Otitis externa after Cyclosporine (Atopica) in dogs

The FDA has received 140 reports of otitis externa in dogs after Cyclosporine. That is 0.9% 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.

140Reports

22%Marked serious

3.6%Recovered

2.9%Died or euthanised

20 daysTypical onset

How soon it started

Same day

9 36%

1–2 days

0 0.0%

3–7 days

0 0.0%

1–4 weeks

7 28%

Over a month

9 36%

How the animals did

Recovered

3 2.1%

Recovered with lasting effects

2 1.4%

Still unwell when reported

20 14%

Died

2 1.4%

Euthanised

2 1.4%

Not known

111 79%

Problems reported at the same time

40 29%

36 26%

31 22%

28 20%

Didn't work as expected

24 17%

Skin rash or irritation

24 17%

Diarrhea

15 11%

Pyoderma

14 10%

Age of the animals

Under 1 year

1–3 years

4–7 years

8–11 years

12+ years

About this medicine

Cyclosporine controls allergic skin disease and some immune conditions.

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

Questions owners ask

Can Cyclosporine cause otitis externa in dogs?: 140 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 20 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 Oclacitinib (Apoquel) 135 reports · 0.5% of its reports

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