Orudis
Topical Ketoprofen Gel for Muscle and Joint Pain Relief
Quick Facts About Orudis
Key Takeaways About Orudis
- Topical NSAID with local action: Orudis gel delivers ketoprofen directly to inflamed tissues through the skin, providing targeted pain relief with minimal systemic side effects compared to oral NSAIDs
- Short-term use only: Treatment must not exceed 7 days. If symptoms persist, consult your doctor for further evaluation
- Critical sun avoidance: Treated skin must not be exposed to sunlight or UV light during use and for 2 weeks after stopping – ketoprofen causes potentially severe photosensitivity reactions
- Not for broken or damaged skin: Never apply to wounds, eczema, acne, infections, or mucous membranes. Wash hands thoroughly after application
- Not recommended for children: Orudis gel is intended for adult use only. Safety and efficacy in children have not been established
What Is Orudis and What Is It Used For?
Orudis is a topical gel containing ketoprofen 2.5%, a non-steroidal anti-inflammatory drug (NSAID) applied to the skin to relieve pain and reduce inflammation at the site of musculoskeletal injuries such as sprains, strains, and sports injuries.
Ketoprofen, the active ingredient in Orudis gel, belongs to the propionic acid class of NSAIDs, the same chemical family as ibuprofen and naproxen. When applied topically, ketoprofen penetrates the skin and reaches therapeutic concentrations in the underlying soft tissues, tendons, ligaments, and joint structures. It works by inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes at the local site, thereby reducing the production of prostaglandins – chemical mediators responsible for inflammation, pain, and swelling.
The primary advantage of topical ketoprofen over oral NSAIDs lies in its targeted delivery. When applied as a gel, systemic absorption is approximately 5% of the equivalent oral dose, which means that the drug reaches high concentrations in the tissues directly beneath the application site while circulating blood levels remain very low. This targeted approach significantly reduces the risk of systemic side effects commonly associated with oral NSAIDs, such as gastrointestinal ulceration, cardiovascular events, and renal impairment.
Orudis gel is specifically indicated for mild to moderate pain associated with musculoskeletal and joint injuries, including:
- Sports injuries – sprains, strains, contusions, and soft tissue injuries sustained during physical activity
- Acute muscle pain – localised muscle soreness, stiffness, and inflammation
- Joint pain – inflammation and pain in superficial joints following injury or overuse
- Tendinitis and bursitis – inflammation of tendons and bursae near the skin surface
Clinical evidence supports the efficacy of topical ketoprofen for acute musculoskeletal pain. A Cochrane systematic review of topical NSAIDs found that ketoprofen gel demonstrated a number needed to treat (NNT) of approximately 2.5 for achieving at least 50% pain relief over 7 days, making it one of the most effective topical NSAIDs available. The European League Against Rheumatism (EULAR) recommends topical NSAIDs as a first-line pharmacological treatment for localised musculoskeletal pain, prior to considering oral analgesics.
Topical NSAIDs like Orudis gel are recommended by international guidelines as a preferred first-line treatment for localised musculoskeletal pain, particularly in older adults and patients at risk of gastrointestinal side effects from oral NSAIDs. The gel formulation allows the active substance to be delivered directly where it is needed, providing effective pain relief with a favourable safety profile.
What Should You Know Before Using Orudis?
Before using Orudis gel, ensure you do not have allergies to ketoprofen or other NSAIDs, and never apply it to broken, infected, or sun-exposed skin. Orudis must not be used during the last three months of pregnancy, and sunlight exposure on treated areas is strictly prohibited.
Contraindications
You should not use Orudis gel if any of the following apply to you:
- Allergy to ketoprofen or any of the other ingredients in the gel (ethanol, carbomer, triethanolamine, lavender oil, purified water)
- History of hypersensitivity reactions (such as asthma symptoms, hay fever, or hives) triggered by fenofibrate, acetylsalicylic acid (aspirin), or other NSAIDs
- Skin conditions on the treatment area – eczema (scaly, itchy rash), acne, skin infections, or open wounds at the intended site of application
- Third trimester of pregnancy – use during the last three months of pregnancy is strictly contraindicated
- History of abnormal skin reactions to sunlight (photosensitivity or photodermatitis)
- Known allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers, or perfumes – cross-reactivity is well documented
Stop using Orudis immediately if you develop any skin reaction, including reactions that occur after simultaneous use of products containing octocrylene. Octocrylene is a common ingredient in many cosmetics and personal care products, including sunscreen, shampoo, after-shave, shower gels, skin creams, lip products, anti-wrinkle creams, make-up removers, and hairspray. Check the ingredient lists of your personal care products carefully.
