Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating abdominal cramps, vomiting and anal irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc.
at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The 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 PEG-3350 and electrolytes for oral solution 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).
Other less common adverse reactions include: abdominal cramps, vomiting, "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use.
( 5.1 , 5.2 , 7.1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
( 5.2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.
( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing.
( 5.4 , 7.1 , 8.6) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease.
Like all medications, Polyethylene Glycol-3350 And Electrolytes can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: