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Ketoprofen

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat rheumatoid arthritis, osteoarthritis, pain, and primary dysmenorrhea (painful periods), depending on the formulation.

Brand names ActronNexcedeOrudisOrudis KTOruvail +3 more
Drug class Nonsteroidal Anti-inflammatory Drug
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Ketoprofen at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ketoprofen is an older NSAID (nonsteroidal anti-inflammatory drug), on the U.S. market since about 1979 and available generically, that treats rheumatoid arthritis, osteoarthritis, pain and painful periods by blocking prostaglandins and leukotrienes, chemicals that drive inflammation. Most people handle it about as well as other NSAIDs, with upset stomach or indigestion the most common complaint. Its boxed warning, the FDA's strongest, covers heart attack, stroke and serious stomach or intestinal bleeding that can strike without warning, so chest pain, slurred speech, black stools or vomiting blood need emergency care. Use the lowest dose for the shortest time, especially if you are older or have heart, kidney or liver disease.

Clinical pearls

  • Taking it with food or milk eases stomach upset and only slows how fast it is absorbed, not how much.
  • The extended-release capsules are for arthritis only and act too slowly for quick pain relief, and never take both forms together.
  • If you are pregnant, avoid it from about 20 weeks on, and do not use it at all from 30 weeks.
  • Tell whoever manages your warfarin, lithium, methotrexate, water pill or ACE inhibitor, and avoid aspirin and probenecid alongside it.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Ketoprofen carries two serious FDA boxed warnings — the highest level of drug warning.

Heart attack and stroke: Like all NSAIDs, ketoprofen increases the risk of serious — potentially fatal — blood clots, heart attack, and stroke. This risk can start within the first weeks of use and goes up the longer you take it or the higher the dose. People who already have heart disease are at the highest absolute risk. Ketoprofen capsules must not be used right after coronary artery bypass graft (CABG) heart surgery. Watch for chest pain, shortness of breath, sudden weakness, or slurred speech and get emergency help immediately if any of these occur.

Stomach and intestinal bleeding: NSAIDs including ketoprofen can cause serious GI bleeding, ulcers, and perforation of the stomach or intestines — events that can be fatal and can occur without any warning signs. Older adults are at the greatest risk. Tell your doctor right away if you notice black or bloody stools, vomit that looks like coffee grounds, or severe stomach pain.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule, Extended-release capsule
Earliest FDA record1979
Companies listing it with the FDA5
FDA label last updatedJul 15, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Ketoprofen, written from its FDA label.

What Ketoprofen is used for

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Ketoprofen is an NSAID available in immediate-release and extended-release capsule forms, with approved uses that vary by formulation.

  • Rheumatoid arthritis — all formulations (Ketoprofen capsules USP, Orudis capsules, and Ketoprofen extended-release capsules) are approved for managing signs and symptoms
  • Osteoarthritis — all formulations are approved for managing signs and symptoms
  • Pain management — Ketoprofen capsules USP and Orudis capsules are approved; Ketoprofen extended-release capsules are not recommended for acute pain due to their slow-release characteristics
  • Primary dysmenorrhea (painful menstrual periods) — Ketoprofen capsules USP and Orudis capsules are approved; Ketoprofen extended-release capsules are not indicated for this use

How Ketoprofen works

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Ketoprofen blocks the enzymes that produce prostaglandins and leukotrienes — the chemical messengers that cause pain, swelling, and fever in the body. It also counteracts bradykinin (a pain-triggering substance) and helps stabilize the membranes of cells involved in inflammation. Together, these actions reduce inflammation, relieve pain, and lower fever.

Only one form of the ketoprofen molecule (the S-enantiomer) is pharmacologically active. After an oral dose, pain relief can begin within 30 minutes for many patients, and the effect may last up to 6 hours with the immediate-release capsules.

Ketoprofen dosage

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Ketoprofen capsules (Ketoprofen USP and Orudis) are taken multiple times a day by mouth, while Ketoprofen extended-release capsules are taken just once daily. Both forms can be taken with food or milk to reduce stomach upset — food slows how quickly the drug is absorbed but doesn't change the total amount that gets into your system. Never take an immediate-release capsule and an extended-release capsule at the same time.

