Regulatory product record
ONSIOR
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- ONSIOR
- DIN
- 02374722
- DPD drug code
- 86004
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET
- Ingredients
- ROBENACOXIB (40 MG)
- Species (DPD record)
- DOGS
- Company
- ELANCO CANADA LIMITED (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 86004
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications11
Post-surgical/acute pain (US: max 3 days; EU: up to 6 days)
CatOn-label (ON_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Post-surgical/acute pain (US: max 3 days; EU: up to 6 days) — Authorized
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Acute pain/inflammation (musculoskeletal, post-op); chronic OA (outside US)
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Acute pain/inflammation (musculoskeletal, post-op); chronic OA (outside US) — Authorized outside US; limited US labeling
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
maximum of 3 days. OstiRobe Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs ≥ 4 months of age; for up to a
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
OstiRobe Injection is indicated 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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
maximum of 3 days. Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs ≥ 4 months of age; for up to a
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens13
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects213
GI (vomiting, soft feces, diarrhea) — Most common, usually mild/self-limiting
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
↑ Liver enzyme activity — With long-term oral use (not always associated with pathology)
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Blood in feces — Reported in some patients
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Effectiveness In a controlled field study (See), a total of 317 male and female dogs representing various breeds were included in the field safety analysis. Robenacoxib-treated dogs ranged in age from 6 months to 15 years and weighed between 2.5 and 53.8 kg. The following table shows the number of dogs exhibiting each observation. Table 1: Adverse reactions reported in the soft tissue surgery field study. *Dogs may have experienced more than one type or occurrence of an event during the study. Most often occurred as a single event. Pain on injection, diarrhea and vomiting were the most commonly reported adverse reactions. Occurrences of hepatopathy, ataxia, skin lesions/urticaria, and anaphylaxis have been associated with the use of robenacoxib. In a month-long pilot study, 3 dogs that received robenacoxib developed hepatic toxicity. Two of these dogs were euthanized and a third dog recovered after prolonged hospitalization and supportive therapy. In foreign market experience, elevated liver enzymes, hepatic necrosis and death have been associated with the long term use of robenacoxib in dogs. Occurrences of liver failure, hepatitis, and cholangiohepatitis have been reported. In two other field studies, bradycardia, 2nd degree heart block in four dogs, and ventricular arrhythmia in one dog were noted in anesthetized dogs treated with robenacoxib injection. Injection site reactions (edema, necrosis, and abscesses), and anaphylactic reactions (panting, drooling, shock, pallor, dyspnea, tachypnea, ataxia) have been associated with the use of robenacoxib injection. Adverse Reaction* Robenacoxib injection N=159 Placebo (0.9% NaCl) N 158 = Pain on injection 18 8 Diarrhea 15 8 Vomiting 10 6 Bradycardia 6 1 Decreased appetite 5 2 Hypotension 2 0 Facial edema, hypersensitivity 1 0 Increased incisional bleeding 1 0
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
In a controlled field study, a total of 249 male and female cats representing 6 breeds, 6 months to 13 years old, weighing 5.5 – 15 lbs were included in the field safety analysis. The following table shows the number of cats exhibiting each observation. The most commonly reported adverse reactions were surgical site bleeding, infected surgery sites, lethargy, vomiting and inappetance. Changes in the clinical pathology values were not considered clinically significant. 1 Cats may have experienced more than one of these signs during the study. 1 Adverse Reactions in the Postoperative Pain Field Study ONSIOR 6 mg Tablets for Cats Placebo Adverse Reaction (robenacoxib) n = 167 (vehicle control) n = 82 Incision site bleeding 7 1 Incision site infection 6 2 Inappetance, weight loss 4 2 Decreased activity, lethargy 4 1 Vomiting 4 1 Cystitis, hematuria 3 0 Hematachezia, diarrhea 3 1 Hair loss, excoriation, bruising 2 0 Respiratory, cardiac arrest 1 0 Incoordination, weakness 1 1 Death 0 1
CatOn-label (ON_LABEL)United States1 source record · View provenance
- Cat · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Injection site swelling19 reports
- Vomiting15 reports
- Not eating14 reports
- Lack of efficacy - NOS13 reports
- Death11 reports
- Lethargy (see also Central nervous system depression in 'Neurological')9 reports
- Diarrhoea7 reports
- Injection site lump6 reports
- Nausea5 reports
