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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.

MAGNESIUM HYDROXIDE: 1,970 Adverse Event Reports & Safety Profile

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1,970
Total FAERS Reports
152 (7.7%)
Deaths Reported
899
Hospitalizations
1,970
As Primary/Secondary Suspect
173
Life-Threatening
97
Disabilities
STRATEGIC SOURCING SERVICES...
Manufacturer

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?

#1 Most Reported
Constipation
754 reports (38.3%)
#2 Most Reported
Pain
640 reports (32.5%)
#3 Most Reported
Fall
616 reports (31.3%)

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

YearReportsDeathsHosp.
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

View full timeline →

What Is MAGNESIUM HYDROXIDE Used For?

IndicationReports
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?

MAGNESIUM HYDROXIDE vs MAGNESIUM OROTATE MAGNESIUM HYDROXIDE vs MAGNESIUM SALICYLATE MAGNESIUM HYDROXIDE vs MAGNESIUM\MAGNESIUM HEPTAHYDRATE MAGNESIUM HYDROXIDE vs MAGNESIUM\POTASSIUM\SODIUM MAGNESIUM HYDROXIDE vs MAGNESIUM\PYRIDOXINE MAGNESIUM HYDROXIDE vs MAGNEVIST MAGNESIUM HYDROXIDE vs MALTOSE MAGNESIUM HYDROXIDE vs MANIDIPINE MAGNESIUM HYDROXIDE vs MANNITOL MAGNESIUM HYDROXIDE vs MAPROTILINE

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