An observational study of adverse drug reactions reported in a rural tertiary care hospital


  • Ravi D. Mala Department of Pharmacology, MNR Medical College, Sangareddy, Telangana, India
  • D. M. Ravichand Department of Pharmacology, MNR Medical College, Sangareddy, Telangana, India
  • B. V. Patil Department of Pharmacology, MNR Medical College, Sangareddy, Telangana, India
  • B. S. Payghan Department of SPM, MNR Medical College, Sangareddy, Telangana, India
  • Anurag Yadav Department of Biochemistry, MNR Medical College, Sangareddy, Telangana, India



Adverse drug reactions, Causality, Severity


Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.

Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.

Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.

Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

Author Biography

Ravi D. Mala, Department of Pharmacology, MNR Medical College, Sangareddy, Telangana, India

Assistant Professor

Department of Pharmacology


WHO. International drug monitoring: the role of national centers. Tech Rep Ser WHO. 1972: 498.

Elzagallaai AA, Greff M, Rieder MJ. Adverse Drug Reactions in Children: The Double-Edged Sword of Therapeutics. Clin Pharmacol Ther. 2017;101:725-35.

Verma R, Vasudevan B, Pragasam V. Severe cutaneous adverse drug reactions. Med J Armed Forces India. 2013;69(4):375-83.

Yadav S. Status of adverse drug reaction monitoring and pharmacovigilance in selected countries. Indian J Pharmacol. 2008;40:4-9.

Tripathi KD. Adverse drug effects, K D Tripathi, Essentials of medical pharmacology. 7th Ed. New Delhi: Jaypee Brothers’ Medical Publishers (p) ltd; 2013: 82.

Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: Comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel. Pharmacoepidemiol Drug Saf. 2005;14:885-90.

Belhekar MN, Taur SR, Munshi RP. A study of agreement between the Naranjo algorithm and WHO UMC criteria for causality assessment of adverse drug reactions. Indian J Pharmacol. 2014;46:117-20.

The use of the WHO-UMC system for standardized case causality assessment. World Health Organization (WHO) - Uppsala Monitoring Centre. Available at: 24734. Accessed on 3 June 2019.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Begaud B, Evreux JC, Jouglard J, et al. Imputation of the unexpected or toxic effects of drugs. Actualization of the methods used in France. Therapie. 1985;40:115-8.

Shrivastava M, Uchit G, Chakravarti A, Joshi G, Mahatme M, Chaudhari H. Adverse Drug Reactions Reported in Indira Gandhi Government Medical College and Hospital, Nagpur. JAPI. 2011;59:1-4.

Gaur S, Paramjeet S, Srivastava B, Bhardwaj R, Ahuja S, Gunjita B. Evaluation of adverse drug reactions in teaching hospital in Kumoun region. JMSCR. 2016;4:12139-45.

Ponnusankar S, Tejaswini M, Chaitanya M. Assessment of Adverse Drug Reactions Based on Spontaneous Signals at Secondary Care Public Hospital. Ind J Pharma Sci. 2015;77(4):490-3.

Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hosp Pharm. 1993;28(12):1199-204.

Zaki SA. Adverse drug reaction and causality assessment scales. Lung India. 2011;28:152 3.

Parida S. Clinical causality assessment for adverse drug reactions. Indian J Anaesth. 2013; 57:325 6.

Rajeshreddy SGSV, Lokesh VP. Causality assessment and the severity of the adverse drug reactions in tertiary care hospital: a pharmacovigilance study. Int J Basic Clin Pharmacol. 2017;6(12):2800-3.




How to Cite

Mala, R. D., Ravichand, D. M., Patil, B. V., Payghan, B. S., & Yadav, A. (2019). An observational study of adverse drug reactions reported in a rural tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 8(11), 2367–2370.



Original Research Articles