FOI release

FOI2026/00351 – Librela adverse events and data sheets

Published 22 May 2026

Your request

Adverse event information relating to Librela and skin conditions.

Our reply

Librela is a veterinary medicinal product (VMP) used for alleviation of pain associated with osteoarthritis in dogs. There are five different strengths authorised in the United Kingdom: Librela 5 mg Solution for Injection for Dogs, Librela 10 mg Solution for Injection for Dogs, Librela 15 mg Solution for Injection for Dogs, Librela 20 mg Solution for Injection for Dogs and Librela 30 mg Solution for Injection for Dogs. 

Please be aware the data provided below are not subject to independent verification and the VMD does not guarantee their accuracy. The figures are based on adverse events submitted to the VMD for the purposes of pharmacovigilance.  

We are able to provide the number of adverse events reports coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities)). All adverse events submitted to the VMD directly or from Marketing Authorisation Holders (MAH, pharmaceutical company) have their clinical signs coded using this standardised approach. Specifics of adverse events submitted are provided within a narrative section of the submission and the codes used may not exactly correlate verbatim with the detail provided in the narrative.

Based on the descriptions and photos of the skin reactions you have provided in your enquiry, we have searched for all adverse event reports containing Librela Solution for Injection for Dogs and any of the following PT level VeDDRA terms in dogs: ‘Alopecia’, ‘Dermal thickening’, ‘Desquamation’, ‘Erythema’, ‘Injection site discharge NOS’, ‘Injection site erythema’, ‘Injection site hair change’, ‘Injection site lesion’, ‘Injection site serous discharge’, ‘Injection site serosanguinous discharge’, ‘Skin lesion NOS’ or ‘Skin textural change’.

We have included all adverse event reports. This includes reports where more than one product was used, reports when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event occurring.

The search criteria above returned a total of 248 case reports containing these terms. We have provided an overview of the breakdown of skin reactions by PT level. Please be aware that some adverse event reports may contain more than one animal.

VeDDRA Preferred Term	Number of reports
Alopecia	118
Dermal thickening	12
Desquamation	18
Erythema	45
Injection site discharge NOS	0
Injection site erythema	5
Injection site hair change	9
Injection site lesion	6
Injection site serous discharge	1
Injection site serosanguinous discharge	2
Injection site skin change	4
Skin lesion NOS	60
Skin textural change	21

Although adverse event report information can be useful to provide a general overview of a VMP, it is important for any clinical decisions regarding the use of a VMP to be based on a risk-benefit discussion specific to the animal or group of animals being administered the VMP. An overall frequency of an adverse event occurring for a VMP does not reflect the actual risk for an individual animal, as there are many individual factors that may contribute to the likelihood of an adverse event occurring. 

The decision to include an adverse event in product information is not based solely on the frequency of reports. The VMD must also consider: 

• Causality assessment – whether there is sufficient scientific evidence to establish a plausible link between the product and the reported event. The fact that an adverse event has occurred following administration of a product does not necessarily mean that event was caused by the product. 

• Confounding factors – animals administered the product may have multiple health conditions or be receiving additional medications. This makes it more difficult to establish whether an adverse event is directly attributable to the product or to other factors. 

• Quality of evidence – robust regulatory decisions require sufficient scientific evidence. Evaluation is dependent on the accuracy and completeness of data provided, and the VMD always considers the likelihood of underreporting when assessing concerns. 

If you or someone else involved with the case has not yet reported this adverse event to the relevant MAH, then we would be grateful if you could do so. MAH contact details can be found within the product information that comes packaged with a medicine, on the MAH’s website, or by searching for the product on the Product Information Database: https://www.vmd.defra.gov.uk/ProductInformationDatabase/, which contains details of all authorised VMPs. The MAH for Librela Solution for Injection for Dogs is Zoetis and their adverse event reporting form can be found here: https://www2.zoetis.co.uk/contact-us/.

MAHs have a legal obligation to report all adverse event reports they receive to the VMD within 30 days of awareness, as per paragraph 57 of The Veterinary Medicines Regulations 2013 and the accompanying guidance in Guideline III Adverse event reporting - GOV.UK.  

If you have already reported the adverse event, you can provide us with the reference number so that we can confirm that this has been received.