Nicorandil-induced peristomal ulcers: is nicorandil also associated with gastrointestinal fistula formation?

Role of nicotinic acid and nicotinamide in nicorandil‐induced ulcerations: from hypothesis to demonstration

“…Five years later, Watson et al (6) described anal ulcers. Since then, many reports of single or multiple nicorandil-induced ulcerations (NIUs) in oral, anal, perianal, vulvovaginal, perivulval, penile, gastrointestinal, colonic, peristomal, skin and ocular locations have been reported (7)(8)(9)(10)(11)(12)(13)(14)(15). Fistulae are now being investigated (16).…”

“…NIUs mostly occur at vulnerable sites, being peristomal after any procedure that creates a stoma, penile after circumcision and perianal after haemorrhoidectomy. Under cardiologists' aegis, nicorandil replacement by a classic NO donor can be done without complication (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16).…”

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.…”

Authors' reply to Herxheimer

“…3 Multiple case reports and series have since described oral, perianal, 4 vulval, 5 and peristomal ulcers, 6 as well as ulceration in the gastrointestinal tract. 7 Wound healing may also be delayed in patients taking this drug.…”