{ "query": "hydrocortisone", "ingredient": "hydrocortisone", "slug": "hydrocortisone", "rxcui": "5492", "brands": [ "Cortef", "Cortifoam", "Ala-Cort", "Ala-Scalp", "Texacort", "Proctocort", "Pandel", "Cortenema", "Alkindi", "Anucort-HC", "Anusol HC", "Aquanil HC", "Aquaphor Itch Relief", "Beta-HC", "Caldecort", "Cortaid", "Corticool", "Cortizone", "Dermacort", "Dermtex HC", "Evesse", "Gynecort", "Hemmorex", "Hemril", "Instacort", "Khindivi", "Locoid", "MiCort-HC", "Monistat Itch Relief", "Nucort", "Procto-Kit", "Procto-Med", "Procto-Pak", "Proctosol", "Proctozone HC", "Recort Plus", "Sarnol-HC", "Scalacort", "Scalpicin Itch Relief", "Solu-Cortef", "U-Cort", "Vagisil Satin", "Westcort" ], "names": [ "hydrocortisone", "hydrocortisone aceponate", "hydrocortisone acetate", "hydrocortisone butyrate", "hydrocortisone cypionate", "hydrocortisone probutate", "hydrocortisone sodium phosphate", "hydrocortisone sodium succinate", "hydrocortisone valerate" ], "classes": [ { "id": "A01AC", "name": "Corticosteroids for local oral treatment" }, { "id": "A07EA", "name": "Corticosteroids acting locally" }, { "id": "C05AA", "name": "Corticosteroids" }, { "id": "D07AA", "name": "Corticosteroids, weak (group I)" }, { "id": "H02AB", "name": "Glucocorticoids" }, { "id": "S01BA", "name": "Corticosteroids, plain" }, { "id": "S02BA", "name": "Corticosteroids" } ], "alternatives": [ "alclometasone", "beclomethasone", "betamethasone", "budesonide", "clobetasol", "clobetasone", "cloprednol", "cortisone", "cortivazol", "deflazacort", "desonide", "dexamethasone", "difluprednate", "fluocinolone acetonide", "fluocinonide", "fluocortolone", "fluorometholone", "loteprednol", "medrysone", "meprednisone", "methylprednisolone", "paramethasone", "prednisolone", "prednisone", "prednylidene", "rimexolone", "tixocortol", "triamcinolone", "vamorolone" ], "label": { "route_mode": "TOPICAL", "route_counts": { "TOPICAL": 132, "RECTAL": 39, "AURICULAR (OTIC)": 34, "ORAL": 23, "INTRAMUSCULAR": 7, "INTRAVENOUS": 7, "OPHTHALMIC": 2 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE Cortifoam \u00ae is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.", "contraindications": "CONTRAINDICATIONS Cortifoam \u00ae is contraindicated in patients who are hypersensitive to any components of this product. Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts.", "warnings_and_cautions": "", "warnings": "WARNINGS General Do not insert any part of the aerosol container directly into the anus. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120\u00b0F. Because Cortifoam \u00ae is not expelled, systemic hydrocortisone absorption may be greater from Cortifoam \u00ae than from corticosteroid enema formulations. If there is not evidence of clinical or proctologic improvement within two or three weeks after starting Cortifoam \u00ae therapy, or if the patient's condition worsens, discontinue the drug. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Cardio-renal Corticosteroids 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. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction...", "adverse_reactions": "ADVERSE REACTIONS (listed alphabetically, under each subsection) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6608 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Allergic reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestati...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infection. Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.", "spl_medguide": "", "clinical_studies": "", "brand_name": "Cortifoam", "manufacturer": "Viatris Specialty LLC", "application_number": "NDA017351", "pharm_class_epc": [], "route": [ "TOPICAL" ], "effective_time": "20240515", "set_id": "0093b694-9fcb-46ae-b1ab-7d0fa204c6c8", "has_boxed_warning": false, "boxed_labels": "0 of 24", "controlled": false, "mentions_rems": false }, "faers": { "total": 79088, "serious": 64614, "death": 11590, "hospitalization": 32506, "primary_suspect": 78880, "top_reactions": [ [ "Off Label Use", 12336 ], [ "Drug Ineffective", 10246 ], [ "Fatigue", 8649 ], [ "Condition Aggravated", 7411 ], [ "Rash", 7060 ], [ "Pain", 6865 ], [ "Nausea", 6488 ], [ "Diarrhoea", 6096 ], [ "Arthralgia", 6074 ], [ "Headache", 6057 ], [ "Dyspnoea", 5594 ], [ "Pyrexia", 5356 ], [ "Vomiting", 5151 ], [ "Infusion Related Reaction", 5091 ], [ "Pruritus", 5043 ] ], "by_year": { "2019": 6313, "2020": 7484, "2021": 7747, "2022": 8240, "2023": 7992, "2024": 7199, "2025": 8253, "2026": 3634 }, "by_year_primary": { "2019": 6313, "2020": 7480, "2021": 7728, "2022": 8195, "2023": 7944, "2024": 7172, "2025": 8219, "2026": 3610 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20261001", "reason": "Failed Impurities/Degradation Specifications.", "firm": "Zydus Pharmaceuticals (USA) Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20250424", "reason": "CGMP