localInjection site scratchingInjection site swellingInjection site hair loss
Body systems
OtherDigestiveSkin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-006149

Received 2026-02-04 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - English
Size / weight
25-49 lb (18.144 Kilogram)
Age
Under 1 year (9 Month)
Sex
Male Unknown
Region
USA
Reactions
ExcitationStiffness limb
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-006013

Received 2026-02-04 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (17.599 Kilogram)
Age
8+ years (8.7 Year)
Sex
Male Unknown
Region
USA
Reactions
Rigidity of limbsHyperextensionExcitation
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-005986

Received 2026-02-04 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Boston
Size / weight
25-49 lb (12.3 Kilogram)
Age
1-3 years (3.6 Year)
Sex
Female Neutered
Region
USA
Reactions
Hives (see also Skin)AngioedemaFacial swelling (see also Skin)
Body systems
Skin & allergyOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-004873

Received 2026-02-03 · MSK · MSK

Serious
Species
Dog
Breed
['Spaniel - King Charles Cavalier', 'Poodle (unspecified)']
Size / weight
10-24 lb (5.4 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Not eatingDehydrationQuietLeukocytosis NOSNeutrophiliaHyponatremiaHypokalaemiaHypochloraemiaMelaenaGastric dilationIleusGastric ulcerAbnormal ultrasound findingLack of efficacy - NOSBloody diarrhoea
Body systems
DigestiveOtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-003960

Received 2026-01-27 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - Staffordshire
Size / weight
50-99 lb (43.091 Kilogram)
Age
8+ years (9 Year)
Sex
Male Unknown
Region
USA
Reactions
General illnessDeath by euthanasiaMedication error NOS
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-003352

Received 2026-01-27 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
DiarrhoeaDecreased appetiteLethargy (see also Central nervous system depression in Neurological)Bloody diarrhoeaDry mucous membraneOpen mouth breathingUnresponsive to stimuliDecreased haematocritIncreased percentage reticulocytesRegenerative anaemiaIntentional misuseThrombocytopeniaHypersalivationHeart murmur
Body systems
DigestiveNeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-004595

Received 2026-01-26 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - American
Age
4-7 years (5.16 Year)
Sex
Female Neutered
Region
USA
Reactions
Other abnormal test result NOSTooth disorderBumps on skinCyst NOSAllergy NOSLoose stoolCrustLocal erythemaLickingDermal noduleOtitis NOSScratchingSneezingDermatitisBehavioural disorder NOSHair loss NOSNasal dischargeWeight gainSkin disorders NOSAlopecia generalAbnormal cytologyLocalised pain NOS (see other SOCs for specific pain)Salivary stainingAnxietySkin lumpMast cell tumourReddening of the skinSkin lesion NOSLack of efficacy (bacteria) - Ehrlichia
Body systems
OtherBehaviorSkin & allergyDigestiveEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-002976

Received 2026-01-20 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
Under 10 lb (2.449 Kilogram)
Age
Under 1 year (2 Month)
Sex
Male Intact
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)VomitingBloody diarrhoeaDiarrhoeaReluctant to moveDecreased body temperaturePale mucous membraneHypoglycaemiaFluid in abdomen NOSFeverDistension of abdomenNeutropeniaLeukocytosis NOSDecreased haematocritNot eatingObtundedHypersalivationAbdominal discomfortDecreased skin turgorBreathing difficultyFlaccid musclesProlonged capillary refill timeRegurgitationLack of efficacy - NOSLymphopeniaMonocytosisLeukopenia NOSHyponatremiaHypercalcaemiaIncreased band neutrophiliaIleusAbnormal radiograph findingIntestinal thickeningHypokalaemiaNasal dischargeIncreased respiratory rateLymphocytosisAbnormal ultrasound findingLateral recumbencyWeak pulseIntentional misuse
Body systems
NeurologicDigestiveOtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-002947

Received 2026-01-20 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.901 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
AnisocoriaTwitchingTachypnoeaHypothermia
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-003528

