Xifaxan Side Effects

Generic name: rifaximin

Note: This document contains side effect information about rifaximin. Some of the dosage forms listed on this page may not apply to the brand name Xifaxan.

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

For the Consumer

Applies to rifaximin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rifaximin (the active ingredient contained in Xifaxan) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.

Less serious side effects are more likely, and may include:

• bloating, gas, stomach pain;

• feeling like you need to empty your bowel urgently;

• feeling like your bowel is not completely empty;

• nausea, vomiting, constipation;

• headache, dizziness;

• tired feeling; or

• swelling in your hands, feet, or torso.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to rifaximin: oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 14%), flatulence (11%), abdominal pain (up to 9%), abdominal distension (up to 8%), rectal tenesmus (7%), upper abdominal pain (6%), defecation urgency (6%), constipation (up to 6%), stomach discomfort (less than 5%), and vomiting (2%). Lower abdominal pain, abdominal tenderness, dry mouth, and esophageal variceal bleed have been reported in greater than 2% but less than 5% of patients. Diarrhea, blood in stool, dry throat, dysentery, fecal abnormality, gingival disorder, inguinal hernia, and dry lips have been reported in less than 2% of patients. Straining and bad taste in mouth have also been reported. Clostridium difficile associated colitis has been reported during postmarketing experience.

Other

Other side effects have included peripheral edema (15%), fatigue (up to 12%), ascites (11%), back pain (6%), pyrexia (up to 6%), chest pain (less than 5%), and pain (less than 5%). Generalized edema, influenza-like illness, contusion, fall, and procedural pain have been reported in greater than 2% but less than 5% of patients. Ear pain, motion sickness, malaise, and hot flashes have been reported in less than 2% of patients.

Nervous system

Nervous system side effects have included dizziness (up to 13%) and headache (10%). Vertigo, amnesia, disturbance in attention, hypoesthesia, memory impairment, and tremor have been reported in greater than 2% but less than 5% of patients. Migraine, syncope, tinnitus, and loss of taste have been reported in less than 2% of patients.

Hypersensitivity

Hypersensitivity side effects have included exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, pruritus, flushing, and anaphylaxis during postmarketing experience and have occurred as early as within 15 minutes of rifaximin (the active ingredient contained in Xifaxan) administration.

Dermatologic

Dermatologic side effects have included pruritus (up to 9%), rash (up to 5%), and cellulitis (greater than 2% but less than 5%). Clamminess, sunburn, and increased sweating have been reported in less than 2% of patients.

Musculoskeletal

Musculoskeletal side effects have included muscle spasms (up to 9%), arthralgia (up to 6%), myalgia (less than 5%), and pain in extremity (greater than 2% but less than 5%). Neck pain and weakness have been reported in less than 2% of patients.

Hematologic

Hematologic side effects have included anemia (8%). Lymphocytosis, monocytosis, and neutropenia have been reported in less than 2% of patients.

Respiratory

Respiratory side effects have included cough (7%), nasopharyngitis (up to 7%), dyspnea (up to 6%), upper respiratory tract infection (less than 5%), and rhinitis (less than 5%). Pneumonia and epistaxis have been reported in greater than 2% but less than 5% of patients. Respiratory tract infection, nasal passage irritation, pharyngitis, pharyngolaryngeal pain, and rhinorrhea have been reported in less than 2% of patients.

Psychiatric

Psychiatric side effects have included depression (7%), insomnia (up to 7%), confusional state (greater than 2% but less than 5%), and abnormal dreams (less than 2%).

Metabolic

Metabolic side effects have included increased weight (greater than 2% but less than 5%), anorexia (less than 5%), and dehydration (less than 5%). Hyperglycemia, hyperkalemia, hypoglycemia, and hyponatremia have been reported in greater than 2% but less than 5% of patients. Decreased weight has been reported in less than 2% of patients.

Genitourinary

Genitourinary side effects have included choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency, and blood in urine in less than 2% of patients.

Cardiovascular

Cardiovascular side effects have included hypotension (greater than 2% but less than 5%).

Hepatic

Hepatic side effects have included increased aspartate aminotransferase in less than 2% of patients.

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