Prescription medicine
Colchicine Brand names: Mitigare, Lodoco, Gloperba, Colcrys
Colchicine (Colcrys) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.122 per colchicine 0.6 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the colchicine FDA label on DailyMed (effective July 22, 2025, Aurobindo Pharma Limited); the NDA 22352 record on Drugs@FDA; every colchicine label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageColchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ).
Forms and strengths
- 0.3 mg
- 0.5 mg
- 0.6 mg
- 0.6 mg/5ml
Tablet; film-coated tablet; capsule; solution.
On the market
- Earliest approval on file
- July 29, 2009 Colcrys, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first September 28, 2016; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 34 of which 30 under generic applications, 10 under brand applications, repackagers included
- Last listed patent
- February 17, 2029 Colcrys tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.122 per tablet Colchicine 0.6 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest December 18, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 26,198 through July 30, 2026
What is colchicine used for?
From the label: indications and usageColchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
Conditions named in the indications of colchicine's FDA labels, with every medicine labeled for each:
From other colchicine labelsGout: Prophylaxis and treatment of gout flares in adults ( 1.1 ).
FDA pharmacologic class: Alkaloid.
Source: FDA drug label (Colchicine), Aurobindo Pharma Limited, effective July 22, 2025 (SPL set dd93a40f-92ab-47ac-9083-b8a7a0b18ad6), via openFDA; the full label on DailyMed
What does the patient leaflet for colchicine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information that I should know about colchicine tablets?Colchicine tablets can cause serious side effects or death if levels of colchicine tablets are too high in your body. Taking certain medicines with colchicine tablets can cause your level of colchicine tablets to be too high, especially if you have kidney or liver problems. Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of colchicine tablets may need to be changed. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Even medicines that you take for a short period of time, such as antibiotics, can interact with colchicine tablets and cause serious side effects or death. Talk to your healthcare provider or pharmacist before taking any new medicine. Especially tell your healthcare provider if you take: • atazanavir sulfate (Reyataz) • clarithromycin (Biaxin) • cyclosporine (Neoral, Gengraf, • darunavir (Prezista) Sandimmune) • fosamprenavir (Lexiva) with ritonavir • fosamprenavir (Lexiva) • indinavir (Crixivan) • itraconazole (Sporanox) • ketoconazole (Nizoral) • lopinavir/ritonavir (Kaletra) • nefazodone (Serzone) • nelfinavir mesylate (Viracept) • ritonavir (Norvir) • saquinavir mesylate (Invirase) • telithromycin (Ketek) • tipranavir (Aptivus) Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can interact with colchicine tablets. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Keep colchicine tablets out of the reach of children.
From the patient leaflet: What should I avoid while taking colchicine tablets?Avoid eating grapefruit or drinking grapefruit juice while taking colchicine tablets. It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store colchicine tablets?Store colchicine tablets at room temperature between 68°F and 77°F (20°C and 25°C). Keep colchicine tablets in a tightly closed container. Keep colchicine tablets out of the light. Keep colchicine tablets and all medicines out of the reach of children. General Information about colchicine tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use colchicine tablets for a condition for which it was not prescribed. Do not give colchicine tablets to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about colchicine tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about colchicine tablets that is written for healthcare professionals.
Source: FDA drug label (Colchicine), Aurobindo Pharma Limited, effective July 22, 2025 (SPL set dd93a40f-92ab-47ac-9083-b8a7a0b18ad6), via openFDA; the full label on DailyMed
Is there a generic for colchicine (Colcrys)?
The FDA approved the first generic colchicine on September 28, 2016. 17 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists colchicine from 30 labelers under a generic (ANDA) application and from 10 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 17 patents for Colcrys tablets, the last expiring on February 17, 2029; a patent listed only for Gloperba oral solution runs to December 20, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2016 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for colchicine (Colcrys)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.122 per Colchicine 0.6 mg tablet, down 27% from $0.167 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Colchicine 0.6 mg tablet (generic)
- Mitigare 0.6 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Colchicine 0.6 mg capsule | Generic | $1.75 per capsule | $52.58 | -41% |
| Colchicine 0.6 mg tablet | Generic | $0.122 per tablet | $3.66 | -27% |
| Lodoco 0.5 mg tablet | Brand | $17.00 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $509.98 | +4% |
| Mitigare 0.6 mg capsule | Brand | $6.03 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $180.88 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has colchicine been recalled?
The FDA's Enforcement Report lists 4 recalls naming colchicine since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of colchicine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 18, 2024 | Class II | Granules Pharmaceuticals Inc. | Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. |
| February 24, 2023 | Class III | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. … |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the colchicine label say about other medicines?
