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Roxee Medication Guide

Bedinvetmab

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Injection Zoetis Inc. Official label facts Owner quick guide first

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Bedinvetmab

Bedinvetmab

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Injection Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Bedinvetmab

For the control of pain associated with osteoarthritis in dogs. Species commonly shown: Both, Dog.

Generic name
Bedinvetmab
Brand names
Librela™, Librela
Manufacturer
Zoetis Inc.
Species
Both, Dog
Dosage forms
Injection, Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Librela™ Librela
Dosage forms
Injection Injectable Solution

Indications / Uses

For the control of pain associated with osteoarthritis in dogs.

Side Effects

Top reported reactions (openFDA): Death by euthanasia, Lethargy (see also Central nervous system depression in Neurological), Polydipsia, Ataxia, Vomiting, Polyuria.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Injection, Injectable Solution

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the control of pain associated with osteoarthritis in dogs.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Overdose (6 reports)
  • Thrombocytosis (3 reports)
  • Leucocytosis NOS (3 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Bedinvetmab; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA reaction aggregate term
Safety signal coverage Reported signals

32 tracked reaction signals; 48 reported cases; 11 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA reaction aggregate term
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA reaction aggregate term
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Overdose (6 reports), Thrombocytosis (3 reports), Leucocytosis NOS (3 reports), Sleepiness - systemic disorder (2 reports), Mass NOS (2 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (2), Behavior (2), Other (25)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (45 reports), Cat (3 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (3), Terrier - Yorkshire (1), ['Shepherd Dog - German', 'Dog (unknown)'] (1), ['Hound (unspecified)', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Bedinvetmab fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Overdose, Thrombocytosis, Leucocytosis NOS

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Bedinvetmab brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA reaction aggregate term · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. Medication usage source · fda_animal_drugs · quick facts
  4. FOI · document · documents
  5. Labeling · document · documents
  6. SPL · document · documents
  7. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Overdose
  • Thrombocytosis
  • Leucocytosis NOS

Most reported reactions:

  • Overdose (6 reports)
  • Thrombocytosis (3 reports)
  • Leucocytosis NOS (3 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
For the control of pain associated with osteoarthritis in dogs.
Form / route / dose
Form: Injectable Solution
Route: Subcutaneous
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Zoetis Inc.
Form: Injectable Solution
Identifiers:
NADA: 141562 NDC Package: 54771-2772-1 NDC Package: 54771-2772-2 NDC Package: 54771-2778-1 NDC Package: 54771-2778-2 NDC Package: 54771-2779-1 NDC Package: 54771-2779-2 NDC Package: 54771-2780-1 NDC Package: 54771-2780-2 NDC Package: 54771-2781-1 NDC Package: 54771-2781-2 NDC Product: 54771
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
155
Matching reports
31
Active filters
1
Selected filters
Reaction: Lethargy (see also Central nervous system depression in Neurological) Clear
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-014390

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Dog
Breed
['Rottweiler', 'Dog (unknown)']
Size / weight
50-99 lb (25.265 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetite
Body systems
NeurologicDigestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014374

Received 2026-03-25 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
50-99 lb (32.205 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Musculoskeletal disorder NOSAggressionUnable to walkUrinary incontinenceMelaenaEmesis (multiple)Lethargy (see also Central nervous system depression in Neurological)Death by euthanasiaNeurological signs NOS
Body systems
OtherBehaviorDigestiveNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-013503

Received 2026-03-23 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (35.017 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
Unable to standMusculoskeletal disorder NOSWeaknessNot eatingLethargy (see also Central nervous system depression in Neurological)Proprioception deficitWeight lossTarry or black stool (see also haemorrhagic diarrhoea)
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-014090

Received 2026-03-20 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Golden
Size / weight
50-99 lb (34.019 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Intact
Region
USA
Reactions
Urinary incontinenceLethargy (see also Central nervous system depression in Neurological)LimpingHind limb paresisFrequent urinationDifficulty in micturitionBloody diarrhoeaDecreased appetite
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-013169

Received 2026-03-19 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
50-99 lb (43.001 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Musculoskeletal disorder NOSCollapse NOS (see also Cardio-vascular and Neurological disorders)Lethargy (see also Central nervous system depression in Neurological)Unable to walkNot eatingWeaknessDeath
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-012910

Received 2026-03-18 · MSK · MSK

Serious
Species
Dog
Breed
Deutsche Dogge, Great Dane
Size / weight
100+ lb (47.174 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
VomitingAppetite lossLethargy (see also Central nervous system depression in Neurological)Heavy breathingDeath
Body systems
DigestiveNeurologicOther
Outcomes
Died

