pharmacopeia
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/api/v1/drug/progesterone

Boxed warning

CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens 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 increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction 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 of the WHI 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 also demonstrated an increased risk of invasive breast cancer.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Progestational Hormone Receptor Agonists.

Progestational Hormone Receptor

Indications

Sourced from openFDA
  • Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Contraindications

Sourced from openFDA
  • Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

See BOXED WARNING . 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the Women’s Health Initiative (WHI) estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES .) Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. b. Coronary Heart Disease In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction [MI], silent MI, or CHD death) reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years).

Adverse reactions

Sourced from openFDA

See BOXED WARNING , 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 progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 6 lists adverse experiences greater than or equal to 2 percent of women who received cyclic progesterone capsules, 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. Table 6. Adverse Experiences (≥2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] Progesterone capsules 200 mg with Congugated 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 Amenorrhea In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of progesterone on secondary amenorrhea was studied in 49 estrogen-primed …

Use in specific populations

Sourced from openFDA

E. Pregnancy Progesterone capsules should not be used during pregnancy. (See CONTRAINDICATIONS .) Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats at doses up to 44 times the human oral dose, in rabbits at a dose of 10 mcg/day delivered locally within the uterus by an implanted device, in guinea pigs at doses of approximately one-half the human oral dose and in rhesus monkeys at doses approximately the human dose, all based on body surface area, and have revealed little or no evidence of impaired fertility or harm to the fetus due to progesterone.

Pharmacokinetics

Sourced from openFDA
Metabolism
A. Absorption After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours.

Overdosage

Sourced from openFDA

No studies on overdosage have been conducted in humans. In the case of overdosage, progesterone capsules should be discontinued and the patient should be treated symptomatically.

Approval history

Sourced from openFDA
  • May 11, 1978NDANDA017362Actavis Labs Ut Inc
  • Jul 31, 1997NDANDA020701Abbvie
  • May 14, 1998NDANDA019781Acertis Pharms
  • Apr 25, 2001ANDAANDA075906Fresenius Kabi Usa
  • Jun 21, 2007NDANDA022057Ferring
  • Oct 28, 2010ANDAANDA091033Hikma Farmaceutica
  • Sep 28, 2012ANDAANDA200456Sofgen Pharms
  • Oct 28, 2018NDANDA210132Mayne Pharma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Crinone, Vaginal Gel, 4% (NDC 0023-6150-04)To be discontinued
    Sponsor: AbbVie Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
22,511 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Headache2,0649.2%
  2. 2Off Label Use1,8398.2%
  3. 3Drug Ineffective1,7707.9%
  4. 4Fatigue1,7577.8%
  5. 5Nausea1,4436.4%
  6. 6Pain1,4286.3%
  7. 7Rash9504.2%
  8. 8Dizziness9484.2%
  9. 9Exposure During Pregnancy9194.1%
  10. 10Foetal Exposure During Pregnancy8443.7%
  11. 11Hypersensitivity8403.7%
  12. 12Diarrhoea8283.7%
  13. 13Hyperhidrosis8163.6%
  14. 14Back Pain7903.5%
  15. 15Maternal Exposure During Pregnancy7843.5%

Literature

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

Clinical trials

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The 10 most recently updated of 1,239 ClinicalTrials.gov registrations naming Progesterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Progesterone work?
Mechanism-of-action class: Progestational Hormone Receptor Agonists.
What is Progesterone used for?
According to FDA labeling, Progesterone carries indications including: Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Progesterone?
Progesterone is classified as Pregnen (4) derivatives, Progesterone, Progestational Hormone Receptor Agonists, Decreased Uterine Smooth Muscle Contraction or Tone, Inhibit Ovarian Follicular Phase, Inhibit Ovulation, Stimulate Breast Glandular Development.
What are the brand names for Progesterone?
Progesterone is marketed under brand names including Bijuva, Crinone, Eazi-Breed CIDR, Endometrin, Prometrium, Synovex C, Synovex S.
What are the contraindications for Progesterone?
Progesterone labeling lists contraindications including: Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts.. Always consult the full prescribing information and a clinician.
Note. Data for progesterone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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