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 ]
•Intrauterine Pregnancy [see Warnings and Precautions]
•Group A streptococcal sepsis (GAS) [see Warnings and Precautions ]
•Pelvic Inflammatory Disease [see Warnings and Precautions]
•Embedment [see Warnings and Precautions ]
•Perforation [see Warnings and Precautions]
•Breast Cancer [see Warnings and Precautions]
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.
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.
REPORTS OF SUSPECTED MIRENA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Mirena. The information is not vetted and should not be considered as verified clinical evidence.
Possible Mirena side effects / adverse reactions in 32 year old female
Reported by a pharmacist from France on 2011-10-03
Patient: 32 year old female weighing 59.9 kg (131.7 pounds)
Reactions: Exophthalmos, Visual Impairment, Headache, Eye Disorder, Migraine With Aura
Other drugs received by patient: Moxifloxacin HCL; Pyostacine
Possible Mirena side effects / adverse reactions in 16 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03
Patient: 16 year old female
Reactions: Device Expulsion, Abdominal Pain, Genital Haemorrhage
Possible Mirena side effects / adverse reactions in 40 year old female
Reported by a physician from Germany on 2011-10-03
Patient: 40 year old female
Reactions: Intraocular Pressure Increased