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 EventsLevonorgestrelN=977 (%)
    Nausea23.1
    Abdominal Pain17.6
    Fatigue16.9
    Headache16.8
    Heavier Menstrual Bleeding13.8
    Lighter Menstrual Bleeding12.5
    Dizziness11.2
    Breast Tenderness10.7
    Other complaints9.7
    Vomiting5.6
    Diarrhea5.0

    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).
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