Daktarin Cream Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of miconazole nitrate/miconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with miconazole nitrate/miconazole cannot be reliably established in individual cases. Further, 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 observe in clinical practice.
Clinical Trial Data: Adverse reactions reported among 834 patients who received miconazole nitrate 2% cream and/or placebo cream base in 21 double-blind clinical trials are presented in Table 1 as follows. Included in the table are all adverse events considered to be related to study drug. A dash indicates that the adverse reaction was not reported by patients in the specified treatment group. (See Table 1.)

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Postmarketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience (Table 2). The frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very rare <1/10000, including isolated reports.
In Table 2, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 2.)

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