What the label lists and what reports show
Colchicine side effects
Colchicine's FDA label: “Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.” FAERS holds 26,198 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (2,399 reports).
- Generic listed
Check it at the source: the colchicine FDA label on DailyMed (effective July 22, 2025, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of colchicine tablets?Colchicine tablets can cause serious side effects or even cause death. See “What is the most important information that I should know about colchicine tablets?”. Get medical help right away if you have: Muscle weakness or pain Numbness or tingling in your fingers or toes Unusual bleeding or bruising Increased infections Feel weak or tired Pale or gray color to your lips, tongue or palms of your hands Severe diarrhea or vomiting FMF: The most common side effects of colchicine tablets in people who have FMF are abdominal pain, diarrhea, nausea and vomiting. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of colchicine tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Aurobindo Pharma Limited, effective July 22, 2025 (SPL set dd93a40f-92ab-47ac-9083-b8a7a0b18ad6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting.
Table 3 Number (%) of Patients with at Least One Drug-Related Treatment-Emergent Adverse Event with an Incidence of ≥ 2% of Patients in Any Treatment Group
This table is printed in the Colchicine label published by Zydus Pharmaceuticals USA Inc. of October 4, 2022; the label quoted above does not print one.
| Reaction | MedDRA System Organ Class MedDRA Preferred Term | Colchicine Dose High (N=52) n (%) | Placebo (N=59) n (%) Low (N=74) n (%) |
|---|---|---|---|
| Number of Patients with at Least One Drug-Related TEAE | 40 (77) | 27 (37) | 16 (27) |
| Gastrointestinal Disorders | 40 (77) | 19 (26) | 12 (20) |
| Diarrhea | 40 (77) | 17 (23) | 8 (14) |
| Nausea | 9 (17) | 3 (4) | 3 (5) |
| Vomiting | 9 (17) | 0 | 0 |
| Abdominal Discomfort | 0 | 0 | 2 (3) |
| General Disorders and Administration Site Conditions | 4 (8) | 1 (1) | 1 (2) |
| Fatigue | 2 (4) | 1 (1) | 1 (2) |
| Metabolic and Nutrition Disorders | 0 | 3 (4) | 2 (3) |
| Gout | 0 | 3 (4) | 1 (2) |
| Nervous System Disorders | 1 (2) | 1 (1.4) | 2 (3) |
| Headache | 1 (2) | 1 (1) | 2 (3) |
| Respiratory Thoracic Mediastinal Disorders | 1 (2) | 2 (3) | 0 |
| Pharyngolaryngeal Pain | 1 (2) | 2 (3) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedFMF Gastrointestinal tract adverse effects are the most frequent side effects in patients initiating colchicine, 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. 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 ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Postmarketing Experience Serious toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation and injury to cells in the renal, hepatic, circulatory and central nervous systems. These most often occur with excessive accumulation or overdosage [see Overdosage (10) ]. The following adverse reactions have been identified with colchicine. These have been generally reversible upon temporarily interrupting treatment or lowering the dose of colchicine. …
Source: FDA drug label, Aurobindo Pharma Limited, effective July 22, 2025 (SPL set dd93a40f-92ab-47ac-9083-b8a7a0b18ad6), via openFDA; the full label on DailyMed
What do FAERS reports show?
26,198 reports list colchicine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,240 are coded as a death and 11,452 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Colchicine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions