Orudis

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Orudis

Property Description
Active Ingredient Ketoprofen
Forms Capsule, Tablet, Suppository, Gel, Injection
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General Purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic, propionic acid derivative

Defining Orudis: Classification and Composition

Orudis is the trade name for a pharmaceutical product whose active ingredient is Ketoprofen, a substance classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). Ketoprofen is a synthetic compound that belongs to the propionic acid derivative class, structurally related to other common NSAIDs. The compound is chemically identified as 2-(3-benzoylphenyl)propanoic acid. The medication is formulated as a single-ingredient product, delivering its therapeutic effects exclusively through the Ketoprofen molecule alongside various inactive excipients.

What Type of Medicine is Ketoprofen and Its General Purpose

As an NSAID, the primary general purpose of Ketoprofen is to provide symptomatic management of physical discomfort by exhibiting a triad of effects: functioning as a potent anti-inflammatory agent, an analgesic for pain relief, and an antipyretic for reducing fever. For instance, it is often employed in scenarios requiring the simultaneous reduction of inflammation and pain associated with acute musculoskeletal conditions in adult patients. NSAIDs like Ketoprofen function by inhibiting the synthesis of prostaglandins, which are key mediators of pain and inflammation. This means the medicine helps to ease discomfort by directly interfering with the body's primary inflammatory and pain-signaling mechanisms.

Orudis: Available Dosage Forms and Key Differentiation

Ketoprofen is available in multiple physical forms to allow for flexible administration, enabling either systemic absorption or a localized effect. It is supplied as capsules or tablets for oral ingestion, a suppository for rectal use, or a gel for topical application onto the skin. The broad spectrum of available forms—oral, rectal, and topical—is a key differentiating feature of Ketoprofen compared to some analogues, allowing for targeted or systemic action as required. Furthermore, an injection (parenteral solution) is utilized when rapid systemic delivery is medically necessary, ensuring versatility in patient care settings.

What side effects are possible with Orudis?

Possible Side Effects and Safety Information for Orudis (Ketoprofen)

Orudis, an NSAID, carries regulatory warnings regarding the potential for serious adverse reactions, which define its official safety profile. This information is derived exclusively from governmental regulatory documents.


Serious Systemic Safety Concerns

The most critical warnings in the regulatory labeling concern the potential for serious cardiovascular thrombotic events, including Myocardial Infarction and Stroke, which may occur early in treatment and can be fatal. Additionally, there is a documented risk of serious gastrointestinal adverse events, such as bleeding, ulceration, and perforation of the stomach or intestines, which may occur without warning symptoms. The risk for both cardiovascular and gastrointestinal events is noted to increase with the duration of use.

Frequency-Classified Adverse Reactions

Adverse reactions classified as common (occurring in one percent or more of patients) in regulatory documents include dyspepsia (indigestion), nausea, abdominal pain, headache, dizziness, and peripheral edema (swelling). Less frequent, but serious, reactions officially documented include acute renal failure, serious hepatic reactions, and severe skin reactions like Stevens-Johnson Syndrome (SJS).


Population-Specific Safety Considerations

The official labeling notes that older adults are at a greater risk for serious gastrointestinal and cardiovascular events. Use during pregnancy after 20 weeks gestation may cause harm to the fetus. Furthermore, the medication is contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery, as documented in regulatory safety restrictions.

These official safety statements structure the understanding of the medicine's risks by detailing consequences across multiple organ systems and identifying specific patient populations at elevated risk.

Overdose and Emergency Response

Orudis Overdose and When to Seek Help

Overdose with Orudis (ketoprofen) requires immediate medical attention, as a large exposure can cause serious, potentially fatal damage in both adults and children. The primary effects of an overdose are related to the gastrointestinal and central nervous systems, with symptoms varying from mild to severe.

