Table 1 Characteristics on adverse event reports related to misoprostol from the FAERS database.

Characteristics	Case number, n	Case proportion, %
Year
2004	32	1.57
2005	37	1.82
2006	52	2.56
2007	56	2.76
2008	43	2.12
2009	31	1.53
2010	44	2.17
2011	35	1.72
2012	43	2.12
2013	53	2.61
2014	52	2.56
2015	33	1.62
2016	71	3.49
2017	218	10.73
2018	85	4.18
2019	118	5.81
2020	453	22.29
2021	254	12.5
2022	154	7.58
2023	114	5.61
2024	54	2.66
Gender
Female	1541	75.84
Male	176	8.66
Unknown	315	15.5
Age
<18	75	3.69
18 ~ 55	1036	50.98
55 ~ 65	37	1.82
>=65	47	2.31
Unknown	837	41.19
Reporter
Consumer	792	38.98
Pharmacist	418	20.57
Physician	404	19.88
Other health-professional	321	15.8
Unknown	72	3.54
Lawyer	24	1.18
Registered Nurse	1	0.05
Reported countries
Other	731	35.97
Germany	453	22.29
United States	379	18.65
France	175	8.61
China	99	4.87
United Kingdom	75	3.69
Italy	65	3.20
Denmark	55	2.71
Route
Other	639	31.45
Oral	535	26.33
Transplacental	408	20.08
Vaginal	343	16.88
Sublingual	50	2.46
Buccal	35	1.72
Rectal	22	1.08
Outcomes
Other serious	1264	53.67
Hospitalization	560	23.78
Life threatening	187	7.94
Death	143	6.07
Congenital anomaly	94	3.99
Disability	86	3.65
Required intervention to Prevent Permanent Impairment/Damage	21	0.89
Adverse event occurrence time - medication date (days)
<7	813	65.25
7 ~ 28	32	2.57
28 ~ 60	13	1.04
>=60	22	1.77
Unknown	366	29.37
Indications
Abortion	135	6.63
Abortion induced	471	23.13
Abortion spontaneous	51	2.50
Induced labour	80	3.93
Labour induction	563	27.65
Others	408	20.04
Postpartum haemorrhage	31	1.52
Unknown	297	14.59

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