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 are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc.
at 1-877-244-9825 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 Polyethylene Glycol 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 - Unflavored 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: