Progesterone: uses, dosing, side effects & brands
Progesterone is a progesterone sold in the U.S. under 5 brand and generic names, for amenorrhea, endometrial hyperplasia and female infertility. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Progesterone
- Treats (across its forms)
- Amenorrhea, Endometrial Hyperplasia and Female Infertility
- Available as
- System · Topical · Insert, extended release · Capsule · Injectable · Insert
- Sold as
- 5 products — Milprosa, Crinone and Progestasert, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $12 for a 30-count supply — not your price
How Prometrium is dosed
From the FDA label for Prometrium (application NDA019781). Other progesterone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prevention of Endometrial Hyperplasia PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing PROMETRIUM Capsules. For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.
Everything below is the FDA label for Prometrium (capsule). Progesterone is also sold as system, topical, insert, extended release, injectable and insert, and those are different medicines to take — follow the label for the one you were prescribed.
Prometrium side effects
See WARNINGS and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of PROMETRIUM Capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 7 lists adverse reactions greater than or equal to 2 percent of women who received cyclic PROMETRIUM Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. TABLE 7. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] PROMETRIUM Capsules 200 mg with Conjugated Estrogens 0.625 mg Placebo (n=178) (n=174) Headache 31 27 Breast Tenderness 27 6 Joint Pain 20 29 Depression 19 12 Dizziness 15 9 Abdominal Bloating 12 5 Hot Flashes 11 35 Urinary Problems 11 9 Abdominal Pain 10 10 Vaginal Discharge 10 3 Nausea / Vomiting 8 7 Worry 8 4 Chest Pain 7 5 Diarrhea 7 4 Night Sweats 7 17 Breast Pain 6 2 Swelling of Hands and Feet 6 9 Vaginal Dryness 6 10 Constipation 3 2 Breast Carcinoma 2 <1 Breast Excisional Biopsy 2 <1 Cholecystectomy 2 <1 Effects on Secondary…
Who shouldn’t take Prometrium
PROMETRIUM is contraindicated in women with any of the following conditions: 1. Hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and is contraindicated in patients allergic to peanuts. 2. Abnormal genital bleeding of unknown etiology. 3. Known, suspected, or history of breast cancer. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. Known liver dysfunction or disease.
Every progesterone product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | System | Generic | $12 | View → | |
| 2 | 70/100 | Prescription | Topical | Generic | $12 | View → | |
| 3 | Not yet rated | Prescription | Insert | Generic | $12 | View → | |
| 4 | Not yet rated | Prescription | Capsule | Generic | $12 | View → | |
| 5 | Not yet rated | Prescription | Capsule | Generic | $12 | View → |
What progesterone pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing progesterone
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Progesterone recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLC · Dec 27, 2024
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Eugia US LLC · Jul 26, 2024
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Coast Quality Pharmacy, LLC dba Anazao Health · Apr 24, 2024
How long progesterone keeps
No progesterone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does progesterone expire? The in-use limits and storage rules from its labelsProgesterone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for progesterone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause of the low reported levels of progesterone in breastmilk, even with the high-dose products, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. The progesterone vaginal ring available outside the US produces maternal blood levels that are lower than those of ovulating women. Expert opinion holds that the risks of progestin-only contraceptive products usually are acceptable for nursing mothers at any time postpartum.
National Institute of Child Health and Human Development, record revised December 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about progesterone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 21,019 reports naming progesterone, and the FDA flagged 56% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- headache1,862 reports
- fatigue1,633 reports
- nausea1,350 reports
- rash907 reports
- exposure during pregnancy892 reports
- foetal exposure during pregnancy892 reports
- dizziness867 reports
- maternal exposure during pregnancy789 reports
Read these as a signal, not a rate. A report does not mean progesterone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is Prometrium?
Prometrium (Progesterone) is a progesterone used to treat Amenorrhea, Endometrial Hyperplasia, Female Infertility, Uterine Hemorrhage.
What kind of drug is progesterone?
The FDA classifies progesterone as a progesterone. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take progesterone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run progesterone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is progesterone sold under?
We track 5 progesterone-containing products in the U.S.: Milprosa, Crinone, Progestasert, Progesterone and Prometrium. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does progesterone come in?
Across the brands we track, progesterone is currently marketed as system, topical, insert, extended release, capsule, injectable and insert, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic progesterone?
Yes. Our catalog lists 1 generic progesterone product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has progesterone been recalled?
The FDA's Enforcement database lists 3 recall records whose product description mentions progesterone. The most recent: Progesterone Injection USP (Dec 27, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Progesterone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/progesterone
- MLA
- “Progesterone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/progesterone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for progesterone on DailyMed (NIH) ↗.