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Carprofen (Carprofen) - Side Effects and Adverse Reactions

 
 



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 1 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

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

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.



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



See index of all Carprofen side effect reports >>

Drug label data at the top of this Page last updated: 2010-08-05

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