| Drug Report: MIRENA (LEVONORGESTREL) | ||||||||
| Primary Suspect Reports: 47,218 Total Reports: 47,507 FDA AERS Reports from 11/01/1997 to 08/27/2012 | ||||||||
| Drug Description : | ||||||||
Mirena (levonorgestrel-releasing intrauterine system) is an intrauterine device (IUD) to prevent pregnancy. Mirena was FDA approved on December 6, 2000 and is manufactured by Bayer Healthcare Pharmaceuticals, Inc. On October 1, 2009 the FDA approved the additional use of Mirena to treat heavy menstrual bleeding in IUD users. |
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| Other Names : | Generic Name : | Report Info: | ||||||
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LEVONORGESTREL | Average Age: 31 Years |
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FDA Listed Names (49) :
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Manufacturer: | Common Conditions: | ||||||
Intrauterine Contraceptive Device With Levonorgestrel) |
Bayer AG (44,418) |
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| Top MIRENA Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
MIRENA Primary Suspect Reports | MIRENA Total Reports |
ROR Score
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PRR Score
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Compare Top Drugs |
| Device Expulsion | 16,904 (36%) | 16,908 (36%) | Premium Feature | Premium Feature |
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| Device Dislocation | 4,559 (10%) | 4,562 (10%) | Premium Feature | Premium Feature |
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| Vaginal Haemorrhage | 4,019 (9%) | 4,034 (8%) | Premium Feature | Premium Feature |
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| Medical Device Complication | 3,786 (8%) | 3,789 (8%) | Premium Feature | Premium Feature |
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| Abdominal Pain | 3,119 (7%) | 3,139 (7%) | Premium Feature | Premium Feature |
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| Amenorrhoea | 2,384 (5%) | 2,392 (5%) | Premium Feature | Premium Feature |
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| Pregnancy With Contraceptive Device | 2,226 (5%) | 2,235 (5%) | Premium Feature | Premium Feature |
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| Procedural Pain | 2,003 (4%) | 2,004 (4%) | Premium Feature | Premium Feature |
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| Abdominal Pain Lower | 1,765 (4%) | 1,771 (4%) | Premium Feature | Premium Feature |
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| Genital Haemorrhage | 1,745 (4%) | 1,746 (4%) | Premium Feature | Premium Feature |
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| Reported Report Outcomes for MIRENA Adverse Events |
| Report Outcomes |
MIRENA Primary Suspect (# of Reports) (11/01/1997 to 08/27/2012) |
MIRENA Total (# of Reports) (11/01/1997 to 08/27/2012) |
| Other | 11,589 (25%) | 11,738 (25%) |
| Hospitalization - Initial or Prolonged | 2,563 (5%) | 2,647 (6%) |
| Disability | 440 (1%) | 450 (1%) |
| Life-Threatening | 355 (1%) | 366 (1%) |
| Required Intervention to Prevent Permanent Impairment/Damage | 346 (1%) | 353 (1%) |
| Congenital Anomaly | 65 (0%) | 67 (0%) |
| Death | 53 (0%) | 55 (0%) |
| Most Recent MIRENA Report Reviews/FDA Reports (Primary Suspect) |
| Report Date | Age | Gender | Conditions | Adverse Events | Outcome |
| 04/02/2013 | 33 YR | F |
Contraception |
Autoimmune Disorder Osteonecrosis |
Disability |
| 08/27/2012 | Not Stated | F |
Contraception |
Unintentional Medical Device Removal By Patient |
Not Stated |
| 08/27/2012 | 19 YR | F |
Contraception |
Post Procedural Haemorrhage |
Other |
| 08/27/2012 | 51 YR | F |
Contraception Menorrhagia |
Device Expulsion Device Difficult To Use |
Not Stated |
| 08/27/2012 | Not Stated | F |
Contraception |
Device Expulsion |
Not Stated |
| 08/27/2012 | Not Stated | F |
Contraception |
Device Expulsion |
Not Stated |
| 08/27/2012 | 35 YR | F |
Menorrhagia |
Device Expulsion |
Not Stated |
| 08/27/2012 | 25 YR | F |
Contraception |
Device Expulsion |
Not Stated |
| 08/27/2012 | 27 YR | F |
Contraception |
Device Expulsion |
Not Stated |
| 08/27/2012 | 29 YR | F |
Contraception |
Device Expulsion |
Not Stated |
