Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). In the United States the only FDA-approved ketoprofen sold today is a prescription capsule taken by mouth, approved for the signs and symptoms of rheumatoid arthritis and osteoarthritis, for pain, and for painful periods (primary dysmenorrhea) (prescribing information). In Europe, ketoprofen is also approved as a gel for the skin. After a 2010 review, the European Medicines Agency said topical ketoprofen should be used only when a doctor prescribes it, because of skin reactions to sunlight (EMA 2010).
Topical ketoprofen is ketoprofen compounded into a gel, cream, or ointment that is applied to the skin over a painful joint or muscle. No topical ketoprofen product is FDA-approved in the United States, so it is made by a compounding pharmacy to a prescriber's order. Bayview Pharmacy prepares it in several strengths and bases, alone or combined with other pain ingredients. Your prescriber decides whether topical ketoprofen fits your situation, and a valid prescription is required.
How does topical ketoprofen work?
Injured or arthritic tissue makes prostaglandins, signaling molecules that drive pain and swelling. In laboratory studies, ketoprofen reduces the production of prostaglandins, although, as with other NSAIDs, exactly how it works is not fully understood (prescribing information). Applied to the skin, the aim is to treat the area underneath while keeping the amount in the rest of the body low.
Some ketoprofen does reach the bloodstream, but far less than from a capsule. In a small study in eight healthy volunteers, a single dose of a compounded 20% ketoprofen gel had a relative bioavailability, compared with a 50 mg capsule, of a median of 0.48%, ranging from 0.18% to 2.1% from person to person (Dowling et al. 2004). A review of a ketoprofen patch reported that total absorption was no more than 10% of the same dose taken by mouth (Mazères 2005).
What is topical ketoprofen prescribed for?
In the United States these uses are off-label: no topical ketoprofen is FDA-approved for them.
Strains, sprains, and other recent injuries. A 2015 Cochrane review of topical NSAIDs for short-term muscle and joint pain combined five studies of ketoprofen gel. For about every 2 or 3 people treated with ketoprofen gel, one more person had a good response, such as at least half their pain relieved, than with a placebo gel. These five studies were from the 1980s, and some used less clearly defined outcomes (Derry et al. 2015).
Arthritis of the knee. A 2016 Cochrane review of longer studies, 6 to 12 weeks and mostly in knee osteoarthritis, found that for about every 7 people treated with topical ketoprofen, one more had a good result than with a placebo gel. The reviewers concluded that topical ketoprofen and diclofenac help a minority of people with osteoarthritis, and they found no evidence for other long-term painful conditions (Derry et al. 2016).
What about ketoprofen combinations?
Prescribers often combine ketoprofen with other ingredients in one gel. The combinations Bayview prepared most in 2026 pair ketoprofen with lidocaine, a numbing medicine; with gabapentin and lidocaine; or with the muscle relaxants baclofen or cyclobenzaprine. These combinations are compounded, are not FDA-approved, and have been studied far less than ketoprofen alone.
In a randomized trial of 399 people with localized chronic pain, a compounded cream of ketoprofen 10%, baclofen 2%, cyclobenzaprine 2%, and lidocaine 2% did not lower pain more than a placebo cream after one month in people whose pain was classified as nociceptive (such as muscle or joint pain). Two other compounded creams tested in the same trial did not either (Brutcher et al. 2019). A 2020 National Academies review of 20 ingredients common in compounded pain creams, which did not include ketoprofen, concluded that there is limited evidence to support the use of compounded topical pain creams (National Academies 2020). Other combinations, including those with ketamine, a controlled substance, are on our custom pain cream page.
Why is topical ketoprofen compounded?
FDA has approved ketoprofen in the United States only in forms taken by mouth. A prescriber who wants ketoprofen applied to the skin needs it compounded. Compounding also lets the prescriber choose the strength, the base (a water-free gel, a cream, or an ointment), the container, and any added ingredients.
| Ketoprofen gel | Ketoprofen combination | |
|---|---|---|
| What it is | Ketoprofen alone in a water-free gel or a cream, often in a metered pump | Ketoprofen with lidocaine, gabapentin, baclofen, or cyclobenzaprine in one gel or ointment |
| Strengths Bayview prepares | Ketoprofen 5%, 10%, 15%, or 20% | Ketoprofen 10% or 20% in the combinations listed under strengths |
| Where it is used | Over a painful joint, tendon, or muscle, as your prescriber directs | Over a painful joint, tendon, or muscle, as your prescriber directs |
This comparison is for education only and is not a statement that either option is better or more effective. A higher percentage is not automatically a better result, and we found no study comparing compounded strengths with one another. Your prescriber chooses the form, strength, and schedule.
