Magnesium hydroxide: adverse event reports filed with FDA

1,109

reports as suspect product

0% of all reports · about 51 a year

74

reports, 12 months to June 2026

110 in the 12 months before

97.4%

marked serious by the reporter

91.9% across the class

13.1%

record death among outcomes, as reported

145 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Magnesium hydroxide reports recording the termmedian drug in calculi dissolution agent

1. Constipationconstipation62.1%689
2. Painpain, site not specified58.1%644
3. Falla fall56.1%622
4. Cognitive disorderproblems with thinking or memory54.9%609
5. Orthostatic hypotension52.2%579
6. Balance disorderproblems with balance52.1%578
7. Hypotensionlow blood pressure50.1%556
8. Sedationdrowsiness from a medicine50%554
9. Depressed level of consciousness47.1%522
10. Mobility decreasedreduced ability to move about47%521
11. Sedation complication45.8%508
12. Blood calcium decreased44.2%490
13. Creatinine renal clearance decreased44.2%490
14. Toxicity to various agentspoisoning or toxic effect of one or more substances43.5%482
15. Off label useused for a purpose or in a way not on the label22.4%248
16. Drug ineffectivethe medicine did not work as expected15.4%171
17. Nauseafeeling sick14.4%160
18. Product use in unapproved indicationused for a purpose not on the label14.2%158
19. Infusion related reactiona reaction during or soon after an infusion12.2%135
20. Abdominal painstomach or belly pain12%133
21. Anaemialow red blood cells11.8%131
22. Dyspnoeashortness of breath11.8%131
23. Malaisegeneral feeling of being unwell10.4%115
24. Therapeutic product effect incomplete10.4%115
25. Headachehead pain10.2%113
26. Pyrexiafever10%111
27. Drug interactionan interaction between medicines8.8%98
28. Drug hypersensitivityan allergic-type reaction to a medicine8.7%97
29. Weight decreasedweight loss8.2%91
30. Erythemaskin redness8.1%90

Top 30 of 413 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the calculi dissolution agent class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,293 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 10.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,109 reports.

Drugs most often listed in the same reports

Other products listed in reports where Magnesium hydroxide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the calculi dissolution agent class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Magnesium hydroxide as a suspect or interacting product; reports listing it only as a concomitant medication (3,162) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.