FOI release

FOI2025/00345 - Librela Adverse events

Published 19 March 2026

Your request

Please can you supply the following information about Librela from the date it was first released until today? The number of recorded cases of:- neutrophilia, collapse, restlessness, wobbliness, confusion, elevated renal parameters, hyposthenuria, frequent urination, overdose, unable to rise, drooling, abnormal ultrasound findings, hind limb paralysis, generally unwell, pale mucous membrane, elevated creatinine, elevated serum alkaline phophatase.

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 have included all adverse event reports. This includes: 

• where an adverse event has occurred that is already listed on the Summary of Product Characteristics
• where more than one product was used
• when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, including prescribing of unauthorised medicines following the prescribing cascade
• where, on further evaluation, there were other reasons for the adverse event occurring such as underlying illnesses or an alternative cause for the clinical signs seen.

Duplicate cases are combined, however if there is doubt as to whether two cases are true duplicates then both cases will be included. VMD databases change over time as new and follow-up information is constantly being received and reviewed. 

Evaluation is dependent on the accuracy and quality of data received from veterinary professionals and animal owners, and reporting frequency can vary over time (reporting frequency may be affected by a product being new to the market or social media interest, for example).  

All adverse events submitted to the VMD have their clinical signs coded using the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA).  We have provided you the number of adverse event reports for Librela from the date of authorisation until 11th December 2025 for the clinical signs requested by low level term (LLT) or preferred term (PT) depending on which term was the closest match to the term you requested. LLT and PT are both hierarchical levels of VeDDRA. Further information regarding VeDDRA can be located on the European Medicines Agency website, including the VeDDRA list of clinical terms for reporting suspected adverse events and the Guidance notes on the use of VeDDRA terminology.   

Term you requested	VeDDRA term	Term type	Number of adverse event reports
Neutrophilia	Neutrophilia	Preferred term	45
Collapse	Collapse NOS	Preferred term	127
Restlessness	Restlessness	Low level term	66
Wobbliness	Wobbliness	Low level term	118
Confusion	Confusion	Low level term	102
Elevated renal parameters	Elevated renal parameters	Low level term	30
Hyposthenuria	Hyposthenuria	Low level term	26
Frequent urination	Frequent urination	Low level term	68
Overdose	Overdose*	Low level term	123
Unable to rise	Unable to rise	Low level term	32
Drooling	Drooling	Low level term	41
Abnormal ultrasound findings	Abnormal ultrasound finding	Preferred term	31
Hindlimb paralysis	Hind limb paralysis	Low level term	36
Generally unwell	Unwell	Low level term	65
Pale mucous membrane	Pale mucous membrane	Preferred term	59
Elevated creatinine	Elevated creatinine	Low level term	70
Elevated serum alkaline phophatase	Elevated serum alkaline phosphatase (ALP)	Preferred term	129

*Regarding the low level term overdose, this term is no longer available in the latest updated version of the VeDDRA dictionary. It was included in the combined list of all VeDDRA codes that have become non-current on 12 June 2025 (available on this page: EudraVigilance Veterinary European Medicines Agency (EMA)). Information on how the VeDDRA list is reviewed can be found on the European Medicines Agency website.

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.  

All medicines whether for human or animal use come with risk, and the benefits of use in wider populations need to outweigh the potential risks. Information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC). The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available Product Information Database.

We continually assess and update our findings relating to products used within the United Kingdom and should there be sufficient data to suggest that an SPC requires alteration or that another appropriate action is required, this will be carried out within the required timeframe, as set out by the current legislation surrounding that veterinary medicinal product or region.

Pharmacovigilance updates are published on gov.uk at https://www.gov.uk/guidance/urgent-safety-updates-for-veterinary-medicines; this also includes any updates involving non-veterinary medicines used in animals.

To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button. The latest update on Librela can be found at Librela solution for injection in dogs - GOV.UK.