ALLOPURINOL SODIUM

N/A

Manufactured by Hikma Pharmaceuticals USA Inc.

1,553 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALLOPURINOL SODIUM

ALLOPURINOL SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. The most commonly reported adverse reactions for ALLOPURINOL SODIUM include DRUG INEFFECTIVE, DYSPNOEA, PYREXIA, OFF LABEL USE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALLOPURINOL SODIUM.

Top Adverse Reactions

DRUG INEFFECTIVE45 reports
DYSPNOEA45 reports
PYREXIA42 reports
OFF LABEL USE40 reports
DIARRHOEA35 reports
FATIGUE30 reports
CONDITION AGGRAVATED28 reports
DIZZINESS26 reports
PNEUMONIA26 reports
HEADACHE25 reports
ASTHENIA24 reports
ARTHRALGIA23 reports
SEPSIS23 reports
WEIGHT DECREASED22 reports
CARDIAC FAILURE CONGESTIVE21 reports
GENERAL PHYSICAL HEALTH DETERIORATION21 reports
MALAISE21 reports
NAUSEA21 reports
PRODUCT USE IN UNAPPROVED INDICATION21 reports
WEIGHT INCREASED21 reports
SOMNOLENCE20 reports
TREMOR20 reports
COUGH19 reports
HYPERTENSION19 reports
RENAL FAILURE ACUTE19 reports
ACUTE KIDNEY INJURY18 reports
DEATH18 reports
DIABETES MELLITUS18 reports
RASH18 reports
FEELING HOT17 reports
HYPOTENSION17 reports
PAIN17 reports
SWELLING17 reports
ANAEMIA16 reports
LOWER RESPIRATORY TRACT INFECTION16 reports
PLEURAL EFFUSION16 reports
DEHYDRATION15 reports
DRUG HYPERSENSITIVITY15 reports
HAEMOGLOBIN DECREASED15 reports
HYPERHIDROSIS15 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION15 reports
OEDEMA PERIPHERAL15 reports
PULMONARY EMBOLISM15 reports
DYSPHAGIA14 reports
ANXIETY13 reports
ATRIAL FIBRILLATION13 reports
BLOOD CREATININE INCREASED13 reports
CONFUSIONAL STATE13 reports
FLUSHING13 reports
MEMORY IMPAIRMENT13 reports
PRODUCTIVE COUGH13 reports
RALES13 reports
RENAL FAILURE13 reports
RENAL IMPAIRMENT13 reports
DRUG INTERACTION12 reports
EPISTAXIS12 reports
CARDIOMEGALY11 reports
COVID 1911 reports
DYSGEUSIA11 reports
DYSPEPSIA11 reports
GASTROOESOPHAGEAL REFLUX DISEASE11 reports
GOUT11 reports
HAEMOPTYSIS11 reports
HYPOGLYCAEMIA11 reports
VERTIGO11 reports
ASCITES10 reports
BODY TEMPERATURE INCREASED10 reports
CONSTIPATION10 reports
CONTUSION10 reports
DECREASED APPETITE10 reports
DRUG INTOLERANCE10 reports
ERYTHEMA10 reports
FEBRILE NEUTROPENIA10 reports
GAIT DISTURBANCE10 reports
HYPOAESTHESIA10 reports
MUSCLE TWITCHING10 reports
MYOCARDIAL INFARCTION10 reports
NIGHTMARE10 reports
PERIPHERAL SWELLING10 reports
PLATELET COUNT DECREASED10 reports
PRURITUS10 reports
RIB FRACTURE10 reports
SEDATION10 reports
THROMBOCYTOPENIA10 reports
TOXICITY TO VARIOUS AGENTS10 reports
VOMITING10 reports
ASTHMA9 reports
BLOOD GLUCOSE INCREASED9 reports
CHILLS9 reports
CONCUSSION9 reports
FEELING ABNORMAL9 reports
FLUID RETENTION9 reports
HOSTILITY9 reports
HYPERKALAEMIA9 reports
INFECTION9 reports
INFLAMMATORY MARKER INCREASED9 reports
INSOMNIA9 reports
IRRITABILITY9 reports
JOINT SWELLING9 reports
LIBIDO INCREASED9 reports

Report Outcomes

Out of 516 classified reports for ALLOPURINOL SODIUM:

Serious 86.2%Non-Serious 13.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male308 (65.1%)
Female165 (34.9%)

Reports by Age

Age 7523 reports
Age 7623 reports
Age 8018 reports
Age 6415 reports
Age 6714 reports
Age 7114 reports
Age 7214 reports
Age 7414 reports
Age 6313 reports
Age 5912 reports
Age 6612 reports
Age 7312 reports
Age 6810 reports
Age 7810 reports
Age 8110 reports
Age 699 reports
Age 108 reports
Age 608 reports
Age 798 reports
Age 828 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALLOPURINOL SODIUM?

This profile reflects 1,553 FDA FAERS reports that mention ALLOPURINOL SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALLOPURINOL SODIUM?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DYSPNOEA, PYREXIA, OFF LABEL USE, DIARRHOEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALLOPURINOL SODIUM?

Labeling and FAERS entries often list Hikma Pharmaceuticals USA Inc. in connection with ALLOPURINOL SODIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.