In the pivotal study 1 , the adverse events (AEs) profile did not differ significantly between the XIFAXAN® 550 mg bd arm and the placebo arm:
- The incidence of AEs was 80.0% in the XIFAXAN® arm and 79.9% in the placebo arm (p>0.05 for all comparisons)
- 9 deaths were reported in the XIFAXAN® arm and 11 in the placebo arm
- Clostridium difficile infection was reported in 2 patients in the XIFAXAN® arm and in none in the placebo arm. In both patients, XIFAXAN® therapy was continued concomitantly with treatment for the infection, from which they fully recovered
The profile and rates of AEs with long-term rifaximin-α treatment (up to 30 months) 2 appeared similar to data reported in 6-month RCT. 1
Adverse reactions listed by MedDRA system organ class and frequency 3
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| MedDRA* System Organ Class | Common (≥1/100 to <1/10) |
Uncommon (≥1/1,000 to <1/100) |
|---|---|---|
| Infections and infestations | – | Clostridial infection, urinary tract infection, candidiasis |
| Blood and lymphatic system disorders | – | Anaemia |
| Metabolism and nutrition disorders | – | Anorexia, hyperkalaemia |
| Respiratory, thoracic, and mediastinal disorders | Dyspnoea | Pleural effusion |
| Nervous system disorders | Dizziness, headache | Balance disorders amnesia, convulsion, attention disorders hypoesthesia, memory impairment |
| Psychiatric disorders | Depression | Confusional state, anxiety, hypersomnia, insomnia |
| Vascular disorders | – | Hot flush |
| Gastrointestinal disorders | Abdominal pain upper, abdominal distension, diarrhoea, nausea, vomiting, ascites | Abdominal pain, oesophageal varices haemorrhage, dry mouth, stomach discomfort |
| Hepatobiliary disorders | – | – |
| Skin and subcutaneous tissue disorders | Rashes, pruritus | – |
| Musculoskeletal and connective tissue disorders | Muscle spasms, arthralgia | Myalgia |
| Renal and urinary disorders | – | Dysuria, pollakiuria |
| General disorders and administration site conditions | Oedema peripheral | Oedema, pyrexia |
| Investigations | – | – |
| Injury, poisoning and procedural complications | – | Fall |
*Medical Dictionary for Regulatory Activities.
GL-HEP-XIF-2000171 April 2021
