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 described below and elsewhere in the labeling include: Pancreatitis [see Warnings and Precautions ( 5.1 )] Sphincter of Oddi Spasm [ see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Constipation [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) are constipation, nausea and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1- 800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial s Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials.
Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year.
Demographic characteristics were comparable between the treatment groups [see Clinical Studies ( 14 )] .
Data described below represent pooled data compared to placebo across the randomized trials.
Pancreatitis Cases of pancreatitis, not associated with sphincter of Oddi spasm, were reported in 2/807 (0.2%) of patients receiving 75 mg and 3/1032 (0.3%) of patients receiving 100 mg VIBERZI twice daily in clinical trials.
Of these 5 cases, 3 were associated with excessive alcohol intake, one was associated with biliary sludge, and in one case the patient discontinued VIBERZI 2 weeks prior to the onset of symptoms.
All pancreatic events resolved with lipase normalization upon discontinuation of VIBERZI, with 80% (4/5) resolving within 1 week of treatment discontinuation.
5 WARNINGS AND PRECAUTIONS Pancreatitis and Sphincter of Oddi Spasm : Monitor patients for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations;
immediately discontinue VIBERZI and seek medical attention if symptoms develop.
( 5.1 , 5.2 ) Hypersensitivity Reactions, including anaphylaxis : Immediately discontinue VIBERZI and seek medical attention if symptoms develop.
( 4 , 5.3 ) Constipation: Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they develop severe constipation.
Avoid use with other drugs that may cause constipation ( 5.4 , 7 ) 5.1 Pancreatitis Pancreatitis, with or without sphincter of Oddi spasm [ see Warnings and Precautions ( 5.1 ) ] , has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder.
Like all medications, Viberzi 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: