{
 "query": "medroxyprogesterone",
 "ingredient": "medroxyprogesterone",
 "slug": "medroxyprogesterone",
 "rxcui": "6691",
 "brands": [
  "Depo-Provera",
  "Provera",
  "depo-subQ provera"
 ],
 "names": [
  "medroxyprogesterone",
  "medroxyprogesterone acetate"
 ],
 "classes": [
  {
   "id": "G03AC",
   "name": "Progestogens"
  },
  {
   "id": "G03DA",
   "name": "Pregnen (4) derivatives"
  },
  {
   "id": "L02AB",
   "name": "Progestogens"
  }
 ],
 "alternatives": [
  "17-alpha-hydroxyprogesterone",
  "desogestrel",
  "drospirenone",
  "etonogestrel",
  "gestronol",
  "levonorgestrel",
  "lynestrenol",
  "megestrol",
  "norethindrone",
  "norgestrienone",
  "progesterone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 20,
   "INTRAMUSCULAR": 14,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "WARNING: 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 WARNIN...",
  "indications_and_usage": "INDICATIONS AND USAGE Medroxyprogesterone acetate 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.",
  "contraindications": "CONTRAINDICATIONS MPA tablets is contraindicated in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of breast cancer. 3. Known or suspected estrogen- or progesterone-dependent neoplasia. 4. Active DVT, PE, or a history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. 6. Known anaphylactic reaction or angioedema to MPA. 7. Known liver impairment or disease. 8. Known or suspected pregnancy.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS See BOXED WARNINGS . 1. Cardiovascular Disorders An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should any of these events occur or be suspected, estrogen plus 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 (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving 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). (See CLINICAL STUDIES .)The increase in risk was demonstrated after the first year and persisted. 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 increas...",
  "adverse_reactions": "ADVERSE REACTIONS See BOXED WARNINGS , 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 The following adverse reactions have been reported in women taking MPA tablets, without concomitant estrogens treatment: 1. Genitourinary system Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions. 2. Breasts Breast tenderness, mastodynia or galactorrhea has been reported. 3. Cardiovascular Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported. 4. Gastrointestinal Nausea, cholestatic jaundice. 5. Skin Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported. 6. Eyes Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis. 7. Central nervous system Mental depression, insomnia, somnolen...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "B. Patient Information Physicians are advised to discuss the Patient Information leaflet with women for whom they prescribe MPA tablets. There may be an increased risk of minor birth defects in children whose mothers are exposed to progestins during the first trimester of pregnancy. The possible risk to the male baby is hypospadias, a condition in which the opening of the penis is on the underside rather than the tip of the penis. This condition occurs naturally in approximately 5 to 8 per 1,000 male births. The risk may be increased with exposure to MPA tablets. Enlargement of the clitoris and fusion of the labia may occur in female babies. However, a clear association between hypospadias, clitoral enlargement and labial fusion with use of MPA tablets has not been established. Inform the patient of the importance of reporting exposure to MPA tablets in early pregnancy.",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL STUDIES Effects on the Endometrium In a 3-year, double-blind, placebo-controlled study of 356 nonhysterectomized, postmenopausal women between 45 and 64 years of age randomized to receive placebo (n=119), 0.625 mg conjugated estrogen only (n=119), or 0.625 mg conjugated estrogen plus cyclic MPA (n=118), results showed a reduced risk of endometrial hyperplasia in the treatment group receiving 10 mg MPA plus 0.625 mg conjugated estrogens compared to the group receiving 0.625 mg conjugated estrogens only. See Table 2 . Table 2. Number (%) of Endometrial Biopsy Changes Since Baseline After 3 Years of Treatment Includes most extreme abnormal result Histological Results Placebo (n=119) CEE CEE = conjugated equine estrogens 0.625 mg/day (n=119) MPA MPA = medroxyprogesterone acetate tablets 10 mg/day for 12 days + CEE (n=118) Normal/No hyperplasia (%) 116 (97) 45 (38) 112 (95) Simple (cystic) hyperplasia (%) 1 (1) 33 (28) 4 (3) Complex (adenomatous) hyperplasia (%) 1 (1) 27 (22) 2 (2) Atypia (%) 0 14 (12) 0 Adenocarcinoma (%) 1 (1) 0 0 In a second 1-year study, 832 postmenopausal women between 45 and 65 years of age were treated with daily 0.625 mg conjugated estrogen (days 1\u201328),...",