  • Always use the lowest dose that controls your symptoms for the shortest time needed
  • Dose adjustments are required for adults over 75, and for people with kidney or liver impairment — your prescriber will guide you
  • If you miss a dose, follow the guidance on your prescription label or ask your pharmacist

Dosing details from the FDA-approved label

From the Ketoprofen prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Rheumatoid Arthritis and Osteoarthritis
    • The recommended starting dose in otherwise healthy patients is 75 mg three times or 50 mg four times a day
    • Maximum: 300 mg/day
    • Smaller doses should be used initially in small individuals or in debilitated or elderly patients; may be taken with antacids, food, or milk to minimize GI effects
  • Management of Pain and Dysmenorrhea
    • 25 to 50 mg every 6 to 8 hours as necessary for mild-to-moderate pain and dysmenorrhea
    • A larger dose may be tried if response was unsatisfactory, but doses above 75 mg have not been shown to give added analgesia
    • Maximum: Daily doses above 300 mg are not recommended
    • Smaller dose initially in small individuals, debilitated or elderly patients, or patients with renal or liver disease
  • Elderly patients over 75 years of age
    • Initial dosage should be reduced
    • Renal function may be reduced with apparently normal serum creatinine and/or BUN levels
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of Ketoprofen Capsules, USP and other treatment options before deciding to use Ketoprofen Capsules, USP. 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 Ketoprofen Capsules, USP, the dose and frequency should be adjusted to suit an individual patient's needs. Concomitant use of Ketoprofen Capsules, USP 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 Ketoprofen Capsules, USP 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 Capsules, USP is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m2 or end-stage renal impairment), the maximum total daily dose of Ketoprofen Capsules, USP should not exceed 100 mg. In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of Ketoprofen Capsules, USP should be reduced for patients over 75 years of age (see Geriatric Use ). It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of Ketoprofen Capsules, USP should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) ketoprofen and should be closely monitored.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ketoprofen side effects

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The most common side effects with ketoprofen involve the digestive system, followed by nervous system effects.

Common side effects

  • Upset stomach or indigestion (most common)
  • Nausea, stomach pain, or diarrhea
  • Constipation or gas
  • Headache
  • Dizziness or drowsiness
  • Ringing in the ears (tinnitus)
  • Skin rash
  • Swelling or fluid retention
  • Gas or loss of appetite
  • Fluid retention or swelling, and changes in kidney function

When to get medical help

  • Chest pain, shortness of breath, sudden weakness, or slurred speech — signs of a heart attack or stroke; call 911 immediately
  • Black, tarry, or bloody stools, or vomiting blood — signs of serious GI bleeding; seek emergency care
  • Severe skin reactions: any new rash, blistering, or peeling skin — stop the drug and call your doctor right away
  • Signs of a severe allergic reaction (anaphylaxis): difficulty breathing, swelling of the face or throat — call 911
  • Signs of liver damage: nausea, fatigue, yellowing of the skin or eyes (jaundice), or upper right belly pain — contact your doctor
  • Significant decrease in urination or signs of kidney problems — tell your doctor promptly
  • Fever, rash, swollen lymph nodes, or facial swelling — possible signs of DRESS (a rare but serious drug reaction); seek care immediately
  • Unexpected weight gain, leg swelling, or worsening shortness of breath — possible heart failure symptoms; contact your doctor

Serious reactions — including GI bleeding, ulcers, heart attack, stroke, severe skin reactions (such as Stevens-Johnson syndrome), liver damage, kidney failure, and severe allergic reactions — are less common but can be life-threatening. Seek immediate medical attention if any of these occur.

Ketoprofen warnings and precautions

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  • Heart attack and stroke: Ketoprofen, like all NSAIDs, raises the risk of serious cardiovascular events. The risk begins early in treatment and increases with higher doses and longer use. It is contraindicated immediately after CABG (coronary artery bypass) surgery.
  • GI bleeding and ulcers: Stomach or intestinal bleeding, ulcers, and perforation can occur at any time — often without warning symptoms. Risk is highest in older adults, those with a history of ulcers, and those who also take aspirin, corticosteroids, or anticoagulants.
  • Kidney damage: Long-term use can cause serious kidney injury. People with existing kidney disease, heart failure, liver dysfunction, or those on diuretics are most at risk.
  • Fetal harm: Ketoprofen should be avoided from about 20 weeks of pregnancy onward, and must not be used at 30 weeks or later due to risk of premature closure of a vital fetal blood vessel and fetal kidney problems.
  • Serious skin reactions: Rare but life-threatening skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Stop ketoprofen immediately if a rash develops.
  • DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms): A rare but potentially fatal reaction involving fever, rash, swollen lymph nodes, and organ involvement. Discontinue ketoprofen and seek care immediately if these signs appear.
  • Liver effects: Liver enzyme elevations are common; rare cases of severe liver failure have occurred. Watch for jaundice, fatigue, or right upper belly pain.

