Acanya Side Effects

Generic name: benzoyl peroxide / clindamycin topical

Note: This document contains side effect information about benzoyl peroxide / clindamycin topical. Some of the dosage forms listed on this page may not apply to the brand name Acanya.

Some side effects of Acanya 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 benzoyl peroxide / clindamycin topical: topical gel, topical kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking benzoyl peroxide / clindamycin 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 any of these serious side effects:

• severe redness, burning, stinging, or peeling of treated skin areas; or

• diarrhea that is watery or bloody.

Less serious side effects of benzoyl peroxide / clindamycin topical may include:

• mild burning or stinging;

• itching or tingly feeling;

• dryness or peeling of treated skin; or

• redness or other irritation.

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 benzoyl peroxide / clindamycin topical: topical gel, topical kit

Dermatologic

Dermatologic side effects have included dry skin (12%), pruritus (2%), peeling (2%), erythema (1%), and sunburn (1%) and reactions at the application site (3%).

Application site reactions including burning, stinging, and pruritus are frequently reported following topical application of the combination of 5% benzoyl peroxide and 1% clindamycin.

Gastrointestinal

Pseudomembranous colitis may be revealed upon endoscopic examination; stool cultures for Clostridium difficile, and stool assays for Clostridium difficile toxin may be helpful diagnostically.

Gastrointestinal side effects have been reported with the use of topical clindamycin. Diarrhea, bloody diarrhea, and colitis, including pseudomembranous colitis, have occurred. Colitis usually manifests as severe persistent diarrhea, severe abdominal cramps, and passage of blood and mucous. Some cases of colitis have been fatal. Due to the possible serious nature of pseudomembranous colitis, patients should be advised to discontinue clindamycin therapy and consult a physician if diarrhea occurs.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and allergic reactions leading to hospitalization during postmarketing experience.

Other

A 14-year-old boy developed reproducible ringing in his right ear and hearing loss while using topical clindamycin and after discontinuing use. He underwent a complete physical exam and labs which failed to find a cause for his symptoms. The patient was restarted on benzoyl peroxide / clindamycin topical and the ringing in his ear increased. He was told to stop all medications and was started on methylprednisolone. The tinnitus decreased in 1 to 2 days with no improvement in the hearing deficit. After the third time he was restarted on benzoyl peroxide/clindamycin gel, the tinnitus returned at an increased level together with right-sided headaches within 1 to 2 days. The patient again stopped using the benzoyl peroxide and clindamycin gel and the tinnitus returned to a low level over 1 to 2 days. It is believed that the clindamycin component played a part in this patient's tinnitus and hearing loss.

Other side effects have included one case of ringing in the ear and partial hearing loss believed to be caused by clindamycin.

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