Plan B One-Step
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Plan B One-Step
Plan B One-Step Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Plan B One-Step (levonorgestrel tablet) is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. People sometimes call it the "morning after pill." Plan B One-Step does not protect you against sexually transmitted diseases. Common side effects include nausea and vomiting, breast tenderness, changes in menstrual period, or headache.
The recommended dosage of Plan B One-Step is one pill as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. It can be used at any time during the menstrual cycle. If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose. Plan B One-Step should not be taken as regular birth control. Do not take Plan B One-Step if you are already pregnant. Consult your doctor before breastfeeding.
Our Plan B One-Step (levonorgestrel tablet) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Plan B One-Step in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.
Less serious side effects may include:
- nausea, diarrhea, or stomach pain;
- dizziness, tired feeling;
- breast pain or tenderness;
- changes in your menstrual periods; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Plan B One-Step (Levonorgestrel Tablet) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Plan B One-Step FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Trials Experience
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.
Plan B One-Step (levonorgestrel tablet) was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Plan B One-Step (levonorgestrel tablet) group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step (levonorgestrel tablet) group and 1.4% in Plan B group were lost to follow-up.
The most common adverse events ( > 10%) in the clinical trial for women receiving Plan B One-Step (levonorgestrel tablet) included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Plan B One-Step (levonorgestrel tablet) users.
Table 1 : Adverse Events in > 4% of Women, by % Frequency
| Most Common Adverse Events (MedDRA) | Plan B One-Step N = 1359 (%) |
| Heavier menstrual bleeding | 30.9 |
| Nausea | 13.7 |
| Lower abdominal pain | 13.3 |
| Fatigue | 13.3 |
| Headache | 10.3 |
| Dizziness | 9.6 |
| Breast tenderness | 8.2 |
| Delay of menses ( > 7 days) | 4.5 |
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Fatigue
Nervous System Disorders
Dizziness, Headache
Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
Read the entire FDA prescribing information for Plan B One-Step (Levonorgestrel Tablet) »
Additional Plan B One-Step Information
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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