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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 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



Possible Mirena side effects in female

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

Patient: female

Reactions: Amenorrhoea

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: Breast Pain, Weight Increased, Food Craving, Abdominal Distension, Headache, 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: Pain

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 39 year old female

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

Patient: 39 year old female

Reactions: Device Dislocation

Drug(s) suspected as cause:
Mirena
    Dosage: 20 mcg/24hr, cont
    Indication: Contraception
    Start date: 2012-07-16
    End date: 2012-08-20

Mirena
    Dosage: 20 mcg/24hr, cont
    Start date: 2012-08-20



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

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 30 year old female

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

Patient: 30 year old female

Reactions: Procedural Pain, Post Procedural 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: Abdominal Pain, Pregnancy With Contraceptive Device

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: Device Expulsion

Drug(s) suspected as cause:
Mirena



Possible Mirena side effects in 29 year old female

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

Patient: 29 year old female, weighing 155.0 kg (341.0 pounds)

Reactions: Device Dislocation

Drug(s) suspected as cause:
Mirena



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

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