Duac Topical Gel

SIDE EFFECTS

The following adverse reaction is described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical trials, 397 subjects used DUAC Gel once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris. All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The percentage of subjects that had symptoms present before treatment (at baseline) and during treatment is presented in Table 1.

Table 1: Local Skin Reactions With Use of DUAC Gel Combined Results From Five Trials (n = 397)

Symptom % of Subjects Using DUAC Gel With Symptom Present
Before Treatment (Baseline) During Treatment
Mild Moderate Severe Mild Moderate Severe
Erythema 28% 3% 0 26% 5% 0
Peeling 6% < 1% 0 17% 2% 0
Burning 3% < 1% 0 5% < 1% 0
Dryness 6% < 1% 0 15% 1% 0
(Percentages derived by number of subjects receiving DUAC Gel with symptom score/number of enrolled subjects receiving DUAC Gel).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of DUAC 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.

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Gel.

Read the Duac Topical Gel (clindamycin benzoyl peroxide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Erythromycin

Avoid using DUAC Gel in combination with erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

Concomitant Topical Medications

Concomitant topical acne therapies should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. DUAC Gel should be used with caution in patients receiving such agents.

Read the Duac Topical Gel Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Duac Topical Gel - User Reviews

Duac Topical Gel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Duac Topical Gel sorted by most helpful. Patient Discussions FAQs

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.


Women's Health

Find out what women really need.