Cort-Biotic Side Effects

Generic name: hydrocortisone / neomycin / polymyxin b otic

Note: This document contains side effect information about hydrocortisone / neomycin / polymyxin b otic. Some of the dosage forms listed on this page may not apply to the brand name Cort-Biotic.

Some side effects of Cort-Biotic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to hydrocortisone / neomycin / polymyxin b otic: otic solution, otic suspension

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydrocortisone / neomycin / polymyxin b otic: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

• severe burning, stinging, or other irritation when using the medication;

• new signs of infection;

• hearing loss; or

• urinating less than usual or not at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hydrocortisone / neomycin / polymyxin b otic: otic solution, otic suspension

Hypersensitivity

Hypersensitivity reactions associated with the anti-infective component of this drug include allergic sensitization manifested by itching and swelling. More serious reactions such as anaphylaxis have rarely been reported.

Neomycin is known to cause contact sensitivity.

Dermatologic

Dermatologic side effects associated with the use of topical corticosteroids have included burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

General

Stinging and burning have been rarely reported when this drug has entered the middle ear.

Nervous system

Neomycin-polymyxin B containing ear drops contributed to sensorineural hearing loss in chronic otitis media patients receiving treatment for extended periods of time.

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