ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE

N/A

Manufactured by Rugby Laboratories

1,232 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE

ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE 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, MAGNESIUM HYDROXIDE, SIMETHICONE include DIARRHOEA, NAUSEA, FATIGUE, HEADACHE, CONSTIPATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE.

Top Adverse Reactions

DIARRHOEA46 reports
NAUSEA45 reports
FATIGUE37 reports
HEADACHE29 reports
CONSTIPATION27 reports
DEATH25 reports
OFF LABEL USE25 reports
DYSPNOEA23 reports
DRUG INEFFECTIVE22 reports
PAIN IN EXTREMITY21 reports
ABDOMINAL PAIN UPPER20 reports
PRURITUS20 reports
ABDOMINAL DISCOMFORT19 reports
ABDOMINAL PAIN19 reports
ARTHRALGIA19 reports
PAIN19 reports
RASH19 reports
SEPSIS18 reports
VOMITING18 reports
DEPRESSION17 reports
DIZZINESS17 reports
URINARY TRACT INFECTION17 reports
WEIGHT DECREASED17 reports
ANXIETY16 reports
MALAISE16 reports
CHRONIC KIDNEY DISEASE15 reports
RENAL FAILURE15 reports
ASTHENIA14 reports
PNEUMONIA14 reports
PYREXIA14 reports
ACUTE KIDNEY INJURY13 reports
FALL13 reports
BACK PAIN12 reports
BLOOD CREATININE INCREASED12 reports
COUGH12 reports
FEELING ABNORMAL12 reports
GASTROOESOPHAGEAL REFLUX DISEASE12 reports
ALOPECIA11 reports
DEHYDRATION11 reports
DRUG DOSE OMISSION11 reports
DYSPEPSIA11 reports
HYDRONEPHROSIS11 reports
HYPERSENSITIVITY11 reports
INSOMNIA11 reports
INTENTIONAL PRODUCT MISUSE11 reports
MUSCLE SPASMS11 reports
OEDEMA PERIPHERAL11 reports
PRODUCT USE IN UNAPPROVED INDICATION11 reports
PRODUCT USE ISSUE11 reports
TREMOR11 reports
ANAEMIA10 reports
CHEST PAIN10 reports
CYTOMEGALOVIRUS INFECTION10 reports
DECREASED APPETITE10 reports
DRY SKIN10 reports
FEBRILE NEUTROPENIA10 reports
HYPOAESTHESIA10 reports
INFLUENZA10 reports
PALPITATIONS10 reports
DYSPHONIA9 reports
PRODUCT DOSE OMISSION ISSUE9 reports
PRODUCT QUALITY ISSUE9 reports
ABDOMINAL DISTENSION8 reports
END STAGE RENAL DISEASE8 reports
ERYTHEMA8 reports
HOT FLUSH8 reports
URTICARIA8 reports
WEIGHT INCREASED8 reports
BRONCHITIS7 reports
COVID 197 reports
DRUG INTERACTION7 reports
DRY MOUTH7 reports
DYSGEUSIA7 reports
HAEMOGLOBIN DECREASED7 reports
MYALGIA7 reports
PERIPHERAL SWELLING7 reports
THERAPEUTIC RESPONSE UNEXPECTED7 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS7 reports
BLOOD PRESSURE INCREASED6 reports
BONE PAIN6 reports
BURNING SENSATION6 reports
CONFUSIONAL STATE6 reports
DYSURIA6 reports
EYE PAIN6 reports
FLUSHING6 reports
GAIT DISTURBANCE6 reports
INJECTION SITE PAIN6 reports
NEPHROGENIC ANAEMIA6 reports
NO ADVERSE EVENT6 reports
SKIN DISCOLOURATION6 reports
SOMNOLENCE6 reports
STOMATITIS6 reports
THROMBOSIS6 reports
ADVERSE DRUG REACTION5 reports
ATRIAL FIBRILLATION5 reports
BLOOD GLUCOSE INCREASED5 reports
CARDIAC DISORDER5 reports
CEREBROVASCULAR ACCIDENT5 reports
DEVICE ISSUE5 reports
ERUCTATION5 reports

Report Outcomes

Out of 554 classified reports for ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE:

Serious 62.5%Non-Serious 37.5%

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

Female334 (63.5%)
Male191 (36.3%)
Unknown1 (0.2%)

Reports by Age

Age 7420 reports
Age 6114 reports
Age 8013 reports
Age 6512 reports
Age 7312 reports
Age 5911 reports
Age 6211 reports
Age 5610 reports
Age 6910 reports
Age 7610 reports
Age 7910 reports
Age 649 reports
Age 669 reports
Age 779 reports
Age 678 reports
Age 607 reports
Age 687 reports
Age 717 reports
Age 787 reports
Age 536 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, MAGNESIUM HYDROXIDE, SIMETHICONE?

This profile reflects 1,232 FDA FAERS reports that mention ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, FATIGUE, HEADACHE, CONSTIPATION, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE?

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