FOI release

FOI2025/00318 - 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:-
RPOA, URINARY INCONTINENCE,PARTIAL LACK OF EFFICACY, LIMB WEAKNESS, DEATH,LACK OF EFFICACY, URINARY TRACT INFECTION, NOT EATING, PANTING, ANOREXIA,DECREASED APPETITE, UNABLE TO WALK, INAPPROPRIATE URINATION, PROPRIOCEPTIONDEFICIT, HIND LIMB PARESIS, WEIGHT LOSS, WEAKNESS, MUSCULOSKELETAL DISORDERNOS, ELEVATED ALANINE AMINOTRANSFERASE (ALT), UNABLE TO STAND, ELEVATEDSERUM ALKALINE PH, FRACTURED BONES, JOINT DAMAGE, RPOA

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 of December 2025 for the clinical signs requested by low level term (LLT)/ preferred term (PT), which is one of the hierarchical levels of VeDDRA. One of the terms you requested does not have a VeDDRA term. Eleven of the requested terms are low level terms, and eleven are preferred terms.

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	Number of adverse event reports
RPOA	No Veddra term so search in case narrative for RPOA	50
Urinary Incontinence	Preferred term	643
Partial lack of efficacy	Low level term	1151
Limb weakness	Low level term	186
Death	Preferred term	497
Lack of efficacy	Preferred term	1550
Urinary tract infection	Preferred term	107
Not eating	Low level term	96
Panting	Low level term	278
Anorexia	Preferred term	524
Decreased appetite	Low level term	70
Unable to walk	Low level term	48
Inappropriate urination	Preferred term	109
Proprioception deficit	Low level term	75
Hind limb paresis	Low level term	57
Weight loss	Preferred term	165
Weakness	Low level term	88
Musculoskeletal disorder NOS	Preferred term	203
Elevated alanine aminotransferase (alt)	Low level term	130
Unable to stand	Low level term	141
Elevated serum alkaline PH (Provided Elevated serum alkaline phosphatase (ALP))	Preferred term	129
Fractured bones (Provided Fracture)	Preferred term	65
Joint damage (Provided Bone and joint disorder NOS)	Preferred term	273

The term ‘rapidly progressive osteoarthritis’ is not yet a recognised term in the veterinary field. It has been borrowed from human medical terminology. It has not been possible for the clinical signs reported to be ‘coded’ in a consistent manner using the terms available. It may have been coded as a ‘bone & joint disorder NOS’ or even ‘uncoded sign’, which would not specifically identify those cases relating to rapidly progressive osteoarthritis, without the full content of the narrative being assessed. Therefore, it is not currently possible to provide a definitive number of cases reporting this type of disorder.  

However, a search of case narratives in our adverse event report database that contain’ rapidly progressive osteoarthritis’ identifies 50 such cases.  

You requested ‘elevated serum alkaline ph’, which does not have an equivalent VeDDRA term. Therefore, we have provided the preferred term: Elevated serum alkaline phosphatase (ALP).

You requested “fractured bones”, which does not have an equivalent VeDDRA term. Therefore, we have provided the preferred term: Fracture.

You requested “joint damage”, which does not have an equivalent VeDDRA term. Therefore, we have provided the preferred term: Bone and joint disorder NOS.

 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.