Warnings and Precautions
Talk to your doctor or pharmacist before using Orudis gel if any of the following conditions apply:
- Asthma – NSAIDs, including topical formulations, may provoke bronchospasm in susceptible individuals, particularly those with aspirin-sensitive asthma
- Heart, liver, or kidney problems – although systemic absorption from topical use is low, patients with pre-existing organ impairment should consult their doctor before use
- History of fixed drug eruption – if you have previously developed round or oval patches of redness, swelling, blistering, or hives that recur at the same skin sites after taking ketoprofen, you may be at risk of a similar reaction with the gel
Exposure to sunlight (even through clouds) or UV light from tanning beds on areas that have been in contact with Orudis gel can cause severe skin reactions (photosensitivity). You must:
- Protect treated areas by wearing clothing during treatment and for two weeks after stopping
- Wash your hands thoroughly after every application to prevent accidental transfer to sun-exposed skin
- Never expose the treated area to direct or indirect sunlight or UV light
Additional important precautions include:
- Do not cover the treated area with bandages or occlusive dressings
- Avoid contact with sensitive skin areas including the mouth, mucous membranes, genitals, rectum, and eyes
- Do not exceed 7 days of treatment – the risk of certain side effects increases with prolonged use
- Ethanol content: Each gram of gel contains 313 mg of ethanol (alcohol), which may cause a burning sensation on damaged skin
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using Orudis gel.
Pregnancy: Orudis gel must not be used during the last three months of pregnancy. Oral forms of NSAIDs during this period can affect the baby's cardiovascular system (premature closure of the ductus arteriosus), impair kidney function, and inhibit labour. Although the risks from topical application are expected to be lower due to reduced systemic absorption, the contraindication applies equally to gel formulations as a precautionary measure. During the first six months of pregnancy, use only if your doctor considers it absolutely necessary, at the lowest possible dose and for the shortest possible duration.
Breastfeeding: It is not known whether ketoprofen passes into breast milk following topical application. As a precautionary measure, breastfeeding should be avoided while using Orudis gel. If you are breastfeeding, consult your doctor before using this product.
Use in Children
Orudis gel is not recommended for use in children. The safety and efficacy of topical ketoprofen in paediatric populations have not been established. If your child has musculoskeletal pain requiring treatment, consult a healthcare professional for appropriate alternatives.
Driving and Operating Machinery
Orudis gel, when used as directed on the skin, is not expected to affect your ability to drive or operate machinery. Topical application results in negligible systemic absorption, and no central nervous system effects have been associated with correct use of the gel.
How Does Orudis Interact with Other Drugs?
Although topical ketoprofen has very low systemic absorption, inform your doctor about all medications you are using, particularly oral NSAIDs, anticoagulants, and methotrexate. Concurrent use of multiple NSAID products may increase the risk of side effects.
Because Orudis gel is applied to the skin and systemic absorption is limited to approximately 5% of the equivalent oral dose, clinically significant drug interactions are uncommon. However, the potential for additive effects exists, particularly when topical ketoprofen is used alongside other anti-inflammatory or anticoagulant medications. It is always good practice to inform your doctor or pharmacist about all medicines you are currently taking, including over-the-counter products and herbal remedies.
