Safety of lansoprazole.

The care with which patients are monitored during clinical trials provides an excellent database to assess the tolerability and safety of drugs. Additional information can be obtained from knowledge of the compound itself, its metabolism and its pharmacological action. Other compounds from the same class can highlight areas that need particular study. All these factors have been used to assess the safety of lansoprazole. Lansoprazole has been administered to 4749 subjects and has been well tolerated. Only 1.2% of patients have been withdrawn from trials because of suspected drug-related events but there was no pattern and no relationship to drug dosage. Diarrhoea (3.2%) and headache (4.7%) were the most commonly reported adverse events.