ArticleEuropean journal of clinical pharmacology2021
A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues.
Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.International journal of clinical pharmacy · 2023Pooled it
- Consumers' experiences and perspectives on reporting adverse drug reactions using digital tools: a qualitative study.International journal of clinical pharmacy · 2026Article
- Reporting Adverse Drug Events: A Comparison of an Online Patient Tool Versus Telephone-Based Monitoring in Community Pharmacy Patients in the Netherlands.Drug safety · 2025Article
- Patient Participation in Monitoring Potential Adverse Drug Events.Applied clinical informatics · 2025Observational
- Consumer views on the use of digital tools for reporting adverse drug reactions: a cross-sectional study.International journal of clinical pharmacy · 2025Article
- Co-Designing a Consumer-Focused Digital Reporting Health Platform to Improve Adverse Medicine Event Reporting: Protocol for a Multimethod Research Project (the ReMedi Project).JMIR research protocols · 2025Article
- Research on the quality supervision strategy of drugs sold on the internet under the MAH system.Frontiers in public health · 2025Article
- Patient reporting of sexual adverse events on an online platform for medication experiences.British journal of clinical pharmacology · 2022Article
- Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study.JMIR formative research · 2022Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeReporting of adverse drug reactions (ADRs) by patients is essential for a comprehensive risk-benefit evaluation of drugs after marketing, but only few data are available regarding patient-centred web-based ADR reporting systems. Hence, we aimed to analyze ADRs reported by patients with a particular emphasis on novel drugs and serious ADRs not yet labelled in the respective summary of product characteristics (SPC).
methodsAll ADR reports received by a web-based, patient-centred platform ( www.nebenwirkungen.de ) between April 1, 2019, and September 1, 2020, were descriptively analyzed. ADRs and drugs were coded automatically according to MedDRA and ATC classification system. SPC labelling of reported ADRs for novel drugs marketed since 2015 was checked manually.
resultsIn total, 13,515 patient reports including 29,529 ADRs were received during the study period (serious ADRs [SADRs] n = 1,318; 4.5%). Women were affected in more than two-thirds of ADR reports. The most common patient-reported ADRs were nausea, dizziness and headache, whereas arrhythmia, intestinal obstruction and erectile dysfunction were the most frequent SADRs. Ciprofloxacin, levothyroxine and venlafaxine were the compounds most frequently suspected for causing both ADRs and SADRs. Regarding novel compounds, 289 reports including 739 ADRs were received (mainly fatigue, headache and myalgia). Three hundred thirty-one (44.8%) out of those ADRs were not yet labelled in the respective SPC, whereof twelve were SADRs.
conclusionThe majority of patient-reported ADRs were non-serious. However, a relevant number of non-labelled even serious ADRs was reported for novel compounds by patients. Despite well-known limitations of patient-reported ADRs, this web-based ADR reporting system contributes to the identification of new ADRs and thus can help to improve patients' safety complementing other pharmacovigilance instruments.
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