The following table summarises the interactions that may be relevant, even with topical administration:
| Drug / Class | Risk Level | Effect | Recommendation |
|---|---|---|---|
| Oral NSAIDs (ibuprofen, diclofenac, naproxen) | Moderate | Additive anti-inflammatory effects; potential increase in systemic NSAID exposure and side effects | Avoid concurrent use of multiple NSAID products unless advised by your doctor |
| Anticoagulants (warfarin, heparin, DOACs) | Low–Moderate | NSAIDs can interfere with platelet function, potentially increasing bleeding risk | Inform your doctor; monitor for signs of unusual bleeding or bruising |
| Aspirin (acetylsalicylic acid) | Low–Moderate | Additive effects on platelet aggregation and potential gastrointestinal effects | Use with caution; discuss with your doctor if taking low-dose aspirin for cardiovascular protection |
| Methotrexate | Low | Oral NSAIDs can reduce renal clearance of methotrexate; risk is minimal with topical use | Inform your doctor; unlikely to be clinically significant with gel application |
| Octocrylene-containing products (sunscreens, cosmetics) | Moderate | Cross-reactivity can trigger contact dermatitis or photosensitivity reactions | Avoid applying octocrylene-containing products to areas treated with Orudis |
| Other topical products | Low | May alter absorption of ketoprofen or cause skin irritation | Do not apply other creams, gels, or ointments to the same area simultaneously |
It is worth noting that the low systemic bioavailability of topical ketoprofen makes serious drug-drug interactions unlikely in clinical practice. However, patients using multiple medications – particularly those on anticoagulant therapy or high-dose methotrexate – should always inform their healthcare provider about all topical products being used.
What Is the Correct Dosage of Orudis?
Apply a thin layer of Orudis gel to the affected area 2–3 times daily for up to 7 days. Do not exceed 15 g of gel per day. Massage gently into the skin and wash your hands thoroughly afterwards.
Always use Orudis gel exactly as your doctor has instructed or as directed in the product information. If you are unsure about the correct use, consult your doctor or pharmacist. Orudis is for external use only and must only be applied to intact, unbroken skin.
How to Apply
- Clean and dry the affected area before application
- Squeeze a thin layer of gel onto your fingertip
- Apply to the painful or inflamed area
- Massage gently into the skin for several minutes until the gel is absorbed
- Wash your hands thoroughly after application (unless your hands are the area being treated)
- Replace the cap on the tube securely after use
Adults
Musculoskeletal Pain and Sports Injuries
Application frequency: Apply a thin layer 2–3 times daily
Maximum daily amount: 15 g of gel per day (approximately 28 cm of gel from the tube)
Duration: Maximum 7 days of treatment
A strip of approximately 7.5 g (about 14 cm of gel) is sufficient for most applications. Apply only enough gel to cover the injured area with a thin layer – using more will not improve effectiveness and may increase the risk of side effects.
Children
Paediatric Use
Orudis gel is not recommended for use in children. Safety and efficacy data in paediatric populations are insufficient. Consult your doctor for appropriate pain relief alternatives for children.
Elderly Patients
No specific dose adjustment is required for elderly patients when using Orudis gel topically. However, older adults may have thinner skin, which could potentially increase absorption. Elderly patients should use the minimum amount needed and follow the same precautions regarding sun exposure and treatment duration. If you have concerns about underlying heart, liver, or kidney conditions, consult your doctor before use.
Missed Application
If you forget to apply the gel at the scheduled time, apply it as soon as you remember. However, if it is nearly time for your next application, skip the missed one and continue with your regular schedule. Do not apply a double amount to compensate for a missed application.
Overdose
If you apply significantly more gel than recommended, it is unlikely to cause serious problems due to the limited systemic absorption of topical formulations. However, if you or someone else accidentally swallows Orudis gel, seek medical advice immediately. Take the packaging with you to the hospital so the doctor knows what has been ingested. Symptoms of oral NSAID overdose may include nausea, vomiting, abdominal pain, drowsiness, and, in severe cases, gastrointestinal bleeding or kidney impairment. Contact your local emergency services or poison control centre for assessment.
What Are the Side Effects of Orudis?
The most common side effects of Orudis gel are local skin reactions at the application site, including redness, eczema, itching, and burning sensation. Serious photosensitivity reactions can occur if treated skin is exposed to sunlight. Stop using the gel and seek medical attention if you develop severe skin reactions or signs of allergic response.
Like all medicines, Orudis gel can cause side effects, although not everyone who uses it will experience them. Because the gel is applied to the skin with limited systemic absorption, side effects are predominantly localised skin reactions. However, allergic and photosensitivity reactions can occur and may be serious.
