Abstract
Background: In India, spontaneous reporting of adverse drug reactions (ADRs) by health-care professionals was initiated in 2010. The drug safety issues for geriatric population are critical due to age-related physiological, pharmacodynamic, and pharmacokinetic changes.

Aims & Objective: To assess the spontaneous reports of ADRs observed in geriatric patients (over 65 years of age) in India from 1 July 2011 to 31 June 2013.

Materials and Methods: The spontaneous reports of 4357 elderly patients (≥65 years) were retrieved at National Pharmacovigilance Centre from the database containing all ADR reports from 90 ADR Monitoring Centres (AMCs) in India under Pharmacovigilance Programme of India (PvPI) for 2 years. These reports were analyzed for various characteristics of patients, drugs, and ADRs using a search and analysis tool.

Results: Of the 4357 geriatric individual case safety reports, more ADRs were reported in the male (57.77%) than in the female (41.38%) patients. Of the total geriatric patients, ADRs reported from 1120 (25.71%) patients were found to be serious, of which 8 (0.71%) were fatal. Cisplatin, carboplatin, cyclophosphamide, acetylsalicylic acid, and insulin were the common drugs prescribed to the elderly patients, and the most common ADRs reported were vomiting, diarrhea, and constipation. In geriatric population, ADRs mostly affected gastrointestinal system and skin and appendages system.

Conclusion: This study from spontaneous reporting indicates the common ADRs in the geriatric patients in India, which will help health-care professionals to better understand the drug safety issues in elderly.

Key words: Adverse Drug Reaction; Geriatric; India; Spontaneous Reporting