Forty years of ibuprofen use

Int J Clin Pract Suppl. 2003 Apr;(135):28-31.


Low-dose ibuprofen is as effective as aspirin and paracetamol for the indications normally treated with over-the-counter (OTC) medications and is associated with the lowest risk of gastrointestinal toxicity of any non-steroidal anti-inflammatory drug. By contrast, even low-dose aspirin is associated with an appreciable risk of gastrointestinal toxicity. Paracetamol is well tolerated and effective in treating mild to moderate pain but there is growing concern about a possible risk of gastrointestinal toxicity and a possible link with asthma in children. The PAIN (Paracetamol, Aspirin, Ibuprofen New tolerability) study was a blinded randomised comparison of the tolerability of OTC analgesics in the treatment of common types of acute pain encountered in the community. A total of 8,677 adults were randomised to treatment with ibuprofen 1200 mg/day, paracetamol 3 g/day or aspirin 3 g/day for 1-7 days. The most common indications for treatment were musculoskeletal conditions (31-33%), colds or flu (19-20%), backache (15-17%), sore throat (11-12%) and headache (10-11%). Significant adverse events were more common with aspirin (10.1%) than ibuprofen (7.0%) (P<0.001) or paracetamol (7.8%). Significant gastrointestinal events were less frequent with ibuprofen (4.0%) than with aspirin (7.1%, P<0.001) or paracetamol (5.3%) (P=0.025). For every 100 patients treated, five more will experience significant adverse events if they are taking aspirin rather than ibuprofen, and four more than if they were taking paracetamol.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Review

MeSH terms

  • Acetaminophen / adverse effects*
  • Analgesics, Non-Narcotic / adverse effects*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Aspirin / adverse effects*
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Ibuprofen / adverse effects*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


  • Analgesics, Non-Narcotic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Acetaminophen
  • Aspirin
  • Ibuprofen