Side effects & safety
Skin reactions. Redness, itching, or a rash where the gel is applied can happen. In the Cochrane reviews, local skin reactions with topical NSAIDs were generally mild and short-lived, and topical ketoprofen did not increase them compared with a placebo gel in the longer arthritis studies (Derry et al. 2015; Derry et al. 2016).
Sun reactions. Ketoprofen on the skin can cause an allergic reaction on treated skin when it is exposed to sunlight (photosensitivity). The European Medicines Agency judged the risk of serious reactions to be very low, about 1 case per 1 million patients treated (EMA 2010). European guidance for topical ketoprofen says to keep treated skin out of the sun, even on hazy days, and away from tanning beds during treatment and for 2 weeks after stopping, and to cover treated areas with clothing outdoors. It also says to stop using it if any skin reaction appears, including after using products that contain octocrylene, a sun filter used in several sunscreens, shampoos, and other cosmetic products (prescriber checklist; EMA assessment report).
NSAID warnings. Ketoprofen capsules carry the boxed warnings shared by NSAIDs: a higher risk of heart attack and stroke, which can be fatal, and of serious bleeding, ulcers, and tears in the stomach or intestines (prescribing information; FDA). Studies found much less ketoprofen reaches the blood from the skin than from a capsule, but these risks are not ruled out. Do not use another NSAID, such as ibuprofen or naproxen, at the same time unless your prescriber tells you to.
Pregnancy and breastfeeding. FDA advises avoiding NSAIDs from 20 weeks of pregnancy unless a health care professional advises otherwise, because they may cause rare but serious kidney problems in the unborn baby that lead to low amniotic fluid. Its list of affected NSAIDs includes ketoprofen, as well as diclofenac products applied to the skin (FDA). LactMed reports low levels of ketoprofen in breast milk when mothers took it, but notes reports of kidney and stomach side effects in breastfed infants from one center and says other medicines are preferred, especially while nursing a newborn or premature infant (LactMed). Tell your prescriber if you are pregnant, planning a pregnancy, or breastfeeding.
Who should not use it?
Do not use topical ketoprofen if you have had an allergic reaction to ketoprofen, or asthma, hives, or another allergic reaction after taking aspirin or another NSAID (prescribing information; EMA assessment report). European labeling also rules it out for people who have had a reaction to sunlight on the skin, a skin allergy to ketoprofen, fenofibrate, tiaprofenic acid, sunscreens, or perfumes, and for anyone who cannot keep treated skin out of the sun during treatment and for 2 weeks after (EMA assessment report). Ketoprofen capsules are not used around heart bypass (CABG) surgery (prescribing information). Do not apply it to broken or infected skin. Tell your prescriber about heart, kidney, liver, or stomach problems, and about every medicine you take, especially blood thinners, aspirin, and other NSAIDs.
How do I get started?
Talk with the doctor or other prescriber who manages your pain. A licensed prescriber decides whether topical ketoprofen is appropriate and chooses the form, strength, and schedule. Bayview Pharmacy does not provide consultations or determine appropriateness. Already have a prescription at another pharmacy? You can transfer it to Bayview. Once you have a prescription, your prescriber can order through Bayview, and a pharmacist is available if you have questions. Topical ketoprofen is part of our compounded medications catalog, alongside our diclofenac gel and custom pain creams.
Clinical details for prescribers
Regulatory. FDA-approved ketoprofen in the United States is oral; the over-the-counter 12.5 mg tablets and the oral film once approved are discontinued, leaving the prescription capsules. Ketoprofen capsules (labeling updated April 2026) are indicated for the signs and symptoms of rheumatoid arthritis and osteoarthritis, the management of pain, and primary dysmenorrhea, with the NSAID boxed warnings for cardiovascular thrombotic events and gastrointestinal bleeding, ulceration, and perforation. Contraindications: hypersensitivity to ketoprofen; asthma, urticaria, or allergic-type reactions after aspirin or other NSAIDs; and the setting of CABG surgery (labeling). No topical ketoprofen is FDA-approved. In the EU, topical ketoprofen remains authorized: a 2010 CHMP referral found the benefit-risk balance positive and restricted it to use on a physician's prescription, with strengthened sun-exposure contraindications and an octocrylene co-sensitization warning (EMA 2010).
503A. FDA's copies guidance states that it generally does not consider a compounded drug a copy when the commercially available product is oral and the compounded product is topical (FDA guidance), so FDA generally would not consider compounded topical ketoprofen essentially a copy of the oral capsules.
Published evidence on topical ketoprofen:
- Acute musculoskeletal pain: Derry et al. 2015, 61 studies. Ketoprofen gel NNT for clinical success (at least 50% pain relief or an equivalent measure) 2.5 (95% CI 2.0 to 3.4) from five studies from the 1980s, some with less well-defined outcomes. Local skin reactions were generally mild and transient and did not differ from placebo; the authors rated clinical success data across topical diclofenac, ibuprofen, ketoprofen, piroxicam, and indomethacin as moderate or high quality (Cochrane).
- Chronic musculoskeletal pain: Derry et al. 2016, 39 studies, 10,631 participants. Topical ketoprofen NNT 6.9 (5.4 to 9.3) in four trials with 2,573 participants, 6 to 12 weeks, mainly knee osteoarthritis; topical diclofenac NNT 9.8. Local adverse events increased with diclofenac but not with ketoprofen. The authors found no evidence for other chronic painful conditions, and systemic adverse event reporting was poor (Cochrane).
- Systemic exposure: Dowling et al. 2004, open-label crossover, n=8 healthy volunteers, single 200 mg dose of ketoprofen 20% in a poloxamer-lecithin organogel vs a 50 mg oral capsule, sampling to 10 hours. Median Cmax 0.021 vs 4.15 mcg/mL; median relative bioavailability 0.48% (range 0.18% to 2.1%), highly variable (Am J Health Syst Pharm). Mazères 2005: total systemic bioavailability of a ketoprofen 100 mg patch no more than 10% of oral ketoprofen 100 mg (Drugs R D). We found no multiple-dose exposure study of compounded ketoprofen gels at 10% to 20%.
- Combinations: Brutcher et al. 2019, double-blind RCT, 399 patients with localized chronic pain. The nociceptive formula (ketoprofen 10% / baclofen 2% / cyclobenzaprine 2% / lidocaine 2%) did not differ from placebo cream in change in average pain at 1 month (difference -0.3, 95% CI -0.9 to 0.2); neuropathic and mixed formulas also did not differ (Ann Intern Med). The 2020 National Academies review of 20 APIs (ketoprofen not among them) concluded that there is limited evidence to support compounded topical pain creams in the general adult population (National Academies).
Labeling points that may matter for topical use:
- Photosensitivity: the CHMP judged the risk of serious photoallergic reactions very low (about 1 per 1 million patients treated) (EMA). EU contraindications: any history of photosensitivity; known hypersensitivity (asthma, allergic rhinitis) to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other NSAIDs; history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, UV blockers, or perfumes; and sun exposure, including hazy sun and solarium UV, during treatment and for 2 weeks after. Counsel: wash hands after each application, no occlusive dressing, protect treated skin with clothing during treatment and for 2 weeks after, and stop at any skin reaction, including after octocrylene-containing products (EMA assessment report; prescriber checklist).
- NSAID class: boxed cardiovascular and gastrointestinal warnings and the CABG contraindication on the oral labeling (labeling). Exposure from topical use is lower but not zero; avoid concurrent oral NSAIDs unless intended.
- Pregnancy: FDA's October 2020 communication advises avoiding NSAIDs at 20 weeks or later (oligohydramnios, fetal renal dysfunction), with the existing advice to avoid them from about 30 weeks (premature closure of the ductus arteriosus). If treatment is needed between about 20 and 30 weeks, FDA advises the lowest effective dose for the shortest duration and considering ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Its table lists ketoprofen and includes topical diclofenac products (FDA).
- Lactation: LactMed (revised June 2025) reports low milk levels after maternal ketoprofen, notes one center's reports of renal and gastrointestinal adverse effects in breastfed infants, and prefers other agents, especially with a newborn or preterm infant (LactMed).
What Bayview compounds (2026 fills):
- Single agent: the one single-agent fill in 2026 was ketoprofen 10% topical gel with DMSO 10% in an anhydrous gel base, 60 g. Ketoprofen 5%, 10%, 15%, and 20% topical gels and creams are prepared on prescription.
- Combinations dispensed most: gabapentin 10% / ketoprofen 20% / lidocaine 5% gel; lidocaine 20% / ketoprofen 20% ointment (jar) or gel (pump); baclofen 2% / gabapentin 6% / ketoprofen 10% / lidocaine 5% gel; ketoprofen 20% / cyclobenzaprine 2% gel; ketoprofen 10% / lidocaine / DMSO gel.
- Ketamine-containing ketoprofen gels are Schedule III; Rhode Island rules and Bayview policy require EPCS for them. They are covered on the custom pain cream page.
- Writing the prescription: each active ingredient and strength, the base and container (for example ketoprofen 10% topical gel, anhydrous base, 60 g pump), the application site and frequency, an ICD-10 code (for example M17.11 unilateral primary osteoarthritis of the right knee, M77.11 lateral epicondylitis of the right elbow, S93.401A sprain of unspecified ligament of right ankle, initial encounter), quantity, and refills.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA. Ordering and account setup are covered on our for providers page.
This information is about prescription medications and is not medical advice. Compounded medications are prescription-only and are not FDA-approved. Your prescriber determines whether topical ketoprofen is appropriate and sets the form, strength, and schedule.
