Benzaclin Side Effects
Please note - some side effects for Benzaclin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Benzaclin - for the Consumer
Benzaclin Gel
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Benzaclin Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Benzaclin Gel:Dry skin; flushing; itching; redness; sunburn.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; peeling; severe diarrhea; stomach cramps or pain.
BenzaClin Care Kit Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using BenzaClin Care Kit Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using BenzaClin Care Kit Gel:Dry skin; flushing; itching; redness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; burning, peeling, or irritation at the application site; severe diarrhea; stomach cramps or pain.
Benzaclin Side Effects - for the Professional
BenzaClin
During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups.
| Local Adverse Events - all causalities in >/= 1% of patients |
|||
|---|---|---|---|
| BenzaClin n = 420 |
Vehicle n = 168 |
||
| Application site reaction | 13 (3%) | 1 (<1%) | |
| Dry skin | 50 (12%) | 10 (6%) | |
| Pruritus | 8 (2%) | 1 (<1%) | |
| Peeling | 9 (2%) | - | |
| Erythema | 6 (1%) | 1 (<1%) | |
| Sunburn | 5 (1%) | - | |
The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.
Hypersensitivity/allergic reactions (including facial swelling and urticaria) have been reported in post-marketing use with BenzaClin Topical Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
TopSide Effects by Body System
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.
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