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Generic Name: Ketoprofen
Class: Other Nonsteroidal Anti-inflammatory Agents
Chemical Name: 3-Benzoyl-α-methylbenzeneacetic acid
Molecular Formula: C16H14O3
CAS Number: 22071-15-4


Special Alerts:

[Posted 07/09/2015]

AUDIENCE: Health Professional, Consumer

ISSUE: FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. See the FDA Drug Safety Communication (Table 1) at: for a list of non-aspirin nonsteroidal anti-inflammatory drug products.

Prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.

  • The risk appears greater at higher doses.

  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

  • There is an increased risk of heart failure with NSAID use.

BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

RECOMMENDATION: Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

For more information visit the FDA website at: and .


  • Cardiovascular Risk
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 Risk may increase with duration of use.1 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.1 (See Cardiovascular Effects under Cautions.)

  • Contraindicated for the treatment of pain in the setting of CABG surgery.1

  • GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals are at greater risk for serious GI events.1 (See GI Effects under Cautions.)


Prototypical NSAIA; propionic acid derivative.1 2 3 4 30 53 93 205

Uses for Oruvail

Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.1 Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.1

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.1 36 96 97 98 99 100 101 102 103 104 105 106 107 108 131 132 134 135 136 137 138 139 147 148 150 153 154 158 205

Has been used in the symptomatic treatment of ankylosing spondylitis.97 104 105 106 108 109 138 142 143 144 146 175 205


Relief of pain.1 121 160 166 171 173 174 235 236 238 239


Symptomatic management of primary dysmenorrhea.1 50 161 164 234

Oruvail Dosage and Administration


  • Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.1


Oral Administration

Administer orally once daily as extended-release capsules or 3 or 4 times daily as conventional capsules.1

Administration with antacids,1 97 102 115 116 142 149 food,1 104 or milk1 may minimize adverse GI effects.

Ketoprofen extended-release capsules are not recommended for the management of acute pain because of slow onset of action.1


To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.1 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.1


Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis

Conventional capsules: Initially, 75 mg 3 times daily or 50 mg 4 times daily.1 Base subsequent dosage on clinical response and tolerance.1

Extended-release capsules: Initially, 200 mg once daily.1 Base subsequent dosage on clinical response and tolerance.1


Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.1


Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.1

Prescribing Limits


Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis

Conventional capsules: Maximum 300 mg daily.1

Extended-release capsules: Maximum 200 mg daily.1

Pain or Dysmenorrhea

Conventional capsules: Maximum 300 mg daily.1

Special Populations

Hepatic Impairment

Maximum recommended initial total dosage is 100 mg daily in patients with hepatic impairment and serum albumin concentrations <3.5 g/dL.1

Renal Impairment

Mild renal impairment: Maximum recommended dosage is 150 mg daily.1

Severe renal impairment (GFR <25 mL/minute per 1.73 m2 or end-stage renal impairment): Maximum recommended dosage is 100 mg daily.1 (See Renal Impairment under Cautions.)

Geriatric Patients

Consider reduced initial dosage in patients >75 years of age.1

Cautions for Oruvail


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Known hypersensitivity to ketoprofen or any ingredient in the formulation.1

  • History of asthma, urticaria, or other sensitivity reactions precipitated by aspirin or other NSAIAs.1 26 48 83 86 89 90 91 92 177

  • Treatment of perioperative pain in the setting of CABG surgery.1



Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.284 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.288 289 290 Information not available on risk associated with ketoprofen at this time.288 289 290

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary. 1

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).284

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.1 (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.1 Use with caution in patients with hypertension; monitor BP.1 Impaired response to certain diuretics may occur.1 (See Specific Drugs under Interactions.)

Fluid retention and edema reported.1 Caution in patients with fluid retention or heart failure.1

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;1 241 242 245 increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.1 233 270 281

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;244 270 273 274 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)244 270 273 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).273

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.1

Potential for overt renal decompensation.1 9 15 26 48 83 177 198 Increased risk of renal toxicity in patients with renal1 15 48 83 177 198 or hepatic1 15 26 48 83 177 198 impairment or heart failure,1 26 48 83 177 198 in geriatric patients,1 48 177 in patients with volume depletion,1 16 26 48 83 177 198 224 and in those receiving a diuretic,1 ACE inhibitor,1 or angiotensin II receptor antagonist.286 (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.1

Immediate medical intervention and discontinuance for anaphylaxis.1

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.1

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported;1 142 can occur without warning.1 Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).1

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.1

Elevations of serum ALT or AST reported.1

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.1 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.1 209 210

Hematologic Effects

Anemia reported rarely.1 141 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.1 209 210

May inhibit platelet aggregation and prolong bleeding time.1 34 40 41 47 54

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1

May mask certain signs of infection.1 83 177 209 210

Obtain CBC and chemistry profile periodically during long-term use.1

Specific Populations


Category C.1 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.1


Not known whether distributed into milk in humans.1 Use not recommended.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1

Geriatric Use

Caution advised.1 Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.1 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.1

