Orudis Side Effects

Generic Name: ketoprofen

Please note - some side effects for Orudis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Orudis - for the Consumer

Orudis

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Orudis:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Orudis:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Orudis Side Effects - for the Professional

Orudis

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, U.S. clinical trials, and/or U.S. postmarketing spontaneous reports.

Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.

Incidence Greater than 1% (Probable Causal Relationship)

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.

* Adverse events occurring in 3 to 9% of patients.

Incidence Less than 1% (Probable Causal Relationship)

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% (Causal Relationship Unknown)

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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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Esophagitis, gastritis, and duodenitis have been associated with the use of ketoprofen. Patients should be encouraged to take their medication with food to minimize these effects.

One manufacturer reports a less than 1% incidence of peptic ulcer or gastrointestinal (GI) bleeding in controlled clinical trials involving 1,076 patients. However, this incidence was greater than 2% in open-label continuation trials in 1,292 patients.

Pancreatitis developed twelve days after initiation of ketoprofen therapy for hip pain in an 80-year-old man. The patient complained of anorexia, weakness, and severe epigastric pain. Both amylase and lipase levels became extremely elevated and slowly returned to normal following discontinuation of ketoprofen.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe GI side effects. Ketoprofen should be used with caution in these patients.

Gastrointestinal side effects have been reported the most frequently. These have included dyspepsia (11.5%), nausea (>3%), abdominal pain (>3%), diarrhea (>3%), constipation (>3%), flatulence, dysphagia, anorexia, and stomatitis. More serious gastrointestinal effects include peptic ulceration, intestinal ulceration, gastrointestinal bleeding, gastrointestinal perforation, and pancreatitis.

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, malaise, and excitation. These effects may be dose related.

Renal

Renal side effects have included reports of renal impairment, including increases in blood urea nitrogen and serum creatinine as well as acute renal failure, interstitial nephritis, dysuria, and nephrotic syndrome. This impairment may or may not be reversible upon discontinuation of ketoprofen. In addition, hematuria and signs and symptoms of urinary tract irritation may occur.

At least one case of irreversible renal failure has been reported. The patient experienced proteinuria, peripheral eosinophilia, and eosinophils in the urine. Hemodialysis was required but the patient eventually died. A second case of glomerulonephritis which was reversible following discontinuation of ketoprofen and use of steroid therapy has also been reported.

Ketoprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ketoprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Patients with reduced renal function may be at increased risk for renal side effects.

Hepatic

Hepatic side effects have included elevations in liver function tests, which may occur in up to 15% of patients. Jaundice has been reported rarely.

Elevations in liver function tests three times normal values have been reported in less than 1% of patients receiving ketoprofen during clinical trials.

Hematologic

Hematologic side effects have included reversible inhibition of platelet aggregation, hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, and thrombocytopenia.

Hematologic side effects have included reports of increase in bleeding time in patients receiving ketoprofen. This is seen in conjunction with a reversible inhibition of platelet aggregation which is restored within 24 hours of the last dose. No consistent effects on other coagulation parameters have been noted.

Dermatologic

Dermatologic side effects have included rash (1% to 3%), alopecia, eczema, pruritus, bullous rash, exfoliative dermatitis, photosensitivity, toxic epidermal necrolysis, positive Nikolsky sign, and skin discoloration. Topical ketoprofen preparations are associated with contact dermatitis and contact photoallergy.

Hypersensitivity

Hypersensitivity side effects have included urticaria, laryngeal edema, fever, conjunctivitis, bronchospasm, and anaphylaxis.

A 21-year-old female developed a pruritic macropapular rash 48 hours after taking a second dose of flurbiprofen 200 mg for a sore throat. Two days later, the patient developed angioedema of the hands and feet along with hypotension. After treatment with methylprednisolone, the skin healed.

Respiratory

Respiratory side effects have included bronchospasm, which may occur in patients with underlying asthma. Caution should be used when administering ketoprofen to these patients. Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, and laryngeal edema have also been reported.

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Cardiovascular side effects have included hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation, arrhythmias and myocardial infarction.

Psychiatric

Psychiatric effects and including persecutory delusions, and auditory and visual scenic hallucinations have been reported in a 64-year-old white woman after taking 600 mg to 700 mg of ketoprofen in a 24 hour period.

Psychiatric side effects have included reports of depression, nervousness, and dreams in greater than 1% of patients in clinical trials.

Metabolic

Metabolic side effects have included weight gain, weight loss, hyponatremia, and thirst.

Musculoskeletal

Musculoskeletal side effects have included myalgia.

Ocular

Ocular side effects have included visual disturbance, conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage and pigmentation change.

Endocrine

Endocrine side effects have included aggravation of diabetes mellitus.

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