Public record
Progesterone: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for progesterone
The FDA label read for progesterone (ENDOMETRIN, application NDA022057) was last revised on 2026-07-29. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-07-29 | |
| Label read | ENDOMETRIN | NDA022057, brand-name application |
| Boxed warning | No | |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient progesterone from an original manufacturer
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Approvals
FDA approval history for progesterone
The earliest FDA approval on file for a progesterone product is 1974-11-01. Drugs@FDA lists 25 applications for it and 168 approved supplements, the most recent on 2026-07-15.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 1974-11-01 | |
| Applications with an approval on file | 25 | |
| New drug applications (NDA) | 9 | |
| Generic applications (ANDA) | 16 | |
| Approved supplements | 168 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-07-15 | |
| Sponsoring companies | 22 |
How this was calculated
Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.
Applications with a single-ingredient progesterone product in Drugs@FDA, all sponsors and strengths
Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.
Patents and generics
Patents and generic approvals for progesterone
The FDA Orange Book lists 15 approved generic applications for progesterone, the first approved on 2001-04-25. 3 listed patents on specific brand products have not yet expired, the last on 2030-01-21; generics of other versions are already approved.
| Measure | Value | Note |
|---|---|---|
| Brand-name applications (NDA) | 7 | |
| Approved generic applications (ANDA) | 15 | first approved 2001-04-25 |
| Companies with a generic not marked discontinued | 10 | |
| Listed patents not yet expired | 3 | |
| Latest listed patent expiry | 2030-01-21 | on any product; may cover only one brand formulation |
| Earliest approval date on file | before 1982 | |
| Products not marked discontinued | 23 of 33 |
How this was calculated
Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.
All single-ingredient progesterone products in the Orange Book, every brand and strength, files dated 2026-10-09
An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.
Medicaid
Medicaid prescriptions for progesterone by state
State Medicaid programmes paid for 740,097 progesterone prescriptions in 2025, with $17.2M reimbursed before rebates. California reported the most (96,124), followed by New York (70,920) and Oregon (54,552); 52 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 740,097 | |
| Total reimbursed before rebates, 2025 | $17.2M | |
| States and territories reporting | 52 | with at least one count CMS did not suppress |
| California | 96,124 prescriptions | $2.7M reimbursed |
| New York | 70,920 prescriptions | $1.6M reimbursed |
| Oregon | 54,552 prescriptions | $787,987 reimbursed |
| Washington | 38,175 prescriptions | $931,613 reimbursed |
| Arizona | 30,025 prescriptions | $710,783 reimbursed |
How this was calculated
Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.
All single-ingredient progesterone products in the FDA NDC Directory, fee-for-service and managed care, 2025
Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.
Pharmacy cost
Pharmacy acquisition cost (NADAC) for progesterone
Retail pharmacies paid an average of $0.2329 per unit for PROGESTERONE 100 MG CAPSULE as of 2026-11-11, compared with $0.2394 twelve months earlier (-2.7%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| PROGESTERONE 100 MG CAPSULE | $0.2329 per unit | 12 months earlier $0.2394 (-2.7%) |
| PROGESTERONE 100 MG VAG INSERT | $8.95 per unit | no price on file 12 months earlier |
| PROGESTERONE 200 MG CAPSULE | $0.4108 per unit | 12 months earlier $0.4179 (-1.7%) |
| PROGESTERONE 500 MG/10 ML VIAL | $1.33 per mL | 12 months earlier $1.55 (-14.6%) |
How this was calculated
Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.
Generic versions of progesterone in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12
NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.
Adverse event reports
FDA adverse event reports naming bloating and progesterone
Through 2026-10-28, FDA had received 307 adverse event reports for progesterone that name bloating (abdominal distension), out of 21,732 reports for the drug in all. 265 of these reports concerned female patients and 3 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming bloating (abdominal distension) | 307 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 1.4% | share of reports received, not of people taking the drug |
| Of those: female patients | 265 | reflects who takes the drug and who files reports |
| Of those: male patients | 3 | |
| Of those: sex not recorded | 39 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: abdominal distension. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), MedDRA term abdominal distension
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming breast tenderness or pain and progesterone
Through 2026-10-28, FDA had received 177 adverse event reports for progesterone that name breast tenderness or pain, out of 21,732 reports for the drug in all. 158 of these reports concerned female patients and 0 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming breast tenderness or pain | 177 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 0.8% | share of reports received, not of people taking the drug |
| Of those: female patients | 158 | reflects who takes the drug and who files reports |
| Of those: male patients | 0 | |
| Of those: sex not recorded | 19 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: breast tenderness, breast pain. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), MedDRA terms breast tenderness, breast pain
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming dizziness and progesterone
Through 2026-10-28, FDA had received 875 adverse event reports for progesterone that name dizziness, out of 21,732 reports for the drug in all. 779 of these reports concerned female patients and 5 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming dizziness | 875 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 4.0% | share of reports received, not of people taking the drug |
| Of those: female patients | 779 | reflects who takes the drug and who files reports |
| Of those: male patients | 5 | |
| Of those: sex not recorded | 91 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: dizziness. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), MedDRA term dizziness
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming drowsiness or sedation and progesterone
