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 The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally.
Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal barium leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction ( 5.3 ) Aspiration pneumonitis: Patients with history of food aspiration or with swallowing disorders are at increased risk ( 5.4 ) 5.1 Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions.
The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria and itching.
A history of bronchial asthma, atopy or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions.
Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
5.2 Intra-abdominal Barium Leakage The use of Liquid E-Z-PAQUE is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications ( 4 )].
Like all medications, E-Z-Paque 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: