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Roxee Medication Guide

Oclacitinib Maleate

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

Reference facts
Reference refreshed
Aug 6, 2026, 7:46 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:46 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.
  • 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
Oclacitinib Maleate

Oclacitinib Maleate

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

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Oclacitinib Maleate

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Species commonly shown: Both, Dog.

Generic name
Oclacitinib Maleate
Brand names
apoquel®, apoquel® chewable
Manufacturer
Zoetis Inc.
Species
Both, Dog
Dosage forms
Tablet, Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
apoquel® apoquel® chewable
Dosage forms
Tablet Chewable Tablets

Indications / Uses

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Warnings / Contraindications

APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

  • APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

Side Effects

Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Seizure NOS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet, Chewable Tablets

Related Medications

Cyclosporine Same category: Allergies / Itching Diphenhydramine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Same category: Allergies / Itching Prednisone Same category: Allergies / Itching Famotidine Same category: GI

Related Conditions

Atopic Dermatitis (Canine Atopy) Demodicosis Pruritus (itching, undifferentiated)

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:

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

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:

  • APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches
  • The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents
  • Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia
  • wobbly/unsteady walking (1 reports)
  • Bloody diarrhoea (1 reports)
  • Blood in vomit (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.

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 Oclacitinib Maleate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-005375
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 19 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-005375
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-2026-US-005375
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), Bloody diarrhoea (1 reports), Blood in vomit (1 reports), Behavioral disorder (unspecified) (1 reports), Azotaemia (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (24 reports), Cat (8 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (2), ['Spaniel - King Charles Cavalier', 'Shih Tzu'] (1), Schnauzer (unspecified) (1), ['Shepherd Dog - Australian', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Oclacitinib Maleate 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

APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches, The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or othe, Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis,, wobbly/unsteady walking, Bloody diarrhoea

Call sooner if Escalation

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

Bottom line: Use this Oclacitinib Maleate 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-2026-US-005375 · 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, 10:06 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches
  • The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents
  • Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia
  • wobbly/unsteady walking
  • Bloody diarrhoea

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Bloody diarrhoea (1 reports)
  • Blood in vomit (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
Dog
Indication / use
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Form / route / dose
Form: Chewable Tablets, Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Zoetis Inc.
Form: Chewable Tablets, Tablet
Identifiers:
NADA: 141345 NADA: 141555 NDC Package: 54771-8721-1 NDC Package: 54771-8721-2 NDC Package: 54771-8721-3 NDC Package: 54771-8722-1 NDC Package: 54771-8722-2 NDC Package: 54771-8722-3 NDC Package: 54771-8723-1 NDC Package: 54771-8723-2 NDC Package: 54771-8723-3 NDC Package: 82712-2004-1 NDC Package: 82712-2004-2 NDC Package: 82712-2004-3 NDC Product: 54771 NDC Product: 82712
Source metadata:

Warnings / Contraindications

APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

  • High: APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.
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
64
Matching reports
64
Active filters
0
Reset
Drill into common report signals
Lack of efficacy - NOS (14) Lethargy (see also Central nervous system depression in Neurological) (9) Vomiting (9) Diarrhoea (8) Other (50) Digestive (20) Effectiveness (20) Neurologic (11)
Showing up to 50 matching reports. Narrow filters to inspect the remaining reports.

USA-USFDACVM-2026-US-014236

Received 2026-03-25 · MSK · MSK

Non-serious
Species
Dog
Breed
['Spaniel - King Charles Cavalier', 'Shih Tzu']
Size / weight
25-49 lb (12.24 Kilogram)
Age
Under 1 year (5.16 Month)
Sex
Male Neutered
Region
USA
Reactions
DiarrhoeaBloody stool
Body systems
DigestiveOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014001

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Schnauzer (unspecified)
Size / weight
Under 10 lb (4.45 Kilogram)
Age
8+ years (13.3 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingDiarrhoeaTense abdomenElevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)Low creatinineThrombocytosis
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-013823

