Adverse drug reactions in the bipolar disorder patients treated with mood stabilizers

Background: Bipolar disorder is a chronic illness requiring long-term use of mood stabilizers such as lithium and sodium valproate. The adverse drug reactions (ADRs) of these medicines can severely affect the quality of life of the patients. A comparative study of ADR profile of lithium and valproate in terms of prevalence, severity, and causality has not been done in the rural population of India. Methodology: A cross-sectional, observational study was done in the psychiatry outpatient department of a tertiary health care center. The bipolar disorder patients on lithium carbonate or divalproate monotherapy were chosen for documentation of ADRs after informed consent. The Naranjo causality algorithm and Modified Hartwig and Siegel scale for severity assessment were applied to all participants. The data obtained were statistically analyzed using Epi Info open-source software. Results: The study participants having mean age of 33.83 +/- 12.02 years comprised nearly equal number of males and females. Tremors (19.4%), polyuria (11.5%), and polydipsia (11.2%) were the most common ADRs due to lithium, whereas nausea (12.6%), anorexia (10.6%), and sedation (9.1%) were more commonly seen in patients on valproate. Most of the ADRs had a mild severity and were categorized as possible in the Naranjo causality algorithm. Conclusion: Although ADRs are common in bipolar disorder patients treated with lithium or valproate, they are often mild and well tolerated by the patients.