Otitis externa after Ketoconazole in dogs

The FDA has received 43 reports of otitis externa in dogs after Ketoconazole. That is 1.9% 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.

43Reports
74%Marked serious
14%Recovered
7.0%Died or euthanised
64 daysTypical onset
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How soon it started

Same day
1 3.3%
1–2 days
2 6.7%
3–7 days
3 10%
1–4 weeks
6 20%
Over a month
18 60%

How the animals did

Recovered
5 12%
Recovered with lasting effects
1 2.3%
Still unwell when reported
15 35%
Died
2 4.7%
Euthanised
1 2.3%
Not known
19 44%

Problems reported at the same time

Age of the animals

Under 1 year
1
1–3 years
11
4–7 years
14
8–11 years
8
12+ years
8

About this medicine

Type: medicine.

Questions owners ask

Can Ketoconazole cause otitis externa in dogs?
43 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 64 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

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