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd Dog - Australian', 'Dog (unknown)']
Size / weight
50-99 lb (41.05 Kilogram)
Age
8+ years (10.4 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSLow thyroxine (T4)
Body systems
EffectivenessOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-013877

Received 2026-03-20 · MSK · MSK

Non-serious
Species
Dog
Breed
Poodle - Standard
Size / weight
50-99 lb (31.75 Kilogram)
Age
8+ years (8 Year)
Sex
Male Neutered
Region
USA
Reactions
ShakingWhiningHead tilt - ear disorder
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013850

Received 2026-03-20 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.99 Kilogram)
Age
8+ years (12.33 Year)
Sex
Male Neutered
Region
USA
Reactions
HyperpigmentationScratchingFungal skin infection NOSBacterial skin infection NOSSkin and tissue infection NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013334

Received 2026-03-20 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (42.8 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013216

Received 2026-03-19 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - Australian
Size / weight
50-99 lb (25.85 Kilogram)
Age
4-7 years (5.83 Year)
Sex
Male Neutered
Region
USA
Reactions
Partial lack of efficacySkin lesion NOSInappropriate elimination NOSPolyuriaPolydipsiaMedication error NOSLickingAbnormal histology NOS
Body systems
EffectivenessOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-013535

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Sex
Female Neutered
Region
USA
Reactions
Anaemia NOSLeukopenia NOSNeutropeniaLethargy (see also Central nervous system depression in Neurological)AnorexiaDiarrhoeaLymphadenopathyEnteritisAbnormal radiograph findingOther abnormal test result NOSUrinary tract infectionIncreased band neutrophiliaPain NOSWobblinessTiredness
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-013403

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (5.987 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Medication error NOS
Body systems
DigestiveOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012701

Received 2026-03-17 · MSK · MSK

Non-serious
Species
Dog
Breed
Coonhound (unspecified)
Size / weight
50-99 lb (36.696 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Unknown
Region
USA
Reactions
Leukopenia NOSNeutropeniaElevated alanine aminotransferase (ALT)Elevated cholesterol (total)
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014523

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (1 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
VomitingWheezingDroolingCoughTachypnoeaLethargy (see also Central nervous system depression in Neurological)Diarrhoea
Body systems
DigestiveOtherNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012722

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - Australian
Size / weight
25-49 lb (19.5 Kilogram)
Age
8+ years (9.9 Year)
Sex
Female Unknown
Region
USA
Reactions
WhiningAnxietyItchingUrine leakageLack of efficacy - NOS
Body systems
OtherBehaviorSkin & allergyEffectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-012291

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Lhasa Apso
Size / weight
10-24 lb (4.853 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Injection site mass NOSInjection site inflammationAbnormal cytology
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013064

Received 2026-03-14 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (39.009 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
DiarrhoeaVomitingAnorexiaSkin lumpLethargy (see also Central nervous system depression in Neurological)BLOOD CHEMISTRY ABNORMAL NOSDermatitisPancreatitis NOSLiver tumour
Body systems
DigestiveOtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-013526

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
['Beagle', 'Dog (unknown)']
Size / weight
25-49 lb (22.044 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (endoparasite) - roundworm NOSLack of efficacy (endoparasite) - hookwormExcessive appetiteAnal and rectal disorder NOS
Body systems
EffectivenessDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-011917

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Spaniel - Cocker American
Size / weight
25-49 lb (11.79 Kilogram)
Age
8+ years (12.5 Year)
Sex
Male Neutered
Region
USA
Reactions
LimpingLickingPain NOSHyperkeratosisBumps on skinLocal swelling (not application site)
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-011712

Received 2026-03-12 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (4.54 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-013281

