A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital


  • Smita Shenoy Department of Pharmacology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
  • Mohit Gupta Department of Surgery, Jagadguru Sri Shivarathreeshwara Medical College, Mysuru, Karnataka, India
  • Sadhana Holla Department of Pharmacology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Udupi, Karnataka, India
  • Madhurima Home Mayo Clinic, 5777 East Mayo Boulevard, Phoenix, USA
  • Harish Thanusubramanian Pfizer India Ltd, Mumbai, Maharashtra, India




Cancer, Hematological, Causality, Predictability


Background: Serious adverse drug reactions (ADRs) cause physical, psychological and economic harm to patients and society. This study was undertaken to understand serious ADRs in a tertiary care hospital and risk factors associated with it.

Methods: The serious adverse reactions that occurred over a one-year period were assessed. The serious adverse drug reactions, action taken, outcome, predictability, suspect drug, causality, patient demographics and risk factors for the reaction was collected. Chi-square test was applied for observing relationships of predisposing factors for serious ADRs.

Results: Out of a total of 984 reported adverse drug reactions, 94 (9.55%) were serious. Hematological disorders (41.05%) were the common serious ADRs followed by electrolyte disturbances (18.94%). Anticancer agents were the suspect drugs for majority of serious ADRs. Serious ADRs contributed to 39 (0.05%) admissions in the hospital. Recovery occurred in 97.87% of the patients. The causality was possible in 91.48% (n=86) and probable in 8.51% (n=8) of the serious adverse drug reactions. Males, patients even with a single concomitant disease and those with more than 2 concomitant medications were at increased risk (p<0.05) for developing serious ADRs.

Conclusions: Serious ADRs are a significant problem in health care. Measures should be taken to detect and treat them at the earliest to reduce suffering of the patient.


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How to Cite

Shenoy, S., Gupta, M., Holla, S., Home, M., & Thanusubramanian, H. (2019). A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 9(1), 101–106. https://doi.org/10.18203/2319-2003.ijbcp20195770



Original Research Articles