Ketoprofen interactions

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Ketoprofen can interact with several common medications — tell your doctor and pharmacist about everything you take.

  • Aspirin — raises the risk of GI bleeding and alters how ketoprofen is processed in the body; generally not recommended together
  • Warfarin and other blood thinners — the combination dramatically increases bleeding risk; requires close monitoring
  • ACE inhibitors — ketoprofen can reduce their blood-pressure-lowering effect
  • Diuretics (water pills) — ketoprofen may reduce their effectiveness and raises the risk of kidney failure
  • Lithium — ketoprofen can raise lithium blood levels by about 15%, increasing the risk of lithium toxicity
  • Methotrexate — ketoprofen may slow methotrexate's elimination, raising the risk of toxicity
  • Probenecid — markedly increases ketoprofen blood levels; this combination should be avoided
  • Digoxin — ketoprofen did not alter digoxin levels in one study, but monitoring is still advisable

Interactions listed in the FDA-approved label

From the Ketoprofen prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • ACE Inhibitors: NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. Give consideration to this interaction in patients taking NSAIDs with ACE-inhibitors.
  • Antacids (magnesium hydroxide and aluminum hydroxide): Concomitant administration does not interfere with the rate or extent of absorption of ketoprofen immediate-release capsules.
  • Aspirin: Ketoprofen does not alter aspirin absorption, but aspirin decreased ketoprofen protein binding and increased ketoprofen plasma clearance from 0.07 L/kg/h to 0.11 L/kg/h. Concomitant administration of ketoprofen and aspirin is not generally recommended because of the potential of increased adverse effects.
  • Diuretics (furosemide, thiazides): NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients; hydrochlorothiazide with ketoprofen reduces urinary potassium and chloride excretion; patients on diuretics are at greater risk of renal failure. Observe the patient closely for signs of renal failure and to assure diuretic efficacy.
  • Digoxin: In 12 patients with congestive heart failure, ketoprofen did not alter serum levels of digoxin.
  • Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance; mean minimum lithium concentration increased 15% and renal clearance decreased by approximately 20%. Observe subjects carefully for signs of lithium toxicity.
  • Methotrexate: Ketoprofen, like other NSAIDs, may change methotrexate elimination, leading to elevated serum levels and increased toxicity. Use caution when NSAIDs are given with methotrexate.
  • Probenecid: Probenecid increases both free and bound ketoprofen by reducing plasma clearance of ketoprofen to about one-third and decreasing its protein binding. The combination of ketoprofen and probenecid is not recommended.
  • Warfarin: Effects of warfarin and NSAIDs on GI bleeding are synergistic, giving a higher risk of serious GI bleeding than either drug alone; ketoprofen did not significantly interfere with warfarin's effect on prothrombin time in 14 normal volunteers. Concurrent therapy requires close monitoring of patients on both drugs.
Read the label’s full interactions text

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 ketoprofen immediate-release 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 the immediate-release capsules. 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 natriuetic effect of furosemide and thiazides in some patients. Hydrochlorothiazide, given concomitantly with ketoprofen, produces a reduction in urinary potassium and chloride excretion compared to hydrochlorothiazide alone. Patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition (see PRECAUTIONS ). During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS: Renal Effects ), as well as to assure diuretic efficacy.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿252 supplements and herbs with documented Ketoprofen interactions, ranked by severity Check Ketoprofen against a supplement or herb →

Before taking Ketoprofen

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  • Recent CABG surgery: Ketoprofen is contraindicated immediately after coronary artery bypass graft surgery
  • Aspirin-sensitive asthma: Do not take ketoprofen if you have ever had bronchospasm, hives, or allergic reactions after taking aspirin or another NSAID
  • Pregnancy: Avoid from about 20 weeks of pregnancy; must not be used at 30 weeks or later due to risk of fetal harm
  • Older adults (especially over 75): Kidney clearance is reduced with age, leading to higher drug levels; start at a lower dose and monitor closely
  • Kidney disease: Dose reduction is required for moderate or severe kidney impairment; ketoprofen extended-release capsules are not recommended in advanced kidney disease
  • Liver disease with low albumin: The unbound (active) fraction of ketoprofen is roughly doubled; start at a lower dose and monitor carefully
  • Heart failure or high blood pressure: Use with caution; ketoprofen can worsen both conditions and blunt the effects of blood pressure and heart failure medications
  • History of peptic ulcers or GI bleeding: Risk of repeat GI bleeding is increased more than 10-fold; discuss alternatives with your doctor