Received 2026-01-19 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Unresponsive to stimuliOpen mouth breathingAnorexiaLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDry mucous membraneBloody diarrhoeaIncreased percentage reticulocytesDecreased haematocritRegenerative anaemiaThrombocytopeniaHypersalivationMurmur
Body systems
OtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-001079

Received 2026-01-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.395 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
LimpingWobblinessMonocytosisLow creatinineSedationUnkempt hair coatGreasy skinPlantigrade postureMuscle atrophy (see also Muscle wasting)Medication error NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-005684

Received 2026-01-14 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Sex
Male Unknown
Region
USA
Reactions
Focal seizureDilated pupilsLow blood pressureBradycardiaIncorrect route of drug administration
Body systems
NeurologicOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-003666

Received 2026-01-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.59 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Pulmonary neoplasmIncreased lung soundsTachypnoeaLaboured breathingWeak pulseCrackles on auscultationDeath by euthanasiaAbnormal ultrasound findingHaemorrhage NOS
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-000100

Received 2026-01-05 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.26 Kilogram)
Age
4-7 years (6.5 Year)
Sex
Male Neutered
Region
USA
Reactions
AtaxiaBalance problemHead shake - behavioural disorderFallingNot eatingDifficulty chewingImpaired hearingDilated pupilsAbnormal pupil light reflexAbnormal movement NOSMuscle atrophy (see also Muscle wasting)Head tilt - neurological disorder (see also Head tilt - ear disorder)
Body systems
NeurologicOtherBehavior
Outcomes
Ongoing

USA-USFDACVM-2025-US-075461

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
Greyhound
Size / weight
50-99 lb (27.3 Kilogram)
Age
8+ years (9 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy - NOSUnrelated death
Body systems
EffectivenessOther
Outcomes
Euthanized

USA-USFDACVM-2025-US-075440

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Golden', 'Poodle - Standard']
Size / weight
50-99 lb (25.5 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSUnrelated death
Body systems
EffectivenessOther
Outcomes
Euthanized

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

Tracked signals
32
Reported cases
32
Serious reports
21
Species represented
2
Grouped by Body System
Digestive (1) · Loss of appetite Skin & allergy (4) · Hair loss at application site, Application site hair loss, Alopecia local Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (23) · Blood clot, Basophilia, Balance problem
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Cat 1
Behavior 1 Dog 1
Behavior 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (16) Cat (16)

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

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Butorphanol Tartrate Injection SPL · SPL Butorphic™ Injection SPL · SPL Torphadine® SPL · SPL

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

6

FOI

6

Butorphanol Tartrate Injection

SPL · SPL

Open original
FDA Structured Product Label

Butorphanol Tartrate 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
Dechra Veterinary Products LLC
ANADA
200-408
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Cat
Composition / specifications
Each milliliter of aqueous solution contains 2 milligrams of butorphanol (as butorphanol tartrate).

Cats

Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures
Dosage
0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram), using 2 milligrams per milliliter solution. For subcutaneous injection.
Limitations
Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Butorphic™ Injection

SPL · SPL

Open original
FDA Structured Product Label

Butorphic™ 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
Cronus Pharma Specialities India Private Ltd.
ANADA
200-332
Status
RX
Form
Liquid (Solution)
Route
Intravenous
Composition / specifications
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).

Horses

Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol per pound of body weight (0.1 milligram per kilogram of body weight). Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torphadine®

SPL · SPL

Open original
FDA Structured Product Label

Torphadine®

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

Sponsor
Dechra Veterinary Products LLC
ANADA
200-322
Status
RX
Form
Liquid (Solution)
Route
Intravenous
Species
Horse
Composition / specifications
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).

Horses

Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. For intravenous use.
Limitations
Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Butorphine™

SPL · SPL

Open original
FDA Structured Product Label

Butorphine™

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
200-446
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Cat
Composition / specifications
Each mL contains 2 mg butorphanol base (as butorphanol tartrate, USP).

Cats

Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Dosage
Administer 0.4 mg of butorphanol per kilogram body weight (0.2 mg/lb). This is equivalent to 1.0 mL solution per 10 lbs body weight.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dolorex®

SPL · SPL

Open original
FDA Structured Product Label

Dolorex®

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

Sponsor
Intervet, Inc.
ANADA
200-239
Status
RX
Form
Liquid (Solution)
Route
Intravenous
Species
Horse
Composition / specifications
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).

Horses

Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. For intravenous use.
Limitations
Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Torbugesic-SA®

SPL · SPL

Open original
FDA Structured Product Label

Torbugesic-SA®

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
141-047
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Cat
Composition / specifications
Each milliliter of aqueous solution contains 2 milligrams of butorphanol (as butorphanol tartrate).

Cats

Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Dosage
0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram)
Limitations
For subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ucm061350.pdf

FOI · FOI

Open original

ucm061797.pdf

FOI · FOI

Open original

ucm061785.pdf

FOI · FOI

Open original

UCM214392.pdf

FOI · FOI

Open original

UCM061667.pdf

FOI · FOI

Open original

UCM490962.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Horse
Rx/OTC: RX
Form/route: Liquid (Solution) • Intravenous, Subcutaneous
Applications: ANADA 200-408 • ANADA 200-332 • ANADA 200-322 • ANADA 200-446 • ANADA 200-239 • NADA 141-047
Documents: 6 (FOI: 6) • SPL: 6 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 183 • Cat 136 • View
Case summaries: 85 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Usage_Inferred (0.78)
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
  • Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Biting -aggression (1) Behavioral disorder (unspecified) (1) Basophilia (1) Balance problem (1) Application site dry skin (1) Apnoea (1)

Identifiers & Packages

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

Identifiers
ANADA: 200239 ANADA: 200322 ANADA: 200332 ANADA: 200408 ANADA: 200446 NADA: 102990 NADA: 103390 NADA: 135780 NADA: 141047 NDC Package: 11695-7044-1 NDC Package: 11695-7044-2 NDC Package: 17033-097-01 NDC Package: 17033-097-05 NDC Package: 54771-2033-1 NDC Package: 54771-2033-2 NDC Package: 57926-722-66 NDC Package: 69043-064-02 NDC Package: 69043-064-05 NDC Package: 73377-107-01 NDC Package: 86136-137-31 NDC Package: 86136-137-69 NDC Product: 11695 NDC Product: 17033 NDC Product: 54771
Package NDC Product NDC Form / Route Status
11695-7044-1 11695 -
11695-7044-2 11695 -
17033-097-01 17033 -
17033-097-05 17033 -
54771-2033-1 54771 -
54771-2033-2 54771 -
57926-722-66 57926 -
69043-064-02 69043 -
69043-064-05 69043 -
73377-107-01 73377 -
86136-137-31 86136 -
86136-137-69 86136 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • ucm061350.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200408
  • ucm061797.pdf • FOI summary • Official • June 13, 2024
    FDA FOI summary for application 200332
  • ucm061785.pdf • FOI summary • Official • Oct. 7, 2022
    FDA FOI summary for application 200322
  • UCM214392.pdf • FOI summary • Official • April 26, 2022
    FDA FOI summary for application 200446
  • UCM061667.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200239
  • UCM490962.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141047

Data Sources & Change Log

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

Official 117 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not norma… (Clinical, 2026-04-15)
  • contraindications: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not norma… (Clinical, 2026-04-15)
  • contraindications: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not norma… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, Death, Diarrhoea, Bradycardia, Injection site swelling. (Clinical, 2026-04-11)
  • usage: For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammat… (Clinical, 2026-04-15)
  • usage: For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammat… (Clinical, 2026-04-15)
  • usage: For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammat… (Clinical, 2026-04-11)
  • contraindications: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not norma… (Official, 2026-04-22)
  • contraindications: Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not norma… (Official, 2026-02-12)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-06)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-05)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-04)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-03)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-02)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-08-01)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-07-31)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-07-30)
  • indications: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings. Butorphic Injection is indicated for re… (Official, 2026-07-29)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:28 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:28 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:28 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:28 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:28 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:07 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
Butorphanol Tartrate Injection
RX
Butorphanol Tartrate
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-408 W Feb 27, 2026
Butorphic™ Injection
RX
Butorphanol Tartrate
Liquid (Solution) • Intravenous
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-332 Approved Jun 13, 2024
Torphadine®
RX
Butorphanol Tartrate
Liquid (Solution) • Intravenous
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-322 Approved Oct 7, 2022
Butorphine™
RX
Butorphanol Tartrate
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Modern Veterinary Therapeutics, LLC ANADA 200-446 W Apr 26, 2022
Dolorex®
RX
Butorphanol Tartrate
Liquid (Solution) • Intravenous
Label highlights
Official documents
Intervet, Inc. ANADA 200-239 Approved Jun 1, 2016
Torbugesic-SA®
RX
Butorphanol Tartrate
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-047 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.

