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The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Orudis-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Oruvail-treated (200 mg/day) patients in trials lasting from 4 to 16 weeks.
Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of Oruvail (ketoprofen) once a day or 75 mg of Orudis (ketoprofen) TID (225 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.
The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs.
Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related. Rare adverse reactions (incidence less than 1%) were collected from one or more of the following sources: foreign reports to manufacturers and regulatory agencies, publications, clinical trials, and/or postmarketing spontaneous reports.
(Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.)
Incidence Greater than 1%
(Adverse events occurring in 3 to 9% of patients are marked with *)
- Digestive: Dyspepsia (11%), nausea*, abdominal pain*, diarrhea*, constipation*, flatulence*, anorexia, vomiting, stomatitis.
- Nervous System: Headache*, dizziness, CNS inhibition (i.e., pooled reports of somnolence, malaise, depression, etc.) or excitation (i.e., insomnia, nervousness, dreams, etc.)*.
- Special Senses: Tinnitus, visual disturbance.
- Skin and Appendages: Rash.
- Urogenital: Impairment of renal function (edema, increased BUN)*, signs or symptoms of urinary-tract irritation.
Incidence Less than 1%
- Body as a Whole: Chills, facial edema, infection, pain, allergic reaction, anaphylaxis.
- Cardiovascular: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation.
- Digestive: Appetite increased, dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, peptic ulcer, gastrointestinal perforation, hematemesis, intestinal ulceration, hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice.
- Hemic: Hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.
- Metabolic and Nutritional: Thirst, weight gain, weight loss, hyponatremia.
- Musculoskeletal: Myalgia.
- Nervous System: Amnesia, confusion, impotence, migraine, paresthesia, vertigo.
- Respiratory: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema.
- Skin and Appendages: Alopecia, eczema, pruritus, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
- Special Senses: Conjunctivitis, conjunctivitis sicca, eye pain, hearing impairment, retinal hemorrhage and pigmentation change, taste perversion.
- Urogenital: Menometrorrhagia, hematuria, renal failure, interstitial nephritis, nephrotic syndrome.
Incidence Less than 1%
The following rare adverse reactions, whose causal relationship to ketoprofen is uncertain, are being listed to serve as alerting information to the physician.
- Body as a Whole: Septicemia, shock.
- Cardiovascular: Arrhythmias, myocardial infarction.
- Digestive: Buccal necrosis, ulcerative colitis, microvesicular steatosis, pancreatitis.
- Endocrine: Diabetes mellitus (aggravated).
- Nervous System: Dysphoria, hallucination, libido disturbance, nightmares, personality disorder, aseptic meningitis.
- Urogenital: Acute tubulopathy, gynecomastia.
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