Title

Comparison of patient-reported adverse drug reactions with pharmacovigilance records in gastrointestinal disorders

Authors

Adithi Umesh Basappa¹, Nandita Tallam², Riyaz Siddiqui^3,*, Dhivya Mohan⁴, Manish Ramesh Bhise⁵ & Aisha Mohammed Kutty⁶

Affiliation

¹Department of Emergency Medicine, ETCM Hospital, Karnataka, India; ²Department of Anatomy, Mediciti institute of medical sciences, Telangana, India; ³Department of Pharmacology, NKP Salve Institute of Medical sciences & RC and LMH, Nagpur, India; ⁴Department of Medicine, Aarupadai Veedu Medical College and Hospital, Tamil Nadu, India; ⁵Department of Pharmaceutics, SGSPS, Institute of Pharmacy, Akola, Affiliated to Sant Gadge Baba Amravati University, India;  ⁶Department of Oncology and Haematology, Portsmouth University Hospital NHS trust, Wessex, United Kingdom, India; *Corresponding author

Email

Adithi Umesh Basappa - E-mail: dradithi25@gmail.com; Phone: +919480182895

Nandita Tallam - E-mail: dr.tallamnandita@gmail.com; Phone: +91 9949390688

Riyaz Siddiqui - E-mail: riyaz19752008@gmail.com

Dhivya Mohan - E-mail: drmohan.dhivya@gmail.com; Phone: +9194443692265

Manish Ramesh Bhise - E-mail: manishbhise.patil@gmail.com; Phone: 8329407345

Aisha Mohammed Kutty - E-mail: draishamkutty@gmail.com; Phone: +44 7554462888

Article Type

Research Article

Date

Received April 1, 2026; Revised April 30, 2026; Accepted April 30, 2026, Published April 30, 2026

Abstract

Adverse drug reactions (ADRs) are frequently under-recognized in patients with gastrointestinal disorders. Differences may exist between patient-reported experiences and formal pharmacovigilance records. Therefore, it is of interest to evaluate self-reported ADRs among 265 adults receiving treatment for gastrointestinal conditions and compared findings with regional pharmacovigilance data from the same period. A structured and pretested survey collected demographic, clinical and ADR-related information. Overall, 51.7% reported at least one ADR, most commonly abdominal discomfort (27.2%), nausea (21.9%) and headache (17.4%). Awareness of formal ADR reporting systems was low, with only 38.5% having heard of such systems and 25.7% knowing how to report. Concordance between patient reports and pharmacovigilance data was high for gastrointestinal and central nervous system reactions but lower for severe and dermatological reactions. Female gender, higher education and polypharmacy were significantly associated with increased ADR reporting (p < 0.05). Thus, gaps in awareness of ADR reporting support integration of patient-reported outcomes into pharmacovigilance systems.
 

Keywords

Adverse drug reaction (ADR), patient-reported outcome, pharmacovigilance, gastrointestinal disorder, drug safety, perception survey, self-reported experience, medication side effect, signal detection and questionnaire-based study
 

Citation

Basappa et al. Bioinformation 22(4): 2035-2039 (2026)

Edited by

A Prashanth

ISSN

0973-2063

Publisher

Biomedical Informatics

License

This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.