Prescription medicine
Medroxyprogesterone Brand names: Provera, Depo-Provera, Depo-Subq
Medroxyprogesterone (Depo-Provera) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $22.85 per mL (Medroxyprogesterone 150 mg/mL) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the medroxyprogesterone FDA label on DailyMed (effective June 29, 2026, Pharmacia & Upjohn Company LLC); the NDA 11839 record on Drugs@FDA; every medroxyprogesterone label on DailyMed.
Highlights of the record
FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY.
Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia .) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders. ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use .) Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. […]
Used for
From the label: indications and usagePROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 104 mg/.65ml
- 150 mg/ml
Tablet; injection (suspension); extended-release injection (suspension).
On the market
- Earliest approval on file
- June 18, 1959 Provera, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first May 15, 1974; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 21 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $22.85 per mL Medroxyprogesterone 150 mg/mL
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 14 since 2013 0 Class I among all firms' recalls; latest April 25, 2025; 14 more by firms not listed as its makers
- FAERS reports
- 49,531 through July 30, 2026
What is medroxyprogesterone used for?
From the label: indications and usagePROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
Conditions named in the indications of medroxyprogesterone's FDA labels, with every medicine labeled for each:
From other medroxyprogesterone labelsBirth control: Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy.
Pain: Management of endometriosis-associated pain.
FDA pharmacologic class: Progestin.
Source: FDA drug label (Provera), NDA011839 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective June 29, 2026 (SPL set a586be28-96af-4fed-a13f-9b94fd4c7405), via openFDA; the full label on DailyMed
What does the patient leaflet for medroxyprogesterone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PROVERA (a progestin hormone)?Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). • Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older. • You and your healthcare provider should talk regularly about whether you still need treatment with PROVERA.
Source: FDA drug label (Provera), NDA011839 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective June 29, 2026 (SPL set a586be28-96af-4fed-a13f-9b94fd4c7405), via openFDA; the full label on DailyMed
Is there a generic for medroxyprogesterone (Depo-Provera)?
The FDA approved the first generic medroxyprogesterone on May 15, 1974. 21 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists medroxyprogesterone from 21 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1959 earliest approval on file
- 1974 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for medroxyprogesterone (Depo-Provera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $22.85 per mL (Medroxyprogesterone 150 mg/mL), up 12% from $20.31 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Medroxyprogesterone 150 mg/mL (generic)
- Depo-provera 150 mg/mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Medroxyprogesterone 10 mg tablet | Generic | $0.152 per tablet | $4.57 | no change |
| Medroxyprogesterone 150 mg/mL | Generic | $22.85 per mL | n/a | +12% |
| Medroxyprogesterone 2.5 mg tablet | Generic | $0.116 per tablet | $3.47 | -1% |
| Medroxyprogesterone 5 mg tablet | Generic | $0.143 per tablet | $4.28 | -2% |
| Depo-provera 150 mg/mL syringe | Brand | $52.34 per mL | n/a | -0.2% |
| Depo-provera 150 mg/mL vial | Brand | $50.99 per mL | n/a | +0.6% |
| Depo-subq provera 104 syringe | Brand | $77.43 per mL | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is medroxyprogesterone in shortage?
No medroxyprogesterone presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated August 31, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| PROVERA, Tablet, 10 mg (NDC 0009-0051-01) | Pfizer Inc. | To Be Discontinued | August 31, 2026 |
| PROVERA, Tablet, 2.5 mg (NDC 0009-0065-01) | Pfizer Inc. | To Be Discontinued | August 31, 2026 |
Every medroxyprogesterone presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has medroxyprogesterone been recalled?
The FDA's Enforcement Report lists 28 recalls naming medroxyprogesterone since 2013: 0 Class I (the most serious), 27 Class II, 1 Class III; 5 still ongoing. 14 of them are by firms that FDA's NDC Directory does not list as a maker of medroxyprogesterone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 25, 2025 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery … |
| December 18, 2024 | Class II | Eugia US LLC | CGMP Deviations |
| October 7, 2022 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products … |
| May 6, 2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Lack of assurance of sterility |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 21, 2021 | Class II | Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy | Lack of Assurance of Sterility |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| May 17, 2018 | Class II | Guardian Pharmacy Services not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the medroxyprogesterone label say about other medicines?
The medroxyprogesterone label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name medroxyprogesterone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bosentan | drug interactions | Some examples of moderate CYP3A inducers are bosentan, efavirenz, etravirine, and modafinil. |
| Carbamazepine | drug interactions | carbamazepine |
| Efavirenz | drug interactions | Some examples of moderate CYP3A inducers are bosentan, efavirenz, etravirine, and modafinil. |
| Estradiol | drug interactions | The following laboratory tests may be affected by progestins including Depo-Provera CI: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol). (b) Gonadotropin levels are decreased. (c) Sex-hormone-binding-globulin concentrations are decreased. … |
| Etravirine | drug interactions | Some examples of moderate CYP3A inducers are bosentan, efavirenz, etravirine, and modafinil. |
| Mitotane | drug interactions | Some examples of strong CYP3A inducers are rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, and St. John's wort (the CYP3A4 induction effect of St. John's wort varies widely and is preparation dependent). |
| Modafinil | drug interactions | Some examples of moderate CYP3A inducers are bosentan, efavirenz, etravirine, and modafinil. |
| Oxcarbazepine | drug interactions | oxcarbazepine |
| Phenobarbital | drug interactions | Some examples of strong CYP3A inducers are rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, and St. John's wort (the CYP3A4 induction effect of St. John's wort varies widely and is preparation dependent). |
| Phenytoin | drug interactions | Some examples of strong CYP3A inducers are rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, and St. John's wort (the CYP3A4 induction effect of St. John's wort varies widely and is preparation dependent). |
| Progesterone | drug interactions | The following laboratory tests may be affected by progestins including Depo-Provera CI: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol). (b) Gonadotropin levels are decreased. (c) Sex-hormone-binding-globulin concentrations are decreased. … |
| Rifampin | drug interactions | Some examples of strong CYP3A inducers are rifampin, carbamazepine, phenytoin, phenobarbital, mitotane, and St. John's wort (the CYP3A4 induction effect of St. John's wort varies widely and is preparation dependent). |
| Testosterone | drug interactions | The following laboratory tests may be affected by progestins including Depo-Provera CI: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol). (b) Gonadotropin levels are decreased. (c) Sex-hormone-binding-globulin concentrations are decreased. … |
| Topiramate | drug interactions | topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. |
Other labels that name medroxyprogesterone
Source: FDA drug label (Provera), NDA011839 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective June 29, 2026 (SPL set a586be28-96af-4fed-a13f-9b94fd4c7405), via openFDA; the full label on DailyMed
What do FAERS reports show for medroxyprogesterone?
The FDA Adverse Event Reporting System holds 49,531 reports that list medroxyprogesterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 988 are coded as a death and 5,086 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,763, against a median of 820 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does medroxyprogesterone compare with medicines for the same use?
2 side-by-side pages set medroxyprogesterone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other progestins
- the pharmacologic class, with prices and generics
- Medroxyprogesterone side effects
- the label's list beside FAERS reports
- Medroxyprogesterone shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other