Magnesium sulfate: adverse event reports filed with FDA

4,016

reports as suspect product

0% of all reports · about 181 a year

288

reports, 12 months to June 2026

412 in the 12 months before

89.7%

marked serious by the reporter

91.9% across the class

8.8%

record death among outcomes, as reported

355 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 sulfate reports recording the termmedian drug in calculi dissolution agent

1. Drug ineffectivethe medicine did not work as expected22%883
2. Maternal exposure during pregnancythe mother took the medicine during pregnancy15.6%628
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine14.6%586
4. Premature babya baby born early13.3%536
5. Off label useused for a purpose or in a way not on the label11.7%469
6. Macular degenerationa disease of the central retina10.9%439
7. Exposure during pregnancythe medicine was taken during pregnancy9.3%374
8. Premature delivery9.3%374
9. Malaisegeneral feeling of being unwell6.6%264
10. Nauseafeeling sick6.4%258
11. Pyrexiafever6.4%258
12. Therapeutic product effect incomplete5.9%238
13. Painpain, site not specified5.8%234
14. Product use in unapproved indicationused for a purpose not on the label5.7%228
15. Weight decreasedweight loss5.2%209
16. Low birth weight baby5.2%208
17. Erythemaskin redness5.2%207
18. Paraesthesia oral5.1%206
19. Chronic sinusitis4.8%191
20. Infusion related reactiona reaction during or soon after an infusion4.7%190
21. Headachehead pain4.6%183
22. Dyspepsiaindigestion4.4%175
23. Abdominal painstomach or belly pain4.3%173
24. Procedural painpain from a procedure4.3%171
25. Anaemialow red blood cells4.1%166
26. Rectal haemorrhage3.9%157
27. Constipationconstipation3.8%153
28. Female genital tract fistula3.8%152
29. Frequent bowel movements3.8%151
30. Haematocheziablood in the stool3.8%151

Top 30 of 829 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. 30.4% 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 4,016 reports.

Drugs most often listed in the same reports

Other products listed in reports where Magnesium sulfate 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 sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (8,813) 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.