Probable fluoxetine-induced hepatomegaly: a case report


  • Jarnail S. Braich Department of Pharmacology, Pt. BD Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India
  • Amiya Sharma Department of Pharmacology, Pt. BD Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India
  • Harsh Vasistha Department of Pharmacology, Pt. BD Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India



Depression, Hepatomegaly, Fluoxetine, SSRIs, Adverse drug reactions


Depressive disorder is a common behavioural, psychiatric disorder. Among various antidepressants selective serotonin reuptake inhibitors (SSRIs) are preferred drugs for the treatment of depression. When second-generation antidepressants SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) are used to treat depression, 0.5–1% of patients develop mildly altered liver function without any symptoms. Various degrees of organ dysfunction are linked with drug-induced liver injury, which is unpredictable and might result from exposure to a drug. We reported suspected fluoxetine-induced hepatomegaly secondary to nine weeks of treatment with an SSRI fluoxetine. Upon cessation of the agent, the patient recovered symptomatically. The evidence is vital that the hepatomegaly in this patient was caused by fluoxetine.


Stokes PE, Holtz A. F1uoxetine tenth anniversary uptake: the progress continues. Clin Ther. 1997;19:1135-250.

Mikocka-Walus A, Prady SL, Pollok J, Esterman AJ, Gordon AL, Knowles S, et al. Adjuvant therapy with antidepressants for the management of inflammatory bowel disease. Cochrane Database Syst Rev. 2019;4(4):CD012680.

Wernicke JF. Safety and side effect profile of fluoxetine. Expert Opinion on Drug Safety. 2004;3(5):495-504.

Marrone G, Vaccaro FG, Biolato M, Miele L, Liguori A, Araneo C, et al. Drug‑induced liver injury 2017: The diagnosis is not easy, but always to keep in mind. Eur Rev Med Pharmacol Sci. 2017;21:1222‑34.

Agrawal R, Almoghrabi A, Attar BM, Gandhi S. Fluoxetine‑induced Stevens‑Johnson syndrome and liver injury. J Clin Pharm Ther. 2019;44:115‑8.

Chu A, Wadhwa R. Selective Serotonin Reuptake Inhibitors. StatPearls Publishing; Treasure Island, FL, USA. 2020.

Carvajal García-Pando A, García del Pozo J, Sánchez AS, Velasco MA, Rueda de Castro AM, Lucena MI: Hepatotoxicity associated with the new antidepressants. J Clin Psychiatry. 2002;63:135-37.

Cooper GL. The safety of fluoxetine: an update. Br J Psychiatry. 1988;3:77-86.

Boyer WF, Blumhardt CL. The safety profile of paroxetine. J Clin Psychiatry. 1992;53:61-6.

Rudolph RL, Derivan AT. The safety and tolerability of venlafaxine hydrochloride: analysis of the clinical trials database. J Clin Psychopharmacol. 1996;16:54S-9S.

Xue F, Strombom I, Turnbull B, Zhu S, Seeger JD. Duloxetine for depression and the incidence of hepatic events in adults. J Clin Psychopharmacol. 2011;31:517-22.

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

World Health Organization. The use of the WHO-UMC system for standardized case causality assessment. Available at: docs/default-source/medicines/pharmacovigilance/ whocausality-assessment.pdf. Accessed on 12 August 2023.

Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat Rev Drug Discov. 2005;4:489-99.

Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002;36(2):451-5.

Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013;144:1419-25.

Reuben A, Koch DG, Lee WM. Drug-induced acute liver failure: results of U.S. multicenter, prospective study. Hepatology. 2010;52(6):2065-76.

Chen M, Borlak J, Tong W. High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury. Hepatology. 2013;58:388-96.

Fontana RJ. Pathogenesis of idiosyncratic drug-induced liver injury and clinical perspectives. Gastroenterology. 2014;146:914-28.

Telles‑Correia D, Barbosa A, Cortez‑Pinto H, Campos C, Rocha NB, Machado S. Psychotropic drugs and liver disease: A critical review of pharmacokinetics and liver toxicity. World J Gastrointest Pharmacol Ther. 2017;8:26‑38.

Soni A, Mane A. Fluoxetine-induced liver injury and skin reaction: A case report. Indian J Psychiatry. 2021;63(4):405-6.




How to Cite

Braich, J. S., Sharma, A., & Vasistha, H. (2023). Probable fluoxetine-induced hepatomegaly: a case report. International Journal of Basic & Clinical Pharmacology, 12(6), 870–873.