chapter  7
51 Pages

Safety and Efficacy of Non-prescription (OTC) Ibuprofen

WithK D Rainsford

Ibuprofen is used on a non-prescription, or over-the-counter (OTC), basis for management of mild to moderate pain, soft-tissue inflammation including dysmenorrhoea, migraine, postoperative pain, dental pain, musculoskeletal conditions, and the relief of fever. Ibuprofen was the first of the new generation of newer nonsteroidal anti-inflammatory drugs and the first analgesic after paracetamol to be given OTC status. A considerable number of clinical trials have been performed in which ibuprofen has been examined for its efficacy in different pain states and the adverse reactions recorded. The adverse reactions were graded into 15-day reports; documented serious reports; and non-serious reports. Ibuprofen is effective at recommended OTC doses for the relief of symptoms of mild to moderate upper respiratory tract infections such as colds and influenza. Ibuprofen is an established therapy for relief of pain in primary dysmenorrhea. The prime consideration for granting of OTC status in the United States was safety in prescription doses, since efficacy was granted.