Fesoterodine
Summary
Persistence. Fesoterodine is degraded in the environment.
Bioaccumulation. Fesoterodine does not have the potential to bioaccumulate in aquatic organisms.
Toxicity. Fesoterodine has low chronic toxicity.
Risk. Both ecotoxicological effect data and environmental measurements are limited for incontinence pharmaceuticals. However, excretion data, available ecotoxicological effect data, and risk assessment using the fish plasma model for both parent compounds and active metabolites consistently indicate a negligible environmental risk associated with the use of the three anticholinergic substances solifenacin, tolterodine, and fesoterodine from a Swedish perspective. For mirabegron, which is considered persistent in the environment, the risk is somewhat higher but still low. Therefore, no substitutions are recommended from an environmental risk perspective.
This summary information is based on previous environmental data for Toviaz (fesoterodine), Pfizer, from Fass dated 2011-05-12. As of 2026-01-16, environmental information for fesoterodine is not available on fass.se. The risk assessment is taken from the Goodpoint 2026 review.
Detailed information
Scientific discussion
Scientific discussion for Toviaz (fesoterodine) states the following: "As per the guideline, a Phase I estimation of exposure based on the fesoterodine fumarate maximum daily dose of 8 mg and the default Fpen value of 0.01, results in a PECsurfacewater =0.04 μg/L, which is > the Action limit of 0.01 μg/L. Therefore, a Phase II assessment is currently underway and will be submitted as a post-approval commitment, 2Q07." According to contact with the Swedish Medical Products Agency, data have been received (e-mail 2019-09-16) with partly the same information presented below in Fass's environmental information for Toviaz 2011-05-12.
Fass environmental information
Fass environmental information for Toviaz (fesoterodine) from Pfizer (downloaded 2011-05-12).
Hazard
Persistence: "The results of the water/sediment studies show that [14C]-SPM 7605 steadily depletes with time from the water-sediment system with notable biotransformation observed in both the aerobic and anaerobic systems. Once in the sediment, degradation continued at a slower rate under anaerobic conditions. At study termination of 100 days, none of the metabolic products exceeded 10% under aerobic conditions, and complete mineralisation of SPM 7605 is expected with time. These results indicate that SPM 7605 will not persist in the environment."
Bioaccumulation: Log Kow = 0 at pH 7.
Toxicity: There are data for 3 trophic levels, most sensitive green algae NOEC 2 200 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden but unclear during which year. PEC/PNEC = 0.1 which gives the risk insignificant.
Environmental assessment by Goodpoint 2026
Both ecotoxicological effect data and environmental measurements are limited for incontinence pharmaceuticals. However, excretion data, available ecotoxicological effect data, and risk assessment using the fish plasma model for both parent compounds and active metabolites consistently indicate a negligible environmental risk associated with the use of the three anticholinergic substances solifenacin, tolterodine, and fesoterodine from a Swedish perspective. For mirabegron, which is considered persistent in the environment, the risk is somewhat higher but still low. Therefore, no substitutions are recommended from an environmental risk perspective.
Author: Health and Medical Care Administration, Region Stockholm