What the label lists and what reports show
Magnesium sulfate and potassium sulfate and sodium sulfate side effects
Magnesium sulfate and potassium sulfate and sodium sulfate's FDA label: “Most common adverse reactions are: Adults (> 2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting.” FAERS holds 4,353 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 (1,637 reports).
- Generic listed
Check it at the source: the magnesium sulfate and potassium sulfate and sodium sulfate FDA label on DailyMed (effective June 30, 2026, Bionpharma 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 sodium sulfate, potassium sulfate, and magnesium sulfate oral solution?Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution can cause serious side effects, including: See " What is the most important information I should know about sodium sulfate, potassium sulfate, and magnesium sulfate oral solution? " Changes in certain blood tests. Your healthcare provider may do blood tests after you take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: vomiting dizziness urinate less than usual seizures nausea stomach area (abdomen) cramping trouble drinking clear liquid heart problems bloating headache trouble swallowing worsening gout Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. […]
Source: FDA drug label, Bionpharma Inc.,, effective June 30, 2026 (SPL set 31d13799-0931-7735-e063-6294a90a6d02), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Adults (> 2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting.
Table 1: Common Adverse Reactions reported in at least 2% of patients in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial
| Symptom | Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution % N = 190 | PEG + E Product % N = 189 |
|---|---|---|
| Overall Discomfort | 54 | 67 |
| Abdominal Distension | 40 | 52 |
| Abdominal Pain | 36 | 43 |
| Nausea | 36 | 33 |
| Vomiting | 8 | 4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions (5.1) ] Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Use in 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) ] Aspiration [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Adults (> 2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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, Bionpharma Inc.,, effective June 30, 2026 (SPL set 31d13799-0931-7735-e063-6294a90a6d02), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,353 reports list magnesium sulfate and potassium sulfate and sodium sulfate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 223 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, 8 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?
- Magnesium sulfate and potassium sulfate and sodium sulfate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions