ADVERSE REACTIONS
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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with EVOCLIN Foam.
The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing EVOCLIN Foam, and its vehicle is presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects
Adverse Reactions
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Number (%) of Subjects
|
|
EVOCLIN Foam
|
Vehicle Foam
|
N = 439
|
N = 154
|
Headache
|
12 (3%)
|
1 (1%)
|
Application site burning
|
27 (6%)
|
14 (9%)
|
Application site pruritus
|
5 (1%)
|
5 (3%)
|
Application site dryness
|
4 (1%)
|
5 (3%)
|
Application site reaction, not otherwise specified
|
3 (1%)
|
4 (3%)
|
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to EVOCLIN Foam.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of EVOCLIN Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorraghic diarrhea. 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.
Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.
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REPORTS OF SUSPECTED EVOCLIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Evoclin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Evoclin side effects / adverse reactions in 57 year old female
Reported by a consumer/non-health professional from United States on 2011-12-07
Patient: 57 year old female
Reactions: Therapeutic Response Unexpected, Hair Growth Abnormal
Suspect drug(s):
Evoclin
Other drugs received by patient: NO Concurrent Medication
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