Vortioxetine
Summary
Persistence. Vortioxetine is persistent.
Bioaccumulation. Vortioxetine has high potential for bioaccumulation.
Toxicity. Vortioxetine has very high chronic toxicity.
Risk. Based on the available environmental risk assessment, the EMA’s scientific committee, CHMP, concluded that vortioxetine (Brintellix) is considered to pose a risk to the environment. Available data do not permit a definitive conclusion on vortioxetine’s environmental risk; CHMP recommended further investigation.
According to EU established criteria, vortioxetine is considered a PBT substance. The toxicity of aquatic organisms is very high, the substance is capable of bioaccumulation and degradation is slowly in the environment.
This summary information comes from assessment report 2013. Environmental information on vortioxetine is missing on fass.se (2026-10-29).
Detailed information
Assessment report
Assessment report for Brintellix (vortioxetine) 24 October 2013, EMA/699150/2013.
Hazard
Persistence: OECD 308: "DT50, water = 2.1–3.7 days, DT50, sediment = not calculable, DT50, whole system = 7.2–50.1 days % shifting to sediment (d100) = 90.7% / 86.7%"
Bioaccumulation: BCF = 2 032–2 121.
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish 0.091 microg/L.
Risk
Th risk, PEC/PNEC, from the assessment report is from a European perspective. "Free base; risk for fish PEC/PNEC > 1", i.e. moderate.
"The compound is considered as PBT. [---] The available data do not allow to conclude definitively on the potential risk of vortioxetine to the environment. The CHMP recommends further investigation." No additional information was found on the EMA website (2026-10-29).
Summary of Product Information (SmPC) for Brintellix
According to the Summary of Product Characteristics (SmPC) for Brintellix on fass.se (accessed 29 October 2026), the following is stated in section 5.3: "Environmental risk assessment studies have shown that vortioxetine may be persistent, bioaccumulative and toxic to the environment (risk to fish). However, the recommended use of vortioxetine is considered to pose a negligible risk to the aquatic and terrestrial environment (see section 6.6)."In addition, section 6.6 states: "This medicinal product may pose a risk to the environment (see section 5.3)."
Author: Health and Medical Care Administration, Region Stockholm