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:

Breast tenderness; changes in menstrual flow; diarrhea; dizziness; headache; nausea; stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Plan B:

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:

Breast tenderness; changes in menstrual flow; diarrhea; dizziness; headache; nausea; stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Plan B One-Step:

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.

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Plan 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.

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

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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.

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