Orudis
- Generic Name: ketoprofen
- Brand Name: Orudis
Orudis (Ketoprofen) side effects drug center
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- Orudis User Reviews
Orudis Side Effects Center
What Is Orudis?
Orudis (ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. Orudis is also used to treat menstrual pain. The brand name Orudis is no longer available in the U.S. It is available in its generic form, ketoprofen.
What Are Side Effects of Orudis?
Common side effects of Orudis (ketoprofen) include:
- upset stomach,
- heartburn,
- stomach pain,
- unusual tiredness,
- constipation,
- diarrhea,
- bloating,
- gas,
- dizziness,
- nervousness,
- lightheadedness,
- drowsiness,
- loss of appetite,
- headache,
- skin itching or rash,
- dry mouth,
- increased sweating,
- runny nose,
- blurred vision, or
- ringing in your ears.
Tell your doctor if you have serious side effects of Orudis (ketoprofen) including:
- allergic reaction (hives, difficulty breathing, or swelling of your face, lips, tongue, or throat),
- chest pain,
- bloody or tarry stools,
- urinating less than usual or not at all,
- confusion,
- depression,
- fever, or
- fast or irregular heartbeat.
Dosage for Orudis
The usual starting dose of Orudis (ketoprofen) is 50 or 75 mg of immediate release capsules every 6 to 8 hours, or 200 mg of extended release capsules once daily. The maximum dose of ketoprofen is 300 mg daily of immediate release capsules or 200 mg daily of extended release capsules. Ketoprofen should be taken with food in order to avoid stomach upset.
What Drugs, Substances, or Supplements Interact with Orudis?
Ketoprofen may interact with cyclosporine, lithium, methotrexate, probenecid, blood thinners, steroids, aspirin, or other nonsterioidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use.
Orudis During Pregnancy or Breastfeeding
During the first 6 months of pregnancy, ketoprofen should be used only when prescribed. Ketoprofen is not recommended for use during the last 3 months of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. It is unknown if ketoprofen passes into breast milk or if it will harm a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Orudis (ketoprofen) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Orudis Consumer Information
Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using ketoprofen and call your doctor at once if you have:
- shortness of breath (even with mild exertion);
- swelling or rapid weight gain;
- nausea, diarrhea, flu-like symptoms (fever, swollen glands, muscle aches, severe weakness);
- a skin rash, no matter how mild;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
- heartburn, stomach pain, gas, nausea, vomiting;
- diarrhea, constipation; or
- dizziness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Orudis (Ketoprofen)
Orudis Professional Information
SIDE EFFECTS
The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Orudis (ketoprofen) -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 (see "WARNINGS").
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 (see "DOSAGE AND ADMINISTRATION"). 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.
Read the entire FDA prescribing information for Orudis (Ketoprofen)
&Copy; Orudis Patient Information is supplied by Cerner Multum, Inc. and Orudis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.