Select dosage with caution because of age-related decreases in renal function.1 Dosage adjustment recommended in geriatric patients >75 years of age.1 May be useful to monitor renal function.1

Hepatic Impairment

Monitor closely.1 Reduced dosage may be necessary; use lowest effective dosage.1 (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.1

Reduced maximum dosage recommended.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Dyspepsia,1 99 100 102 104 105 109 114 118 123 134 136 139 234 nausea,1 96 99 104 106 109 115 123 125 129 132 135 136 137 138 139 140 234 abdominal pain,1 104 115 127 135 136 137 138 140 234 diarrhea,1 102 104 105 107 114 127 132 133 234 constipation,1 99 104 105 107 109 118 132 135 143 flatulence,1 96 109 137 147 149 155 anorexia,1 107 109 135 137 147 vomiting,1 104 105 109 125 135 136 137 139 stomatitis,1 105 132 146 149 headache,1 99 102 104 105 106 109 118 123 127 129 234 dizziness,1 104 106 109 118 127 131 132 138 234 CNS depression,106 109 138 147 155 158 173 190 CNS excitation,1 104 105 132 150 155 161 tinnitus,1 118 119 164 visual disturbances,1 rash,1 96 104 105 127 132 135 155 190 renal impairment.1 105 118 125 135 158 187 205 224

Interactions for Oruvail

Protein-bound Drugs

Potential for ketoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs.52 78 Observe for adverse effects.209 210 211

Specific Drugs




ACE inhibitors

Reduced BP response to the ACE inhibitor1

Monitor BP1

Angiotensin II receptor antagonists

Reduced BP response to the angiotensin II receptor antagonist291

Monitor BP291

Antacids (magnesium- or aluminum-containing)

Conventional capsules: Pharmacokinetic interaction unlikely1

Anticoagulants (warfarin)

Possible bleeding complications1

Increased PT reported 240

Caution advised 1


Decreased ketoprofen protein binding1 52

Increased risk of GI ulceration or other complications 1

No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs284

Concomitant use not recommended1

Clinical importance of pharmacokinetic changes unknown1


Pharmacokinetic interaction unlikely1

Diuretics (furosemide, thiazides)

Reduced natriuretic effects1

Monitor for diuretic efficacy and renal failure1


Increased plasma lithium concentrations1 209 229

Monitor for lithium toxicity1 209 229


Possible increased and prolonged blood concentrations of methotrexate1 24 210 216 217 218 219 221 231

Use with caution1


Decreased clearance of ketoprofen and/or its conjugates78

Concomitant use not recommended1


Possible altered elimination of ketoprofen; no change in the pharmacokinetics of salicylate52

Clinical importance unknown52

Thrombolytic agents (streptokinase)

Possible bleeding complications39

Use with caution39

Oruvail Pharmacokinetics



Well absorbed following oral administration; bioavailability is about 90%.1 Peak plasma concentration usually attained within 0.5–2 hours (conventional capsules) or 6–7 hours (extended-release capsules).1 58 60 61 62 64 66 69 71


Food delays time to peak plasma concentration by <1 hour or about 2 hours following administration as conventional capsules or extended-release capsules, respectively.1



Distributed into synovial fluid57 64 67 68 71 227 and the CNS.75

Not known whether ketoprofen is distributed into human milk.1

Plasma Protein Binding

>99% (mainly albumin).1 75



Rapidly and extensively metabolized in the liver; active metabolites not identified.1 2 45 59

Elimination Route

Excreted principally in urine.1 57 59 60 61 62 70 72 80 228


Conventional capsules: 2–4 hours.1

Extended-release capsules: 5.4 hours.1

Special Populations

Renal Impairment: Half-life (when given as conventional capsules) prolonged to about 3 hours in patients with mild renal impairment and to about 5–9 hours in patients with moderate to severe renal impairment.1




Conventional and Extended-release Capsules

Tight1 , light resistant containers2 at 25°C1 2 ; protect from direct light and excessive heat and humidity.1


  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.264 265 266 267 268 269 270

  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.1 31 34 42 43 205

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.1

  • Risk of serious cardiovascular events with long-term use.1

  • Risk of GI bleeding and ulceration.1 247 255

  • Risk of serious skin reactions.1 Risk of anaphylactoid and other sensitivity reactions.1

  • Risk of hepatotoxicity.1

  • Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.1

  • Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.1

  • Importance of discontinuing ketoprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.1 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.1

  • Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Importance of avoiding ketoprofen in late pregnancy (third trimester).1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name



Dosage Forms


Brand Names




50 mg*

Ketoprofen Capsules

Mylan, Teva

75 mg*

Ketoprofen Capsules

Mylan, Teva

Capsules, extended-release

200 mg*

Ketoprofen Capsules extended-release




Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ketoprofen 50MG Capsules (TEVA PHARMACEUTICALS USA): 90/$20.98 or 180/$31.98

Ketoprofen 75MG Capsules (TEVA PHARMACEUTICALS USA): 60/$16.99 or 180/$34.98

Ketoprofen CR 200MG 24-hr Capsules (MYLAN): 30/$134.99 or 90/$404.98

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions August 27, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.


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