Daktarin Oral Gel 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 based on the comprehensive assessment of the available adverse event information. A causal relationship with 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 observed in clinical practice.
The safety of DAKTARIN Oral Gel was evaluated in 88 adult patients with oral candidiasis or oral mycoses who participated in one randomized, active-controlled, double-blind clinical trial and three open-label clinical trials. These patients took at least one dose of DAKTARIN Oral Gel and provided safety data.
Adverse reactions reported by DAKTARIN Oral Gel-treated adult patients in the four clinical trials are shown in Table 1. (See Table 1.)

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The safety of DAKTARIN Oral Gel was evaluated in 23 pediatric patients with oral candidiasis who participated in one randomized, active-controlled, open-label clinical trial in pediatric patients aged ≤ 1 month to 10.7 years. These patients took at least one dose of DAKTARIN Oral Gel and provided safety data.
Adverse reactions reported by DAKTARIN Oral Gel-treated pediatric patients in the one clinical trial are presented in Table 2. (See Table 2.)

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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 3). In each table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and < 1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000, including isolated reports.
In Table 3, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 3.)

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