Adverse drug reaction monitoring on antiretroviral therapy in human immunodeficiency virus patients in a tertiary care hospital


  • Nirav M. Patel Department of Pharmacology, GMERS Medical College, Valsad, Gujarat
  • Hardik V. Vaniya Department of Pharmacology, M P Shah Medical College, Jamnagar, Gujarat
  • Jitendra M. Agrawal Department of Pharmacology, GMERS Medical College, Gotri, Gujarat
  • Jayesh D. Balat Department of Pharmacology, M P Shah Medical College, Jamnagar, Gujarat
  • Anil P. Singh Department of Pharmacology, PDU Medical College, Rajkot, Gujarat
  • Hiren R. Trivedi Department of Pharmacology, M P Shah Medical College, Jamnagar, Gujarat



Adverse drug reaction, Antiretroviral therapy, Human immunodeficiency virus


Background: The aim of current study was to assess the pattern of adverse drug reactions (ADRs) in patients receiving antiretroviral (ARV) therapy.

Methods: A prospective, observational study was carried out for duration of 15 months. Clinical and treatment data were collected from patients, who underwent ARV therapy during the study period. CDSCO forms were used to record the ADRs. Causality, severity and preventability were assessed by suitable scales.

Result: Out of 216 patients 165 (76%) patients develop ADRs. Total of 274 ADRs were noted among 165 patients (1.66 ADR/patient). Out of them 100 (60.60%) were males and 65 (39.39%) were females. The most common ADR was gastrointestinal disorders (83, 30.29%). The most numbers of ADRs were observed in ZLN (Zidovudine + Lamivudine + Nevirapine) regimen (54%) followed by SLN (Stavudine + Lamivudine + Nevirapine) regimen (26%). According to WHO causality assessment scale most ADRs were possible (236, 86.13%). Hartwig and Siegel severity scale show 243 (88.69%) ADRs were moderate. Schumock and Thornton scale show all, ADRs were “not preventable.”

Conclusion: Early detection of drug toxicity helps to treat the patient and modify the drug regimen to minimize toxic effects.


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How to Cite

Patel, N. M., Vaniya, H. V., Agrawal, J. M., Balat, J. D., Singh, A. P., & Trivedi, H. R. (2016). Adverse drug reaction monitoring on antiretroviral therapy in human immunodeficiency virus patients in a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 4(5), 907–911.



Original Research Articles