Impaired hearing after Miconazole + Polymyxin B + Prednisolone in dogs

The FDA has received 96 reports of impaired hearing in dogs after Miconazole + Polymyxin B + Prednisolone. That is 8.8% of all reports for this medicine, compared with 0.0% across reports for all dog medicines, so it is reported unusually often with this medicine.

96Reports

96%Marked serious

34%Recovered

0.0%Died or euthanised

5 daysTypical onset

How soon it started

Same day

9 11%

1–2 days

14 17%

3–7 days

24 29%

1–4 weeks

17 21%

Over a month

18 22%

How the animals did

Recovered

13 14%

Recovered with lasting effects

20 21%

Still unwell when reported

47 49%

Not known

16 17%

Problems reported at the same time

Loss of hearing

15 16%

Deafness

12 13%

Behaviour change

10 10%

Didn't work as expected

10 10%

Partial deafness

4 4.2%

Underdose

4 4.2%

Lethargy

3 3.1%

Itching

3 3.1%

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 impaired hearing in dogs?: 96 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 5 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 Miconazole + Polymyxin B + Prednisolone in dogs · Medicines most reported with impaired hearing