MISOPROSTOL for Postpartum haemorrhage: Side Effects & Safety Data
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There are 43 adverse event reports in the FDA FAERS database where MISOPROSTOL was used for Postpartum haemorrhage.
Most Reported Side Effects for MISOPROSTOL
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 632 | 17.9% | 18 | 141 |
| Haemorrhage | 588 | 16.6% | 1 | 168 |
| Abortion incomplete | 535 | 15.1% | 1 | 91 |
| Product use in unapproved indication | 296 | 8.4% | 25 | 79 |
| Maternal exposure during pregnancy | 261 | 7.4% | 18 | 55 |
| Pain | 231 | 6.5% | 4 | 52 |
| Foetal exposure during pregnancy | 221 | 6.2% | 43 | 46 |
| Foetal exposure during delivery | 204 | 5.8% | 6 | 34 |
| Drug ineffective | 190 | 5.4% | 5 | 81 |
| Anaemia | 185 | 5.2% | 0 | 79 |
| Vomiting | 185 | 5.2% | 3 | 84 |
| Pregnancy | 179 | 5.1% | 0 | 6 |
| Exposure during pregnancy | 178 | 5.0% | 11 | 58 |
| Drug ineffective for unapproved indication | 177 | 5.0% | 2 | 56 |
| Nausea | 153 | 4.3% | 0 | 59 |
Other Indications for MISOPROSTOL
Labour induction (615)
Abortion induced (524)
Product used for unknown indication (245)
Abortion (110)
Rheumatoid arthritis (66)
Induced labour (64)
Abortion spontaneous (54)
Induction of cervix ripening (50)
Abortion missed (34)
Uterine atony (28)
Other Drugs Used for Postpartum haemorrhage
CARBOPROST TROMETHAMINE (199)
TRANEXAMIC ACID (67)
OXYTOCIN (62)
METHYLERGONOVINE (24)
OXYTOCIN\SODIUM (19)
FIBRINOGEN HUMAN (17)
CARBOPROST (15)
ERGONOVINE (15)
COAGULATION FACTOR VIIA RECOMBINANT HUMAN (12)
SULPROSTONE (11)