Vortioxetine, a novel antidepressant for the treatment of major depressive disorder (MDD), is a 5-HT3, 5-HT7 and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist, and serotonin (5-HT) transporter inhibitor [Citation1]. Vortioxetine is approved by the U.S. Food and Drug Administration (FDA) for MDD in adults between 10 and 20 mg a day. The vortioxetine may have a safer profile compared with other traditional antidepressants, with a reduced risk of weight gain and sexual dysfunction; however, rates of nausea tended to be numerically higher in trials [Citation2]. Here, we present three cases about vortioxetine-induced nausea and its management.
A 27-year-old woman who has MDD and drug-naïve was started on vortioxetine 10 mg/day and increased to 20 mg/day progressively. She had nausea for 5 days after the dosage increase. We intented to continue treatment by reducing the dosage to 15 mg daily. Her nausea symptom did not persist after lowering the dosage. The second case was 23-year-old man who was taking escitalopram 10 mg/day because of MDD. During this treatment, he was suffering from the sexual dysfunctions so his treatment was switched to vortioxetine 10 mg/day and then 20 mg/day with cross-tapering. After 20 mg/day of vortioxetine the nausea adverse effect started. He intented to continue with same dosage so we added metoclopramide 10 mg/day to his medication. The nausea was disappeared immediately with this combination. The last case was 32-year-old woman diagnosed with MDD and gastroesophageal reflux disease (GERD). She was taking only lansoprazole 15 mg/day. Accordingly, we decided to start vortioxetine treatment 10 mg/day. She had a nausea symptom during her treatment and wanted to terminate the vortioxetine medication. We increased the lansoprazole 30 mg/day because of the exacerbation probability of GERD symptoms. After two days there was not any sign of nausea and then she could continue vortioxetine with the same dosage.
The side-effect profile of vortioxetine is similar to SSRIs, with gastrointestinal symptoms being most common. Nausea showed a clear dose effect and most patients who had nausea during treatment with vortioxetine reported nausea during the first weeks of dosing. Use of the Naranjo Adverse Drug Reactions Probability Scale [Citation3] indicated a “probable” relationship between the nausea and vortioxetine in our cases above. For vortioxetine, the most common treatment-emergent adverse events leading to withdrawal was nausea. Nausea was most often transient, with a median duration of 9–16 days, for doses from 5 to 20 mg/day [Citation4]. The rates of serious adverse events were similar at all dosing levels when compared to the SNRI group. Vortioxetine generally had lower rates of adverse events at the lower dose levels but for higher doses, adverse events were generally similar to an SNRI [Citation5]. Its additional antagonism of 5-HT3 receptors may partly counteract gastrointestinal adverse effects but nausea has an important role on drug discontinuation. Therefore, nausea is a common but preventable adverse effect during vortioxetine treatment. However, the clinicians may cope with nausea by lowering dosage, adding antiemetic or managing the treatment of comorbid factors.
Disclosure statement
No potential conflict of interest was reported by the authors.
References
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- Citrome L. Vortioxetine for major depressive disorder: a systematic review of the efficacy and safety profile for this newly approved antidepressant–what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int J Clin Pract. 2014;68(1):60–82. doi: 10.1111/ijcp.12350
- Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–245. doi: 10.1038/clpt.1981.154
- Baldwin DS, Chrones L, Florea I, et al. The safety and tolerability of vortioxetine: analysis of data from randomized placebo-controlled trials and open-label extension studies. J Psychopharmacol. 2016;30(3):242–252. doi: 10.1177/0269881116628440
- Meeker AS, Herink MC, Haxby DG, et al. The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis. Syst Rev. 2015;4(1):21. doi: 10.1186/s13643-015-0001-y