Acanya Side Effects
Please note - some side effects for Acanya may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Acanya - for the Consumer
Acanya 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 Acanya Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Acanya Gel:Mild burning, dryness, itching, peeling, redness, or stinging of the skin.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody or watery stools; severe burning, dryness, itching, peeling, redness, stinging, or swelling of the skin; severe or persistent diarrhea; stomach cramps or pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAcanya Side Effects - for the Professional
Acanya
Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.
The following selected adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).
During clinical trials, patients were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of patients that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown in Table 1.
| Before Treatment (Baseline) |
Maximum During Treatment |
End of Treatment (Week 12) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Mild | Mod.* | Severe | Mild | Mod.* | Severe | Mild | Mod.* | Severe | |
|
|||||||||
| Erythema | 22 | 4 | 0 | 25 | 5 | < 1 | 15 | 2 | 0 |
| Scaling | 8 | < 1 | 0 | 18 | 3 | 0 | 8 | 1 | 0 |
| Itching | 10 | 2 | 0 | 15 | 2 | 0 | 6 | < 1 | 0 |
| Burning | 3 | < 1 | 0 | 8 | 2 | 0 | 2 | < 1 | 0 |
| Stinging | 2 | < 1 | 0 | 6 | 1 | 0 | 1 | < 1 | 0 |
Postmarketing Experience
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.
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 - for Healthcare Professionals
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.
TopMore Acanya resources
- Acanya Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Acanya Prescribing Information (FDA)
- Acanya Consumer Overview
- BenzaClin Prescribing Information (FDA)
- Benzaclin Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Benzaclin Consumer Overview
- Duac Prescribing Information (FDA)
- Duac Gel MedFacts Consumer Leaflet (Wolters Kluwer)
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