Orudis Side Effects
Generic Name: ketoprofen
Note: This document contains side effect information about ketoprofen. Some of the dosage forms listed on this page may not apply to the brand name Orudis.
Some side effects of Orudis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to ketoprofen: oral capsule, oral capsule extended release, oral tablet, oral tablet enteric coated, oral tablet extended release
Along with its needed effects, ketoprofen (the active ingredient contained in Orudis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ketoprofen:More common
- Abdominal pain
- bloody urine
- decreased frequency or amount of urine
- increased blood pressure
- increased thirst
- loss of appetite
- lower back or side pain
- swelling of face, fingers, feet, or lower legs
- troubled breathing
- unusual tiredness or weakness
- weight gain
- Bladder pain
- cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- swelling or inflammation of the mouth
- Back pain
- bleeding from rectum
- bleeding gums
- blistering, peeling, loosening of skin
- blood in vomit
- bloody nose
- bloody, black, or tarry stools
- blurred vision
- body aches or pain
- burning feeling in chest or stomach
- burning, dry or itching eyes
- change in color of eye
- chest pain
- clay-colored stools
- cold hands and feet
- cough or hoarseness
- coughing or spitting up blood
- cracks in the skin
- dark urine
- decreased urination
- decreased vision or other changes in vision
- difficult or labored breathing
- difficulty swallowing
- dilated neck veins
- discharge, excessive tearing
- dryness or soreness of throat
- extreme fatigue
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling faint, dizzy, or lightheadedness
- feeling of warmth or heat
- fever with or without chills
- flushing or redness of skin, especially on face and neck
- general tiredness and weakness
- hives or welts
- increased sensitivity of skin to sunlight
- joint or muscle pain
- light-colored stools
- loss of heat from the body
- muscle pain or cramps
- noisy breathing
- pale or blue lips, fingernails, or skin
- pale skin
- pinpoint red or purple spots on skin
- pounding in the ears
- problems with bleeding or clotting
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- redness or other discoloration of skin
- redness or soreness around fingernails or loosening of the fingernails
- redness, pain, swelling of eye, eyelid, or inner lining of eyelid
- runny nose
- scaly skin
- severe abdominal cramping
- severe or continuing stomach pain
- severe sunburn
- shortness of breath
- skin rash, encrusted, scaly and oozing
- slow heartbeat
- slow or irregular breathing
- sores, ulcers, or white spots on lips or in mouth
- stomach pain or upset
- swelling of face, ankles, or hands
- tender, swollen glands in neck
- tenderness in stomach area
- tightness in chest
- trouble in swallowing
- troubled breathing with exertion
- unpleasant breath odor
- unusual bleeding or bruising
- upper right abdominal pain
- voice changes
- vomiting of blood
- vomiting of material that looks like coffee grounds, severe and continuing
- yellow eyes or skin
- Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fast or shallow breathing
- pain or discomfort in chest, upper stomach, or throat
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
Some side effects of ketoprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- excess air or gas in stomach or intestines
- feeling sad or empty
- full feeling
- general feeling of discomfort or illness
- lack of appetite
- loss of interest or pleasure
- passing gas
- trouble concentrating
- trouble sleeping
- unable to sleep
- Continuing ringing or buzzing or other unexplained noise in ears
- disturbed color perception
- double vision
- halos around lights
- hearing loss
- loss of vision
- night blindness
- overbright appearance of lights
- tunnel vision
- weight loss
For Healthcare Professionals
Applies to ketoprofen: compounding powder, oral capsule, oral capsule extended release, oral tablet
Esophagitis, gastritis, and duodenitis have been associated with the use of ketoprofen (the active ingredient contained in Orudis) 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 side effects have included headache, dizziness, somnolence, malaise, and excitation. These effects may be dose related.
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 (the active ingredient contained in Orudis) 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 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 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 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 (the active ingredient contained in Orudis) preparations are associated with contact dermatitis and contact photoallergy.
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 side effects have included bronchospasm, which may occur in patients with underlying asthma. Caution should be used when administering ketoprofen (the active ingredient contained in Orudis) to these patients. Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, and laryngeal edema have also been reported.
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 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 (the active ingredient contained in Orudis) 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 side effects have included weight gain, weight loss, hyponatremia, and thirst.
Musculoskeletal side effects have included myalgia.
Ocular side effects have included visual disturbance, conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage and pigmentation change.
Endocrine side effects have included aggravation of diabetes mellitus.
More about Orudis (ketoprofen)
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