{
 "query": "megestrol",
 "ingredient": "megestrol",
 "slug": "megestrol",
 "rxcui": "6703",
 "brands": [],
 "names": [
  "megestrol",
  "megestrol acetate"
 ],
 "classes": [
  {
   "id": "G03AC",
   "name": "Progestogens"
  },
  {
   "id": "G03DB",
   "name": "Pregnadien derivatives"
  },
  {
   "id": "L02AB",
   "name": "Progestogens"
  }
 ],
 "alternatives": [
  "chlormadinone",
  "demegestone",
  "desogestrel",
  "dienogest",
  "drospirenone",
  "dydrogesterone",
  "etonogestrel",
  "gestronol",
  "levonorgestrel",
  "lynestrenol",
  "medrogestone",
  "medroxyprogesterone",
  "nomegestrol",
  "norethindrone",
  "norgestrienone",
  "promegestone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 20
  },
  "boxed_warning": "",
  "indications_and_usage": "Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Limitations of Use Therapy with megestrol acetate oral suspension for weight loss should only be insti\u2011tuted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases. Megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss. Megestrol acetate oral suspension is a progestin indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) (1) .",
  "contraindications": "\u2022 History of hypersensitivity to megestrol acetate or any component of the formulation. \u2022 Pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )]. \u2022 History of hypersensitivity to megestrol acetate or any component of the formulation ( 4 ). \u2022 Pregnancy ( 4 )( 8.1 ).",
  "warnings_and_cautions": "\u2022 Use with caution in patients with a history of thromboembolic disease (5.1) . \u2022 Fetal Effects: May cause fetal harm. Females of reproductive potential should be advised to avoid becoming pregnant ( 5.2 ). \u2022 Clinical cases of overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate in the stressed and non-stressed state (5.3) . \u2022 New onset and exacerbation of pre-existing diabetes have been reported (5.4) . 5.1 General \u2022 Effects on HIV viral replication have not been determined. \u2022 Use with caution in patients with a history of thromboembolic disease. 5.2 Fetal Toxicity Based on animal studies, megestrol acetate may cause fetal harm when administered to a pregnant woman. Pregnant rats treated with low doses of megestrol acetate resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses. There are no available human data to assess for any drug associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. If this drug is used during ...",
  "warnings": "",
  "adverse_reactions": "The most common adverse events occurring in > 5% of all patients receiving 800mg/20mL of megestrol acetate oral suspension in the two clinical efficacy trials were nausea, diarrhea, impotence, rash, flatulence, hypertension, and asthenia (6.2) . To report SUSPECTED ADVERSE REACTIONS, contact TWi Pharmaceuticals, Inc. at 1-844-518-2989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Serious and Otherwise Important Adverse Reactions The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling: \u2022 Hypersensitivity [see Contraindications ( 4 )] \u2022 Thromboembolic Disease [see Warnings and Precautions ( 5.1 )] \u2022 Adrenal Insufficiency [see Warnings and Precautions ( 5.3 )] \u2022 Diabetes [see Warnings and Precautions ( 5.4 )] 6.2 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reactions 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 safety of megestrol acetate oral suspension, 125 mg/mL was based on three studies of megestrol...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 ) 12/2018 Warnings and Precautions ( 5.2 ) 12/2018",
  "information_for_patients": "The prescriber should inform the patient about the product differences to avoid overdosing or underdosing of megestrol acetate. The recommended adult dosage of megestrol acetate oral suspension is one teaspoon (5 mL) once a day [see Dosage and Administration ( 2 )]. Patients using megestrol acetate oral suspension should receive the following instructions: \u2022 This medication is to be used as directed by the physician. \u2022 Megestrol acetate oral suspension (625 mg/5 mL) does not contain the same amount of megestrol acetate as Megace oral suspension or any of the other megestrol acetate oral suspensions. Megestrol acetate oral suspension contains 625 mg of megestrol acetate per 5 mL (125mg/mL) whereas Megace oral suspension and other megestrol acetate oral suspensions contain 800 mg per 20 mL (40 mg/mL). \u2022 Report any adverse reaction experiences while taking this medication. \u2022 