Mirena Side Effects

Generic Name: levonorgestrel

Please note - some side effects for Mirena 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 Mirena - for the Consumer

Mirena IUD

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 Mirena IUD:

Acne; back pain; breast pain; breast tenderness; changes in sex drive; cramps; depression; hair loss; headache; irregular bleeding; lack of menstrual bleeding; nausea; nervousness; skin problems; stomach pain; vomiting; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; changes in vision; chills; dizziness; fever; genital sores; lack of menstrual period; mental or mood changes; numbness of an arm or leg; painful sexual intercourse; prolonged heavy menstrual bleeding; severe headache or dizziness; severe pain or tenderness in the abdomen or pelvis; sharp or crushing chest pain; spotting instead of your usual period; sudden leg pain; sudden severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; unusual or odorous vaginal discharge; unusual vaginal swelling or bleeding; yellowing of the skin or eyes.

Mirena Side Effects - for the Professional

Mirena

The most serious adverse reactions associated with the use of Mirena are discussed above in the WARNINGS and PRECAUTIONS sections. Very common adverse reactions (>1/10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts. Other adverse events are listed below using MedDRA (9.0) terms. Adverse reactions reported by 5% or more of clinical trial subjects include:

Abdominal/pelvic pain

Vaginal discharge

Nausea

Headache

Nervousness

Vulvovaginitis

Dysmenorrhea

Back pain

Weight increase

Breast pain/tenderness

Acne

Decreased libido

Depressed mood

Cervicitis/Papanicolaou smear normal, class II

Hypertension

Other relevant reported adverse reactions occurring in less than 5% of subjects include: migraine, vomiting, anemia, dyspareunia, alopecia, eczema, pruritis, rash, urticaria, abdominal distension, altered mood, hirsutism, edema.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Mirena: device breakage and angioedema. 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.

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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