Adverse Events During Oral Colchicine Use

A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Sarah Stewart; Kevin Chih Kai Yang; Kate Atkins; Nicola Dalbeth; Philip C. Robinson


Arthritis Res Ther. 2020;22(28) 

In This Article

Abstract and Introduction


Background: Colchicine is a widely used drug to treat inflammatory diseases. Due to its long historical use in medicine, controlled clinical trials have been small and there remains some caution with the use of this drug in patients with co-morbidities. The aim of the study is to systematically examine the side effect profile of colchicine in controlled clinical trials across all published indications.

Methods: A systematic review was conducted in accordance with PRISMA methodology. The Cochrane Library, MEDLINE and EMBASE were searched for double-blind controlled trials of oral colchicine in adult patients that reported adverse event data. Meta-analyses were used to determine the relative risk (RR) of adverse events in colchicine users compared to comparator groups.

Results: A total of 4915 studies were initially identified and after exclusions, 35 randomised controlled trials with placebo (n = 30) or active comparators (n = 5) were included. The most common diseases studied were gout, liver cirrhosis and pericarditis. There were a total of 8659 pooled participants, 4225 participants were randomised to receive colchicine, 3956 to placebo and 411 to an active comparator. Diarrhoea was reported in 17.9% of colchicine users versus 13.1% in comparator groups (RR 2.4, 95% confidence interval (CI) 1.6, 3.7). Any gastrointestinal event was reported in 17.6% of colchicine users and 13.1% of comparators (RR 1.7, 95% CI 1.3, 2.3). Adverse liver events were reported in 1.9% of colchicine users versus 1.1% in the comparator groups (RR 1.6, 95% CI 0.9, 3.0). Muscle events were reported in 4.2% of colchicine users and 3.3% in the comparator groups (RR 1.3, 95% CI 0.8, 1.9). Haematology events were reported in 0.6% of colchicine users and 0.4% of comparator groups (RR 1.34 (0.64, 2.82). No study reported neuropathy events. Other sensory events were reported in 1.1% of colchicine users and 1.5% of comparator groups (RR 1.4, 95% CI 0.3, 6.7). Infectious events were reported in 0.4% of colchicine users and 2.1% of comparator groups (RR 1.0, 95% CI 0.7, 1.5). No study reported death as an adverse event.

Conclusion: Colchicine increases the rate of diarrhoea and gastrointestinal adverse events but does not increase the rate of liver, sensory, muscle, infectious or haematology adverse events or death.


Colchicine is an anti-inflammatory agent which is widely used for the treatment of gout and also used extensively for familial Mediterranean fever, Behcet's disease and pericarditis. Its use in the management of gout has increased due to the widespread recommendation that it be used as a gout flare prophylaxis when urate-lowering therapy is initiated.[1] It is used continuously for long periods of time in individuals with familial Mediterranean fever and Behcet's disease. However, due to its long historical use in medicine, it has not been subjected to the same registration trials that contemporary medicines require. There remains uncertainty regarding its use in certain risk groups including those with kidney and liver impairment, at higher doses, and with CYP3A4 inhibitors.[2] It has previously been used in an intravenous preparation, but this is no longer used due to the adverse safety profile of this administration method.[3]

Although the adverse event profile of colchicine has been reported in various individual clinical trials and for single indications like pericarditis,[4] it has not been studied systematically to our knowledge. The aim of this study was to examine the adverse events of colchicine reported in randomised controlled trials using a systemic review and meta-analysis methodology.