Prescription medicine
Ketoprofen Brand names: Orudis
Ketoprofen (Orudis) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $6.46 per ketoprofen ER 200 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ketoprofen FDA label on DailyMed (effective February 15, 2026, Misemer Pharmaceuticals, Inc.); the NDA 18754 record on Drugs@FDA; every ketoprofen label on DailyMed.
Highlights of the record
FDA label of February 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Ketoprofen capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events. 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP.
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 200 mg
Capsule; extended-release capsule.
On the market
- Earliest approval on file
- January 9, 1986 Orudis, Wyeth Ayerst; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first December 22, 1992; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.46 per capsule Ketoprofen ER 200 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2018 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 13,039 through July 30, 2026
What is ketoprofen used for?
From the label: indications and usageCarefully 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. Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea.
Conditions named in the indications of ketoprofen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Ketoprofen), Misemer Pharmaceuticals, Inc., effective February 15, 2026 (SPL set d0f47ab6-29ff-df07-e053-2a95a90a2b51), via openFDA; the full label on DailyMed
What does the patient leaflet for ketoprofen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids” and “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDS o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o for the shortest time needed
Source: FDA drug label (Ketoprofen), Misemer Pharmaceuticals, Inc., effective February 15, 2026 (SPL set d0f47ab6-29ff-df07-e053-2a95a90a2b51), via openFDA; the full label on DailyMed
Is there a generic for ketoprofen (Orudis)?
The FDA approved the first generic ketoprofen on December 22, 1992. 10 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ketoprofen from 5 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 1992 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ketoprofen (Orudis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.46 per Ketoprofen ER 200 mg capsule, up 14% from $5.65 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ketoprofen ER 200 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ketoprofen ER 200 mg capsule | Generic | $6.46 per capsule | $193.86 | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ketoprofen been recalled?
The FDA's Enforcement Report lists 1 recall naming ketoprofen since 2018: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of ketoprofen and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ketoprofen label say about other medicines?
The ketoprofen label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name ketoprofen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | Ketoprofen capsules USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Digoxin | drug interactions | Digoxin In a study in 12 patients with congestive heart failure where ketoprofen and digoxin were concomitantly administered, ketoprofen did not alter the serum levels of digoxin. |
| Furosemide | drug interactions | Diuretics NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. |
| Hydrochlorothiazide | drug interactions | Hydrochlorothiazide, given concomitantly with ketoprofen, produces a reduction in urinary potassium and chloride excretion compared to hydrochlorothiazide alone. |
| Lithium | drug interactions | Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Magnesium hydroxide | drug interactions | Antacids Concomitant administration of magnesium hydroxide and aluminum hydroxide does not interfere with the rate or extent of the absorption of ketoprofen administered as ketoprofen capsules. |
| Methotrexate | drug interactions | Methotrexate Ketoprofen, like other NSAIDs, may cause changes in the elimination of methotrexate leading to elevated serum levels of the drug and increased toxicity. |
| Probenecid | drug interactions | Probenecid Probenecid increases both free and bound ketoprofen by reducing the plasma clearance of ketoprofen to about one-third, as well as decreasing its protein binding. Therefore, the combination of ketoprofen and probenecid is not recommended. |
| Warfarin | drug interactions | Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. |
Other labels that name ketoprofen
Source: FDA drug label (Ketoprofen), Misemer Pharmaceuticals, Inc., effective February 15, 2026 (SPL set d0f47ab6-29ff-df07-e053-2a95a90a2b51), via openFDA; the full label on DailyMed
What do FAERS reports show for ketoprofen?
The FDA Adverse Event Reporting System holds 13,039 reports that list ketoprofen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,182 are coded as a death and 6,466 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ketoprofen?
29 other medicines are given the same way (oral) and in the same FDA class as ketoprofen or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Pain, Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Pain, Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain, Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
Every medicine labeled for the same conditions as ketoprofen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ketoprofen
- 29 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Ketoprofen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other