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What the label lists and what reports show

Polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride side effects

Polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride's FDA label: “Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.” FAERS holds 392 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 (50 reports).

  • Generic listed

Check it at the source: the polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride FDA label on DailyMed (effective April 14, 2026, Wilshire 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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution?

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause serious side effects, including: See Section “What is the most important information I should know about PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution?” changes in certain blood tests. Your healthcare provider may do blood tests after you take PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: vomiting nausea bloating dizziness stomach (abdominal) cramping headache urinate less than usual trouble drinking clear liquid heart problems. […]

Source: FDA drug label, NDA019797 (Azurity), as published by Wilshire Pharmaceuticals, Inc., effective April 14, 2026 (SPL set 4e442a72-b13b-4869-8a1d-59356095b091), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.

From the label: adverse reactions, continued

The following serious or otherwise important adverse reactions 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 )]. Renal Impairment [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative 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 )] Direct Ingestion [see Warnings and Precautions ( 5.8 )]. The following adverse reactions have been identified during post-approval use of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. …

Source: FDA drug label, NDA019797 (Azurity), as published by Wilshire Pharmaceuticals, Inc., effective April 14, 2026 (SPL set 4e442a72-b13b-4869-8a1d-59356095b091), via openFDA; the full label on DailyMed

What do FAERS reports show?

392 reports list polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 123 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 21 reactions below, 6 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.

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