Evra 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 norelgestromin/ethinyl estradiol based on the comprehensive assessment of the available adverse event information. A causal relationship with norelgestromin/ethinyl estradiol usually 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 EVRA was evaluated in 3330 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy. These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medication and provided safety data.
The most common adverse reactions reported during clinical trials were breast symptoms, headache, application site disorder and nausea. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, breast engorgement and female breast pain), nausea, headache and emotional lability.
Adverse reactions reported by ≥1% of EVRA-treated subjects in these trials are shown in Table 3. (See Table 3.)

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Additional adverse reactions that occurred in <1% of EVRA-treated subjects in the previously mentioned clinical trial dataset are listed in Table 4. (See Table 4.)

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Postmarketing data: Additional adverse reactions first identified during postmarketing experience with EVRA are included in Table 5. 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; Not known Cannot be estimated from the available data.
In Table 5, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 5.)

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