Description
Allopurinol 100 mg Tablets is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.
Drug Label Highlights
These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS.
ALLOPURINOL tablets, for oral use
Initial U.S. Approval:1966
Indications And Usage
Allopurinol Tablets is a xanthine oxidase inhibitor indicated for the management of:
Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) (1)
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 (1)
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 (1)
Limitations of Use
Allopurinol Tablets is not recommended for the treatment of asymptomatic hyperuricemia. (1)
Dosage And Administration
Gout: Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. (2.1, 2.2)
Hyperuricemia Associated with Cancer Therapy: The recommended dosage is:
Recurrent Calcium Oxalate Calculi: The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily. (2.5)
Dosage in Patients with Renal Impairment: See FPI for dosage modifications in patients with renal impairment. (2.6)
Dosage Forms And Strengths
Tablets: 100 mg and 300 mg, scored (3)
Contraindications
Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets. (4)
Warnings And Precautions
- Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue Allopurinol Tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)
- Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)
- Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of Allopurinol Tablets. (5.3)
- Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)
- Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)
- Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)
- Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue Allopurinol Tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)
- Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)
- Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of Allopurinol Tablets. (5.3)
- Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)
- Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)
- Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)
Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue Allopurinol Tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)
Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)
Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of Allopurinol Tablets. (5.3)
Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)
Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)
Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)
Adverse Reactions
Most common adverse reactions (incidence > 1%) are nausea, diarrhea, and increase in liver function tests. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. (7.1)
Capecitabine: Avoid concomitant use. (7.2)
Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. (7.2)
Pegloticase: Discontinue and refrain from initiating treatment with allopurinol tablets. (7.2)
See FPI for complete list of significant drug interactions. (7.2)
Use In Specific Populations
Pregnancy: May cause fetal harm. (8.1)
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2024
DailyMed highlights last updated: 2026-06-24 22:34:08









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