This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mirena (Levonorgestrel) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (10915)
Death (8)
Life Threatening Events (44)
Disability (70)
Reports by Reaction Type
Device Expulsion (4424),
Device Dislocation (1921),
Abdominal Pain (789),
Vaginal Haemorrhage (787),
Pregnancy With Contraceptive Device (664),
Genital Haemorrhage (629),
Pain (525),
Procedural Pain (470),
Uterine Perforation (424),
Amenorrhoea (402),
Device Difficult To Use (402),
Menorrhagia (308)
Below are a few examples of reports where side effects / adverse reactions may be related to Mirena (Levonorgestrel). For a complete list or a specific selection of reports, please use the links above.
Possible Mirena side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 51 year old female
Reactions: Device Expulsion, Device Difficult To Use
Drug(s) suspected as cause:
Mirena
Indication: Menorrhagia
Mirena
Dosage: 20 mcg/24hr, unk
Indication: Contraception
Start date: 2012-08-17
End date: 2012-08-17
Possible Mirena side effects in 29 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 29 year old female
Reactions: Uterine Perforation
Drug(s) suspected as cause:
Mirena
Dosage: 20 mcg/24hr, cont
Indication: Contraception
Start date: 2012-08-20
Mirena
Indication: Menorrhagia
Possible Mirena side effects in female
Reported by a consumer/non-health professional from Austria on 2012-08-27
Patient: female
Reactions: Malaise, Poisoning
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 25 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 25 year old female
Reactions: Device Dislocation
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Expulsion, Vaginal Haemorrhage
Drug(s) suspected as cause:
Mirena
Dosage: unk
Indication: Contraception
Start date: 2011-12-20
Mirena
Indication: Menorrhagia
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Dislocation, Vaginal Haemorrhage
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female
Reactions: Menstrual Disorder, Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 35 year old female
Reported by a physician from United States on 2012-08-27
Patient: 35 year old female
Reactions: Device Expulsion, Device Difficult To Use
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: female
Reactions: Amenorrhoea, Urinary Tract Infection, Menorrhagia
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 47 year old female
Reported by a physician from Norway on 2012-08-27
Patient: 47 year old female
Reactions: Device Expulsion, Candidiasis
Drug(s) suspected as cause:
Mirena
Mirena
Dosage: 20 mcg/24hr, cont
Start date: 2011-10-11
End date: 2012-08-09
Possible Mirena side effects in 27 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 27 year old female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Dosage: 20 mcg/24hr, cont
Start date: 2012-08-10
Mirena
Dosage: 20 mcg/24hr, cont
Indication: Contraception
Start date: 2012-08-09
End date: 2012-08-10
Possible Mirena side effects in 31 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 31 year old female
Reactions: Device Expulsion, Pregnancy With Contraceptive Device
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Medical Device Complication, Abdominal Pain Lower, Abdominal Pain, Nausea, Pyrexia, Vaginal Haemorrhage
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from Austria on 2012-08-27
Patient: female
Reactions: Loss of Consciousness
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Abdominal Pain, Abdominal Distension, Vaginal Haemorrhage
Drug(s) suspected as cause:
Mirena
Indication: Endometriosis
Mirena
Dosage: 20 mcg/24hr, cont
Indication: Contraception
Possible Mirena side effects in 23 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 23 year old female
Reactions: Amenorrhoea, Hypoaesthesia, Headache, Asthenia, Abdominal Pain Upper, Vaginal Haemorrhage
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 27 year old female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 35 year old female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Device Dislocation
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Unintentional Medical Device Removal by Patient
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 40 year old female
Reactions: Cervix Carcinoma Stage 0
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 51 year old female
Reported by a consumer/non-health professional from Austria on 2012-08-27
Patient: 51 year old female
Reactions: Burnout Syndrome, Suicidal Ideation, Vaginal Haemorrhage, Weight Increased, Device Expulsion, Anhedonia, Amenorrhoea, Mood Altered, Depression, Cervix Carcinoma Stage 0, Post Procedural Haemorrhage, Procedural Pain, Ovarian Cyst, Hypomenorrhoea, NO Adverse Event, Mental Disorder
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 29 year old female
Reported by a physician from United States on 2012-08-27
Patient: 29 year old female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Dosage: 20 ?g/d, cont
Indication: Contraception
Start date: 2012-03-22
End date: 2012-06-25
Mirena
Dosage: 20 ?g/d, cont
Start date: 2012-07-17
End date: 2012-08-01
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Dislocation
Drug(s) suspected as cause:
Mirena
Dosage: 20 mcg/24hr, cont
Mirena
Dosage: 20 mcg/24hr, cont
Possible Mirena side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Device Expulsion
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 32 year old female
Reported by a physician from United States on 2012-08-27
Patient: 32 year old female
Reactions: Headache
Drug(s) suspected as cause:
Mirena
Possible Mirena side effects in 25 year old female
Reported by a physician from United States on 2012-08-27
Patient: 25 year old female
Reactions: Medical Device Complication, Menstrual Disorder, Device Dislocation
Drug(s) suspected as cause:
Mirena
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