Nicorandil-associated para-stomal ulceration: case series

Abstract

Nicorandil is a vasodilator used to control severe angina. It has been associated with oral and anal ulceration that resolves upon withdrawal of the drug. We report a series of four patients, all of whom were receiving nicorandil therapy and developed nonspecific para-stomal ulcerations of similar clinical and histological appearance. All ulcers healed on withdrawal of nicorandil with no relapse. To the best of our knowledge, nicorandil-associated para-stomal ulcers have not been reported before. It is imperative to be aware of this association to prevent the persistence of these extremely painful ulcerations, and to avoid unnecessary and inappropriate interventions with substantial morbidity in a group of high-risk patients.

Nicorandil-induced terminal ileal ulceration--a probable link

“…Other than initial headaches in approximately one-third of patients, adverse effects are found in less than 5% of patients and include gastrointestinal symptoms, fatigue and malaise, and dizziness. It has been reported in association with anal,2 oral, colonic,3 parastomal4 and intestinal ulceration 5 , 6. There are two previous reports linking ileal ulceration with nicorandil.…”

Diverticular fistulation is associated with nicorandil usage

“…[2][3][4] Oral and anal ulceration have been most frequently reported, though colorectal, 2 ileal, peristomal 5 and genital ulceration 6,7 have also been described. Ulceration has been reported at various times following starting treatment with the drug ranging from weeks to years.…”

Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review

“…The literature reports the involvement of the ileum in the context of surgical stomata as well [19,20,101,102]; apart from rare cases of cutaneous manifestation of Crohn's disease, peristomal ulcerations in clinical practice usually recognize a mechanical cause [103]. The drug is considered in fact the commonest cause of stoma ulceration in patients not affected by inflammatory bowel disease.…”

“…Perianal fistulating disease whilst taking nicorandil appears more rare, constituting 1.9% and 1.2% of the MHRA and WHO gastrointestinal reaction reports, respectively. Data from the literature regarding 165 patients with ulcerations of the distal gastrointestinal tract [18][19][20]93,96,101,102, is presented in table 3.…”