Assessment of adverse drug reaction profile of the disease-modifying anti-rheumatic drugs at the department of orthopaedics in a tertiary care hospital, Silchar, Assam, India


  • Vijoy S. Kairi Department of Pharmacology, Silchar Medical College, Assam, India
  • Pinaki Chakravarty Department of Pharmacology, Silchar Medical College, Assam, India
  • Arun Kumar Sipani Department of Orthopaedics, Silchar Medical College, Assam, India



Adverse reactions, Combinations, DMARDs, Rheumatoid arthritis


Background: The mainstay of treatment of Rheumatoid Arthritis (RA) is the use of the disease-modifying anti-rheumatic drugs (DMARDs). Methotrexate, sulfasalazine and hydroxychloroquine are some of the DMARDs which are used in combination for the treatment of RA. The current study was undertaken to assess the adverse drug reactions (ADRs) of DMARDs that are commonly encountered with the treatment of RA.

Methods: The present study was designed as a prospective, observational study on newly diagnosed patients with RA. Patients diagnosed with RA above 18 years (excluding pregnant women) of either sex who were prescribed DMARDs in combination were included. ADRs reported spontaneously by the patients and also responses obtained in a questionnaire related to likely ADRs from the patients was recorded in the case record form. Statistical analysis was done using graph pad and p value <0.05 was considered to be statistically significant.

Results: A total of 47 patients attending the Outpatient Department of Orthopaedics, Silchar Medical College and Hospital, Silchar, Assam, India were screened for the study. ADRs were monitored up to the last visit on 41 patients excluding the patients who were lost and who were not able to adhere to the treatment. A total of 27 ADRs were reported from 19 ADR forms. Gastrointestinal manifestations were the most common adverse effects of combination DMARDs seen in 10 patients (24.39%). Severity assessment done using modified Hartwig and Siegel scale that showed majority of the ADRs were mild (74.07%).

Conclusions: Present study showed that DMARDs are well-tolerated and have an acceptable toxicity profile as majority of ADRs seen were mild. It was however difficult to prevent the occurrence of ADRs. Proper monitoring of therapy is needed for early recognition of ADRs.


Aletaha D, Kapral T, Smolen JS. Toxicity profiles of traditional disease modifying antirheumatic drugs for rheumatoid arthritis. Ann Rheumatic Dis. 2003;62(5):482-6.

Boon NA, Colledge NR, Walker BR, Hunter JAA. Davidson’s Principles and Practice of Medicine. 20th ed. USA: Churchill Livingstone Elsevier; 2006.

Brunton LL, Hilal-Dandan R, Knollman BC. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 13th ed. USA: McGraw-Hill Companies; 2011.

Paulus HE. The use of combinations of disease‐modifying antirheumatic agents in rheumatoid arthritis. Arthritis Rheumatism Off J Am Coll Rheumatol. 1990;33(1):113-20.

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.

Riley J, Wilton LV, Shakir SA. A post-marketing observational study to assess the safety of mibefradil in the community in England. Int J Clin Pharmacol Therapeutics. 2002;40(6):241-8.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.

Faich GA. US adverse drug reaction surveillance 1989-1994. Pharmacoepidemiol Drug Safety. 1996;5(6):393-8.

Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham III CO, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheumatism. 2010;62(9):2569-81.

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

Sandoval DM, Alarcon GS, Morgan SL. Adverse events in methotrexate-treated rheumatoid arthritis patients. Rheumatol. 1995;34(2):49-56.

Buhroo AM, Baba AN. Adverse effects of low-dose methotrexate in patients with rheumatoid arthritis. IJPMR. 2006;17(2):21-5.

Bologna C, Viu P, Jorgensen C, Sany J. Effect of age on the efficacy and tolerance of methotrexate in rheumatoid arthritis. Rheumatol. 1996;35(5):453-7.

Singh P, Bharat S, Bano M, Gaur S, Srivastava B. Adverse drug reactions in rheumatoid arthritis patients taking combination DMARDs. JMSCR. 2016;4(8):12115-24.

Prabha ML, Rani AG, Balasubramanian M, Ramya JE. Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital. Int J Basic Clin Pharmacol. 2016;5:805-9.

Gilani ST, Khan DA, Khan FA, Ahmed M. Adverse effects of low dose methotrexate in rheumatoid arthritis patients. J Coll Physicians Surg Pak. 2012;22(2):101-4.

Mavrikakis M, Papazoglou S, Sfikakis PP, Vaiopoulos G, Rougas K. Retinal toxicity in long term hydroxychloroquine treatment. Ann Rheumatic Dis. 1996;55(3):187-9.

Jallouli M, Francès C, Piette JC, Moguelet P, Factor C, Zahr N, et al. Hydroxychloroquine-induced pigmentation in patients with systemic lupus erythematosus: a case-control study. JAMA Dermatol. 2013;149(8):935-40.




How to Cite

Kairi, V. S., Chakravarty, P., & Sipani, A. K. (2019). Assessment of adverse drug reaction profile of the disease-modifying anti-rheumatic drugs at the department of orthopaedics in a tertiary care hospital, Silchar, Assam, India. International Journal of Basic & Clinical Pharmacology, 8(5), 1007–1012.



Original Research Articles