Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
BothReference partialNot FDA-approved for animalsMultiple FDA labelers
Official label facts
Owner quick guide first
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Some reference facts for this medication are still being verified.
Not FDA-approved as an animal drug.
No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.
Do not start, stop, or change treatment without your veterinarian.
Data freshness
Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.
Roxee has a partial reference profile for this medication. Some primary facts still need verification.
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 Drug Product Listing Directory (NDC):Source FDA| Refreshed Aug 6, 2026, 7:47 PM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
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
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Gabapentin
Gabapentin
Drug type: Generic ingredient
• Branded profile • Not FDA-approved for animals
Both86% reference complete
Species: Both
Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.
Medication Snapshot
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Gabapentin
Used for neuropathic pain and as an adjunct for seizure control; also used for situational anxiety/sedation in some cases. Species commonly shown: Both.
Generic name
Gabapentin
Brand names
GABAPENTIN, SolutitionKits
Manufacturer
Multiple FDA labelers
Species
Both
Completeness
86%
Validation
Incomplete
Brand names
GABAPENTINSolutitionKits
Indications / Uses
Used for neuropathic pain and as an adjunct for seizure control; also used for situational anxiety/sedation in some cases.
Administration / How To Give
Oral
Storage
Store at room temperature.
Warnings / Contraindications
Use caution with kidney disease; dose adjustments may be needed.
Use caution with kidney disease; dose adjustments may be needed.
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 contextLimited
Roxee has limited cited overview evidence for Gabapentin; use the official documents and your veterinarian's instructions for product-specific decisions.
Source: openFDA reaction aggregate term
Safety signal coverageReported signals
32 tracked reaction signals; 60 reported cases; 7 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Source: openFDA reaction aggregate term
Interpretation guardrailNot 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 signalLabel / review
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Source: openFDA reaction aggregate term
Weaker signalReported 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.
Domestic Shorthair (2), Retriever - Labrador (2), Schnauzer - Miniature (1), Crossbred Canine/dog (1). These are report metadata, not proof that a breed is at higher risk.
What your vet may verify
Fit for this patientVet check
Verify whether Gabapentin fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Evidence limitationsEvidence review
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
What to watch next
Watch listOwner-safe
Use caution with kidney disease, dose adjustments may be needed, Thrombocytopenia, Elevated symmetrical dimethylarginine, Conjunctivitis
Call sooner ifEscalation
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Bottom line: Use this Gabapentin brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
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-008917
Received 2026-01-29
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.53 Kilogram)
Age
1-3 years (1.33 Year)
Sex
Male Neutered
Region
USA
Reactions
PtyalismTremorSeizure NOSAggressionLeukocytosis NOSNeutrophiliaEosinopeniaHypernatraemiaElevated cholesterol (total)Eyes rolling backHyperactivityElevated haematocritDisorientationUrinary tract obstruction/blockageAnaemia NOSOther abnormal test result NOSMydriasisActing tenseMental confusionTwitchingBradycardiaDecreased heart rateBehavioural disorder NOSHaematuriaProteinuria
Body systems
OtherNeurologicBehaviorSkin & allergy
Outcomes
Outcome Unknown
USA-USFDACVM-2026-US-007621
Received 2026-01-23
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.9 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site skin change NOSInjection site alopeciaInjection site weeping (see also Skin)DehiscenceInjection site mucopurulent dischargeInjection site necrosis
Body systems
OtherSkin & allergy
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-003253
Received 2026-01-16
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.53 Kilogram)
Age
1-3 years (1.33 Year)
Sex
Male Neutered
Region
USA
Reactions
PtyalismTremorSeizure NOSAggressionLeukocytosis NOSNeutrophiliaEosinopeniaHypernatraemiaElevated cholesterol (total)Eyes rolling backHyperactivityElevated haematocritDisorientationUrinary tract obstruction/blockageAnaemia NOSOther abnormal test result NOSMydriasisActing tenseMental confusionTwitchingBradycardiaDecreased heart rateBehavioural disorder NOSHaematuriaProteinuria
Body systems
OtherNeurologicBehaviorSkin & allergy
Outcomes
Outcome Unknown
USA-USFDACVM-2025-US-075379
Received 2025-12-23
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (8.618 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site hair lossReddening of the skinWeight lossSkin lesion NOSWoundAbnormal cytologyDiscomfort NOSSkin necrosisItchingFacial swelling (see also Skin)Facial rash (For urticaria see Immune SOC)
Body systems
Skin & allergyOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-074820
