Evidence map›Paper›PMID 41280586›Full record

ArticleJournal of family medicine and primary care2025

Causality, severity, seriousness, and preventability of adverse drug reactions: A retrospective analysis.

Saurav Misra, Tirthankar Deb, Manmeet Kaur, Jayant Kumar Kairi, Kashish Sindhwani

Abstract read
In one paragraph

Article in Journal of family medicine and primary care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Observational
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Saurav MisraDepartment of Pharmacology, Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, India.
Tirthankar DebDepartment of Pharmacology, All India Institute of Medical Sciences, Kalyani, West Bengal, India.
Manmeet KaurDepartment of Pharmacology, Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, India.
Jayant Kumar KairiDepartment of Pharmacology, Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, India.
Kashish SindhwaniDepartment of Pharmacology, Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Adverse drug reactions (ADRs) are a significant cause of preventable morbidity and mortality. They account for 10-20% of hospital admissions and have a high economic impact on healthcare infrastructure. This study aims to provide information about the pattern, causality, severity, seriousness, and preventability of an ADR reported during the study period. Material and Methods: This was an observational, rétrospective, record-based study to analyze all submitted spontaneous Individual Case Safety Reports (ICSRs) during three years (April 2020-March 2023) at the ADR monitoring center under PvPI. Data obtained from ICSRs were carefully evaluated for quality, based on their essential elements. The ADR outcome was categorized into recovered, recovering, not recovered upon discharge, fatal, and unknown. The information in the ICSRs was used to assess the causality, preventability, severity, and seriousness of the ADRs. Results: Out of 380 Individual Case Safety Reports (ICSRs) from April 2020 to March 2023, 313 fully completed ICSRs were analyzed. The number of adverse drug reactions was higher in males ( Conclusion: Adverse drug reactions (ADRs) are a global problem and a major concern for patient safety. Monitoring and reporting ADRs is crucial to reduce their incidence and enhance pharmacovigilance. There is a need to increase awareness among patients, clinicians, and staff members about reporting and preventing ADRs.

Indexed as

Adverse drug reactions (ADRs)causalityoutcomespreventabilityseriousnessseverity

Identifiers

PMID41280586
PMCPMC12633994

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Registered trials

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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.