E-Z-Disk
Generic: BARIUM SULFATE
Basic Information
Manufacturer
E-Z-EM, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c759668b-5cf1-b237-00c8-a5e4733b6f4c
Indications & Usage
1 INDICATIONS AND USAGE E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.
E-Z-DISK is a radiographic contrast agent indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.
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E-Z-DISK is a radiographic contrast agent indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.
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Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Intra-abdominal Barium Leakage [see Warnings and Precautions ( 5.2 )] Baroliths and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Aspiration Pneumonitis [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies.
Because some of these 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: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older.
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
Because some of these 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: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older.
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