title: Aspirin or acetaminophen? A comparison from data collected by the Spanish Drug Monitoring System.
abstract: To characterize and compare the toxicity profiles of aspirin and acetaminophen when used by large populations, all records of adverse drug reactions to these drugs reported to the Spanish Drug Monitoring System from 1982 to 1991 were analyzed. According to these data, aspirin-induced reactions were more serious than those reactions to acetaminophen; the severity of all the reactions in both cases was associated with time of exposure and with the accumulated dose administered. For GI reactions to aspirin no association was found between severity and time of exposure or dose, although an association with age was found. There were no differences between the proportions of deaths, malformations, and renal damage recorded for either of the two groups. Proportions of hematological and hepatic disturbances were greater with acetaminophen. Adverse drug reaction data for aspirin and acetaminophen from spontaneous reporting seem to be consistent with data coming from observational studies.
authors.affiliation: Castilla Y Leon Regional Center of Pharmacovigilance, Faculty of Medicine, University of Valladolid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Carvajal
authors.forename: J R
authors.initials: JR
authors.lastname: Prieto
authors.forename: A
authors.initials: A
authors.lastname: Alvarez Requejo
authors.forename: L H
authors.initials: LH
authors.lastname: Martin Arias
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends; D017677:Age Distribution; D000368:Aged; D001241:Aspirin / Q000009:adverse effects*; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D003625:Data Collection; D005194:Family Practice; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D013030:Spain / Q000453:epidemiology
chemical_list: D000082:Acetaminophen; D001241:Aspirin