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Mirena (Levonorgestrel) - Side Effect Reports to FDA

 
 



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 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



Possible Mirena side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 41 year old female

Reactions: Device Expulsion

Drug(s) suspected as cause:
Mirena



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

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 United States on 2012-08-27

Patient: female

Reactions: Device Expulsion

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 33 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 33 year old female

Reactions: Back Pain, Genital Haemorrhage, Ectopic Pregnancy With Intrauterine Device

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 19 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 19 year old female

Reactions: Post Procedural Haemorrhage

Drug(s) suspected as cause:
Mirena



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 Dislocation

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 21 year old female

Reported by a physician from United States on 2012-08-27

Patient: 21 year old female

Reactions: Device Expulsion

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 24 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 24 year old female

Reactions: Device Expulsion

Drug(s) suspected as cause:
Mirena

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