- Angioedema – swelling of the face, tongue, or throat; difficulty swallowing or breathing; hives
- Severe skin reactions – blistering, peeling, or bleeding of the skin (with or without rash), including the lips, eyes, mouth, nose, genitals, hands, or feet, possibly with flu-like symptoms such as fever, chills, or muscle aches
- Fixed drug eruption – round or oval patches of redness and swelling, blistering, hives, or itching that recur at the same site each time you are exposed to ketoprofen
Uncommon
May affect up to 1 in 100 people
- Local skin redness (erythema) at the application site
- Eczema (dermatitis) at the application site
- Itching (pruritus) at or around the treated area
- Burning or stinging sensation upon application
Rare
May affect up to 1 in 1,000 people
- Serious skin reactions following sun exposure (photosensitivity dermatitis)
- Allergic skin reactions including hives (urticaria)
- Eczema with blistering or pus-filled blisters that may spread or become generalised
Very Rare
May affect up to 1 in 10,000 people
- Worsening of pre-existing kidney impairment
Not Known
Frequency cannot be determined from available data
- Anaphylactic shock (severe, life-threatening allergic reaction)
- Allergic reactions (hypersensitivity)
- Fixed drug eruption (recurring skin reaction at the same site)
- Severe blistering skin reactions (Stevens-Johnson syndrome-like reactions)
The risk of photosensitivity deserves particular attention. Ketoprofen is one of the topical NSAIDs most frequently associated with photosensitivity reactions. These reactions can occur not only on the directly treated area but may also spread to other skin sites that have come into accidental contact with the gel (for example, through transfer from the hands). The reaction may persist for days or weeks after exposure and can range from mild redness to severe, blistering dermatitis requiring medical treatment.
If you develop any side effect, even one not listed above, stop treatment and consult your doctor. Reporting suspected adverse reactions after the medicine has been authorised is important, as it allows continuous monitoring of the benefit-risk balance of the product.
How Should You Store Orudis?
Store Orudis gel at room temperature below 25°C, out of the sight and reach of children. Do not use after the expiry date printed on the tube and carton.
Proper storage of medications is essential to ensure they remain safe and effective throughout their shelf life. Follow these guidelines for storing Orudis gel:
- Temperature: Store at or below 25°C (77°F). Do not freeze the gel
- Keep out of reach: Store out of the sight and reach of children at all times
- Expiry date: Do not use the gel after the expiry date stated on the carton and tube. The expiry date refers to the last day of the stated month
- After opening: Replace the cap securely after each use. Use within the period recommended on the packaging
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired medication to your pharmacy for proper disposal. These measures help protect the environment
What Does Orudis Contain?
Each gram of Orudis gel contains 25 mg of ketoprofen as the active ingredient. The gel also contains ethanol, carbomer, triethanolamine, lavender oil, and purified water.
Active Ingredient
The active substance is ketoprofen. Each gram of Orudis gel contains 25 mg of ketoprofen (2.5% w/w). Ketoprofen is a non-steroidal anti-inflammatory drug that works by inhibiting the production of prostaglandins – substances in the body that cause inflammation, pain, and swelling.
Other Ingredients (Excipients)
The other ingredients in Orudis gel are:
- Ethanol (alcohol) – acts as a solvent and enhances skin penetration; may cause a burning sensation on damaged skin (313 mg per gram of gel)
- Carbomer – a gelling agent that gives the product its gel consistency
- Triethanolamine – a pH adjuster that helps stabilise the gel formulation
- Lavender oil – provides the characteristic scent of the product
- Purified water – the base solvent of the gel
Appearance and Pack Sizes
Orudis gel is a colourless, transparent gel with a lavender scent. It is available in aluminium tubes containing 30 g or 60 g of gel. Each pack contains one tube of 30 g or 60 g, or two tubes of 60 g. Not all pack sizes may be marketed in every country.
Ketoprofen was first synthesised in the 1960s and has been used clinically since the 1970s. It is available in multiple formulations worldwide, including oral tablets, capsules, suppositories, injectable solutions, and topical gels and patches. The topical gel formulation was developed to provide localised pain relief while minimising the systemic side effects associated with oral NSAID use. Ketoprofen is included in the pharmacopoeias of major regulatory agencies including the European Medicines Agency (EMA) and is approved for use in numerous countries worldwide.