  "brand_name": "medroxyprogesterone acetate",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "NDA011839",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260521",
  "set_id": "2627eb11-06bf-4a45-9172-094468e3ca07",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25725,
  "serious": 19657,
  "death": 397,
  "hospitalization": 2889,
  "primary_suspect": 25693,
  "top_reactions": [
   [
    "Meningioma",
    11285
   ],
   [
    "Drug Ineffective",
    868
   ],
   [
    "Off Label Use",
    845
   ],
   [
    "Nausea",
    800
   ],
   [
    "Headache",
    789
   ],
   [
    "Fatigue",
    777
   ],
   [
    "Pain",
    680
   ],
   [
    "Meningioma Benign",
    588
   ],
   [
    "Device Leakage",
    585
   ],
   [
    "Drug Dose Omission By Device",
    540
   ],
   [
    "Dizziness",
    518
   ],
   [
    "Vomiting",
    496
   ],
   [
    "Depression",
    476
   ],
   [
    "Anxiety",
    474
   ],
   [
    "Dyspnoea",
    469
   ]
  ],
  "by_year": {
   "2019": 1166,
   "2020": 1200,
   "2021": 1209,
   "2022": 1223,
   "2023": 1070,
   "2024": 1278,
   "2025": 3013,
   "2026": 10449
  },
  "by_year_primary": {
   "2019": 1166,
   "2020": 1199,
   "2021": 1206,
   "2022": 1219,
   "2023": 1064,
   "2024": 1275,
   "2025": 3008,
   "2026": 10440
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20241218",
   "reason": "CGMP Deviations",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220506",
   "reason": "Lack of assurance of sterility",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 25,
  "nda": 4,
  "anda": 21,
  "first_approval": "19590618",
  "rems": false,
  "rems_last": "19751021",
  "labeling_supplements": 52,
  "labeling_recent": 6,
  "sponsors": [
   "AMARIN PHARMS",
   "AMNEAL",
   "AMPHASTAR PHARMS INC",
   "BARR",
   "CIPLA",
   "DURAMED PHARMS BARR",
   "ESI",
   "EUGIA PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/18/1959"
 },
 "trials": {
  "total": 237,
  "completed": 156,
  "terminated": 22,
  "with_results": 55,
  "industry": 45,
  "phase3": 47,
  "results_share": 0.3525641025641026,
  "terminated_share": 0.09282700421940929
 },
 "pubmed": {
  "rct": 348,
  "meta": 18,
  "recent_rct": 24,
  "cochrane": [
   {
    "pmid": "16856087",
    "title": "Depot medroxyprogesterone versus norethisterone oenanthate for long-acting progestogenic contraception",
    "year": "2006"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "medroxyprogesterone",
   "Depo-Provera",
   "Provera",
   "depo-subQ provera"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 397209,
  "beneficiaries": 106907,
  "spend": 8737651.58,
  "by_brand": [
   {
    "brand": "Medroxyprogesterone Acetate",
    "claims": 395960,
    "per_claim": 21.82034107,
    "is_generic": true
   },
   {
    "brand": "Depo-Subq Provera 104",
    "claims": 927,
    "per_claim": 57.040776699,
    "is_generic": false
   },
   {
    "brand": "Depo-Provera",
    "claims": 178,
    "per_claim": 56.809438202,
    "is_generic": false
   },
   {
    "brand": "Provera",
    "claims": 144,
    "per_claim": 240.83645833,
    "is_generic": false
   }
  ],
  "per_claim": 21.99761732488438
 },
 "mdl": [
  {
   "number": "3140",
   "title": "Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation",
   "judge": "Rodgers, M. Casey",
   "court": "FLN",
   "docket": "3:25-md-3140",
   "actions": "",
   "matched": "provera"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "estradiol cypionate + medroxyprogesterone acetate",
  "matched": "medroxyprogesterone acetate",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 14723,
  "fills": 397209,
  "per_million": 37066.12891450093,
  "ratio": 13.386349414163535,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "37,066 FDA reports naming it as the suspect drug per million Medicare fills, 13.4x the median drug on this site (-15)",
    "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": 66,
   "letter": "C",
   "why": [
    "348 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 35% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 21 generic makers (-3)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (21 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "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 meningioma, nausea. 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, desogestrel, drospirenone? What would make you pick one of those instead?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}