JAMA · 1980 · 57 citations · 4 references
PharmacyPharmacologyPharmacotherapyClinical PharmacologyDrug InformationPharmacovigilanceAdverse Drug Reaction MonitoringAdverse Drug Reaction ReportingAdverse Drug ReactionsAdverse Event ReportingDrug Safety MonitoringSpontaneous Reporting SystemsAdverse Drug Reaction AnalysisAdverse Drug Reaction Reporting SystemsAdverse Reactions ReportingConfusionPatient-reported Adverse Event MonitoringSpontaneous Reporting System AnalysisSuspected Adverse Drug Reaction ReportingSuspected Adverse Reaction Assessment
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.
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CIMETIDINE: INTERACTION WITH ORAL ANTICOAGULANTS IN MAN
M J Serlin · The Lancet · 1979 · 314 citations
Evaluation of Spontaneous Reports of Adverse Reactions to Drugs
W.H.W. Inman, David A. Evans · BMJ · 1972 · 15 citations