Worldwide safety experience with diclofenac.

Worldwide use of diclofenac sodium since 1974 has yielded an extensive body of data on the safety of this drug. Documentation is derived from clinical trials, post-marketing surveillance, special studies, and spontaneous reports of adverse drug reactions from foreign countries. Comprehensive safety data from foreign studies show that diclofenac is safer and better tolerated than aspirin and is comparable in safety to ibuprofen and naproxen. Safety data from clinical trials in the United States, in which most patients received 150 mg daily of diclofenac, show that patients receiving diclofenac had lower rates of adverse reactions than patients receiving any of the comparative nonsteroidal anti-inflammatory drugs, except for naproxen at 500 mg daily. Special safety studies performed outside the United States address organ systems and patient groups of particular concern with nonsteroidal anti-inflammatory drugs, i.e., effects of diclofenac on gastrointestinal, renal, hepatic, and hemostatic systems; use in children and the elderly; and interactions with concomitant medications.