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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ALUMINUM HYDROXIDE: 199 Adverse Event Reports & Safety Profile

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199
Total FAERS Reports
65 (32.7%)
Deaths Reported
83
Hospitalizations
199
As Primary/Secondary Suspect
60
Life-Threatening
68
Disabilities
Belmora LLC
Manufacturer

Route: ORAL · Manufacturer: Belmora LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 19881201 · Latest Report: 20250708

What Are the Most Common ALUMINUM HYDROXIDE Side Effects?

#1 Most Reported
Drug interaction
90 reports (45.2%)
#2 Most Reported
Schizoaffective disorder
89 reports (44.7%)
#3 Most Reported
Electrocardiogram qt prolonged
89 reports (44.7%)

All ALUMINUM HYDROXIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug interaction 90 45.2% 0 1
Drug level increased 89 44.7% 0 0
Electrocardiogram qt prolonged 89 44.7% 0 0
Schizoaffective disorder 89 44.7% 0 0
Nausea 51 25.6% 39 47
Somnolence 50 25.1% 40 47
Abdominal distension 45 22.6% 45 41
Vomiting 45 22.6% 42 41
Off label use 44 22.1% 42 40
Condition aggravated 43 21.6% 40 38
Constipation 43 21.6% 40 38
Abdominal pain 42 21.1% 41 38
Anaemia 41 20.6% 40 37
Appendicitis 41 20.6% 41 37
Ascites 41 20.6% 41 37
Diabetes mellitus 41 20.6% 41 38
General physical health deterioration 41 20.6% 40 37
Stress 41 20.6% 41 37
Swelling 41 20.6% 41 38
Thrombosis 41 20.6% 41 38

Who Reports ALUMINUM HYDROXIDE Side Effects? Age & Gender Data

Gender: 66.8% female, 33.2% male. Average age: 71.1 years. Most reports from: CA. View detailed demographics →

Is ALUMINUM HYDROXIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2002 1 1 0
2011 1 0 1
2012 1 0 0
2013 4 0 1
2015 3 0 2
2017 1 0 0
2018 1 0 0
2019 1 0 1
2020 18 16 16
2021 1 1 1
2023 1 0 0
2025 1 0 1

View full timeline →

What Is ALUMINUM HYDROXIDE Used For?

IndicationReports
Abdominal discomfort 78
Product used for unknown indication 56
Constipation 35

ALUMINUM HYDROXIDE vs Alternatives: Which Is Safer?

ALUMINUM HYDROXIDE vs ALUMINUM HYDROXIDE\DIMETHICONE\MAGNESIUM HYDROXIDE ALUMINUM HYDROXIDE vs ALUMINUM HYDROXIDE\MAGNESIUM ALUMINUM HYDROXIDE vs ALUMINUM HYDROXIDE\MAGNESIUM HYDROXIDE ALUMINUM HYDROXIDE vs ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY ALUMINUM HYDROXIDE vs ALVERINE\DIMETHICONE ALUMINUM HYDROXIDE vs AMANTADINE ALUMINUM HYDROXIDE vs AMBIEN ALUMINUM HYDROXIDE vs AMBISOME ALUMINUM HYDROXIDE vs AMBRISENTAN ALUMINUM HYDROXIDE vs AMBROSIA ARTEMISIIFOLIA POLLEN

Official FDA Label for ALUMINUM HYDROXIDE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use helps prevent sunburn. if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage & Administration

Directions

  • shake well before use 1,200-1,200-120 mg/30 mL
  • Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor 2,400-2,400-240 mg/30 mL
  • Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period Children under 12 years of age Ask a doctor

Warnings

Warnings Ask a doctor or pharmacist before use if you have kidney disease are on a sodium-restricted diet or a magnesium-restricted diet are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product (Regular Strength) do not take more than 8 tablespoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor laxative effect may occur When using this product (Extra Strength) do not take more than 16 teaspoonfuls in 24 hours do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor laxative effect may occur Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

1,200-1,200-120 mg/30 mL Active ingredients (in each 30 mL)

Purpose

Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid Magnesium hydroxide 1,200 mg......................................................Antacid Simethicone 120 mg......................................................................Antigas 2,400-2,400-240 mg/30 mL Active ingredient (in each 30 mL)

Purpose

Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid Magnesium hydroxide 2,400 mg......................................................Antacid Simethicone 240 mg......................................................................Antigas

Inactive Ingredients

Inactive ingredients (Regular Strength) benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, saccharin sodium, sodium alginate, sorbitol solution, water, xanthan gum

Inactive ingredients (Extra Strength Cool Mint) benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum

Inactive ingredients (Extra Strength Cherry) benzyl alcohol, edetate disodium, glycerin, natural and artificial flavors, purified water, simethicone emulsion, sodium alginate, sodium saccharin, sorbitol solution, xanthan gum