Comparative Profile of Adverse Drug Reactions with Antimicrobials:Women Vs Men.

ABSTRACT

The current retrospective cross sectional study was undertaken using suspected ADR data collection form used under Pharmacovigiliance Programme of India (PvPI). A total of 2586 ADR events were recorded in 3years out of which 392(15.15%) were because of antimicrobials. males constituted 253 patients (64.54%) and females constituted 139 patients (35.45%) with male female ratio as 1.81. Adults were more commonly affected followed by geriatric and pediatric population in both the groups. I.V route followed by oral route of drug administration accounted maximum ADR in similar way in both the genders. Monotherapy was responsible for 81.81% for males and 82.01% for females. Among combinations 78.26% in males and 64% in females were irrational as per latest WHO13th essential drug list. Majority of ADR, 88.14% and 92.80% were of moderate severity among males and females respectively. Maximum ADR were latent, type-A, probable in nature as per Naranjo and WHO-UMC scale. Inj.ceftriaxone followed by tab. azithromycin, tab.ofloxacin-ornidazole were the commonest antimicrobials responsible for ADRs in both the genders. The most common system involved was dermatological followed by GI in both males and females. On statistical comparison, no significant differences were observed among both the genders in any of the parameters except causality assessment scale (P<0.5). The current study suggests the ADRs due to antimicrobials are a significant health problem. No major gender related differences were observed in ADR profile of our study cohort.