Acanya Gel

Acanya Gel

Acanya Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Acanya (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) For Topical Use is an antibiotic used to treat acne. A common side effect of Acanya is skin irritation.

The recommended dosage of Acanya is a pea sized amount applied to your face once a day. Other topical antibiotics can interact with Acanya. Tell your doctor all medications you use. Do not get Acanya in your mouth, eyes, vagina, or on your lips. Do not use Acanya if you have Crohn's disease, ulcerative colitis, or severe diarrhea with past antibiotic use. If you are pregnant, only use Acanya if the potential benefit outweighs the potential risk to the fetus. Talk to your doctor about using Acanya if you are breastfeeding.

Our Acanya (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) For Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Acanya in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Acanya (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Acanya FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials 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 and may not reflect the rates observed in practice.

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, subjects 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 subjects 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.

Table 1: Local Skin Reactions -Percent of Subjects with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773)

  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
*Mod. = Moderate

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.

Read the entire FDA prescribing information for Acanya (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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