What the label lists and what reports show

Magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients side effects

Magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients's FDA label: “Most common adverse reactions (>2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.” FAERS holds 102 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 nausea (29 reports).

No generic listed

Check it at the source: the magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients 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 SUFLAVE?
SUFLAVE can cause serious side effects, including: See "What is the most important information I should know about SUFLAVE?" Changes in certain blood tests. Your healthcare provider may do blood tests after you take SUFLAVE 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. SUFLAVE 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 d5710a04-2b0a-402c-a8b0-025766f1a437), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
Most common adverse reactions (>2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache.

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

Reaction	SUFLAVE (%) N=233	Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic…
Nausea	13	9
Abdominal distension	6	3
Vomiting	6	3
Abdominal pain c	3	4
Headache	3	2

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, continued
The following serious or otherwise important adverse reactions 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 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (>2%) are: nausea, abdominal distension, vomiting, abdominal pain and headache. ( 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 trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUFLAVE was evaluated in two randomized, parallel group, multicenter, investigator-blinded clinical trials in 929 adult patients undergoing colonoscopy.

Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective January 31, 2026 (SPL set d5710a04-2b0a-402c-a8b0-025766f1a437), via openFDA; the full label on DailyMed

What do FAERS reports show?

102 reports list magnesium sulfate, polyethylene glycol 3350 and 3 other ingredients among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 3 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, 11 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

Nausea (named in the label)29
Vomiting (named in the label)22
Abdominal Distension (named in the label)12
Headache (named in the label)10
Drug Ineffective (a use or a product term, not a reaction)8
Pruritus (named in the label)8
Dehydration (named in the label)7
Dizziness (named in the label)7
Urticaria (named in the label)7
Abdominal Pain (named in the label)6
Abdominal Pain Upper5
Chills5
Abdominal Discomfort4
Anal Incontinence4
Asthenia4
Gastrooesophageal Reflux Disease4
Hyperhidrosis4
Loss Of Consciousness (named in the label)4
Malaise4
Retching4
Wrong Technique In Product Usage Process (a use or a product term, not a reaction)4
Arthralgia3
Diarrhoea (named in the label)3
Fatigue3
Feeling Abnormal3

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

What next?

Magnesium sulfate, polyethylene glycol 3350 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