Colchicine

The mechanism by which colchicine tablets exert its beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation and migration of neutrophils thought to mediate some gout symptoms.

• Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( Error!ICD-10: M10.9

• Patients with renal or hepatic impairment should not be given colchicine tablets 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.contraindicated

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. The recommended dosage of colchicine tablets depends on the patient’s age, renal function, hepatic function and use of coadministered drugs [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] . Colchicine tablets are administered orally without regard to meals. Colchicine tablets are not an analgesic medication and should not be used to treat pain from other causes. • Gout Flares: Prophylaxis of Gout Flares: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age ( Error! Hyperlink reference not valid. ). Maximum dose 1.2 mg/day. 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 ( Error! Hyperlink reference not valid. ). • FMF: Adults and children older than 12 years 1.2 - 2.4 mg; children 6 to 12 years 0.9 - 1.8 mg; children 4 to 6 years 0.3 - 1.8 mg ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). o Give total daily dose in one or two divided doses ( Error! Hyperlink reference not valid. ). o 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 ( Error! Hyperlink reference not valid. ).

• Fatal overdoses have been reported with colchicine in adults and children. Keep colchicine tablets out of the reach of children ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • Blood dyscrasias: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported ( Error! Hyperlink reference not valid. ). • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • 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 ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • Neuromuscular toxicity: Myotoxicity including rhabdomyolysis may occur, especially in combination with other drugs known to cause this effect. Consider temporary interruption or discontinuation of colchicine tablets ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). 5.1 Fatal Overdose Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine [see Error! Hyperlink reference not valid. ] . Colchicine tablets should be kept out of the reach of children.

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 colchicine tablets 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 colchicine tablets, usually presenting within 24 hours, and occurring in up to 20% of patients given therapeutic doses. Typical symptoms include cramping, nausea, diarrhea, abdominal pain and vomiting. These events should be viewed as dose-limiting if severe, as they can herald the onset of more significant toxicity. • 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 ( Error! Hyperlink reference not valid. ). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888- 375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• In the presence of mild to moderate renal or hepatic impairment, adjustment of dosing is not required for treatment of gout flare, prophylaxis of gout flare and FMF, but patients should be monitored closely ( Error! Hyperlink reference not valid. ). • In patients with severe renal impairment for prophylaxis of gout flares, the starting dose should be 0.3 mg/day for gout flares, no dose adjustment is required, but a treatment course should be repeated no more than once every two weeks. In FMF patients, start with 0.3 mg/day, and any increase in dose should be done with close monitoring ( Error! Hyperlink reference not valid. ). • In patients with severe hepatic impairment, a dose reduction may be needed in prophylaxis of gout flares and FMF patients; while a dose reduction may not be needed in gout flares, a treatment course should be repeated no more than once every two weeks ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ). • For patients undergoing dialysis, the total recommended dose for prophylaxis of gout flares should be 0.3 mg given twice a week with close monitoring. For treatment of gout flares, the total recommended dose should be reduced to 0.6 mg (one tablet) x 1 dose and the treatment course should not be repeated more than once every two weeks.

Metabolism

Absorption In healthy adults, colchicine tablets are absorbed when given orally, reaching a mean C max of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in one to two hours (range 0.5 to 3 hours) after a single dose administered under fasting conditions. Following oral administration of colchicine tablets given as 1.8 mg colchicine over one hour to healthy, young adults under fasting conditions, colchicine appears to be readily absorbed, reaching mean maximum plasma concentrations of 6.2 ng/mL at a median 1.81 hours (range: 1.0 to 2.5 hours).

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a four day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions such as myelosuppression. There was 100% mortality in those who ingested more than 0.8 mg/kg. The first stage of acute colchicine toxicity typically begins within 24 hours of ingestion and includes gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea and significant fluid loss, leading to volume depletion. Peripheral leukocytosis may also be seen. Life-threatening complications occur during the second stage, which occurs 24 to 72 hours after drug administration, attributed to multiorgan failure and its consequences. Death is usually a result of respiratory depression and cardiovascular collapse.

• Nov 23, 1976ANDAANDA084279Watson Labs
• May 13, 2008ANDAANDA040618Ingenus Pharms Llc
• Sep 26, 2014NDANDA204820Hikma Intl Pharms
• Sep 28, 2016ANDAANDA204711Amneal Pharms
• Nov 29, 2018ANDAANDA208678Ph Health
• Jan 30, 2019NDANDA210942Scilex Pharms
• Feb 8, 2019ANDAANDA211250Alkem Labs Ltd
• Jun 16, 2023NDANDA215727Agepha Pharma Fz

1. 1Diarrhoea2,3739.2%
2. 2Off Label Use2,1408.3%
3. 3Drug Ineffective1,9987.8%
4. 4Nausea1,7826.9%
5. 5Fatigue1,6036.2%
6. 6Arthralgia1,3355.2%
7. 7Dyspnoea1,3355.2%
8. 8Acute Kidney Injury1,2955.0%
9. 9Headache1,2424.8%
10. 10Toxicity To Various Agents1,2224.7%
11. 11Vomiting1,1964.6%
12. 12Pain1,1344.4%
13. 13Drug Interaction1,1134.3%
14. 14Gout1,1004.3%
15. 15Rash9673.8%

