Drug profile
Allopurinol
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- ( 2.1 , 2.2 ) Patients with normal kidney function: Initial dosage is 100 mg
orally daily.
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
- Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is
reached (maximum 800 mg daily).
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.3 ) Patients with impaired kidney function: The initial dosage is 50 mg orally
daily.
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- 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.
Source: US FDA label for allopurinol (Allopurinol), section 'pediatric use',
retrieved 2026-08-29
- 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 (maximum 800 mg
daily).
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
- 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.
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- Follow recommendations for titration in patients with renal impairment until
target serum uric acid level is reached.
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.5 ) Dosage in Patients with Renal Impairment: See FPI for dosage modifications
in patients with renal impairment.
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.6 ) 2.1 Recommended Testing Prior to Treatment Initiation Prior to initiating
treatment with allopurinol tablets in patients with gout, assess the following
baseline tests: serum uric acid level, complete blood count, chemistry panel,
liver function tests (serum alanine aminotransferase [ALT], aspartate
aminotransferase [AST], alkaline phosphatase, and total bilirubin), kidney
function tests (serum creatinine and eGFR).
Source: US FDA label for allopurinol (Allopurinol), section 'dosage and
administration', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- In patients with pre-existing liver disease, monitor liver enzymes periodically.
Source: US FDA label for allopurinol (Allopurinol), section 'warnings and
cautions', retrieved 2026-08-29
PREGNANCY
- Risk Summary Based on findings in animals, allopurinol tablets may cause fetal
harm when administered to a pregnant woman.
Source: US FDA label for allopurinol (Allopurinol), section 'pregnancy', retrieved
2026-08-29
- Adverse developmental outcomes have been described in exposed animals (see Data).
Source: US FDA label for allopurinol (Allopurinol), section 'pregnancy', retrieved
2026-08-29
- Allopurinol and its metabolite oxypurinol have been shown to cross the placenta
following administration of maternal allopurinol.
Source: US FDA label for allopurinol (Allopurinol), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- ( 8.1 ) Lactation: Advise not to breastfeed.
Source: US FDA label for allopurinol (Allopurinol), section 'use in specific
populations', retrieved 2026-08-29
- It is uncertain whether these findings represented a fetal effect or an effect
secondary to maternal toxicity. 8.2 Lactation Risk Summary Allopurinol and
oxypurinol are present in human milk.
Source: US FDA label for allopurinol (Allopurinol), section 'use in specific
populations', retrieved 2026-08-29
- There was no report of effects of allopurinol on the breastfed infant or on milk
production.
Source: US FDA label for allopurinol (Allopurinol), section 'use in specific
populations', retrieved 2026-08-29