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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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.

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.

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.

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.

Plan B Side Effects - for the Professional

Plan B

 The most common adverse reactions (≥10%) in clinical trials included heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness (10%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Barr Laboratories at 1-800-330-1271 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

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.

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