ABSTRACT
Background: Adverse drug reactions (ADR) are the fourth leading cause of mortality and a great concern in therapeutics. Pharmacovigilance is more important in India as the health care system is inadequate with poor doctor-patient ratio, high incidence of self-medication, and presence of counterfeit drugs. The present study was conducted with the aim of analyzing the pattern of ADR occurring in a rural tertiary care hospital with a newly established pharmacovigilance center and to identify the most frequent ADRs, common drugs implicated and severity of reactions. Methods: A non-interventional observational prospective study was conducted over a year. The red boxes for dropping the filled yellow ADR forms were installed in all the wards and outpatient departments. Additional information and missing data were obtained personally by either consulting the physician or through case sheets. Results: The most common class of drugs implicated in the causation of ADRs was antimicrobials (52%), followed by drugs acting on the central nervous system. The most commonly observed ADRs were dermatological Type B reactions. The majority of the reactions belonged to possible or probable category, but no reaction was categorized as definite. Conclusion: Dermatological reactions are the most common ADR occurring in our hospital and antimicrobials are the most common causative drugs. The reporting rate was adequate, and there is still a need for increasing the awareness and knowledge about ADR reporting system and pharmacovigilance for promoting the safe use of drugs.