USA-USFDACVM-2026-US-012782

Received 2026-03-17 · MSK · MSK

Serious
Species
Dog
Breed
Setter - English
Size / weight
25-49 lb (21.772 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Dilated renal pelvisIntestinal thickeningAbnormal ultrasound findingBradycardiaPale mucous membraneDiarrhoeaWeight lossLethargy (see also Central nervous system depression in Neurological)LymphomaMedication error NOS
Body systems
OtherDigestiveNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-013316

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd Dog - German', 'Dog (unknown)']
Size / weight
50-99 lb (31.842 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Emesis (multiple)Reluctant to moveUnable to riseDifficulty to riseWeaknessNot eatingNot drinkingHeavy breathingPantingLethargy (see also Central nervous system depression in Neurological)Increased heart rateIncreased respiratory rateAbdominal discomfortDehydrationLeukocytosis NOSMonocytosisAbnormal ultrasound finding
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-012871

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Retriever - Chesapeake Bay']
Size / weight
50-99 lb (37.195 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
AtaxiaLethargy (see also Central nervous system depression in Neurological)AgitationTremorCoughAbnormal radiograph findingUrinary incontinenceElevated alanine aminotransferase (ALT)Faecal incontinenceSeizure NOSHead tremorMedication error NOS
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012478

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Terrier - Bull - American Pit']
Size / weight
50-99 lb (31.298 Kilogram)
Age
8+ years (14 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb weaknessDecreased appetiteDeath by euthanasiaLethargy (see also Central nervous system depression in Neurological)Panting
Body systems
OtherDigestiveNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-011300

Received 2026-03-12 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (35.38 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingWeaknessTremorLethargy (see also Central nervous system depression in Neurological)Weight lossAnaemia NOSAbnormal radiograph findingMedication error NOS
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-011323

Received 2026-03-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Male Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Behavioural disorder NOSDelayed healing
Body systems
NeurologicBehaviorOther
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-009056

Received 2026-02-26 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (28.49 Kilogram)
Age
8+ years (8.42 Year)
Sex
Female Unknown
Region
USA
Reactions
Weight lossLethargy (see also Central nervous system depression in Neurological)Limb weakness
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-008052

Received 2026-02-16 · MSK · MSK

Serious
Species
Dog
Breed
['Chihuahua', 'Poodle (unspecified)']
Size / weight
Under 10 lb (3.937 Kilogram)
Age
8+ years (16 Year)
Sex
Male Neutered
Region
USA
Reactions
Renal failureDeath by euthanasiaLeukocytosis NOSElevated blood urea nitrogen (BUN)Elevated serum alkaline phosphatase (ALP)Not eatingNot drinkingConstipationLethargy (see also Central nervous system depression in Neurological)HyperglycaemiaAbnormal radiograph findingCorneal ulcerWalking slowlyNeck pain - neurologicalOral massToothache
Body systems
OtherNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-005003

Received 2026-02-04 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
50-99 lb (4 Kilogram)
Age
8+ years (1 Year)
Sex
Female Unknown
Region
USA
Reactions
Addison's diseaseLethargy (see also Central nervous system depression in Neurological)FebrileDecreased pulse oxygenationAspiration pneumoniaHypotensionElevated lactateHind limb paresisReduced reflexesDeath
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-001321

Received 2026-01-09 · MSK · MSK

Serious
Species
Dog
Breed
Collie (unspecified)
Size / weight
50-99 lb (38.192 Kilogram)
Age
8+ years (8 Year)
Sex
Female Unknown
Region
USA
Reactions
Lack of efficacy - NOSSkin scabAbnormal cytologyBacterial skin infection NOSFlaking skinHair loss NOSLethargy (see also Central nervous system depression in Neurological)Decreased appetiteExcessive chewing, licking and/or groomingPain NOSLocal erythemaLacerationSoft stoolSkin lesion NOSDermal cyst(s)Salivary stainingSkin ulcerGeneralised red spotHyperkeratosis
Body systems
EffectivenessOtherSkin & allergyNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-075421

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
25-49 lb (20.865 Kilogram)
Age
8+ years (11 Year)
Sex
Female Unknown
Region
USA
Reactions
Emesis (multiple)Not eatingLethargy (see also Central nervous system depression in Neurological)Reluctant to moveSeizure NOS
Body systems
DigestiveOtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2025-US-075395

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (30.754 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Not eatingWobblinessLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2025-US-075264

