Generic name
Progesterone: adverse event reports filed with FDA
5,498 reports list it as a suspect or interacting product, 2004–2026. Class: Progesterone. Also reported as Progesterone Cream, Progesterone Inj, Progesterone Injection.
- 5,498
- reports as suspect product
- 0% of all reports · about 244 a year
- 843
- reports, 12 months to June 2026
- 612 in the 12 months before
- 76%
- marked serious by the reporter
- 78% across the class
- 4.6%
- record death among outcomes, as reported
- 251 reports · not verified by FDA
5,498 adverse event reports received by FDA list progesterone, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 13,852 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 843 reports listed it, up 38% from 612 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 244 reports a year and 0% of the 20,646,523 reports in the database, and 72.3% of the reports for the progesterone class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded exposure during pregnancy (12.6%), off label use (11.9%) and foetal exposure during pregnancy (11.7%). A report can list several reactions, so shares add to more than 100%; 1,003 different terms appear across these reports. Exposure during pregnancy is recorded in 12.6% of these reports, about the same share as in the median progesterone drug (12.6%).
76% of the reports are marked serious by the reporter (78% across the class); 4.6% record death among the outcomes and 20.2% record hospitalisation, as reported. 36.7% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (24.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Progesterone reports recording the termmedian drug in progesterone
- Exposure during pregnancythe medicine was taken during pregnancy12.6%691
- Off label useused for a purpose or in a way not on the label11.9%654
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine11.7%645
- Headachehead pain11.7%642
- Painpain, site not specified10.2%562
- Product use issuea problem in how the product was used9.7%536
- Hypersensitivityan allergic-type reaction9.7%532
- Hyperhidrosisexcessive sweating9.2%504
- Hepatic enzyme increasedraised liver enzymes8.7%479
- Food allergy8.6%472
- Immunodeficiency8.5%465
- Asthmaasthma8.2%450
- Drug ineffectivethe medicine did not work as expected8.2%450
- Fatiguetiredness8.2%450
- Drug hypersensitivityan allergic-type reaction to a medicine8.1%444
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease8%442
- Maternal exposure during pregnancythe mother took the medicine during pregnancy7.8%431
- Upper respiratory tract infectiona cold or similar infection7.7%426
- Rash erythematousa red rash7.7%421
- Fluid retentionthe body holding extra fluid7.3%400
- Rashskin rash6.9%382
- Overdosea dose above the recommended amount6.8%372
- Temperature regulation disorder6.8%372
- Constipationconstipation6.6%362
- Back painback pain6.5%358
- Prescribed overdose6.5%358
- Hypertensionhigh blood pressure6.5%355
- Erythemaskin redness6.3%349
- Intentional product misusedeliberate use not as intended6.3%347
Top 30 of 1,003 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the progesterone class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 7,604 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 41.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hormone replacement therapy | 491 | 8.9% |
| Assisted reproductive technology | 240 | 4.4% |
| Maternal exposure timing unspecified | 191 | 3.5% |
| In vitro fertilisation | 148 | 2.7% |
| Menopause | 115 | 2.1% |
| Assisted fertilisation | 78 | 1.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 5,498 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Progesterone reports |
|---|---|---|
| Estradiol | 951 | 17.3% |
| Ketoprofen | 619 | 11.3% |
| Pantoprazole magnesium | 619 | 11.3% |
| Bupropion hydrochloride | 616 | 11.2% |
| Advair Hfa | 601 | 10.9% |
| Orencia | 601 | 10.9% |
| Vitamin c | 582 | 10.6% |
| Actemra | 578 | 10.5% |
| Clonidine | 555 | 10.1% |
| Rituximab | 552 | 10% |
Other products listed in reports where Progesterone is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Progesterone | Progesterone | All reports |
|---|---|---|---|
| Reports as suspect product | 5,498 | 7,604 | 20,646,523 |
| Share of that pool | — | 72.3% | 0% |
| Reports, latest 12 months | 843 | — | 1,332,454 |
| Marked serious | 76% | 78% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 46 | 59 | 91 |
| Hospitalisation recorded, per 1,000 reports | 202 | 174 | 213 |
| Consumer-filed share | 33.1% | 32.5% | 45.8% |
| Top term, share of reports | Exposure during pregnancy 12.6% | median 12.6% | 0.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the progesterone class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prometrium | brand | 1,351 | 19 | 83% |
| Crinone | brand | 755 | 105 | 84.1% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Progesterone reports
How many adverse event reports has FDA received for Progesterone?
5,498 reports list Progesterone as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 843 of them arrived in the latest 12 months. Another 13,852 list it only as a concomitant medication.
What reactions are recorded in Progesterone reports?
exposure during pregnancy (12.6%), off label use (11.9%), foetal exposure during pregnancy (11.7%), headache (11.7%) and pain (10.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Progesterone was responsible.
How serious are the reports?
76% are marked serious by the reporter. Among the outcomes recorded, 4.6% of reports include death and 20.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (36.7%), consumer or non-health professional (33.1%) and physician (18.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Progesterone rising?
843 reports in the 12 months to June 2026, up 38% from 612 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Progesterone was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Progesterone?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Progesterone as a suspect or interacting product; reports listing it only as a concomitant medication (13,852) are excluded. 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.