Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
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Official label facts
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Reference facts
Reference refreshed
Aug 6, 2026, 7:46 p.m.
These are the reference facts Roxee uses on browse cards and quick facts.
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FDA application data refreshed
Aug 6, 2026, 7:46 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, 7:46 PM UTC
The reference fact projection used for browse cards and quick facts.
Animal Drugs @ FDA:Source FDA| Refreshed Aug 6, 2026, 7:46 PM UTC
Applications/products are imported from FDA export data.
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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
Maropitant
Maropitant
Drug type: Generic ingredient
• Generic profile • No FDA branded products linked
BothTabletRx required100% 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.
Maropitant
For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 Months of Age: Species commonly shown: Both, Dog, Cat.
For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 Months of Age:
Warnings / Contraindications
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Side Effects
Top reported reactions (openFDA): Vomiting, Diarrhoea, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lethargy (see also Central nervous system depression in Neurological), Not eating.
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 Maropitant; 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; 62 reported cases; 3 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.
Retriever - Labrador (2), Schnauzer - Miniature (1), Pug (1), ['Mastiff (unspecified)', '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 Maropitant 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
For oral use in dogs only, CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the preventi, The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointest, The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, Hepatomegaly
Call sooner ifEscalation
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Bottom line: Use this Maropitant brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
High: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Showing up to 50 matching reports.
Narrow filters to inspect the remaining reports.
USA-USFDACVM-2026-US-014449
Received 2026-03-25
· MSK
· MSK
Serious
Species
Dog
Breed
Schnauzer - Miniature
Size / weight
10-24 lb (10.16 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
LamenessWobblinessLethargy (see also Central nervous system depression in Neurological)Unable to walkWeaknessFeverImmune-mediated polyarthritisGastritisAbdominal cavity disorder NOSAbnormal ultrasound findingHyperproteinaemiaLymphopeniaEosinopeniaMedication error NOS
Not himself/herselfBehavioural disorder NOSDisorientationDilated pupilsLethargy (see also Central nervous system depression in Neurological)AtaxiaNot eating
Body systems
OtherBehaviorNeurologic
Outcomes
Outcome Unknown
USA-USFDACVM-2026-US-013484
Received 2026-03-20
· MSK
· MSK
Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (28.576 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
LimpingLimb weaknessCoughNeurological signs NOSWobblinessCollapse NOS (see also Cardio-vascular and Neurological disorders)FeverJoint painJoint swellingGait abnormalityTense musclesElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)HyperglycaemiaNeutrophiliaAbnormal radiograph findingImmune-mediated polyarthritisBlood in faecesMedication error NOS
CoughAbnormal radiograph findingHeart murmurEosinophiliaLack of efficacy (endoparasite) - heartworm
Body systems
OtherEffectiveness
Outcomes
Ongoing
USA-USFDACVM-2026-US-012895
Received 2026-03-19
· MSK
· MSK
Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (30.844 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Unknown
Region
USA
Reactions
Injection site painInjection site swellingEmesis (multiple)Decreased appetitePica NOSLocalised pain NOS (see other SOCs for specific pain)Eosinophilia
Body systems
OtherSkin & allergyDigestive
Outcomes
Ongoing
USA-USFDACVM-2026-US-012910
Received 2026-03-18
· MSK
· MSK
Serious
Species
Dog
Breed
Deutsche Dogge, Great Dane
Size / weight
100+ lb (47.174 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingAppetite lossLethargy (see also Central nervous system depression in Neurological)Heavy breathingDeath
Body systems
DigestiveNeurologicOther
Outcomes
Died
USA-USFDACVM-2026-US-014257
Received 2026-03-17
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.53 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb amputationInjection site sarcomaBehavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)Localised pain NOS (see other SOCs for specific pain)VocalisationLimpingInjection site mass NOS
Body systems
OtherBehaviorNeurologic
Outcomes
Outcome Unknown
USA-USFDACVM-2026-US-013808
Received 2026-03-17
· MSK
· MSK
Serious
Species
Dog
Breed
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog)
Lethargy (see also Central nervous system depression in Neurological)VomitingAnorexiaTachycardiaFeverIncreased salivationAbnormal radiograph findingNeurological signs NOSIntentional misuseAgitation
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing
USA-USFDACVM-2026-US-012794
Received 2026-03-17
· MSK
· MSK
Serious
Species
Cat
Breed
Russian
Size / weight
Under 10 lb (2.223 Kilogram)
Age
Under 1 year (17 Week)
Sex
Male Intact
Region
USA
