Mouth ulceration has long been a recognised adverse effect of nicorandil, however healthcare professionals should now consider nicorandil treatment as a possible cause in patients with symptoms of gastrointestinal ulceration.
The ulceration can be severe and, in a few patients, has led to perforation. Ulcers are refractory to treatment and only respond to withdrawal of nicorandil. Withdrawal should take place only under the supervision of a cardiologist.
Further information: MHRA