Prescription medicine
Allopurinol Brand names: Aloprim; first approved as Zyloprim
Allopurinol (Zyloprim) is a prescription medicine with an FDA approval on record since 1966. FDA's NDC Directory lists it from 44 generic labelers, and pharmacies paid $0.0315 per allopurinol 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the allopurinol FDA label on DailyMed (effective May 21, 2026, Rising Pharma Holdings, Inc.); the NDA 16084 record on Drugs@FDA; every allopurinol label on DailyMed.
Highlights of the record
FDA label of May 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAllopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult pat
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 500 mg/25ml
Tablet; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 19, 1966 Zyloprim, Casper Pharma Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first December 10, 1985; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 47 of which 44 under generic applications, 5 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0315 per tablet Allopurinol 100 mg tablet
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest June 7, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 155,998 through July 30, 2026
What is allopurinol used for?
From the label: indications and usageAllopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. […]
Conditions named in the indications of allopurinol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Xanthine Oxidase Inhibitor.
Source: FDA drug label (Allopurinol), Rising Pharma Holdings, Inc., effective May 21, 2026 (SPL set 30ad5ba2-1cef-4933-b104-0597f6a2aaa2), via openFDA; the full label on DailyMed
Is there a generic for allopurinol (Zyloprim)?
The FDA approved the first generic allopurinol on December 10, 1985. 24 generic applications are approved; 14 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 allopurinol from 44 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1966 earliest approval on file
- 1985 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for allopurinol (Zyloprim)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0315 per Allopurinol 100 mg tablet, down 20% from $0.0396 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.
- Allopurinol 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Allopurinol 100 mg tablet | Generic | $0.0315 per tablet | $0.946 | -20% |
| Allopurinol 200 mg tablet | Generic | $1.84 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $55.21 | -70% |
| Allopurinol 300 mg tablet | Generic | $0.0522 per tablet | $1.57 | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is allopurinol in shortage?
No allopurinol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated February 19, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Allopurinol, Tablet, 100 mg (NDC 0591-5543-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | February 19, 2026 |
| Allopurinol, Tablet, 100 mg (NDC 0591-5543-10) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | February 19, 2026 |
| Allopurinol, Tablet, 300 mg (NDC 0591-5544-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | February 19, 2026 |
| Allopurinol, Tablet, 300 mg (NDC 0591-5544-05) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | February 19, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has allopurinol been recalled?
The FDA's Enforcement Report lists 7 recalls naming allopurinol since 2013: 0 Class I (the most serious), 6 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of allopurinol and that holds 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 |
|---|---|---|---|
| June 7, 2024 | Class II | Dr. Reddy's Laboratories, Inc. | Presence of foreign substance. |
| January 16, 2023 | Class II | Preferred Pharmaceuticals, Inc. | Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards … |
| January 12, 2023 | Class II | Accord Healthcare, Inc. | Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| May 5, 2020 | Class II | Mylan Institutional LLC | Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and … |
| July 20, 2015 | Class III | Qualitest Pharmaceuticals | Failed Tablet/Capsule Specifications; report of oversized and discolored tablets |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the allopurinol label say about other medicines?
The allopurinol label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name allopurinol. 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 |
|---|---|---|
| Amoxicillin | drug interactions | DRUG INTERACTIONS The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. |
| Ampicillin | drug interactions | DRUG INTERACTIONS The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. |
| Azathioprine | drug interactions | Avoid concomitant use. ( 7.2 ) Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. |
| Bendamustine | drug interactions | DRUG INTERACTIONS The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. |
| Bleomycin | drug interactions | Clinical Impact; Concomitant use of allopurinol with cyclophosphamide and other cytotoxic agents (doxorubicin, bleomycin, procarbazine, mechloroethamine) increases bone marrow suppression among patients with neoplastic disease, except leukemia. |
| Capecitabine | drug interactions | Clinical Impact; Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites, which may decrease capecitabine efficacy. |
| Colchicine | warnings and precautions | Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. |
| Cyclophosphamide | drug interactions | Clinical Impact; Concomitant use of allopurinol with cyclophosphamide and other cytotoxic agents (doxorubicin, bleomycin, procarbazine, mechloroethamine) increases bone marrow suppression among patients with neoplastic disease, except leukemia. |
| Cyclosporine | drug interactions | Cyclosporine Clinical Impact Concomitant use of allopurinol increases cyclosporine concentrations, which may increase the risk of adverse reactions. Intervention Increase frequency of monitoring cyclosporine concentrations as reflected in its prescribing information and modify the dosage of cyclosporine as appropriate … |
| Doxorubicin | drug interactions | Clinical Impact; Concomitant use of allopurinol with cyclophosphamide and other cytotoxic agents (doxorubicin, bleomycin, procarbazine, mechloroethamine) increases bone marrow suppression among patients with neoplastic disease, except leukemia. |
| Fluorouracil | drug interactions | Fluorouracil Clinical Impact Based on non-clinical data, allopurinol may decrease anti-tumor activity due to suppression of phosphorylation of 5-fluorouracil. Intervention Concomitant administration with fluorouracil should be avoided. |
| Mechlorethamine | drug interactions | However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine. |
| Mercaptopurine | drug interactions | Avoid concomitant use. ( 7.2 ) Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. |
| Pegloticase | drug interactions | Clinical Impact; Concomitant use of allopurinol tablets and pegloticase may potentially blunt the rise of serum uric acid levels and increase the risk of pegloticase related anaphylaxis in patients whose uric acid level increase to above 6 mg/dL. |
Every other medicine the allopurinol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Procarbazine | drug interactions | Clinical Impact; Concomitant use of allopurinol with cyclophosphamide and other cytotoxic agents (doxorubicin, bleomycin, procarbazine, mechloroethamine) increases bone marrow suppression among … |
| Theophylline | drug interactions | Clinical Impact; Concomitant use of allopurinol doses greater than or equal to 600 mg/day may decrease the clearance of theophylline |
| Warfarin | drug interactions | Warfarin Clinical Impact Allopurinol may inhibit the metabolism of warfarin, possibly enhancing its anticoagulant effect. Intervention Monitor patients on concomitant therapy for excessive … |
Other labels that name allopurinol
Source: FDA drug label (Allopurinol), Rising Pharma Holdings, Inc., effective May 21, 2026 (SPL set 30ad5ba2-1cef-4933-b104-0597f6a2aaa2), via openFDA; the full label on DailyMed
What do FAERS reports show for allopurinol?
The FDA Adverse Event Reporting System holds 155,998 reports that list allopurinol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21,961 are coded as a death and 76,437 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 allopurinol?
4 other medicines are given the same way (oral) and in the same FDA class as allopurinol 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 |
|---|---|---|---|---|
| Febuxostat | Gout | 23 labelers | $0.191 per tablet 40 mg tablet | No current entry |
| Colchicine | Gout | 30 labelers | $0.122 per tablet 0.6 mg tablet | No current entry |
| Probenecid | Gout | 6 labelers | $0.636 per tablet 500 mg tablet | No current entry |
| Colchicine and probenecid | Gout | 4 labelers | $0.830 per tablet Probenecid-colchicine tablet | No current entry |
Every medicine labeled for the same conditions as allopurinol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does allopurinol compare with medicines for the same use?
2 side-by-side pages set allopurinol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to allopurinol
- 4 medicines for the same use
- Other xanthine oxidase inhibitors
- the pharmacologic class, with prices and generics
- Allopurinol side effects
- the label's list beside FAERS reports
- Allopurinol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other