Documented Overdose Manifestations

Symptoms that may occur after a large overdose include common signs like drowsiness, vomiting, and abdominal pain. More severe, life-threatening clinical manifestations documented in regulatory sources can include:

  • Central Nervous System Effects: Lack of energy, seizures, and coma.
  • Respiratory Distress: Shallow or difficult breathing.
  • Gastrointestinal Complications: Possible internal bleeding from the stomach or intestines, which may be severe enough to require a blood transfusion.

Required Emergency Actions

The severity of the outcome is directly linked to the amount of drug swallowed and how quickly treatment is received. If an overdose is suspected, contact emergency services or a poison control center right away, even if the symptoms appear mild.

Patients may undergo monitoring of vital signs, supportive care, and treatments such as activated charcoal to help remove the drug from the body. Severe kidney damage is a possible outcome, which may necessitate dialysis, and in some cases, the damage may be permanent. Prompt medical evaluation is critical to manage these time-sensitive risks.

Therapeutic Uses of Orudis

What Orudis Treats: Main Uses and Benefits

Orudis (Ketoprofen) is commonly used to help with managing the symptoms related to physical discomfort and inflammatory states across several key clinical domains. It is considered relevant for easing symptoms associated with chronic rheumatic conditions.

This medication is applied across domains where additional symptomatic support is needed, including conditions like rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, primary dysmenorrhea, and pain from soft tissue injuries (sprains and strains). It helps address symptom clusters like joint pain, swelling, stiffness, and fever, which often interfere with daily functioning.

Quick Fact: Relief for Joint Pain & Inflammation Orudis plays a role in managing symptoms stemming from inflammatory and irritative processes in the joints and soft tissues.

“The medication provides support that helps ease the overall symptom burden and may assist with managing difficult symptomatic episodes.”

Orudis is commonly used during phases when symptoms become more noticeable, such as managing acute pain and inflammation following postoperative pain or during flares of chronic illness. It contributes to easing the overall symptom load and assists with maintaining a sense of stability during temporary episodes of heightened discomfort.

Regulatory References

  1. NIH DailyMed

Eligibility and Restrictions for Use

Orudis (ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to manage pain and inflammation associated with conditions like osteoarthritis, rheumatoid arthritis, and mild to moderate pain. However, dueis potential risks, not everyone can safely use this medication.


Who Can Use Orudis (Ketoprofen)?

Orudis is generally prescribed for adults to treat:

  • Chronic Inflammatory Conditions: Such as rheumatoid arthritis and osteoarthritis.
  • Acute Pain: Including pain following surgery (non-CABG), dental procedures, or primary dysmenorrhea (menstrual cramps).

Who Should Not Use Orudis?

Orudis is contraindicated in several groups due to the risk of serious side effects. You should not take Orudis if you have:

  • A known allergy to ketoprofen, aspirin, or other NSAIDs (which may cause symptoms like asthma, hives, or severe allergic reactions).
  • A history of or currently active gastrointestinal bleeding or peptic ulcer disease.
  • Severe heart failure or recent Coronary Artery Bypass Graft (CABG) surgery.
  • Severe kidney or liver disease.
  • Are in the third trimester of pregnancy (after 28 weeks), as it can harm the fetus and cause delivery complications.

Use is generally not recommended for children or adolescents, and elderly patients should use it with caution, typically starting at a lower dose due to an increased risk of adverse effects, particularly GI bleeding and kidney problems. Always discuss your full medical history with your healthcare provider before starting treatment.

What should I know about interactions with other medicines?

Orudis (ketoprofen), a nonsteroidal anti-inflammatory drug (NSAID), can interact with several other medications, which may alter the effectiveness of the drugs or increase the risk of serious side effects. Patients should inform their healthcare provider of all prescription, nonprescription, vitamin, and herbal supplements they are taking.

Major Interaction Categories

Interacting Medicine/Product Potential Effect/Risk
Other NSAIDs or Aspirin Increased risk of serious gastrointestinal issues, such as bleeding and ulcers.
Anticoagulants (e.g., Warfarin) Significantly increased risk of bleeding and hemorrhage.
Diuretics (Water Pills) May decrease the effect of the diuretic and increase the risk of kidney problems.
ACE Inhibitors and ARBs May reduce the blood pressure-lowering effect and increase the risk of kidney impairment.
Methotrexate May increase the concentration of methotrexate in the blood, leading to greater toxicity.
Lithium Can elevate plasma lithium levels, increasing the risk of lithium toxicity.