Received 2025-12-23 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (37.467 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Urinary incontinenceUnable to standFaecal incontinenceNot eatingNot drinkingDifficulty going up/down stairsLimb weaknessBumping into wallsRecumbencyDeath
Body systems
NeurologicOther
Outcomes
Died

USA-USFDACVM-2025-US-075270

Received 2025-12-19 · MSK · MSK

Serious
Species
Dog
Breed
['Pointer (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (35.698 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSDeathLocal erythemaUnderdoseLethargy (see also Central nervous system depression in Neurological)Blood in vomit
Body systems
EffectivenessOtherNeurologicDigestive
Outcomes
Died

USA-USFDACVM-2025-US-073880

Received 2025-12-15 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
50-99 lb (28.304 Kilogram)
Age
8+ years (11 Year)
Sex
Female Intact
Region
USA
Reactions
DeathLethargy (see also Central nervous system depression in Neurological)Emesis (multiple)
Body systems
OtherNeurologicDigestive
Outcomes
Died

USA-USFDACVM-2025-US-072922

Received 2025-12-12 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull - American Pit
Size / weight
50-99 lb (28.894 Kilogram)
Age
8+ years (13 Year)
Sex
Male Intact
Region
USA
Reactions
Pain NOSUrinary incontinenceLethargy (see also Central nervous system depression in Neurological)AnorexiaDeath
Body systems
OtherNeurologicDigestive
Outcomes
Died

USA-USFDACVM-2025-US-073005

Received 2025-12-08 · MSK · MSK

Serious
Species
Dog
Breed
['Bichon Frise', 'Poodle - Miniature']
Size / weight
10-24 lb (8.21 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
WeaknessLethargy (see also Central nervous system depression in Neurological)Unable to standUrine leakageAnaemia NOSElevated creatinineDistension of abdomenCoughPale mucous membraneTachypnoeaShiveringDeathElevated temperature
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2025-US-072887

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (34.428 Kilogram)
Age
8+ years (13 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Unable to standWeakness
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-071646

Received 2025-12-04 · MSK · MSK

Serious
Species
Dog
Breed
['Collie - Border', 'Dog (unknown)']
Size / weight
25-49 lb (20.321 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)GrowlingBiting -aggression (see also Skin and appendages disorders)Not himself/herselfPacingCoughEmesis (multiple)RegurgitationWeaknessAtaxiaNot eatingElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated renal parametersHyperphosphataemiaUnable to walk
Body systems
NeurologicOtherBehaviorDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-071867

Received 2025-12-02 · MSK · MSK

Non-serious
Species
Cat
Breed
Maine Coon
Size / weight
10-24 lb (7.257 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
Prescribing errorVomitingDiarrhoeaLethargy (see also Central nervous system depression in Neurological)
Body systems
OtherDigestiveNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-072463

Received 2025-12-01 · MSK · MSK

Non-serious
Species
Dog
Breed
['Rottweiler', 'Retriever - Labrador']
Size / weight
50-99 lb (27.76 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Proprioception deficitMusculoskeletal disorder NOSLethargy (see also Central nervous system depression in Neurological)AnorexiaReluctant to moveBradycardiaArrhythmiaPyrexiaLymphocytosisLeucocytosis NOSLow thyroxine (T4)Elevated symmetrical dimethylarginine (SDMA)Urinary tract infection
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-072107

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (40.1 Kilogram)
Age
8+ years (10.5 Year)
Sex
Male Neutered
Region
USA
Reactions
VocalisationAbnormal tail posturePain NOSWeight lossDecreased appetiteVomitingChewing disorderPantingTremblingLying downAnxietyExcessive chewing, licking and/or groomingMuscle atrophy (see also Muscle wasting)Musculoskeletal disorder NOSAbnormal radiograph findingSpondylosisJoint effusionElevated gamma-glutamyl transferase (GGT)LymphopeniaLethargy (see also Central nervous system depression in Neurological)Thoracic painDeath by euthanasiaMedication error NOS
Body systems
OtherDigestiveBehaviorNeurologic
Outcomes
Euthanized

USA-USFDACVM-2025-US-070121

Received 2025-11-21 · MSK · MSK

Non-serious
Species
Dog
Breed
['Shepherd Dog - German', 'Dog (unknown)']
Size / weight
50-99 lb (36.015 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Decreased appetiteWobblinessNot himself/herself
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-065982

Received 2025-11-03 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (9.344 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)AnorexiaPale mucous membraneDecreased haematocritThrombocytopeniaImmune mediated haemolytic anaemiaHyperthermiaHeavy breathingFluid in abdomen NOSWeight lossIntentional misuse
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-065104

