ALUMINUM HYDROXIDE: 199 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is ALUMINUM HYDROXIDE Used For?
| Indication | Reports |
|---|---|
| Abdominal discomfort | 78 |
| Product used for unknown indication | 56 |
| Constipation | 35 |
ALUMINUM HYDROXIDE vs Alternatives: Which Is Safer?
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