Rifaximin adverse reactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Adverse Reactions
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 irritation.
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.)
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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).
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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 ].
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.[1]
References
Adapted from the FDA Package Insert.