Androgel Adverse Reactions

At the recommended dosage, the most common adverse reactions observed with ANDROGEL 16.2 mg/g gel were psychiatric disorders and skin reactions at the application site.
The table as follows shows the adverse reactions reported during the 182-day double-blind period of a Phase III clinical trial of ANDROGEL 16.2 mg/g gel and more frequently in the ANDROGEL 16.2 mg/g gel treated group (n=234) than in the placebo treated group (n=40). (See Table 1.)

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Due to the presence of alcohol in this medicine, frequent application to the skin may cause skin irritation and dryness.
The following adverse reactions have been identified during the post-approval period of ANDROGEL 16.2 mg/g. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a clear causal relationship with drug exposure. (See Table 2.)

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The following adverse reactions were identified during the post-approval period for products containing testosterone. (See Table 3.)

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ADR Reporting Statement: Important: Immediately seek medical attention at the first sign of adverse drug reaction.