Levonorgestrel Side Effects

Some side effects of levonorgestrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to levonorgestrel: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking levonorgestrel: 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 of levonorgestrel 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.

For Healthcare Professionals

Applies to levonorgestrel: intrauteral device, oral tablet, subcutaneous implant

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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