Evaluation of a worldwide spontaneous reporting system with cimetidine

JAMA. 1980 May 16;243(19):1912-4.

Abstract

Adverse reactions to cimetidine have been identified through the manufacturer's Worldwide Spontaneous Reporting System. Reactions not observed during clinical trials-mental confusion, interstitial nephritis, and potentiation of oral anticoagulants-were identified and added to the prescribing information for cimetidine while further studies were undertaken. The monitoring of the drug's adverse reaction profile is ongoing so that new types of reactions can be identified.

Publication types

  • Clinical Trial

MeSH terms

  • Anticoagulants / pharmacology
  • Cimetidine / adverse effects*
  • Clinical Trials as Topic
  • Confusion / chemically induced
  • Drug Synergism
  • Guanidines / adverse effects*
  • Humans
  • International Cooperation*
  • Nephritis, Interstitial / chemically induced
  • United Kingdom
  • United States

Substances

  • Anticoagulants
  • Guanidines
  • Cimetidine