MISOPROSTOL for Labour induction: Side Effects & Safety Data

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There are 615 adverse event reports in the FDA FAERS database where MISOPROSTOL was used for Labour induction.

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