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
Showing simplified owner view. Switch to Vet View for full technical detail.
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
Illustration placeholder
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.
LamenessWobblinessLethargy (see also Central nervous system depression in Neurological)Unable to walkWeaknessFeverImmune-mediated polyarthritisGastritisAbdominal cavity disorder NOSAbnormal ultrasound findingHyperproteinaemiaLymphopeniaEosinopeniaMedication error NOS
Body systems
OtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-014374
Received 2026-03-25
· MSK
· MSK
Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (32.205 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Musculoskeletal disorder NOSAggressionUnable to walkUrinary incontinenceMelaenaEmesis (multiple)Lethargy (see also Central nervous system depression in Neurological)Death by euthanasiaNeurological signs NOS
Body systems
OtherBehaviorDigestiveNeurologic
Outcomes
Euthanized
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-013169
Received 2026-03-19
· MSK
· MSK
Serious
Species
Dog
Breed
Rottweiler
Size / weight
50-99 lb (43.001 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Musculoskeletal disorder NOSCollapse NOS (see also Cardio-vascular and Neurological disorders)Lethargy (see also Central nervous system depression in Neurological)Unable to walkNot eatingWeaknessDeath
Body systems
OtherNeurologic
Outcomes
Died
USA-USFDACVM-2026-US-012782
Received 2026-03-17
· MSK
· MSK
Serious
Species
Dog
Breed
Setter - English
Size / weight
25-49 lb (21.772 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Dilated renal pelvisIntestinal thickeningAbnormal ultrasound findingBradycardiaPale mucous membraneDiarrhoeaWeight lossLethargy (see also Central nervous system depression in Neurological)LymphomaMedication error NOS
Body systems
OtherDigestiveNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-013278
Received 2026-03-16
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.8 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
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-013066
Received 2026-03-16
· MSK
· MSK
Serious
Species
Dog
Breed
Samoyed
Size / weight
50-99 lb (24.948 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)ShakingPale mucous membraneCold feeling of extremityVomitingTachycardiaLaboured breathingTachypnoeaDehydrationWeak pulseTense abdomenHypochloraemiaHyponatremiaAzotaemiaHypocalcaemiaHypoglycaemiaHyperphosphataemiaHypoproteinaemiaHypoalbuminaemiaLow alanine aminotransferase (ALT)Elevated lactateIncreased percentage reticulocytesLymphocytosisMonocytosisAbnormal red blood cellHypotensionAbdominal effusionAspiration pneumoniaHeart murmurGastric perforationLateral recumbencySepticaemiaCoagulopathyHypernatraemiaHypercalcaemiaElevated serum alkaline phosphatase (ALP)NeutrophiliaStridor (Upper respiratory; for lower respiratory see also Bronchial rale)Unresponsive to stimuliCyanotic mucous membranesThrombosisOedema of the extremities (see also other SOCs for most applicable oedema)Pitting oedemaLamenessElevated aspartate aminotransferase (AST)Stertor
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing
USA-USFDACVM-2026-US-012478
Received 2026-03-16
· MSK
· MSK
Serious
Species
Dog
Breed
['Retriever - Labrador', 'Terrier - Bull - American Pit']
Size / weight
50-99 lb (31.298 Kilogram)
Age
8+ years (14 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb weaknessDecreased appetiteDeath by euthanasiaLethargy (see also Central nervous system depression in Neurological)Panting
Body systems
OtherDigestiveNeurologic
Outcomes
Euthanized
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-011895
Received 2026-03-11
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.377 Kilogram)
Age
1-3 years (1.5 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingLocalised pain NOS (see other SOCs for specific pain)Limb non-weight bearingLethargy (see also Central nervous system depression in Neurological)Not eatingHead tremorIncreased respiratory ratePlantigrade postureLimb weaknessProprioception deficitCutaneous emphysemaAbnormal radiograph findingKnuckling
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-011648
Received 2026-03-10
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.126 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Emesis (multiple)Weight lossLethargy (see also Central nervous system depression in Neurological)Blood in vomitAbnormal ultrasound findingWeaknessDecreased appetiteINEFFECTIVE, ANTIEMETICDigestive tract disorder NOS
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-010089
Received 2026-03-07
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.4 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
HypotensionBradycardiaHypernatraemiaLying downLethargy (see also Central nervous system depression in Neurological)Reduced responses
Body systems
OtherNeurologic
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-008769
Received 2026-02-28
· MSK
· MSK
Serious
Species
Cat
Breed
Russian
Size / weight
Under 10 lb (4.3 Kilogram)
Age
8+ years (19 Year)
Sex
Male Neutered
Region
USA
Reactions
