Dexamethasone
Summary
Persistence. Dexamethasone is potentially persistent.
Bioaccumulation. Dexmethasone has low potential for bioaccumulation.
Toxicity. Dexamethasone may have low acute toxicity. However, the reported values are given as greater than and are not according to the guidelines. The actual values may be lower.
Risk. Risk of environmental impact of dexamethasone cannot be excluded, since there is not sufficient ecotoxicity data available. EMA has requested literature analysis on the known endocrine disruptor activity of dexamethasone in the fish species or submit a protocol for a Fish Full Life-Cycle test for endorsement as appropriate. However, no such information was found on the EMA website as of 2025-06-17.
This summary information comes from fass.se. Corresponding information about bioaccumulation is also available in assessment reports.
Detailed information
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.
Assessment report Neofordex
Assessment report for Neofordex (dexamethasone), 17 December 2015, EMA/CHMP/6613/2016.
Hazard
Persistence: No data.
Bioaccumulation: OECD107: log Kow of dexamethasone 1.83. log Kow of dexamethasone acetate 2.9.
Toxicity: No data.
Risk
"PECsurfacewater of dexamethasone, refined 0.00189 µg/L. PECsurfacewater of dexamethasone acetate, refined 0.00209 µg/L. Conslusion > 0.01 threshold: No."
"The applicant should revise the ERA to include the proposed transformation study in aquatic sediment systems, consumption data on dexamethasone acetate in relation to its use in multiple myeloma, literature analysis on the known endocrine disruptor activity of dexamethasone in the fish species or submit a protocol for a Fish Full Life-Cycle test for endorsement as appropriate." No such information was found during a search on the EMA website on 2025-06-17.
Assessment report Ozurdex 2010
Assessment report for Ozurdex (dexamethasone), EMA/457364/2010.
Hazard
Persistence: No data.
Bioaccumulation: log Kow 2.06 ± 0,58.
Toxicity: No data.
Risk
"The dexamethasone PECsurface water value is 0.007 μg/L, below the action limit of 0.01 μg/L and dexamethasone is not a PBT substance as log Kow does not exceed 4.5 (2.06 ± 0.58). It is concluded that Ozurdex intravitreal implant is unlikely to represent a risk for the environment following its prescribed usage in patients."
Assessment report Ozurdex 2014
Assessment report for Ozurdex for type II variation, 24 July 2014, EMA/492068/2014.
"The environmental exposure assessment was conducted to determine the predicted aquatic concentrations of the active ingredient, dexamethasone, in surface water. As Ozurdex can be prescribed for the treatment of more than one indication, the PECsurface water has been calculated as the sum all of three clinical indications RVO, uveitis and DME, taking into account prevalence data and treatment regimens, resulting in a PECsurface water of 1.69*10-5 µg/L. This is less than the threshold of 0.01 µg/L. Therefore and since dexamethasone is not a persistent bioaccumulative and toxic drug, as log Kow does not exceed 4.5 (2.06 ± 0.58), further risk studies have not been performed. This was considered acceptable by the CHMP."
Fass environmental information Isopto-Maxidex
Fass environmental information for Isopto-Maxidex (dexamethasone) from Novartis (retrieved on 2025-06-17).
Hazard
Persistence: "Ready degradability: 0 %, not readily biodegradable (OECD301E). ... "As dexamethasone does not fulfil the criteria for ready biodegradability, the following phrase is chosen for degradation potential: ‘Dexamethasone is potentially persistent’."
Bioaccumulation: log Kow = 1.83 (method unknown).
Toxicity: There are data for 2 trophic levels, most sensitive algae and crustacean EC50 > 100.0 mg/L. Comment. Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
"Calculation of a risk ratio is not possible, as there is not sufficient environmental toxicity data available. Therefore, the following phrase is used: "Risk of environmental impact of dexametasone cannot be excluded, since there is not sufficient ecotoxicity data available."
Fass environmental information Dexametason Abcur
Fass environmental information for Dexametason Abcur (dexamethasone) from Abcur (retrieved on 2025-06-17).
Hazard
Persistence: No data.
Bioaccumulation: Log K of 1.83 (unknown method).
Toxicity: No data.
Risk
Risk of environmental impact of dexamethasone cannot be excluded, due to the lack of environmental toxicity data.
References
- European Medicines Agency. European public assessment report (EPAR) for Neofordex (dexamethasone), 17 December 2015, EMA/CHMP/6613/2016.
- European Medicines Agency. European public assessment report (EPAR) for Ozurdex (dexamethasone), EMA/457364/2010.
- European Medicines Agency. European public assessment report (EPAR) for Ozurdex for type II variation, 24 July 2014, EMA/492068/2014.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm