Meds A-Z
Robenacoxib
Detailed information about Robenacoxib
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to...
What it does:
COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs.
When it's needed:
Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.
Call your vet sooner if you notice:
- Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.
Commonly reported reactions:
- (2 reports)
- (1 reports)
- (1 reports)
What to 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?
Robenacoxib
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200832 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141320 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.
- High: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Cat (22) Dog (10)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055626
Storage & Handling
Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.
Documents
Official label facts are separated from secondary summaries.
Official documents: 17 • Secondary summaries: 0
- FOI Summary oA 200-832 Approved December 22, 2025.pdf · FOI
- A-200832-A-0000-OT-AA_PI.pdf · Labeling
- A-200832-A-0000-OT-AA_CIS.pdf · Labeling
- Robenacoxib · SPL
- UCM388186.pdf · FOI
- UCM256758.pdf · FOI
- UCM304417.pdf · Labeling
- N-141320-C-0047-NL-AA_PI.pdf · Labeling
- onsior® Tablets for Cats · SPL
- UCM532540.pdf · FOI
- UCM461153.pdf · FOI
- N-141443-C-0014-NL-AA_PI.pdf · Labeling
- onsior® injection · SPL
- UCM504543.pdf · FOI
- Onsior_PI.pdf · Labeling
- Onsior_CI.pdf · Labeling
- onsior™ · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17827 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2341 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2342 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18160/Robenacoxib · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/877 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/876 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/14 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/743 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2218/onsior%C2%AE%20Tablets%20for%20Cats · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/935 · document · FOI
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 7:40 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:01 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:19 AM UTC
Diagnosis-code mappings are not available for this medication yet.
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 58198-4875-1 | 58198 | - | |
| 58198-4886-1 | 58198 | - | |
| 58198-5911-0 | 58198 | - | |
| 73377-097-01 | 73377 | - | |
| 86117-080-16 | 86117 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
A-200832-A-0000-OT-AA_CIS.pdf
• Official label • Official
• Jan. 21, 2026
FDA official labeling for application 200832
-
A-200832-A-0000-OT-AA_PI.pdf
• Official label • Official
• Jan. 21, 2026
FDA official labeling for application 200832
-
FOI Summary oA 200-832 Approved December 22, 2025.pdf
• FOI summary • Official
• Jan. 21, 2026
FDA FOI summary for application 200832
-
N-141320-C-0047-NL-AA_PI.pdf
• Official label • Official
• April 4, 2024
FDA official labeling for application 141320
-
UCM304417.pdf
• Official label • Official
• April 4, 2024
FDA official labeling for application 141320
-
UCM256758.pdf
• FOI summary • Official
• April 4, 2024
FDA FOI summary for application 141320
-
UCM388186.pdf
• FOI summary • Official
• April 4, 2024
FDA FOI summary for application 141320
-
N-141443-C-0014-NL-AA_PI.pdf
• Official label • Official
• Sept. 1, 2020
FDA official labeling for application 141443
-
UCM461153.pdf
• FOI summary • Official
• Sept. 1, 2020
FDA FOI summary for application 141443
-
UCM532540.pdf
• FOI summary • Official
• Sept. 1, 2020
FDA FOI summary for application 141443
-
Onsior_CI.pdf
• Official label • Official
• March 8, 2018
FDA official labeling for application 141463
-
Onsior_PI.pdf
• Official label • Official
• March 8, 2018
FDA official labeling for application 141463
-
UCM504543.pdf
• FOI summary • Official
• March 8, 2018
FDA FOI summary for application 141463
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- overdose_info: Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required. (Clinical, 2026-02-12)
- storage_handling: Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light. (Clinical, 2026-02-12)
- contraindications: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lact… (Official, 2026-02-12)
- side_effects: May cause GI upset (vomiting, diarrhea), reduced appetite; rare cases of severe kidney or GI complications have been reported. (Official, 2026-02-12)
- usage: COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs. (Official, 2026-02-12)
- side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 19:40 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 |
|---|---|---|---|---|
|
Robenacoxib
RX
Robenacoxib
Tablet
• Oral
|
ZYVET AH, Inc. | ANADA 200-832 | Approved | Jan 21, 2026 |
|
onsior® Tablets for Cats
RX
Robenacoxib
Tablet
• Oral
|
Elanco US Inc. | NADA 141-320 | Approved | Apr 4, 2024 |
|
onsior® injection
RX
Robenacoxib
Injection
• Subcutaneous
|
Elanco US Inc. | NADA 141-443 | Approved | Sep 1, 2020 |
|
onsior™
RX
Robenacoxib
Tablet
• Oral
|
Elanco US Inc. | NADA 141-463 | Approved | Mar 8, 2018 |
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.
