Evaluation of a worldwide spontaneous reporting system with cimetidine
T. G. Davis, D. L. Pickett and J. H. Schlosser
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.