Previcox Chewable Tablets Side Effects

Please note - some side effects for Previcox Chewable Tablets may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Previcox Chewable Tablets Side Effects - for the Professional

Previcox Chewable Tablets

Osteoarthritis

In controlled field studies, 128 dogs (ages 11 months to 15 years) were evaluated for safety when given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally once daily for 30 days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed adverse reactions during the study.

Adverse Reactions Seen in U.S. Field Studies
Adverse Reactions Previcox
n=128
Active Control
n=121
Vomiting 5 8
Diarrhea 1 10
Decreased Appetite or Anorexia 3 3
Lethargy 1 3
Pain 2 1
Somnolence 1 1
Hyperactivity 1 0

PREVICOX (firocoxib) Chewable Tablets were safely used during field studies concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics.

Soft-tissue Surgery

In controlled field studies evaluating soft-tissue postoperative pain and inflammation, 258 dogs (ages 10.5 weeks to 16 years) were evaluated for safety when given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for up to two days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Soft-tissure Surgery Postoperative Pain Field Studies
Adverse Reactions Firocoxib Group
n=127
Control Group*
n=131
*
Sham-dosed (pilled)
Vomiting 5 6
Diarrhea 1 1
Bruising at Surgery Site 1 1
Respiratory Arrest 1 0
SQ Crepitus in Rear Leg and Flank 1 0
Swollen Paw 1 0

Orthopedic Surgery

In a controlled field study evaluating orthopedic postoperative pain and inflammation, 226 dogs of various breeds, ranging in age from 1 to 11.9 years in the PREVICOX-treated groups and 0.7 to 17 years in the control group were evaluated for safety. Of the 226 dogs, 118 were given Previcox Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for a total of three days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Orthopedic Surgery Postoperative Pain Field Study
Adverse Reactions Firocoxib Group
n=118
Control Group*
n=108
A case may be represented in more than one category.
*
Sham-dosed (pilled).
One dog had hemorrhagic gastroenteritis.
Vomiting 1 0
Diarrhea 2 1
Bruising at Surgery Site 2 3
Inappetence/Decreased Appetite 1 2
Pyrexia 0 1
Incision Swelling, Redness 9 5
Oozing Incision 2 0

Post-Approval Experience (Rev. 2009)

The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:

Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal perforation, hematemesis, hematachezia, weight loss, gastrointestinal ulceration, peritonitis, abdominal pain, hypersalivation, nausea

Urinary: elevated BUN, elevated creatinine, polydypsia, polyuria, hematuria, urinary incontinence, proteinuria, kidney failure, azotemia, urinary tract infection

Neurological/Behavioral/Special Sense: depression/lethargy, ataxia, seizures, nervousness, confusion, weakness, hyperactivity, tremor, paresis, head tilt, nystagmus, mydriasis, aggression, uveitis

Hepatic: elevated ALP, elevated ALT, elevated bilirubin, decreased albumin, elevated AST, icterus, decreased or increased total protein and globulin, pancreatitis, ascites, liver failure, decreased BUN

Hematological: anemia, neutrophilia, thrombocytopenia, neutropenia

Cardiovascular/Respiratory: tachypnea, dyspnea, tachycardia

Dermatologic/Immunologic: pruritis, fever, alopecia, moist dermatitis, autoimmune hemolytic anemia, facial/muzzle edema, urticaria

In some cases, death has been reported as an outcome of the adverse events listed above.

For a complete listing of adverse reactions for firocoxib reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

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