Composition / specifications
For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.
Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.
The dose of ONSIOR tablets is 0.45 mg/lb (1 mg/kg) orally once daily, for a maximum of 3 days.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.
For subcutaneous injection in cats greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. The first dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given.
Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in cats greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert).
ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.
For subcutaneous injection in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. The first dose should be administered approximately 45 minutes prior to surgery, at the same time as the pre-anesthetic agents are given.
Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in dogs greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert). If subsequent doses are given by subcutaneous injection, different sites for each injection should be used (See Adverse Reactions).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.
-
Labeling A-200832-A-0000-OT-AA_PI.pdf
-
Labeling A-200832-A-0000-OT-AA_CIS.pdf
- Robenacoxib (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM388186.pdf
Summary
This supplement provides for lowering the age limit to > 4 months of age. All cats should still meet the minimum weight requirement of 5.5 lbs (2.5 kg). -
FOI UCM256758.pdf
Summary
ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats > 5.5 lbs (2.5 kg) and > 6 months of age; for up to a maximum of 3 days. -
Labeling UCM304417.pdf
-
Labeling N-141320-C-0047-NL-AA_PI.pdf
- onsior® Tablets for Cats (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM532540.pdf
Summary
For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs > 4 months of age; for up to a maximum of 3 days. -
FOI UCM461153.pdf
Summary
For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats = 4 months of age; for up to a maximum of 3 days. -
Labeling N-141443-C-0014-NL-AA_PI.pdf
- onsior® injection (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM504543.pdf
Summary
For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs = 5.5 lbs (2.5 kg) and = 4 months of age; for up to a maximum of 3 days. -
Labeling Onsior_PI.pdf
-
Labeling Onsior_CI.pdf
- onsior™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.
Side Effects
May cause GI upset (vomiting, diarrhea), reduced appetite; rare cases of severe kidney or GI complications have been reported.
Source: FDA openFDA • Reference
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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.
Cat, Domestic Longhair, Male, 6 month, 2.631 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Hyperthermia, Underdose • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-056102
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 6.00 Month
- Weight: 2.631 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Unassigned
Cat, Domestic Shorthair, Male, 16 year, 4.53 kilogram • Drug: MSK, Injection, Unknown • Reactions: Pain NOS, Pyelonephritis, Blood clot, Constipation, Malaise… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055974
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 16.00 Year
- Weight: 4.530 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Injection
Cat, Snowshoe, Male, 1 year, 4.264 kilogram • Drug: MSK, Injection, Unknown, Dose: 1 tablet per animal • Reactions: Vomiting, Blood in vomit, Death, Anaphylaxis • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-055626
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 1.00 Year
- Weight: 4.264 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Injection
- Dose: 1 tablet per animal
Cat, Domestic Shorthair, Male, 10 year, 4.926 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 24 per hour • Reactions: Vomiting • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055800
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 10.00 Year
- Weight: 4.926 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 1 tablet per animal
- Frequency: 24 per hour
Cat, Domestic Shorthair, Male, 6 year, 6.35 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 0.50 mL per animal, Frequency: 1 per day • Reactions: Elevated temperature, Decreased appetite, Weight loss, Gum disorder NOS • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055975
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 6.00 Year
- Weight: 6.350 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Injection
- Dose: 0.50 mL per animal
- Frequency: 1 per day
Dog, Dog (unknown), Mixed, 1 year, 8 kilogram • Drug: MSK, Oral • Reactions: Elevated C-reactive protein, Pain NOS, Other abnormal test result NOS, IRON LOW, BLOOD • Outcome: Outcome Unknown
- Report ID: ESP-USFDACVM-2025-ES-000003
- Serious AE: No
- Treated For AE: No
- Sex: Mixed
- Age: 1.00 Year
- Weight: 8.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Dog, Spaniel - Portuguese Water, Female, 7 year, 17 kilogram • Drug: MSK, Subcutaneous • Reactions: Increased heart rate, Increased respiratory rate, Hypertension • Outcome: Recovered/Normal
- Report ID: SWE-USFDACVM-2024-SE-000007
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 7.00 Year
- Weight: 17.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
Dog, Chihuahua, Female, 9 year, 6.35 kilogram • Drug: MSK, Unknown • Reactions: Increased heart rate, Scratching, Cardiac arrest • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2024-US-077252
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 9.00 Year
- Weight: 6.350 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required.
Storage & Handling
Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.
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