Evidence map›Paper›PMID 41069921›Full record

ArticleCureus2025

The Pattern of Adverse Drug Reaction Reporting at a Regional Pharmacovigilance Center in North India: A Retrospective Observational Study.

Pankaj K Gupta, Jasleen Kaur, Gayatri Devi, Shilpa Chaudhary, Jyoti Maria

Abstract read
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

What it found

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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

1 citing paper in PubMed.

  1. Observational
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.

Pankaj K GuptaPharmacology, Employees' State Insurance Corporation Medical College and Hospital, Faridabad, Faridabad, IND.
Jasleen KaurPharmacology, Employees' State Insurance Corporation Medical College and Hospital, Faridabad, Faridabad, IND.
Gayatri DeviPharmacology, Employees' State Insurance Corporation Medical College and Hospital, Faridabad, Faridabad, IND.
Shilpa ChaudharyPharmacology/Pharmacovigilance, Employees' State Insurance Corporation Medical College and Hospital, Faridabad, Faridabad, IND.
Jyoti MariaPharmacology, Employees' State Insurance Corporation Medical College and Hospital, Faridabad, Faridabad, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Adverse drug reactions (ADRs) are one of the common causes of morbidity and mortality and contribute significantly to the healthcare burden. However, they are largely preventable. Pharmacovigilance can help alert healthcare providers about possible ADRs. It can also help protect the patients from the probable side effects of medications in the future. Methodology This retrospective study included ADRs reported in ESIC Medical College & Hospital, Faridabad, an ADR monitoring center under the National Co-ordination Centre-Pharmacovigilance Programme of India and the Indian Pharmacopoeia Commission, Ghaziabad. The assessment was performed to analyze the pattern of ADRs reported from January 2022 to December 2022. Reports were scrutinized based on patient demographics, drug characteristics, type of ADRs, outcomes, causality, severity, and seriousness. The data were collected and entered into the standard ADR reporting form. Each reported adverse event was assessed individually. Causality was determined using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale. Results A total of 282 reported/notified suspected ADRs from different departments were analyzed and reported over 12 months. Almost 78% (n = 156) of ADRs were seen in the adult age group (21-60 years). Antibiotics were the most frequently implicated drug class, presenting 36% (n = 72) of ADRs. Causality assessment, vital for linking ADRs to drugs, was performed using the WHO-UMC scale. Overall, 91% (n = 182) of ADRs were classified as "probable" and 8% (n = 16) as "possible," with no cases categorized as "certain" or "unlikely." Conclusions The study provides important insights into serious ADRs reported in 2022 at a tertiary care center in India. Adults were predominantly affected, with antibiotics, especially cephalosporins, being common culprits. Most ADRs were recognized and labeled, confirming known drug-event relationships, though a few potentially novel or rare ADRs were noted.

Indexed as

adverse drug reactionscausality assessmentpatient safetypharmacovigilanceseverity of adr

Identifiers

PMID41069921
PMCPMC12505011

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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.