Progesterone
Progesterone is a hormone used in several forms: to support pregnancy in fertility treatment, to treat missed periods (secondary amenorrhea), to protect the uterine lining during estrogen therapy after menopause, and to treat abnormal uterine bleeding.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 55 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Progesterone is a hormone identical to the one the ovaries make, used to support pregnancy in fertility treatment, restart missed periods, control abnormal uterine bleeding and protect the uterine lining during estrogen therapy after menopause; it dates to about 1960 and is available generically. Most people handle it well, noticing drowsiness, dizziness, breast tenderness or bloating if anything. Its boxed warning covers estrogen plus progestin, which raised the risk of blood clots, stroke, heart attack, invasive breast cancer and probable dementia, so it is never a way to protect your heart or memory. Use the lowest dose for the shortest time, and recheck the need with your prescriber.
Clinical pearls
- Prometrium and generic progesterone capsules contain peanut oil, so avoid them if you have a peanut allergy.
- Take the capsules at bedtime so drowsiness works for you; food raised absorption in a study, so keep meals consistent.
- If you take it with estrogen, tell your surgeon, since stopping 4 to 6 weeks before clot-prone surgery may be advised.
- Mention it before blood work, since progesterone with estrogen can shift liver, clotting and thyroid test results.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Progestins taken with estrogen should not be used to prevent heart disease, heart attacks, strokes, or dementia.
In a large study of postmenopausal women, estrogen plus progestin raised the risk of blood clots in the legs and lungs, stroke, heart attack, and invasive breast cancer. In women 65 and older, it also raised the risk of probable dementia. It is unknown whether this applies to younger postmenopausal women.
These risks are assumed to be similar for other doses and forms of estrogen and progestin. Talk regularly with your healthcare provider about whether you still need treatment.
Patient information guide A plain-language walkthrough of Progesterone, written from its FDA label.
What Progesterone is used for
▾
Progesterone is a hormone with different approved uses depending on the product.
- Endometrin vaginal insert: supports embryo implantation and maintains pregnancy up to 10 weeks in infertile women under 35 in fertility treatment.
- Progesterone vaginal inserts: support embryo implantation and early pregnancy in fertility treatment for infertile women.
- Crinone vaginal gel: the 8% strength is for progesterone supplementation or replacement in fertility treatment; the 4% strength treats secondary amenorrhea.
- Prometrium and Progesterone oral capsules: prevent endometrial hyperplasia (overgrowth of the uterine lining) in postmenopausal women with a uterus taking conjugated estrogens tablets, and treat secondary amenorrhea.
- Progesterone injection (intramuscular): treats amenorrhea and abnormal uterine bleeding due to hormonal imbalance when there is no structural cause such as fibroids or uterine cancer.
- P25 Progesterone Cream: described as giving temporary relief of menopausal symptoms such as hot flashes. Other listed creams are labeled for external cosmetic use.
How Progesterone works
▾
Progesterone capsules contain micronized progesterone, which is chemically identical to the progesterone made by the ovaries. Micronizing it (grinding it into very fine particles) helps your body absorb more of it.
Progesterone dosage
▾
The regimen depends on the product, so follow your prescriber and your label.
- Prometrium and Progesterone capsules: taken orally once daily at bedtime for a set number of days. Take with a full glass of water while standing if swallowing is hard.
- Endometrin and Progesterone vaginal inserts: placed in the vagina two or three times daily, starting the day after egg retrieval, for up to 10 weeks.
- Crinone: placed in the vagina, with frequency depending on the use and strength.
- Progesterone injection: given into a muscle over several days by a healthcare professional.
- Creams: applied to the skin once or twice daily, as directed.
Dosing details from the FDA-approved label
From the Progesterone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Assisted Reproductive Technology – women who require progesterone supplementation (Crinone 8%, vaginal)
- 90 mg vaginally once daily
- If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10 to 12 weeks
- Assisted Reproductive Technology – women with partial or complete ovarian failure who require progesterone replacement (Crinone 8%, vaginal)
- 90 mg vaginally twice daily
- If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10 to 12 weeks
- Secondary Amenorrhea (Crinone, vaginal gel)
- Crinone 4% vaginally every other day up to a total of six doses
- For women who fail to respond, a trial of Crinone 8% every other day up to a total of six doses may be instituted
- A dosage increase from the 4% gel can only be accomplished by using the 8% gel; increasing the volume of gel does not increase the amount of progesterone absorbed
- Progesterone vaginal insert / Endometrin (starting the day after oocyte retrieval)
- 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration
- Efficacy in women 35 years of age and older has not been clearly established; the appropriate dose in this age group has not been determined
- Prevention of Endometrial Hyperplasia (oral capsules)
- 200 mg orally as a single daily dose at bedtime for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets
- For difficulty swallowing, take with a glass of water while in the standing position
- Treatment of Secondary Amenorrhea (oral capsules)
- Single daily dose of 400 mg at bedtime for 10 days
- For difficulty swallowing, take with a glass of water while in the standing position
- Amenorrhea (intramuscular injection)
- Five to 10 mg are given for six to eight consecutive days
- Withdrawal bleeding can be expected 48 to 72 hours after the last injection if there has been sufficient ovarian activity to produce a proliferative endometrium
- Functional Uterine Bleeding (intramuscular injection)
- Five to 10 mg are given daily for six doses
- When estrogen is given as well, progesterone is begun after two weeks of estrogen therapy; if menstrual flow begins during injections, they are discontinued
- BUNUSS Phyto-Pro Skin Cream (topical)
- Apply one pump once or twice daily
- A pattern of 3 weeks of use with a 1-week pause is recommended (or as directed by a doctor)
- P75 Lav / P50 / P25 Progesterone Cream (transdermal)
- Apply once or twice a day
- Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together, or use as directed by your physician
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia Progesterone capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing progesterone capsules. For these women, progesterone capsules should be taken with a glass of water while in the standing position. HOW SUPPLIED Progesterone, capsules 100 mg are available as an oval yellow, opaque, capsule imprinted with P-3 in black ink. NDC 68788-8709-3 (Bottle of 30) Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature] Protect from excessive moisture Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Manufactured for: Bionpharma Inc. Princeton, NJ 08540, USA 05/2023 For India Manufacturing Site MADE IN INDIA 04/2023 204000861
Read the full Dosage and Administration section on DailyMed →
Progesterone side effects
▾
In a trial of progesterone capsules taken with estrogen, these were reported most often:
Common side effects
- Headache
- Breast tenderness
- Joint pain
- Depression
- Dizziness
- Abdominal bloating
- Vaginal discharge
- Nausea or vomiting
When to get medical help
- Get emergency help for signs of a stroke or heart attack, such as sudden weakness, trouble speaking, or chest pain.
- Get help for signs of a blood clot in the leg or lung, such as leg swelling or pain, or sudden shortness of breath.
- Call your doctor right away if you have sudden partial or complete vision loss, bulging eyes, double vision, or a sudden migraine.
- Tell your doctor about any lump in your breast or abnormal mammogram.
- Report unexplained or persistent abnormal vaginal bleeding.
Progesterone warnings and precautions
▾
- Estrogen plus progestin raises the risk of blood clots, stroke, heart attack, and invasive breast cancer.
- In women 65 and older, estrogen plus progestin raised the risk of probable dementia.
- It should not be used to prevent heart disease or dementia.
- Stop and call your doctor right away if a stroke, clot, or sudden vision loss occurs or is suspected.
- Get yearly breast exams and regular mammograms.
- Persistent abnormal vaginal bleeding needs evaluation.
Progesterone interactions
▾
Few interactions are described in the label.
- Ketoconazole: slowed progesterone breakdown in lab testing.
- Lab tests: estrogen plus progestin can change liver, clotting, and thyroid results, so tell any lab or doctor you take it.
Interactions listed in the FDA-approved label
From the Progesterone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Hepatic function tests (sulfobromophthalein retention and others): Estrogen plus progestin therapy may increase sulfobromophthalein retention and other hepatic function test results.
- Coagulation tests: Estrogen plus progestin therapy may increase prothrombin factors VII, VIII, IX and X.
- Pregnanediol determination: Estrogen plus progestin therapy may alter pregnanediol determination results.
- Thyroid function tests: Estrogen plus progestin therapy may increase PBI and butanol extractable protein bound iodine and decrease T3 uptake values.
Read the label’s full interactions text
C. Drug–Laboratory Test Interactions The following laboratory results may be altered by the use of estrogen plus progestin therapy: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin factors VII, VIII, IX and X. Pregnanediol determination. Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Progesterone
▾
- Peanut allergy: progesterone capsules contain peanut oil and must not be used.
- Do not use capsules with undiagnosed abnormal vaginal bleeding.
- Do not use capsules with a history of breast cancer, blood clots, stroke, or heart attack.
- Do not use capsules with known liver disease.
- Do not use capsules if pregnant or suspected pregnant.
- Endometrin has not been clearly shown to work in women 35 and older.
- Tell your doctor about high blood pressure, diabetes, smoking, high cholesterol, or obesity.
Progesterone overdose
▾
No overdose studies have been done in humans. For Prometrium capsules, the label says to stop the medicine and treat symptoms.