Through 2026-10-28, FDA had received 379 adverse event reports for progesterone that name drowsiness or sedation, out of 21,732 reports for the drug in all. 337 of these reports concerned female patients and 3 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming drowsiness or sedation | 379 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 1.7% | share of reports received, not of people taking the drug |
| Of those: female patients | 337 | reflects who takes the drug and who files reports |
| Of those: male patients | 3 | |
| Of those: sex not recorded | 39 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: somnolence, sedation. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), MedDRA terms somnolence, sedation
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming mood changes and progesterone
Through 2026-10-28, FDA had received 159 adverse event reports for progesterone that name mood changes, out of 21,732 reports for the drug in all. 142 of these reports concerned female patients and 2 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming mood changes | 159 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 0.7% | share of reports received, not of people taking the drug |
| Of those: female patients | 142 | reflects who takes the drug and who files reports |
| Of those: male patients | 2 | |
| Of those: sex not recorded | 15 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: mood swings, mood altered. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), MedDRA terms mood swings, mood altered
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming unexpected vaginal or uterine bleeding and progesterone
Through 2026-10-28, FDA had received 536 adverse event reports for progesterone that name unexpected vaginal or uterine bleeding, out of 21,732 reports for the drug in all. 476 of these reports concerned female patients and 0 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming unexpected vaginal or uterine bleeding | 536 | |
| All reports for progesterone | 21,732 | |
| Share of this drug's reports naming it | 2.5% | share of reports received, not of people taking the drug |
| Of those: female patients | 476 | reflects who takes the drug and who files reports |
| Of those: male patients | 0 | |
| Of those: sex not recorded | 60 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: vaginal haemorrhage, intermenstrual bleeding, uterine haemorrhage. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports with progesterone as a single-ingredient active substance (any brand), 3 MedDRA terms for unexpected vaginal or uterine bleeding
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
Most reported events in FDA adverse event reports for progesterone
Through 2026-10-28, FDA had received 21,732 adverse event reports for progesterone, 12,201 of them marked serious by the reporter. The symptom terms named most often were headache (2,044), fatigue (1,773) and pain (1,395).
| Measure | Value | Note |
|---|---|---|
| All reports received | 21,732 | |
| Reports the reporter marked serious | 12,201 | death, hospitalisation, disability or similar outcome |
| Headache | 2,044 reports | |
| Fatigue | 1,773 reports | |
| Pain | 1,395 reports | |
| Nausea | 1,354 reports | |
| Rash | 953 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example off label use) were left out of the list.
Reports where FDA recorded progesterone as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Recalls
FDA drug recalls naming progesterone
FDA enforcement reports list 4 drug recall entries naming progesterone from 2014 to 2025-01-15. 0 of them are for compounded or other unlisted products and 4 for products FDA lists under a label. The most common stated reason was contamination or particles (2 of 4).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 4 | |
| For products FDA lists under an approved or registered label | 4 | |
| For compounded or other unlisted products | 0 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 3 | |
| Class III | 1 | |
| Most recent recall reported | 2025-01-15 | |
| Most common stated reason | contamination or particles | 2 of 4 entries |
How this was calculated
Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.
Recalls of single-ingredient progesterone products, plus compounded or unlisted products whose description names it
Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.
Clinical studies
Registered clinical studies of progesterone
ClinicalTrials.gov lists 1,265 registered studies that name progesterone as an intervention as of 2026-11-11. Of these, 123 are recruiting, 695 are completed and 214 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 1,265 |
| Recruiting now | 123 |
| Not yet recruiting | 44 |
| Completed | 695 |
| Terminated, withdrawn or suspended | 155 |
| Phase 3 (including phase 2/3) | 214 |
| Phase 2 (including phase 1/2) | 235 |
| Phase 1 | 101 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches progesterone, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Population data
How progesterone is distributed in US adults
In the 2021 to 2023 US national health survey, the median progesterone was 5.1 ng/dL in men aged 20 to 39 and 14.4 ng/dL in women aged 20 to 39. Half of people in each group fall below the median; the row notes give the range covering the middle 90%.
| Measure | Value | Note |
|---|---|---|
| Men 20 to 39, median | 5.1 ng/dL | middle 90% of people: 0.93 to 13.0; 611 people tested |
| Men 40 to 59, median | 4.2 ng/dL | middle 90% of people: 0.74 to 12.6; 710 people tested |
| Men 60 and over, median | 3.9 ng/dL | middle 90% of people: 0.91 to 11.3; 1,178 people tested |
| Women 20 to 39, median | 14.4 ng/dL | middle 90% of people: 1.7 to 1970; 793 people tested |
| Women 40 to 59, median | 5.2 ng/dL | middle 90% of people: 0.61 to 1103; 894 people tested |
| Women 60 and over, median | 2.6 ng/dL | middle 90% of people: 0.61 to 9.2; 1,340 people tested |
How this was calculated
Computed survey-weighted 5th, 50th and 95th percentiles from the CDC public file by sex and age band, using the sample weight WTPH2YR. Groups with fewer than 50 people are left out.
US adults aged 20 and over who gave a sample in NHANES 2021 to 2023, CDC variable LBXPG4 (Progesterone (ng/dL))
These are population distributions, not clinical reference ranges or treatment targets. They include people with and without health conditions and people on medication. Laboratories differ in method and units.
Articles on Progesterone
- Oral Micronized Progesterone: Manufacturing, Supply & Shortage History
- Oral Micronized Progesterone Monitoring Schedule: Labs & Exams
- Oral Micronized Progesterone Off-Label Uses with Evidence Levels
- Oral Micronized Progesterone Patent & Generic Timeline
- Oral Micronized Progesterone Regulatory Status: US, EU, Canada, UK
- Oral Micronized Progesterone Safety Signals and FDA Actions