FOI release

FOI2025/00310 - 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 to today : TACHYCARDIA, UNUSUAL TIREDNESS, TREMOR, UNABLE TO STAND, DOG UNCOMFORTABLE, UNUSUAL STOOL COLOUR, EXCESSIVE VOCALISATION, WHEEZING, DOSE ORALLY GIVEN, LACK OF EFFICACY, RIASED ALANINE AMINOTRANSFERASE (ALT), LETHARGY, POLYDIPSIA, SEIZURE
ANAEMIA, ELEVATED SERUM ALKALINE PHOSPHATASE (ALP), ELAVATED TOTAL BULIRUBIN

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 9th 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
Tachycardia	Tachycardia	Preferred term	63
Unusual tiredness	Tiredness	Low level term	20
Tremor	Tremor	Preferred term	124
Unable to stand	Unable to stand	Low level term	141
Dog uncomfortable	Uncomfortable	Low level term	24
Unusual stool colour	Unusual stool colour	Low level term	1
Excessive vocalisation	Vocalisation	Preferred term	110
Wheezing	Wheezing	Low level term	6
Lack of efficacy	Lack of efficacy	Preferred term	1550
Riased alanine aminotransferase (ALT)	Elevated alanine aminotransferase (ALT)	Low level term	130
Lethargy	Lethargy	Preferred term	524
Polydipsia	Polydipsia	Preferred term	1167
Seizure	Seizure	Preferred term	136
Anaemia	Anaemia	Preferred term	66
Elevated serum alkaline phosphatase (ALP)	Elevated serum alkaline phosphatase (ALP)	Preferred term	129
Elavated total bulirubin	Elevated total bilirubin	Preferred term	22

There is no VeDDRA term for ‘dose orally given’, therefore we searched the database for any narratives that noted oral administration of Librela. We did not find any reports where Librela was administered orally, however it is important to note that information on route of administration is not always provided within adverse event reports.

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.