What the label lists and what reports show
Polyethylene glycol 3350, potassium chloride and 3 other ingredients side effects
Polyethylene glycol 3350, potassium chloride and 3 other ingredients's FDA label: “Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).” FAERS holds 2,262 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 (273 reports).
- Generic listed
Check it at the source: the polyethylene glycol 3350, potassium chloride and 3 other ingredients FDA label on DailyMed (effective April 15, 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 GoLYTELY?GoLYTELY can cause serious side effects, including: See Section “What is the most important information I should know about GoLYTELY?” changes in certain blood tests. Your healthcare provider may do blood tests before and after you take GoLYTELY to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: • vomiting • stomach (abdominal) cramping • nausea � • headache • bloating • urinate less than usual • dizziness • trouble drinking clear liquid 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, Azurity Pharmaceuticals, Inc., effective April 15, 2026 (SPL set 7609ecf7-0ce0-4fbb-9c27-30987f689575), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsGastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations 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 )] The following adverse reactions associated with the use of GoLYTELY were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )]. Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). …
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective April 15, 2026 (SPL set 7609ecf7-0ce0-4fbb-9c27-30987f689575), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,262 reports list polyethylene glycol 3350, potassium chloride and 3 other ingredients among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 554 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.
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?
- Polyethylene glycol 3350, potassium chloride and 3 other ingredients: 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