Pharmacologic class (EPC) · 4 drug pages

Calculi dissolution agent: adverse event reports filed with FDA

8,293 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,293
reports across the class: 0% of all reports; 846
reports, 12 months to June 2026: 1,260 in the 12 months before; 91.9%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Calculi dissolution agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 8,293 adverse event reports received by FDA, 0% of the database, from March 2004 to June 2026.

846 reports arrived in the 12 months to June 2026, down 33% from 1,260 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 91.9% of the class's reports are marked serious, 19% record death among the outcomes and 52.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (22.5%), pain (18.8%) and off label use (18.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Magnesium sulfate	generic	4,016	288	89.7%	Drug ineffective
Magnesium oxide	generic	1,926	197	92%	Condition aggravated
Magnesium citrate	generic	1,242	287	94.1%	Off label use
Magnesium hydroxide	generic	1,109	74	97.4%	Constipation

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected22.5%1,866
Painpain, site not specified18.8%1,556
Off label useused for a purpose or in a way not on the label18.5%1,535
Constipationconstipation13.8%1,142
Nauseafeeling sick13%1,081
Maternal exposure during pregnancythe mother took the medicine during pregnancy12.7%1,055
Therapeutic product effect incomplete11.3%938
Infusion related reactiona reaction during or soon after an infusion11%913
Product use in unapproved indicationused for a purpose not on the label10.9%907
Headachehead pain10.6%880
Dyspnoeashortness of breath10.3%857
Condition aggravatedthe condition being treated got worse10.2%847
Falla fall9.6%798
Mobility decreasedreduced ability to move about9.4%780
Abdominal painstomach or belly pain9.3%769
Malaisegeneral feeling of being unwell9.2%761
Drug hypersensitivityan allergic-type reaction to a medicine8.9%734
Macular degenerationa disease of the central retina8.7%725
Hypotensionlow blood pressure8.7%723
Exposure during pregnancythe medicine was taken during pregnancy8.5%703
Foetal exposure during pregnancythe unborn baby was exposed to the medicine8.3%691
Pyrexiafever8.1%669
Hypertensionhigh blood pressure7.7%636
Vomitingbeing sick7.6%628
Cognitive disorderproblems with thinking or memory7.5%626

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death19%1,577

Life-threatening23.4%1,939

Hospitalisation (initial or prolonged)52.2%4,326

Disability14.2%1,176

Congenital anomaly12%999

Other serious74.5%6,177

Not serious8.1%670

Patient age

Under 21.2%98

2 to 110.9%78

12 to 170.9%78

18 to 4422.9%1,900

45 to 6410%832

65 to 7414.5%1,204

75 and over15.3%1,267

Age not given34.2%2,836

Who reported

Physician20.6%1,705

Pharmacist4.8%402

Other health professional58.8%4,874

Lawyer0.2%15

Consumer or non-health professional13.3%1,105

Not given2.3%192

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Calculi dissolution agent reports

Which drugs are in the Calculi dissolution agent class on this site?

Magnesium sulfate, Magnesium oxide, Magnesium citrate and Magnesium hydroxide. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

8,293 reports through June 2026, 846 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (22.5%), pain (18.8%), off label use (18.5%), constipation (13.8%) and nausea (13%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.