How your body processes Progesterone
▾
After swallowing progesterone capsules, blood levels peak within about 3 hours. Eating food increased how much was absorbed. The liver breaks progesterone down, and the waste products leave mainly through the kidneys and bile. The effects of liver or kidney problems have not been studied.
How to store Progesterone
▾
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Progesterone
126 supplements and herbal products have documented interactions with Progesterone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 91
- Minor · 33
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Progesterone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Progesterone — the kind of thing our pharmacy team would talk through with you at the counter.
What is progesterone used for?
▾
How should I take the capsules?
▾
What side effects should I expect?
▾
When should I call my doctor right away?
▾
Who shouldn't take progesterone capsules?
▾
Can progesterone with estrogen protect my heart or memory?
▾
Is Progesterone available over the counter?
▾
When was Progesterone first available?
▾
Who makes Progesterone?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Progesterone on HelloPharmacist
Progesterone forms and strengths (how it comes)
Progesterone is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Prometrium and Progesterone capsules prevent endometrial hyperplasia in postmenopausal women with a uterus who take conjugated estrogens tablets.
- Prometrium and Progesterone capsules treat secondary amenorrhea.
- Prometrium and Progesterone capsules are taken once daily at bedtime.
- If swallowing is hard, Prometrium and Progesterone capsules should be taken with a glass of water while standing.
Injection
How this form is used
- Progesterone injection treats amenorrhea and abnormal uterine bleeding due to hormonal imbalance when there is no underlying structural cause such as fibroids or uterine cancer.
- Progesterone injection is given into a muscle and can be irritating at the injection site.
- Progesterone injection is given daily over several days, depending on the condition.
Topical (transdermal) gel
How this form is used
- P25 Progesterone Cream is described as giving temporary relief from menopausal symptoms such as hot flashes.
- P25, P50 and P75 Lav Progesterone Creams are applied once or twice a day, or as directed by your physician.
- P25, P50 and P75 Lav Progesterone Creams are massaged into the inner arms, thighs, or chest.
Vaginal cream or gel
How this form is used
- Crinone 8% provides progesterone supplementation or replacement in fertility treatment for women with progesterone deficiency.
- Crinone 4% treats secondary amenorrhea, and Crinone 8% is used if a woman does not respond to Crinone 4%.
- Crinone is given vaginally. For fertility treatment, Crinone 8% is used once or twice daily.
- For secondary amenorrhea, Crinone is given every other day for up to six doses.
- Using more Crinone gel does not increase the amount of progesterone absorbed.
Vaginal insert
How this form is used
- Endometrin supports embryo implantation and helps maintain pregnancy up to 10 weeks in infertile women under 35 in fertility treatment.
- Progesterone vaginal inserts support embryo implantation and early pregnancy in fertility treatment for infertile women.
- Endometrin and Progesterone vaginal inserts are placed in the vagina two or three times daily.
- Endometrin and Progesterone vaginal inserts start the day after egg retrieval and continue for up to 10 weeks.
- For Endometrin and Progesterone vaginal inserts, effectiveness in women 35 and older has not been clearly established.
Topical cream, ointment or gel
How this form is used
- BUNUSS Phyto-Pro Skin Cream is applied as one pump once or twice daily to clean, dry skin and massaged until absorbed.
- BUNUSS Phyto-Pro Skin Cream is used in a pattern of 3 weeks on and 1 week off, or as a doctor directs.
- With BUNUSS Phyto-Pro Skin Cream, wash your hands after use and avoid direct sunlight on the area.
Progesterone on the U.S. market: products, makers and brands
How Progesterone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
28 companies list 83 Progesterone product records with the FDA, mostly as capsule, injection, topical (transdermal) gel; the earliest marketing or approval year on record is 1960. Brand names on the directory include Prometrium, Eazi-Breed CIDR, Crinone and 5 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (71) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Progesterone is used (Medicaid data)
A general measure of how commonly Progesterone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Progesterone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Progesterone prescribed? Of the 1,601 medications we measure, Progesterone ranks #214 by Medicaid prescriptions — more than 87% of them.
Utilization by Progesterone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
progesterone 100 MG Oral Capsule Most dispensed
Summed across the 7 of 100 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 260243
progesterone 200 MG Oral Capsule
Summed across the 5 of 113 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312641
progesterone 50 MG/ML Injectable Solution
Summed across the 5 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312644
progesterone 100 MG Vaginal Insert
Summed across the 2 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 725094
progesterone 0.08 MG/MG Vaginal Gel
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312645
progesterone 0.04 MG/MG Vaginal Gel
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312643
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Progesterone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 21 of 237 listed Progesterone NDCs with Medicaid activity.
