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The spectrum of adverse effects of ketoprofen is similar to that of ibuprofen.
Ketoprofen was originally approved for over-the-counter sales in the USA by the FDA, but in the same year, in Italy, the Ministry of Health transferred two ketoprofen-containing products from non-prescription to prescription status [ ]. The reasons for this difference are not clear.
A fatal asthmatic reaction has been described [ ], and severe bronchospasm with respiratory and cardiac arrest has been reported in a young man with a history of mild asthma after he took ketoprofen [ ]. Topical application can provoke asthma in predisposed subjects [ ].
Even topical formulations of NSAIDs should be avoided in patients with a history of analgesic-induced asthma [ ].
A 74-year-old woman with a history of sinusitis, nasal polyps, and analgesic-induced asthma had a sudden life-threatening attack of asthma 2 hours after the application of a 2% ketoprofen adhesive tape. Asthma had not previously occurred when she had used a 0.3% ketoprofen adhesive patch.
Retention of salt and water, sometimes with reversible pseudotumor cerebri, can occur with ketoprofen [ ].
The overall frequency of adverse reactions was 15–50% in different trials; gastrotoxicity predominated, at a frequency of 6.5–42% [ ], even after rectal administration. In some epidemiological studies, ketoprofen in prescription doses was more gastrotoxic than other NSAIDs [ , ].
There are very few data on the gastrointestinal toxicity of over-the-counter doses of ketoprofen. In an endoscopic short-term study in healthy subjects ketoprofen was associated with significant gastrointestinal toxicity [ ]. Another endoscopic study showed that the R-enantiomer of ketoprofen has less gastrointestinal toxicity than the racemic mixture or the S-enantiomer while retaining good analgesic activity [ ].
Local symptoms, including rectal bleeding, can accompany treatment with ketoprofen suppositories (8.3% of patients) [ ].
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