{
 "query": "dexamethasone",
 "ingredient": "dexamethasone",
 "slug": "dexamethasone",
 "rxcui": "3264",
 "brands": [
  "Ozurdex",
  "Maxidex",
  "Hemady",
  "Decadron",
  "Dexlyt",
  "Dextenza",
  "Dexycu"
 ],
 "names": [
  "dexamethasone",
  "dexamethasone acetate",
  "dexamethasone acetate anhydrous",
  "dexamethasone isonicotinate",
  "dexamethasone phosphate",
  "dexamethasone sodium phosphate",
  "dexamethasone trimethyl acetate"
 ],
 "classes": [
  {
   "id": "A01AC",
   "name": "Corticosteroids for local oral treatment"
  },
  {
   "id": "C05AA",
   "name": "Corticosteroids"
  },
  {
   "id": "D07AB",
   "name": "Corticosteroids, moderately potent (group II)"
  },
  {
   "id": "H02AB",
   "name": "Glucocorticoids"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "S01BA",
   "name": "Corticosteroids, plain"
  },
  {
   "id": "S02BA",
   "name": "Corticosteroids"
  },
  {
   "id": "S03BA",
   "name": "Corticosteroids"
  }
 ],
 "alternatives": [
  "alclometasone",
  "beclomethasone",
  "betamethasone",
  "budesonide",
  "ciclesonide",
  "clobetasol",
  "clobetasone",
  "clocortolone",
  "cloprednol",
  "cortisone",
  "cortivazol",
  "deflazacort",
  "desonide",
  "difluprednate",
  "flumethasone",
  "flunisolide",
  "fluocinolone acetonide",
  "fluocinonide",
  "fluocortolone",
  "fluorometholone",
  "fluprednidene",
  "fluticasone",
  "fluticasone furoate",
  "hydrocortisone",
  "hydrocortisone butyrate",
  "hydrocortisone probutate",
  "loteprednol",
  "medrysone",
  "meprednisone",
  "methylprednisolone",
  "mometasone",
  "paramethasone",
  "prednisolone",
  "prednisone",
  "prednylidene",
  "rimexolone",
  "tixocortol",
  "triamcinolone",
  "vamorolone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 87,
   "INTRAMUSCULAR": 70,
   "INTRAVENOUS": 70,
   "OPHTHALMIC": 51,
   "INTRA-ARTICULAR": 37,
   "INTRALESIONAL": 37,
   "SOFT TISSUE": 37,
   "AURICULAR (OTIC)": 13,
   "TOPICAL": 2,
   "INTRACANALICULAR": 1,
   "INTRAVITREAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. (\u200e 1 )",
  "contraindications": "is contraindicated in patients with: Hypersensitivity to dexamethasone, or any of the excipients. Rare instances of anaphylactic reactions have been reported [see Adverse Reactions (\u200e 6 ), Description ( \u200e11 )] . Systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections [see Warnings and Precautions (\u200e 5.2 )] . \u2022 Patients with hypersensitivity to dexamethasone (\u200e 4 ) \u2022 Patients with systemic fungal infections (\u200e 4 )",
  "warnings_and_cautions": "\u2022 Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing\u2019s syndrome, and hyperglycemia can occur. Monitor patients for these conditions with chronic use. ( \u200e5.1 ) \u2022 Immunosuppression and Increased Risk of Infections: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections. (\u200e 5.2 ) \u2022 Alteration in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels. (\u200e 5.3 ) \u2022 Venous and Arterial Thromboembolism: Risk increased; consider anticoagulant prophylaxis and monitor for evidence of thromboembolism. (\u200e 5.4 ) \u2022 Vaccination: Avoid the administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. ( \u200e5.5 ) \u2022 Ophthalmic Effects: May include cataracts, infections, and glaucoma. (\u200e 5.6 ) \u2022 Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. (\u200e 5.7 ) \u2022 Osteoporosis: Increased risk; monitor for changes in bone density with chronic use. (\u200e 5.8 ) \u2022 Behavioral...