Evaluation of a worldwide spontaneous reporting system with cimetidine

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 in...

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Bibliographic Details
Published inJAMA : the journal of the American Medical Association Vol. 243; no. 19; p. 1912
Main Authors Davis, T G, Pickett, D L, Schlosser, J H
Format Journal Article
LanguageEnglish
Published United States 16.05.1980
Subjects
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
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Summary: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.
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.1980.03300450026015