ADVERSE REACTIONS
Adverse reaction data were derived from patients who received oxaprozin in multidose, controlled, and open-label clinical trials, and from worldwide marketing experience. Rates for events occurring in more than 1% of patients, and for most of the less common events, are based on 2253 patients who took 1200 to 1800 mg oxaprozin per day in clinical trials. Of these, 1721 were treated for at least 1 month, 971 for at least 3 months, and 366 for more than 1 year. Rates for the rarer events and for events reported from worldwide marketing experience are difficult to estimate accurately and are only listed as less than 1%.
Incidence Greater Than 1%
In clinical trials of oxaprozin or in patients taking other NSAIDs, the following adverse reactions occurred atan incidence greater than 1%.
Cardiovascular system: edema.
Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.
Hematologic system: anemia, increased bleeding time.
Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.
Skin and appendages: pruritus, rash.
Special senses: tinnitus.
Urogenital system: abnormal renal function, dysuria or frequency.
Incidence Less Than 1%
The following adverse reactions were reported in clinical trials, from worldwide marketing experience (in italics) or in patients taking other NSAIDs.
Body as a whole: appetite change, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis, serum sickness.
Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including hepatitis, liver failure, stomatitis, hemorrhoidal or rectal bleeding, pancreatitis.
Hematologic system: agranulocytosis, aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, pancytopenia, purpura, thrombocytopenia, leukopenia.
Metabolic system: hyperglycemia, weight changes.
Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.
Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.
Skin: alopecia, angioedema, urticaria, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, sweat, toxic epidermal necrolysis (Lyell's syndrome).
Special senses: blurred vision, conjunctivitis, hearing decrease.
Urogenital: acute interstitial nephritis, cystitis, hematuria, increase in menstrual flow, nephrotic syndrome, oliguria/polyuria, proteinuria, renal insufficiency, acute renal failure, decreased menstrual flow.
|
REPORTS OF SUSPECTED OXAPROZIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Oxaprozin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Oxaprozin side effects / adverse reactions in 24 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-07
Patient: 24 year old female
Reactions: Vomiting, Nausea, Large Intestinal Obstruction, Toxicity TO Various Agents, Somnolence, Overdose, Anticonvulsant Drug Level Increased, Abdominal Distension, Dizziness, Sinus Tachycardia
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Oxaprozin
Dosage: 30 df, unk
Oxaprozin
Dosage: 600 mg, unk
Carbamazepine
Dosage: 200 mg, unk
Indication: Epilepsy
Carbamazepine
Dosage: 280 df, unk
Possible Oxaprozin side effects / adverse reactions in 24 year old female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-20
Patient: 24 year old female
Reactions: Somnolence, Abdominal Distension, Dizziness, Gastrointestinal Sounds Abnormal, Multiple Drug Overdose, Blood Creatinine Increased, Blood Sodium Decreased, Blood Glucose Increased, Vomiting, Nausea, Laceration, Blood Potassium Increased, Toxicity TO Various Agents, Intestinal Obstruction, Blood Pressure Diastolic Increased, Haemodialysis, Sinus Tachycardia
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Carbamazepine
Dosage: 56000 mg; x1; po
Administration route: Oral
Indication: Intentional Overdose
Oxaprozin
Dosage: 18000 mg; x1; po
Administration route: Oral
Indication: Intentional Overdose
Possible Oxaprozin side effects / adverse reactions in 24 year old female
Reported by a physician from Turkey on 2011-11-15
Patient: 24 year old female
Reactions: Vomiting, Nausea, Large Intestinal Obstruction, Somnolence, Overdose, Dizziness, Electrolyte Imbalance, Sinus Tachycardia, Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Carbamazepine
Oxaprozin
Dosage: 30x 600mg tablets
Administration route: Oral
Indication: Overdose
Carbamazepine
Carbamazepine
Dosage: 280x 200mg tablets
Administration route: Oral
Indication: Overdose
Carbamazepine
Dosage: 280x 200mg tablets
Administration route: Oral
Indication: Epilepsy
|