Ketoprofen overdose

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Taking too much ketoprofen most commonly causes lethargy, drowsiness, nausea, vomiting, and stomach pain — symptoms that usually improve with supportive care. In large overdoses, more serious problems such as respiratory depression, seizures, low or high blood pressure, GI bleeding, and kidney failure can occur.

There is no specific antidote. If an overdose is suspected, contact Poison Control (1-800-222-1222) or seek emergency care immediately. Do not try to induce vomiting unless directed by medical personnel.

What Ketoprofen does in the body

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Ketoprofen relieves pain by reducing the concentration of prostaglandins — substances that sensitize nerve endings to pain — at the site of inflammation. In clinical studies with immediate-release capsules, 33% to 68% of patients reported some pain relief within 30 minutes of a single oral dose. Pain relief (measured by how long patients went before needing another dose) lasted up to 6 hours in 26% to 72% of patients in postoperative pain and dysmenorrhea studies.

Ketoprofen also prolongs bleeding time by about 3 to 4 minutes by reducing platelet stickiness, though it does not significantly change platelet count or standard clotting tests.

How your body processes Ketoprofen

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Immediate-release ketoprofen capsules are rapidly absorbed, with peak blood levels reached within 30 minutes to 2 hours. Ketoprofen extended-release capsules absorb much more slowly, reaching peak levels at around 6 to 7 hours after dosing. Food slows the rate of absorption from both forms but does not reduce the total amount absorbed. Ketoprofen is more than 99% bound to plasma proteins (mainly albumin) and is metabolized in the liver; its primary elimination route is through the kidneys.

The half-life (the time for blood levels to fall by half) is about 2 hours for immediate-release capsules and about 5 hours for extended-release capsules. In older adults and people with kidney or liver impairment, the drug is cleared more slowly, leading to higher and more prolonged blood levels — which is why lower starting doses are recommended in these groups.

How to store Ketoprofen

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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

252

Supplements & herbs that interact with Ketoprofen

252 supplements and herbal products have documented interactions with Ketoprofen in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 217
  • Minor · 28
ACTIVATED CHARCOAL Major ASARABACCA Major BEER Major DANSHEN Major PIRACETAM Major SIBERIAN COCKLEBUR Major WINE Major ACONITE Moderate +244 more
Every supplement checked against Ketoprofen — ranked by severity The full interaction hub: 7 major · 217 moderate · 28 minor · every one linked to its full report. Check Ketoprofen against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Ketoprofen has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Insufficient Evidence
See the full Ketoprofen nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Ketoprofen: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ketoprofen — the kind of thing our pharmacy team would talk through with you at the counter.

What conditions is ketoprofen actually prescribed for?

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Ketoprofen is mainly used for rheumatoid arthritis and osteoarthritis — both the regular capsules (including Orudis) and the extended-release capsules cover those. The regular capsules are also approved for general pain and painful menstrual periods (primary dysmenorrhea). The extended-release version isn't designed for short-term or acute pain — its slow-release format just isn't the right fit for that.

Should I take ketoprofen with food or on an empty stomach?

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Either way works in terms of how much drug gets into your system — food doesn't change the total absorption. But taking it with food, milk, or even an antacid can ease stomach upset, which is one of the most common complaints. If your stomach bothers you on ketoprofen, try taking it with a meal or a glass of milk and let your doctor know if it doesn't help.

What side effects should I watch out for?

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The most common ones are digestive — things like indigestion, nausea, stomach pain, diarrhea, or constipation. Headache, dizziness, and ringing in the ears can also happen. Most of these are manageable. The ones you need to act on fast are: black or bloody stools, vomiting blood, chest pain, sudden weakness or slurred speech, a new rash or blistering skin, or difficulty breathing. Those are emergencies — don't wait to call.

I've heard NSAIDs can be rough on the heart — should I be worried?

▾
It's a real risk worth knowing about. Ketoprofen, like all NSAIDs, raises the chances of heart attack and stroke — even in people without existing heart problems. The risk is higher at bigger doses and with longer use. If you have heart disease, high blood pressure, or have recently had a heart attack or bypass surgery, your doctor needs to weigh this carefully before prescribing it. Always use the lowest dose that works, for as short a time as possible.

