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that youngsters [1%):<1%; 1% to 4% in patients without a gallbladder), abdominal distention (3%), flatulence (3%), viral gastroenteritis (3%), gastroesophageal reflux disease ( 2%) Hepatic: Increased serum ALT (2% to 3%), increased serum AST ( 2%) Respiratory: Upper respiratory tract infection (5%), nasopharyngitis (4%), bronchitis (3%), asthma ( 2%), bronchospasm ( 2%), respiratory failure ( 2%), wheezing ( 2%)> <1% (Limited to important or life-threatening): Increased liver enzymes, pancreatitis Warnings/Precautions Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities. Patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have been reported during postmarketing surveillance. Some reactions occurred following the first or second dose. Discontinue immediately in patients who develop signs or symptoms of a hypersensitivity reaction. Pancreatitis: May cause pancreatitis, with or without sphincter of Oddi spasm, including serious cases (some fatal) requiring hospitalization. Primarily occurs in patients without a gallbladder (use is contraindicated). Most reported serious pancreatitis cases occurred within a week of starting treatment; some developed after one or two doses. Avoid chronic or acute excessive alcohol use during therapy. Monitor for signs and symptoms of pancreatitis; discontinue use if new or worsening abdominal pain that may radiate to the back or shoulder (with or without nausea/vomiting) develops. Sphincter of Oddi spasm: May cause sphincter of Oddi spasm resulting in pancreatitis or elevated hepatic enzymes; most reported serious cases occurred during the first week of treatment, while some developed symptoms after one or two doses. Discontinue use if patients experience symptoms of sphincter of Oddi spasm such as acute worsening of epigastric- or biliary-type abdominal pain (eg, right upper quadrant pain) that may radiate to the back or shoulder with or without nausea/vomiting, associated with elevations of pancreatic enzymes or hepatic transaminases. Permanently discontinue use in patients who develop biliary duct obstruction or sphincter of Oddi spasm. Disease-related concerns: Hepatic impairment: Plasma concentrations are increased in patients with hepatic impairment; contraindicated in patients with severe hepatic impairment. Use with caution in patients with mild-to-moderate hepatic impairment; dosage adjustment required. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Abuse potential: Current data suggest that eluxadoline has some potential for drug abuse and psychological dependence. Naloxone should be considered in the event of overdose. Monitoring Parameters Monitor for signs/symptoms of pancreatitis (new or worsening abdominal pain that may radiate to the back, with or without nausea/vomiting) or sphincter of Oddi spasm (eg, acute epigastric or biliary pain with hepatic or pancreatic enzyme elevations); hepatic impairment; impaired mental or physical abilities. Pregnancy Considerations Adverse events have not been observed in animal reproduction studies. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience common cold symptoms or nausea. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), abdominal pain, constipation, or abdominal pain that moves to back or shoulder with or without nausea and vomiting (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about eluxadoline Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En EspaƱol 136 Reviews Add your own review/rating Drug class: peripheral opioid receptor mixed agonists/antagonists Consumer resources Eluxadoline Eluxadoline (Advanced Reading) Professional resources Eluxadoline (AHFS Monograph) Other brands: Viberzi Related treatment guides Irritable Bowel Syndrome> ] Drug Status Rx Availability Prescription only 4 CSA Schedule Some potential for abuse Approval History Drug history at FDA Eluxadoline Rating 136 User Reviews 6.6 /10 136 User Reviews 6.6 Rate it! 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