Headache as an Adverse Effect of Trintellix (vortioxetine)
Trintellix (vortioxetine) can cause headache. [1] Headache has been reported as a treatment-emergent adverse event in clinical studies. [2]
Evidence from Clinical Studies
In a 6-month and 18-month pediatric major depressive disorder (MDD) long-term extension, headache was the most common treatment-emergent adverse event in the 18-month extension (13.8% of patients). [2] In a study comparing vortioxetine oral drop solution versus tablet in healthy adults, more headache events were reported with the oral drop solution (7 vs 1). [3]
Frequency and Clinical Context
Headache is listed as a nervous system disorder adverse reaction in postmarketing experience. [1] Discontinuation or abrupt cessation can be associated with transient adverse reactions that include headache in clinical trials. [1]
Dose-Related Considerations
Higher doses of vortioxetine are associated with increased overall adverse-event discontinuation rates in pooled placebo-controlled studies, which can increase the likelihood that headache is noticed clinically. [4]
When Headache Requires Urgent Evaluation
Headache associated with significant neurologic symptoms warrants immediate medical evaluation. [1] Headache can also occur as a sign of hyponatremia (low sodium) in patients taking serotonergic antidepressants, including Trintellix. [1]
Practical Management in Care Delivery
Headache that emerges after starting or changing vortioxetine should be documented as an adverse event and assessed for severity, timing, and associated symptoms. [1]