{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "colchicine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age ( 2.1 ).",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Treatment of Gout Flares: 1.2 mg (two tablets) at the first sign of a gout flare followed by 0.6 mg (one tablet) one hour later ( 2.1 ).",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the maximum recommended daily dose ( 2.2 ).",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of colchicine in children of all ages with FMF has been evaluated in uncontrolled studies. There does not appear to be an adverse effect on growth in children with FMF treated long-term with colchicine. Safety and effectiveness of colchicine in pediatric patients with gout has not been established.",
        "source": "US FDA label for colchicine (Colchicine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "The long-term use of colchicine is established for FMF and the prophylaxis of gout flares, but the safety and efficacy of repeat treatment for gout flares has not been evaluated. The dosing regimens for colchicine tablets are different for each indication and must be individualized.",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age ( 2.1 ).",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Treatment of gout flares with colchicine tablets are not recommended in patients receiving prophylactic dose of colchicine tablets and CYP3A4 inhibitors.",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "For the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see Clinical Pharmacology ( 12.3 ), Use in Specific Populations ( 8.6 )] .",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "For patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet).",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Maximum daily dose of 1.2 mg to 2.4 mg Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) Table 2 Colchicine Tablets Dose Adjustment for Coadministration with Protease Inhibitors Protease Inhibitor Clinical Comment w/Colchicine -Prophylaxis of Gout Flares w/Colchicine -Treatment of Gout Flares w/Colchicine -Treatment of FMF Atazanavir sulfate (Reyataz) Patients with renal or hepatic impairment should not be given colchicine with Reyataz.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Darunavir (Prezista) Patients with renal or hepatic impairment should not be given colchicine with Prezista/ ritonavir.",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day) 0.6 mg twice a day 0.3 mg once a day 0.6 mg once a day 0.3 mg once every other day Fosamprenavir (Lexiva) with Ritonavir Patients with renal or hepatic impairment should not be given colchicine with Lexiva/ritonavir.",
        "source": "US FDA label for colchicine (Colchicine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).",
        "source": "US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Although animal reproductive and developmental studies were not conducted with colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range.",
        "source": "US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.",
        "source": "US FDA label for colchicine (Colchicine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility Case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible.",
        "source": "US FDA label for colchicine (Colchicine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "A case report indicated that azoospermia was reversed when therapy was stopped.",
        "source": "US FDA label for colchicine (Colchicine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      },
      {
        "text": "Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility.",
        "source": "US FDA label for colchicine (Colchicine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/colchicine.json",
        "verbatim": true
      }
    ]
  }
}