Other Important Interactions

The concomitant use of Orudis with corticosteroids (such as prednisone) can increase the risk of gastrointestinal bleeding. Similarly, concurrent use with Selective Serotonin Reuptake Inhibitors (SSRIs) may also increase the risk of bleeding. Probenecid can significantly increase ketoprofen levels in the blood, necessitating a dose adjustment of Orudis. Additionally, alcohol consumption should be minimized or avoided as it can heighten the risk of severe gastrointestinal adverse effects.

Mechanism of Action

The physiological actions of Ketoprofen (Orudis) are rooted in its capacity to modulate key signaling pathways involved in the generation of prostaglandins. It achieves this by primarily inhibiting specific enzyme systems responsible for generating crucial lipid mediators.

Ketoprofen's core action is the competitive and reversible inhibition of both Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. By blocking these key enzymes, the drug interrupts the arachidonic acid cascade, reducing the formation of prostaglandins (PGE2) that drive heightened physiological responses. This mechanism results in the reduction of prostanoid-driven signaling in affected tissues and the central nervous system.

Peripherally, the reduction of prostaglandins lowers the sensitization threshold of nociceptors, modulating their response to stimuli. Centrally, the drug acts within the hypothalamus to limit PGE2 production, which affects the body's thermoregulatory center set-point. This coordinated activity results in the modulation of signaling dynamics within nociceptive and thermoregulatory pathways. The drug's non-selective approach defines its mechanistic boundary by also impacting regulatory mechanisms, such as those maintaining the integrity of the gastrointestinal mucosal barrier and regulating renal blood flow.

Dosage and Administration Information

Orudis (ketoprofen) is a nonsteroidal anti-inflammatory drug (NSAID) available in immediate-release and extended-release capsule formulations. It is essential to follow the specific instructions provided by your healthcare professional and those detailed in the accompanying Medication Guide to minimize risks and ensure effectiveness.

General Administration Guidelines

  • Dosing: Always use the lowest effective dose for the shortest duration necessary to achieve treatment goals. Doses vary significantly based on the formulation (e.g., immediate-release up to four times daily; extended-release typically once daily) and the condition being treated, such as arthritis or acute pain. Consult the label or your doctor for your specific regimen.
  • With Food: To reduce the risk of stomach upset, it is generally recommended to take Orudis capsules with a full glass of water, food, milk, or an antacid.
  • Extended-Release (ER) Capsules: If you are prescribed the extended-release form, swallow the capsule whole. Do not crush, chew, or break the extended-release capsule, as this can affect the drug's release and increase the risk of adverse effects.

Missed Dose

If you miss a dose and are taking the medication regularly, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose. Do not take a double dose to compensate for the one you missed, and continue with your regular schedule.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Orudis (Ketoprofen)

The research basis for Orudis (ketoprofen) includes official clinical evaluation studies, primarily through Randomized Controlled Trials (RCTs) and comprehensive scientific reviews. These studies were used in research exploring how symptoms change over time across different conditions characterized by fluctuating or episodic manifestations.


Evidence for Use in Chronic Inflammatory Conditions

This section summarizes the research structure, primarily the Randomized Controlled Trials (RCTs) and systematic reviews, that have explored the measurement of symptoms and key patient-reported outcomes, such as pain intensity, joint swelling, and functional status. Orudis was studied for its potential role in conditions associated with acute or disruptive episodes, such as rheumatoid arthritis and osteoarthritis. Studies reported patterns where outcomes related to systemic or functional imbalance were often numerically similar to those reported for the comparator medications studied.

Evidence for Use in Acute Pain Management

This part details the types of short-term, controlled clinical studies that form the basis for the documented use of Orudis in temporary pain states, including postoperative pain. Acute pain conditions were studied using highly focused, short-term RCTs, monitoring outcomes describing episodic or acute changes.