Not drinkingNot eatingDullnessAnaemia NOSCardiac disorder NOSHeart murmurPale mucous membraneAtaxiaOliguriaRenal failureDeath by euthanasiaInappetenceLethargy (see also Central nervous system depression in Neurological)AscitesThird eyelid protrusionLateral recumbencyAcute renal failureDehydrationProlonged capillary refill timeHyperglycaemiaSplenic neoplasm NOSHead bobbingElevated blood urea nitrogen (BUN)Elevated creatinineAbnormal radiograph findingAzotaemiaDecreased packed cell volume (PCV)DullHypernatraemia
Body systems
OtherNeurologic
Outcomes
Euthanized
USA-USFDACVM-2026-US-009056
Received 2026-02-26
· MSK
· MSK
Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (28.49 Kilogram)
Age
8+ years (8.42 Year)
Sex
Female Unknown
Region
USA
Reactions
Weight lossLethargy (see also Central nervous system depression in Neurological)Limb weakness
Body systems
OtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-008246
Received 2026-02-24
· MSK
· MSK
Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
100+ lb (48.08 Kilogram)
Age
4-7 years (7.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Death by euthanasiaNot himself/herselfLethargy (see also Central nervous system depression in Neurological)VomitingHaemorrhage NOSWeight lossSternoabdominal recumbencyDehydrationDiabetic ketoacidosisAcute pancreatitisAzotaemia
Body systems
OtherNeurologicDigestive
Outcomes
Euthanized
USA-USFDACVM-2026-US-006203
Received 2026-02-10
· MSK
· MSK
Serious
Species
Dog
Breed
Mountain Dog - Bernese
Size / weight
50-99 lb (35.698 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)InappetenceSwollen lip (see also Skin)Localised pain NOS (see other SOCs for specific pain)Ocular dischargeNot drinkingSmelly breathLip smackingWalking difficultyAbdominal painDrooping eyelidReluctant to moveOral ulcerationTongue ulcerationIntentional misuse
Body systems
NeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2026-US-007418
Received 2026-02-09
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (8.7 Kilogram)
Age
1-3 years (2.8 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSNot eatingLethargy (see also Central nervous system depression in Neurological)General pain (see other SOCs for specific pain)Facial oedemaTrigeminus paralysisOral ulcerationIntentional misuse
Body systems
EffectivenessOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2026-US-004494
Received 2026-02-03
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (6.804 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Injection site cystInjection site sarcomaInjection site lumpInjection site discharge NOSInjection site irritationLethargy (see also Central nervous system depression in Neurological)Elevated symmetrical dimethylarginine (SDMA)HypoalbuminaemiaThrombocytosisHyperkalaemiaAbnormal radiograph findingConstipationPain NOSAbnormal cytologyDecreased appetiteLicking at injection site
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
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-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-003268
Received 2026-01-14
· MSK
· MSK
Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (5.8 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingLethargy (see also Central nervous system depression in Neurological)RetchingDental diseaseDry mucous membraneDehydrationAnorexiaBloody diarrhoeaIncreased heart rateIncreased respiratory ratePale mucous membraneJaundiceHeart murmurTense abdomenLeukocytosis NOSNeutrophiliaLymphocytosisMonocytosisLow platelet countAzotaemiaElevated blood urea nitrogen (BUN)HyperphosphataemiaElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated total bilirubinElevated cholesterol (total)Blood in urineProteinuriaLiver disorder NOSPancreas disorderIntestinal thickeningUrinary tract disorder NOSNon-regenerative anaemiaHypokalaemiaNot eatingDecreased red blood cell countDecreased haematocritPolyuriaPolydipsiaAbdominal discomfortIncreased percentage reticulocytesPlatelet disorder NOSLack of efficacy - NOSGut sounds decreasedOther blood disorder NOSBilirubinuriaAbnormal ultrasound findingElevated gamma-glutamyl transferase (GGT)ThrombocytosisIleus
Body systems
DigestiveNeurologicOtherEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2025-US-075421
Received 2025-12-29
· MSK
· MSK
Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
25-49 lb (20.865 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Not eatingLethargy (see also Central nervous system depression in Neurological)Reluctant to moveSeizure NOS
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing
USA-USFDACVM-2025-US-075044
Received 2025-12-23
· MSK
· MSK
Serious
Species
Dog
Breed
Siberian Husky
Size / weight
50-99 lb (26.58 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
Clonic seizureBiting -aggression (see also Skin and appendages disorders)Partial blindnessSeizure NOSFoaming at the mouthOral bleedingLethargy (see also Central nervous system depression in Neurological)WobblinessUnable to focusUrinationLateral recumbencyVocalisationBalance problemStaringElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)
Body systems
NeurologicBehaviorOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-074895
Received 2025-12-19
· MSK
· MSK
Serious
Species
Dog
Breed
Bloodhound
Size / weight
