ADVERSE REACTIONS
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.
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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
Suspect drug(s):
Mirena
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
Suspect drug(s):
Mirena
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
Suspect drug(s):
Mirena
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