- Other abnormal test result NOS5 reports
- Bloody diarrhoea4 reports
- Cardiac arrest4 reports
Cat
- Lethargy (see also Central nervous system depression in 'Neurological')397 reports
- Not eating394 reports
- Anorexia308 reports
- Lack of efficacy - NOS306 reports
- Fever304 reports
- Behavioural disorder NOS294 reports
- Death by euthanasia286 reports
- Vomiting278 reports
- Other abnormal test result NOS270 reports
- Lethargy (see also Central nervous system depression in Neurological)248 reports
- Weight loss223 reports
- Death222 reports
Monitoring2
GI signs; renal parameters (water intake, BUN/creatinine, USG) if long-term
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Dogs on long-term therapy: manufacturer recommends liver enzymes at start, 2, 4, 8 weeks, then every 3–6 months
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications10
GI ulcers; hypersensitivity; hepatic disease (dogs)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
OstiRobe Injection should not be used in dogs that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
OstiRobe Injection should not be used in cats that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Robenacoxib Injection should not be used in dogs that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Robenacoxib Injection should not be used in cats that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions22
Cardiac/renal impairment, dehydration, hypovolemia, hypotension; feline hepatic dysfunction; avoid with corticosteroids/other NSAIDs — observe ≥24h treatment-free period when switching
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Feed timing matters more than for most NSAIDs in cats — give without food (or only a small partial meal) to maximize absorption.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Manufacturer explicitly prohibits mixing with other veterinary medicinal products (no compatibility data).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Wash hands after handling tablets; pregnant women near term advised to wear gloves (manufacturer instruction).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
For subcutaneous use in dogs and cats only. See reverse side for instructions for use in cats. Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental exposure to humans. Do not administer robenacoxib injection or tablets in conjunction with any other oral or injectable NSAID or corticosteroid. Do not use for more than 3 days. Serious adverse events have been reported, including hepatopathy, with the long term use (28 day study) of robenacoxib tablets in dogs (See Adverse Reactions). Safety not demonstrated for longer than 3 days. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety). All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data prior to administration of an NSAID.
Species not recordedOn-label (ON_LABEL)United States3 source records · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
ACE inhibitors, diuretics — Possible ↑ renal risk / ↓ diuretic effect
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Aspirin, corticosteroids, other NSAIDs — ↑ GI toxicity — avoid
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Fluconazole — Possible ↑ levels (class effect extrapolation)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Highly protein-bound drugs — Possible displacement interactions
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Methotrexate — Serious toxicity risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics13
Bioavailability — 84% fasted / 62% fed (dog); 49% fasted / 10% fed (cat)
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — ~98–99.9%
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 0.6–1.7h (dog); 0.8–1.9h (cat)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Hepatic
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — ~65–70% biliary, remainder renal
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Not established; manufacturer does not recommend use in pregnant/lactating/breeding animals.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1044–1046; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 713–715 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references16
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- PHARMACOKINETICS OF A SINGLE INTRAMUSCULAR DOSE OF ROBENACOXIB IN TIGERS (PANTHERA TIGRIS).
Study summary not available in the imported record. Open the original citation to review the study.
- Lack of Effectiveness of Tramadol for Earlier Limb Weight-Bearing After Femoral Head and Neck Excision in 38 Dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetics of a Single Oral Dose of Robenacoxib in Hispaniolan Parrots (Amazona ventralis).
Study summary not available in the imported record. Open the original citation to review the study.
- Intramuscular administration of robenacoxib in Caribbean flamingos (Phoenicopterus ruber) results in rapid absorption and a short plasma half-life.
Study summary not available in the imported record. Open the original citation to review the study.
- Evaluation of cats treated with robenacoxib after gastrointestinal surgery.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.