Received 2025-10-30 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
50-99 lb (43.4 Kilogram)
Sex
Male Neutered
Region
USA
Reactions
Decreased appetiteLethargy (see also Central nervous system depression in Neurological)InappetenceElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Decreased haematocritDecreased packed cell volume (PCV)Low platelet countDiscomfort NOSLoss of hearingLocalised oedema (not application site)Hearing decreased
Body systems
DigestiveNeurologicOther
Outcomes
Outcome Unknown

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
48
Serious reports
11
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Appetite loss, Appetite disorder NOS Skin & allergy (2) · Hair loss, Alopecia NOS Behavior (2) · Anxiety, Aggression Other (25) · Overdose, Thrombocytosis, Leucocytosis NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 6 Dog 0
Other 3 Dog 0
Other 3 Dog 0
Other 2 Dog 0
Other 2 Dog 0
Other 2 Dog 0
Other 2 Dog 0
Other 2 Dog 0

Species coverage: Dog (45) Cat (3)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Unknown - 6
Other Dog Unknown - 3
Other Dog Unknown - 3
Other Dog Unknown - 2
Other Dog Unknown - 2
Other Dog Unknown - 2
Other Dog Unknown - 2
Other Dog Unknown - 2
Other Dog Unknown - 2
Other Dog Unknown - 2
Digestive Dog Serious - 1
Skin & allergy Dog Unknown - 1
Other Dog Unknown - 1
Digestive Dog Serious - 1
Digestive Dog Non-serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Skin & allergy Dog Unknown - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Unknown - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Unknown - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Unknown - 1
Other Cat Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

1

SPL

2

FOI

1

N-141562-C-0024-NL-AA_PI.pdf

Official label / PI · Labeling

Librela™

SPL · SPL

FDA Structured Product Label

Librela™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
141-562
Status
RX
Form
Injectable Solution
Route
Subcutaneous
Species
Dog
Composition / specifications
5, 10, 15, 20, and 30 mg bedinvetmab/mL in sterile solution

Dogs

Indication

For the control of pain associated with osteoarthritis in dogs.

Dosage

Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.

Librela SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Librela. Use the source link for the full official labeling record.

FOI Summary oN 141-562 Approved May 5, 2023.pdf

FOI · FOI

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:46 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Librela
Manufacturer mapping: Zoetis Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Injectable Solution Subcutaneous
Applications: NADA 141-562
NDC: Packages 54771-2772-1 54771-2772-2 54771-2778-1 54771-2778-2 54771-2779-1 54771-2779-2 Products 54771
Documents: 2 (FOI: 1) • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 344 Cat 9 View
Case summaries: 155 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes
ICD10_CM: M19.90
Unspecified osteoarthritis, unspecified site

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Overdose (6) Thrombocytosis (3) Leucocytosis NOS (3) Sleepiness - systemic disorder (2) Mass NOS (2) Lying down (2) Immune mediated haemolytic anaemia (2) Hyperkalaemia (2)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141562 NDC Package: 54771-2772-1 NDC Package: 54771-2772-2 NDC Package: 54771-2778-1 NDC Package: 54771-2778-2 NDC Package: 54771-2779-1 NDC Package: 54771-2779-2 NDC Package: 54771-2780-1 NDC Package: 54771-2780-2 NDC Package: 54771-2781-1 NDC Package: 54771-2781-2 NDC Product: 54771
Package NDC Product NDC Form / Route Status
54771-2772-1 54771 -
54771-2772-2 54771 -
54771-2778-1 54771 -
54771-2778-2 54771 -
54771-2779-1 54771 -
54771-2779-2 54771 -
54771-2780-1 54771 -
54771-2780-2 54771 -
54771-2781-1 54771 -
54771-2781-2 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 122 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Death by euthanasia, Lethargy (see also Central nervous system depression in Neurological), Polydipsia, Ataxia, Vomiting, Pol… (Clinical, 2026-04-11)
  • dosage_forms: Injection (Official, 2026-08-06)
  • dosage_forms: Injection (Official, 2026-08-05)
  • dosage_forms: Injection (Official, 2026-08-04)
  • dosage_forms: Injection (Official, 2026-08-03)
  • dosage_forms: Injection (Official, 2026-08-02)
  • dosage_forms: Injection (Official, 2026-08-01)
  • dosage_forms: Injection (Official, 2026-07-31)
  • dosage_forms: Injection (Official, 2026-07-30)
  • dosage_forms: Injection (Official, 2026-07-29)
  • dosage_forms: Injection (Official, 2026-07-28)
  • dosage_forms: Injection (Official, 2026-07-27)
  • dosage_forms: Injection (Official, 2026-07-26)
  • dosage_forms: Injection (Official, 2026-07-25)
  • dosage_forms: Injection (Official, 2026-07-25)
  • dosage_forms: Injection (Official, 2026-07-22)
  • dosage_forms: Injection (Official, 2026-07-22)
  • dosage_forms: Injection (Official, 2026-07-22)
  • dosage_forms: Injection (Official, 2026-07-20)
  • dosage_forms: Injection (Official, 2026-07-19)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Librela™
RX
Bedinvetmab
Injectable Solution Subcutaneous
Zoetis Inc. NADA 141-562 Approved Feb 19, 2025

