Chemical formula: C₈H₉N₃O₄ Molecular mass: 211.177 g/mol PubChem compound: 47528
Nicorandil interacts in the following cases:
In patients concomitantly receiving NSAIDs including acetylsalicylic acid for both cardiovascular prevention and anti-inflammatory doses, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage.
Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.
Due to lack of data, caution is advised to use nicorandil in patients with heart failure class NHYA III or IV.
Caution is advised when nicorandil is used in combination with other medical products that may increase potassium levels.
If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants, alcohol), the blood pressure lowering effect may be increased.
Dapoxetine should be prescribed with caution in patients taking nicorandil due to possible reduced orthostatic tolerance.
Nicorandil induced ulceration may occur at different locations in the same patient. They are refractory to treatment and most only respond to withdrawal of nicorandil treatment. If ulceration(s) develops, nicorandil should be discontinued. Healthcare professionals should be aware of the importance of a timely diagnosis of nicorandil-induced ulcerations and of a rapid withdrawal of nicorandil treatment in case of occurrence of such ulcerations. Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil.
Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil. Patients taking acetylsalicylic acid or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) concomitantly are at increased risk for severe complications such as gastrointestinal haemorrhage. Therefore caution is advised when concomitant use of acetylsalicylic acid or NSAIDs and nicorandil is considered.
If advanced, ulcers may develop into perforation, fistula, or abscess formation. Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment.
Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported. Therefore, caution is advised when concomitant use is considered.
Nicorandil should be used with caution in patients with glucose-6-phosphate dehydrogenase deficiency. Nicorandil acts in part through its organic nitrate moiety. The metabolism of organic nitrates can result in the formation of nitrites which may trigger methemoglobinaemia in patients with glucse-6-phosphate dehydrogenase deficiency.
Severe hyperkalaemia has been reported very rarely with nicorandil. Nicorandil should be used with care in combination with other medical products that may increase potassium levels, especially in patients with moderate to severe renal impairment.
Very rare conjunctivitis, conjunctival ulcer and corneal ulcer have been reported with nicorandil. Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations. If ulceration(s) develops, nicorandil should be discontinued.
There are no or limited amount of data from the use of nicorandil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of nicorandil during pregnancy.
Animal studies have shown that nicorandil is excreted in small amounts into the breast milk. It is not known whether nicorandil is excreted in human milk, therefore nicorandil is not recommended during breastfeeding.
There are insufficient data on fertility to estimate the risk for humans.
Nicorandil has an influence on the ability to drive and use machines. Indeed, as with other vasodilators, blood pressure lowering effects as well as dizziness and feeling weakness induced by nicorandil can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants). Therefore, patients should be advised not to drive or use machines if these symptoms occur.
The most common adverse reaction reported in clinical trials is headache occurring in more than 30% of patients, particularly in the first days of treatment and responsible for most of study withdrawal.
Progressive dose titration may reduce the frequency of these headaches.
In addition, serious adverse reactions including ulcerations and their complications were reported during the post marketing surveillance of nicorandil.
The frequencies of adverse reactions reported with nicorandil are summarised in the following list by system organ class (in MedDRA) and by frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Very rare: Hyperkalaemia
Very common: Headache
Common: Dizziness
Very rare: Corneal ulcer, conjunctival ulcer, conjunctivitis
Not known: Diplopia
Common: Heart rate increased
Common: Cutaneous vasodilation with flushing
Uncommon: Decrease in blood pressure
Common: Vomiting, nausea
Rare: Gastrointestinal ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below)
Not known: Gastrointestinal haemorrhage
Very rare: Liver disorders such as hepatitis, cholestasis, or jaundice
Rare: Rash, pruritus
Very rare: Angioedema, skin and mucosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations).
Rare: Myalgia
Common: Feeling of weakness
Complications of gastrointestinal ulceration such as perforation, fistula, or abscess formation sometimes leading to gastrointestinal haemorrhage and weight loss have been reported.
In addition, the following adverse reactions have been reported with different frequencies in the IONA (Impact of Nicorandil in Angina) study, where nicorandil has been used on top of standard therapy in patients with stable angina and at high risk of cardiovascular events.
Common: Rectal bleeding
Uncommon: Mouth ulcer
Very rare: Abdominal pain
Uncommon: Angioedema
Uncommon: Myalgia
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
