Nicorandil: Drug Recall Demanded Over Severe Ulcer Risk – France 2026
French health authorities are facing renewed calls for the immediate withdrawal of nicorandil, a medication used to treat angina, following reports of severe adverse reactions, including deaths linked to organ perforation. The independent medical review publication, Prescrire, has formally requested the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) and the Haute Autorité de Santé (HAS) to remove the drug from the market, citing unacceptable risks to patients.
The call for withdrawal comes amid ongoing alerts from the ANSM regarding ulcerations and serious complications associated with nicorandil. Prescrire’s letter, dated March 19, 2026, asserts that the available data demonstrate a net harm for patients taking the medication and that continued availability represents an unacceptable risk. More than 50,000 patients in France currently have prescriptions for nicorandil.
Nicorandil is indicated for symptomatic treatment of angina, specifically for patients who have contraindications or intolerance to first-line treatments like beta-blockers and calcium channel antagonists, according to the ANSM. Several generic versions of the drug are currently marketed in France, including those manufactured by Almus France (Biogaran), Biogaran, Double-E Pharm Limited (EG Labo – Laboratoires Eurogenerics), Sandoz, Viatris Santé, and Zentiva France.
The primary concern centers on the potential for severe ulcerations affecting the skin, mucous membranes, and even the eyes. These ulcerations can lead to complications such as perforation, fistula formation, abscesses, and gastrointestinal hemorrhage, the ANSM warns. The risk is heightened in elderly patients, those taking multiple medications concurrently, and individuals with diverticular disease.
Prescrire has advised against the use of nicorandil since 2011, arguing that its risks outweigh its benefits. The publication’s latest appeal is based on a French study conducted by several regional pharmacovigilance centers, which identified 62 cases of nicorandil-related ulcerations between 2017 and 2024. Prescrire contends this figure is an underestimate, noting that initial reports of ulcerations linked to the drug surfaced as early as the late 1990s.
The review publication states that these ulcerations often progress for months, frequently given that the link to nicorandil is not recognized and the medication is not discontinued. Consequences include pain, feeding difficulties, weight loss, bleeding, abscesses, fistulas, hospitalizations, and surgical interventions.
Despite these concerns, nicorandil remains reimbursable by the French social security system at a rate of 65%, with nearly one million boxes of the medication reimbursed to approximately 71,000 patients through outpatient pharmacies in 2024, according to Prescrire.
The ANSM advises patients to immediately discontinue treatment and consult a physician if they experience symptoms such as red, painful, watery eyes; oral, skin, digestive, or perineal ulcers; digestive bleeding; abdominal pain; or unexplained rapid weight loss. The agency also cautions against combining nicorandil with medications used to treat inflammation or cardiovascular problems, such as corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, as this may increase the risk and severity of ulcerations.
In 2015, the Haute Autorité de Santé’s transparency commission upheld its favorable opinion regarding coverage of nicorandil. There have been no further evaluations by this commission since then.