ADVERSE REACTIONS
Adverse reaction data were derived from patients who received DAYPRO 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 DAYPRO 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 DAYPRO or in patients taking other NSAIDs, the following adverse reactions occurred at an 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 changes, 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.
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REPORTS OF SUSPECTED DAYPRO SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Daypro. The information is not vetted and should not be considered as verified clinical evidence.
Possible Daypro side effects / adverse reactions in 36 year old female
Reported by a physician from United States on 2012-01-23
Patient: 36 year old female weighing 49.9 kg (109.8 pounds)
Reactions: Malaise, Chest Pain, Ulcer Haemorrhage, Epistaxis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Daypro
Possible Daypro side effects / adverse reactions in 67 year old male
Reported by a pharmacist from United States on 2012-03-05
Patient: 67 year old male
Reactions: Night Sweats, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pyrexia, Rash Maculo-Papular
Adverse event resulted in: hospitalization
Suspect drug(s):
Daypro
Possible Daypro side effects / adverse reactions in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-03-13
Patient: 34 year old female
Reactions: Abdominal Discomfort, Acne, Alopecia, FAT Tissue Increased
Suspect drug(s):
Daypro
Dosage: unk
Start date: 2008-01-01
Skelaxin
Dosage: unk
Indication: Intervertebral Disc Degeneration
Start date: 2008-01-01
Other drugs received by patient: Naproxen (Aleve); Naproxen (Aleve); Ultram; Percocet; Excedrin; Demerol; Tramadol; Excedrin
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