Ulceration from nicorandil

Painful perianal ulcers with nicorandil

“…It is licensed in Europe (Austria, Denmark, France, Ireland, the Netherlands, Portugal, UK) and elsewhere for this indication. It is not approved for marketing in the US 12345678…”

“…Patients may present with ulcers, which are usually painful, in the mouth, around the anus, or on the cornea, skin, or genitalia 214151617. Those with ulcers in the bowel may present with gastrointestinal haemorrhage.…”

“…Various mechanisms for nicorandil-associated ulceration have been proposed, but none has been validated 2915…”

“…Many case reports describe nicorandil-associated ulcers234518; however, few studies have evaluated risks at the population level. A nationwide epidemiological study from Taiwan found that 25.8% (183/710) of nicorandil users developed gastrointestinal ulceration compared with 9.3% (61 281/659 081) of a cohort of non-users from the general population (adjusted hazard ratio (aHR) 1.43; 95% confidence interval, 1.23 to 1.65; 6848 excess cases per 100 000 patient years of use) 17.…”

“…Nicorandil, a drug occasionally used to treat symptoms of angina, can cause a rare but serious adverse reaction of painful, non-healing ulcers that affect the skin and mucosa 1. Failure to recognise this adverse drug reaction can result in serious harm to some patients 2345. The danger is increased because nicorandil treatment is usually initiated by cardiologists, but this rare adverse reaction usually presents to others, including general practitioners, surgeons, dentists, ophthalmologists, and dermatologists.…”