pharmacopeia
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/api/v1/drug/barium-sulfate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Imaging Contrast Activity; X-Ray Contrast Activity.

Indications

Sourced from openFDA
  • Liquid E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients.

Contraindications

Sourced from openFDA
  • Liquid E-Z-PAQUE is contraindicated in patients with the following conditions: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE ( 4 )contraindicated

Dosage & administration

Sourced from openFDA

Adults: Recommended oral dose is 150 mL to 750 mL (87g to 435g of barium sulfate, respectively) ( 2.1 ) Pediatric patients: adjust dose based on relative GI volume ( 2.1 ) 2.1 Recommended Dosage The optimal oral dose of Liquid E-Z-PAQUE will vary depending on the size and anatomy of the patient and the procedure being performed. The recommended oral dose of Liquid E-Z-PAQUE: Adults: 150 to 750 mL (87 g to 435 g of barium sulfate, respectively). Volumes closer to 150 mL are recommended for examination of the esophagus and stomach and volumes up to 750 mL are recommended for examination of the small bowel Pediatric Patients: Adjust dose based on GI volume For examinations of the upper GI tract, administer a volume sufficient to fully distend the esophagus or stomach. For small bowel examinations: Age birth to less than 2 years: 30 mL to 75 mL Age 2 years to less than 17 years: 75 mL to 480 mL 2.2 Administration Instructions For oral use only Shake bottle vigorously for 30 seconds prior to oral administration to fully suspend product Administer undiluted Ensure patients have nothing by mouth for the following time period prior to the examination: Neonates and Infants < 3 months 2 hours Infants 3-12 months 3 hours > 12 months of age 4 hours Discard any unused suspension Encourage patients to maintain hydration following the barium sulfate procedure

Warnings & precautions

Sourced from openFDA

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 )].

Adverse reactions

Sourced from openFDA

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

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Liquid E-Z-PAQUE is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . 8.2 Lactation Risk Summary Liquid E-Z-PAQUE is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to Liquid E-Z-PAQUE [see Clinical Pharmacology ( 12.3 ) . 8.4 Pediatric Use The efficacy of Liquid E-Z-PAQUE in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, and small bowel during single contrast radiographic procedures [see Clinical Pharmacology ( 12.1 )] . Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration ( 2.1 )] . Liquid E-Z-PAQUE is contraindicated in pediatric patients with tracheo-esophageal fistula. [see Contraindications ( 4 )]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [ see Warnings and Precautions ( 5.1 )].

Approval history

Sourced from openFDA
  • Jan 11, 2016NDANDA208036Bracco
  • Jan 15, 2016NDANDA208143Bracco
  • Oct 14, 2016NDANDA208844Bracco
  • Aug 1, 2025NDANDA219840Bracco

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
431 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Aspiration6916%
  2. 2No Adverse Event347.9%
  3. 3Urticaria286.5%
  4. 4Diarrhoea276.3%
  5. 5Pruritus194.4%
  6. 6Acute Kidney Injury184.2%
  7. 7Dyspnoea184.2%
  8. 8Renal Failure184.2%
  9. 9Vomiting173.9%
  10. 10Chronic Kidney Disease153.5%
  11. 11Rash153.5%
  12. 12Abdominal Pain143.2%
  13. 13Cough143.2%
  14. 14Nausea143.2%
  15. 15Drug Hypersensitivity122.8%

Literature

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Recent PubMed references pinned to Barium Sulfate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 31 ClinicalTrials.gov registrations naming Barium Sulfate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Barium Sulfate work?
Mechanism-of-action classes: Imaging Contrast Activity; X-Ray Contrast Activity.
What is Barium Sulfate used for?
According to FDA labeling, Barium Sulfate carries indications including: Liquid E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Barium Sulfate?
Barium Sulfate is classified as Radiographic Contrast Agent, Imaging Contrast Activity, X-Ray Contrast Activity.
What are the contraindications for Barium Sulfate?
Barium Sulfate labeling lists contraindications including: Liquid E-Z-PAQUE is contraindicated in patients with the following conditions: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for barium-sulfate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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