Medroxyprogesterone

Medroxyprogesterone acetate (MPA) injectable suspension, inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

• Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

• The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see Warnings and Precautions ( 5.2 ) ].contraindicated

The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (2.1) 2.1 Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection. Use for longer than 2 years is not recommended (unless other birth control methods are considered inadequate) due to the impact of long-term medroxyprogesterone acetate injectable suspension treatment on bone mineral density (BMD) [see Warnings and Precautions (5.1)] . Dosage does not need to be adjusted for body weight [ see Clinical Studies ( 14.1 )] . To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week.

Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis. ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.5 ) Liver Function: Discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop. ( 5. 7) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.1 2) 5.1 Loss of Bone Mineral Density Use of medroxyprogesterone acetate injectable suspension reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess the reversibility of loss of BMD in adolescents was conducted with medroxyprogesterone acetate injectable suspension.

The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section ( 5 ): Loss of Bone Mineral Density [ see Warnings and Precautions ( 5.1 ) ] Thromboembolic disease [ see Warnings and Precautions ( 5.2 ) ] Breast Cancer [ see Warnings and Precautions ( 5.3 ) ] Anaphylaxis and Anaphylactoid Reactions [ see Warnings and Precautions ( 5.5 ) ] Bleeding Irregularities [ see Warnings and Precautions ( 5. 10) ] Weight Gain [ see Warnings and Precautions ( 5. 11) ] Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies 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 the two clinical trials with medroxyprogesterone acetate injectable suspension, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of medroxyprogesterone acetate injectable suspension.

Nursing Mothers : Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. ( 8.3 ) Pediatric Patients : Medroxyprogesterone acetate injectable suspension is not indicated before menarche. ( 8.4 ) 8.1 Pregnancy Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy. [ See Contraindications and Warnings and Precautions ( 5.1 7).] 8.3 Nursing Mothers Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. [ See Warnings and Precautions ( 5.1 3) .] 8.4 Pediatric Use Medroxyprogesterone acetate injectable suspension is not indicated before menarche. Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

Metabolism

Absorption Following a single 150 mg IM dose of medroxyprogesterone acetate injectable suspension in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. Distribution Plasma protein binding of MPA averages 86%.

• Jun 18, 1959NDANDA011839Pfizer
• Oct 29, 1992NDANDA020246Pfizer
• Nov 17, 1995NDANDA020527Wyeth Pharms
• Aug 9, 1996ANDAANDA040159Barr
• Dec 17, 2004NDANDA021583Pfizer
• Nov 28, 2017ANDAANDA077334Amphastar Pharms Inc
• Nov 28, 2017ANDAANDA077235Amphastar Pharms Inc
• Oct 12, 2018ANDAANDA210227Xiromed

1. 1Breast Cancer10,96321%
2. 2Breast Cancer Female10,18420%
3. 3Meningioma2,8645.5%
4. 4Breast Cancer Metastatic1,9463.8%
5. 5Drug Ineffective1,8293.5%
6. 6Nausea1,4402.8%
7. 7Headache1,4002.7%
8. 8Pain1,3032.5%
9. 9Depression1,2792.5%
10. 10Fatigue1,2272.4%
11. 11Anxiety1,1012.1%
12. 12Weight Increased1,0442.0%
13. 13Dizziness1,0252.0%
14. 14Off Label Use8941.7%
15. 15Dyspnoea8481.6%

