Xerese Side Effects

Generic name: acyclovir / hydrocortisone topical

Note: This document contains side effect information about acyclovir / hydrocortisone topical. Some of the dosage forms listed on this page may not apply to the brand name Xerese.

Some side effects of Xerese 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 acyclovir / hydrocortisone topical: topical cream

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

Stop using this medicine and call your doctor at once if you have severe burning, stinging, or irritation of treated skin.

Less serious side effects of acyclovir / hydrocortisone topical may include:

• mild burning or tingling after applying the medicine;

• skin dryness or flaking;

• bitter taste in your mouth after applying the medicine; or

• skin redness or discoloration;

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 acyclovir / hydrocortisone topical: topical cream

General

During clinical trials, most side effects were local and occurred around the application site.

Local

Local side effects have been reported most commonly and have included local skin reactions (less than 1%). Local skin reactions in the area of the application site have included drying or flaking of the skin, burning or tingling after application, erythema, pigmentation changes, and application site reaction (including signs and symptoms of inflammation). A high and cumulative irritation potential under occlusive and semiocclusive conditions was reported during a 21 day cumulative irritation study.

Hypersensitivity

Hypersensitivity side effects have included contact allergy, sensitization to hydrocortisone, and possible sensitization to the drug's base.

During a photosafety study, one subject developed a contact allergy to propylene glycol (one of the inactive ingredients of the cream base).

Dermatologic

Dermatologic side effects have included contact dermatitis.

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