Head shake - ear disorder after Spinosad (Comfortis) in dogs

The FDA has received 39 reports of head shake - ear disorder in dogs after Spinosad. That is 0.1% of all reports for this medicine, compared with 0.1% across reports for all dog medicines, so it is reported less often than average with this medicine.

39Reports

33%Marked serious

72%Recovered

2.6%Died or euthanised

7 daysTypical onset

How soon it started

Same day

11 39%

1–2 days

2 7.1%

3–7 days

2 7.1%

1–4 weeks

2 7.1%

Over a month

11 39%

How the animals did

Recovered

16 41%

Recovered with lasting effects

12 31%

Still unwell when reported

3 7.7%

Euthanised

1 2.6%

Not known

7 18%

Problems reported at the same time

12 31%

11 28%

8 21%

7 18%

5 13%

4 10%

4 10%

External ear disorder

4 10%

Age of the animals

Under 1 year

1–3 years

4–7 years

8–11 years

12+ years

About this medicine

Spinosad kills fleas; monthly chewable.

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

Questions owners ask

Can Spinosad cause head shake - ear disorder in dogs?: 39 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 7 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).

All reported side effects of Spinosad in dogs · Medicines most reported with head shake - ear disorder