Reactions
UnwellMuscle tremorVomitingNot eatingGastrointestinal foreign body NOSLack of efficacy - NOSWeight lossDehydrationLethargy (see also Central nervous system depression in Neurological)
AtaxiaLethargy (see also Central nervous system depression in Neurological)AgitationTremorCoughAbnormal radiograph findingUrinary incontinenceElevated alanine aminotransferase (ALT)Faecal incontinenceSeizure NOSHead tremorMedication error NOS
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteLimpingFeverSwollen lymph nodeWeight lossPolyuriaPolydipsiaEmesis (multiple)Nasal dischargeLaboured breathingStridor (Upper respiratory; for lower respiratory see also Bronchial rale)Gait abnormalityJoint painJoint effusionImmune-mediated polyarthritisLymphopeniaHypoalbuminaemiaElevated globulinsElevated aspartate aminotransferase (AST)Elevated serum alkaline phosphatase (ALP)
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing
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-012294
Received 2026-03-16
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.26 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingHypersalivationHypoglycaemiaHypotensionAbnormal ultrasound findingHidingBehavioural disorder NOSLethargy (see also Central nervous system depression in Neurological)HypothermiaDehydrationNeutropeniaDiarrhoeaSoft stool
CoughMegaoesophagusDecreased red blood cell countHyponatremiaHypochloraemiaLeukocytosis NOSNeutrophiliaMonocytosisHyperproteinaemiaHyperalbuminaemiaElevated globulinsIncreased urine concentrationProteinuriaEosinophiliaIncreased percentage reticulocytesHigh sodium-potassium ratio (Na:K ratio)Skin lesion NOS
Body systems
Other
Outcomes
Ongoing
USA-USFDACVM-2026-US-012730
Received 2026-03-13
· MSK
· MSK
Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (7.62 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
EmesisLack of efficacy - NOS
Body systems
DigestiveEffectiveness
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-012224
Received 2026-03-13
· MSK
· MSK
Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3 Kilogram)
Age
8+ years (12.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Tongue disorder NOSTongue ulcerationDroolingUnwellTracheal and laryngeal disorder NOSCrustDecreased appetiteLaryngeal oedemaCoughHead tilt - neurological disorder (see also Head tilt - ear disorder)Swallowing disorder NOSLocal swelling (not application site)Lethargy (see also Central nervous system depression in Neurological)Nasal dischargeMalaiseDehydrationOcular discharge
Body systems
OtherDigestiveNeurologicSkin & allergy
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-012217
Received 2026-03-13
· MSK
· MSK
Non-serious
Species
Cat
Breed
Domestic Longhair
Size / weight
Under 10 lb (1.992 Kilogram)
Age
Under 1 year (5 Month)
Sex
Female Intact
Region
USA
Reactions
Elevated temperatureDecreased body temperature
Body systems
Other
Outcomes
Ongoing
USA-USFDACVM-2026-US-012003
Received 2026-03-13
· MSK
· MSK
Non-serious
Species
Cat
Breed
Persian
Size / weight
Under 10 lb (3.36 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
Hypersalivation
Body systems
Digestive
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-011861
Received 2026-03-12
· MSK
· MSK
Non-serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (24.267 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Intact
Region
USA
Reactions
HypersalivationRegurgitationIntentional misuse
Body systems
DigestiveOther
Outcomes
Ongoing
USA-USFDACVM-2026-US-013398
Received 2026-03-11
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
FallingSeizure NOSDeathRigidity
Body systems
OtherNeurologic
Outcomes
Died
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-011867
Received 2026-03-11
· MSK
· MSK
Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.992 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
Tendon rupture
Body systems
Other
Outcomes
Ongoing
USA-USFDACVM-2026-US-011403
Received 2026-03-11
· MSK
· MSK
Serious
Species
Dog
Breed
['Shepherd Dog (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (25.62 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
DehiscenceIntestinal perforationPleural effusionPeritonitisDeath by euthanasiaPeriodontal disorderOral cavity disorder NOSSurgical site disorderAbdominal discomfortAbnormal radiograph finding
Body systems
Other
Outcomes
Euthanized
USA-USFDACVM-2026-US-011296
Received 2026-03-11
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (3.629 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
Tendon rupturePancreas disorderDeath
Body systems
Other
Outcomes
Died
USA-USFDACVM-2026-US-013131
Received 2026-03-10
· MSK
· MSK
Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Immediate pain upon injection
Body systems
Other
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-012018
Received 2026-03-10
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (2.95 Kilogram)
Age
8+ years (13.8 Year)
Sex
Male Neutered
Region
USA
Reactions
Death
Body systems
Other
Outcomes
Died
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-013065
Received 2026-03-09
· MSK
· MSK
Serious
Species
Dog
Breed
['Beagle', 'Chihuahua']
Sex
Unknown Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-012923
Received 2026-03-09
· MSK
· MSK
Serious
Species
Cat
Breed
Domestic Shorthair
Age
4-7 years (7 Year)
Sex
Unknown Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Recovered/Normal
USA-USFDACVM-2026-US-010813
Received 2026-03-09
· MSK
· MSK
Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.7 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
