Oruvail

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ketoprofen works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen is used to treat pain or inflammation caused by arthritis.

The ketoprofen regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only ketoprofen extended-release capsules are used for treating arthritis. This form of ketoprofen will not work fast enough to treat acute pain.

Ketoprofen may also be used for purposes not listed in this medication guide.

Ketoprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ketoprofen, especially in older adults.

Ketoprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ketoprofen, especially in older adults.

You should not use ketoprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

Taking ketoprofen during the last 3 months of pregnancy may harm the unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether ketoprofen passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Ketoprofen is not approved for use by anyone younger than 18 years old.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Ketoprofen may be taken with food or milk if it upsets your stomach.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

Since ketoprofen is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Oruvail is part of the drug classes:

• Antiinflammatory preparations, non steroids for topical use

• Propionic acid derivatives

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ketoprofen works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen is used to treat pain or inflammation caused by arthritis.

The ketoprofen regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only ketoprofen extended-release capsules are used for treating arthritis. This form of ketoprofen will not work fast enough to treat acute pain.

Ketoprofen may also be used for purposes not listed in this medication guide.

Ask your doctor before using ketoprofen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use ketoprofen if you are also using any of the following drugs:

• lithium;

• methotrexate;

• probenecid;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with ketoprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoprofen in children below 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alacepril
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cilazapril
• Delapril
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Imidapril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Pentopril
• Perindopril
• Pindolol
• Practolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Temocapril
• Timolol
• Trandolapril
• Valsartan
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Asthma or
• Bleeding problems or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease (e.g., congestive heart failure) or
• High blood pressure or
• Kidney disease or
• Liver disease (e.g., hepatitis) or
• Stomach or intestinal ulcers or bleeding or
• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

This section provides information on the proper use of a number of products that contain ketoprofen. It may not be specific to Oruvail. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food, milk, or antacid unless your doctor tells you otherwise .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
    • Children—Use and dose must be determined by your doctor .
  • For mild to moderate pain or menstrual cramps:
    • Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
    • Children—Use and dose must be determined by your doctor .
• For oral dosage form (extended-release capsules):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every day.
    • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a medicine 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:

• 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

• 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

• 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 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:

• 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

• 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked if you are on Oruvail for a long time. Talk with your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to Oruvail.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• If you are 65 or older, use Oruvail (ketoprofen extended-release capsules) with care. You could have more side effects.
• NSAIDs like this medicine may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when Oruvail is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

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]

Some side effects of Oruvail may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.