Over the counter non-steroidal anti-inflammatory drugs and risk of gastrointestinal bleeding

J Epidemiol Biostat. 2000;5(2):137-42.


Background: Independent analyses of data from a case-control study conducted by the American College of Gastroenterology (ACG) were performed to evaluate and quantify potential risks of gastrointestinal (GI) bleeding associated with use of analgesics at over the counter (OTC) doses.

Methods: Information on recent (within the past week) use of multiple analgesics, plus data on tobacco, alcohol and other factors, were obtained from 627 patients enrolled in the ACG GI bleeding registry and from 590 procedure-matched controls. Odds ratios (OR) were calculated as the measure of association between GI bleeding and the exposures of interest.

Results: Risk of GI bleeding was increased 2-3 fold among recent users of aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) at OTC doses, with risk increasing in a dose-related manner. In contrast, no excess was found among acetaminophen (paracetamol) users. Alcohol consumption was also a risk factor, with doubled risks of GI bleeding among drinkers.

Discussion: While these study results are not definitive, the findings are consistent with limited other data also reviewed, and suggest the need for further epidemiologic research to clarify the association between use of NSAIDs at OTC levels and risk of GI bleeding, and to determine whether NSAIDs and alcohol may interactively combine to enhance risk.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Alcohol Drinking / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Case-Control Studies
  • Female
  • Gastrointestinal Hemorrhage / chemically induced*
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Risk Factors


  • Anti-Inflammatory Agents, Non-Steroidal