FDA Adverse Events Reports (FAERS) Summary for CYTOTEC

These tables and charts are based on 3,450 total reports for CYTOTEC (MISOPROSTOL) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 3,383 pharmaceutical company-submitted and non-U.S. FAERS reports and 67 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 67 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CYTOTEC summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with CYTOTEC (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	OFF LABEL USE	486
2	FOETAL EXPOSURE DURING PREGNANCY	359
3	PRODUCT USE IN UNAPPROVED INDICATION	220
4	FOETAL EXPOSURE DURING DELIVERY	197
5	FEVER	147
6	MATERNAL EXPOSURE DURING PREGNANCY	143
7	PAIN	131
8	NAUSEA	114
9	DIARRHEA	113
10	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	110
11	EXPOSURE DURING PREGNANCY	108
12	VOMITING	108
13	ABDOMINAL PAIN	103
14	UTERINE TACHYSYSTOLE	99
15	FOETAL HEART RATE DECREASED	95
16	HEADACHE	88
17	BLEEDING	87
18	DRUG INEFFECTIVE	80
19	MALAISE	80
20	PRODUCT USE ISSUE	80
21	VAGINAL HAEMORRHAGE	80
22	INTERSTITIAL LUNG DISEASE	79
23	SHORTNESS OF BREATH	77
24	PNEUMONIA	77
25	FATIGUE	74
26	ANEMIA	71
27	VENTRICULAR SEPTAL DEFECT	70
28	ITCHING	69
29	RASH	69
30	ABORTION INDUCED	66
31	PREMATURE BABY	65
32	FALL	62
33	DIZZINESS	60
34	DRUG EXPOSURE DURING PREGNANCY	60
35	COMPLICATION OF DEVICE INSERTION	59
36	ANXIETY	58
37	CHILLS	58
38	PLATELET COUNT DECREASED	58
39	UTERINE RUPTURE	58
40	JOINT PAIN	57
41	LACK OF STRENGTH AND ENERGY (ASTHENIA)	57
42	PAIN IN EXTREMITY	56
43	PROCEDURAL PAIN	56
44	TREMOR	56
45	INSOMNIA	55
46	GESTATIONAL DIABETES	54
47	HAEMOGLOBIN DECREASED	54
48	HIGH BLOOD PRESSURE	54
49	CONSTIPATION	52
50	HEART DISEASE CONGENITAL	51
51	LIVER FUNCTION ABNORMAL	51
52	DECREASED APPETITE	50
53	NUMBNESS	49
54	CHEST PAIN	48
55	DRUG HYPERSENSITIVITY	48
56	PLEURAL EFFUSION	48
57	DEATH	47
58	LOSS OF CONSCIOUSNESS	47
59	SWELLING OF LIMBS	47
60	SMALL FOR DATES BABY	47
61	C-REACTIVE PROTEIN INCREASED	46
62	CONDITION AGGRAVATED	45
63	ASPARTATE AMINOTRANSFERASE INCREASED	43
64	BACK PAIN	43
65	NEONATAL HYPOXIA	43
66	WHITE BLOOD CELL COUNT DECREASED	42
67	ALT LIVER ENZYME INCREASED	41
68	UTERINE PERFORATION	41
69	COUGH	40
70	DEPRESSION	39
71	FOETAL DISTRESS SYNDROME	39
72	GAIT DISTURBANCE	39
73	INJURY	39
74	METRORRHAGIA	39
75	RESPIRATORY DISORDER NEONATAL	39
76	TRUNCUS ARTERIOSUS PERSISTENT	39
77	CONGENITAL CARDIOVASCULAR ANOMALY	37
78	DEVICE DIFFICULT TO USE	37
79	POSTPARTUM HAEMORRHAGE	37
80	RHEUMATOID ARTHRITIS	37
81	CARDIAC SEPTAL DEFECT	36
82	COMMON COLD	36
83	PELVIC PAIN	36
84	URINARY TRACT INFECTION	36
85	ABDOMINAL PAIN UPPER	35
86	DEVICE DISLOCATION	35
87	LOW BIRTH WEIGHT BABY	35
88	SEPSIS	35
89	UTERINE HAEMORRHAGE	35
90	WEIGHT DECREASED	35
91	RESPIRATORY FAILURE	34
92	RAPID HEART RATE (TACHYCARDIA)	34
93	ABDOMINAL PAIN LOWER	33
94	ATRIAL SEPTAL DEFECT	33
95	BLOOD LACTATE DEHYDROGENASE INCREASED	33
96	DEVICE EXPULSION	33
97	BLOOD CLOTTING DISORDER	33
98	KIDNEY IMPAIRMENT	33
99	ABDOMINAL DISCOMFORT	32
100	CIRCULATORY COLLAPSE	32

Latest Known Outcomes for Reactions Reported for CYTOTEC

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1567
2	Patient recovered	1082
3	Patient has not recovered/symtoms have not resolved	451
4	Patient is recovering/symptoms resolving	276
5	Patient died	228
6	Patient has recovered but has consequent health issues	100

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2003	1
2004	141
2005	96
2006	116
2007	112
2008	137
2009	97
2010	137
2011	151
2012	179
2013	165
2014	153
2015	160
2016	174
2017	210
2018	182
2019	158
2020	451
2021	189
2022	155
2023	110
2024	80
2025	74
2026	22

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	207
11-20	91
21-30	395
31-40	470
41-50	192
51-60	218
61-70	293
71-80	221
81-90	73
91+	12

Based on 2172 reports that included a patient age.

CYTOTEC Total Reports

Male	Female	Unknown	Total
816	2269	365	3,450

Top Countries Reporting

	Country	Number of Reports
1	Germany	909
2	United States	562
3	Japan	316
4	France	184
5	Canada	65
6	Italy	56
7	EU	42
8	Denmark	37
9	Switzerland	33
10	United Kingdom	30

Outcomes for Reports

Serious: 3123
Not Serious: 327
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Labour induction
Abortion induced
Abortion
Intra-uterine contraceptive device insertion
BOWEL OBSTRUCTION

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1988-12-27

CYTOTEC (MISOPROSTOL) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with CYTOTEC? Rate CYTOTEC at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for CYTOTEC reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.