The following adverse reaction is described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
- Colitis [see WARNINGS AND PRECAUTIONS].
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|
|Burning||3%||< 1%||0||5%||< 1%||0|
|(Percentages derived by number of subjects receiving DUAC Gel with symptom score/number of enrolled subjects receiving DUAC Gel).|
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.