Pet Drug Reports

Oclacitinib (Apoquel)adverse event reports that FDA received

Active ingredient

The name in brackets is a brand name with this active ingredient.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

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From February 2013 to June 2026, FDA received 30,692 adverse event reports that name a drug with oclacitinib as its active ingredient. Of the 30,692 reports, 28,974 (94.4%) are about dogs. 463 reports are about cats (1.5%).

In January to March 2026, FDA received 682 reports that name this drug. The signs that appear in the largest number of the 30,692 reports are "Lack of efficacy - NOS", "Vomiting" and "Lethargy". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 2.4% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 94.4% of the reports that name this drug, and 72.6% of all reports.

Since the last update of the FDA data

The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:

  • All species: from 595 to 682.
  • Dog: from 544 to 627.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 682 reports that name oclacitinib: 627 dog, 32 cat, 0 horse, 23 other or not given.

All updatesFeed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 30,692 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Lack of efficacy - NOS[the product did not have the expected effect]12.6%3,881 reports
  2. Vomiting11.4%3,499 reports
  3. Lethargy[unusually tired or inactive]10.1%3,093 reports
  4. Ineffective, atopy control[legacy FDA term: the product did not have the expected effect (atopy control)]8.8%2,707 reports
  5. Diarrhoea[diarrhea]7.7%2,374 reports
  6. Ineffective, loss of effect[legacy FDA term: the product did not have the expected effect (loss of effect)]5.9%1,807 reports
  7. Other abnormal test result NOS[abnormal laboratory result, type not specified]4.7%1,437 reports
  8. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]3.9%1,208 reports
  9. Seizure NOS[seizure, type not specified]3.8%1,155 reports
  10. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]3.4%1,056 reports
  11. Anorexia[not eating]3.3%998 reports
  12. Leucopenia NOS[low white blood cell count]2.8%867 reports
  13. Overdose[more than the labelled amount was given]2.8%865 reports
  14. Death by euthanasia[the animal was euthanized]2.7%842 reports
Show the next 16 signs
  1. Behavioural disorder NOS[behaviour change, type not specified]2.6%806 reports
  2. Polydipsia[drinking more than usual]2.5%761 reports
  3. Weight loss2.3%715 reports
  4. Decreased appetite2.3%711 reports
  5. Tablets, Abnormal[a product quality report, not a sign in an animal]2.3%702 reports
  6. Neutropenia[low neutrophil count]2.2%662 reports
  7. Polyuria[passing more urine than usual]2.2%660 reports
  8. Not eating2.1%654 reports
  9. Death2.1%633 reports
  10. Dermal mass2%601 reports
  11. Partial lack of efficacy[the product worked less well than expected]1.9%598 reports
  12. Inappropriate schedule of drug administration1.9%593 reports
  13. Aggression1.9%580 reports
  14. Underdose[less than the labelled amount was given]1.9%578 reports
  15. Anaemia NOS[low red blood cell count]1.9%577 reports
  16. Panting1.7%528 reports

The list shows 30 of 2,078 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog94.4%28,974
  • Cat1.5%463
  • Human exposure0.5%152
  • Horseunder 0.1%13
  • Lynxunder 0.1%2
  • Monkeyunder 0.1%2

The share is of all 30,692 reports that name oclacitinib. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog9,935 reports. Largest count in one month: 288 (Sep 2025)
Cat319 reports. Largest count in one month: 22 (Sep 2025)
Horse8 reports

No chart: no month has 5 or more reports.

Other or not given704 reports. Largest count in one month: 35 (Oct 2024)

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name oclacitinib, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20261,179600481,287
20252,76712321883,080
20242,4677922362,784
20231,511351891,636
20221,350122971,461
20211,3352031031,461
20201,7702431021,899
20191,836130671,916
20182,403400812,524
20173,952210744,047
20163,906180713,995
20152,666130502,729
20141,77450341,813
20135800260

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal15.4%4,723
  • Recovered with Sequela[recovered, with a lasting effect]0.2%69
  • Ongoing56.7%17,394
  • Died2.2%681
  • Euthanized2.8%845
  • Outcome Unknown19.3%5,937

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 30,692 reports that name oclacitinib.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue69.8%21,423
  • Lack of expected effectiveness13.4%4,122
  • Both safety and lack of expected effectiveness12.8%3,940
  • Manufacturing or product defect3.9%1,193
  • Otherunder 0.1%14

29,554 reports say if the event was serious. 31% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year1%297
  • 1 to 3 years16.3%5,002
  • 4 to 7 years30.8%9,447
  • 8 to 11 years28.5%8,736
  • 12 years and over11.9%3,641
  • Age not given11.6%3,569

Weight of the animal

  • Under 5 kg (11 lb)6.8%2,091
  • 5 to 9.9 kg (11 to 22 lb)19.9%6,110
  • 10 to 24.9 kg (22 to 55 lb)24.4%7,485
  • 25 to 44.9 kg (55 to 99 lb)30.5%9,358
  • 45 kg and over (99 lb and over)4.8%1,471
  • Weight not given13.6%4,177

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral89.3%27,420
  • Subcutaneous0.2%47
  • Topical0.1%33
  • Otherunder 0.1%13
  • Ophthalmicunder 0.1%8
  • Parenteralunder 0.1%6

Each bar is on a scale of 0 to 100%.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

  • Apoquel

What the Green Book records give

Applications with an approval in force
2
Approved species
Dogs
Dose forms
Chewable Tablets, Tablet
Routes
Oral
Sale
RX (prescription)
Earliest approval date in the records

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
ApoquelOclacitinibZoetis Inc.DogsNADA 141-345
Apoquel chewableOclacitinibZoetis Inc.DogsNADA 141-555

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Oclacitinib: adverse event reports that FDA received. https://petdrugreports.com/drug/oclacitinib/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.

Do the reports show that the drug caused the signs?

No. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received 2,947 reports in the 12 months to June 2026. It received 3,018 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 30,692 reports received from February 2013 to June 2026, 69.8% are about a safety issue only. 26.3% are about a lack of expected effectiveness, alone or with a safety issue. 3.9% are about a defect of the product or its package.