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Oruvail Side Effects

Generic name: ketoprofen

Medically reviewed by Drugs.com. Last updated on Feb 24, 2022.

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 Oruvail.

For the Consumer

Applies to ketoprofen: oral capsule, oral capsule extended release

Warning

Oral route (Tablet; Capsule; Capsule, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ketoprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Side effects requiring immediate medical attention

Along with its needed effects, ketoprofen (the active ingredient contained in Oruvail) 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

  • Bloody urine
  • decreased frequency or amount of urine
  • headache
  • increased blood pressure
  • increased thirst
  • loss of appetite
  • lower back or side pain
  • nausea
  • stomach pain
  • swelling of the face, fingers, feet, or lower legs
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Less common

  • Bladder pain
  • cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • skin rash
  • swelling or inflammation of the mouth

Rare

  • Back pain
  • bleeding from the rectum
  • bleeding gums
  • blistering, peeling, loosening of the skin
  • blood in vomit
  • bloody nose
  • bloody, black, or tarry stools
  • blurred vision
  • body aches or pain
  • burning feeling in the chest or stomach
  • burning, dry or itching eyes
  • change in color of eye
  • chest pain or tightness
  • chills
  • clay-colored stools
  • cold hands and feet
  • coma
  • confusion
  • congestion
  • constipation
  • 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 of warmth or heat
  • fever with or without chills
  • flushing or redness of the skin, especially on the face and neck
  • general tiredness and weakness
  • heartburn
  • increased sensitivity of the 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 the 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 the fingernails or loosening of the fingernails
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • runny nose
  • scaly skin
  • severe stomach cramping
  • severe or continuing stomach pain
  • severe sunburn
  • skin rash, encrusted, scaly and oozing
  • slow heartbeat
  • slow or irregular breathing
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain or upset
  • sweating
  • swelling of face, ankles, or hands
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • trouble in swallowing
  • trouble breathing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • voice changes
  • vomiting of blood
  • vomiting of material that looks like coffee grounds, severe and continuing
  • yellow eyes or skin

Symptoms of overdose

  • Change in consciousness
  • difficulty or trouble breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular, fast or slow, or shallow breathing
  • loss of consciousness
  • pain or discomfort in chest, upper stomach, or throat
  • pale or blue lips, fingernails, or skin
  • seizures
  • unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Side effects not requiring immediate medical attention

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
  • belching
  • bloated
  • discouragement
  • dreams
  • excess air or gas in the 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
  • trouble concentrating
  • trouble sleeping

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

General

The most frequently reported side effects were gastrointestinal in nature and included dyspepsia, abdominal pain, nausea, diarrhea, constipation, and flatulence.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 11.5%)

Common (1% to 10%): Abdominal pain, diarrhea, constipation, flatulence, anorexia, vomiting, stomatitis, nausea, gastralgia

Uncommon (0.1% to 1%): Gastritis

Rare (0.01% to 0.1%): Peptic ulcer

Very rare (less than 0.01%): Pancreatitis

Frequency not reported: Dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, gastrointestinal (GI) perforation, hematemesis, intestinal ulceration, buccal necrosis, ulcerative colitis, microvesicular steatosis, ulcerative colitis exacerbated, Crohn's disease exacerbated, GI bleeding, mouth ulcer, sore tongue, GI hemorrhage[Ref]

Nervous system

Common (1% to 10%): Headache, central nervous system (CNS) inhibition, CNS excitation, somnolence, dizziness

Rare (less than 0.1%): Paresthesia

Frequency not reported: Amnesia, migraine, taste perversion, convulsions, drowsiness, dysgeusia, optic neuritis[Ref]

Cardiovascular

Frequency not reported: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation, shock, arrhythmia, myocardial infarction, heart failure exacerbated, atrial fibrillation, flushing, vasculitis[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, transaminases increased, bilirubin elevated

Frequency not reported: Hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice, liver function abnormal[Ref]

Renal

Frequency not reported: Renal failure/acute renal failure, interstitial nephritis, nephrotic syndrome, renal function tests abnormal, acute tubulopathy[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, nervousness

Frequency not reported: Confusion, dysphoria, hallucination, libido disturbance, nightmares, personality disorder, tension, anxiety, mood altered[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Pruritus

Frequency not reported: Purpura, alopecia, eczema, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, angioedema, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, bruising[Ref]

Ocular

Common (1% to 10%): Visual disturbance

Frequency not reported: Conjunctivitis, conjunctivitis sicca, eye pain, retinal hemorrhage, retinal pigmentation change[Ref]

Genitourinary

Common (1% to 10%): Urinary tract irritated

Frequency not reported: Impotence, menometrorrhagia, hematuria, gynecomastia[Ref]

Hematologic

Rare (less than 0.1%): Anemia, hemorrhagic anemia

Frequency not reported: Hypocoagulability, agranulocytosis, hemolysis, thrombocytopenia, neutropenia, bone marrow failure, bone marrow aplasia, hemolytic anemia, leukopenia[Ref]

Respiratory

Rare (less than 0.1%): Asthma/asthma attack

Frequency not reported: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema[Ref]

Metabolic

Frequency not reported: Appetite increased, hyponatremia, diabetes mellitus aggravated, hyperkalemia[Ref]

Musculoskeletal

Frequency not reported: Myalgia[Ref]

Immunologic

Rare (less than 0.1%): Anaphylaxis

Frequency not reported: Allergic reaction[Ref]

Local

Frequency not reported: Rectal bleeding, rectal pain, rectal burning, rectal pruritus, rectal tenesmus[Ref]

Other

Common (1% to 10%): Malaise, tinnitus, edema, BUN increased

Uncommon (0.1% to 1%): Fatigue

Rare (less than 0.1%): Weight gain

Frequency not reported: Infection, pain, facial edema, chills, weight loss, thirst, vertigo, hearing impaired, septicemia, aseptic meningitis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate." (2013):

4. "Product Information. Ketoprofen ER (ketoprofen)." Mylan Pharmaceuticals Inc (2016):

5. "Product Information. Ketoprofen (ketoprofen)." Teva Pharmaceuticals USA (2016):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.