Evra Adverse Reactions

norelgestromin + ethinylestradiol




Zuellig Pharma
Full Prescribing Info
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 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 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 each table, 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 < 1/1,000; Very rare < 1/10000, including isolated reports.
In Table 5, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 5.)

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