Ketoprofen — uses, dosing, side effects & the brands that sell it · pharmaranks
Ketoprofen: uses, dosing, side effects & brands
Ketoprofen is a nonsteroidal anti-inflammatory drug sold in the U.S. under 3 brand and generic names, for rheumatoid arthritis, dysmenorrhea and osteoarthritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Nonsteroidal Anti-Inflammatory Drug
Treats
Rheumatoid Arthritis, Dysmenorrhea and Osteoarthritis
From the FDA label for Actron (application NDA020499). Other ketoprofen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Carefully consider the potential benefits and risks of ORUDIS and other treatment options before deciding to use ORUDIS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with ORUDIS, the dose and frequency should be adjusted to suit an individual patient's needs. Concomitant use of ORUDIS and ketoprofen extended-release capsules is not recommended. If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of ORUDIS daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk. In patients with mildly impaired renal function, the maximum recommended total daily dose of ketoprofen ORUDIS is 150 mg. In patients with a more severe renal impairment (GFR less than 25…
Ketoprofen side effects
The incidence of common adverse reactions (above 1%) was obtained from a population of 835 ORUDIS-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 patients treated with ketoprofen extended-release capsules in trials lasting from 4 to 16 weeks. Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of ketoprofen extended-release capsules once a day or 75 mg of ORUDIS (ketoprofen) TID (255 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients, the rate was greater than 2%. The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs (see WARNINGS ). Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related (see DOSAGE AND…
Every ketoprofen product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Ketoprofen pill imprints
Imprint
Strength
Colour
Shape
Maker
KETO75
75 mg
white
capsule
—
KETO;50
50 mg
green
capsule
—
KETO75
75 mg
white
capsule
—
KETO25
25 mg
green
capsule
—
KETO50
50 mg
green
capsule
—
KETO75
75 mg
Frequently asked questions
What is ketoprofen?
Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula: C 16 H 14 O 3 M.W. 254.29 It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. ORUDIS (ketoprofen) Capsules USP contains 75 mg of ketoprofen USP for oral administration. Inactive Ingredients Drug Product Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate. Capsule Shell Constituents 75 mg: Edible printing ink, gelatin, sodium lauryl sulfate and titanium dioxide. chemicalstructure
What kind of drug is ketoprofen?
The FDA classifies ketoprofen as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ketoprofen with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ketoprofen against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ketoprofen sold under?
We track 3 ketoprofen-containing products in the U.S.: Nexcede, Actron and Orudis Kt. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ketoprofen come in?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take ketoprofen
ORUDIS is contraindicated in patients who have shown hypersensitivity to ketoprofen. ORUDIS should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see WARNINGS, Anaphylacroid Reactions and PRECAUTIONS, Preexisting Asthma ). ORUDIS is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Ketoprofen drug interactions
The following drug interactions were studied with ketoprofen doses of 200 mg/day. The possibility of increased interaction should be kept in mind when ORUDIS doses greater than 50 mg as a single dose or 200 mg of ketoprofen per day are used concomitantly with highly bound drugs. ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Antacids Concomitant administration of magnesium hydroxide and aluminum hydroxide does not interfere with the rate or extent of the absorption of ketoprofen administered as ORUDIS. Aspirin Ketoprofen does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased ketoprofen protein binding and increased ketoprofen plasma clearance from 0.07 L/kg/h without aspirin to 0.11 L/kg/h with aspirin. The clinical significance of these changes is not known; however, as with other NSAIDs, concomitant administration of ketoprofen and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. Hydrochlorothiazide, given concomitantly with ketoprofen, produces a reduction in urinary potassium and chloride…
Across the brands we track, ketoprofen is currently marketed as film and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ketoprofen?
We do not currently list a generic-labelled ketoprofen product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.