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Complications Over OTC: A Comprehensive Analysis of Risks, Misuse, and Regulatory Challenges in Over-the-Counter Medications
Subject area: Biological & Medical Sciences · Area of research: Pharmacy
DOI: https://doi.org/10.64388/IREV9I7-1713238
Abstract
Over-the-counter (OTC) medications are widely used for the management of minor and self-limiting health conditions due to their accessibility and convenience. However, inappropriate use in the absence of professional supervision has emerged as a significant contributor to preventable adverse health outcomes, particularly in low- and middle-income settings such as India. Misuse of OTC drugs commonly involves excessive dosing, prolonged consumption, polypharmacy, and failure to recognize contraindications or clinically relevant drug interactions. This review examines complications associated with the unsupervised use of commonly available OTC medications, including nonsteroidal anti-inflammatory drugs, antihistamines, antacids and acid-suppressing agents, cough suppressants, laxatives, and topical corticosteroids. The discussion integrates pharmacological mechanisms of toxicity with clinical evidence describing organ-specific adverse effects involving the gastrointestinal, renal, hepatic, cardiovascular, and neurological systems. Increased vulnerability among elderly individuals, pregnant women, children, and patients with chronic illnesses is highlighted. Regulatory challenges governing OTC medicines in India are critically evaluated in comparison with international practices, with emphasis on gaps in pharmacovigilance, labeling, and post- marketing surveillance. The role of community pharmacists in promoting rational OTC use through patient counseling and early risk identification is also discussed. Strengthening regulatory oversight and public health education is essential to reduce avoidable harm while maintaining therapeutic accessibility.
Keywords
Over-The-Counter Medications, Self-Medication, Adverse Drug Reactions, Pharmacovigilance, Public Health; Pharmaceutical Regulation
How to cite this paper
@article{1713238,
author = {Galaba Yamini Padmasri, Pusunuri Pranitha, Chiruvolulanka Dharmik Ram Teja , Subhadeep Pratihar, Varshitha Asukolla},
title = {Complications Over OTC: A Comprehensive Analysis of Risks, Misuse, and Regulatory Challenges in Over-the-Counter Medications},
journal = {Iconic Research And Engineering Journals},
year = {2026},
volume = {9},
number = {7},
pages = {68-83},
issn = {2456-8880},
url = {https://www.irejournals.com/formatedpaper/1713238.pdf},
abstract = {Over-the-counter (OTC) medications are widely used for the management of minor and self-limiting health conditions due to their accessibility and convenience. However, inappropriate use in the absence of professional supervision has emerged as a significant contributor to preventable adverse health outcomes, particularly in low- and middle-income settings such as India. Misuse of OTC drugs commonly involves excessive dosing, prolonged consumption, polypharmacy, and failure to recognize contraindications or clinically relevant drug interactions. This review examines complications associated with the unsupervised use of commonly available OTC medications, including nonsteroidal anti-inflammatory drugs, antihistamines, antacids and acid-suppressing agents, cough suppressants, laxatives, and topical corticosteroids. The discussion integrates pharmacological mechanisms of toxicity with clinical evidence describing organ-specific adverse effects involving the gastrointestinal, renal, hepatic, cardiovascular, and neurological systems. Increased vulnerability among elderly individuals, pregnant women, children, and patients with chronic illnesses is highlighted. Regulatory challenges governing OTC medicines in India are critically evaluated in comparison with international practices, with emphasis on gaps in pharmacovigilance, labeling, and post- marketing surveillance. The role of community pharmacists in promoting rational OTC use through patient counseling and early risk identification is also discussed. Strengthening regulatory oversight and public health education is essential to reduce avoidable harm while maintaining therapeutic accessibility.},
keywords = {Over-The-Counter Medications, Self-Medication, Adverse Drug Reactions, Pharmacovigilance, Public Health; Pharmaceutical Regulation},
month = {January},
doi = {https://doi.org/10.64388/IREV9I7-1713238}
}