Species: Cat
Composition / specifications
Each milliliter of aqueous solution contains 2 milligrams of butorphanol (as butorphanol tartrate).
Cats
Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures
Dosage
0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram), using 2 milligrams per milliliter solution. For subcutaneous injection.
Limitations
Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. 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
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).
Horses
Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol per pound of body weight (0.1 milligram per kilogram of body weight). Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).
Horses
Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. For intravenous use.
Limitations
Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Cat
Composition / specifications
Each mL contains 2 mg butorphanol base (as butorphanol tartrate, USP).
Cats
Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Dosage
Administer 0.4 mg of butorphanol per kilogram body weight (0.2 mg/lb). This is equivalent to 1.0 mL solution per 10 lbs body weight.
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: Horse
Composition / specifications
Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate).
Horses
Indication
For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
Dosage
0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. For intravenous use.
Limitations
Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Cat
Composition / specifications
Each milliliter of aqueous solution contains 2 milligrams of butorphanol (as butorphanol tartrate).
Cats
Indication
For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Dosage
0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligrams per kilogram)
Limitations
For subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats of kittens less than 4 months of age has not been determined. 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 the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to a maximum of 0.5 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. 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

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Blood clot (1) • Cat Basophilia (1) • Cat Balance problem (1) • Dog Application site serous discharge (1) • Dog Application site reddening (1) • Cat
Show more (18)
Application site lesion (1) • Cat Application site dry skin (1) • Dog Application site discharge NOS (1) • Cat Apnoea (1) • Dog Anisocoria (1) • Cat Angioedema (1) • Dog Anaphylaxis (1) • Cat Allergy NOS (1) • Dog Agitation (1) • Cat Abnormal urine odour (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal Schirmer tear test (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal pupil light reflex (1) • Dog Abnormal movement NOS (1) • Cat Abnormal menace reflex test (1) • Dog Abnormal cytology (1) • Cat Abdominal discomfort (1) • Dog

Showing top 5 for Other.

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

Adverse Event Case Summaries (openFDA)

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

Cat, Domestic Shorthair, Male, 10 month, 5 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014624
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Month
  • Weight: 5.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Seizure NOS
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 11 year, 3.992 kilogram • Drug: MSK, Unassigned, Intramuscular • Reactions: Facial pruritus, Medication error NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014454
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 3.992 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Unassigned
Reactions Reported:
Facial pruritus Medication error NOS
Outcomes: Recovered/Normal

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

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

Cat, Ragdoll, Male, 10 year, 5.498 kilogram • Drug: MSK, Unknown • Reactions: Head tilt - neurological disorder, Unsteady walking (ataxia) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014107
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 5.498 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Head tilt - neurological disorder Unsteady walking (ataxia)
Outcomes: Outcome Unknown

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

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

Dog, Crossbred Canine/dog, Female, 1 year, 14.969 kilogram • Drug: MSK, Injection, Intramuscular • Reactions: Vocalisation, Restlessness, Intentional misuse • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012798
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 14.969 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection
Reactions Reported:
Vocalisation Restlessness Intentional misuse
Outcomes: Ongoing

Dog, Poodle - Standard, Female, 6 year, 18.552 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Drooling, Nausea, Injection site swelling • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014481
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 18.552 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Drooling Nausea Injection site swelling
Outcomes: Ongoing

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

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

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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