Prescription medication · Progestogen Hormone
progesterone
Also sold as Prometrium. Progesterone capsules are used to prevent the lining of the uterus from growing too much in women who have gone through menopause and are taking estrogen.
Data updated 2026-05-15
- 21,004
- FDA reportsModerately reported
- 7
- InteractionsFew interactions
- 99% less
- Generic vs brandHuge savings
- 4
- Recall records
What the data shows
progesterone (Prometrium) is a prescription Progestogen Hormone, reported at a middle-of-the-pack volume (21,004 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
progesterone (Prometrium) is a prescription Progestogen Hormone. Progesterone capsules are used to prevent the lining of the uterus from growing too much in women who have gone through menopause and are taking estrogen.
Progesterone capsules contain a hormone that helps regulate your menstrual cycle and supports pregnancy. It is also used to prevent overgrowth of the uterine lining in women taking estrogen after menopause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$15.99/unit
Generic Price
$0.21/unit
Generic Savings
99%
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Progesterone capsules are used to prevent the lining of the uterus from growing too much in women who have gone through menopause and are taking estrogen.
Common side effects
Headache, Breast tenderness, Joint pain
Key warnings
Estrogen plus progestin therapy should not be used to prevent heart disease or dementia.
The sections below are summarized in plain English from progesterone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Progesterone is a hormone naturally produced by your body. This medicine works by increasing progesterone levels in your body. This helps to regulate your menstrual cycle and protect the uterus.
How to Take It
To prevent uterine overgrowth, take 200 mg each night at bedtime for 12 days of a 28-day cycle, along with your estrogen tablet. To restart your period, take 400 mg each night at bedtime for 10 days. If you have trouble swallowing the capsules, take them with a full glass of water while standing up.
This is a plain-language summary of progesterone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
You should not take progesterone capsules if you are pregnant or think you might be pregnant. Talk to your doctor if you become pregnant while taking this medicine. It is not known if progesterone passes into breast milk. Talk to your doctor about the risks and benefits of breastfeeding while taking this medicine.
This is a plain-language summary of progesterone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of progesterone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68-77°F) and protect from moisture. Keep out of reach of children.
Side Effects (from patient reports)
Based on 21,004 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for progesterone, by number of reports
- Headache
Headache
1,946 reports
- Tiredness
Tiredness
1,673 reports
- Pain
Pain
1,369 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,362 reports
- Skin rash
Skin rash
903 reports
- Feeling lightheaded
Feeling lightheaded
886 reports
- Exposure to the drug during pregnancy
Exposure to the drug during pregnancy
879 reports
- Allergic reaction
Allergic reaction
802 reports
- Excessive sweating
Excessive sweating
783 reports
- Diarrhea
Diarrhea
779 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for progesterone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where progesterone sits
progesterone has more FDA adverse-event reports than 56% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is progesterone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 21,004 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
21,004
Reports Mentioning Death
476
2.3% of reports — not proof of cause
Hospitalization Reports
3,394
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | HEADACHE | 1,946 |
| 3 | FATIGUE | 1,673 |
| 5 | PAIN | 1,370 |
| 6 | NAUSEA | 1,362 |
| 7 | RASH | 903 |
| 8 | DIZZINESS | 886 |
| 9 | EXPOSURE DURING PREGNANCY | 879 |
| 10 | HYPERSENSITIVITY | 802 |
| 11 | HYPERHIDROSIS | 783 |
| 12 | DIARRHOEA | 779 |
| 13 | MATERNAL EXPOSURE DURING PREGNANCY | 763 |
| 14 | BACK PAIN | 761 |
| 15 | INSOMNIA | 742 |
| 17 | CONSTIPATION | 714 |
| 18 | ARTHRALGIA | 699 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Estrogen plus progestin therapy should not be used to prevent heart disease or dementia. Estrogen plus progestin may increase your risk of blood clots, stroke, heart attack, breast cancer, and dementia. Progesterone with estrogens should be prescribed at the lowest effective doses and for the shortest duration.
Known Drug Interactions
Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations ("minipills" that do not contain an estrogen) may be an inadequate method of contraception during isotretinoin capsules therapy. Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum ® 7/7/7 Tablets as an oral contraceptive agent, isotretinoin capsules at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of...
Mechanism: This drug can interfere with 'mini-pills' that only contain progesterone, making them less reliable for preventing pregnancy.
What to do: You should use a more effective form of birth control or two different methods to ensure you do not become pregnant.
The effect of progesterone on theophylline clearance is unknown. albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit...
Mechanism: It is not fully known how progesterone affects theophylline, but it may change how quickly your body clears the drug. This could lead to theophylline levels being higher or lower than expected.
What to do: Tell your doctor if you start or stop taking hormone therapy. They may need to check your blood levels to make sure your theophylline dose is still safe and effective.
7.4 Oral Contraceptives Amoxicillin and Clavulanate Potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Mechanism: This antibiotic changes the bacteria in your gut, which can prevent your body from absorbing birth control hormones properly.
What to do: Use a backup method of birth control, such as condoms, while taking this antibiotic to prevent pregnancy.
7.4 Oral Contraceptives AUGMENTIN may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Mechanism: This antibiotic can change the bacteria in your gut, which makes it harder for your body to absorb the hormones in birth control pills.
What to do: Use a backup method of birth control, such as condoms, while taking this antibiotic to prevent pregnancy.
Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension. The following laboratory tests may be affected by progestins including medroxyprogesterone acetate injectable suspension: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol). (g) The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent.
Mechanism: Medroxyprogesterone can reduce the levels of progesterone measured in your body.
What to do: Your doctor should be aware of this interaction when testing your hormone levels.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take this to prevent heart disease?
Will this medicine cause dementia?
Can this medicine cause cancer?
What if I am allergic to peanuts?
Can I take this if I have abnormal vaginal bleeding?
Can I take this if I have a history of blood clots?
Can I take this if I have liver problems?
What does this medicine look like?
How should I store this medicine?
What should I do if I experience side effects?
What are the common side effects of progesterone?
Does progesterone interact with other medications?
What drug class is progesterone?
Is there a generic version of progesterone?
Is progesterone safe during pregnancy?
Has progesterone been recalled?
Active Recalls
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLC
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Eugia US LLC
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
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anastrozole
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Anastrozole is a medicine used to treat breast cancer in women after menopause.
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bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
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cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
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clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
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Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for progesterone
The FDA label for progesterone (sold under brand names such as Prometrium) classifies it as a prescription-only medication in the Progestogen Hormone class. Progesterone capsules are used to prevent the lining of the uterus from growing too much in women who have gone through menopause and are taking estrogen. Official labeling lists 9 commonly reported side effects, including Headache, Breast tenderness, Joint pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 21,004 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.21 versus $15.99 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 16, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages