Colchicine (Colcrys, Mitigare) 0.6 mg Tablets: Prescription Anti-inflammatory for Acute Gout Flares, Prophylaxis, and Familial Mediterranean Fever

Information last reviewed: May 2026 — for educational purposes only.

Colchicine (Colcrys, Mitigare) is a prescription alkaloid derived from the autumn crocus (Colchicum autumnale) with potent anti-inflammatory activity, used primarily for the treatment and prevention of acute gout flares and for familial Mediterranean fever (FMF). Unlike allopurinol, colchicine does not lower serum uric acid — it disrupts the inflammatory cascade triggered by urate crystal deposition. It works by binding to tubulin and preventing its polymerisation into microtubules, which inhibits neutrophil mobility, degranulation, and migration into the affected joint. Without the influx of neutrophils, the acute inflammatory response that produces the extreme pain and swelling of a gout attack is suppressed.

Colchicine has a narrow therapeutic index — the difference between the therapeutic dose and a toxic dose is small. GI toxicity (nausea, vomiting, diarrhoea, abdominal cramps) is dose-limiting and occurs at doses only slightly above the therapeutic range. Historically, high-dose colchicine regimens were used but caused unacceptable toxicity; modern dosing uses the low-dose regimen validated in the AGREE trial (1.2 mg then 0.6 mg one hour later), which provides equivalent efficacy to high-dose regimens with dramatically less GI toxicity.

What Is Colchicine?

Colchicine inhibits microtubule polymerisation by binding to free tubulin dimers, halting cell division and — critically for gout — blocking neutrophil motility. It also inhibits the NLRP3 inflammasome and IL-1β release — key inflammatory mediators in both gout and now known to be relevant in cardiovascular inflammation (emerging use: colchicine for cardiovascular risk reduction — COLCOT and LoDoCo2 trials demonstrated colchicine 0.5 mg/day reduces cardiovascular events in post-MI and stable CAD patients). It is not a uric-acid lowering agent and does not dissolve crystals.

Prescription Status

Colchicine is prescription-only in the United States. This has been the case since the FDA took regulatory action in 2009–2010, requiring colchicine to undergo formal NDA review. The result was Colcrys (approved dose-limited labelling, higher cost than the old bulk supply colchicine) and later Mitigare (approved for flare prophylaxis only). Generic colchicine tablets are also now available at significantly reduced cost.

Strengths and Available Forms

• 0.6 mg tablets (Colcrys, Mitigare, generic) — the standard unit dose; all approved regimens are based on 0.6 mg tablet multiples
• 0.6 mg/5 mL oral solution — for patients who cannot swallow tablets; same pharmacokinetics
• No IV colchicine is approved by the FDA (was withdrawn due to fatal overdose incidents)

Acute gout flare regimen (FDA-approved low-dose): 1.2 mg (two 0.6 mg tablets) at flare onset, then 0.6 mg one hour later. Do not repeat within 3 days. Total dose: 1.8 mg per flare episode. Most effective when started within 12–24 hours of flare onset. Efficacy drops substantially if treatment delayed more than 48–72 hours.

Flare prophylaxis (during initiation of ULT): 0.6 mg once daily (or 0.6 mg twice daily if tolerated) for 3–6 months when starting allopurinol or febuxostat to prevent mobilisation flares.

Familial Mediterranean fever (FMF): 0.6 mg twice daily (1.2 mg/day) as chronic suppressive therapy. Can increase to 1.8 mg/day if partially controlled.

Price of Colchicine

Generic colchicine 0.6 mg tablets are available at most US pharmacies. Brand-name Colcrys is considerably more expensive due to its FDA-approved NDA status. For cost-sensitive patients, generic colchicine provides equivalent clinical efficacy. Insurance generally covers generic colchicine, though prior authorisation may be required for Colcrys brand in some plans.

Frequently Asked Questions

What are the serious drug interactions with colchicine?

Colchicine has potentially life-threatening interactions with several commonly co-prescribed drugs. It is metabolised by CYP3A4 and transported by P-glycoprotein (P-gp). Strong CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, ketoconazole, itraconazole, atazanavir, ritonavir) and P-gp inhibitors (e.g., cyclosporine, quinidine, verapamil) can dramatically increase colchicine plasma concentrations — sometimes by several hundred percent — leading to severe and potentially fatal toxicity including neuromuscular blockade, rhabdomyolysis, and multi-organ failure. When co-prescribing these agents, colchicine dose must be reduced substantially (e.g., one 0.6 mg dose without repeating) and never used in patients with renal or hepatic impairment if a strong inhibitor is co-prescribed. Hold colchicine or use an alternative anti-inflammatory when these drugs are prescribed concurrently.

Why is colchicine used for cardiovascular disease prevention now?

Beyond gout and FMF, colchicine 0.5 mg/day has emerged as a clinically significant anti-inflammatory cardiovascular therapy following two landmark randomised trials: COLCOT (2019) showed colchicine 0.5 mg/day reduced major adverse cardiovascular events by 23% in post-MI patients. LoDoCo2 (2020) showed similar reduction in stable coronary artery disease. The mechanism is thought to involve colchicine's inhibition of neutrophil-mediated and NLRP3 inflammasome-driven vascular inflammation. The FDA approved Lodoco (colchicine 0.5 mg) in June 2023 for this cardiovascular indication — the first anti-inflammatory (non-lipid-lowering) therapy to receive FDA approval for reducing cardiovascular risk after MI and in chronic CAD.

Can colchicine be used in patients with kidney disease?

Colchicine requires dose adjustment or avoidance in moderate-to-severe renal impairment (CrCl <30 mL/min) because it and its metabolites are partially renally excreted. In severe renal failure (CrCl <10 mL/min) or on dialysis, colchicine use is generally not recommended for acute flares (use corticosteroids instead as they are safer in renal failure). Prophylactic dosing of 0.6 mg every other day (or less frequently) may be used cautiously in moderate CKD under specialist supervision. Colchicine toxicity in renal failure is particularly dangerous due to accumulation. Hepatic metabolism pathways also play a role, so caution in hepatic impairment too.

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