Metformin related adverse events: A prospective observational study in health care centers of western Odisha

  • Sanjeeb Kumar Kar Gayatri College of Pharmacy, Sambalpur, Odisha-768200
  • Susovita Khuntia Bioclinica India, Mysore, Karnataka
  • Shubhrata Nayak Omega Health Care Services Private Limited, Murgeshpallya, Bangalore, Karnataka-560017
Keywords: Metformin, diabetes, anti-diabetic therapy, adverse events


Introduction: The most common adverse drug reactions were lactic acidosis followed by hypoglycemia, hypersensitivity reactions, nausea, decreased appetite, vomiting, weakness, and diarrhea.

Objectives: The study was done to explore the management of the patients having diabetes by primary care physicians, and the adverse reactions associated with the dose regimens. This study provided information regarding the adverse drug reactions that could be developed in any patient and increases the risk to the patient.

Methods: A qualitative In-Depth Interview study was conducted among the primary care physicians at ten primary health care centers at Sambalpur city of Odisha, India. The data were analyzed using content analysis. This was a prospective observational study (March 2019 - September 2019) among diabetes patients receiving metformin. Data were collected and analyzed to find out the demographic characteristics, causality, and severity of adverse events with metformin regimens.

Results: It was seen that 8 % of cases could be assessed as certain and 24 % could be assessed as probable. Most (60 %) cases were assessed as possible. Severity assessment of ADRs by modified Hart wig and Siegel's severity Scale (n=143) indicates 64% of the case were mild and 34% of cases are moderately severe.

Conclusions: Hence with an aim of patient safety quality of the drug formulations has to be improved that could ultimately improve drug safety.


Download data is not yet available.

Author Biographies

Sanjeeb Kumar Kar, Gayatri College of Pharmacy, Sambalpur, Odisha-768200

Department of Pharmaceutical Chemistry

Susovita Khuntia, Bioclinica India, Mysore, Karnataka

Senior Drug Safety Associate

Shubhrata Nayak, Omega Health Care Services Private Limited, Murgeshpallya, Bangalore, Karnataka-560017

Medical Coder


DeFronzo, R., Fleming, G. A., Chen, K., & Bicsak, T. A. (2016). Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism: clinical and experimental, 65(2), 20–29.

Filioussi, K., Bonovas, S., & Katsaros, T. (2003). Should we screen diabetic patients using biguanides for megaloblastic anaemia?. Australian family physician, 32(5), 383–384.

Hostalek, U., Gwilt, M., & Hildemann, S. (2015). Therapeutic Use of Metformin in Prediabetes and Diabetes Prevention. Drugs, 75(10), 1071–1094.

Jabbour, S., & Ziring, B. (2011). Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgraduate medicine, 123(1), 15–23.

Kim, C. H., Han, K. A., Oh, H. J., Tan, K. E., Sothiratnam, R., Tjokroprawiro, A., & Klein, M. (2012). Safety, tolerability, and efficacy of metformin extended-release oral antidiabetic therapy in patients with type 2 diabetes: an observational trial in Asia. Journal of diabetes, 4(4), 395–406.

Palmer, S. C., Mavridis, D., Nicolucci, A., Johnson, D. W., Tonelli, M., Craig, J. C., Maggo, J., Gray, V., De Berardis, G., Ruospo, M., Natale, P., Saglimbene, V., Badve, S. V., Cho, Y., Nadeau-Fredette, A. C., Burke, M., Faruque, L., Lloyd, A., Ahmad, N., Liu, Y., … Strippoli, G. F. (2016). Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes: A Meta-analysis. JAMA, 316(3), 313–324.

Rath, B., Naik, M. R., Rath, B., Bhoi, R., Prakash, J. (2020). Cutaneous adverse drug reactions in a tertiary care hospital: an observational study. Journal of pharmacovigilance and drug research, 1(1), 6-9.

Shurrab, N. T., & Arafa, E. A. (2020). Metformin: A review of its therapeutic efficacy and adverse effects. Obesity medicine, 17 (2020), 100186

Siavash, M., Tabbakhian, M., Sabzghabaee, A. M., & Razavi, N. (2017). Severity of Gastrointestinal Side Effects of Metformin Tablet Compared to Metformin Capsule in Type 2 Diabetes Mellitus Patients. Journal of research in pharmacy practice, 6(2), 73–76.

How to Cite
Kar SK, Khuntia S, Nayak S. Metformin related adverse events: A prospective observational study in health care centers of western Odisha. jpadr [Internet]. 2020Dec.1 [cited 2024Feb.21];1(2):32-4. Available from: