Prescription medication · Anti-Gout Agent
colchicine
Also sold as Colcrys, Mitigare. Colchicine is used to prevent and treat gout flares in adults.
Data updated 2026-05-15
- 28,502
- FDA reportsModerately reported
- 28
- InteractionsSeveral interactions
- 63% less
- Generic vs brandBig savings
- $6.90
- Brand price (NADAC)
What the data shows
colchicine (Colcrys) is a prescription Anti-Gout Agent, reported at a middle-of-the-pack volume (28,502 FDA reports), whose generic runs roughly half the brand price or less (63% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
colchicine (Colcrys) is a prescription Anti-Gout Agent. Colchicine is used to prevent and treat gout flares in adults.
Colchicine is a medicine used to prevent or treat gout flares and Familial Mediterranean Fever (FMF). It works by reducing inflammation and pain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$6.90/unit
Generic Price
$2.53/unit
Generic Savings
63%
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Colchicine is used to prevent and treat gout flares in adults.
Common side effects
Diarrhea, Abdominal pain, Nausea
Key warnings
Taking too much colchicine can be fatal in both adults and children.
The sections below are summarized in plain English from colchicine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Colchicine reduces inflammation in the body. It does this by blocking certain processes that cause swelling and pain. This helps to relieve gout flares and manage FMF symptoms.
Side Effects (from patient reports)
Based on 28,502 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for colchicine, by number of reports
- Diarrhoea
Diarrhoea
2,660 reports
- Nausea
Nausea
1,940 reports
- Fatigue
Fatigue
1,747 reports
- Dyspnoea
Dyspnoea
1,467 reports
- Acute Kidney Injury
Acute Kidney Injury
1,436 reports
- Arthralgia
Arthralgia
1,432 reports
- Headache
Headache
1,323 reports
- Gout
Gout
1,275 reports
- Vomiting
Vomiting
1,257 reports
- Pain
Pain
1,231 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for colchicine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where colchicine sits
colchicine has more FDA adverse-event reports than 63% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is colchicine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 28,502 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
28,502
Reports Mentioning Death
3,416
12.0% of reports — not proof of cause
Hospitalization Reports
11,915
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 2,660 |
| 4 | NAUSEA | 1,940 |
| 5 | FATIGUE | 1,747 |
| 6 | DYSPNOEA | 1,467 |
| 7 | ACUTE KIDNEY INJURY | 1,436 |
| 8 | ARTHRALGIA | 1,432 |
| 9 | HEADACHE | 1,323 |
| 10 | GOUT | 1,275 |
| 11 | VOMITING | 1,257 |
| 12 | PAIN | 1,231 |
| 13 | TOXICITY TO VARIOUS AGENTS | 1,151 |
| 14 | DRUG INTERACTION | 1,113 |
| 15 | RENAL FAILURE | 1,040 |
| 16 | RASH | 1,031 |
| 17 | PYREXIA | 933 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Taking too much colchicine can be fatal in both adults and children. Keep this medicine out of the reach of children. Colchicine can also cause serious blood problems and muscle weakness. Certain medicines can interact with colchicine and cause life-threatening problems. Talk to your doctor about all the medicines you take.
Known Drug Interactions
Fluconazole No Dose Adjustment Fluconazole: [see Pharmacokinetics ( 12.3 )] Anti-Gout Agents: Colchicine (in patients with renal or hepatic impairment) Contraindicated Colchicine: Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). The dose of colchicine should be reduced when co-administered with clarithromycin in patients with normal renal and hepatic function [see Contraindications ( 4.4 ) and Warnings and Precautions ( 5.4 )] . Colchicine (in patients with normal renal and hepatic function) Use With Caution Antipsychotics: Pimozide Contraindicated...
Mechanism: Clarithromycin blocks the enzymes and transporters that remove colchicine from your body, which can lead to toxic levels of the drug.
Anti-gout: colchicine ↑ colchicine Co-administration is contraindicated in patients with renal and/or hepatic impairment due to potential for serious and/or life-threatening reactions. For patients without renal or hepatic impairment: Treatment of gout-flares – co-administration of colchicine in patients on darunavir/ritonavir: 0.6 mg (1 tablet) × 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Prophylaxis of gout-flares – co-administration of colchicine in patients on darunavir/ritonavir: If the original regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once...
Mechanism: Darunavir makes it harder for your body to get rid of colchicine, which can cause the medicine to reach toxic levels. This is especially dangerous for people with liver or kidney problems.
Miscellaneous Drugs and Other Substances Colchicine Patients with renal or hepatic impairment: Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: In people with liver or kidney issues, itraconazole prevents the body from removing colchicine, which can lead to dangerous side effects.
Anti-gout colchicine ↑ colchicine Co-administration contraindicated due to potential for serious and/or life-threatening reactions in patients with renal and/or hepatic impairment [see Contraindications (4) ] .
Mechanism: Ritonavir stops the body from processing colchicine, which can cause the drug to reach toxic levels. This is very dangerous and can be life-threatening, especially for people with liver or kidney disease.
Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with atorvastatin. Intervention: Consider the risk/benefit of concomitant use of colchicine with atorvastatin.
Mechanism: Both drugs can cause muscle damage, and taking them together increases the risk of a severe muscle breakdown.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take colchicine for pain other than gout?
What should I do if I experience diarrhea while taking colchicine?
Can I drink alcohol while taking colchicine?
What if I have kidney or liver problems?
How quickly does colchicine work for a gout flare?
Can I take colchicine with other medications?
Is colchicine safe for long-term use?
What should I do if I accidentally take too much colchicine?
Can colchicine affect my fertility?
Does food affect how I take colchicine?
What are the common side effects of colchicine?
Does colchicine interact with other medications?
What drug class is colchicine?
Is there a generic version of colchicine?
What pregnancy or breastfeeding source fields are listed for colchicine?
Related Medications in Anti-Gout Agent
Other drugs grouped near colchicine - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with colchicine →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with colchicine →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with colchicine →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with colchicine →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with colchicine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for colchicine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 28,502.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.99%.
- cefuroxime Δ 0.04 pts · 11,087 reports · Second-Generation Cephalosporin 11.94%death share
- zolpidem Δ 0.06 pts · 131,653 reports · Non-Benzodiazepine Hypnotic (Z-Drug) 11.92%death share
- glycopyrrolate Δ 0.07 pts · 5,225 reports · Long-Acting Muscarinic Antagonist (LAMA) 12.06%death share
- exemestane Δ 0.11 pts · 20,856 reports · Aromatase Inhibitor (Steroidal) 11.88%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for colchicine
The FDA label for colchicine (sold under brand names such as Colcrys, Mitigare) classifies it as a prescription-only medication in the Anti-Gout Agent class. Colchicine is used to prevent and treat gout flares in adults. Official labeling lists 4 commonly reported side effects, including Diarrhea, Abdominal pain, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 28,502 voluntary reports. The database also lists 28 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $2.53 versus $6.90 for the brand - a 63% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: July 1, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages