Head shake - ear disorder after Miconazole + Polymyxin B + Prednisolone in dogs

The FDA has received 23 reports of head shake - ear disorder in dogs after Miconazole + Polymyxin B + Prednisolone. That is 2.1% of all reports for this medicine, compared with 0.1% across reports for all dog medicines, so it is reported unusually often with this medicine.

23Reports

43%Marked serious

43%Recovered

0.0%Died or euthanised

1 daysTypical onset

How soon it started

Same day

7 37%

1–2 days

4 21%

3–7 days

0 0.0%

1–4 weeks

3 16%

Over a month

5 26%

How the animals did

Recovered

7 30%

Recovered with lasting effects

3 13%

Still unwell when reported

5 22%

Not known

8 35%

Problems reported at the same time

6 26%

5 22%

5 22%

4 17%

4 17%

Didn't work as expected

4 17%

Ear discharge

4 17%

Application site reaction

3 13%

Age of the animals

Under 1 year

1–3 years

4–7 years

8–11 years

12+ years

About this medicine

Prednisolone reduces inflammation and immune activity.

Steroids commonly cause increased thirst, urination and appetite, especially at higher doses.

Questions owners ask

Can Miconazole + Polymyxin B + Prednisolone cause head shake - ear disorder in dogs?: 23 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 1 day 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).

Head shake - ear disorder with similar medicines

Head shake - ear disorder after Prednisone 40 reports · 0.4% of its reports

All reported side effects of Miconazole + Polymyxin B + Prednisolone in dogs · Medicines most reported with head shake - ear disorder