Ibuprofen

Detaljerade 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.

EMA's Scientific Discussion

EMA's Scientific Discussion for Pedea (ibuprofen), 2005-10-21.

Given the very limited use of ibuprofen for the treatment of patent ductus arteriosus (PDA) in preterm neonates, environmental exposure was considered negligible compared with the much larger use of ibuprofen in other non-orphan indications. Therefore, a detailed environmental risk assessment was considered unnecessary.

Assessment report Ibuprofen Gen.Orph

Assessment report for Ibuprofen Gen.Orph, 14 December 2023, EMA/586586/2023.

"No environmental risk assessment (ERA) studies were submitted. This was justified by the applicant as the introduction of Ibuprofen Gen.Orph manufactured by Gen.Orph is considered unlikely to result in any significant increase in the combined sales volumes for all ibuprofen containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar".

Comment on generics

After the implementation of the latest European Medicines Agency (EMA) ERA guideline (1 September 2024), a generic company has the following options for Article 10 procedures under Directive 2001/83/EC:

i) to argue that a full ERA is not required because the pharmaceutical substance belongs to certain substance groups (e.g., so-called natural substances);

ii) to identify an official ERA from a previously accepted product and use it; or

iii) to develop its own ERA according to the latest EMA ERA guideline.

Arguments for not submitting an Environmental Risk Assessment (ERA) based on the claim that total environmental exposure has not increased (via total sales volumes) belong to the previous ERA guideline system (2006–2024) and are no longer applicable. Regarding option ii), it should be noted that if a reference ERA exists, the generic company must demonstrate that its conclusions remain technically relevant (since the latest ERA guideline introduced several new technical requirements absent in the previous ERA guideline) and in terms of exposure (showing that the estimated exposure used in the reference ERA remains reasonable). Regulatory authorities (national and EMA) recommend that generic companies attempt to obtain reference ERA documentation from other companies via a so-called Letter of Access (LoA). However, if this is not possible, it remains feasible to argue that the conclusions of an existing reference ERA are still relevant based on information gathered from public assessment reports (summarized descriptions of environmental risk assessments) and product information (to confirm that dosages, indications, etc., have not changed). It should be noted that in some cases, reference ERAs approved between 2006 and 2024 may need to be modified (e.g., with additional experimental studies). If no previous reference ERA can be identified or used, the generic company must commit to developing its own ERA.

Fass environmental information

Fass environmental information for Pedea from Recordati (retrieved on 2026-07-08).

Hazard

Persistence: No data.

Bioaccumulation: Log D_ow = 0.45 at pH 7.4.

Toxicity: No data.

Risk

Risk of environmental impact of ibuprofen cannot be excluded, due to the lack of environmental toxicity

Measurements and other information

In Sweden, ibuprofen has been measured in surface waters and in fish. In fish in concentrations far below therapeutic levels (Report Goodpoint 2016) .

Ibuprofen has been detected in treated wastewater, and surface water in Region Stockholm during the years 2012–2016.

European Union Priority Substances Directive

Ibuprofen is included in the Priority Substances Directive for surface waters (2008/105/EC) and is subject to an environmental quality standard (EQS).

Report Goodpoint 2019

Comparative assessment of environmental risk when using diclofenac, naproxen, ibuprofen, ketoprofen, etoricoxib, celecoxib and paracetamol from a Swedish perspective (Report Goodpoint 2019). From an environmental risk point of view, the exchange of diclofenac is recommended for any of the other investigated NSAIDs/analgesics. [...] Paracetamol is a very safe alternative from an environmental point of view. The others are also considered to pose low environmental risk, but slightly increased for ketoprofen. The risk factors for ketoprofen, naproxen, ibuprofen, celecoxib, etoricoxib and paracetamol are not considered so great that an exchange with another substance is recommended. Environmental measurements as well as efficacy studies of both celecoxib and etoricoxib are required."