Pharmacologic class (EPC) · 3 drug pages

Progesterone: adverse event reports filed with FDA

7,604 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.

7,604
reports across the class: 0% of all reports; 967
reports, 12 months to June 2026: 793 in the 12 months before; 78%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Progesterone 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 7,604 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

967 reports arrived in the 12 months to June 2026, up 22% from 793 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 78% of the class's reports are marked serious, 5.9% record death among the outcomes and 17.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are exposure during pregnancy (15.8%), headache (15.7%) and off label use (15.6%). 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
Progesterone	generic	5,498	843	76%	Exposure during pregnancy
PrometriumProgesterone	brand	1,351	19	83%	Breast cancer
CrinoneProgesterone	brand	755	105	84.1%	Exposure during pregnancy

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

Exposure during pregnancythe medicine was taken during pregnancy15.8%1,203
Headachehead pain15.7%1,194
Off label useused for a purpose or in a way not on the label15.6%1,183
Painpain, site not specified13.9%1,058
Hypersensitivityan allergic-type reaction13.4%1,018
Hyperhidrosisexcessive sweating13.2%1,002
Hepatic enzyme increasedraised liver enzymes12.8%976
Product use issuea problem in how the product was used12.8%971
Food allergy12.6%957
Immunodeficiency12.6%955
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease11.7%888
Asthmaasthma11.5%873
Upper respiratory tract infectiona cold or similar infection11.4%864
Rash erythematousa red rash11.3%856
Drug hypersensitivityan allergic-type reaction to a medicine10.9%829
Fatiguetiredness10.8%825
Fluid retentionthe body holding extra fluid10.3%784
Temperature regulation disorder10%764
Overdosea dose above the recommended amount9.9%753
Rashskin rash9.9%752
Hypertensionhigh blood pressure9.8%744
Joint swellinga swollen joint9.8%743
Prescribed overdose9.6%733
Drug ineffectivethe medicine did not work as expected9.6%731
Back painback pain9.3%707

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

Death5.9%446

Life-threatening2.5%187

Hospitalisation (initial or prolonged)17.4%1,323

Disability2%153

Congenital anomaly6.2%474

Other serious66.6%5,066

Not serious22%1,672

Patient age

Under 21.3%97

2 to 110.3%21

12 to 170.7%52

18 to 4422.3%1,692

45 to 6422.6%1,717

65 to 742.4%184

75 and over0.6%49

Age not given49.9%3,792

Who reported

Physician16.5%1,254

Pharmacist4.6%350

Other health professional35.5%2,702

Lawyer4.3%324

Consumer or non-health professional32.5%2,468

Not given6.7%506

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 Progesterone reports

Which drugs are in the Progesterone class on this site?

Progesterone, Prometrium and Crinone. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

7,604 reports through June 2026, 967 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?

exposure during pregnancy (15.8%), headache (15.7%), off label use (15.6%), pain (13.9%) and hypersensitivity (13.4%).

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.