Can I take ketoprofen if I'm pregnant?

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Ketoprofen is not safe during pregnancy from about 20 weeks onward, and it is definitely off-limits at 30 weeks or later. At those stages it can cause serious harm to your baby — including problems with their kidneys and a dangerous early closure of an important blood vessel in their heart. If you're pregnant or trying to become pregnant, talk to your doctor before taking ketoprofen.

Are there any common medications I should not mix with ketoprofen?

▾
Yes — a few important ones. Aspirin combined with ketoprofen raises GI bleeding risk, so they're generally not taken together. If you're on warfarin (a blood thinner), the combination seriously increases bleeding risk and needs close monitoring. Ketoprofen can also reduce how well blood pressure medications and water pills (diuretics) work. And if you take lithium or methotrexate, ketoprofen can push those drug levels higher than they should be. Always give your doctor and pharmacist a full list of everything you take.

Is Ketoprofen available over the counter?

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No. Ketoprofen is a prescription medicine: every Ketoprofen product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ketoprofen first available?

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The earliest FDA record we hold for Ketoprofen is from 1979: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ketoprofen was first used.

Who makes Ketoprofen?

▾
5 companies currently list Ketoprofen products in the FDA's NDC Directory, including Misemer Pharmaceuticals, Inc., Allegis Pharmaceuticals, Inc., Marnel Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ketoprofen on HelloPharmacist

📊Ketoprofen supplement interactions252 checked — ranked by severity 🌿Drug & Supplement CheckerKetoprofen vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ketoprofen NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ketoprofen Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ketoprofen forms and strengths (how it comes)

Ketoprofen is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Orudis
How this form is used
What it may be used for
  • Orudis capsules are indicated for rheumatoid arthritis and osteoarthritis
  • Orudis capsules are indicated for general pain management
  • Orudis capsules are indicated for primary dysmenorrhea (painful menstrual periods)
  • Ketoprofen capsules USP are indicated for rheumatoid arthritis, osteoarthritis, pain, and primary dysmenorrhea
Important instructions
  • Ketoprofen and Orudis capsules are taken by mouth multiple times daily — follow your prescriber's schedule
  • Can be taken with food, milk, or antacids to reduce stomach upset; food slows absorption but does not reduce the total amount absorbed
  • Do not take Ketoprofen capsules USP or Orudis at the same time as ketoprofen extended-release capsules
  • Older adults (over 75), those with reduced kidney function, or those with low albumin levels should start at a lower dose as directed by their prescriber
Available strengths 3 strengths
25 mg 50 mg 75 mg
8 FDA-listed product records ⓘ

Extended-release capsule

By mouth
How this form is used
What it may be used for
  • Ketoprofen extended-release capsules are indicated for rheumatoid arthritis and osteoarthritis
  • Ketoprofen extended-release capsules are not recommended for acute (short-term) pain because of their slow-release design
Important instructions
  • Ketoprofen extended-release capsules are taken once daily by mouth
  • A high-fat meal may delay the time to peak absorption by about 2 hours, but does not reduce the total amount absorbed
  • Do not take ketoprofen extended-release capsules at the same time as ketoprofen immediate-release capsules or Orudis
  • Older adults and those with kidney or liver impairment should start at a reduced dose as directed by their prescriber
Available strengths 1 strength
200 mg
2 FDA-listed product records ⓘ

Ketoprofen on the U.S. market: products, makers and brands

How Ketoprofen appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5 companies list 7 Ketoprofen product records with the FDA, mostly as capsule, extended-release capsule; the earliest marketing or approval year on record is 1979. Brand names on the directory include Actron, Nexcede, Orudis and 5 more; the rest are generics.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
2
Brand names
7
FDA-listed product records ⓘ
1979
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Misemer Pharmaceuticals, Inc.43%
Allegis Pharmaceuticals, Inc.14%
Marnel Pharmaceuticals, Inc.14%
Mylan Pharmaceuticals Inc.14%
Oncora Pharma, LLC14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ketoprofen is used (Medicaid data)

A general measure of how commonly Ketoprofen is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ketoprofen is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

16,480
Medicaid prescriptions filled (Q1–Q4 2025)
$2.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ketoprofen prescribed? Of the 1,601 medications we measure, Ketoprofen ranks #835 by Medicaid prescriptions — more than 48% of them.

