"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Mirena Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
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 to prevent pregnancy for up to 5 years and should be inserted by a trained healthcare provider. The most 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.
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. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptives including Mirena. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant serum.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Mirena in Detail - Patient Information: Side Effects
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)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mirena FDA Prescribing Information: 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 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 LNG IUS (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 two 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.
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.
- Device breakage
Read the entire FDA prescribing information for Mirena (Levonorgestrel-Releasing Intrauterine System)
Additional Mirena Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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