Recent PubMed references pinned to Medroxyprogesterone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• The association between depot medroxyprogesterone acetate and meningiomas: Emerging data and their relevance to the South African context.
  South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde · 2026 · Burman RJ, De Waal R, Cohen K, et al.
  PMID 42246798DOI 10.7196/SAMJ.2026.v116i1.4529
• Metformin sensitizes endometriosis to medroxyprogesterone acetate treatment through MIG-6 mediated signaling.
  Journal of molecular medicine (Berlin, Germany) · 2026 · Gao G, Duan L, Zhu F, et al.
  PMID 41945107DOI 10.1007/s00109-026-02655-z
• Understanding clients' and providers' perspectives on the implementation of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) for self-injection programming in Nigeria.
  BMJ global health · 2026 · Challa S, Griffith M, Jegede A, et al.
  PMID 41748268DOI 10.1136/bmjgh-2024-018763
• AKR1C inhibitors medroxyprogesterone acetate and mefenamic acid exhibit antitumor activity alone and combined with carboplatin in platinum-resistant high-grade serous ovarian cancer models.
  Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2026 · Marolt N, Zottel A, Annibali D, et al.
  PMID 41702359DOI 10.1016/j.biopha.2026.119079
• The Progesterone Challenge Test as a Functional Biomarker of Endometrial Cancer Risk: Results from a Prospective Feasibility Study.
  Cancer prevention research (Philadelphia, Pa.) · 2026 · Neilson A, Woima R, Dodani D, et al.
  PMID 41630399DOI 10.1158/1940-6207.CAPR-25-0444
• Comparative Effectiveness of Levonorgestrel Implant and Depot Medroxyprogesterone Acetate Injectable for Women Living With HIV on Dolutegravir-Based Antiretroviral Therapy.
  Pharmacoepidemiology and drug safety · 2026 · Mollan KR, Pence BW, Westreich D, et al.
  PMID 41549859DOI 10.1002/pds.70297
• Live Birth Outcomes After Extended or Repeated High-Dose Medroxyprogesterone Acetate Therapy for Fertility-Sparing Management of Endometrial Neoplasia: A Single-Center Retrospective Case Series.
  The journal of obstetrics and gynaecology research · 2026 · Yamamura A, Okunomiya A, Yanai A, et al.
  PMID 41534944DOI 10.1111/jog.70178
• Injectable contraceptives differentially affect the hypothalamic-pituitary-gonadal axis and amenorrhea incidence†.
  Biology of reproduction · 2026 · Bick AJ, Avenant C, Capitaine CK, et al.
  PMID 41489365DOI 10.1093/biolre/ioaf292

The 10 most recently updated of 234 ClinicalTrials.gov registrations naming Medroxyprogesterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Intrauterine Stent Placement Following Hysteroscopic Septum Resection
  Recruiting · Interventional · 320 enrolled · Weill Medical College of Cornell University
  NCT07032506updated 2026-06-12
• SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer
  Not yet recruiting · Phase 4 · Interventional · 80 enrolled · Hospital Universitari de Bellvitge
  NCT07462663updated 2026-06-10
• Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
  Recruiting · Phase 2 · Interventional · 104 enrolled · Fudan University
  NCT05247268updated 2026-06-04
• TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC
  Recruiting · Phase 2 · Interventional · 10 enrolled · Fudan University
  NCT06914297updated 2026-06-04
• Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
  Recruiting · Phase 4 · Interventional · 65 enrolled · University of Pennsylvania
  NCT06665997updated 2026-05-28
• Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months
  Recruiting · Phase 3 · Interventional · 207 enrolled · Bayer
  NCT06904274updated 2026-05-27
• Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
  Recruiting · Phase 2 · Phase 3 · Interventional · 1,615 enrolled · Leiden University Medical Center
  NCT05255653updated 2026-05-15
• A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
  Recruiting · Phase 2 · Interventional · 250 enrolled · Merck Sharp & Dohme LLC
  NCT06979596updated 2026-05-13
• Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV
  Not yet recruiting · Observational · 105 enrolled · University of Alabama at Birmingham
  NCT07516548updated 2026-05-08
• Nanocrystalline Megestrol Acetate Versus Placebo for Anorexia in Patients With Unresectable Hepatocellular Carcinoma Receiving TACE Combined With Targeted and Immunotherapy
  Not yet recruiting · Phase 2 · Interventional · 88 enrolled · Nanfang Hospital, Southern Medical University
  NCT07565415updated 2026-05-04

Frequently asked questions

How does Medroxyprogesterone work?

Medroxyprogesterone acetate (MPA) injectable suspension, inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

What is Medroxyprogesterone used for?

According to FDA labeling, Medroxyprogesterone carries indications including: Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Medroxyprogesterone?

Medroxyprogesterone is classified as Pregnen (4) derivatives, Progestogens, Progestin, Progestational Hormone Receptor Agonists, Decreased Follicle Stimulating Hormone Secretion, Decreased Growth Hormone Secretion, Gonadotropin Releasing Hormone Alteration, Inhibit Ovarian Follicular Phase, Inhibit Ovulation, Stimulate Breast Glandular Development.

What are the brand names for Medroxyprogesterone?

Medroxyprogesterone is marketed under brand names including Depo-Provera, Provera, depo-subQ provera.

What are the contraindications for Medroxyprogesterone?

Medroxyprogesterone labeling lists contraindications including: The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see Warnings and Precautions ( 5.2 ) ].. Always consult the full prescribing information and a clinician.