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 clinical trials of a drug cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), 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. Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243)
|Before Treatment (Baseline)||During Treatment||End of Treatment (Week 12)|
|Burning||5||< 1||< 1||7||1||< 1||3||< 1||0|
|Stinging||5||< 1||0||7||0||< 1||3||0||< 1|
|*Mod. = Moderate|
Because postmarketing adverse 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 hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.