Received 2025-12-22
· MSK
· MSK
Non-serious
Species
Dog
Breed
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)
Age
4-7 years (4.8 Year)
Sex
Male Neutered
Region
USA
Reactions
LimpingSwelling NOSLimb non-weight bearingConstipationLack of efficacy (endoparasite) - heartwormPain NOSPica NOSLocalised pain NOS (see other SOCs for specific pain)
Body systems
OtherSkin & allergyEffectiveness
Outcomes
Outcome Unknown
USA-USFDACVM-2025-US-074107
Received 2025-12-16
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.296 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
PruritusAlopecia NOSSkin lesion NOSDermatitis
Body systems
Skin & allergyOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-072787
Received 2025-12-15
· MSK
· MSK
Serious
Species
Dog
Breed
Poodle - Standard
Size / weight
25-49 lb (20.412 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Intact
Region
USA
Reactions
Death by euthanasiaConjunctivitisUlceration NOSEar canal erythemaWeltBumps on skinSkin inflammation NOSAnorexiaPain NOSDifficulty to risePyodermaAbnormal histology NOSSeizure NOSNeutropeniaMonocytosisElevated creatinineThrombocytopeniaHyperkeratosisPruritus
Body systems
OtherDigestiveNeurologicSkin & allergy
Outcomes
Euthanized
USA-USFDACVM-2025-US-074043
Received 2025-12-11
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.175 Kilogram)
Age
8+ years (9 Year)
Sex
Female Neutered
Region
USA
Reactions
Reddening of the skinItchingLocalised hair lossSkin irritation
Body systems
OtherSkin & allergy
Outcomes
Outcome Unknown
USA-USFDACVM-2025-US-074653
Received 2025-12-09
· MSK
· MSK
Serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (37.376 Kilogram)
Age
8+ years (11.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Joint swellingBone and joint disorder NOSSarcoma NOS
Body systems
Skin & allergyOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-072504
Received 2025-12-04
· MSK
· MSK
Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (29.03 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
Otitis externaTrigeminus paralysisVomitingCoughMuscle atrophy (see also Muscle wasting)Elevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)HypersalivationUnusual stool colourErythema (for urticaria see Immune SOC)Elevated gamma-glutamyl transferase (GGT)Elevated total bilirubinAbnormal ultrasound findingHepatic fibrosisHepatitisLethargy (see also Central nervous system depression in Neurological)AngioedemaGeneralised rashDyspnoeaIncreased lung soundsLeucocytosis NOSIcterusAbnormal radiograph findingJaw disorder
Body systems
OtherDigestiveSkin & allergyNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-072174
Received 2025-12-01
· MSK
· MSK
Non-serious
Species
Dog
Breed
Terrier - Yorkshire
Size / weight
10-24 lb (6.12 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Partial lack of efficacyAlopeciaErythema (for urticaria see Immune SOC)PapuleExcoriationSkin scabBacterial skin infection NOSAbnormal cytology
Body systems
EffectivenessSkin & allergyOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-069108
Received 2025-11-19
· MSK
· MSK
Serious
Species
Cat
Breed
Cat (other)
Size / weight
10-24 lb (5.352 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Skin lesion NOSFacial pruritusAlopecia
Body systems
OtherSkin & allergy
Outcomes
Ongoing
USA-USFDACVM-2025-US-070057
Received 2025-11-18
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.9 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site skin change NOSInjection site alopeciaInjection site weeping (see also Skin)DehiscenceInjection site mucopurulent dischargeInjection site necrosis
Body systems
OtherSkin & allergy
Outcomes
Ongoing
Tap or hover a reaction to see what it means in plain language.
Tracked signals
32
Reported cases
60
Serious reports
7
Species represented
2
Grouped by Body System
Effectiveness (1)
· Lack of efficacy (endoparasite) - tapeworm
Other (31)
· Thrombocytopenia, Elevated symmetrical dimethylarginine, Conjunctivitis
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Effectiveness
Lack of efficacy (endoparasite) - tapeworm (2) • Dog
Showing top 5 for Effectiveness.
Other
Thrombocytopenia (4) • Dog
Elevated symmetrical dimethylarginine (4) • Dog
Conjunctivitis (3) • Dog
Urolithiasis (2) • Dog
Unclassifiable adverse event (2) • Dog
Show more (26)
Trembling (2) • Dog
Skin lesion NOS (2) • Dog
Respiratory tract infection NOS (2) • Dog
Regurgitation (2) • Dog
Reduced globulins (2) • Dog
Pyoderma (2) • Dog
Proprioception deficit (2) • Dog
Knuckling (2) • Dog
Hypophosphataemia (2) • Dog
Hypokalaemia (2) • Cat
Hepatomegaly (2) • Cat
Fracture (2) • Dog
Erythema (2) • Dog
Elevated alanine aminotransferase (2) • Cat
Decreased activity (2) • Cat
Death (2) • Cat
Confusion (2) • Dog
Abnormal radiograph finding (1) • Cat
Abnormal movement NOS (1) • Dog
Abnormal menace reflex test (1) • Cat
Abnormal histology NOS (1) • Dog
Abnormal cytology (1) • Dog
Abdominal pain (1) • Dog
Abdominal effusion (1) • Dog
Abdominal discomfort (1) • Dog
Abdominal cavity disorder NOS (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.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
Overdose can cause severe sedation, loss of coordination, muscle tremors, and respiratory depression. Emergency care: IV fluids, monitoring.
Storage & Handling
Store at room temperature.
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This medication has not been reviewed by a veterinarian yet.
Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.