{
 "query": "ursodeoxycholate",
 "ingredient": "ursodeoxycholate",
 "slug": "ursodeoxycholate",
 "rxcui": "62427",
 "brands": [],
 "names": [
  "ursodeoxycholate",
  "ursodiol"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 41
  },
  "boxed_warning": "",
  "indications_and_usage": "250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and URSO Forte (ursodiol) tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )",
  "contraindications": "Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. ( 4 )",
  "warnings_and_cautions": "Abnorma l Liver F unction T ests : Liver function tests (\u03b3-GT, alkaline phosphatase, AST, ALT) and bilirubin level should be monitored. Treatment discontinuation should be considered if parameters increase to a level considered clinically significant in patients with stable historical liver function test levels. Caution should be exercised to maintain patients\u2019 bile flow. ( 5.1 ) Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis : Monitor for obstructive gastrointestinal symptoms; if symptoms occur, hold ursodiol until a clinical evaluation has been conducted. ( 5.2 ) 5.1 Abnormal Liver Function Tests Liver function tests (\u03b3-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels. Caution has to be exercised to maintain the bile flow of the patients taking ursodiol. 5.2 Enterol...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions reported with the use of ursodiol during worldwide postmarketing and clinical experience (\u22651%) are, in alphabetical order: abdominal discomfort, abdominal pain, alopecia, diarrhea, nausea, pruritus, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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 clinical practice. The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials. ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS UDCA n (%) Placebo n (%) UDCA n (%) Placebo n (%) Diarrhea --- --- 1 (1.32) --- Elevated creatinine --- --- 1 (1.32) --- Elevated blood glucose 1 (1.18) --- 1 (1.32) --- Leukopenia --- --- 2 (2.63) --- Peptic ulcer --- --- 1 (1.32) --- Skin rash --- --- 2 (2.63) --- Thrombocytopenia --- --- 1 (1.32) --- Note: Those adverse reactions occurring at the same or highe...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.2 ) 1/2023",
  "information_for_patients": "Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis Advise patients or their caretaker(s) to notify their healthcare provider if they experience obstructive gastrointestinal symptoms due to the risk of enteroliths [see Warnings and Precautions ( 5.2 )]. Drug Interactions Patients should be informed that absorption of URSO 250 and URSO Forte may be reduced if they are taking bile acid sequestering agents, such as cholestyramine and colestipol, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol [see Drug Interactions ( 7 )] . Distributed by: Allergan USA, Inc. Madison, NJ 07940 www.allergan.com URSO 250 \u00ae and URSO Forte \u00ae are registered trademarks of Allergan Sales, LLC. \u00a9 2023 Allergan. All rights reserved. v4.0USPI785 A picture containing clipart Description generated with very high confidence",
  "spl_medguide": "",
  "clinical_studies": "6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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 clinical practice. The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials. ADVERSE REACTIONS VISIT AT 12 MONTHS VISIT AT 24 MONTHS UDCA n (%) Placebo n (%) UDCA n (%) Placebo n (%) Diarrhea --- --- 1 (1.32) --- Elevated creatinine --- --- 1 (1.32) --- Elevated blood glucose 1 (1.18) --- 1 (1.32) --- Leukopenia --- --- 2 (2.63) --- Peptic ulcer --- --- 1 (1.32) --- Skin rash --- --- 2 (2.63) --- Thrombocytopenia --- --- 1 (1.32) --- Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity). UDCA = Ursodeoxycholic acid = Ursodiol In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 p...",
  "brand_name": "Urso 250",
  "manufacturer": "Allergan, Inc.",
  "application_number": "NDA020675",
  "pharm_class_epc": [
   "Bile Acid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230112",
  "set_id": "e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 30036,
  "serious": 25347,
  "death": 4332,
  "hospitalization": 14055,
  "primary_suspect": 29904,
  "top_reactions": [
   [
    "Off Label Use",
    2540
   ],
   [
    "Pruritus",
    1621
   ],
   [
    "Diarrhoea",
    1575
   ],
   [
    "Pyrexia",
    1422
   ],
   [
    "Nausea",
    1345
   ],
   [
    "Fatigue",
    1318
   ],
   [
    "Drug Ineffective",
    1238
   ],
   [
    "Pneumonia",
    1081
   ],
   [
    "Death",
    948
   ],
   [
    "Vomiting",
    944
   ],
   [
    "Anaemia",
    940
   ],
   [
    "Decreased Appetite",
    813
   ],
   [
    "Headache",
    807
   ],
   [
    "Dyspnoea",
    776
   ],
   [
    "Acute Kidney Injury",
    737
   ]
  ],
  "by_year": {
   "2019": 3009,
   "2020": 2822,
   "2021": 2834,
   "2022": 2513,
   "2023": 2325,
   "2024": 2314,
   "2025": 2580,
   "2026": 1202
  },
  "by_year_primary": {
   "2019": 3007,
   "2020": 2818,
   "2021": 2828,
   "2022": 2486,
   "2023": 2286,
   "2024": 2301,
   "2025": 2553,
   "2026": 1189
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 24,
  "nda": 2,
  "anda": 22,
  "first_approval": "19871231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 3,
  "sponsors": [
   "ABBVIE",
   "ABHAI LLC",
   "ADAPTIS",
   "AMNEAL PHARMS CO",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX",
   "EPIC PHARMA",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1987"
 },
 "trials": {
  "total": 220,
  "completed": 98,
  "terminated": 30,
  "with_results": 27,
  "industry": 60,
  "phase3": 58,
  "results_share": 0.2755102040816326,
  "terminated_share": 0.13636363636363635
 },
 "pubmed": {
  "rct": 7,
  "meta": 0,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ursodeoxycholate"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 488896,
  "beneficiaries": 111500,
  "spend": 78153338.53,
  "by_brand": [
   {
    "brand": "Ursodiol",
    "claims": 488500,
    "per_claim": 158.63242612,
    "is_generic": true
   },
   {
    "brand": "Reltone",
    "claims": 343,
    "per_claim": 1752.3980466,
    "is_generic": false
   },
   {
    "brand": "Urso",
    "claims": 28,
    "per_claim": 1113.0175,
    "is_generic": false
   },
   {
    "brand": "Urso Forte",
    "claims": 25,
    "per_claim": 1166.454,
    "is_generic": false
   }
  ],
  "per_claim": 159.8567763491622
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6043,
  "fills": 488896,
  "per_million": 12360.502029061396,
  "ratio": 4.4639676152089764,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 82,
   "letter": "B",
   "why": [
    "12,361 FDA reports naming it as the suspect drug per million Medicare fills, 4.5x the median drug on this site (-13)",
    "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": 6,
   "letter": "F",
   "why": [
    "7 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 28% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)",
    "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (22 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pruritus, diarrhoea, pyrexia. 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?",
  "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.)"
 ]
}