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What the label lists and what reports show

Magnesium sulfate and potassium chloride and sodium sulfate side effects

Magnesium sulfate and potassium chloride and sodium sulfate's FDA label: “Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain.” FAERS holds 1,582 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is vomiting (826 reports).

  • No generic listed

Check it at the source: the magnesium sulfate and potassium chloride and sodium sulfate FDA label on DailyMed (effective January 31, 2026, Azurity Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of SUTAB?

SUTAB can cause serious side effects, including: See "What is the most important information I should know about SUTAB?" Changes in certain blood tests. Your healthcare provider may do blood tests after you take SUTAB to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: o vomiting o nausea o bloating o dizziness o stomach (abdominal) o headache o urinate less than usual cramping o trouble drinking clear liquid Heart problems. SUTAB may cause abnormal heartbeats. Seizures. Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding. Serious allergic reactions. […]

Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective January 31, 2026 (SPL set c020e973-dccf-4862-999e-17db6209a48a), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain.

From the label: adverse reactions, continued

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective January 31, 2026 (SPL set c020e973-dccf-4862-999e-17db6209a48a), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,582 reports list magnesium sulfate and potassium chloride and sodium sulfate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 41 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Side effects hub
the most reported medicines and reactions