Paws Over Profits · FDA source library
FDA publications on Librela
Read the FDA’s safety review, notices to veterinarians and dog owners, cumulative adverse event reports, promotional letters, and original approval record. Each link opens the FDA’s own publication.
Where is the Client Information Sheet? It was added to Librela’s labeling in 2025 and is included on the first page of the FDA-hosted labeling PDF linked below.
How to read the FDA adverse event reports
Each quarterly link shows a cumulative snapshot of reports received from May 5, 2023 through the date shown. The reports overlap, so do not add their totals together. An adverse event report does not establish that Librela caused the event, and these summaries cannot establish how often an event occurs among treated dogs. FDA’s September 2024 review separately analyzed reports through March 31, 2024. To search inside a PDF, open it and use your browser’s Find command (Ctrl+F on Windows; Command+F on Mac).
Safety review & communications
Start with the review, veterinary notice and owner information.
Standard Adverse Event Review: Librela
FDA pharmacovigilance review of reports received from approval through March 31, 2024. Includes its methods, case series, discussion and recommendations.
Dear Veterinarian Letter: adverse events reported after Librela
FDA notice to veterinarians describing neurologic, urinary and other reported events and asking clinicians to report suspected events.
Librela Client Information Sheet
Information for dog owners about treatment, signs to watch for and when to contact a veterinarian.
Safety-related labeling changes for Librela
FDA explains the 2025 additions to the label, including post-approval experience, information for dog owners and the Client Information Sheet.
Quarterly adverse event snapshots
Direct FDA PDFs, ordered by reporting cutoff date.
Adverse event reports: Q1 2024
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q2 2024
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q3 2024
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q4 2024
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q1 2025
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q2 2025
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q3 2025
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q4 2025
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q1 2026
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Adverse event reports: Q2 2026
FDA database summary of reported clinical signs for Librela (bedinvetmab), from May 5, 2023 through this cutoff. This is a cumulative snapshot, not only reports from this quarter.
Letters about promotional claims
Two FDA Untitled Letters to Zoetis concerning promotional materials.
Untitled Letter: misleading efficacy claims
FDA describes false or misleading efficacy claims on Zoetis’s Librela professional website, including presentation of the clinical trial results.
Untitled Letter: false or misleading promotional videos
FDA addresses risk-related claims in Zoetis Petcare YouTube videos involving Librela, Solensia and Revolution Plus.
Original approval record
Background on the evidence reviewed when Librela was first approved.
Freedom of Information Summary: original Librela approval
FDA summary of the evidence supporting Librela’s original approval, including the U.S. and European field studies and animal safety information. This approval FOI summary is different from the later FOIA adverse event reports.
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