{
 "query": "colchicine",
 "ingredient": "colchicine",
 "slug": "colchicine",
 "rxcui": "2683",
 "brands": [
  "Mitigare",
  "Lodoco",
  "Colcrys",
  "Gloperba"
 ],
 "names": [
  "colchicine"
 ],
 "classes": [
  {
   "id": "M04AC",
   "name": "Preparations with no effect on uric acid metabolism"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 49
  },
  "boxed_warning": "",
  "indications_and_usage": "(colchicine, USP) tablets are an alkaloid indicated for: \u2022 Prophylaxis and treatment of gout flares in adults ( 1.1 ). \u2022 Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). COLCRYS is not an analgesic medication and should not be used to treat pain from other causes. 1.1 Gout Flares COLCRYS (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares. \u2022 Prophylaxis of Gout Flares: COLCRYS is indicated for prophylaxis of gout flares. \u2022 Treatment of Gout Flares: COLCRYS tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) COLCRYS (colchicine, USP) tablets are indicated in adults and children 4 years or older for treatment of familial Mediterranean fever (FMF).",
  "contraindications": "Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. Patients with renal or hepatic impairment should not be given COLCRYS in conjunction with P-gp or strong CYP3A4 inhibitors ( 5.3 ). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses ( 7 ).",
  "warnings_and_cautions": "\u2022 Fatal overdoses have been reported with colchicine in adults and children. Keep COLCRYS out of the reach of children ( 5.1 , 10 ). \u2022 Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported ( 5.2 ). \u2022 Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine ( 5.2 , 5.3 , 5.4 , 6 , 10 ). \u2022 Drug interaction P-gp and/or CYP3A4 inhibitors: Coadministration of colchicine with P-gp and/or strong CYP3A4 inhibitors has resulted in life-threatening interactions and death ( 5.3 , 7 ). \u2022 Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of COLCRYS ( 5.4 , 7 ). 5.1 Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [ see Overdosage (10) ]. COLCRYS should be kept out of the reach of children. 5.2 Blood Dyscrasias Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia and aplastic anemia have been reported with colchicine used in therapeu...",
  "warnings": "",
  "adverse_reactions": "Prophylaxis of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhea. Treatment of Gout Flares: The most common adverse reactions reported in the clinical trial for gout were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting. These effects are usually mild, transient and reversible upon lowering the dose ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Prophylaxis of Gout Flares The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. Treatment of Gout Flares The most common adverse reactions reported in the clinical trial with COLCRYS for treatment of gout flares were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating COLCRYS, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, n...",
  "drug_abuse_and_dependence": "Tolerance, abuse or dependence with colchicine has not been reported.",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration Prophylaxis of Gout Flares ( 2.1 ) 11/2012",
  "information_for_patients": "See FDA-approved Medication Guide. 17.1 Dosing Instructions Patients should be advised to take COLCRYS as prescribed, even if they are feeling better. Patients should not alter the dose or discontinue treatment without consulting with their doctor. If a dose of COLCRYS is missed: \u2022 For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible. \u2022 For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 12 hours, then resume the previous dosing schedule. \u2022 For prophylaxis without treatment for a gout flare, or FMF, take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped the patient should not double the next dose. 17.2 Fatal Overdose Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. COLCRYS should be kept out of the reach of children. 17.3 Blood Dyscrasias Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia and thrombocytopenia may occur with COLCRYS. 17.4 Drug and Food Interactions Patients should be ad...",
  "spl_medguide": "MEDICATION GUIDE COLCRYS (KOL-kris) (colchicine) tablets Read the Medication Guide that comes with COLCRYS before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COLCRYS when you start taking it and at regular checkups. What is the most important information that I should know about COLCRYS? COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body. \u2022 Taking certain medicines with COLCRYS can cause your level of COLCRYS to be too high, especially if you have kidney or liver problems. \u2022 Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of COLCRYS may need to be changed. \u2022 Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. \u2022 Even medicines that you take for a short period of time, such as antibiotics, can interact with COLCRYS and cause serious side effects or death. \u2022...",
  "clinical_studies": "The evidence for the efficacy of colchicine in patients with chronic gout is derived from the published literature. Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients with gout initiating treatment with urate-lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares. The efficacy of a low-dosage regimen of oral colchicine (COLCRYS total dose 1.8 mg over one hour) for treatment of gout flares was assessed in a multicenter, randomized, double-blind, placebo-controlled, parallel group, one week, dose-comparison study. Patients meeting American College of Rheumatology criteria for gout were randomly assigned to three groups: high-dose colchicine (1.2 mg, then 0.6 mg hourly \u00d7 6 hours [4.8 mg total]); low-dose colchicine (1.2 mg, then 0.6 mg in 1 hour [1.8 mg total] followed by five placebo doses hourly); or placebo (two capsules, then one capsule hourly \u00d7 6 hours). Patients took the first dose within 12 hours of the onset of the flare and recorded pain intensity (11-point Likert scale) and adverse events over 72 hours. The efficacy of colchicine was measured based o...",
