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ketoprofen

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Brand names: Orudis

Nonsteroidal Anti-Inflammatory Drug (NSAID) Rx

Ketoprofen extended-release capsules are a type of NSAID medicine. They help reduce pain and swelling.

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.

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.

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.

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.

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 8,054 FDA adverse event reports.

Headache
1,152
Pain
1,076
Tiredness
895
Medicine not working
748
Nausea
747
Fever
725
Using medicine for unapproved purpose
699
Pain at injection site
673
Rheumatoid arthritis
671
Allergic reaction
668

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

Death-Related Reports

1,136

Hospitalization Reports

6,176

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 7,267 (63%)
Male 4,238 (37%)

Age Distribution

0–17 425
18–44 2,386
45–64 3,316
65–74 1,595
75+ 1,201

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 HEADACHE 1,152
2 PAIN 1,076
3 FATIGUE 895
4 DRUG INEFFECTIVE 748
5 NAUSEA 746
6 PYREXIA 725
7 OFF LABEL USE 699
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

Reactions in Death Reports

PYREXIA 174
OVERDOSE 165
CONSTIPATION 148
PAIN 147
DRUG INEFFECTIVE 144
RASH 143
OFF LABEL USE 136
FATIGUE 135
DEATH 134
HYPERHIDROSIS 130

Reactions in Hospitalization Reports

ACUTE KIDNEY INJURY 407
VOMITING 392
NAUSEA 333
DIARRHOEA 316
DRUG INTERACTION 309
PYREXIA 308
DYSPNOEA 274
DRUG INEFFECTIVE 270
PAIN 270
HEADACHE 264

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

moderate probenecid

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.

moderate warfarin

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, venlafa...

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.

minor aspirin

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.

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Common Questions

Can I use ketoprofen for a headache?
Ketoprofen extended-release is not recommended for acute pain. Talk to your doctor about other options.
Can I take ketoprofen with aspirin?
It is generally not recommended to take ketoprofen with aspirin due to the potential for increased side effects.
What should I do if I experience stomach pain while taking ketoprofen?
Talk to your doctor if you experience stomach pain. They may lower your dose or recommend other treatments.
Can ketoprofen affect my blood pressure?
Yes, ketoprofen can increase blood pressure in some people.
Is it safe to drink alcohol while taking ketoprofen?
It is best to avoid alcohol while taking ketoprofen, as it can increase the risk of stomach problems.
Can ketoprofen interact with other medications I am taking?
Yes, ketoprofen can interact with several medications, including blood thinners, heart medications, and lithium. Tell your doctor about all the medicines you take.
How long does it take for ketoprofen to start working?
Ketoprofen extended-release capsules are not for immediate relief. It may take days or weeks to feel the full effect.
Can I drive or operate machinery while taking ketoprofen?
Ketoprofen can cause dizziness or drowsiness. Be careful driving or operating machinery until you know how this medicine affects you.
What if I have kidney problems?
If you have kidney problems, your doctor may need to lower your dose of ketoprofen.
Can ketoprofen cause allergic reactions?
Yes, ketoprofen can cause allergic reactions, including severe reactions. Seek medical attention if you experience hives, difficulty breathing, or swelling.
What are the common side effects of ketoprofen?
The most commonly reported side effects of ketoprofen include Upset stomach, Nausea, Abdominal pain, Diarrhea, Constipation. Based on 8,054 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ketoprofen interact with other medications?
Yes, ketoprofen has 9 known drug interactions. Notable interactions include probenecid, warfarin, hydrochlorothiazide. Always inform your doctor about all medications you are taking.
What drug class is ketoprofen?
ketoprofen belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) drug class. It requires a prescription (Rx). Ketoprofen extended-release capsules treat the symptoms of rheumatoid arthritis and osteoarthritis.
Is ketoprofen safe during pregnancy?
Talk to your doctor if you are pregnant, may become pregnant, or are breastfeeding. NSAIDs may harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 8,054 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

All federal data sources used on this page