Patterns of adverse drug reactions in a tertiary care hospital: A prospective observational study with implications for clinical research and pharmacovigilance in India
Year: 2026
Type: article
Study design: Observational Study
Abstract: INTRODUCTION The rapid advancement of pharmacotherapy brings therapeutic benefits but also carries the risk of adverse effects. Epidemiological studies estimate that adverse drug reactions (ADRs) rank among the fourth to sixth leading causes of mortality.[1] The World Health Organization (WHO) defines an ADR as “a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.”[2] While no drug is entirely free from side effects,[3] pharmacovigilance plays a critical role in preventing ADRs. The WHO describes pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.”[4] In response, India launched the Pharmacovigilance Programme of India under Ministry of Health and Family Welfare in 2010, which is coordinated by the Indian Pharmacopoeia Commission since 2011.[5] Previous Indian studies have documented high rates of cutaneous ADRs (CADRs).[6] A recent study conducted in Eastern India reported that 30.18% of patients experienced morbilliform eruptions.[7] METHODS A prospective observational study was conducted from February 2024 to July 2024 in the dermatology department. Approval was obtained from the Institutional Ethics Committee CSP/23/MAY/128/398. Patients presenting with cutaneous or systemic ADRs, whether self-reported or referred, were included in the study. Written informed consent was obtained from each participant before enrollment in the study. Over 6 months, data from 112 ADR cases were collected and documented. Data analysis done with SPSS software used on Windows, Chennai,Tamil Nadu, India through the WHO-UMC scale, in accordance with national pharmacovigilance protocols.[8] Data were cross checked by two independent reviewers to improve validity and completeness. RESULTS Demographics Of 112 patients, 62 (55.4%) were female, and 50 (44.6%) were male. Most cases fell within the 21-40 age group. Clinical presentation The clinical presentation, rashes accounted for 53.98% of ADRs, followed by itching (30.97%), redness (10.62%), swelling (8.85%), and systemic symptoms such as fever (4.42%). Bullous lesions and lichenoid eruptions were rare. One case of nonsteroidal anti-inflammatory drugs (NSAID)-induced lichenoid dermatitis was reported, with a 1-week latency. Drug categories When evaluating drug categories associated with different types of ADRs, antibiotics emerged as the most frequent category across all symptom groups. Out of (30 cases) of itching, (27 cases) were attributed to antibiotics, (2 cases) to analgesics, and (1 case) to a proton pump inhibitor (PPI). Rashes, the most common ADR overall, are primarily associated with antibiotics (38 cases), followed by analgesics (11 cases), and isolated cases linked to antifungals, oral hypoglycaemic agents, and PPIs. Redness was observed in 10 patients, with antibiotics contributing to nine of these cases and one with analgesics. Swelling occurred in nine individuals, predominantly caused by antibiotics (seven cases), analgesics (two cases), and antifungals (one case). Latency Among 112 ADR cases, rashes were most common (47.27%), with 47 out of 53 occurring within 1 day. Itching was reported in 27.1%, predominantly within 1 day. Redness (9.3%) and swelling also appeared exclusively within 24 h. Atypical reactions were seen in 4.6%, all presenting after 1 day. Statistical analysis Chi-square value (χ2) = 83.55, degrees of freedom df = 24, P = 1.64 × 10−8. This indicates a highly significant association between the drug class and type of ADR (P < 0.001) DISCUSSION A study from Eastern India done by Saha et al. showed antibiotics to be the leading cause of ADR’s, with presentation of maculopapular eruptions and itching being the most common.[7] Similar trends were noted with two other studies, one in Odisha by Rath R, Nalik MR, Rath R, Mohanty M, Panda P, Sahoo S where, antimicrobials (62.4%) followed by NSAIDs (12.9%) were the leading causes of CADR cutaneous adverse drug reactions.[9] In a study conducted by Naik S, Pereira LA, Naik R, Zore J, Dessai S, Kamat D in a centre located in Goa had similar patterns of results showing antibiotics as the leading cause.[10] Global literature also confirms antimicrobials as primary triggers for CADRs.[11] NSAIDs had a unique association with lichenoid eruptions, whereas antibiotics were implicated in both itching and rashes. These findings suggest possible immunological mechanisms specific to each drug class and its associated clinical presentation. The majority of the cases had early-onset reactions. Systemic reactions generally exhibited longer latency periods, which is consistent with delayed-type hypersensitivity mechanisms. A recent study conducted by Phillips EJ, Mallal SA. HLA and drug hypersensitivity can predict severe CADRs.[12] However, it is difficult in a densely populated country like India. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W7128467075