85/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
Colchicine Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
65,499 FDA adverse event reports analyzed
Last updated: 2026-05-12
COLCHICINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 65,499 FDA adverse event reports, COLCHICINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for COLCHICINE include DIARRHOEA, OFF LABEL USE, DRUG INEFFECTIVE, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COLCHICINE.
Colchicine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 65,499 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Diarrhoea, Off Label Use, Drug Ineffective. Of classified reports, 77.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious adverse events, particularly renal and cardiovascular issues.
Diverse range of reactions, including gastrointestinal, respiratory, and neurological symptoms. Significant number of drug interactions and contraindications reported.
Patients taking Colchicine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Colchicine can interact with various drugs, including those affecting renal function and cardiac health, necessitating careful monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Colchicine received a safety concern score of 85/100 (high concern). This is based on a 77.9% serious event ratio across 28,486 classified reports. The score accounts for 65,499 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 14,937, Female: 11,127, Unknown: 135. The most frequently reported age groups are age 68 (561 reports), age 72 (512 reports), age 65 (494 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,486 classified reports for COLCHICINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Colchicine can interact with various drugs, including those affecting renal function and cardiac health, necessitating careful monitoring.
If you are taking Colchicine, here are important things to know. The most commonly reported side effects include diarrhoea, off label use, drug ineffective, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and consult healthcare providers for any new symptoms. Inform healthcare providers of all medications and supplements being taken to avoid potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for specific patient populations.
The FDA has received approximately 65,499 adverse event reports associated with Colchicine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Colchicine include Diarrhoea, Off Label Use, Drug Ineffective, Nausea, Fatigue. By volume, the top reported reactions are: Diarrhoea (2,660 reports), Off Label Use (2,268 reports), Drug Ineffective (2,213 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Colchicine.
Out of 28,486 classified reports, 22,192 (77.9%) were classified as serious and 6,294 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Colchicine break down by patient sex as follows: Male: 14,937, Female: 11,127, Unknown: 135. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Colchicine adverse events are: age 68: 561 reports, age 72: 512 reports, age 65: 494 reports, age 60: 490 reports, age 74: 489 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Colchicine adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Colchicine include: Dyspnoea, Acute Kidney Injury, Arthralgia, Headache, Gout. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Colchicine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Colchicine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High rate of serious adverse events, particularly renal and cardiovascular issues.
Key safety signals identified in Colchicine's adverse event data include: Acute kidney injury and renal failure are among the most serious reported reactions.. Cardiac failure and arrhythmias are also notable safety signals.. Over 20% of reports involve off-label use, highlighting potential misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Colchicine can interact with various drugs, including those affecting renal function and cardiac health, necessitating careful monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Colchicine.
Patients should strictly follow prescribed dosages and consult healthcare providers for any new symptoms. Inform healthcare providers of all medications and supplements being taken to avoid potential drug interactions.
Colchicine has 65,499 adverse event reports on file with the FDA. Diverse range of reactions, including gastrointestinal, respiratory, and neurological symptoms. The volume of reports for Colchicine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for specific patient populations. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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