Recent PubMed references pinned to Colchicine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• A Randomized Trial to Investigate the Effects of Low-Dose Colchicine in Patients with Hypertension: Rationale and Design of the COlchicine and HypERtENsion Trial (COHERENT).
  Journal of clinical hypertension (Greenwich, Conn.) · 2026 · Langhoff AF, Johansen ND, Frimodt-Møller M, et al.
  PMID 42210033DOI 10.1111/jch.70296
• Colchicine in Cardiovascular Disease: Evidence Structure, Clinical Efficacy, Safety, and Translational Positioning Across Cardiovascular Syndromes.
  International journal of molecular sciences · 2026 · Omidian H, Cubeddu LG, Gill EJ, et al.
  PMID 42196392DOI 10.3390/ijms27104419
• Elucidation of colchicine degradation pathways under UVC, UVC/H(2)O(2) and UVC/S(2)O(8)(2-) processes: proposed transformation products identification, mechanistic insights and in silico evaluation.
  Chemosphere · 2026 · Marson EO, Santos GM, Costa LG, et al.
  PMID 42139916DOI 10.1016/j.chemosphere.2026.144959
• A Flexible Wearable Electronics System for Electrocardiographic Assessment of Colchicine Therapy for Post-MI Remodeling.
  Sensors (Basel, Switzerland) · 2026 · Huang W, Gong X, Yang M, et al.
  PMID 42122537DOI 10.3390/s26092814
• Colchicine alleviates severe acute pancreatitis in rats by inhibiting acinar cell ferroptosis via LCN2/MAPK/ERK signaling axis.
  European journal of histochemistry : EJH · 2026 · Yang L, Zheng X, Zhang Y, et al.
  PMID 42112745DOI 10.4081/ejh.2026.4557
• Comparison of the Effectiveness of Potassium Para-aminobenzoate and Colchicine in the Treatment of Peyronie Disease: A Retrospective Study.
  Nigerian journal of clinical practice · 2026 · Kervancioglu E, Goren MR, Ozer C, et al.
  PMID 42085088DOI 10.4103/njcp.njcp_11_26
• Effects of colchicine on SAH-induced vascular damage in an experimental subarachnoid hemorrhage model.
  Turkish journal of medical sciences · 2026 · Demir E, Demirtaş C, Sönmez C, et al.
  PMID 42058978DOI 10.55730/1300-0144.6192
• Mechanisms and therapeutic potential of colchicine in atherosclerotic cardiovascular disease.
  Nature cardiovascular research · 2026 · Xia X, Yang F, Liao Y, et al.
  PMID 42045490DOI 10.1038/s44161-026-00807-5

The 10 most recently updated of 322 ClinicalTrials.gov registrations naming Colchicine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
  Active not recruiting · Phase 4 · Interventional · 200 enrolled · Massachusetts General Hospital
  NCT05850091updated 2026-06-12
• COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction
  Terminated · Phase 2 · Phase 3 · Interventional · 54 enrolled · University Hospital, Montpellier
  NCT04420624updated 2026-06-12
• RegoNivo vs Standard of Care Chemotherapy in AGOC
  Completed · Phase 3 · Interventional · 462 enrolled · Australasian Gastro-Intestinal Trials Group
  NCT04879368updated 2026-06-10
• Colchicine's Effect on Inflammatory Markers
  Recruiting · Phase 4 · Interventional · 24 enrolled · Ayesha Ather
  NCT07287345updated 2026-06-08
• Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
  Completed · Phase 3 · Interventional · 120 enrolled · Insel Gruppe AG, University Hospital Bern
  NCT04870424updated 2026-06-03
• Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
  Not yet recruiting · Phase 2 · Interventional · 150 enrolled · Brigham and Women's Hospital
  NCT06855433updated 2026-05-29
• Colchicine for the Prevention of Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Strategy-Stratified, Randomized, Double-Blind, Placebo-Controlled Trial
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 400 enrolled · National Taiwan University Hospital
  NCT07611019updated 2026-05-28
• Colchicine for Autoimmune and Subacute Thyroiditis
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 300 enrolled · Mansoura University
  NCT07571681updated 2026-05-28
• Study to Evaluate the Safety of Colchicine
  Active not recruiting · Phase 1 · Interventional · 30 enrolled · Rutgers, The State University of New Jersey
  NCT05335148updated 2026-05-20
• Ilaris NIS in Korea
  Recruiting · Observational · 25 enrolled · Novartis Pharmaceuticals
  NCT06838143updated 2026-05-19

Frequently asked questions

How does Colchicine work?

The mechanism by which colchicine tablets exert its beneficial effect in patients with FMF has not been fully elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation and migration of neutrophils thought to mediate some gout symptoms.

What is Colchicine used for?

According to FDA labeling, Colchicine carries indications including: Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( Error!. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Colchicine?

Colchicine is classified as Preparations with no effect on uric acid metabolism, Alkaloid, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Tubulin Interactions, Unknown Cellular or Molecular Interaction, Cellular Growth Phase Arrest, Decreased Phagocytosis.

What are the brand names for Colchicine?

Colchicine is marketed under brand names including Colcrys, Gloperba, Lodoco, Mitigare.

What are the contraindications for Colchicine?

Colchicine labeling lists contraindications including: Patients with renal or hepatic impairment should not be given colchicine tablets 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.. Always consult the full prescribing information and a clinician.