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Drug Information for Levonorgestrel Tablets, 0.75 mg (Rebel Distributors Corp.): ADVERSE REACTIONS
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The most common adverse events in the clinical trial for women receiving levonorgestrel tablets included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in =5% of levonorgestrel tablets users.
Table 3 Adverse Events in =5% of Women, by % Frequency Most Common Adverse Events LevonorgestrelN=977 (%) Nausea 23.1 Abdominal Pain 17.6 Fatigue 16.9 Headache 16.8 Heavier Menstrual Bleeding 13.8 Lighter Menstrual Bleeding 12.5 Dizziness 11.2 Breast Tenderness 10.7 Other complaints 9.7 Vomiting 5.6 Diarrhea 5.0
Levonorgestrel tablets demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
Nausea: Occurred in 23% of women taking levonorgestrel tablets (compared to 50% with Yuzpe)
Vomiting: Occurred in 6% of women taking levonorgestrel tablets (compared to 19% with Yuzpe)
- Drug Information Provided by National Library of Medicine (NLM).