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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) 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 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