Otitis externa after Miconazole + Polymyxin B + Prednisolone in dogs

26 reports to the FDA describe otitis externa in dogs given Miconazole + Polymyxin B + Prednisolone. That is 2.4% 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.

26Reports

54%Marked serious

27%Recovered

0.0%Died or euthanised

52 daysTypical onset

How soon it started

Same day

2 11%

1–2 days

1 5.6%

3–7 days

0 0.0%

1–4 weeks

4 22%

Over a month

11 61%

How the animals did

Recovered

4 15%

Recovered with lasting effects

3 12%

Still unwell when reported

7 27%

Not known

12 46%

Problems reported at the same time

Itching

8 31%

Didn't work as expected

8 31%

Skin rash or irritation

6 23%

6 23%

6 23%

5 19%

4 15%

4 15%

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 otitis externa in dogs?: 26 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 52 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 Prednisone 41 reports · 0.5% of its reports
Otitis externa after Prednisolone 21 reports · 1.7% of its reports

All reported side effects of Miconazole + Polymyxin B + Prednisolone in dogs · Medicines most reported with otitis externa