Summary

More frequently reported side effects include: abdominal pain, constipation, lower abdominal pain, nausea, upper abdominal pain, and vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to eluxadoline: oral tablet.

Serious side effects of Eluxadoline

Along with its needed effects, eluxadoline 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 immediately if any of the following side effects occur while taking eluxadoline:

Rare

• Bloating
• chills
• constipation
• darkened urine
• fast heartbeat
• fever
• indigestion
• loss of appetite
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• vomiting
• yellow eyes or skin

Incidence not known

• Cough
• difficulty swallowing
• dizziness
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

Other side effects of Eluxadoline

Some side effects of eluxadoline 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:

Less common

• Body aches or pain
• cough producing mucus
• difficulty with breathing
• ear congestion
• excess air or gas in the stomach or bowels
• fever
• full feeling
• headache
• loss of voice
• muscle aches
• passing gas
• pressure in the stomach
• sneezing
• sore throat
• stuffy or runny nose
• swelling of abdominal or stomach area

For Healthcare Professionals

Applies to eluxadoline: oral tablet.

General

The most commonly reported adverse reactions included constipation, nausea, and abdominal pain.^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea, abdominal pain, vomiting, abdominal distention, flatulence, viral gastroenteritis

Uncommon (0.1% to 1%): Sphincter of Oddi spasm, pancreatitis

Frequency not reported: Gastroesophageal reflux disease

Postmarketing reports: Hospitalizations and deaths due to pancreatitis, particularly in patients without a gallbladder^[Ref]

As of February 2017, the US FDA has received 120 reports of serious pancreatitis or death associated with this drug; 76 of these patients were hospitalized and 2 died. Both patients who died did not have a gallbladder; 56 of the 68 patients who reported gallbladder status did not have a gallbladder and had been receiving the recommended dose. Also reported among these cases were 6 with sphincter of Oddi spasm and 16 with abdomen pain.

Sphincter of Oddi spasm occurred in 0.2% (n=807) and 0.8% (n=1032) of patients receiving 75 mg and 100 mg twice a day, respectively. Sphincter of Oddi spasm manifested as abdominal pain with lipase elevation of less than 3 times the upper limit of normal in 1 patient, and elevated hepatic enzymes associated with abdominal pain in the second patient. For the 8 patients taking 100 mg twice a day, sphincter of Oddi spasm manifested in 1 patient as pancreatitis and as elevated hepatic enzymes associated with abdominal pain in the other 7 patients. Of 1317 patients with a gallbladder, no patients experienced a sphincter of Oddi spasm, while 2 of 165 patients and 8 of 184 patients in the 75 mg and 100 mg twice a day groups, respectively, experienced sphincter of Oddi spasm. Onset of symptoms occurred within the first week in 80% (8 of 10) of patients and no cases occurred greater than 1 month after treatment onset. The 1 case of sphincter of Oddi spasm-induced pancreatitis occurred within minutes of taking the first dose of the drug and resolved within 24 hours of discontinuation.

Pancreatitis not associated with sphincter of Oddi spasm was reported in 0.2% (n=807) and 0.3% (n=1032) of patients receiving 75 mg and 100 mg twice a day, respectively. Of these 5 cases, 3 were associated with excessive alcohol intake, 1 with biliary sludge, and 1 was reported 2 weeks after the patient discontinued therapy. All resolved within 1 week of therapy discontinuation.

Constipation was the most commonly reported adverse event in clinical trials with 50% of case reported within the first 2 weeks, and the majority within the first 3 months. Rates of severe constipation were less than 1%. After 3 months, the incidence of constipation was similar across active treatment and placebo groups.

Gastroesophageal reflux disease was reported in 2% or less of patients in clinical trials.^[Ref]

Hepatic

Increased AST was reported in 2% or less of patients in clinical trials.^[Ref]

Frequency not reported: Increased AST, increased ALT^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis

Frequency not reported: Asthma, bronchospasm, respiratory failure, wheezing^[Ref]

Asthma, bronchospasm, respiratory failure, and wheezing were reported in 2% or less of patients in clinical trials.^[Ref]

Dermatologic

Common (1% to 10%): Rash^[Ref]

Rash included terms such as dermatitis, dermatitis allergic, rash, rash erythematous, rash generalized, rash maculopapular, rash popular, rash pruritic, urticaria, and idiopathic urticaria.^[Ref]

Nervous system

Common (1% to 10%): Dizziness

Frequency not reported: Sedation, somnolence^[Ref]

Sedation and somnolence was reported in 2% or less of patients in clinical trials.^[Ref]

Psychiatric

Euphoric mood was reported in 2% or less of patients in clinical trials.^[Ref]

Frequency not reported: Euphoric mood^[Ref]

Other

Feeling drunk was reported in 2% or less of patients in clinical trials.^[Ref]

Common (1% to 10%): Fatigue

Frequency not reported: Feeling drunk^[Ref]