Evaluation the pattern of adverse drug reactions by non-steroidal anti-inflammatory drugs at the outpatient orthopedics department of a university teaching hospital in north India


  • Harpreet Singh Sidhu Department of Pharmacology, M.M. Institute of Medical Sciences and Research, Ambala, Haryana, India http://orcid.org/0000-0003-3313-1034
  • Akshay Sadhotra Department of Pharmacology, M.M. Institute of Medical Sciences and Research, Ambala, Haryana, India




Adverse drug reactions, Fixed dose combination, India, Pharmacovigilance


Background: The study was conducted with an aim to evaluate the pattern of occurrence of adverse drug reactions (ADRs) of Non-steroidal anti-inflammatory drugs (NSAIDs) in orthopedic patients in a tertiary care teaching hospital of North India.

Methods: An observational study was carried out in the orthopedic outpatient department at the tertiary care hospital for the period of six months. All patients diagnosed with acute pain and receiving NSAIDs were included. The documented ADRs were assessed for causality, severity and preventability using Naranjo’s algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively.

Results: A total of 84 ADRs were reported from 51 patients. The most common ADRs observed were from gastrointestinal (38%) followed by skin (18%) and autonomic nervous system (12%). Maximum number of ADRs were reported in patients on diclofenac (47%) followed by piroxicam (44%). Upon causality assessment, majority of the reactions were possible (61.5% with WHO-UMC scale, and 57.1% with Naranjo’s algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (73.4%) were assessed as mild and 66.7% of the ADRs were probably preventable.

Conclusions: Authors conclude that incidence of ADRs can be decreased and compliance can be improved by early detection and management.


Hartrick CT. Tapentadol immediate release for the relief of moderate-to-severe acute pain. Expert Opin Pharmacother. 2009;16:2687-96.

Pattanittum P, Turner T, Green S, Buchbinder R. Non-steroidal anti-inflammatory drugs (NSAIDs) for treating lateral elbow pain in adults. Cochrane Database Syst Rev. 2013;5:CD003686.

Fennerty MB. NSAID-related gastrointestinal injury: evidencebased approach to a preventable complication. Postgrad Med. 2001;110(87-8):91-4.

Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. Br J Clin Pharmacol. 2007;65:795-6.

Chakraborti A. Fixed dose combinations in therapy. Express Pharma. 2007; 2:62-3.

Dureja GP, Jain PN, Joshi M, Saxena A, Das G, Ahdal J, et al. Addressing the barriers related with opioid therapy for management of chronic pain in India. Pain Management. 2017 Jul;7(4):311-30.

World Health Organization. International drug monitoring: The role of national centres. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1972;498:1-25.

World Health Organization (WHO). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. WHO, Geneva, 2002.

Naing L, Winn T, Rusli BN. Practical issues in calculating the sample size for prevalence studies. Arch Orofacial Sci. 2006;1:9-14.

World Health Organization. Uppsala monitoring centre. Causality assessment of suspected adverse reactions. Available at: http://who-umc. org/Graphics/24734.pdf. Accessed 26 July 2016.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Therapeut. 1981;30(2):239-45.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Sys Pharma. 1992 Sep 1;49(9):2229-32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hospital Pharma. 1992 Jun;27(6):538.

Nice guidelines for acute upper gastrointestinal bleeding in over 16s: management. Available at: https://www.nice.org.uk/guidance/cg141. Accessed 26 July 2016.

Maheshwari N, Wagh RJ, Chincholkar AS, Gupta M. Prescription pattern monitoring of nonsteroidal anti-inflammatory drugs (NSAIDs) in urban health centre in Talegaon. Int J Pharma Bio Sci. 2015;6:596-602.

Muraraiah S, Rajarathna K, Vishwanath M, Ramaswamy A, Kamath SD, Seshu S. Evaluation of WHO prescribing indicators among orthopaedic in-patients at a tertiary care hospital. J Chem Pharm Res. 2014;6:278-80.

Review: could diclofenac cause gastritis?. Available at: http://www.ehealthme.com/ds/diclofenac? sodium/gastritis. Accessed 14 August 2016.

National List of Essential Medicines of India. 2015. Available at: http://www.cdsco.nic.in/forms/Default .aspx. Accessed 26 July2016.

Sen S, Bathini P. Auditing analgesic use in post-operative setting in a teaching hospital. JCDR. 2015 Apr;9(4):FC01.

Salman MT, Akram MF, Rahman S, Khan FA, Haseen MA, Khan SW. Drug prescribing pattern in surgical wards of a teaching hospital in North India. Indian J e Practising Doctor. 2008;5(2):5-8.

Patel NS, Shah RB, Buch JG. Drug utilization pattern of NSAIDs assessed with the anatomical therapeutic chemical classification/defined daily dose system in an orthopedic department. Drugs Therapy Perspectives. 2015 Oct 1;31(10):358-64.

Gor AP, Saksena M. Adverse drug reactions of nonsteroidal anti-inflammatory drugs in orthopedic patients. J Pharmacol Pharmacotherapeut. 2011 Jan;2(1):26.

De Paepe P, Petrovic M, Outtier L, Van Maele GE, Buylaert W. Drug interactions and adverse drug reactions in the older patients admitted to the emergency department. Acta Clin Belgica. 2013 Feb 1;68(1):15-21.

Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ. 1998;316(7140):1295-98.

Moore N, Pollack C, Butkerait P. Adverse drug reactions and drug-drug interactions with over-the-counter NSAIDs. Therapeutics Clin Risk Managem. 2015;11:1061.

Hameed L, Onyekwere CA, Otegbayo JA, Abdulkareem FB. A clinicopathological study of dyspeptic subjects in Lagos, Nigeria. Gastroenterol Insights. 2012 May 28;4(1):11.

Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int. 2012 Jun 1;32(6):1491-502.

Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar 1;121(1-2):22-8.

Tripathi S, Shah R, Sharma DC. Analgesic activity of fixed dose combinations of paracetamol with diclofenac sodium and paracetamol with tramadol on different pain models in healthy volunteers-A randomized double blind crossover study. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):465.

Dashputra Amruta V. Utilization of analgesics in perioperative cases of teaching hospital. Int J Med Pharmaceut Sci. 2013;3(6):14-9.




How to Cite

Sidhu, H. S., & Sadhotra, A. (2018). Evaluation the pattern of adverse drug reactions by non-steroidal anti-inflammatory drugs at the outpatient orthopedics department of a university teaching hospital in north India. International Journal of Basic & Clinical Pharmacology, 7(10), 1974–1980. https://doi.org/10.18203/2319-2003.ijbcp20183933



Original Research Articles