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Plan B (Levonorgestrel) - Side Effects and Adverse Reactions

 


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ADVERSE REACTIONS

The most common adverse events in the clinical trial for women receiving Plan B® 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 Plan B® users.

Table 3 Adverse Events in >/=5% of Women, by % Frequency
Most Common Adverse Events Plan B®
Levonorgestrel
N=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

Plan B® demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:

  • Nausea: Occurred in 23% of women taking Plan B® (compared to 50% with Yuzpe)
  • Vomiting: Occurred in 6% of women taking Plan B® (compared to 19% with Yuzpe)

DRUG ABUSE AND DEPENDENCE

There is no information about dependence associated with the use of Plan B® .

Page last updated: 2006-12-08

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