  "brand_name": "Colcrys",
  "manufacturer": "Proficient Rx LP",
  "application_number": "NDA022352",
  "pharm_class_epc": [
   "Alkaloid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20221001",
  "set_id": "d6adc880-5499-4691-93f3-27c87902d5fc",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25309,
  "serious": 19726,
  "death": 2730,
  "hospitalization": 10447,
  "primary_suspect": 25084,
  "top_reactions": [
   [
    "Off Label Use",
    2348
   ],
   [
    "Diarrhoea",
    2314
   ],
   [
    "Drug Ineffective",
    2049
   ],
   [
    "Nausea",
    1674
   ],
   [
    "Fatigue",
    1607
   ],
   [
    "Acute Kidney Injury",
    1550
   ],
   [
    "Arthralgia",
    1292
   ],
   [
    "Dyspnoea",
    1256
   ],
   [
    "Headache",
    1255
   ],
   [
    "Vomiting",
    1070
   ],
   [
    "Pain",
    1066
   ],
   [
    "Gout",
    1059
   ],
   [
    "Toxicity To Various Agents",
    1032
   ],
   [
    "Rash",
    974
   ],
   [
    "Chronic Kidney Disease",
    907
   ]
  ],
  "by_year": {
   "2019": 2596,
   "2020": 2549,
   "2021": 2043,
   "2022": 2073,
   "2023": 2181,
   "2024": 2291,
   "2025": 2542,
   "2026": 1145
  },
  "by_year_primary": {
   "2019": 2594,
   "2020": 2539,
   "2021": 2020,
   "2022": 2038,
   "2023": 2130,
   "2024": 2254,
   "2025": 2496,
   "2026": 1133
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20241218",
   "reason": "Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.",
   "firm": "Granules Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 23,
  "nda": 6,
  "anda": 17,
  "first_approval": "20090729",
  "rems": false,
  "rems_last": "20110720",
  "labeling_supplements": 6,
  "labeling_recent": 1,
  "sponsors": [
   "AGEPHA PHARMA FZ",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "ANNORA PHARMA",
   "AR HOLDING CO INC",
   "AUROBINDO PHARMA LTD",
   "DR REDDYS",
   "GRANULES"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/29/2009"
 },
 "trials": {
  "total": 332,
  "completed": 160,
  "terminated": 34,
  "with_results": 64,
  "industry": 77,
  "phase3": 95,
  "results_share": 0.4,
  "terminated_share": 0.10240963855421686
 },
 "pubmed": {
  "rct": 253,
  "meta": 156,
  "recent_rct": 107,
  "cochrane": [
   {
    "pmid": "41224205",
    "title": "Colchicine for the secondary prevention of cardiovascular events",
    "year": "2025"
   },
   {
    "pmid": "39927511",
    "title": "Colchicine for the primary prevention of cardiovascular events",
    "year": "2025"
   },
   {
    "pmid": "34658014",
    "title": "Colchicine for the treatment of COVID-19",
    "year": "2021"
   },
   {
    "pmid": "34438469",
    "title": "Colchicine for acute gout",
    "year": "2021"
   },
   {
    "pmid": "26816301",
    "title": "Colchicine for prevention of cardiovascular events",
    "year": "2016"
   },
   {
    "pmid": "25164988",
    "title": "Colchicine for pericarditis",
    "year": "2014"
   },
   {
    "pmid": "25123076",
    "title": "Colchicine for acute gout",
    "year": "2014"
   },
   {
    "pmid": "25521793",
    "title": "Biologics, colchicine, corticosteroids, immunosuppressants and interferon-alpha for Neuro-Beh\u00e7et's Syndrome",
    "year": "2014"
   },
   {
    "pmid": "17054279",
    "title": "Colchicine for acute gout",
    "year": "2006"
   },
   {
    "pmid": "15846629",
    "title": "Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis",
    "year": "2005"
   },
   {
    "pmid": "15106254",
    "title": "Colchicine for primary biliary cirrhosis",
    "year": "2004"
   },
   {
    "pmid": "14583964",
    "title": "Colchicine as an oral corticosteroid sparing agent for asthma",
    "year": "2003"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 133939.53,
  "records": 729,
  "by_name": [
   [
    "Lodoco",
    93741.71
   ],
   [
    "Gloperba",
    40177.89
   ],
   [
    "Mitigare",
    19.93
   ]
  ],
  "names_checked": [
   "colchicine",
   "Mitigare",
   "Lodoco",
   "Colcrys",
   "Gloperba"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1542308,
  "beneficiaries": 649200,
  "spend": 90462292.0,
  "by_brand": [
   {
    "brand": "Colchicine",
    "claims": 1495868,
    "per_claim": 50.516086446,
    "is_generic": true
   },
   {
    "brand": "Mitigare",
    "claims": 44946,
    "per_claim": 311.98120122,
    "is_generic": false
   },
   {
    "brand": "Lodoco",
    "claims": 723,
    "per_claim": 837.59630705,
    "is_generic": false
   },
   {
    "brand": "Colcrys",
    "claims": 719,
    "per_claim": 328.57874826,
    "is_generic": false
   },
   {
    "brand": "Gloperba",
    "claims": 52,
    "per_claim": 629.95153846,
    "is_generic": false
   }
  ],
  "per_claim": 58.65384346057986
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "RemovedFromEml",
  "name": "colchicine",
  "matched": "colchicine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5883,
  "fills": 1542308,
  "per_million": 3814.4132041070916,
  "ratio": 1.3775667828155806,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "3,814 FDA reports naming it as the suspect drug per million Medicare fills, 1.4x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "253 randomized trials and 156 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist",
    "Only 40% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 17 generic makers (-1)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $133,940 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (17 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea. 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.)"
 ]
}