MAGNESIUM HYDROXIDE: 1,970 Adverse Event Reports & Safety Profile
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Drug Class: Calculi Dissolution Agent [EPC] · Route: ORAL · Manufacturer: STRATEGIC SOURCING SERVICES LLC · HUMAN OTC DRUG · FDA Label: Available
First Report: 1950 · Latest Report: 20250924
What Are the Most Common MAGNESIUM HYDROXIDE Side Effects?
All MAGNESIUM HYDROXIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Constipation | 754 | 38.3% | 33 | 674 |
| Pain | 640 | 32.5% | 37 | 604 |
| Fall | 616 | 31.3% | 1 | 593 |
| Cognitive disorder | 600 | 30.5% | 0 | 586 |
| Orthostatic hypotension | 572 | 29.0% | 1 | 564 |
| Balance disorder | 570 | 28.9% | 0 | 557 |
| Hypotension | 559 | 28.4% | 4 | 547 |
| Sedation | 548 | 27.8% | 0 | 539 |
| Depressed level of consciousness | 515 | 26.1% | 1 | 506 |
| Drug ineffective | 514 | 26.1% | 53 | 145 |
| Mobility decreased | 509 | 25.8% | 19 | 493 |
| Sedation complication | 494 | 25.1% | 0 | 490 |
| Blood calcium decreased | 479 | 24.3% | 0 | 472 |
| Creatinine renal clearance decreased | 478 | 24.3% | 0 | 471 |
| Toxicity to various agents | 476 | 24.2% | 3 | 463 |
| Off label use | 281 | 14.3% | 55 | 197 |
| Product use issue | 213 | 10.8% | 26 | 20 |
| Diarrhoea | 211 | 10.7% | 32 | 49 |
| No adverse event | 199 | 10.1% | 18 | 18 |
| Nausea | 196 | 10.0% | 51 | 138 |
Who Reports MAGNESIUM HYDROXIDE Side Effects? Age & Gender Data
Gender: 80.4% female, 19.6% male. Average age: 71.9 years. Most reports from: CA. View detailed demographics →
Is MAGNESIUM HYDROXIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 0 |
| 2002 | 1 | 1 | 0 |
| 2003 | 1 | 0 | 0 |
| 2005 | 1 | 0 | 0 |
| 2006 | 20 | 0 | 0 |
| 2007 | 3 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 2 | 1 | 0 |
| 2010 | 2 | 0 | 0 |
| 2011 | 9 | 1 | 1 |
| 2012 | 7 | 2 | 0 |
| 2013 | 9 | 2 | 1 |
| 2014 | 43 | 0 | 5 |
| 2015 | 48 | 0 | 8 |
| 2016 | 47 | 1 | 3 |
| 2017 | 40 | 1 | 0 |
| 2018 | 44 | 0 | 3 |
| 2019 | 47 | 0 | 19 |
| 2020 | 37 | 11 | 10 |
| 2021 | 11 | 2 | 2 |
| 2022 | 18 | 1 | 2 |
| 2023 | 46 | 2 | 5 |
| 2024 | 18 | 0 | 5 |
| 2025 | 12 | 0 | 5 |
What Is MAGNESIUM HYDROXIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 683 |
| Constipation | 635 |
| Gastrointestinal disorder | 149 |
| Ill-defined disorder | 17 |
| Bowel movement irregularity | 15 |
| Laxative supportive care | 11 |
| Pericoronitis | 11 |
| Pneumonia | 10 |
| Muscle spasms | 9 |
| Nervous system disorder prophylaxis | 9 |
MAGNESIUM HYDROXIDE vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Calculi Dissolution Agent [EPC]
Official FDA Label for MAGNESIUM HYDROXIDE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses as Antacid
- relieves
- heartburn
- sour stomach
- acid indigestion
- and upset stomach associated with these symptoms
Uses as Saline Laxative
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 1/2 to 6 hours
Dosage & Administration
Directions shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older 2 to 4 tablespoonfuls children 6 to 11 years 1 to 2 tablespoonfuls children under 6 years ask a doctor Directions for 12 oz shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose for accurate dosing, only use the dosing cup provided mL = milliliter age dose adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor
Directions for 12 oz shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor drink a full glass (8 oz) of liquid with each dose for accurate dosing, only use the dosing cup provided mL = milliliter age dose adults and children 12 years and over 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor
Warnings
Warnings for Antacid Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet Ask a doctor or pharmacist before use If you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product
- do not take more than 60 mL (2 doses) in a 24-hour period
- do not use the maximum dosage for more than 2 weeks except under the advice and superision of a doctor
- may cause a laxative effect If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Warnings for Saline Laxative Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
- abdominal pain, nausea, or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use If you are
- presently taking a prescription drug. This product may interact with certain prescription drugs. Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a seriouscondition.
- you need to use a laxative for more that 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active Ingredients: Hepar oryctolagus (Lliver) 4X, Magnesium hydroxydatum (Magnesium hydroxide) 4X
Inactive Ingredients
Inactive ingredients ammonium hydroxide, carmine, carnauba wax, corn syrup, ethanol, ethyl acetate, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6, gum arabic, hydrogenated coconut oil, isopropanol, lecithin (soy), maltodextrin, methylparaben, natural and artificial flavors, n-butanol, phosphoric acid, propylene glycol, propylparaben, shellac, sodium benzoate, sorbitol, sucrose, titanium dioxide, water, white beeswax