{
 "query": "fludrocortisone",
 "ingredient": "fludrocortisone",
 "slug": "fludrocortisone",
 "rxcui": "4452",
 "brands": [],
 "names": [
  "fludrocortisone",
  "fludrocortisone acetate"
 ],
 "classes": [
  {
   "id": "H02AA",
   "name": "Mineralocorticoids"
  }
 ],
 "alternatives": [
  "aldosterone",
  "desoxycorticosterone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 16
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Fludrocortisone acetate tablets USP, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.",
  "contraindications": "CONTRAINDICATIONS Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION THE USE OF FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER THAN THOSE INDICATED HEREIN IS NOT ADVISED. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. However, since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, edema or weight gain. Periodic ch...",
  "adverse_reactions": "ADVERSE REACTIONS Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis. When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid. Musculoskeletal \u2014muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures. Gastrointestinal \u2014peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis. Dermatologic \u2014impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsu...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients The physician should advise the patient to report any medical history of heart disease, high blood pressure, or kidney or liver disease and to report current use of any medicines to determine if these medicines might interact adversely with fludrocortisone acetate (see Drug Interactions ). Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice. The patient's understanding of his steroid-dependent status and increased dosage requirement under widely variable conditions of stress is vital. Advise the patient to carry medical identification indicating his dependence on steroid medication and, if necessary, instruct him to carry an adequate supply of medication for use in emergencies. Stress to the patient the importance of regular follow-up visits to check his progress and the need to promptly notify the physician of dizziness, severe or continuing headaches, swelling of feet or lower legs, or unusual weight gain. Advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next d...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "FLUDROCORTISONE ACETATE",
  "manufacturer": "AvPAK",
  "application_number": "ANDA040431",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260108",
  "set_id": "2cd3965d-cab9-a97c-db61-7d03ced154f3",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 10225,
  "serious": 7371,
  "death": 1328,
  "hospitalization": 3923,
  "primary_suspect": 10186,
  "top_reactions": [
   [
    "Dizziness",
    732
   ],
   [
    "Fatigue",
    720
   ],
   [
    "Drug Ineffective",
    719
   ],
   [
    "Fall",
    715
   ],
   [
    "Death",
    619
   ],
   [
    "Nausea",
    581
   ],
   [
    "Off Label Use",
    550
   ],
   [
    "Hypotension",
    519
   ],
   [
    "Diarrhoea",
    484
   ],
   [
    "Headache",
    476
   ],
   [
    "Asthenia",
    428
   ],
   [
    "Hallucination",
    384
   ],
   [
    "Confusional State",
    373
   ],
   [
    "Pneumonia",
    364
   ],
   [
    "Malaise",
    361
   ]
  ],
  "by_year": {
   "2019": 1029,
   "2020": 1039,
   "2021": 858,
   "2022": 750,
   "2023": 677,
   "2024": 779,
   "2025": 797,
   "2026": 463
  },
  "by_year_primary": {
   "2019": 1029,
   "2020": 1038,
   "2021": 856,
   "2022": 746,
   "2023": 672,
   "2024": 770,
   "2025": 787,
   "2026": 455
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 8,
  "nda": 1,
  "anda": 7,
  "first_approval": "19550818",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 5,
  "labeling_recent": 0,
  "sponsors": [
   "ADAPTIS",
   "BARR",
   "CASPER PHARMA LLC",
   "CHARTWELL RX",
   "HIKMA PHARMS",
   "IMPAX LABS",
   "NOVITIUM PHARMA",
   "ZYDUS LIFESCIENCES"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/18/1955"
 },
 "trials": {
  "total": 74,
  "completed": 40,
  "terminated": 8,
  "with_results": 10,
  "industry": 23,
  "phase3": 15,
  "results_share": 0.25,
  "terminated_share": 0.10810810810810811
 },
 "pubmed": {
  "rct": 32,
  "meta": 6,
  "recent_rct": 4,
  "cochrane": [
   {
    "pmid": "34000076",
    "title": "Fludrocortisone for orthostatic hypotension",
    "year": "2021"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fludrocortisone"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 497178,
  "beneficiaries": 119372,
  "spend": 11947137.43,
  "by_brand": [
   {
    "brand": "Fludrocortisone Acetate",
    "claims": 497178,
    "per_claim": 24.029899613,
    "is_generic": true
   }
  ],
  "per_claim": 24.02989961341813
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fludrocortisone",
  "matched": "fludrocortisone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2012,
  "fills": 497178,
  "per_million": 4046.840367031526,
  "ratio": 1.461507331973709,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 97,
   "letter": "A",
   "why": [
    "4,047 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (1.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 34,
   "letter": "F",
   "why": [
    "32 randomized trials and 6 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 25% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (7 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dizziness, fatigue, fall. How would we recognize and handle those?",
  "Why this one over aldosterone, desoxycorticosterone? 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.)"
 ]
}