MIRENA for Menorrhagia: Side Effects & Safety Data
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There are 383 adverse event reports in the FDA FAERS database where MIRENA was used for Menorrhagia.
Most Reported Side Effects for MIRENA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Device expulsion | 1,300 | 34.5% | 0 | 10 |
| Injury | 788 | 20.9% | 0 | 467 |
| Pain | 685 | 18.2% | 0 | 296 |
| Device dislocation | 677 | 18.0% | 0 | 182 |
| Uterine perforation | 644 | 17.1% | 0 | 395 |
| Emotional distress | 577 | 15.3% | 0 | 363 |
| Genital haemorrhage | 410 | 10.9% | 0 | 75 |
| Abdominal pain lower | 342 | 9.1% | 0 | 89 |
| Device difficult to use | 307 | 8.2% | 0 | 77 |
| Device issue | 292 | 7.8% | 0 | 205 |
| Abdominal pain | 286 | 7.6% | 0 | 119 |
| Anxiety | 281 | 7.5% | 0 | 209 |
| Depression | 239 | 6.3% | 0 | 166 |
| Procedural pain | 217 | 5.8% | 0 | 49 |
| Drug ineffective | 203 | 5.4% | 0 | 82 |
Other Indications for MIRENA
Contraception (2,813)
Endometriosis (12)
Menstrual cycle management (12)
Product used for unknown indication (12)
Dysmenorrhoea (10)
Adenomyosis (6)
Genital haemorrhage (6)
Uterine leiomyoma (6)
Menstruation irregular (5)
Other Drugs Used for Menorrhagia
LEVONORGESTREL (5,370)
ETHINYL ESTRADIOL\ETONOGESTREL (152)
LEUPROLIDE (131)
TRANEXAMIC ACID (110)
DROSPIRENONE\ETHINYL ESTRADIOL (106)
MEDROXYPROGESTERONE (86)
ETONOGESTREL (85)
ETHINYL ESTRADIOL\NORETHINDRONE (82)
DIENOGEST\ESTRADIOL (47)
NORETHINDRONE (45)