Safety and Efficacy of Non-prescription, Over-the-Counter (OTC) Ibuprofen

Ibuprofen is amongst the most widely used non-steroidal anti-inflammatory drugs (NSAIDs) sold for non-prescription, or over-the-counter (OTC), use worldwide. This chapter provides data and analyses from clinical trials and evidence for the safety of OTC ibuprofen, especially in comparison with other OTC analgesics. It summarizes the comparative efficacy of ibuprofen. The relative safety and efficacy of ibuprofen requires consideration in special groups such as the elderly, young and during pregnancy and lactation. For these groups the frequently accepted view that safety at OTC doses in normal adults may be extended to being similar in these special groups may be generally applicable. The chapter also summarizes the use of NSAIDs alone or in association with other drugs used by pregnant women. The use of COX inhibitors is associated with infertility, miscarriage and prolongation of gestation which may be related to their effects on PGs.