What the label lists and what reports show
Ascorbic acid, polyethylene glycol 3350 and 4 other ingredients side effects
Ascorbic acid, polyethylene glycol 3350 and 4 other ingredients's FDA label: “Most common adverse reactions (≥ 5%) are: • Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain.” FAERS holds 3,195 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 (589 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the ascorbic acid, polyethylene glycol 3350 and 4 other ingredients FDA label on DailyMed (effective October 31, 2025, Salix 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 MoviPrep?MoviPrep can cause serious side effects, including: • Changes in certain blood tests. Your healthcare provider may do blood tests after you take MoviPrep to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: o vomiting o seizures o kidney problems o heart problems o dizziness o dry mouth o feel faint, weak or lightheaded especially when you stand up (orthostatic hypotension) • 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. • Serious allergic reactions. […]
Source: FDA drug label, Salix Pharmaceuticals, Inc., effective October 31, 2025 (SPL set 8ff46193-2a3b-4de0-9572-775dda8cd8b2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5%) are: • Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain.
Table 2: Common Adverse Reactions Reported in at least 5% of patients in either treatment group Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal…
| Reaction | MoviPrep One-Day Evening Only Dosing Regimen (N=169) | 90 mL Oral Sodium Phosphate Solution (N=171) |
|---|---|---|
| Abdominal distension | 60% | 41% |
| Anal discomfort | 51% | 52% |
| Thirst | 47% | 65% |
| Nausea | 47% | 47% |
| Abdominal pain | 39% | 32% |
| Sleep disorder | 35% | 29% |
| Rigors | 34% | 30% |
| Hunger | 30% | 71% |
| Malaise | 27% | 53% |
| Vomiting | 7% | 8% |
| Dizziness | 7% | 18% |
| Headache | 2% | 5% |
| Hypokalemia | 0% | 6% |
| Hyperphosphatemia | 0% | 6% |
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 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 Renal Impairment [see Warnings and Precautions (5.4)] • Colonic Mucosal Ulceration, 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)] • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions (5.8)] • Risks in Patients with Phenylketonuria [see Warnings and Precautions (5.9)] • Hypersensitivity Reactions [see Warnings and Precautions (5.10)] Most common adverse reactions (≥ 5%) are: • Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. ( 6.1 ) • One-Day (Evening-Only): abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness.
Source: FDA drug label, Salix Pharmaceuticals, Inc., effective October 31, 2025 (SPL set 8ff46193-2a3b-4de0-9572-775dda8cd8b2), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,195 reports list ascorbic acid, polyethylene glycol 3350 and 4 other ingredients among the medicines taken, each a report of something that happened, not proof the medicine caused it; 263 are coded as a death and 1,123 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 23 reactions below, 13 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?
- Ascorbic acid, polyethylene glycol 3350 and 4 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