Side Effects > Mirena

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 or tenderness; changes in menstrual bleeding (eg, spotting); changes in sex drive; dizziness, lightheadedness, bleeding, or cramping during placement; headache; nausea; vomiting; weight gain.

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

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; fever; genital sores; mental or mood changes (eg, depression); missed menstrual period; numbness of an arm or leg; painful sexual intercourse; prolonged heavy menstrual bleeding; severe pain or tenderness in the abdomen or pelvis; sharp or crushing chest pain; 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.

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Mirena Side Effects - for the Professional

Mirena

The following most serious adverse reactions associated with the use of Mirena are discussed in greater detail in the Warnings and Precautions section (5):

• Ectopic Pregnancy [see Warnings and Precautions (5.1)]
• Intrauterine Pregnancy [see Warnings and Precautions (5.2)]
• Group A streptococcal sepsis (GAS) [see Warnings and Precautions (5.3)]
• Pelvic Inflammatory Disease [see Warnings and Precautions (5.4)]
• Embedment [see Warnings and Precautions (5.6)]
• Perforation [see Warnings and Precautions (5.7)]
• Breast Cancer [see Warnings and Precautions (5.10)]

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data provided reflect the experience with the use of Mirena in the adequate and well-controlled studies for contraception (n=2,339) and heavy menstrual bleeding (n=80). For the contraception indication, Mirena was compared to a copper IUD (n=1,855), to another formulation of levonorgestrel intrauterine system (n=390) and to a combined oral contraceptive (n=94) in women 18 to 35 years old. The data cover more than 92,000 woman-months of exposure. For the treatment of heavy menstrual bleeding indication (n=80), the subjects included women aged 26 to 50 with confirmed heavy bleeding and exposed for a median of 183 treatment days of Mirena (range 7 to 295 days). The frequencies of reported adverse drug reactions represent crude incidences.

The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the contraception studies.

The most common adverse reactions (≥5% users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%), ovarian cysts (12%), headache/migraine (7.7%), acne (7.2%), depressed/altered mood (6.4%), menorrhagia (6.3%), breast tenderness/pain (4.9%), vaginal discharge (4.9%) and IUD expulsion (4.9%).

Other relevant adverse reactions occurring in <5% of subjects include nausea, nervousness, vulvovaginitis, dysmenorrhea, back pain, weight increase, decreased libido, cervicitis/Papanicolaou smear normal/class II, hypertension, dyspareunia, anemia, alopecia, skin disorders including eczema, pruritus, rash and urticaria, abdominal distention, hirsutism and edema.

6.2 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.

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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.

Other

Other side effects have included postmarketing reports of device breakage and angioedema.

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