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Mirena (Levonorgestrel Intrauterine) - Side Effects and Adverse Reactions

 
 



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.



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



See index of all Mirena side effect reports >>

Drug label data at the top of this Page last updated: 2008-08-05

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