Xifaxan Adverse Reactions

In clinical studies in subjects who received rifaximin for treatment of traveller’s diarrhoea adverse reactions considered as being at least possibly related to rifaximin have been categorised by organ system and frequency.
MedDRA System Organ Class: Common: (≥1/100 to <1/10), Uncommon: (≥ 1/1,000 to < 1/100).
Infections and Infestations: Uncommon: Candidiasis, herpes simplex, nasopharyngitis, pharyngitis, upper respiratory tract infection.
Blood and Lymphatic System Disorder: Uncommon: Lymphocytosis, monocytosis, neutropenia.
Metabolism and Nutrition Disorders: Uncommon: Decreased appetite, dehydration.
Psychiatric Disorders: Abnormal dreams, depressed mood, insomnia, nervousness.
Nervous System Disorders: Common: Dizziness, headache. Uncommon: Hypoesthesia, migraine, paraesthesia, sinus headache, somnolence.
Eye Disorders: Uncommon: Diplopia.
Ear and Labyrinth Disorders: Uncommon: Ear pain, vertigo.
Cardiac Disorders: Uncommon: Palpitations.
Vascular Disorders: Uncommon: Increased blood pressure, hot flush.
Respiratory, Thoracic, and Mediastinal Disorders: Uncommon: Cough, dry throat, dyspnoea, nasal congestion, oropharyngeal pain, rhinorrhea.
Gastrointestinal Disorders: Common: Abdominal pain, constipation, defecation urgency, diarrhoea, flatulence, bloating and distension, nausea and vomiting symptoms, rectal tenesmus. Uncommon: Upper abdominal pain, dry lips, dyspepsia, gastrointestinal motility disorder, hard faeces, haematochezia, mucous stools, taste disorders.
Hepatobiliary Disorders: Uncommon: Increased aspartate aminotransferase.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rashes, eruptions and exanthemas, NEC, sunburn.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Back pain, muscle spasms, muscular weakness, myalgia, neck pain.
Renal and Urinary Disorders: Uncommon: Blood in urine, glycosuria, pollakiuria, polyuria, proteinuria.
Reproductive System and Breast Disorders: Uncommon: Polymenorrhoea.
General Disorders and Administration Site Conditions: Common: Pyrexia. Uncommon: Asthenic conditions, chills, cold sweat, hyperhidrosis, influenza-like illness, peripheral oedema, pain and discomfort NEC.
Post-Marketing Experience: During post-approval, use of rifaximin further undesirable effects have been reported. The frequency of these reactions is not known (cannot be estimated from the available data).
Infections and Infestations: Clostridial infections.
Blood and Lymphatic System Disorder: Thrombocytopenia.
Immune System Disorders: Anaphylactic responses, angioedemas, hypersensitivity.
Vascular Disorders: Presyncope.
Hepatobiliary Disorders: Liver function tests abnormalities.
Skin and Subcutaneous Tissue Disorders Dermatitis: Eczema, erythemas, pruritus NEC, urticarias.
Investigations: International normalised ratio abnormalities.