MISOPROSTOL for Induced labour: Side Effects & Safety Data
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There are 64 adverse event reports in the FDA FAERS database where MISOPROSTOL was used for Induced labour.
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)
Abortion spontaneous (54)
Induction of cervix ripening (50)
Postpartum haemorrhage (43)
Abortion missed (34)
Uterine atony (28)