Frequently Asked Questions About Orudis
Orudis is a topical gel containing ketoprofen 2.5%, a non-steroidal anti-inflammatory drug (NSAID). It is used for the relief of mild to moderate pain and inflammation associated with muscle and joint injuries, such as sports injuries, sprains, strains, and bruises. The gel is applied directly to the skin over the affected area, where it provides localised pain relief and reduces inflammation without the need for oral medication.
No. You must not expose the treated skin to sunlight or UV light (including tanning beds) during treatment and for 2 weeks after stopping treatment. Ketoprofen can cause severe photosensitivity reactions, including serious skin rashes and blistering, when treated skin is exposed to UV radiation. Always cover treated areas with clothing when outdoors, and wash your hands thoroughly after application to prevent accidental transfer to other skin areas.
Orudis gel should not be used for more than 7 days. If your symptoms have not improved or have worsened after 7 days of treatment, stop using the gel and consult your doctor. Prolonged use increases the risk of side effects, particularly skin reactions and photosensitivity. Your doctor may recommend alternative treatments if your pain persists beyond one week.
Orudis gel must not be used during the last 3 months (third trimester) of pregnancy, as NSAIDs can cause serious complications for the unborn baby, including premature closure of the ductus arteriosus and impaired kidney function. During the first 6 months of pregnancy, it should only be used if your doctor considers it absolutely necessary and at the lowest effective dose for the shortest possible time. If you are pregnant or planning to become pregnant, always consult your doctor before using any medication.
While topical ketoprofen has low systemic absorption, you should inform your doctor if you are using other medications, especially oral NSAIDs (such as ibuprofen or diclofenac), anticoagulants (blood thinners), aspirin, or methotrexate. Using multiple NSAID products simultaneously may increase the risk of side effects. Paracetamol (acetaminophen) is generally considered safe to use alongside topical ketoprofen, but always consult your doctor or pharmacist before combining pain medications.
If you develop any skin reaction – including redness, rash, itching, blistering, or swelling – stop using Orudis immediately and contact your doctor or healthcare professional. Do not re-apply the gel. In rare cases, ketoprofen gel can cause severe photosensitivity reactions or generalised allergic reactions. Seek immediate medical attention if you experience swelling of the face, tongue, or throat, difficulty breathing or swallowing, or widespread skin blistering or peeling.
References
- Derry S, Wiffen PJ, Kalso EA, et al. Topical analgesics for acute and chronic pain in adults – an overview of Cochrane Reviews. Cochrane Database of Systematic Reviews. 2017;(5):CD008609. doi:10.1002/14651858.CD008609.pub2
- Derry S, Moore RA, Gaskell H, McIntyre M, Wiffen PJ. Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database of Systematic Reviews. 2015;(6):CD007402. doi:10.1002/14651858.CD007402.pub3
- European Medicines Agency (EMA). Ketoprofen – Summary of Product Characteristics. EMA/CHMP Assessment Report. Available at: ema.europa.eu
- Baraf HSB, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs & Aging. 2011;28(1):27–40.
- NICE (National Institute for Health and Care Excellence). Osteoarthritis: care and management. Clinical guideline CG177. Updated 2022. Available at: nice.org.uk
- Coaccioli S. Ketoprofen 2.5% gel: a clinical overview. European Review for Medical and Pharmacological Sciences. 2011;15(8):943–949.
- EULAR (European League Against Rheumatism). Recommendations for the management of soft tissue rheumatism. Annals of the Rheumatic Diseases. 2023.
- World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- European Medicines Agency (EMA). Photosensitivity and ketoprofen: updated risk assessment. Pharmacovigilance Risk Assessment Committee (PRAC). 2014.
- British National Formulary (BNF). Ketoprofen – topical preparations. National Institute for Health and Care Excellence. Updated 2024.
Editorial Team
Medical Review
Reviewed by the iMedic Medical Review Board – an independent panel of board-certified physicians specialising in rheumatology, clinical pharmacology, and musculoskeletal medicine. All content follows international guidelines from WHO, EULAR, ACR, and NICE.
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This article is based on peer-reviewed medical literature, regulatory product information, and international clinical guidelines. Evidence level: 1A (systematic reviews and meta-analyses of randomised controlled trials). No commercial funding or pharmaceutical sponsorship.
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