Cytotec (misoprostol) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Cytotec
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Misoprostol
Class: Prostaglandin E1 analog

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 1,495 adverse event reports that name Cytotec. In these reports the drug is a suspect or interacting product.

In the same period, 1,900 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 33 reports in the 12 months to June 2026 and 29 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 33 (under 0.1%) name Cytotec. Reports for patients aged 18 to 44 were 42.1% of the reports that name Cytotec and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Cytotec is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 6 reports that name Cytotec.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 14.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 147 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 1,495 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 147 terms.

Reaction terms in the reports that name Cytotec, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,495 reports
Off label useused for a purpose or in a way not on the label	432	28.9%
Product use in unapproved indicationused for a purpose not on the label	216	14.4%
Foetal exposure during delivery	193	12.9%
Drug ineffective for unapproved indication	105	7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	102	6.8%
Uterine tachysystole	99	6.6%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	90	6%
Foetal heart rate decreased	90	6%
Haemorrhagebleeding	76	5.1%
Product use issuea problem in how the product was used	63	4.2%
Pyrexiafever	63	4.2%
Vomitingbeing sick	59	3.9%
Drug exposure during pregnancythe medicine was taken during pregnancy	54	3.6%
Vaginal haemorrhagevaginal bleeding	52	3.5%
Abdominal painstomach or belly pain	44	2.9%
Uterine rupture	44	2.9%
Painpain, site not specified	42	2.8%
Neonatal hypoxia	41	2.7%
Pruritusitching	41	2.7%
Chillschills or shivering	39	2.6%
Tremorshaking	37	2.5%
Diarrhoealoose or frequent stools	35	2.3%
Foetal distress syndrome	33	2.2%
Metrorrhagia	32	2.1%
Nauseafeeling sick	32	2.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	29	1.9%
Headachehead pain	27	1.8%
Premature separation of placenta	27	1.8%
Drug ineffectivethe medicine did not work as expected	26	1.7%
Foetal heart rate abnormal	26	1.7%
Postpartum haemorrhage	26	1.7%
Circulatory collapsecollapse of the circulation	24	1.6%
Developmental delayslower development in a child	24	1.6%
Dyspnoeashortness of breath	24	1.6%
Post abortion haemorrhage	24	1.6%
Loss of consciousnesspassing out	23	1.5%
Malaisegeneral feeling of being unwell	23	1.5%
Uterine haemorrhage	23	1.5%
Exposure during pregnancythe medicine was taken during pregnancy	21	1.4%
Premature babya baby born early	21	1.4%
Dizzinesslight-headedness or unsteadiness	20	1.3%
Induced abortion failed	20	1.3%
Abdominal discomfortstomach discomfort	18	1.2%
Cardiovascular disorder	18	1.2%
Abortion induced	17	1.1%
Caesarean section	17	1.1%
Endometritis	17	1.1%
Abortion	16	1.1%
Condition aggravatedthe condition being treated got worse	16	1.1%
Uterine atony	16	1.1%

Download all 147 terms of Cytotec (CSV)

The counts add to more than 1,495 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Misoprostol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Misoprostol	Generic name	5,334
Cytotec (this page)	Brand name	1,495

Sum of the separately reported names: 6,829. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Cytotec, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	32	31	2	4	11	2	1	21	1
2005	30	29	1	5	10	1	2	20	1
2006	40	38	5	8	17	7	2	17	2
2007	51	45	9	8	15	2	0	30	6
2008	47	43	5	7	18	1	1	23	4
2009	37	35	7	5	18	0	1	20	2
2010	24	23	1	1	11	1	1	17	1
2011	27	26	2	6	13	3	0	17	1
2012	36	31	7	0	5	4	2	20	5
2013	56	52	4	6	23	5	2	34	4
2014	48	37	9	7	11	2	3	17	11
2015	39	29	4	5	17	2	2	14	10
2016	54	51	2	5	22	3	5	32	3
2017	128	112	18	8	48	3	14	57	16
2018	61	54	5	11	22	0	5	40	7
2019	58	51	4	6	20	1	2	35	7
2020	357	350	11	32	58	23	14	319	7
2021	117	111	6	10	23	7	4	91	6
2022	78	72	2	4	24	5	3	54	6
2023	72	72	7	5	28	12	10	44	0
2024	40	35	2	9	9	2	1	28	5
2025	50	50	3	3	11	4	3	43	0
2026	13	12	0	4	4	3	4	10	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Cytotec, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Cytotec, by the year in which FDA received them
Year	Reports
2004	29
2005	31
2006	40
2007	49
2008	51
2009	37
2010	43
2011	36
2012	56
2013	49
2014	43
2015	46
2016	48
2017	118
2018	55
2019	55
2020	356
2021	117
2022	91
2023	55
2024	35
2025	44
2026	11

Reports that name Cytotec, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Cytotec
Age	Reports	Share
Under 2	43	2.9%
2 to 11	12	0.8%
12 to 17	14	0.9%
18 to 44	629	42.1%
45 to 64	96	6.4%
65 to 74	35	2.3%
75 and over	21	1.4%
Age not given	645	43.1%

Sex of the patient in the reports that name Cytotec
Sex	Reports	Share
Female	1,060	70.9%
Male	197	13.2%
Unknown or not given	238	15.9%

Type of reporter in the reports that name Cytotec
Reporter	Reports	Share
Physician	337	22.5%
Pharmacist	93	6.2%
Other health professional	281	18.8%
Lawyer	24	1.6%
Consumer or non-health professional	707	47.3%
Not given	53	3.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 15.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cytotec record
Indication as recorded (MedDRA)	Reports	Share
Labour induction	460	30.8%
Abortion induced	266	17.8%
Abortion	64	4.3%
Induced labour	33	2.2%
Abortion spontaneous	22	1.5%
Abortion missed	16	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,495 reports.

Drugs in the same reports

Other drugs that the reports of Cytotec name, in any role, in order of name
Drug	Reports that name the two
Arthrotec	20
Aspirin	18
Celebrex	20
Diclofenac sodium	29
Enbrel	25
Methotrexate	24
Orencia	21
Oxytocin	18
Paracetamol	19
Prednisolone	27

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Misoprostol same ingredient
Arthrotec same class
Diclofenac sodium/misoprostol same class
Cytosine Arabinoside next in the A to Z list
Cytoxan next in the A to Z list
Cytosar next in the A to Z list
Dabigatran next in the A to Z list
Cytomel next in the A to Z list
Dabigatran etexilate next in the A to Z list
Cytogam next in the A to Z list
Dabigatran etexilate mesylate next in the A to Z list
Cytarabine/Cytarabine Hydrochloride/Cytarabine Ocfosfate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CytotecThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Cytotec: adverse event reports that FDA received. https://reportedreactions.com/drug/cytotec/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Cytotec as a suspect or interacting product. The 1,900 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Cytotec was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Cytotec?

No. It is a count of what people reported to FDA: 1,495 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (47.3%), physician (22.5%) and other health professional (18.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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