{
 "query": "progesterone",
 "ingredient": "progesterone",
 "slug": "progesterone",
 "rxcui": "8727",
 "brands": [
  "Crinone",
  "Endometrin"
 ],
 "names": [
  "progesterone"
 ],
 "classes": [
  {
   "id": "G03DA",
   "name": "Pregnen (4) derivatives"
  }
 ],
 "alternatives": [
  "17-alpha-hydroxyprogesterone",
  "gestronol",
  "medroxyprogesterone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 80,
   "TRANSDERMAL": 8,
   "INTRAMUSCULAR": 4,
   "VAGINAL": 4,
   "SUBLINGUAL": 2,
   "TOPICAL": 2
  },
  "boxed_warning": "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, Pr...",
  "indications_and_usage": "INDICATIONS AND USAGE 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": "CONTRAINDICATIONS 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. Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. Known liver dysfunction or disease. Known or suspected pregnancy.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 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 Hear...",
  "adverse_reactions": "ADVERSE REACTIONS 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 reactions 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 Reactions (\u2265 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 Conjugated 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 ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "B. Patient Information General: This product contains peanut oil and should not be used if you are allergic to peanuts. Physicians are advised to discuss the contents of the Patient Information leaflet with patients for whom they prescribe progesterone capsules.",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL STUDIES Effects on the endometrium In a randomized, double-blind clinical trial, 358 postmenopausal women, each with an intact uterus, received treatment for up to 36 months. The treatment groups were: Progesterone capsules at the dose of 200 mg per day for 12 days per 28-day cycle in combination with conjugated estrogens 0.625 mg per day (n=120); conjugated estrogens 0.625 mg per day only (n=119); or placebo (n=119). The subjects in all three treatment groups were primarily Caucasian women (87 percent or more of each group). The results for the incidence of endometrial hyperplasia in women receiving up to 3 years of treatment are shown in Table 3. A comparison of the progesterone capsules plus conjugated estrogens treatment group to the conjugated estrogens only group showed a significantly lower rate of hyperplasia (6 percent combination product versus 64 percent estrogen alone) in the progesterone capsules plus conjugated estrogens treatment group throughout 36 months of treatment. TABLE 3. Incidence of Endometrial Hyperplasia in Women Receiving 3 Years of Treatment Endometrial Diagnosis Treatment Group Conjugated Estrogens 0.625 mg + Progesterone Capsules 200 mg (cycli...",
  "brand_name": "Progesterone",
  "manufacturer": "AvKARE",
  "application_number": "ANDA205229",
  "pharm_class_epc": [
   "Progesterone [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260513",
  "set_id": "1637ac18-3a37-f3d5-e063-6394a90af157",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 20758,
  "serious": 11773,
  "death": 431,
  "hospitalization": 3319,
  "primary_suspect": 20703,
  "top_reactions": [
   [
    "Headache",
    1951
   ],
   [
    "Off Label Use",
    1869
   ],
   [
    "Fatigue",
    1695
   ],
   [
    "Drug Ineffective",
    1619
   ],
   [
    "Pain",
    1350
   ],
   [
    "Nausea",
    1278
   ],
   [
    "Foetal Exposure During Pregnancy",
    1063
   ],
   [
    "Exposure During Pregnancy",
    1056
   ],
   [
    "Rash",
    913
   ],
   [
    "Hypersensitivity",
    874
   ],
   [
    "Maternal Exposure During Pregnancy",
    867
   ],
   [
    "Dizziness",
    832
   ],
   [
    "Product Use Issue",
    826
   ],
   [
    "Hyperhidrosis",
    804
   ],
   [
    "Diarrhoea",
    756
   ]
  ],
  "by_year": {
   "2019": 1732,
   "2020": 1726,
   "2021": 1533,
   "2022": 1577,
   "2023": 1807,
   "2024": 2190,
   "2025": 2402,
   "2026": 1675
  },
  "by_year_primary": {
   "2019": 1731,
   "2020": 1726,
   "2021": 1532,
   "2022": 1562,
   "2023": 1798,
   "2024": 2184,
   "2025": 2393,
   "2026": 1662
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20241227",
   "reason": "Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240726",
   "reason": "Presence of Particulate Matter: Complaint received of a glass particle in the vial.",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210226",
   "reason": "Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130919",
   "reason": "Discoloration; due to prolonged heat exposure.",
   "firm": "Ferring Pharmaceuticals Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 25,
  "nda": 9,
  "anda": 16,
  "first_approval": "19741101",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 106,
  "labeling_recent": 3,
  "sponsors": [
   "ABBVIE",
   "ACCORD HLTHCARE",
   "ACERTIS PHARMS",
   "ACTAVIS LABS UT INC",
   "ALZA",
   "AM REGENT",
   "AMNEAL PHARMS NY",
   "BIONPHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/01/1974"
 },
 "trials": {
  "total": 1265,
  "completed": 694,
  "terminated": 155,
  "with_results": 267,
  "industry": 243,
  "phase3": 214,
  "results_share": 0.38472622478386165,
  "terminated_share": 0.1225296442687747
 },
 "pubmed": {
  "rct": 846,
  "meta": 170,
  "recent_rct": 115,
  "cochrane": [
   {
    "pmid": "42746927",
    "title": "Progesterone receptor modulators for endometriosis",
    "year": "2026"
   },
   {
    "pmid": "28742263",
    "title": "Progesterone receptor modulators for endometriosis",
    "year": "2017"
   },
   {
    "pmid": "28444736",
    "title": "Selective progesterone receptor modulators (SPRMs) for uterine fibroids",
    "year": "2017"
   },
   {
    "pmid": "28005271",
    "title": "Progesterone for acute traumatic brain injury",
    "year": "2016"
   },
   {
    "pmid": "25924648",
    "title": "Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding",
    "year": "2015"
   },
   {
    "pmid": "24068368",
    "title": "Combined oestrogen and progesterone for preventing miscarriage",
    "year": "2013"
   },
   {
    "pmid": "23903965",
    "title": "Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth",
    "year": "2013"
   },
   {
    "pmid": "23076947",
    "title": "Progesterone for acute traumatic brain injury",
    "year": "2012"
   },
   {
    "pmid": "22419287",
    "title": "Progesterone for premenstrual syndrome",
    "year": "2012"
   },
   {
    "pmid": "21249708",
    "title": "Progesterone for acute traumatic brain injury",
    "year": "2011"
   },
   {
    "pmid": "19370587",
    "title": "Progesterone for premenstrual syndrome",
    "year": "2009"
   },
   {
    "pmid": "17054277",
    "title": "Progesterone for preventing pre-eclampsia and its complications",
    "year": "2006"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2030.58,
  "records": 36,
  "by_name": [
   [
    "Endometrin",
    2030.58
   ]
  ],
  "names_checked": [
   "progesterone",
   "Crinone",
   "Endometrin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 216,
  "beneficiaries": 100,
  "spend": 7794.88,
  "by_brand": [
   {
    "brand": "Progesterone",
    "claims": 216,
    "per_claim": 36.087407407,
    "is_generic": true
   }
  ],
  "per_claim": 36.087407407407404
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "progesterone vaginal ring",
  "matched": "progesterone",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 86,
   "letter": "B",
   "why": [
    "846 randomized trials and 170 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 38% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 16 generic makers (-4)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $2,031 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (16 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are headache, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over 17-alpha-hydroxyprogesterone, gestronol, medroxyprogesterone? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}