Otitis externa after Oclacitinib (Apoquel) in dogs

The FDA has received 135 reports of otitis externa in dogs after Oclacitinib. That is 0.5% of all reports for this medicine, compared with 0.2% across reports for all dog medicines, so it is reported unusually often with this medicine.

135Reports

47%Marked serious

6.7%Recovered

6.7%Died or euthanised

48 daysTypical onset

How soon it started

Same day

11 12%

1–2 days

2 2.2%

3–7 days

3 3.3%

1–4 weeks

22 24%

Over a month

52 58%

How the animals did

Recovered

9 6.7%

Still unwell when reported

97 72%

Died

3 2.2%

Euthanised

6 4.4%

Not known

20 15%

Problems reported at the same time

Didn't work as expected

58 43%

Lethargy

23 17%

Skin rash or irritation

23 17%

22 16%

16 12%

16 12%

15 11%

13 9.6%

Age of the animals

Under 1 year

1–3 years

4–7 years

8–11 years

12+ years

About this medicine

Oclacitinib controls itching from allergies (tablet, a JAK inhibitor).

Products with this ingredient include Apoquel. The FDA hides brand names in its public data, so these reports cover every product with the same active ingredients.

Questions owners ask

Can Oclacitinib cause otitis externa in dogs?: 135 reports link the two, but a report alone does not prove the medicine was the cause: other illnesses, other medicines or coincidence can be involved. Your vet can judge it for your animal.
How soon after a dose was it reported?: In half of the reports with dates, it started within 48 days of the first dose.
What should I do?: Don't give another dose until you've spoken to your vet, and keep the packaging so you can tell them the product and dose. Your vet can also report it to the FDA (or you can, through the manufacturer or FDA form 1932a).

Otitis externa with similar medicines

Otitis externa after Cyclosporine (Atopica) 140 reports · 0.9% of its reports

All reported side effects of Oclacitinib in dogs · Medicines most reported with otitis externa