ADVERSE REACTIONS
The safety of XIFAXAN™ Tablets 200 mg taken three times a day (TID) was evaluated in 320 patients in two placebo-controlled clinical trials with 95% of patients receiving at least three days of treatment with XIFAXAN™ Tablets. All adverse events for XIFAXAN™ Tablets 200 mg TID that occurred at a frequency ≥2% in the two placebo-controlled trials combined are provided in Table 2. (These include adverse events that may be attributable to the underlying disease.)
Table 2. All Adverse Events With an Incidence ≥2% Among Patients Receiving XIFAXAN™ Tablets, 600 mg/day, in Placebo-Controlled Studies | MedDRA Preferred Term | Number (%) of Patients |
|---|
XIFAXAN™
Tablets,
600 mg/day
(N = 320) | Placebo
N = 228 |
|---|
|
|---|
Flatulence
| 36 (11.3%)
| 45 (19.7%)
|
Headache
| 31 (9.7%)
| 21 (9.2%)
|
Abdominal Pain NOS
| 23 (7.2%)
| 23 (10.1%)
|
Rectal Tenesmus
| 23 (7.2%) | 20 (8.8%)
|
Defecation Urgency
| 19 (5.9%)
| 21 (9.2%)
|
Nausea
| 17 (5.3%)
| 19 (8.3%)
|
Constipation
| 12 (3.8%)
| 8 (3.5%)
|
Pyrexia
| 10 (3.1%) | 10 (4.4%)
|
Vomiting NOS
| 7 (2.2%)
| 4 (1.8%)
|
The following adverse events, presented by body system, have also been reported in <2% of patients taking XIFAXAN™ Tablets in the two placebo-controlled clinical trials where the 200 mg taken three times a day dose was used. The following includes adverse events 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
Postmarketing Experience
The following events: hypersensitivity reactions, including allergic dermatitis, rash, angioneurotic edema, urticaria, and pruritus; have been identified during foreign postapproval use of XIFAXAN™ Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
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