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What the label lists and what reports show

Ketoprofen side effects

Ketoprofen's FDA label lists its adverse reactions in its own words. FAERS holds 13,039 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (1,231 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the ketoprofen FDA label on DailyMed (effective February 15, 2026, Misemer Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 ketoprofen-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 patients treated with ketoprofen extended-release capsules in trials lasting from 4 to 16 weeks. Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of ketoprofen extended-release capsules once a day or 75 mg of ketoprofen immediate-release capsules TID (255 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; …

Source: FDA drug label, Misemer Pharmaceuticals, Inc., effective February 15, 2026 (SPL set d0f47ab6-29ff-df07-e053-2a95a90a2b51), via openFDA; the full label on DailyMed

What do FAERS reports show?

13,039 reports list ketoprofen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,182 are coded as a death and 6,466 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Headache (named in the label)1,231
  • Pain (a use or a product term, not a reaction)1,139
  • Fatigue931
  • Nausea (named in the label)799
  • Drug Ineffective (a use or a product term, not a reaction)773
  • Off Label Use (a use or a product term, not a reaction)766
  • Infusion Site Pain764
  • Pyrexia756
  • Hypersensitivity (named in the label)705
  • Rheumatoid Arthritis (a use or a product term, not a reaction)697
  • Hyperhidrosis693
  • Back Pain690
  • Diarrhoea (named in the label)685
  • Rash (named in the label)667
  • Erythema656
  • Constipation (named in the label)644
  • Vomiting (named in the label)641
  • Drug Hypersensitivity634
  • Hepatic Enzyme Increased616
  • Asthma608
  • Overdose (a use or a product term, not a reaction)607
  • Dyspnoea (named in the label)587
  • Immunodeficiency585
  • Food Allergy567
  • Upper Respiratory Tract Infection561

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ketoprofen: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions