For patients in the ISENTRESS 400 mg twice daily + OBT arm and the comparator placebo + OBT arm, the most commonly reported adverse reactions (> 10% in either group), of all intensities and regardless of causality were: diarrhoea in 17.6% and 20.6%, nausea in 11.2% and 15.2%, headache in 10.1% and 12.4%, pyrexia in 6.3% and 11.0% of patients, respectively.