Fetal Toxicity [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )] \u2022 Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy. \u2022 Advise female patients of reproduc...",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of megestrol acetate oral suspension, 125 mg/mL, was based on two trials of megestrol acetate oral suspension (40 mg/mL). These two trials are described below. Trial 1 One was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate (MA) at doses of 100 mg, 400 mg, and 800 mg per day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 270 patients entered on study, 195 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure. The percent of patients gaining 2.3 kg or more at maximum weight gain in 12 study weeks was statistically significantly greater for the 800 mg (64%) and 400 mg (57%) MA-treated groups than for the placebo group (24%). Mean weight increased from baseline to last evaluation in 12 study weeks in the 800 mg MA-treated group by 3.5 kg, the 400 mg MA group by 1.9 kg, the 100 mg MA group by 0.9 kg and decreased in the placebo group by 0.7 kg. Mean weight changes at 4, 8 and 12 weeks for patients evaluable for efficacy in the two clin...",
  "brand_name": "Megestrol Acetate",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA203139",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220401",
  "set_id": "6342df31-afce-4deb-b992-e08e2a4b2b77",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 8226,
  "serious": 6511,
  "death": 2056,
  "hospitalization": 3684,
  "primary_suspect": 8204,
  "top_reactions": [
   [
    "Death",
    991
   ],
   [
    "Fatigue",
    791
   ],
   [
    "Diarrhoea",
    741
   ],
   [
    "Decreased Appetite",
    663
   ],
   [
    "Nausea",
    579
   ],
   [
    "Asthenia",
    568
   ],
   [
    "Off Label Use",
    466
   ],
   [
    "Pneumonia",
    445
   ],
   [
    "Weight Decreased",
    430
   ],
   [
    "Dyspnoea",
    421
   ],
   [
    "Vomiting",
    331
   ],
   [
    "Pain",
    321
   ],
   [
    "Constipation",
    311
   ],
   [
    "Anaemia",
    308
   ],
   [
    "Malignant Neoplasm Progression",
    300
   ]
  ],
  "by_year": {
   "2019": 809,
   "2020": 725,
   "2021": 661,
   "2022": 566,
   "2023": 508,
   "2024": 431,
   "2025": 404,
   "2026": 164
  },
  "by_year_primary": {
   "2019": 807,
   "2020": 724,
   "2021": 661,
   "2022": 563,
   "2023": 500,
   "2024": 423,
   "2025": 404,
   "2026": 164
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 18,
  "nda": 3,
  "anda": 13,
  "first_approval": "19710818",
  "rems": false,
  "rems_last": "19750603",
  "labeling_supplements": 27,
  "labeling_recent": 0,
  "sponsors": [
   "BARR",
   "BRISTOL MYERS SQUIBB",
   "CHARTWELL",
   "ENDO OPERATIONS",
   "HIKMA",
   "NOVITIUM PHARMA",
   "PHARMOBEDIENT",
   "STRIDES PHARMA INTL"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/18/1971"
 },
 "trials": {
  "total": 126,
  "completed": 48,
  "terminated": 18,
  "with_results": 19,
  "industry": 36,
  "phase3": 40,
  "results_share": 0.3958333333333333,
  "terminated_share": 0.14285714285714285
 },
 "pubmed": {
  "rct": 146,
  "meta": 10,
  "recent_rct": 10,
  "cochrane": [
   {
    "pmid": "23543530",
    "title": "Megestrol acetate for treatment of anorexia-cachexia syndrome",
    "year": "2013"
   },
   {
    "pmid": "15846706",
    "title": "Megestrol acetate for the treatment of anorexia-cachexia syndrome",
    "year": "2005"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "megestrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 492517,
  "beneficiaries": 180593,
  "spend": 28214776.3,
  "by_brand": [
   {
    "brand": "Megestrol Acetate",
    "claims": 492517,
    "per_claim": 57.286908472,
    "is_generic": true
   }
  ],
  "per_claim": 57.28690847219487
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 991,
  "fills": 492517,
  "per_million": 2012.1132874601285,
  "ratio": 0.7266702058084399,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "2,012 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death appears in 2.7x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 56,
   "letter": "D",
   "why": [
    "146 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "Only 40% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (13 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, fatigue, diarrhoea, decreased appetite. How would we recognize and handle those?",
  "Why this one over chlormadinone, demegestone, desogestrel? 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.)"
 ]
}