50-99 lb (41.28 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Stiffness NOSWalking difficultyGeneralised weaknessNeutropeniaLow platelet countPain NOSDecreased appetiteVomitingElevated liver enzymes NOSFluid in abdomen NOSLiver disorder NOSOther immune system disorder NOSFeverLeucopenia NOSDistension of abdomenHypoglycaemiaAnaemia NOSIndigestion
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-074457
Received 2025-12-19
· MSK
· MSK
Serious
Species
Dog
Breed
['Beagle', 'Dog (unknown)']
Size / weight
25-49 lb (14.061 Kilogram)
Age
1-3 years (3.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)AgitationSeizure NOSElevated symmetrical dimethylarginine (SDMA)FallingStiffness NOSConfusionShivering
Body systems
NeurologicOther
Outcomes
Outcome Unknown
USA-USFDACVM-2025-US-072814
Received 2025-12-10
· MSK
· MSK
Serious
Species
Dog
Breed
Pinscher - Miniature
Size / weight
Under 10 lb (4.037 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)TremblingLimpingHead downWalking difficultyFeverLack of efficacy - NOSElevated globulinsBlood in urineImmune-mediated polyarthropathyElevated protein:creatinine ratioProteinuriaIntentional misuse
Body systems
NeurologicOtherEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2025-US-072729
Received 2025-12-05
· MSK
· MSK
Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
25-49 lb (17.6 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Leucopenia NOSAnaemia NOSHypoalbuminaemiaNeutropeniaPyodermaReduced globulinsHypophosphataemiaNon-regenerative anaemiaLow serum alkaline phosphatase (ALP)Pale mucous membraneElevated alanine aminotransferase (ALT)Decreased packed cell volume (PCV)Lethargy (see also Central nervous system depression in Neurological)HypocalcaemiaElevated aspartate aminotransferase (AST)HypoproteinaemiaProteinuriaElectrolyte disorderDisorder of red blood cell NOSElevated creatine-kinase (CK)Other coagulation investigation abnormalityIncreased band neutrophiliaElevated mean corpuscular volume (MCV)LymphopeniaOther abnormal test result NOSDiarrhoeaPanleucopeniaEosinopeniaDecreased haematocritIncreased percentage reticulocytes
Body systems
OtherNeurologicDigestive
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-072463
Received 2025-12-01
· MSK
· MSK
Non-serious
Species
Dog
Breed
['Rottweiler', 'Retriever - Labrador']
Size / weight
50-99 lb (27.76 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Proprioception deficitMusculoskeletal disorder NOSLethargy (see also Central nervous system depression in Neurological)AnorexiaReluctant to moveBradycardiaArrhythmiaPyrexiaLymphocytosisLeucocytosis NOSLow thyroxine (T4)Elevated symmetrical dimethylarginine (SDMA)Urinary tract infection
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing
USA-USFDACVM-2025-US-072107
Received 2025-12-01
· MSK
· MSK
Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.1 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
VocalisationAbnormal tail posturePain NOSWeight lossDecreased appetiteVomitingChewing disorderPantingTremblingLying downAnxietyExcessive chewing, licking and/or groomingMuscle atrophy (see also Muscle wasting)Musculoskeletal disorder NOSAbnormal radiograph findingSpondylosisJoint effusionElevated gamma-glutamyl transferase (GGT)LymphopeniaLethargy (see also Central nervous system depression in Neurological)Thoracic painDeath by euthanasiaMedication error NOS
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Euthanized
USA-USFDACVM-2025-US-075182
Received 2025-11-24
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.76 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Cold feeling to the touchDecreased appetiteLack of efficacy - NOSBehavioural disorder NOSVomitingRenal disorder NOSLethargy (see also Central nervous system depression in Neurological)Elevated renal parametersArthritisReluctant to moveWeight gainWobblinessDental diseaseRespiratory tract infection NOSAnaemia NOSElevated creatinineHypercalcaemiaFeverDehydrationDiarrhoeaDecreased haematocritDecreased red blood cell countDigestive tract disorder NOSSicknessDistressDiabetesDecreased body temperatureDeath by euthanasia
Body systems
OtherDigestiveEffectivenessBehaviorNeurologic
Outcomes
Euthanized
USA-USFDACVM-2025-US-070121
Received 2025-11-21
· MSK
· MSK
Non-serious
Species
Dog
Breed
['Shepherd Dog - German', 'Dog (unknown)']
Size / weight
50-99 lb (36.015 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteWobblinessNot himself/herself
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-067000
Received 2025-11-14
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
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 misuseUnderdoseThrombocytopeniaHeart murmurHypersalivation
Body systems
DigestiveNeurologicOther
Outcomes
Ongoing
USA-USFDACVM-2025-US-068234
Received 2025-11-12
· MSK
· MSK
Serious
Species
Cat
Breed
Cat (unknown)
Sex
Mixed Unknown
Region
USA
Reactions
DeathHaematocheziaDecreased appetiteRegurgitationLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDeath by euthanasia
Body systems
OtherDigestiveNeurologic
Outcomes
DiedEuthanizedOutcome Unknown
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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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.