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Benzaclin 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 Benzaclin.

For the Consumer

Applies to benzoyl peroxide / clindamycin topical: external gel, external kit

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad irritation where this drug is used.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where this drug is used.
  • Dry skin.
  • Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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%).[Ref]

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

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.[Ref]

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.[Ref]

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.[Ref]

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

References

1. "Product Information. BenzaClin Topical Gel (benzoyl peroxide-clindamycin topical)" Aventis Pharmaceuticals, Swiftwater, PA.

2. Breneman D, Savin R, VandePol C, Vamvakias G, Levy S, Leyden J "Double-blind, randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide / clindamycin topical gel in the treatment of patients with moderate to severe rosacea." Int J Dermatol 43 (2004): 381-7

3. Scissors B, Shwayder T "Topical clindamycin reproducibly causing tinnitus in a 14-year-old boy." J Am Acad Dermatol 54(5 Suppl) (2006): S243-4

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

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