ArticleDrug safety2013
Distinguishing hazards and harms, adverse drug effects and adverse drug reactions : implications for drug development, clinical trials, pharmacovigilance, biomarkers, and monitoring.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Pooled it
- Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis.Drug safety · 2019Pooled it
- Adverse events in people taking macrolide antibiotics versus placebo for any indication.The Cochrane database of systematic reviews · 2019Pooled it
- Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems.Drug safety · 2026Review
- Making a case for using MDMA-assisted psychotherapy for borderline personality disorder and complex PTSD: a descriptive systematic review of the literature.Therapeutic advances in psychopharmacology · 2026Review
- Real-world evaluation of select adverse drug reactions and healthcare utilization associated with parenteral Ibuprofen and ketorolac in adult and pediatric patients.Frontiers in pain research (Lausanne, Switzerland) · 2024Article
- Article
- Artificial Intelligence in Pharmacovigilance: An Introduction to Terms, Concepts, Applications, and Limitations.Drug safety · 2022Article
- Harms in Systematic Reviews Paper 1: An introduction to research on harms.Journal of clinical epidemiology · 2022Article
- Adverse drug reactions associated with amitriptyline - protocol for a systematic multiple-indication review and meta-analysis.Systematic reviews · 2020Article
- Article
- Categorization and association analysis of risk factors for adverse drug events.European journal of clinical pharmacology · 2018Review
- Effects of anticoagulation therapy with vitamin K antagonists on hospitalizations and emergency room accesses in Grosseto (Italy).Journal of preventive medicine and hygiene · 2018Article
- Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study.Frontiers in pharmacology · 2018Article
- Quality of pharmacotherapy in old age: focus on lists of Potentially Inappropriate Medications (PIMs) : Consensus statements from the European Science Foundation exploratory workshop.European journal of clinical pharmacology · 2016Article
- Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology.Journal of psychopharmacology (Oxford, England) · 2016Article
- Clinical and economic burden of adverse drug reactions.Journal of pharmacology & pharmacotherapeutics · 2013Review
- [Not Available].The Canadian journal of hospital pharmacyArticle
- Multiplicity of Terms Related to Patient Safety: A Hindrance to Progress.The Canadian journal of hospital pharmacyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The terms 'adverse drug effects' and 'adverse drug reactions' are commonly used interchangeably, but they have different implications. Adverse drug reactions arise when a compound (e.g. a drug or metabolite, a contaminant or adulterant) is distributed in the same place as a body tissue (e.g. a receptor, enzyme, or ion channel), and the encounter results in an adverse effect (a physiological or pathological change), which results in a clinically appreciable adverse reaction. Both the adverse effect and the adverse reaction have manifestations by which they can be recognized: adverse effects are usually detected by laboratory tests (e.g. biochemical, haematological, immunological, radiological, pathological) or by clinical investigations (e.g. endoscopy, cardiac catheterization), and adverse reactions by their clinical manifestations (symptoms and/or signs). This distinction suggests five scenarios: (i) adverse reactions can result directly from adverse effects; (ii) adverse effects may not lead to appreciable adverse reactions; (iii) adverse reactions can occur without preceding adverse effects; (iv) adverse effects and reactions may be dissociated; and (v) adverse effects and reactions can together constitute syndromes. Defining an adverse drug reaction as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product" suggests a definition of an adverse drug effect: "a potentially harmful effect resulting from an intervention related to the use of a medicinal product, which constitutes a hazard and may or may not be associated with a clinically appreciable adverse reaction and/or an abnormal laboratory test or clinical investigation, as a marker of an adverse reaction."
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.