Deviations", "firm": "KENIL HEALTHCARE PRIVATE LIMITED", "status": "Terminated" }, { "class": "Class II", "date": "20220413", "reason": "cGMP deviations: Temperature abuse", "firm": "Mckesson Medical-Surgical Inc. Corporate Office", "status": "Terminated" }, { "class": "Class II", "date": "20210315", "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "firm": "Cardinal Health Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20190711", "reason": "CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.", "firm": "US Pharmaceuticals Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20180507", "reason": "Failed Stability Specifications", "firm": "Perrigo New York", "status": "Terminated" } ], "recall_total": 6, "drugsfda": { "applications": 149, "nda": 22, "anda": 88, "first_approval": "19511221", "rems": false, "rems_last": "", "labeling_supplements": 53, "labeling_recent": 7, "sponsors": [ "ABLE", "ABRAXIS PHARM", "ACTAVIS MID ATLANTIC", "ALLERGAN HERBERT", "ALPHARMA US PHARMS", "ALTANA", "AMBIX", "ANI PHARMS" ], "unapproved": false, "first_approval_fmt": "12/21/1951" }, "trials": { "total": 1585, "completed": 867, "terminated": 148, "with_results": 215, "industry": 235, "phase3": 161, "results_share": 0.24798154555940022, "terminated_share": 0.09337539432176656 }, "pubmed": { "rct": 460, "meta": 37, "recent_rct": 70, "cochrane": [] }, "payments": { "year": "2024", "usd": 79864.25, "records": 124, "by_name": [ [ "Alkindi", 79864.25 ] ], "names_checked": [ "hydrocortisone", "Cortef", "Cortifoam", "Ala-Cort", "Ala-Scalp", "Texacort", "Proctocort", "Pandel", "Cortenema", "Alkindi", "Anucort-HC", "Anusol HC", "Aquanil HC", "Aquaphor Itch Relief", "Beta-HC", "Caldecort", "Cortaid", "Corticool", "Cortizone", "Dermacort", "Dermtex HC", "Evesse", "Gynecort", "Hemmorex", "Hemril", "Instacort", "Khindivi", "Locoid", "MiCort-HC", "Monistat Itch Relief", "Nucort", "Procto-Kit", "Procto-Med", "Procto-Pak", "Proctosol", "Proctozone HC", "Recort Plus", "Sarnol-HC", "Scalacort", "Scalpicin Itch Relief", "Solu-Cortef", "U-Cort", "Vagisil Satin", "Westcort" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 3004258, "beneficiaries": 1581642, "spend": 59276848.00999999, "by_brand": [ { "brand": "Hydrocortisone", "claims": 2634143, "per_claim": 17.255463731, "is_generic": true }, { "brand": "Procto-Med HC", "claims": 257304, "per_claim": 16.124454808, "is_generic": false }, { "brand": "Proctozone-HC", "claims": 53297, "per_claim": 17.242594893, "is_generic": false }, { "brand": "Hydrocortisone Valerate", "claims": 24734, "per_claim": 54.91887402, "is_generic": true }, { "brand": "Hydrocortisone Butyrate", "claims": 16202, "per_claim": 350.34860696, "is_generic": true }, { "brand": "Proctosol-HC", "claims": 13760, "per_claim": 21.840724564, "is_generic": false }, { "brand": "Cortef", "claims": 2648, "per_claim": 231.07422205, "is_generic": false }, { "brand": "Cortifoam", "claims": 821, "per_claim": 617.65911084, "is_generic": false }, { "brand": "Ala-Cort", "claims": 628, "per_claim": 14.77066879, "is_generic": false }, { "brand": "Ala-Scalp", "claims": 208, "per_claim": 685.83081731, "is_generic": false }, { "brand": "Texacort", "claims": 195, "per_claim": 270.33610256, "is_generic": false }, { "brand": "Anusol-HC", "claims": 164, "per_claim": 154.32371951, "is_generic": false }, { "brand": "Proctocort", "claims": 78, "per_claim": 333.605, "is_generic": false }, { "brand": "Pandel", "claims": 31, "per_claim": 1169.8645161, "is_generic": false }, { "brand": "Cortenema", "claims": 25, "per_claim": 328.966, "is_generic": false }, { "brand": "Hydrocortisone Acetate", "claims": 20, "per_claim": 46.8275, "is_generic": true } ], "per_claim": 19.730944549369593 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "hydrocortisone", "matched": "hydrocortisone", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 19001, "fills": 3004258, "per_million": 6324.68982357707, "ratio": 2.284147559889501, "median": 2768.949753790441 }, "scores": { "safety": { "score": 88, "letter": "A", "why": [ "6,325 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)", "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 60, "letter": "D", "why": [ "460 randomized trials and 37 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "No Cochrane review found (-5)", "Only 25% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 86, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 6 Class II, 0 Class III across 88 generic makers (-6)", "7 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $79,864 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 (88 applications)", "29 same-class alternatives exist" ], "weight": 0.1 } }, "total": 84, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, condition aggravated. 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.)" ] }