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Allopurinol

Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint dest.

Prescription medicine Oral Safety alerts on record

How to use Allopurinol

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

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 i …

How to take it and how often
  • 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
  • Patients with normal kidney function: Initial dosage is 100 mg orally daily
  • Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maximum 800 mg daily)
  • Patients with impaired kidney function: The initial dosage is 50 mg orally daily
  • Follow recommendations for titration in patients with renal impairment until target serum uric acid level is reached
  • See complete information in the Full Prescribing Information (FPI)
  • Hyperuricemia Associated with Cancer Therapy : The recommended dosage is: Adults: 300 mg to 800 mg orally daily
  • Pediatric patients: 100 mg/m 2 orally every 8 hours to 12 hours (10 mg/kg/day, maximum 800 mg/day) See complete information in the FPI
  • Recurrent Calcium Oxalate Calculi : The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily
  • Dosage in Patients with Renal Impairment: See FPI for dosage modifications in patients with renal impairment. …
Strengths it comes in

Allopurinol tablets, USP have functional scoring and are available in the following strengths: 100 mg: White, round, flat face, beveled edge tablets. The upper layer is bisected and debossed with “2083/V”. The lower layer is plain. 300 mg: Orange, round and biconvex tablets. The upper layer is bisected and debossed with “2084/V”. The lower layer is plain. …

Children
  • Hyperuricemia Associated with Cancer Therapy The safety and effectiveness of allopurinol for the management of pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels have been established in approximately 200
  • Pediatric patients
  • The efficacy and safety profile observed in this patient population were similar to that observed
  • In adults. …
While you are taking it
  • Administration Advise patients to take allopurinol tablets after meals to minimize gastric irritation
  • If a single dose of allopurinol tablets is occasionally forgotten, there is no need to double the dose at the next scheduled time
  • Skin Rash and Hypersensitivity Inform patients that allopurinol tablets may increase the risk of serious and sometimes fatal dermatologic reactions. …
Talk to a doctor first if
  • Allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets
  • Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets
Medicines it may not mix with

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. …

Warnings

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. …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions ( 5.1 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Hepatoxicity [see Warnings and Precautions ( 5.4 )] Myelosuppression [see Warnings and Precautions ( 5.5 )] Potential Effect on Driving and Use of Machinery [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of allopurinol tablets were identified in literature, unpublished clinical trials or postmarketing reports. …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Based on findings in animals, allopurinol tablets may cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been described in exposed animals (see Data). Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. …

If you take too much

In the management of overdosage there is no specific antidote for allopurinol tablets. Both allopurinol tablets and oxipurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of allopurinol tablets is unknown.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-07-08.

Brands around the world

Products with Allopurinol as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

AllopurinolALLOPURINOL 100 mg/1 · Tablet · A-S Medication Solutions
NDC 50090-7696Label
AllopurinolALLOPURINOL 100 mg/1 · Tablet · A-S Medication Solutions
NDC 50090-7697Label
AllopurinolALLOPURINOL 100 mg/1 · Tablet · Actavis Pharma, Inc.
NDC 0591-5543Label
AllopurinolALLOPURINOL 300 mg/1 · Tablet · Cardinal Health 107, LLC
NDC 55154-7981Label
AllopurinolALLOPURINOL 100 mg/1 · Tablet · Indoco Remedies Limited
NDC 14445-170Label

Nigeria (NAFDAC)

NAFDACAllopurinol Tablets A4-5688NAFDACMultichris Allopurinol 300 mg Tablets B4-8171

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.U.S. FDA Class II
7 Jun 2024 · Dr. Reddy's Laboratories, Inc. · TerminatedPresence of foreign substance.
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05U.S. FDA Class II
26 Jan 2022 · CARDINAL HEALTHCARE · TerminatedCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, AhU.S. FDA Class II
12 Jan 2023 · Accord Healthcare, Inc. · TerminatedPresence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383U.S. FDA Class II
16 Jan 2023 · Preferred Pharmaceuticals, Inc. · TerminatedPresence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Allopurinol

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Allopurinol

What is Allopurinol used for?

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 p (From the official U.S. FDA label.)

How do I take Allopurinol?

Follow your prescription or the leaflet in your pack. The official label says: 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 ) Patients with normal kidney function: Initial dosage is 100 mg orally daily. Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maxim…

Do I need a prescription for Allopurinol?

Usually yes. Allopurinol is a prescription medicine in most countries. Rules differ by country.

What brands contain Allopurinol?

Allopurinol is sold under names such as Zyloprim, Aloprim, Allopurinol. Brand names differ between countries.

How can I check that my Allopurinol is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.