Prescription medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
ketoprofen
Also sold as Orudis. Ketoprofen extended-release capsules treat the symptoms of rheumatoid arthritis and osteoarthritis.
Data updated 2026-05-15
- 12,302
- FDA reportsModerately reported
- 9
- InteractionsFew interactions
- $6.62
- Generic price (NADAC)
What the data shows
ketoprofen (Orudis) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID), reported less often than most tracked drugs (12,302 FDA reports), with 9 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
ketoprofen (Orudis) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID). Ketoprofen extended-release capsules treat the symptoms of rheumatoid arthritis and osteoarthritis.
Ketoprofen extended-release capsules are a type of NSAID medicine. They help reduce pain and swelling.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$6.62/unit
Generic Available
Yes (2 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Ketoprofen extended-release capsules treat the symptoms of rheumatoid arthritis and osteoarthritis.
Common side effects
Upset stomach, Nausea, Abdominal pain
Key warnings
NSAIDs like ketoprofen can increase the risk of heart attack and stroke, which can be fatal.
The sections below are summarized in plain English from ketoprofen's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Ketoprofen works by reducing substances in the body that cause pain and swelling. It blocks the production of prostaglandins. Prostaglandins contribute to inflammation and pain.
How to Take It
Carefully consider the benefits and risks before using ketoprofen. Take the lowest dose that works for you, for the shortest time needed. For rheumatoid arthritis and osteoarthritis, the usual starting dose is 200 mg daily. Your doctor may adjust the dose based on how you respond to the medicine.
This is a plain-language summary of ketoprofen's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant, may become pregnant, or are breastfeeding. NSAIDs may harm your unborn baby. Ketoprofen may pass into breast milk.
This is a plain-language summary of ketoprofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of ketoprofen's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store ketoprofen capsules at room temperature (68° to 77°F). Keep away from direct light, excessive heat, and humidity.
Side Effects (from patient reports)
Based on 12,302 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ketoprofen, by number of reports
- Headache
Headache
1,152 reports
- Pain
Pain
1,076 reports
- Tiredness
Tiredness
895 reports
- Nausea
Nausea
747 reports
- Fever
Fever
725 reports
- Pain at injection site
Pain at injection site
673 reports
- Rheumatoid arthritis
Rheumatoid arthritis
671 reports
- Allergic reaction
Allergic reaction
668 reports
- Back pain
Back pain
660 reports
- Excessive sweating
Excessive sweating
656 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for ketoprofen each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ketoprofen sits
ketoprofen has more FDA adverse-event reports than 44% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ketoprofen; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 12,302 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
12,302
Reports Mentioning Death
1,136
9.2% of reports — not proof of cause
Hospitalization Reports
6,176
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | HEADACHE | 1,152 |
| 2 | PAIN | 1,076 |
| 3 | FATIGUE | 895 |
| 5 | NAUSEA | 746 |
| 6 | PYREXIA | 725 |
| 8 | INFUSION SITE PAIN | 673 |
| 9 | RHEUMATOID ARTHRITIS | 671 |
| 10 | HYPERSENSITIVITY | 667 |
| 11 | BACK PAIN | 659 |
| 12 | HYPERHIDROSIS | 656 |
| 13 | DIARRHOEA | 642 |
| 14 | ERYTHEMA | 638 |
| 15 | CONSTIPATION | 615 |
| 16 | DRUG HYPERSENSITIVITY | 614 |
| 17 | RASH | 607 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
NSAIDs like ketoprofen can increase the risk of heart attack and stroke, which can be fatal. This risk may happen early in treatment and increases with longer use. You should not take this medicine if you are having heart bypass surgery (CABG). NSAIDs also increase the risk of serious stomach and intestine problems like bleeding and ulcers, which can be fatal. These can occur without warning, and older adults are at higher risk.
Known 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.
Mechanism: Probenecid slows down how quickly the body clears ketoprofen, leading to higher levels of the drug in the blood.
What to do: This combination is not recommended and should be avoided.
Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline,...
Mechanism: Ketoprofen is an anti-inflammatory drug that adds to the blood-thinning effect of warfarin. This combination makes it more likely for you to experience bleeding or bruising.
What to do: Watch for unusual bruising or bleeding and report it to your doctor. Your blood levels may need to be checked more frequently.
Hydrochlorothiazide, given concomitantly with ketoprofen, produces a reduction in urinary potassium and chloride excretion compared to hydrochlorothiazide alone.
Mechanism: Ketoprofen can change how your kidneys handle salt and minerals when you are also taking this water pill. This can reduce the amount of potassium and chloride you pass in your urine.
What to do: Your doctor may want to monitor your kidney function and mineral levels through regular blood tests.
Diuretics NSAIDs can reduce the natriuetic effect of furosemide and thiazides in some patients.
Mechanism: Ketoprofen can stop furosemide from working as well to remove salt and water from your body. This happens because the pain reliever interferes with the way the water pill affects your kidneys.
What to do: Your doctor may need to check your blood pressure or fluid levels more often. They might adjust your dose if the water pill is not working correctly.
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.
Mechanism: Aspirin makes ketoprofen leave your body faster and changes how it travels in your blood. Taking both at the same time can also increase your risk of having bad side effects.
What to do: You should generally avoid taking these two medicines together. Talk to your doctor about safer ways to manage your pain.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I use ketoprofen for a headache?
Can I take ketoprofen with aspirin?
What should I do if I experience stomach pain while taking ketoprofen?
Can ketoprofen affect my blood pressure?
Is it safe to drink alcohol while taking ketoprofen?
Can ketoprofen interact with other medications I am taking?
How long does it take for ketoprofen to start working?
Can I drive or operate machinery while taking ketoprofen?
What if I have kidney problems?
Can ketoprofen cause allergic reactions?
What are the common side effects of ketoprofen?
Does ketoprofen interact with other medications?
What drug class is ketoprofen?
Is ketoprofen safe during pregnancy?
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What the FDA Data Shows for ketoprofen
The FDA label for ketoprofen (sold under brand names such as Orudis) classifies it as a prescription-only medication in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. Ketoprofen extended-release capsules treat the symptoms of rheumatoid arthritis and osteoarthritis. Official labeling lists 14 commonly reported side effects, including Upset stomach, Nausea, Abdominal pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,302 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $6.62.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: July 15, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages