colchicine
Brand names: Colcrys, Mitigare
Colchicine is a medicine used to prevent or treat gout flares and Familial Mediterranean Fever (FMF). It works by reducing inflammation and pain.
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.
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.
How to Take It
Take colchicine tablets by mouth. You can take it with or without food. The dose depends on what you are treating. Follow your doctor's instructions carefully. Do not take more than prescribed.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Colchicine may harm your unborn baby. It is not known if colchicine passes into breast milk. Talk to your doctor about the risks and benefits of taking colchicine while breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store colchicine tablets at room temperature (68° to 77°F) in a tight, light-resistant container, away from light.
Side Effects (from patient reports)
Based on 17,757 FDA adverse event reports.
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
Death-Related Reports
3,416
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 |
| 2 | OFF LABEL USE | 2,268 |
| 3 | DRUG INEFFECTIVE | 2,212 |
| 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 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) 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.
What to do: Avoid this combination if you have kidney or liver issues, and ensure your doctor reduces your colchicine dose if your organs are healthy.
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 a...
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.
What to do: People with liver or kidney disease must avoid this combination. Others will need their doctor to carefully lower their colchicine dose.
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.
What to do: If you have kidney or liver disease, do not take these together and wait two weeks after stopping itraconazole before using colchicine.
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.
What to do: Avoid taking these medications at the same time. Your doctor should provide a different treatment for your gout.
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.
What to do: Your doctor should carefully weigh the risks and benefits before prescribing these two drugs together.
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?
Is colchicine safe during pregnancy?
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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
Why some drugs demand precise dosing and monitoring
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 17,757 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: July 1, 2025
Read our methodology — how this data is sourced, computed, and verified.
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