Entero-H oral and rectal

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Applies to barium sulfate: oral cream, oral liquid, oral paste, oral powder for suspension, oral suspension, oral tablet

Along with its needed effects, barium sulfate (the active ingredient contained in Entero-H) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking barium sulfate:

• Bloating
• constipation (severe, continuing)
• cramping (severe)
• nausea or vomiting
• stomach pain
• tightness in the chest
• troubled breathing

• Anxiety
• blood in the stools
• blood in the urine
• blurred vision
• bruising
• chest pain
• confusion
• cough
• coughing or vomiting blood
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• hives or welts, itching, or skin rash
• noisy breathing
• persistent bleeding or oozing from puncture sites, mouth, or nose
• redness of the skin
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness

Some side effects of barium sulfate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation or diarrhea
• cramping

Applies to barium sulfate: compounding powder, oral capsule, oral cream, oral paste, oral powder for reconstitution, oral suspension, oral tablet, oral and rectal powder for reconstitution, oral and rectal suspension, rectal powder for reconstitution, rectal suspension

General

General side effects including severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have been reported.[Ref]

Other

Other side effects caused by procedural complications have been rare. Procedural complications have included aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.[Ref]

Cardiovascular

It is of the utmost importance to be completely prepared to treat any EKG changes.[Ref]

Cardiovascular side effects including EKG changes have been reported following or during barium enema procedures.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, diarrhea, and abdominal cramping accompanying the use of barium sulfate (the active ingredient contained in Entero-H) formulations have been infrequent and usually mild.[Ref]

Some side effects of Entero-H may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.