Received 2026-03-09 · MSK · MSK

Serious
Species
Dog
Breed
Shiba Inu
Size / weight
10-24 lb (11.3 Kilogram)
Age
4-7 years (4.5 Year)
Sex
Female Neutered
Region
USA
Reactions
SquintingHorner's syndromeNeurogenic keratoconjunctivitis sicca (KCS)HyperaemiaOcular dischargeFacial paralysisEar canal disorderCryingHidingPain NOSTympanic alterationPalpebral disorder NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011047

Received 2026-03-09 · MSK · MSK

Non-serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (38.555 Kilogram)
Age
1-3 years (2.33 Year)
Sex
Female Neutered
Region
USA
Reactions
Leukopenia NOSNeutropenia
Body systems
Other
Outcomes
Outcome Unknown

CAN-USFDACVM-2026-CA-000026

Received 2026-03-05 · MSK · MSK

Serious
Species
Dog
Breed
Collie - Border
Size / weight
25-49 lb (13.7 Kilogram)
Age
1-3 years (2.3 Year)
Sex
Male Neutered
Region
USA
Reactions
Otitis externaLack of efficacy (bacteria) - NOSEar discharge
Body systems
OtherEffectiveness
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010329

Received 2026-03-04 · MSK · MSK

Non-serious
Species
Dog
Breed
['Shih Tzu', 'Dog (unknown)']
Size / weight
10-24 lb (10.16 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
EmesisLack of efficacy - NOS
Body systems
DigestiveEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-010178

Received 2026-03-03 · MSK · MSK

Serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (5.579 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
UrolithiasisUrinary tract infectionBlood in urine
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-013719

Received 2026-02-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (33.75 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
Vomiting bile
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010486

Received 2026-02-24 · MSK · MSK

Non-serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (13.11 Kilogram)
Age
8+ years (15.4 Year)
Sex
Male Neutered
Region
USA
Reactions
Partial lack of efficacy
Body systems
Effectiveness
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-006293

Received 2026-02-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (41.549 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOSDermal massEar canal inflammationElevated serum alkaline phosphatase (ALP)HyperproteinaemiaHypochloraemia
Body systems
EffectivenessOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-006566

Received 2026-02-12 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (7.802 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Anaemia NOSNeutrophiliaThrombocytosisOther abnormal test result NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-006095

Received 2026-02-11 · MSK · MSK

Serious
Species
Dog
Breed
['American Pit Bull Terrier', 'Dog (unknown)']
Size / weight
50-99 lb (41.73 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Neutered
Region
USA
Reactions
HypersalivationDeathSeizure NOSDiarrhoeaPericardial effusionDigestive tract disorder NOSHepatopathyNephropathyFemale reproductive tract disorder NOSPulmonary haemorrhageGastric dilationLateral recumbencySkin disorders NOSPetechiae NOSNecropsy performedAsystoleCyanotic mucous membranes
Body systems
DigestiveOtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-005958

Received 2026-02-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.8 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Diarrhoea
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-005375

Received 2026-02-05 · MSK · MSK

Non-serious
Species
Dog
Breed
['Hound (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (34.69 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Allergic dermatitisEar infection NOSAbnormal cytologyOther ear disorder NOSApplication site painApplication site reddeningApplication site inflammation
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-007782

Received 2026-01-28 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
100+ lb (47.62 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Urinary bladder disorder NOSAnaemia NOSSepticaemiaUnresponsive to stimuliDeath by euthanasiaEmphysema NOS (see Respiratory for pulmonary emphysema)
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-003069

Received 2026-01-22 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
100+ lb (47.62 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Urinary bladder disorder NOSAnaemia NOSSepticaemiaUnresponsive to stimuliDeath by euthanasiaEmphysema NOS (see Respiratory for pulmonary emphysema)
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2025-US-075257

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
Terrier (unspecified)
Size / weight
Under 10 lb (3.36 Kilogram)
Age
4-7 years (6.9 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-075415

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
Chihuahua
Size / weight
Under 10 lb (3.583 Kilogram)
Age
1-3 years (1.5 Year)
Sex
Female Unknown
Region
USA
Reactions
Leucocytosis NOSElevated bile acidsOverdose
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-075064

Received 2025-12-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Boston
Size / weight
10-24 lb (8.16 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
RashAlopecia
Body systems
Skin & allergy
Outcomes
Ongoing

USA-USFDACVM-2025-US-075305

Received 2025-12-22 · MSK · MSK

Non-serious
Species
Dog
Breed
Bulldog - English
Size / weight
50-99 lb (29.94 Kilogram)
Age
8+ years (11.2 Year)
Sex
Female Unknown
Region
USA
Reactions
Urinary incontinence
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-075291

Received 2025-12-22 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (44.45 Kilogram)
Age
8+ years (10.9 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOSSeizure NOSOther abnormal test result NOSAtaxiaMusculoskeletal disorder NOSElevated serum alkaline phosphatase (ALP)
Body systems
EffectivenessNeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074714

Received 2025-12-22 · MSK · MSK

Non-serious
Species
Dog
Breed
Bulldog - English
Size / weight
50-99 lb (44.906 Kilogram)
Age
8+ years (8.58 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy (protozoa) - GiardiaLack of efficacy (endoparasite) - hookworm
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-075270

Received 2025-12-19 · MSK · MSK

Serious
Species
Dog
Breed
['Pointer (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (35.698 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSDeathLocal erythemaUnderdoseLethargy (see also Central nervous system depression in Neurological)Blood in vomit
Body systems
EffectivenessOtherNeurologicDigestive
Outcomes
Died

USA-USFDACVM-2025-US-074452

Received 2025-12-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - West Highland White
Size / weight
10-24 lb (6.53 Kilogram)
Age
8+ years (8 Year)
Sex
Female Unknown
Region
USA
Reactions
Partial lack of efficacy
Body systems
Effectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-074392

Received 2025-12-17 · MSK · MSK

Non-serious
Species
Dog
Breed
['Shepherd Dog - German', 'Siberian Husky']
Size / weight
50-99 lb (34.019 Kilogram)
Age
8+ years (9 Year)
Sex
Female Unknown
Region
USA
Reactions
Difficulty going up/down stairsLying downHigh leg gait
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-074296

Received 2025-12-17 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever (unspecified)', 'Retriever - Labrador']
Size / weight
50-99 lb (35.879 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSDrunken gaitUnable to walk
Body systems
BehaviorOther
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074486

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (29.8 Kilogram)
Age
4-7 years (5.1 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-074416

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (33.339 Kilogram)
Age
1-3 years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Aggression
Body systems
Behavior
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074249

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Boston
Size / weight
25-49 lb (17.83 Kilogram)
Age
8+ years (9.75 Year)
Sex
Male Neutered
Region
USA
Reactions
ProteinuriaHypoalbuminaemia
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-073869

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (7.7 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Decreased urine concentrationProteinuriaInappropriate urinationWeight loss
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-074244

Received 2025-12-15 · MSK · MSK

Non-serious
Species
Dog
Breed
Shepherd Dog - Australian
Size / weight
50-99 lb (29.937 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)
Body systems
Neurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074363

Received 2025-12-14 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (37.8 Kilogram)
Age
8+ years (11.3 Year)
Sex
Male Neutered
Region
USA
Reactions
WoundLick granulomaExternal ear disorder NOSPerianal inflammationMusculoskeletal disorder NOSHeavy breathingPantingDecreased appetiteScootingActive urine sedimentFungal skin infection NOSSkin lesion NOSLack of efficacy - NOS
Body systems
OtherDigestiveEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2025-US-074324

Received 2025-12-09 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Poodle - Standard']
Size / weight
10-24 lb (10.841 Kilogram)
Age
8+ years (10.4 Year)
Sex
Female Neutered
Region
USA
Reactions
Abnormal red blood cellIncreased band neutrophiliaOverdose
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-072836

Received 2025-12-08 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
Under 10 lb (3.774 Kilogram)
Age
8+ years (18 Year)
Sex
Female Unknown
Region
USA
Reactions
KnucklingOverdose
Body systems
Other
Outcomes
Ongoing

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

Tracked signals
32
Reported cases
32
Serious reports
19
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Bloody diarrhoea, Blood in vomit Skin & allergy (1) · Hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Behavioral disorder (unspecified), Anxiety, Aggression Other (24) · Blood in urine, BLOOD CHEMISTRY ABNORMAL NOS, Bacterial skin infection NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Dog 1
Digestive 1 Dog 1
Behavior 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Dog (24) Cat (8)

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

apoquel® chewable SPL · SPL apoquel® SPL · SPL N-141555-Q-0004-OT-AA_foi.pdf FOI · FOI

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

2

apoquel® chewable

SPL · SPL

Open original
FDA Structured Product Label

apoquel® chewable

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
141-555
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet

Dogs

Indication

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Dosage

The dose is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy.

apoquel®

SPL · SPL

Open original
FDA Structured Product Label

apoquel®

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
141-345
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet

Dogs

Indication
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Dosage
Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
Limitations
APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

N-141555-Q-0004-OT-AA_foi.pdf

FOI · FOI

Open original

UCM363901.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, 7:46 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.
  • 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: Dog
Rx/OTC: RX
Form/route: Chewable Tablets, Tablet • Oral
Applications: NADA 141-555 • NADA 141-345
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 204 • Cat 0 • View
Case summaries: 64 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: L20.9
Atopic dermatitis, unspecified

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
  • APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Bloody diarrhoea (1) Blood in vomit (1) Behavioral disorder (unspecified) (1) Azotaemia (1) Asystole (1) Aspiration pneumonia (1) Arrhythmia (1)

Identifiers & Packages

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

Identifiers
NADA: 141345 NADA: 141555 NDC Package: 54771-8721-1 NDC Package: 54771-8721-2 NDC Package: 54771-8721-3 NDC Package: 54771-8722-1 NDC Package: 54771-8722-2 NDC Package: 54771-8722-3 NDC Package: 54771-8723-1 NDC Package: 54771-8723-2 NDC Package: 54771-8723-3 NDC Package: 82712-2004-1 NDC Package: 82712-2004-2 NDC Package: 82712-2004-3 NDC Product: 54771 NDC Product: 82712
Package NDC Product NDC Form / Route Status
54771-8721-1 54771 -
54771-8721-2 54771 -
54771-8721-3 54771 -
54771-8722-1 54771 -
54771-8722-2 54771 -
54771-8722-3 54771 -
54771-8723-1 54771 -
54771-8723-2 54771 -
54771-8723-3 54771 -
82712-2004-1 82712 -
82712-2004-2 82712 -
82712-2004-3 82712 -

Enriched Documents

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

  • N-141555-Q-0004-OT-AA_foi.pdf • FOI summary • Official • Oct. 17, 2024
    FDA FOI summary for application 141555
  • UCM363901.pdf • FOI summary • Official • Aug. 17, 2023
    FDA FOI summary for application 141345

Data Sources & Change Log

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

Official 14 Clinical 6 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclo… (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • 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, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Clinical, 2026-04-11)
  • usage: Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Clinical, 2026-04-16)
  • contraindications: APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclo… (Official, 2026-04-22)
  • contraindications: APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclo… (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Official, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Diarrhoea, Lethargy (see also Central nervous system depression… (Official, 2026-02-12)
  • usage: Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-22)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-17)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-15)
  • usage: Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-15)
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 2026-04-17 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-17 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-17 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-17 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-17 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-17 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-16 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:07 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-16 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:05 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
apoquel® chewable
RX
Oclacitinib
Chewable Tablets • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-555 Approved Oct 17, 2024
apoquel®
RX
Oclacitinib
Tablet • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-345 Approved Aug 17, 2023

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet
Dogs
Indication

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Dosage

The dose is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet
Dogs
Indication
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Dosage
Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
Limitations
APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

FDA page: Open in Animal Drugs @ FDA

Usage

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

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) • Dog Bloody diarrhoea (1) • Dog Blood in vomit (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog Anxiety (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Blood in urine (1) • Cat BLOOD CHEMISTRY ABNORMAL NOS (1) • Dog Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Cat Asystole (1) • Dog
Show more (19)
Aspiration pneumonia (1) • Cat Arrhythmia (1) • Cat Application site reddening (1) • Dog Application site pain (1) • Dog Application site inflammation (1) • Dog Anuria (1) • Cat Anal and rectal disorder NOS (1) • Dog Anaemia NOS (1) • Cat Allergic dermatitis (1) • Dog Agitation (1) • Dog Acute renal failure (1) • Cat Acute pancreatitis (1) • Dog Active urine sediment (1) • Dog Accidental exposure (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal red blood cell (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Dog Abnormal cytology (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.

Dog, ['Spaniel - King Charles Cavalier', 'Shih Tzu'], Male, 5.16 month, 12.24 kilogram • Drug: MSK, Unknown • Reactions: Diarrhea, Bloody stool • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014236
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.16 Month
  • Weight: 12.240 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Diarrhea Bloody stool
Outcomes: Recovered/Normal

Dog, Schnauzer (unspecified), Male, 13.3 year, 4.45 kilogram • Drug: MSK, Tablet, Oral • Reactions: Vomiting, Diarrhea, Tense abdomen, Elevated serum alkaline phosphatase, Elevated alanine aminotransferase… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014001
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.30 Year
  • Weight: 4.450 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Vomiting Diarrhea Tense abdomen Elevated serum alkaline phosphatase Elevated alanine aminotransferase Low creatinine Thrombocytosis
Outcomes: Ongoing

Dog, ['Shepherd Dog - Australian', 'Dog (unknown)'], Male, 10.4 year, 41.05 kilogram • Drug: MSK, Tablet, Oral • Reactions: Lack of efficacy - NOS, Low thyroxine • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013823
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.40 Year
  • Weight: 41.050 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Lack of efficacy - NOS Low thyroxine
Outcomes: Ongoing

Dog, Poodle - Standard, Male, 8 year, 31.75 kilogram • Drug: MSK, Unknown, Frequency: 1 per day • Reactions: Shaking, Whining, Head tilt - ear disorder • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013877
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 31.750 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Frequency: 1 per day
Reactions Reported:
Shaking Whining Head tilt - ear disorder
Outcomes: Ongoing

Dog, Shih Tzu, Male, 12.33 year, 6.99 kilogram • Drug: MSK, Unknown • Reactions: Hyperpigmentation, Scratching, Fungal skin infection NOS, Bacterial skin infection NOS, Skin and tissue infection NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013850
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.33 Year
  • Weight: 6.990 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Hyperpigmentation Scratching Fungal skin infection NOS Bacterial skin infection NOS Skin and tissue infection NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 8 year, 42.8 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-013334
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 42.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 5.83 year, 25.85 kilogram • Drug: MSK, Tablet, Oral, Frequency: 24 per hour • Reactions: Partial lack of efficacy, Skin lesion NOS, Inappropriate elimination NOS, Polyuria, Polydipsia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013216
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.83 Year
  • Weight: 25.850 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Frequency: 24 per hour
Reactions Reported:
Partial lack of efficacy Skin lesion NOS Inappropriate elimination NOS Polyuria Polydipsia Medication error NOS Licking Abnormal histology NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Female • Drug: MSK, Unknown • Reactions: Anaemia NOS, Leukopenia NOS, Neutropenia, Tiredness (lethargy), Loss of appetite… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013535
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Anaemia NOS Leukopenia NOS Neutropenia Tiredness (lethargy) Loss of appetite Diarrhea Lymphadenopathy Enteritis Abnormal radiograph finding Other abnormal test result NOS Urinary tract infection Increased band neutrophilia Pain NOS Wobbliness
Outcomes: Ongoing

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

Overdose Information

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Storage & Handling

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