Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Molecular Formula: C30H26CaO6•2H2O
CAS Number: 53746-45-5
Medically reviewed on Mar 6, 2017
- Cardiovascular Risk
Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).137 500 502 508 b Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)
Contraindicated in the setting of CABG surgery.508
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).137 b Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.137 b Geriatric individuals are at greater risk for serious GI events.100 137 b (See GI Effects under Cautions.)
Uses for Fenoprofen Calcium
Consider potential benefits and risks of fenoprofen therapy as well as alternative therapies before initiating therapy with the drug.100 137 b Use lowest possible effective dosage and shortest duration of therapy consistent with patient’s treatment goals.100 137 b
Fenoprofen Calcium Dosage and Administration
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.100 137 b Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.100 137 b
Osteoarthritis or Rheumatoid ArthritisOral
Osteoarthritis or Rheumatoid ArthritisOral
No dosage adjustments recommended.100
Use not recommended in patients with advanced renal disease.100
No dosage adjustments recommended.
Cautions for Fenoprofen Calcium
In the setting of CABG surgery.508
History of significant renal impairment.100
Cardiovascular Thrombotic Effects
NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508
Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500
Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508
In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508
Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511
Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.141 142 143 145 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.100 137 500 508
Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease.505 511 512 516 Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia.508 Contraindicated in the setting of CABG surgery.508
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.100 137 138 502 508 (See Specific Drugs under Interactions.)
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;100 104 105 108 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.100 124 127 134
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;107 124 125 126 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)107 124 125 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).125
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.100 137 Use with caution in patients with hypertension; monitor BP.100 137
Heart Failure and Edema
NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema.508 (See Specific Drugs under Interactions.)
Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.508
Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.507
Potential for overt renal decompensation.100 137 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.100 137 140 (See Renal Impairment under Cautions.)
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.100 137 Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).100 137
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.100
Elevations of serum ALT or AST reported.100
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.100 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.100
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.100
May mask certain signs of infection.b
Obtain CBC and chemistry profile periodically during long-term use.100
Safety and efficacy not established in children <18 years of age.100
Use with caution in patients ≥65 years of age.100 Geriatric patients appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.100 b Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.100 b
Common Adverse Effects
Interactions for Fenoprofen Calcium
Possible pharmacokinetic interaction; potential for fenoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).100 b d Observe for adverse effects if used with other protein-bound drugs.100 b
Possible deterioration of renal function in individuals with renal impairment144
Angiotensin II receptor antagonists
Reduced BP response to angiotensin II receptor antagonist possible144
Possible deterioration of renal function in individuals with renal impairment144
Antacids (aluminum- and magnesium-containing)
Anticoagulants (e.g., warfarin)
Diuretics (furosemide and thiazides)
Fenoprofen Calcium Pharmacokinetics
Onset of analgesic activity reportedly occurs within 15–30 minutes following oral administration.b
Duration of analgesic activity: 4–6 hours.b
Plasma Protein Binding
Not substantially removed by hemodialysis or peritoneal dialysis.100
Capsules and Tablets
Tight containers at 20–25°C.100
Advice to Patients
Risk of serious cardiovascular events (e.g., MI, stroke).100 500 508 b Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.100 500 508 b
Risk of hepatotoxicity.100 b Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.100 b
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.100
Importance of informing patients of other important precautionary information.100 (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
200 mg (of fenoprofen)
400 mg (of fenoprofen)
600 mg (of fenoprofen)*
Fenoprofen Calcium Tablets
AHFS DI Essentials. © Copyright 2019, Selected Revisions March 6, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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