{ "query": "triamcinolone", "ingredient": "triamcinolone", "slug": "triamcinolone", "rxcui": "10759", "brands": [ "Zilretta", "Oralone", "Aller-Cort", "AllerNaze", "Hexatrione", "Kenalog", "Kourzeq", "Nasacort", "Trianex", "Triderm", "Triesence", "Xipere" ], "names": [ "triamcinolone", "triamcinolone acetonide", "triamcinolone acetonide 21-dipotassium phosphate", "triamcinolone diacetate", "triamcinolone hexacetonide" ], "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": "R03BA", "name": "Glucocorticoids" }, { "id": "S01BA", "name": "Corticosteroids, plain" } ], "alternatives": [ "alclometasone", "beclomethasone", "betamethasone", "budesonide", "ciclesonide", "clobetasol", "clobetasone", "clocortolone", "cloprednol", "cortisone", "cortivazol", "deflazacort", "desonide", "dexamethasone", "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", "vamorolone" ], "label": { "route_mode": "TOPICAL", "route_counts": { "TOPICAL": 165, "INTRA-ARTICULAR": 31, "INTRAMUSCULAR": 30, "NASAL": 27, "DENTAL": 7, "INTRALESIONAL": 3, "OPHTHALMIC": 3, "INTRA-ARTERIAL": 2, "SOFT TISSUE": 1 }, "boxed_warning": "", "indications_and_usage": "INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.", "contraindications": "CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.", "warnings_and_cautions": "", "warnings": "", "adverse_reactions": "ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.", "spl_medguide": "", "clinical_studies": "", "brand_name": "Triamcinolone Acetonide", "manufacturer": "Proficient Rx LP", "application_number": "ANDA087385", "pharm_class_epc": [ "Corticosteroid [EPC]" ], "route": [ "TOPICAL" ], "effective_time": "20231201", "set_id": "1bc85267-249f-4c55-9a8a-06d265263cb5", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 63122, "serious": 30959, "death": 4889, "hospitalization": 13584, "primary_suspect": 63025, "top_reactions": [ [ "Drug Ineffective", 10320 ], [ "Off Label Use", 5296 ], [ "Rash", 4716 ], [ "Pruritus", 4559 ], [ "Fatigue", 3958 ], [ "Pain", 3927 ], [ "Nausea", 3920 ], [ "Diarrhoea", 3499 ], [ "Headache", 3258 ], [ "Product Use In Unapproved Indication", 3207 ], [ "Arthralgia", 3083 ], [ "Condition Aggravated", 2948 ], [ "Vomiting", 2821 ], [ "Dizziness", 2737 ], [ "Psoriasis", 2703 ] ], "by_year": { "2019": 4636, "2020": 4820, "2021": 4809, "2022": 5264, "2023": 7975, "2024": 7118, "2025": 7117, "2026": 3754 }, "by_year_primary": { "2019": 4635, "2020": 4818, "2021": 4797, "2022": 5259, "2023": 7937, "2024": 7103, "2025": 7098, "2026": 3750 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20230928", "reason": "Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.", "firm": "Eugia US LLC", "status": "Ongoing" }, { "class": "Class II", "date": "20220817", "reason": "CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.", "firm": "Padagis US LLC", "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 III", "date": "20140129", "reason": "Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.", "firm": "Fougera Pharmaceuticals Inc.", "status": "Terminated" } ], "recall_total": 5, "drugsfda": { "applications": 155, "nda": 21, "anda": 104, "first_approval": "19571203", "rems": false, "rems_last": "", "labeling_supplements": 67, "labeling_recent": 7, "sponsors": [ "ABBVIE", "ACTAVIS MID ATLANTIC", "ALCON RES", "ALEMBIC", "ALKEM LABS LTD", "ALLERGAN", "ALPHARMA US PHARMS", "AMNEAL" ], "unapproved": false, "first_approval_fmt": "12/03/1957" }, "trials": { "total": 1155, "completed": 592, "terminated": 145, "with_results": 225, "industry": 229, "phase3": 187, "results_share": 0.38006756756756754, "terminated_share": 0.12554112554112554 }, "pubmed": { "rct": 563, "meta": 48, "recent_rct": 98, "cochrane": [] }, "payments": { "year": "2024", "usd": 479206.43, "records": 1557, "by_name": [ [ "Zilretta", 303183.7 ], [ "Xipere", 175709.75 ], [ "Triesence", 312.98 ] ], "names_checked": [ "triamcinolone", "Zilretta", "Oralone", "Aller-Cort", "AllerNaze", "Hexatrione", "Kenalog", "Kourzeq", "Nasacort", "Trianex", "Triderm", "Triesence", "Xipere" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 6647245, "beneficiaries": 3906562, "spend": 69556954.96, "by_brand": [ { "brand": "Triamcinolone Acetonide", "claims": 6643424, "per_claim": 10.171488665, "is_generic": true }, { "brand": "Zilretta", "claims": 2092, "per_claim": 926.93097992, "is_generic": false }, { "brand": "Kenalog-40", "claims": 867, "per_claim": 21.096366782, "is_generic": false }, { "brand": "Kenalog-80", "claims": 492, "per_claim": 32.656260163, "is_generic": false }, { "brand": "Kenalog-10", "claims": 284, "per_claim": 22.79084507, "is_generic": false }, { "brand": "Oralone", "claims": 86, "per_claim": 40.388488372, "is_generic": false } ], "per_claim": 10.464027572325074 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": null, "name": "triamcinolone acetonide", "matched": "triamcinolone acetonide", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 17951, "fills": 6647245, "per_million": 2700.517281971704, "ratio": 0.9752857661194253, "median": 2768.949753790441 }, "scores": { "safety": { "score": 95, "letter": "A", "why": [ "2,701 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site", "Death share in reports is near or below the FAERS average (0.9x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 65, "letter": "C", "why": [ "563 randomized trials and 48 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 38% of completed registered trials posted results (-8)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 86, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 4 Class II, 0 Class III across 104 generic makers (-6)", "7 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 85, "letter": "B", "why": [ "Pharma paid doctors $479,206 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 (104 applications)", "39 same-class alternatives exist" ], "weight": 0.1 } }, "total": 85, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are rash, pruritus. 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.)" ] }