ALUMINUM HYDROXIDE

N/A

Manufactured by Rugby Laboratories

4,296 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALUMINUM HYDROXIDE

ALUMINUM HYDROXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rugby Laboratories. The most commonly reported adverse reactions for ALUMINUM HYDROXIDE include DRUG INTERACTION, ELECTROCARDIOGRAM QT PROLONGED, DRUG LEVEL INCREASED, SCHIZOAFFECTIVE DISORDER, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALUMINUM HYDROXIDE.

Top Adverse Reactions

DRUG INTERACTION161 reports
ELECTROCARDIOGRAM QT PROLONGED161 reports
DRUG LEVEL INCREASED153 reports
SCHIZOAFFECTIVE DISORDER153 reports
OFF LABEL USE93 reports
PRODUCT USE ISSUE82 reports
NAUSEA75 reports
VOMITING71 reports
SOMNOLENCE69 reports
PAIN63 reports
DIABETES MELLITUS62 reports
DYSPNOEA62 reports
CONDITION AGGRAVATED59 reports
GENERAL PHYSICAL HEALTH DETERIORATION58 reports
SEPSIS58 reports
ABDOMINAL PAIN57 reports
ANAEMIA56 reports
PULMONARY EMBOLISM56 reports
PYREXIA56 reports
DRUG INEFFECTIVE55 reports
DEATH53 reports
STRESS53 reports
ABDOMINAL DISTENSION52 reports
CONSTIPATION50 reports
HYPERTENSION50 reports
ASCITES49 reports
THROMBOSIS49 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME48 reports
HEADACHE46 reports
PNEUMONIA46 reports
SWELLING46 reports
VENTRICULAR FIBRILLATION46 reports
APPENDICITIS45 reports
DRY MOUTH45 reports
INTENTIONAL PRODUCT MISUSE45 reports
APPENDICOLITH44 reports
BACTERIAL INFECTION44 reports
CARDIOGENIC SHOCK44 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION44 reports
MYASTHENIA GRAVIS44 reports
BLOOD CHOLESTEROL INCREASED43 reports
DRUG HYPERSENSITIVITY43 reports
HYPONATRAEMIA43 reports
NEURALGIA43 reports
DRUG INTOLERANCE42 reports
FATIGUE42 reports
ASTHENIA40 reports
BLOOD PHOSPHORUS INCREASED40 reports
BLOOD URIC ACID INCREASED40 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE40 reports
HYPERPHOSPHATAEMIA40 reports
PRODUCT USE IN UNAPPROVED INDICATION40 reports
HYPOPHOSPHATAEMIA39 reports
SLEEP DISORDER38 reports
DIARRHOEA37 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION36 reports
IRON DEFICIENCY36 reports
ARTHRALGIA34 reports
MUSCULOSKELETAL STIFFNESS33 reports
PAIN IN EXTREMITY33 reports
CHEST PAIN31 reports
ARTHRITIS30 reports
RASH30 reports
WEIGHT DECREASED30 reports
FALL29 reports
GAIT DISTURBANCE29 reports
BACK PAIN28 reports
ANALGESIC THERAPY26 reports
DRUG THERAPY26 reports
MUSCULOSKELETAL PAIN26 reports
ACUTE KIDNEY INJURY25 reports
BLOOD CREATININE INCREASED25 reports
INSOMNIA25 reports
RENAL FAILURE25 reports
COUGH24 reports
DIZZINESS24 reports
SLEEP DISORDER THERAPY24 reports
ABDOMINAL PAIN UPPER23 reports
SINUS RHYTHM23 reports
ABDOMINAL DISCOMFORT22 reports
COVID 1922 reports
FEBRILE NEUTROPENIA22 reports
JOINT SWELLING22 reports
LIVER DISORDER22 reports
CHOLELITHIASIS21 reports
PRURITUS20 reports
SEPTIC SHOCK20 reports
LIMB INJURY19 reports
MALAISE19 reports
ULCER19 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED18 reports
ACUTE MYOCARDIAL INFARCTION18 reports
DEEP VEIN THROMBOSIS18 reports
HEPATIC STEATOSIS18 reports
JOINT RANGE OF MOTION DECREASED18 reports
MOVEMENT DISORDER18 reports
NEPHROPATHY18 reports
OEDEMA PERIPHERAL18 reports
OSTEOARTHRITIS18 reports
PSORIASIS18 reports

Report Outcomes

Out of 704 classified reports for ALUMINUM HYDROXIDE:

Serious 96.4%Non-Serious 3.6%

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

Female404 (60.0%)
Male268 (39.8%)
Unknown1 (0.1%)

Reports by Age

Age 8062 reports
Age 6825 reports
Age 8222 reports
Age 6418 reports
Age 7716 reports
Age 6515 reports
Age 5313 reports
Age 6013 reports
Age 7013 reports
Age 3312 reports
Age 6912 reports
Age 7110 reports
Age 669 reports
Age 769 reports
Age 458 reports
Age 488 reports
Age 728 reports
Age 738 reports
Age 748 reports
Age 557 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 ALUMINUM HYDROXIDE?

This profile reflects 4,296 FDA FAERS reports that mention ALUMINUM HYDROXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALUMINUM HYDROXIDE?

Frequently reported terms in FAERS include DRUG INTERACTION, ELECTROCARDIOGRAM QT PROLONGED, DRUG LEVEL INCREASED, SCHIZOAFFECTIVE DISORDER, OFF LABEL USE, PRODUCT USE ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALUMINUM HYDROXIDE?

Labeling and FAERS entries often list Rugby Laboratories in connection with ALUMINUM HYDROXIDE. 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.