Compare Progesterone products
A representative set of FDA-listed product records for Progesterone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 100 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 100 mg | Oral | Acertis Pharmaceuticals, LLC | NDA | View NDC → |
| 200 mg | Oral | Acertis Pharmaceuticals, LLC | NDA | View NDC → |
| 100 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 200 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 100 mg | Oral | Asclemed USA, Inc. × 5 listings | ANDA | View NDC → |
| 200 mg | Oral | Asclemed USA, Inc. × 5 listings | ANDA | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Bionpharma Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Bionpharma Inc. × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 100 mg | Oral | direct rx | ANDA | View NDC → |
| 200 mg | Oral | Direct Rx × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 100 mg | Oral | Dr. Reddys Laboratories, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Dr. Reddys Laboratories, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 200 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 100 mg | Oral | Northstar Rx LLC × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Northstar Rx LLC × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 100 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 200 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Preferred Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Proficient Rx LP × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | Redpharm Drug | ANDA | View NDC → |
| 100 mg | Oral | Remedyrepack Inc. × 3 listings | ANDA | View NDC → |
| 100 mg | Oral | Xiromed, LLC | ANDA | View NDC → |
| 200 mg | Oral | Xiromed, LLC | ANDA | View NDC → |
| 💊Injection | ||||
| 50 mg/mL | Intramuscular | Eugia US LLC | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg | Intramuscular | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 50 mg/mL | Intramuscular | Xiromed, Llc | ANDA | View NDC → |
| 💊Topical (transdermal) gel | ||||
| 1 mg/mg | Transdermal | Shyne Brands × 2 listings | UNAPPROVED DRUG OTHER | View NDC → |
| 25 mg/85 g | Transdermal | Shyne Brands | UNAPPROVED DRUG OTHER | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 16.9 mg/mL | Topical | Jiashen International Trade Limited | UNAPPROVED DRUG OTHER | View NDC → |
| 💊Vaginal cream or gel | ||||
| 45 mg/1.125 g | Vaginal | Allergan, Inc. | NDA | View NDC → |
| 90 mg/1.125 g | Vaginal | Allergan, Inc. | NDA | View NDC → |
| 💊Vaginal insert | ||||
| 100 mg | Vaginal | Ferring Pharmaceuticals Inc. | NDA | View NDC → |
| 100 mg | Vaginal | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 100 mg | Vaginal | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mg | Vaginal | Xiromed, Llc | ANDA | View NDC → |
Showing 83 of 83 products — FDA National Drug Code Directory. See every product, package size and price: browse all 83 Progesterone NDCs →
Progesterone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Progesterone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Progesterone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Progesterone FDA approval history
How Progesterone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Progesterone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Progesterone recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 Lots: Batch # 1PR24010, Expiry: 02/28/2027 FDA record D-0186-2025 →
- Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10. Lots: Lot #: CPR230029A FDA record D-0624-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 8727 5 dose forms · 9 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 374412In current FDA listingsClinical drug / strength (SCD) 50 MG/MLRxCUI 312644 -
Dose form (SCDF) Oral Capsule RxCUI 373616In current FDA listings -
Dose form (SCDF) Topical Oil RxCUI 2716917In current FDA listingsClinical drug / strength (SCD) 213 MG/MLRxCUI 2716918 -
Dose form (SCDF) Vaginal Gel RxCUI 377270In current FDA listings -
Dose form (SCDF) Vaginal Insert RxCUI 2109022In current FDA listings
Look up RxCUI 8727 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Progesterone supply and shortage status
Whether Progesterone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Progesterone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 100 mg | $0.229 per capsule | NDC details & price history |
| Capsule · Oral | 200 mg | $0.404 per capsule | NDC details & price history |
| Injection, Solution · Intramuscular | 50 mg/mL | $1.36 per mL | NDC details & price history |
| Insert · Vaginal | 100 mg | $15.15 each | NDC details & price history |
| Gel · Vaginal | 45 mg/1.125 g | $16.84 per gram | NDC details & price history |
| Gel · Vaginal | 90 mg/1.125 g | $27.97 per gram | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Progesterone brand names
Progesterone is sold under 8 brand names in the FDA directory — Prometrium, Eazi-Breed CIDR, Crinone, Endometrin and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Progesterone: manufacturers and labelers
28 companies list Progesterone products with the FDA. By number of product records, the largest are Asclemed USA, Inc., Bryant Ranch Prepack, Proficient Rx LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 4 more on the FDA NDC directory.
Progesterone drug class (RxNorm)
Progesterone belongs to the Progesterone class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Progesterone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Acertis Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →