"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
- Patient Information:
Details with Side Effects
The most common adverse events in the clinical trial for women receiving Plan B® (levonorgestrel) 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® (levonorgestrel) users.
Adverse Events in ≥ to 5% of Women, by % Frequency
|Plan B® |
N = 977 (%)
|Heavier Menstrual Bleeding||13.8|
|Lighter Menstrual Bleeding||12.5|
Plan B® (levonorgestrel) demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
- Nausea: Occurred in 23% of women taking Plan B® (levonorgestrel) (compared to 50% with Yuzpe)
- Vomiting: Occurred in 6% of women taking Plan B® (levonorgestrel) (compared to 19% with Yuzpe)
DRUG ABUSE AND DEPENDENCE
There is no information about dependence associated with the use of Plan B® (levonorgestrel) .
Read the Plan B (levonorgestrel) Side Effects Center for a complete guide to possible side effects
Theoretically, the effectiveness of low-dose progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics. It is not known whether the efficacy of Plan B® (levonorgestrel) would be affected by these or any other medications.
Read the Plan B Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/24/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Plan B Information
Plan B - User Reviews
Plan B User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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