Xifaxan Side Effects

Generic Name: rifaximin

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

Side Effects of Xifaxan - for the Consumer

Xifaxan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xifaxan:

Dizziness; gas; headache; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Xifaxan:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; flushing; unusual hoarseness); bloody stools; fever; severe diarrhea; severe or persistent tiredness or weakness; shortness of breath; stomach pain or cramping; swelling of the hands, ankles, feet, or stomach.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Xifaxan Side Effects - for the Professional

Xifaxan

Clinical Studies Experience

        Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed 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.

        Travelers’ Diarrhea

        The safety of Xifaxan 200 mg taken three times a day was evaluated in patients with travelers’ diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with Xifaxan. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.

        Discontinuations due to adverse reactions occurred in 0.4% of patients.  The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irrigation.

        All adverse reactions for Xifaxan 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)

 

Table 1. All Adverse Reactions With an Incidence ≥2% Among Patients Receiving Xifaxan Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies

MedDRA Preferred Term	Number (%) of Patients
	Xifaxan Tablets, 600 mg/day (N = 320)	Placebo N = 228
*NOS: Not otherwise specified
Flatulence	36 (11%)	45 (20%)
Headache	31 (10%)	21 (9%)
Abdominal Pain NOS*	23 (7%)	23 (10%)
Rectal Tenesmus	23 (7%)	20 (9%)
Defecation Urgency	19 (6%)	21 (9%)
Nausea	17 (5%)	19 (8%)
Constipation	12 (4%)	8 (4%)
Pyrexia	10 (3%)	10 (4%)
Vomiting NOS	7 (2%)	4 (2%)

        The following adverse reactions, presented by body system, have also been reported in <2% of patients taking Xifaxan in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers’ diarrhea.  The following includes adverse reactions regardless of causal relationship to drug exposure.

        Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia

        Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus

        Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort

        General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness

        Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS

        Injury and Poisoning: Sunburn

        Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased

        Metabolic and Nutritional Disorders: Anorexia, dehydration

        Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain

        Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste

        Psychiatric Disorders: Insomnia

        Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency

        Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea

        Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased

        Vascular Disorders: Hot flashes NOS

 

        Hepatic Encephalopathy

        The data described below reflect exposure to Xifaxan 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days).  The safety of Xifaxan 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280).  The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black.  Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in Xifaxan 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease).

 

Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving Xifaxan and at a Higher Incidence Than Placebo

	Number (%) of Patients
MedDRA Preferred Term	Xifaxan Tablets 550 mg TWICE DAILY   N = 140	Placebo N = 159
	Edema peripheral	21 (15%)	13 (8%)
Nausea	20 (14%)	21 (13%)
Dizziness	18 (13%)	13 (8%)
Fatigue	17 (12%)	18 (11%)
Ascites	16 (11%)	15 (9%)
Muscle spasms	13 (9%)	11 (7%)
Pruritus	13 (9%)	10 (6%)
Abdominal pain	12 (9%)	13 (8%)
Abdominal distension	11 (8%)	12 (8%)
Anemia	11 (8%)	6 (4%)
Cough	10 (7%)	11 (7%)
Depression	10 (7%)	8 (5%)
Insomnia	10 (7%)	11 (7%)
Nasopharyngitis	10 (7%)	10 (6%)
Abdominal pain upper	9 (6%)	8 (5%)
Arthralgia	9 (6%)	4 (3%)
Back pain	9 (6%)	10 (6%)
Constipation	9 (6%)	10 (6%)
Dyspnea	9 (6%)	7 (4%)
Pyrexia	9 (6%)	5 (3%)
Rash	7 (5%)	6 (4%)

        The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking Xifaxan 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure.

 

        Ear and Labyrinth Disorders: Vertigo

        Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort

        General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS

        Infections and Infestations: Cellulitis, pneumonia, rhinitis, upper respiratory tract infection NOS

        Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain

        Investigations: Weight increased

        Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia

        Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity

        Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor

        Psychiatric Disorders: Confusional state

        Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis

        Vascular Disorders: Hypotension

Postmarketing Experience

        The following adverse reactions have been identified during post approval use of Xifaxan.  Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.   These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to Xifaxan. 

        Infections and Infestations 

        Cases of C. difficile-associated colitis have been reported [see Warnings and Precautions (5.2)].

        General

        Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported.  These events occurred as early as within 15 minutes of drug administration.

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Side Effects by Body System - for Healthcare Professionals

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 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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