ADVERSE REACTIONS
During investigational studies with an oral carprofen caplet formulation at 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 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 caplet (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 frompre-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)
Observation
|
carprofen caplet (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.
Gastointestinal: 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.
Behavorial: 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 1-888-708-3326.
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REPORTS OF SUSPECTED CARPROFEN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Carprofen. The information is not vetted and should not be considered as verified clinical evidence.
Possible Carprofen side effects / adverse reactions in 38 year old female
Reported by a physician from United States on 2011-12-20
Patient: 38 year old female
Reactions: Completed Suicide, Toxicity TO Various Agents
Adverse event resulted in: death
Suspect drug(s):
Quinine Sulfate
Administration route: Oral
Carprofen
Administration route: Oral
Quetiapine
Administration route: Oral
Acetaminophen/diphenhydramine
Administration route: Oral
Hydromorphone HCL
Administration route: Oral
Possible Carprofen side effects / adverse reactions in 58 year old female
Reported by a physician from United States on 2011-12-21
Patient: 58 year old female
Reactions: Completed Suicide, Respiratory Arrest, Cardiac Arrest
Adverse event resulted in: death
Suspect drug(s):
Diphenhydramine HCL
Administration route: Oral
Carprofen
Administration route: Oral
Levothyroxine Sodium
Administration route: Oral
Possible Carprofen side effects / adverse reactions in 38 year old female
Reported by a physician from United States on 2012-01-04
Patient: 38 year old female
Reactions: Toxicity TO Various Agents
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Carprofen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Quetiapine
Administration route: Oral
Indication: Suicide Attempt
Acetaminophen/diphenhydramine
Administration route: Oral
Indication: Suicide Attempt
Quinine Sulfate
Administration route: Oral
Indication: Suicide Attempt
Other drugs received by patient: Hydromorphone HCL; Escitalopram; ALL Other Therapeutic Drugs
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