Applies to polyethylene glycol 3350 with electrolytes: oral powder for solution.

Serious side effects

Along with its needed effects, polyethylene glycol 3350 with electrolytes may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking polyethylene glycol 3350 with electrolytes:

More common

• Full or bloated feeling
• pain in the upper stomach
• pressure in the stomach
• stomach pain
• swelling of the stomach area
• vomiting

Rare

• Confusion
• decreased urine output
• dizziness
• dry mouth
• fast or irregular heartbeat
• headache
• increased thirst
• loss of appetite
• loss of consciousness
• muscle pain or cramps
• numbness or tingling in the hands, feet, fingertips, lips, or mouth
• seizures
• swelling of the face, ankles, or hands
• unusual tiredness or weakness

Incidence not known

• Blistering, crusting, irritation, itching, or reddening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or black, tarry stools
• bloody urine
• blue lips and fingernails
• blurred vision
• chest pain or tightness
• chills
• constipation
• cough
• coughing that sometimes produces a pink frothy sputum
• cracked, dry, scaly skin
• difficult, fast, noisy breathing
• difficulty swallowing
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• heartburn
• hives, itching, skin rash
• increase in heart rate
• increased sweating
• lightheadedness
• lower back or side pain
• nausea
• nervousness
• pale skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• rapid weight gain
• runny nose
• severe stomach pain
• slow heartbeat
• sunken eyes
• swelling of the neck
• thirst
• throat tightness
• tingling of the hands or feet
• tremor
• trouble breathing
• unusual weight gain or loss
• vomiting of blood or material that looks like coffee grounds
• wrinkled skin

Other side effects

Some side effects of polyethylene glycol 3350 with electrolytes may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, itching, or pain around the anus
• difficulty with sleeping
• feeling unusually cold
• general feeling of discomfort or illness
• hunger
• shivering

Less common

• Belching
• indigestion
• stomach discomfort or upset

For Healthcare Professionals

Applies to polyethylene glycol 3350 with electrolytes: oral kit, oral powder for reconstitution.

General

The most common adverse events were abdominal distension, anal discomfort, thirst, nausea, and abdominal pain. Since diarrhea is considered part of the efficacy of this product, it was not defined as an adverse reaction.^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal distension (59.8%), anal discomfort (52%), nausea (47.3%), abdominal pain (39.1%), vomiting (12.8%)

Common (1% to 10%): Upper abdominal pain, dyspepsia

Frequency not reported: Upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, borborygmi, flatulence^[Ref]

Metabolic

Very common (10% or more): Hunger (70.8%)

Common (1% to 10%): Hypokalemia, hyperphosphatemia

Frequency not reported: Electrolyte disturbances, hyperkalemia^[Ref]

Other

Very common (10% or more): Rigors (33.7%), malaise (26.6%)

Frequency not reported: Peripheral edema^[Ref]

Nervous system

Very common (10% or more): Dizziness (18.1%)

Common (1% to 10%): Headache^[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (34.9%)^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction

Postmarketing reports: Hypersensitivity reactions (including anaphylaxis, rash, angioedema, urticaria, lip and facial swelling, dyspnea, chest tightness, throat tightness)^[Ref]

Cardiovascular

Frequency not reported: Asystole^[Ref]

Dermatologic

Frequency not reported: Urticaria, dermatitis^[Ref]

Respiratory

Frequency not reported: Rhinorrhea, acute pulmonary edema, acute pulmonary edema after aspirating the PEG-based preparation^[Ref]