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Oruvail Side Effects

Generic Name: ketoprofen

Note: This page contains side effects data for the generic drug ketoprofen. It is possible that some of the dosage forms included below may not apply to the brand name Oruvail.

For the Consumer

Applies to ketoprofen: oral capsule, oral capsule extended release, oral solution, oral syrup, oral tablet, oral tablet enteric coated, oral tablet extended release

As well as its needed effects, ketoprofen (the active ingredient contained in Oruvail) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ketoprofen, check with your doctor immediately:

More common:
  • Abdominal pain
  • bloody urine
  • decreased frequency or amount of urine
  • headache
  • increased blood pressure
  • increased thirst
  • loss of appetite
  • lower back or side pain
  • nausea
  • swelling of face, fingers, feet, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common:
  • Bladder pain
  • cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • rash
  • 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
  • chills
  • clay-colored stools
  • cold hands and feet
  • coma
  • confusion
  • congestion
  • constipation
  • convulsions
  • cough or hoarseness
  • coughing or spitting up blood
  • cracks in the skin
  • dark urine
  • decreased urination
  • decreased vision or other changes in vision
  • diarrhea
  • 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
  • heartburn
  • hives or welts
  • increased sensitivity of skin to sunlight
  • indigestion
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of heat from the body
  • muscle pain or cramps
  • nervousness
  • 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
  • sweating
  • 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
  • wheezing
  • yellow eyes or skin
Symptoms of overdose:
  • 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

Minor Side Effects

Some ketoprofen side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Acid or sour stomach
  • belching
  • bloated
  • discouragement
  • dreams
  • excess air or gas in stomach or intestines
  • excitation
  • feeling sad or empty
  • full feeling
  • general feeling of discomfort or illness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • passing gas
  • sleepiness
  • sleeplessness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
Less common:
  • 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 Oruvail) 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.[Ref]

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.[Ref]

Nervous system

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


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 (the active ingredient contained in Oruvail) 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.[Ref]

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.[Ref]


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

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


Hematologic side effects have included reports of increase in bleeding time in patients receiving ketoprofen (the active ingredient contained in Oruvail) 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.[Ref]

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


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 Oruvail) preparations are associated with contact dermatitis and contact photoallergy.[Ref]


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.[Ref]

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


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 Oruvail) to these patients. Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, and laryngeal edema have also been reported.[Ref]


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.[Ref]

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


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 Oruvail) in a 24 hour period.[Ref]

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


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


Musculoskeletal side effects have included myalgia.[Ref]


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


Endocrine side effects have included aggravation of diabetes mellitus.[Ref]


1. "Product Information. Oruvail (ketoprofen)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

2. Lanza FL, Codispoti JR, Nelson EB "An endoscopic comparison of gastroduodenal injury with over-the-counter doses of ketoprofen and acetaminophen." Am J Gastroenterol 93 (1998): 1051-4

3. Collins AJ, Davies J, Dixon ASJ "A prospective endoscopic study of the effect of orudis and oruvail on the upper gastrointestinal tract, in patients with osteoarthritis." Br J Rheumatol 27 (1988): 106-9

4. "Product Information. Orudis (ketoprofen)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

5. Cobb TK, Pierce JR Jr "Acute pancreatitis associated with ketoprofen." South Med J 85 (1992): 430-1

6. Tijhuis GJ, Teepe RGC, Smith SJ "Toxic epidermal necrolysis related to ketoprofen." Dermatology 190 (1995): 176

7. Singh G, Ramey DR, Morfeld D, Fries JF "Comparative toxicity of non-steroidal anti-inflammatory agents." Pharmacol Ther 62 (1994): 175-91

8. Stambaugh J, Drew J "A double-blind parallel evaluation of the efficacy and safety of a single dose of ketoprofen in cancer pain." J Clin Pharmacol 28 (1988): s34-9

9. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-9

10. Pazmino PA, Pazmino PB "Ketoprofen-induced irreversible renal failure." Nephron 50 (1988): 70-1

11. Sennesael J, Van den Houte K, Verbeelen D "Reversible membranous glomerulonephritis associated with ketoprofen." Clin Nephrol 26 (1986): 213-5

12. Gandini R, Cunietti E, Pappalepore V, et al "Effects of intravenous high doses of ketoprofen on blood clotting, bleeding time and platelet aggregation in man." J Int Med Res 11 (1983): 243

13. Tosti A, Gaddoni G, Valeri F, Bardazzi F "Contact allergy to ketoprofen: report of 7 cases." Contact Dermatitis 23 (1991): 112-3

14. Mozzanica N, Pigatto PD "Contact and photocontact allergy to ketoprofen: clinical and experimental study." Contact Dermatitis 23 (1990): 336-40

15. Meggitt SJ, Farr PM "Pseudoporphyria and propionic acid non-steroidal anti-inflammatory drugs." Br J Dermatol 141 (1999): 591-2

16. Hindsen M, Isaksson M, Persson L, Zimersson E, Bruze M "Photoallergic contact dermatitis from ketoprofen induced by drug-contaminated personal objects." J Am Acad Dermatol 50 (2004): 215-9

17. Schreuder G "Ketoprofen: possible idiosyncratic acute bronchospasm." Med J Aust 152 (1990): 332-3

18. Johnson AG, Nguyen TV, Day RO "Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis." Ann Intern Med 121 (1994): 289-300

19. Gurwitz JH, Avron J, Bohn RL, Glynn RJ, Monane M, Mogun H "Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy." JAMA 272 (1994): 781-6

20. Tavcar R, Dernovsek MZ, Brosch S "Ketoprofen intoxication delirium." J Clin Psychopharmacol 19 (1999): 95-6

It is possible that some side effects of Oruvail may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.