Nizoral 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 ketoconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with ketoconazole 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 ketoconazole (Nizoral) 2% Cream was evaluated in 1079 subjects in 30 clinical trials where ketoconazole (Nizoral) 2% Cream was applied topically to the skin.
Adverse reactions that were reported for ≥1% of ketoconazole (Nizoral) 2% Cream-treated subjects are shown in Table 1. (See Table 1.)

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Additional adverse reactions that occurred in <1% of ketoconazole (Nizoral) 2% Cream-treated subjects in the clinical datasets are listed in Table 2. (See Table 2.)

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Post-marketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during post-marketing (Table 3). In the 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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