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described in detail in other labeling sections: Hypersensitivity [see Contraindications ( \u200e4 )] Alterations in Endocrine Function [see Warnings and Precautions ( \u200e5.1 )] Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (\u200e 5.2 ) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions (\u200e 5.3 )] Venous and Arterial Thromboembolism [see Warnings and Precautions (\u200e 5.4 )] Vaccination [see Warnings and Precautions (\u200e 5.5 )] Ophthalmic Effects [see Warnings and Precautions (\u200e 5.6 )] Gastrointestinal Perforation [see Warnings and Precautions (\u200e 5.7 )] Osteoporosis [see Warnings and Precautions (\u200e 5.8 )] Myopathy [see Warnings and Precautions ( \u200e5.9 )] Behavioral and Mood Disturbances [see Warnings and Precautions ( \u200e5.10 )] Kaposi's Sarcoma [see Warnings and Precautions ( \u200e5.11 )] HEMADY in Combination with Anti-Myeloma Products [see Warnings and Precautions ( \u200e5.12 )] Embryo-Fetal Toxicity [see Warnings and Precautions (\u200e 5.13 )] The following adverse reactions associated with the use of HEMADY or other corticosteroids were identified in clinical trials or postmarketing reports....",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Immunosuppression and Increased Risk of Infection ( 5.2 ) 6/2024 Warnings and Precautions, Kaposi\u2019s Sarcoma ( 5.11 ) 6/2024",
  "information_for_patients": "Discuss the following with patients prior to treatment with HEMADY: Administration HEMADY is administered as part of combination regimens with anti-myeloma products; instruct patients to take HEMADY exactly as prescribed in the Prescribing Information of the anti-myeloma products administered with HEMADY [see Dosage and Administration ( \u200e2.1 ) and Warning and Precautions (\u200e 5.12 )] . Inform elderly patients regarding dose-reduction, if needed [see Dosage and Administration (\u200e 2.2 ) and Use in Specific Populations (\u200e 8.5 )] . Warn patients to not stop taking HEMADY abruptly or without first checking with their healthcare providers as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency [see Warnings and Precautions (\u200e 5.1 )] . HEMADY may be taken with or without food. Alterations in Endocrine Function Advise patients to inform any medical attendants that they are taking corticosteroids, as prolonged use may cause adrenal insufficiency, Cushing's syndrome and make patients dependent on corticosteroids. Instruct patients to notify their healthcare provider if they have diabetes, or thyroid gland problems as the dose of medications used to contro...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Hemady",
  "manufacturer": "Edenbridge Pharmaceuticals LLC.",
  "application_number": "NDA211379",
  "pharm_class_epc": [
   "Corticosteroid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260109",
  "set_id": "6b9cf32c-6d60-4853-bbfd-2304ffc2c129",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 303652,
  "serious": 253858,
  "death": 48278,
  "hospitalization": 115348,
  "primary_suspect": 303237,
  "top_reactions": [
   [
    "Off Label Use",
    25089
   ],
   [
    "Fatigue",
    18184
   ],
   [
    "Diarrhoea",
    17751
   ],
   [
    "Plasma Cell Myeloma",
    15374
   ],
   [
    "Nausea",
    15005
   ],
   [
    "Death",
    14080
   ],
   [
    "Pneumonia",
    13820
   ],
   [
    "Drug Ineffective",
    13766
   ],
   [
    "Neutropenia",
    11442
   ],
   [
    "Pyrexia",
    11340
   ],
   [
    "Thrombocytopenia",
    10313
   ],
   [
    "Dyspnoea",
    10273
   ],
   [
    "Anaemia",
    9317
   ],
   [
    "Febrile Neutropenia",
    9081
   ],
   [
    "Vomiting",
    8918
   ]
  ],
  "by_year": {
   "2019": 28340,
   "2020": 30039,
   "2021": 33007,
   "2022": 29974,
   "2023": 26204,
   "2024": 23222,
   "2025": 20998,
   "2026": 9894
  },
  "by_year_primary": {
   "2019": 28335,
   "2020": 30034,
   "2021": 32982,
   "2022": 29875,
   "2023": 26135,
   "2024": 23119,
   "2025": 20920,
   "2026": 9875
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260204",
   "reason": "Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU ",
   "firm": "SOMERSET THERAPEUTICS LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240523",
   "reason": "Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20181220",
   "reason": "GMP Deviations: A silicone particulate was noted in Ozurdex.",
   "firm": "Allergan, PLC.",
   "status": "Completed"
  },
  {
   "class": "Class III",
   "date": "20171106",
