Cited by 4,807Pharmacovigilance and Adverse Drug ReactionsPatient Safety and Medication ErrorsPharmaceutical Practices and Patient Outcomes

Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies

Lazarou, Jason, Pomeranz, Bruce H., Corey, Paul N.·1998·JAMA

Abstract

OBJECTIVE: To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. DATA SOURCES: Four electronic databases were searched from 1966 to 1996. STUDY SELECTION: Of 153, we selected 39 prospective studies from US hospitals. DATA EXTRACTION: Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. DATA SYNTHESIS: The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. CONCLUSIONS: The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.

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Crossref · 10.1001/jama.279.15.1200

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  • Persistent post-withdrawal tardive dyskinesia and persistent post-withdrawal supersensitivity psychosis may be associated with loss of clinical effects, modifications of illness course, and refractoriness to treatment.

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Authors
Lazarou, J., Pomeranz, B. H., & Corey, P. N.
Affiliations
University of Toronto (CA)
Venue
JAMA
Published
1998-04-15
Volume
279
Issue
15
Pages
1200
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W1969879564
Cited by
4,807
References
54
Citations by year
2026: 57 · 2025: 92 · 2024: 108 · 2023: 119 · 2022: 128 · 2021: 183 · 2020: 152 · 2019: 141 · 2018: 172 · 2017: 182 · 2016: 215 · 2015: 214 · 2014: 246 · 2013: 225 · 2012: 258
FWCI
171.85
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords
adverse drug reactions, hospitalized patients, incidence, serious adverse drug reactions, fatal adverse drug reaction, hospitalization, drug safety, causes of death
MeSH terms
Data Collection, Hospitals, Humans, Iatrogenic Disease, Inpatients, Prospective Studies, United States, Incidence, Linear Models, Health Care Surveys, Drug-Related Side Effects and Adverse Reactions

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