Mirena

Mirena (levonorgestrel-releasing intrauterine device) is a form of birth control that is indicated for intrauterine contraception for up to 5 years and for the treatment of heavy menstrual bleeding in women. Mirena is a hormone-releasing system placed in your uterus (intra-uterine device, or IUD) to prevent pregnancy for up to 5 years. Common side effects of Mirena are:

• missed periods (amenorrhea),
• bleeding and spotting between periods,
• heavier bleeding during the first few weeks after device insertion,
• abdominal/pelvic pain,
• ovarian cysts,
• back pain,
• headache/migraine,
• nervousness,
• dizziness,
• nausea,
• vomiting,
• bloating,
• breast tenderness or pain,
• weight gain,
• changes in hair growth,
• acne,
• depression,
• changes in mood,
• loss of interest in sex,
• itching or skin rash, and
• puffiness in the face, hands, ankles, or feet.

Mirena contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a dose rate of approximately 20 mcg/day. This rate decreases progressively to half that value after 5 years. Mirena must be removed by the end of the fifth year and can be replaced at the time of removal with a new Mirena if continued contraceptive protection is desired. Drug interactions and warnings include potential interactions with insulin, warfarin (Coumadin) and steroids. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Mirena should not be used during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if it is left in place during pregnancy. Tell your doctor right away if you become pregnant while using the Mirena intrauterine system. Small amounts of progestins such as those in Mirena pass into breast milk. If you have recently had a baby and are breastfeeding, wait until your baby is at least 6 weeks old before you start using Mirena.

Our Mirena Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help 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.

The levonorgestrel intrauterine device may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device.

Call your doctor at once if you have a serious side effect such as:

• severe cramps or pelvic pain;
• extreme dizziness, feeling like you might pass out;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• severe pain in your side or lower stomach;
• pale skin, weakness, easy bruising or bleeding;
• fever, chills, or other signs of infection;
• pain during sexual intercourse;
• sudden numbness or weakness, especially on one side of the body;
• sudden or severe headache, confusion, problems with vision, sensitivity to light;
• jaundice (yellowing of the skin or eyes); or
• signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• irregular menstrual periods, changes in bleeding patterns or flow;
• breakthrough bleeding, or heavier menstrual bleeding during the first few weeks after device insertion;
• back pain;
• headache, nervousness, mild dizziness;
• nausea, vomiting, bloating;
• breast tenderness or pain;
• weight gain, acne, changes in hair growth;
• mood changes, loss of interest in sex;
• mild itching, skin rash; or
• puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mirena (Levonorgestrel-Releasing Intrauterine System)

SIDE EFFECTS

The following serious or otherwise important adverse reactions are discussed in elsewhere in the labeling:

• Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
• Intrauterine Pregnancy [see WARNINGS AND PRECAUTIONS]
• Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
• Pelvic Inflammatory Disease [see WARNINGS AND PRECAUTIONS]
• Alterations of Bleeding Patterns [see WARNINGS AND PRECAUTIONS]
• Perforation [see WARNINGS AND PRECAUTIONS]
• Expulsion [see WARNINGS AND PRECAUTIONS]
• Ovarian Cysts [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 as well as in the supportive and uncontrolled studies for contraception and heavy menstrual bleeding (n=5,091). The data cover more than 12,101 women-years of exposure, mainly in the contraception studies (11,761 women-years). The frequencies of reported adverse drug reactions represent crude incidences.

The most common adverse reactions ( ≥ 10% users) are alterations of menstrual bleeding patterns [including unscheduled uterine bleeding (31.9%), decreased uterine bleeding (23.4%), increased scheduled uterine bleeding (11.9%), and female genital tract bleeding (3.5%)], abdominal/pelvic pain (22.6%), amenorrhea (18.4%), headache/migraine (16.3%), genital discharge (14.9%), and vulvovaginitis (10.5%). Adverse reactions reported in ≥ 5% of users are shown in Table 1.

Table 1 : Adverse Reactions ≥ 5% Reported in Clinical Trials with Mirena

System Organ Class	Adverse Reactions	% (N= 5,091)
Reproductive system and breast disorders	alteration of menstrual bleeding pattern, including:
	unscheduled uterine bleeding	31.9
	decreased uterine bleeding	23.4
	increased scheduled uterine bleeding	11.9
	female genital tract bleeding	3.5
	amenorrhea	18.4
	genital discharge	14.9
	vulvovaginitis	10.5
	breast pain	8.5
	benign ovarian cyst and associated complications	7.5
	dysmenorrhea	6.4
Gastrointestinal disorders	abdominal/pelvic pain	22.6
Nervous system disorders	headache/migraine	16.3
Musculoskeletal and connective tissue disorders	back pain	7.9
Skin and subcutaneous tissue disorders	acne	6.8
Psychiatric disorders	depression/depressive mood	6.4

Other adverse reactions occurring in < 5% of subjects include alopecia, (partial and complete) device expulsion, hirsutism, nausea, and PID/endometritis.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Mirena. 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.

• Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke
• Device breakage
• Hypersensitivity (including rash, urticaria and angioedema)
• Increased blood pressure

Read the entire FDA prescribing information for Mirena (Levonorgestrel-Releasing Intrauterine System)

© Mirena Patient Information is supplied by Cerner Multum, Inc. and Mirena Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.