Norocarp Side Effects

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

Norocarp Side Effects - for the Professional

Norocarp

During investigational studies of osteoarthritis with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1 %), and constipation (0.3%). The product vehicle served as control.

There were no serious adverse events reported during clinical field studies with once daily oral administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study(2 mg/lb once daily)
Observation carprofen
(n=129)
Placebo
(n=132)
Inappetence 1.6 1.5
Vomiting 3.1 3.8
Diarrhea/Soft stool 3.1 4.5
Behavior change 0.8 0.8
Dermatitis 0.8 0.8
PU/PD 0.8 --
SAP increase 7.8 8.3
ALT increase 5.4 4.5
AST increase 2.3 0.8
BUN increase 3.1 1.5
Bilirubinuria 16.3 12.1
Ketonuria 14.7 9.1

Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical relevance.

During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)

*A single dog may have experienced more than one occurrence of an event.

Observation* carprofen
(n=148)
Placebo
(n=149)
Vomiting 10.1 13.4
Diarrhea/Soft stool 6.1 6.0
Ocular disease 2.7 0
Inappetence 1.4 0
Dermatitis/skin lesion 2.0 1.3
Dysrhythmia 0.7 0
Apnea 1.4 0
Oral/periodontal disease 1.4 0
Pyrexia 0.7 1.3
Urinary tract disease 1.4 1.3
Wound drainage 1.4 0

Post-Approval Experience:

Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system.

Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.

Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.

Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.

Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria.

Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness.

Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.

Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.

Immunologic or hypersensitivity: Facial swelling, hives, erythema.

In rare situations, death has been associated with some of the adverse reactions listed above. To report a suspected adverse reaction call 1-866-591-5777.

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