Pharmacologic class (EPC) · 3 drug pages

Prostaglandin E1 analog: adverse event reports filed with FDA

9,132 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

9,132
reports across the class: 0% of all reports; 158
reports, 12 months to June 2026: 160 in the 12 months before; 58.1%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Prostaglandin E1 analog is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 9,132 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

158 reports arrived in the 12 months to June 2026, close to the 160 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 58.1% of the class's reports are marked serious, 4.1% record death among the outcomes and 25.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are haemorrhage (18.4%), abortion incomplete (17.8%) and off label use (9.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Misoprostol	generic	5,334	115	44.6%	Abortion incomplete
ArthrotecDiclofenac sodium and misoprostol	brand	2,303	10	66.8%	Drug ineffective
CytotecMisoprostol	brand	1,495	33	92.9%	Off label use

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Haemorrhagebleeding18.4%1,684
Abortion incomplete17.8%1,626
Off label useused for a purpose or in a way not on the label9.5%870
Painpain, site not specified7.8%711
Drug ineffectivethe medicine did not work as expected7.7%706
Anaemialow red blood cells6.5%594
Pregnancypregnancy6%552
Drug hypersensitivityan allergic-type reaction to a medicine5.9%535
Nauseafeeling sick5.5%502
Muscle spasmsmuscle cramps5.2%475
Vomitingbeing sick5.1%466
Dizzinesslight-headedness or unsteadiness4.8%439
Abdominal painstomach or belly pain3.8%343
Pyrexiafever3.5%318
Infectionan infection, type not specified3.4%311
Product use in unapproved indicationused for a purpose not on the label3.3%303
Malaisegeneral feeling of being unwell3.3%302
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease3.3%302
Drug intolerancethe medicine was not tolerated3.3%297
Maternal exposure during pregnancythe mother took the medicine during pregnancy3.2%293
Fatiguetiredness2.8%260
Condition aggravatedthe condition being treated got worse2.7%251
Menorrhagiaheavy periods2.7%243
Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.5%227
International normalised ratio fluctuation2.4%219

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death4.1%377

Life-threatening4.6%424

Hospitalisation (initial or prolonged)25.5%2,332

Disability3.4%315

Congenital anomaly2.4%222

Other serious35.5%3,244

Not serious41.9%3,824

Patient age

Under 20.8%71

2 to 110.1%13

12 to 171.6%146

18 to 4455.3%5,049

45 to 6411.2%1,023

65 to 744.1%371

75 and over3.7%340

Age not given23.2%2,119

Who reported

Physician14.6%1,330

Pharmacist3.1%279

Other health professional54.4%4,968

Lawyer0.3%30

Consumer or non-health professional22.6%2,065

Not given5%460

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Prostaglandin E1 analog reports

Which drugs are in the Prostaglandin E1 analog class on this site?

Misoprostol, Arthrotec and Cytotec. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

9,132 reports through June 2026, 158 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

haemorrhage (18.4%), abortion incomplete (17.8%), off label use (9.5%), pain (7.8%) and drug ineffective (7.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.