Gyno-Pevaryl 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 econazole nitrate based on the comprehensive assessment of the available adverse event information. A causal relationship with econazole nitrate 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.
Clinical trial data: The safety of GYNO-PEVARYL Vaginal Ovules was evaluated in 3630 patients who participated in 32 clinical trials. Adverse reactions reported for ≥1% of patients treated with either GYNO-PEVARYL Vaginal Ovules in these studies are shown in Table 1. (See Table 1.)

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Adverse reactions that occurred in <1% of patients treated with either GYNO-PEVARYL Vaginal Ovules in the 32 clinical trials are listed 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). 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 3, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 3.)

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