DullBradycardiaLow blood pressure
Body systems
Other
Outcomes
Recovered/Normal
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
Skin lumpSurgical site disorderSkin inflammation NOSReddening of the skinIntentional misuseApplication site irritationApplication site reddeningApplication site inflammationContamination NOS
AnaphylaxisEmesis (multiple)LimpnessLateral recumbencyPale mucous membranePantingInvoluntary defecationLow blood pressureFoaming at the mouthLethargy (see also Central nervous system depression in Neurological)Not eatingDiarrhoea
Body systems
OtherDigestiveNeurologic
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
Tap or hover a reaction to see what it means in plain language.
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-833
Status
RX
Form
Chewable Tablets
Route
Oral
Composition / specifications
16 mg, 24 mg, 60 mg, or 160 mg of maropitant as maropitant citrate per tablet
Dogs
Indication
For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
Dosage
For Prevention of Acute Vomiting in dogs 2 - 7 months of age: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days. For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-785
Status
RX
Form
Tablet
Route
Oral
Composition / specifications
16 mg, 24 mg, 60 mg, or 160 mg of maropitant citrate per tablet
Dogs
Indication
For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
Dosage
For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days.
For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
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
141-262
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
Dogs (7 Months of Age and Older)
Indication
For the prevention of acute vomiting.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs (4 Months of Age and Older)
Indication
For the prevention of vomiting due to motion sickness.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight
once daily for up to 2 consecutive days
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg).
Dogs (2-7 Months)
Indication
For the prevention of acute vomiting.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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
141-263
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous, Intravenous
Species
Dog • Cat
Composition / specifications
Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate.
Dogs (2-4 Months of Age)
Indication
For Prevention and Treatment of Acute Vomiting in Dogs:
Dogs 2-4 Months of Age:
Dosage
Administer subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Dogs (4 Months of Age and Older)
Indication
For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents.
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time, 45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Indication
For Prevention and Treatment of Acute Vomiting in Dogs:
Dogs 2-4 Months of Age:
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Cats (4 Months of Age and Older)
Indication
For Treatment of Vomiting in Cats 4 Months of Age and Older
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
FOI Summary oA 200-833 Approved January 12, 2026.pdf
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
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. (Contraindication, High)
UCM050060.pdf • FOI summary • Official • Jan. 31, 2019
FDA FOI summary for application 141262
UCM453543.pdf • FOI summary • Official • Jan. 31, 2019
FDA FOI summary for application 141262
ucm062313.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141263
UCM314825.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141263
UCM314823.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141263
UCM484493.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141263
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
Official 121Clinical 9Manufacturer 0Marketing 0
Current Field Facts
contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restric… (Clinical, 2026-04-15)
contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restric… (Clinical, 2026-04-15)
contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restric… (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, Diarrhoea, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lethargy (… (Clinical, 2026-04-11)
usage: For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 M… (Clinical, 2026-04-15)
usage: For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 M… (Clinical, 2026-04-15)
usage: For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 M… (Clinical, 2026-04-11)
contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restric… (Official, 2026-04-22)
contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restric… (Official, 2026-02-12)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-06)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-05)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-04)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-03)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-02)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-08-01)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-07-31)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (Official, 2026-07-30)
indications: Dogs:Â For the prevention and treatment of acute vomiting.Cats:Â For the treatment of vomiting. For the prevention and treatment of acute vomiting in dogs. For… (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.
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.
Composition / specifications
16 mg, 24 mg, 60 mg, or 160 mg of maropitant as maropitant citrate per tablet
Dogs
Indication
For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
Dosage
For Prevention of Acute Vomiting in dogs 2 - 7 months of age: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days. For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer Maropitant Citrate Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
16 mg, 24 mg, 60 mg, or 160 mg of maropitant citrate per tablet
Dogs
Indication
For the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.
Dosage
For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days.
For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days.
Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
Dogs (7 Months of Age and Older)
Indication
For the prevention of acute vomiting.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs (4 Months of Age and Older)
Indication
For the prevention of vomiting due to motion sickness.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight
once daily for up to 2 consecutive days
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg).
Dogs (2-7 Months)
Indication
For the prevention of acute vomiting.
Dosage
Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days
Limitations
For oral use in dogs only.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate.
Dogs (2-4 Months of Age)
Indication
For Prevention and Treatment of Acute Vomiting in Dogs:
Dogs 2-4 Months of Age:
Dosage
Administer subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Dogs (4 Months of Age and Older)
Indication
For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents.
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time, 45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Indication
For Prevention and Treatment of Acute Vomiting in Dogs:
Dogs 2-4 Months of Age:
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Cats (4 Months of Age and Older)
Indication
For Treatment of Vomiting in Cats 4 Months of Age and Older
Dosage
Administer intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
For the prevention of acute vomiting. For the prevention of vomiting due to motion sickness. For Prevention and Treatment of Acute Vomiting in Dogs: Dogs 2-4 Months of Age:
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg). Federal law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.
Top Reported Reactions (openFDA)
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Digestive
Drooling (2) • Dog
Showing top 5 for Digestive.
Skin & allergy
Hives (2) • Dog
Showing top 5 for Skin & allergy.
Effectiveness
Lack of efficacy (endoparasite) - tapeworm (2) • Dog
Showing top 5 for Effectiveness.
Other
Hepatomegaly (4) • Cat
Hypokalaemia (3) • Cat
Anaphylaxis (3) • Dog
Wobbliness (2) • Cat
Vocalisation (2) • Dog
Show more (24)
Unclassifiable adverse event (2) • Dog
Syncope (2) • Cat
Respiratory tract infection NOS (2) • Dog
Reduced globulins (2) • Dog
Not drinking (2) • Dog
Muscle atrophy (2) • Dog
Loose stool (2) • Dog
Local erythema (2) • Dog
Limb non-weight bearing (2) • Dog
Injection site skin discolouration (2) • Dog
Hypoproteinaemia (2) • Dog
Fracture (2) • Dog
Elevated temperature (2) • Dog
Elevated gamma-glutamyl transferase (2) • Cat
Conjunctivitis (2) • Dog
Collapse NOS (2) • Cat
Cardiac enlargement (2) • Cat
Abdominal pain (2) • Cat
Abnormal radiograph finding (1) • Dog
Abnormal posture NOS (1) • Dog
Abnormal histology NOS (1) • Dog
Abnormal cytology (1) • Cat
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.
Neurogenic keratoconjunctivitis siccaCorneal ulcerNasal cavity disorder NOSAbnormal Schirmer tear test
Outcomes: Ongoing
Dog, ['Mastiff (unspecified)', 'Crossbred Canine/dog'], Male, 1 year, 29.574 kilogram • Drug: MSK, Tablet, Oral, Dose: 60 Milligram per animal, Frequency: 1 per day • Reactions: Hypotension, Not eating, Nausea, Drowsiness - systemic disorder, Pain NOS… • Outcome: Euthanized
Report ID: USA-USFDACVM-2026-US-014066
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 1.00 Year
Weight: 29.574 Kilogram
Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 60 Milligram per animal
Frequency: 1 per day
Reactions Reported:
HypotensionNot eatingNauseaDrowsiness - systemic disorderPain NOSVomitingRegurgitationDiscoloured urineCoughCrustHyperproteinaemiaHypoalbuminaemiaLeukocytosis NOSNeutrophiliaFluid in abdomen NOSSepticaemiaIntestinal disorder NOSAbdominal cavity disorder NOSElevated lactateAbnormal cytologyDuodenal ulcerIntestinal perforationDeath by euthanasiaLack of efficacy - NOSIntentional misuse
Outcomes: Euthanized
Dog, Male, 12 year, 4.536 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 4.50 mL per dose, Frequency: 1 per day • Reactions: Lateral recumbency, Agonal breathing, Death • Outcome: Died
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
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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.