Ketoprofen was not pulled from the market for safety reasons. The over-the-counter version, sold as Orudis KT, was voluntarily discontinued by its manufacturer Wyeth in 2005 as a business decision. The FDA formally confirmed that the product “was not withdrawn from sale for reasons of safety or effectiveness.” Prescription-strength ketoprofen, however, is still available in the United States.
Why Orudis KT Disappeared From Store Shelves
In August 2005, Wyeth notified the FDA that it would stop manufacturing Orudis KT, the 12.5 mg over-the-counter tablet. The product was then moved to the FDA’s “Discontinued Drug Product List,” a category specifically for drugs removed from the market for reasons other than safety or effectiveness. That distinction matters: drugs pulled for dangerous side effects end up on a different list entirely.
Wyeth never publicly detailed exactly why it stopped making Orudis KT, but the timing and context point to commercial factors. By the mid-2000s, the OTC pain reliever market was dominated by ibuprofen (Advil, Motrin) and naproxen (Aleve), both cheaper to produce and far more recognized by consumers. Ketoprofen never gained the same brand loyalty or shelf space, and maintaining a product with low market share simply wasn’t worth it for the manufacturer.
Prescription Ketoprofen Is Still Available
If you’ve been told ketoprofen is completely gone, that’s not quite right. Prescription-strength ketoprofen capsules (50 mg and 75 mg) and extended-release capsules (200 mg) are still listed as available in the U.S. Your doctor can prescribe them for osteoarthritis, rheumatoid arthritis, moderate pain, and menstrual cramps. The typical dose for arthritis is 75 mg three times daily or 50 mg four times daily, while the extended-release version is taken once a day.
That said, because no major brand name markets it aggressively, some pharmacies may not stock it routinely. You might need to request it specifically, and your pharmacist may need to order it. This limited shelf presence contributes to the impression that the drug has vanished.
Ketoprofen’s Safety Compared to Other NSAIDs
One reason people assume ketoprofen was removed for safety is the broader wave of NSAID scrutiny that hit in the mid-2000s, particularly after Vioxx was pulled in 2004. But ketoprofen’s safety profile holds up well under examination. A meta-analysis published in the Annals of the Rheumatic Diseases compared ketoprofen head-to-head with ibuprofen and diclofenac and found virtually identical risk. The likelihood of experiencing a side effect on ketoprofen versus the other two was statistically indistinguishable, with a risk ratio of 1.02 and no serious adverse events observed in the analysis.
Like all NSAIDs, ketoprofen carries the standard class risks: stomach irritation, potential kidney strain with long-term use, and a small increase in cardiovascular events at high doses. But none of these risks are elevated compared to the ibuprofen or naproxen sitting in your medicine cabinet right now.
Topical Ketoprofen and Skin Reactions
Topical ketoprofen gel, used in some countries for localized joint and muscle pain, did draw regulatory attention in Europe over photosensitivity reactions. When skin treated with the gel was exposed to sunlight, some patients developed allergic skin reactions. There was also a concern about cross-reactivity with octocrylene, a UV filter found in many sunscreens and cosmetic products.
The European Medicines Agency investigated and concluded the risk was extremely low: roughly 1 serious photoallergic reaction per million patients treated. The agency kept topical ketoprofen on the market but required updated labeling advising patients to avoid sun exposure on treated skin. This issue applies only to the topical gel, not to oral capsules.
Availability Outside the United States
Ketoprofen remains widely used internationally. It is actively marketed across Europe, including in Germany, France, and the U.K., as well as throughout Asia, Latin America, and the Middle East. In many of these markets it is available both over the counter and by prescription, in oral and topical forms. The drug’s unavailability as an OTC product is largely an American phenomenon driven by one manufacturer’s commercial decision, not a global safety concern.
Veterinary Bans for Environmental Reasons
There is one context where ketoprofen has genuinely been banned, and it has nothing to do with human safety. When vultures feed on the carcasses of livestock treated with certain NSAIDs, the drug residues cause kidney failure and a fatal condition called visceral gout in the birds. This devastated vulture populations across South Asia starting in the 1990s, initially linked to diclofenac.
Bangladesh became the first country to ban veterinary ketoprofen in 2021, and India followed in 2023. Nepal has proposed a similar ban. These restrictions apply only to veterinary use in livestock, specifically to protect critically endangered vulture species. They have no bearing on whether the drug is safe for people to take.