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog
Composition / specifications
5, 10, 15, 20, and 30 mg bedinvetmab/mL in sterile solution
Dogs
Indication

For the control of pain associated with osteoarthritis in dogs.

Dosage

Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the control of pain associated with osteoarthritis in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Dog Appetite loss (1) • Dog Appetite disorder NOS (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Alopecia NOS (1) • Dog

Showing top 5 for Skin & allergy.

Behavior
Anxiety (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Overdose (6) • Dog Thrombocytosis (3) • Dog Leucocytosis NOS (3) • Dog Sleepiness - systemic disorder (2) • Dog Mass NOS (2) • Dog
Show more (20)
Lying down (2) • Dog Immune mediated haemolytic anaemia (2) • Dog Hyperkalaemia (2) • Dog Heart murmur (2) • Dog Decreased haematocrit (2) • Dog Arched back (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (1) • Dog Agitation (1) • Dog Agglutination test, positive (1) • Dog Addison's disease (1) • Dog Accidental exposure (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal tail posture (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal posture NOS (1) • Cat Abnormal movement NOS (1) • Dog Abnormal cytology (1) • Dog Abnormal adrenocorticotropic hormone (ACTH) stimulation test (1) • Dog Abdominal discomfort (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Terrier - Yorkshire, Female, 14 year, 6.804 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 5 Milligram per animal • Reactions: Death, Seizure NOS, Lack of efficacy - NOS, Falling • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-014464
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 5 Milligram per animal
Reactions Reported:
Death Seizure NOS Lack of efficacy - NOS Falling
Outcomes: Died

Dog, ['Shepherd Dog - German', 'Dog (unknown)'], Male, 12 year, 40.823 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 1 dose per animal, Frequency: 1 per month • Reactions: Sudden death • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-014360
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 40.823 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 1 dose per animal
  • Frequency: 1 per month
Reactions Reported:
Sudden death
Outcomes: Died

Dog, Retriever - Labrador, Female, 13 year, 27.669 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 20 Milligram per animal • Reactions: Diarrhea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014465
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 27.669 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 20 Milligram per animal
Reactions Reported:
Diarrhea
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Male, 15 year, 32.795 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 20 Milligram per animal, Frequency: 1 per month • Reactions: Diarrhea • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014463
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 15.00 Year
  • Weight: 32.795 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 20 Milligram per animal
  • Frequency: 1 per month
Reactions Reported:
Diarrhea
Outcomes: Ongoing

Dog, ['Hound (unspecified)', 'Dog (unknown)'], Female, 10 year, 17.69 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 10 Milligram per animal • Reactions: Unable to stand, Death by euthanasia • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-014404
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 17.690 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 10 Milligram per animal
Reactions Reported:
Unable to stand Death by euthanasia
Outcomes: Euthanized

Dog, ['Rottweiler', 'Dog (unknown)'], Female, 12 year, 25.265 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 15 Milligram per animal, Frequency: 1 per month • Reactions: Tiredness (lethargy), Decreased appetite • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014390
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 25.265 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 15 Milligram per animal
  • Frequency: 1 per month
Reactions Reported:
Tiredness (lethargy) Decreased appetite
Outcomes: Recovered/Normal

Dog, Retriever - Labrador, Male, 11 year, 47.174 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 30 Milligram per animal, Frequency: 1 per month • Reactions: Partial lack of efficacy • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014361
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 47.174 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 30 Milligram per animal
  • Frequency: 1 per month
Reactions Reported:
Partial lack of efficacy
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 10 year, 32.205 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 20 Milligram per animal • Reactions: Musculoskeletal disorder NOS, Aggression, Unable to walk, Urinary incontinence, Melaena… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-014374
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 32.205 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
  • Dose: 20 Milligram per animal
Reactions Reported:
Musculoskeletal disorder NOS Aggression Unable to walk Urinary incontinence Melaena Vomiting Tiredness (lethargy) Death by euthanasia Neurological signs NOS
Outcomes: Euthanized

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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