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Librela remains FDA-approved for pain associated with osteoarthritis in dogs. Owners should understand what has changed, what symptoms require a call to the veterinarian, and why the FDA’s report totals do not show how many dogs were harmed by the drug.
What the FDA said about Librela
Librela is the brand name for bedinvetmab, a monoclonal antibody administered by a veterinarian as a weight-based, once-monthly injection under the dog’s skin. The FDA approved it on May 5, 2023, for pain associated with canine osteoarthritis.
On December 16, 2024, the FDA’s Center for Veterinary Medicine sent a “Dear Veterinarian” letter concerning adverse-event reports involving dogs treated with Librela. The agency identified reports involving:
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- Ataxia, or impaired balance and coordination
- Seizures
- Paresis, meaning weakness or partial paralysis
- Recumbency, or being unable to rise or remain standing
- Urinary incontinence
- Increased urination
- Increased thirst
Some reports recorded death or euthanasia as an outcome. The FDA communication was directed to veterinarians; it was not described by the agency as a recall or as an urgent alert ordering owners to stop treatment.
What changed on the Librela label
On February 18, 2025, the FDA approved labeling changes that give veterinarians and owners more detailed safety information. Before each injection, the veterinarian must provide and discuss the Librela Client Information Sheet with the dog’s owner.
The updated labeling includes a Post-Approval Experience section listing reported events by body system, as well as an Information for Dog Owners section. The listed events include:
| Body system | Reported events |
|---|---|
| Neurological | Ataxia, seizures, paresis, proprioception deficits and paralysis |
| General | Loss of appetite, lethargy and recumbency |
| Urinary | Increased thirst, increased urination or frequent urination, and urinary incontinence |
| Gastrointestinal | Vomiting and diarrhea |
| Musculoskeletal | Muscle weakness, muscle tremors and lameness |
The label says serious adverse reactions can occur with or without warning and may result in death. It also advises veterinarians to develop an exercise plan. A dog that has been inactive because of arthritis pain may suddenly become more active after receiving pain relief, increasing the risk of injury if activity rises too quickly.
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Symptoms owners should not ignore
The FDA’s owner information says to contact a veterinarian if a dog develops any of the following after receiving Librela:
- Balance problems or trouble walking
- Weakness or difficulty standing
- Paralysis
- Seizures
- Increased drinking or urination
- Loss of bladder control
- Vomiting or diarrhea
- Any other concerning change in health
A seizure, sudden paralysis, collapse, severe weakness, or inability to stand warrants prompt veterinary attention. If your regular clinic is closed, call an emergency veterinary hospital for advice rather than waiting for the next scheduled appointment.
How many Librela adverse-event reports are there?
The latest FDA Freedom of Information Act report listed 18,056 total Librela adverse-drug-event reports received from May 5, 2023, through June 30, 2026. FDA’s search was performed on July 14, 2026. Of those reports:
| Reported subject | Number of reports |
|---|---|
| Dogs | 17,779 |
| Cats | 9 |
| Other species | 4 |
| Accidental human exposure | 140 |
| Total | 18,056 |
These figures need careful interpretation. The 17,779 figure means the FDA database contained that many reports involving dogs. It does not mean that 17,779 dogs were proven to have been harmed by Librela, and it does not mean that all of them experienced severe reactions or died.
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An adverse-event report does not establish that the medication caused the event. A dog may have an underlying illness, be taking other medications, or experience an unrelated medical problem. One report can also contain several clinical signs, so the sign totals cannot be added together. The reports cannot be used to calculate the percentage of treated dogs affected because the FDA does not have a complete denominator for all dogs that received Librela. Underreporting is also possible, while publicity can increase reporting.
What to discuss before the next injection
Before each dose, tell the prescribing veterinarian about any new symptom and provide a complete list of medications and supplements. In particular, discuss:
- Any existing or new balance problem, difficulty walking, or trouble standing.
- Seizures, weakness, collapse, paralysis, or changes in coordination.
- Increased thirst, increased urination, or loss of bladder control.
- Vomiting, diarrhea, loss of appetite, or unusual lethargy.
- Every prescription drug, over-the-counter product, and supplement the dog receives.
- Any previous treatment with a monoclonal antibody.
Do not decide independently to continue, delay, or replace Librela. The veterinarian can weigh the dog’s osteoarthritis pain, mobility, medical history, other treatments, and the reported risks.
What to do if you suspect an adverse event
- Contact the prescribing veterinarian and describe when the symptom began, when the most recent injection was given, and whether the symptom is worsening.
- Seek emergency veterinary care for severe or rapidly developing signs such as seizures, collapse, paralysis, or inability to stand.
- Record the dog’s other illnesses, medications, supplements, and recent changes in activity.
- Ask the clinic for the Librela injection date and vial lot number if available.
- Report the event to Zoetis at 1-888-963-8471 or directly through the FDA’s animal-drug reporting process.
When reporting, include the dog’s medical history, the number of Librela injections received, the timing of the suspected reaction, and the vial lot number if it can be obtained.
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Is Librela recalled or banned?
No. The FDA materials covered here are a veterinarian letter, adverse-event monitoring information, and a labeling update. They do not constitute a Librela recall, permanent ban, or withdrawal. Librela remains identified in FDA labeling as an approved treatment for pain associated with osteoarthritis in dogs.
That approval does not mean every dog is a good candidate or that serious reactions are impossible. It means the treatment remains available under its approved labeling, with the updated warnings and owner discussion requirements. The appropriate decision for an individual dog belongs with the veterinarian who knows its health history.
FAQ
Did the FDA recall Librela?
No. The FDA issued a Dear Veterinarian letter on December 16, 2024 and updated Librela’s labeling on February 18, 2025. The documents do not announce a recall or ban, and Librela remains FDA-approved for canine osteoarthritis pain.
What are the serious side effects associated with Librela?
FDA labeling lists reported events including balance problems, seizures, weakness, paresis or paralysis, difficulty standing, urinary incontinence, increased thirst or urination, vomiting, diarrhea, lethargy, lameness, muscle tremors and recumbency. Death, including euthanasia, was reported in some cases.
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Does the figure of 17,779 mean that many dogs were harmed by Librela?
No. It is the number of reports involving dogs in the FDA database through June 30, 2026. An adverse-event report does not prove Librela caused the event, and the figure cannot be used to calculate the percentage of treated dogs affected.
Should I stop my dog’s Librela injections?
Do not stop, continue, or replace treatment without speaking with the prescribing veterinarian. Before the next injection, discuss your dog’s symptoms, medical history, medications, supplements, activity level and any previous monoclonal-antibody treatment.
The Bottom Line
The FDA has not recalled or banned Librela, but its safety information now includes serious reported events such as seizures, impaired balance, weakness, paralysis, urinary problems, gastrointestinal symptoms and, in some reports, death or euthanasia. Watch for changes in walking, standing, coordination, drinking, urination, appetite and behavior; contact a veterinarian promptly about concerning symptoms. Before every injection, review the updated risks and benefits with the prescribing veterinarian.
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