The colchicine label names 34 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name colchicine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amlodipine | drug interactions | Two pharmacokinetic studies evaluated the effects of co-administration of posaconazole (300 mg QD), ciprofloxacin (500 mg BID), amlodipine (5 to 10 mg QD), and carvedilol (20 to 40 mg QD) on the systemic levels of colchicine. |
| Aprepitant | drug interactions | Drug class: Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil; Outcome/effect: Significant increase in colchicine plasma concentration is anticipated.; … |
| Atazanavir | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin tipranavir/ritonavir; … |
| Atorvastatin | drug interactions | Concomitant Drug Class or Food: HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin; Noted or Anticipated Outcome: Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a stable long-term regimen of the other has resulted in myopathy and … |
| Carvedilol | drug interactions | Two pharmacokinetic studies evaluated the effects of co-administration of posaconazole (300 mg QD), ciprofloxacin (500 mg BID), amlodipine (5 to 10 mg QD), and carvedilol (20 to 40 mg QD) on the systemic levels of colchicine. |
| Cimetidine | drug interactions | Four pharmacokinetic studies evaluated the effects of co-administration of voriconazole (200 mg BID), fluconazole (200 mg QD), cimetidine (800 mg BID), and propafenone (225 mg BID) on systemic levels of colchicine. |
| Ciprofloxacin | drug interactions | Two pharmacokinetic studies evaluated the effects of co-administration of posaconazole (300 mg QD), ciprofloxacin (500 mg BID), amlodipine (5 to 10 mg QD), and carvedilol (20 to 40 mg QD) on the systemic levels of colchicine. |
| Clarithromycin | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Cyclosporine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Darunavir | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin tipranavir/ritonavir; … |
| Digoxin | drug interactions | Concomitant Drug Class or Food: Digitalis Glycosides: digoxin; Noted or Anticipated Outcome: P-gp substrate; rhabdomyolysis has been reported; Clinical Comment: Weigh the potential benefits and risks and carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during … |
| Diltiazem | drug interactions | Drug class: Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil; Outcome/effect: Significant increase in colchicine plasma concentration is anticipated.; … |
| Erythromycin | drug interactions | Drug class: Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil; Outcome/effect: Significant increase in colchicine plasma concentration is anticipated.; … |
| Fenofibrate | warnings and precautions | Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate (themselves associated with myotoxicity) or cyclosporine with colchicine may potentiate the development of myopathy [see Drug Interactions (7) ]. |
Every other medicine the colchicine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Fenofibric acid | warnings and precautions | Concomitant use of atorvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, gemfibrozil, fenofibrate, fenofibric acid or benzafibrate (themselves associated with myotoxicity) or cyclosporine … |
| Fluconazole | drug interactions | Drug class: Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil; … |
| Fluvastatin | drug interactions | Concomitant Drug Class or Food: HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin; … |
| Fosamprenavir | contraindications | … strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). |
| Gemfibrozil | drug interactions | Concomitant Drug Class or Food: Other Lipid-Lowering Drugs: fibrates, gemfibrozil; Noted or Anticipated Outcome: Pharmacokinetic and/or pharmacodynamic interaction: the addition of one drug to a … |
| Itraconazole | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin … |
| Ketoconazole | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin … |
| Lopinavir and ritonavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Lovastatin | drug interactions | Concomitant Drug Class or Food: HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin; … |
| Nefazodone | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin … |
| Nelfinavir | drug interactions | … indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin tipranavir/ritonavir; … |
| Norethindrone | drug interactions | Drug class: Oral contraceptives Ethinyl estradiol and norethindrone (Ortho-Novum 1/35); Outcome/effect: In healthy female volunteers given coadministered with 0.6 mg colchicine twice daily, hormone … |
| Posaconazole | drug interactions | Two pharmacokinetic studies evaluated the effects of co-administration of posaconazole (300 mg QD), ciprofloxacin (500 mg BID), amlodipine (5 to 10 mg QD), and carvedilol (20 to 40 mg QD) on the … |
| Pravastatin | drug interactions | Concomitant Drug Class or Food: HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin; … |
| Propafenone | drug interactions | … (200 mg BID), fluconazole (200 mg QD), cimetidine (800 mg BID), and propafenone (225 mg BID) on systemic levels of colchicine. |
| Ranolazine | drug interactions | Drug class: P- glycoprotein Inhibitors † cyclosporine ranolazine; Outcome/effect: Significant increase in colchicine plasma levels is anticipated with P-gp inhibitors.; … |
| Ritonavir | drug interactions | Drug class: Strong CYP3A4 Inhibitors † atazanavir clarithromycin darunavir/ritonavir indinavir itraconazole ketoconazole lopinavir/ritonavir nefazodone nelfinavir ritonavir saquinavir telithromycin … |
| Simvastatin | drug interactions | Concomitant Drug Class or Food: HMG-Co A Reductase Inhibitors: atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin; … |
| Verapamil | drug interactions | Drug class: Moderate CYP3A4 Inhibitors amprenavir aprepitant diltiazem erythromycin fluconazole, fosamprenavir (prodrug of amprenavir) verapamil; … |
| Voriconazole | drug interactions | Four pharmacokinetic studies evaluated the effects of co-administration of voriconazole (200 mg BID), fluconazole (200 mg QD), cimetidine (800 mg BID), and propafenone (225 mg BID) on systemic levels … |
Other labels that name colchicine
Source: FDA drug label (Colchicine), 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 for colchicine?
The FDA Adverse Event Reporting System holds 26,198 reports that list colchicine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as colchicine?
3 other medicines are given the same way (oral) and in the same FDA class as colchicine or labeled mainly for the same use (gout), the same class first. Gout lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Allopurinol | Gout | 42 labelers | $0.0315 per tablet 100 mg tablet | A presentation being discontinued |
| Febuxostat | Gout | 23 labelers | $0.191 per tablet 40 mg tablet | No current entry |
| Probenecid | Gout | 6 labelers | $0.636 per tablet 500 mg tablet | No current entry |
Every medicine labeled for the same conditions as colchicine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does colchicine compare with medicines for the same use?
3 side-by-side pages set colchicine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to colchicine
- 3 medicines for the same use
- Other alkaloids
- the pharmacologic class, with prices and generics
- Colchicine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other