  • Research on Topical Application

    A specialized area of study involved the topical gel formulation of Orudis for localized discomfort. The research highlights changes measured during the study period for local pain outcomes, but comparative evidence is lacking regarding the systemic versus topical approaches.


Long-Term Studies and Follow-up Duration

The vast majority of the research exploring short-term symptom changes, particularly the main controlled trials for systemic use, typically had limited follow-up durations. Evidence is limited regarding outcomes related to long-term chronic management, and the available data relies more heavily on post-marketing surveillance reports rather than primary controlled trial evidence.

Research Gaps and What Remains Uncertain

Official documentation notes that data for certain groups remain insufficient; dedicated studies to establish the systemic use and study outcomes of ketoprofen in the pediatric population are lacking. Evidence quality may vary across studies, and comparative evidence is lacking in some areas, demonstrating that evidence is limited for applications beyond superficial joints.

Frequently Asked Questions (FAQ)

Common questions about Orudis (FAQ)

Q: How quickly should I expect Orudis to start helping with pain?

Studies included in the official product information indicate that a percentage of patients taking immediate-release capsules reported experiencing some pain relief within 30 minutes of a single dose. This range is based on observations from short-term pain relief studies mentioned in regulatory documents.


Q: How long does the pain relief from Orudis typically last?

In clinical studies, the duration of effective pain relief varied. Official product information, based on clinical studies, mentions relief persisting for up to six hours in a significant portion of patients. The required frequency of dosing is related to this duration of effect.


Q: What happens if I accidentally skip a dose of Orudis?

The regulatory instruction is to take the missed dose right away if you remember it and are taking the medication regularly. However, if it is almost time for your next scheduled dose, you should skip the missed one. Official guidance advises against taking a double dose to compensate.


Q: Can taking Orudis affect my sleep?

Official safety documents list drowsiness and sleepiness as potential side effects. These effects may impact alertness and are categorized as common, meaning they are observed in one percent or more of patients.


Q: What should I avoid eating or drinking while I'm taking Orudis?

Official product information states that alcohol consumption should be minimized or avoided entirely. This is because alcohol may significantly increase the risk of serious gastrointestinal side effects, such as bleeding in the stomach or intestines.


Q: Can I take a regular multivitamin while I'm on Orudis?

The official product information does not list a specific interaction with multivitamins, but it advises informing your healthcare provider of all prescription, over-the-counter, and vitamin supplements. The purpose is to allow a healthcare provider to assess any potential for drug interactions.


Q: Does Orudis interact with any herbal supplements like turmeric or ginger?

Official regulatory information requires patients to inform their healthcare provider of all herbal supplements they are taking. This is necessary because interactions may potentially alter the drug’s effectiveness or increase the risk of side effects.


Q: How is the release formula different in Orudis SR/ER capsules?

The extended-release (ER) formulations are manufactured to release the active ingredient, ketoprofen, at a controlled rate over a prolonged period. This mechanism is intended to allow for less frequent dosing compared to the immediate-release capsules, which release the drug for absorption over a shorter duration.


Q: Why is Orudis sometimes used for gout flares?

Orudis is officially indicated for the management of acute pain and inflammation. Its approved anti-inflammatory and analgesic properties align with the symptomatic treatment needed for conditions like a gout flare, even though gout may not be listed as a primary indication.


Q: Is it normal to feel a little dizzy after taking Orudis?

Yes, dizziness is listed in the official safety data as a commonly reported side effect. This means it has been observed in one percent or more of patients during clinical trials, making it an acknowledged possible effect of the medication.


Q: Why does Orudis sometimes make people feel tired?

Fatigue and drowsiness are reported adverse reactions in the medication's safety profile. These effects, which relate to the central nervous system, may be experienced by some patients while taking the drug.


Q: Can Orudis affect my blood pressure readings?

Regulatory documents explicitly state that Nonsteroidal Anti-inflammatory Drugs (NSAIDs) can cause new high blood pressure or worsen pre-existing high blood pressure. Official labeling indicates that blood pressure may need to be monitored during treatment.


Q: What kind of stomach protection might be needed with long-term Orudis use?

The official prescribing information emphasizes the risk of serious gastrointestinal issues, which increases with the duration of use. Due to the heightened risk of GI issues, patients with risk factors may require additional protective measures as determined by their healthcare provider.


Q: Will Orudis interfere with birth control pills?

There is no general regulatory contraindication listed for the combined use of Orudis and oral contraceptives. However, all patients are advised to inform their healthcare provider of all medications, including hormonal birth control, to allow a healthcare provider to assess for potential interactions.


Q: Is there a maximum amount of days or weeks I should take Orudis for?

Official guidelines emphasize that NSAIDs should be used at the lowest effective dose for the shortest duration possible. This precaution is advised because the risk of serious side effects, such as cardiovascular or gastrointestinal events, can increase with the duration of use.


Q: Do you need a prescription to get Orudis?

Ketoprofen, the active ingredient in Orudis, is available in both prescription-only strengths and lower, over-the-counter (OTC) doses, depending on the country and specific formulation. This distinction often means different doses are classified as prescription versus non-prescription.


Q: Can Orudis cause temporary changes in vision?

Official documentation lists blurred vision as a potential adverse reaction. Any visual disturbances should be discussed with a healthcare professional.


Q: What evidence supports the use of Orudis for postoperative pain?

The official indication for Orudis is for the management of mild to moderate pain. This indication is based on the results of controlled clinical studies that assessed its role in managing pain, which includes pain experienced after surgical procedures.


Q: Can Orudis make me feel anxious or jittery?

Official adverse reaction lists include nervousness, psychiatric changes, and mental/mood changes. These effects may manifest as feelings of anxiety or being jittery in some patients.


Q: Is Orudis safe for people with controlled asthma?

The medication is strictly contraindicated for individuals who have experienced asthma, hives, or severe allergic reactions after taking aspirin or other NSAIDs. While controlled asthma is not an absolute contraindication, caution is advised for all asthma patients due to the risk of exacerbation.


Q: What should I do if my pain is not relieved by Orudis?

Official documents advise that if pain persists or worsens beyond a certain period, the medication should be discontinued. This indicates that failure to achieve adequate pain relief warrants stopping use and consulting with a healthcare professional.


Q: Are there any long-term studies on the safety of Orudis?

While the primary controlled clinical trials for systemic use had limited follow-up durations, the risks of serious cardiovascular and gastrointestinal events are emphasized by regulators. Warnings indicate that these risks may increase with the duration of use, suggesting that long-term safety data relies heavily on post-marketing surveillance.


Q: Can I take Orudis with a probiotic?

The official product information does not list a specific interaction with probiotics. However, regulatory guidance consistently advises informing your healthcare provider of all supplements, including probiotics, to allow for an assessment of potential drug interactions.


Q: Is there any research on Orudis for treating migraines?

Orudis is not specifically indicated for the treatment of migraines. Its approved use is for the temporary relief of minor aches and pains, which can include general headaches, but its formal indications do not specify migraine therapy.

How should Orudis be stored and disposed of?

How to Store and Dispose of Orudis?

The storage and disposal of Orudis (Ketoprofen) are governed by specific regulatory guidelines to maintain product quality and ensure safety.

Official Storage Requirements

Requirement Type Regulatory Rule
Temperature Store at Controlled Room Temperature (20 C–25 C or 68 F–77 F).
Protection Keep away from excess heat, moisture, and direct light.
Packaging Must be kept in a tightly closed container with a child-resistant closure.

Disposal and Safety Rules

To prevent accidental access, the medication must be stored out of the sight and reach of children, typically in a high, secure location. Do not keep outdated or expired medicine. For disposal, regulatory documents advise against flushing the product down the toilet or drain. Unused or expired medication should be discarded via a drug take-back program or, if unavailable, mixed with an undesirable substance and placed in a sealed bag before being thrown into household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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