Objective: The most commonly reported side effects of salsalate are gastrointestinal events,
and few reports are available on its cutaneous side effects. We therefore assessed cutaneous
side effects among diabetic/pre-diabetic patients treated with salsalate.
Methodology: In a randomized placebo-controlled trial, we evaluated cutaneous side effects
in 52 diabetic and 124 pre-diabetic patients, 90 of whom received 3 g/day salsalate and 86 of
whom receive a placebo for four weeks. The evaluation was carried out every week using a
checklist completed by a single general practitioner.
Results: The difference between the salsalate- and placebo-treated groups in overall prevalence
of cutaneous reactions was not significant (26.7% versus 17.4%; P < 0.05). Side effects included
urticaria (nine (10.1%) salsalate-treated versus six (6.9%) placebo-treated), rashes (five (5.5%)
salsalate-treated versus three (3.4%) placebo-treated), pruritus (six (6.7%) salsalate-treated
versus three (3.4%) placebo-treated), and edema (two (2.2%) salsalate-treated versus one
(1.2%) placebo-treated); in addition, one (1.1%) case of erythema nodosum and one (1.1%) of
vasculitis were observed in the salsalate-treated group. In the salsalate group, therapy was
discontinued by the physician for three (3.3%) patients because of acute and severe vasculitis,
erythema nodosum and urticaria and two (2.2%) patients stopped the treatment themselves
because of mild urticaria compared with two patients who stopped using the placebo.
Conclusions: Salsalate can cause several and, in some cases, severe cutaneous side effects
in patients with diabetes/pre-diabetes. Because these cutaneous eruptions can raise various
concerns, including patient non-compliance, greater attention should be paid to dermatological
problems in patients under salsalate treatment