Plan B Side Effects
Generic Name: levonorgestrel
Please note - some side effects for Plan B may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Plan B - for the Consumer
Plan B
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Plan B:
Seek medical attention right away if any of these SEVERE side effects occur when using Plan B:Breast tenderness; changes in menstrual flow; diarrhea; dizziness; headache; nausea; stomach pain; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); lower stomach pain; missed menstrual period; spotting instead of your usual period.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Plan B One-Step
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Plan B One-Step:
Seek medical attention right away if any of these SEVERE side effects occur when using Plan B One-Step:Breast tenderness; changes in menstrual flow; diarrhea; dizziness; headache; nausea; stomach pain; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe and persistent lower stomach pain; missed menstrual period; spotting instead of your usual period.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopPlan B Side Effects - for the Professional
Plan B
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 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 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 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 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 users.
|
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
Side Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects have included hypertension.
Dermatologic
Dermatologic side effects have included acne and other skin disorders.
Gastrointestinal
Gastrointestinal side effects have included abdominal pain, nausea, vomiting and diarrhea.
Genitourinary
Genitourinary side effects have included leukorrhea, vaginitis, dysmenorrhea, breast pain, abnormal pap smear and decreased libido. Very common adverse reactions (greater than 1 in 10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts.
Nervous system
Nervous system side effects have included headache, dizziness and nervousness.
Respiratory
Respiratory side effects have included upper respiratory infection and sinusitis.
General
General side effects have included weight gain and fatigue.
Psychiatric
Psychiatric side effects have included depression.
Musculoskeletal
Musculoskeletal side effects have included back pain.
Other
Other side effects have included postmarketing reports of device breakage and angioedema.
TopMore Plan B resources
- Plan B MedFacts Consumer Leaflet (Wolters Kluwer)
- Plan B Advanced Consumer (Micromedex) - Includes Dosage Information
- Plan B Prescribing Information (FDA)
- Plan B Consumer Overview
- Levonorgestrel Professional Patient Advice (Wolters Kluwer)
- Mirena Prescribing Information (FDA)
- Mirena Advanced Consumer (Micromedex) - Includes Dosage Information
- Mirena IUD MedFacts Consumer Leaflet (Wolters Kluwer)
- Mirena Consumer Overview
- Next Choice Prescribing Information (FDA)
- Plan B One-Step Consumer Overview
- Plan B One-Step MedFacts Consumer Leaflet (Wolters Kluwer)
- Plan B One-Step Advanced Consumer (Micromedex) - Includes Dosage Information
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