FDA label
What is allopurinol used for?
The FDA-approved uses of allopurinol, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Allopurinol Tablets are 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; ...”
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Allopurinol, tablet
Indications and Usage, quoted from the label by Indoco Remedies Limited (ANDA204467). Cross-references to other label sections are left out.
Allopurinol Tablets are 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 Tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Source: DailyMed label, set id 48a9a6c3-4604-421e-a323-1133888aaf76, version 2, effective August 21, 2025. NDC 14445-170, one of 161 listings for this product.
Allopurinol, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by Fresenius Kabi USA, LLC (ANDA212363). Cross-references to other label sections are left out.
Allopurinol for injection is indicated for 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 and who cannot tolerate oral therapy.
Source: DailyMed label, set id 2caf5eed-2408-4ce0-bd0d-04f4c90e434d, version 3, effective January 24, 2023. NDC 65219-380, one of 3 listings for this product.
Questions
What is allopurinol used for?
The FDA label says: “Allopurinol Tablets are 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; ...”
What drug class is allopurinol?
FDA lists allopurinol in the Xanthine Oxidase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Allopurinol
- Is Allopurinol a controlled substance?Federal schedule
- Generic for AloprimFDA Orange Book
- Generic for LopurinFDA Orange Book
- Generic for ZyloprimFDA Orange Book
- Xanthine Oxidase Inhibitors listFDA drug class
- NDC 0591-5543Allopurinol NDC record
- NDC 0591-5544Allopurinol NDC record
- NDC 63187-240Allopurinol NDC record