FOI release

FOI2025/00321 - 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:- vestibular disorder, fever, difficulty rising, abnormal test results, cough, anxiety, nystagmus, elevated SDMA, difficulty standing, wobbling while standing, disorientation, haematuria, pacing, reluctant to move, shaking, tremors, trembling.

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 10th 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. In the context of VeDDRA, the abbreviation NOS stands for Not Otherwise Specified. 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
Vestibular disorder	Vestibular disorder NOS	Low level term	107
Fever	Fever	Low level term	6
Difficulty rising	Difficulty to rise	Low level term	26
Abnormal test results	Other abnormal test result NOS	Low level term	89
Cough	Cough	Low level term	67
Anxiety	Anxiety	Preferred term	180
Nystagmus	Nystagmus	Low level term	78
Elevated SDMA	Elevated symmetrical dimethylarginine (SDMA)	Low level term	41
Difficulty standing	Difficulty standing	Low level term	39
Wobbling while standing	Wobbliness	Low level term	118
Disorientation	Disorientation	Low level term	76
Haematuria	Haematuria	Preferred term	112
Pacing	Pacing	Low level term	74
Reluctant to move	Reluctant to move	Preferred term	61
Shaking	Shaking	Low level term	85
Tremors	Tremor	Preferred term	124
Trembling	Trembling	Low level term	29

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.