   "reason": "Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).",
   "firm": "West-Ward Pharmaceuticals Corp.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20171106",
   "reason": "Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).",
   "firm": "West-Ward Pharmaceuticals Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 125,
  "nda": 19,
  "anda": 80,
  "first_approval": "19581030",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 104,
  "labeling_recent": 9,
  "sponsors": [
   "ABBVIE",
   "ABRAXIS PHARM",
   "ALCON",
   "ALLERGAN HERBERT",
   "ALPHARMA US PHARMS",
   "ALVOGEN",
   "AMNEAL",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/30/1958"
 },
 "trials": {
  "total": 4822,
  "completed": 2325,
  "terminated": 643,
  "with_results": 1045,
  "industry": 1489,
  "phase3": 942,
  "results_share": 0.44946236559139785,
  "terminated_share": 0.13334715885524678
 },
 "pubmed": {
  "rct": 2367,
  "meta": 283,
  "recent_rct": 568,
  "cochrane": [
   {
    "pmid": "30480776",
    "title": "Adverse side effects of dexamethasone in surgical patients",
    "year": "2018"
   },
   {
    "pmid": "30152137",
    "title": "Adverse side effects of dexamethasone in surgical patients",
    "year": "2018"
   },
   {
    "pmid": "29121400",
    "title": "Dexamethasone as an adjuvant to peripheral nerve block",
    "year": "2017"
   },
   {
    "pmid": "11687075",
    "title": "Intravenous dexamethasone for extubation of newborn infants",
    "year": "2001"
   },
   {
    "pmid": "10796193",
    "title": "Intravenous dexamethasone for extubation of newborn infants",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 801109.21,
  "records": 9700,
  "by_name": [
   [
    "Ozurdex",
    537580.97
   ],
   [
    "Dextenza",
    263528.24
   ]
  ],
  "names_checked": [
   "dexamethasone",
   "Ozurdex",
   "Maxidex",
   "Hemady",
   "Decadron",
   "Dexlyt",
   "Dextenza",
   "Dexycu"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1573189,
  "beneficiaries": 940047,
  "spend": 23903156.94,
  "by_brand": [
   {
    "brand": "Dexamethasone",
    "claims": 1472228,
    "per_claim": 12.548622883,
    "is_generic": true
   },
   {
    "brand": "Dexamethasone Sodium Phosphate",
    "claims": 96184,
    "per_claim": 33.528215608,
    "is_generic": true
   },
   {
    "brand": "Dexamethasone Intensol",
    "claims": 1977,
    "per_claim": 56.124481538,
    "is_generic": false
   },
   {
    "brand": "Ozurdex",
    "claims": 1126,
    "per_claim": 1663.8524067,
    "is_generic": false
   },
   {
    "brand": "Maxidex",
    "claims": 1040,
    "per_claim": 95.240961538,
    "is_generic": false
   },
   {
    "brand": "Hemady",
    "claims": 634,
    "per_claim": 189.80847003,
    "is_generic": false
   }
  ],
  "per_claim": 15.194078359307115
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "dexamethasone",
  "matched": "dexamethasone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 53914,
  "fills": 1573189,
  "per_million": 34270.51676562701,
  "ratio": 12.376720349913821,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 77,
   "letter": "B",
   "why": [
    "34,271 FDA reports naming it as the suspect drug per million Medicare fills, 12.4x the median drug on this site (-15)",
    "Death appears in 1.7x the share of reports seen across all of FAERS (-3)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 90,
   "letter": "A",
   "why": [
    "2367 randomized trials and 283 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist",
    "Only 45% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 2 Class III across 80 generic makers (-5)",
    "9 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $801,109 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (80 applications)",
    "39 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, plasma cell myeloma. 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 alclometasone, beclomethasone, betamethasone? 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.)"
 ]
}