Where Ketoprofen ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #835 of 1,601
#830 Theophylline 16,886 Rx #831 Raltegravir 16,834 Rx #832 Glyburide and Metformi... 16,761 Rx #833 Travoprost Ophthalmic 16,632 Rx #834 Bromocriptine 16,540 Rx #835 Ketoprofen 16,480 Rx #836 Bicalutamide 16,214 Rx #837 Sodium Polystyrene Sul... 16,195 Rx #838 Diclofenac Ophthalmic 16,149 Rx #839 Elagolix 16,122 Rx #840 Ranibizumab Injection 16,116 Rx

Utilization by Ketoprofen product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

24 HR ketoprofen 200 MG Extended Release Oral Capsule

16,480 Medicaid prescriptions (Q1–Q4 2025) 100% of Ketoprofen prescriptions shown $2.9M gross reimbursement (before rebates) ≈ $178 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 359697

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ketoprofen, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 7 listed Ketoprofen NDCs with Medicaid activity.

Compare Ketoprofen products

A representative set of FDA-listed product records for Ketoprofen — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
75 mg Oral Allegis Pharmaceuticals, Inc. ANDA View NDC →
75 mg Oral Marnel Pharmaceuticals, Inc. ANDA View NDC →
25 mg Oral Misemer Pharmaceuticals, Inc. ANDA View NDC →
50 mg Oral Misemer Pharmaceuticals, Inc. ANDA View NDC →
75 mg Oral Misemer Pharmaceuticals, Inc. ANDA View NDC →
50 mg Oral Oncora Pharma, LLC ANDA View NDC →
💊Extended-release capsule
200 mg Oral Mylan Pharmaceuticals Inc. ANDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Ketoprofen NDCs →

Ketoprofen FDA approval history

How Ketoprofen went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Ketoprofen was first approved by the FDA in 1979; the first generic version was approved in 1992. It remains available in U.S. pharmacies today.

1979
First FDA approval
1992
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Ketoprofen recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ketoprofen recalls since July 2021.

✅No Ketoprofen recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ketoprofen RxCUI 6142 6 dose forms · 10 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 372536 In current FDA listings
    Clinical drug / strength (SCD) 24 HR ketoprofen 100 MG RxCUI 314059 24 HR ketoprofen 200 MG RxCUI 359697
  2. Dose form (SCDF) Injectable Solution RxCUI 372537 No current FDA listing
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 246236 100 MG/ML RxCUI 1551477
  3. Dose form (SCDF) Oral Capsule RxCUI 372535 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 197854 50 MG RxCUI 197855 75 MG RxCUI 197856
  4. Dose form (SCDF) Oral Tablet RxCUI 372540 No current FDA listing
    Clinical drug / strength (SCD) 12.5 MG RxCUI 199169
  5. Dose form (SCDF) Rectal Suppository RxCUI 372539 No current FDA listing
    Clinical drug / strength (SCD) 100 MG RxCUI 199553
  6. Dose form (SCDF) Topical Gel RxCUI 377957 No current FDA listing
    Clinical drug / strength (SCD) 0.025 MG/MG RxCUI 105999

Look up RxCUI 6142 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Ketoprofen costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule, Extended Release · Oral 200 mg $6.46 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Ketoprofen brand names

Ketoprofen is sold under 8 brand names in the FDA directory — Actron, Nexcede, Orudis, Orudis KT and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Actron Nexcede Orudis Orudis KT Oruvail Ketofen Ketomed Kiprofen

Who makes Ketoprofen: manufacturers and labelers

5 companies list Ketoprofen products with the FDA. By number of product records, the largest are Misemer Pharmaceuticals, Inc., Allegis Pharmaceuticals, Inc., Marnel Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Misemer Pharmaceuticals, Inc. 3 Allegis Pharmaceuticals, Inc. 1 Marnel Pharmaceuticals, Inc. 1 Mylan Pharmaceuticals Inc. 1 Oncora Pharma, LLC 1

Ketoprofen drug class (RxNorm)

Ketoprofen belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Propionic acid derivatives, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ketoprofen page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ketoprofen.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ketoprofen after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
7
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Jul 15, 2024
Composite sections available
23
Linked SPL Set ID
198a4140-f4c0-4478-9157-ee1d68d0bb96
Linked SPL Document ID
2dad8626-e0dd-46ad-9e75-069c6e82fc20
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →