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Nicorandil Side Effects

Common Nicorandil Side Effects


The most commonly reported Nicorandil side effects (click to view or check a box to report):

Chest Pain (4)
Fall (3)
Hypotension (3)
Bradycardia (3)
Dyspnoea (2)
Femur Fracture (2)
Abscess (2)
Atrial Fibrillation (2)
Blood Albumin Increased (2)
Therapeutic Response Unexpected (2)
Angina Pectoris (2)
Agitation (2)
Post Procedural Haemorrhage (2)
Monocyte Count Decreased (2)
Hyperkalaemia (2)
Oedema Peripheral (2)
Overdose (2)
Rhabdomyolysis (2)
Pneumonia (2)
Staphylococcal Infection (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Nicorandil Side Effects Reported to FDA

The following Nicorandil reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Nicorandil on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Urosepsis
This is a report of a 64-year-old female patient (weight: NA) from GB, suffering from the following symptoms/conditions: NA, who was treated with Nicorandil (dosage: NA, start time: NS), combined with:
  • Salbutamol
  • Omeprazole
  • Amlodipine
  • Atorvastatin
  • Seretide
  • Aspirin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Urosepsis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in urosepsis side effect. The patient was hospitalized.

Gastrointestinal Disorder, Pneumonia
This report suggests a potential Nicorandil (nicorandil) Gastrointestinal Disorder, Pneumonia side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from JAPAN was diagnosed with the following symptoms/conditions: NA and used Nicorandil (nicorandil) (dosage: NA) starting Apr 07, 2012. Soon after starting Nicorandil (nicorandil) the patient began experiencing various side effects, including:
  • Gastrointestinal Disorder
  • Pneumonia
Drugs used concurrently:
  • Lasix /0032601/ (furosemide)
  • Risedronate Sodium (17.5 Mg Weekly, Oral)
  • Aspirin
  • Famotidine
  • Lipitor
  • Aldactone
  • Carvedilol
  • Selbex (teprenone)
The patient was hospitalized. Although Nicorandil (nicorandil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gastrointestinal disorder, may still occur.

Rhabdomyolysis
This Rhabdomyolysis problem was reported by a physician from UNITED KINGDOM. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: angina pectoris,blood cholesterol increased,poor peripheral circulation,gastrooesophageal reflux disease,localised infection. On Apr 13, 2012 this consumer started treatment with Nicorandil (dosage: NA). The following drugs were being taken at the same time:
  • Simvastatin
  • Cilostazol (Indication: Circulation)
  • Omeprazole
  • Fusidic Acid
  • Flucloxacillin
When commencing Nicorandil, the patient experienced the following unwanted symptoms/side effects:
  • Rhabdomyolysis
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as rhabdomyolysis, may become evident only after a product is in use by the general population.

Skin Exfoliation, Chest Pain, Atrial Fibrillation
This is a report of a 79-year-old female patient (weight: NA) from JAPAN. The patient developed the following symptoms/conditions: NA and was treated with Nicorandil (nicorandil) (dosage: (df Oral)) starting Apr 01, 2012. Concurrently used drugs:
  • Amiodarone Hcl ((df))
  • Diltiazem Hydrochloride ((df Oral))
  • Warfarin Sodium ((df Oral))
Soon after that, the consumer experienced the following side effects:
  • Skin Exfoliation
  • Chest Pain
  • Atrial Fibrillation
This opens a possibility that Nicorandil (nicorandil) treatment could cause the above reactions, including skin exfoliation, and some female subjects may be more susceptible.


Fall, Tendon Rupture, Tendon Pain
A 67-year-old female patient (weight: NA) from UNITED KINGDOM with the following symptoms/conditions: NA started Nicorandil (nicorandil) treatment (dosage: NA) on Mar 09, 2012. Soon after starting Nicorandil (nicorandil) treatment, the subject experienced various side effects, including:
  • Fall
  • Tendon Rupture
  • Tendon Pain
Concurrently used drugs:
  • Levothyroxine Sodium
  • Simvastatin
  • Dilzem Xl (diltiazem Hydrochloride)
  • Levofloxacin (500 Mg, Oral)
  • Clopidegrel
  • Prednisolone (Oral)
  • Movicol (polyethyl, Glyc. W/potas. Chlor./sod. Bicarb.)
  • Tropium (chlordiazepoxide Hydrochloride)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Nicorandil (nicorandil).

Swelling Face
A 72-year-old female patient from DENMARK (weight: NA) experienced symptoms, such as: NA and was treated with Nicorandil(dosage: NA). The treatment was initiated on Mar 29, 2012. After that a consumer reported the following side effect(s):
  • Swelling Face
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Nicorandil efficacy:
  • Amlodipine
  • Valproic Acid
  • Omeprazole
  • Tramadol Hcl
  • Simvastatin
  • Quinine Sulfate
  • Moviprep
  • Doxycycline Hyclate (100 Mg; Po)


Fall, Agitation, Femur Fracture
In this report, Nicorandil was administered for the following condition: NA.A 89-year-old male consumer from JAPAN (weight: NA) started Nicorandil treatment (dosage: 10 Mg, Unk) on Apr 03, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Fall
  • Agitation
  • Femur Fracture
A possible interaction with other drugs could have contributed to this reaction:
  • Exelon (4.5 Mg Daily)
  • Exelon (9 Mg, Daily)
  • Amlodipine Besylate (5 Mg, Unk)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Nicorandil treatment could be related to the listed above side effect(s).

Fall, Femur Fracture, Agitation
This is a report of the following Nicorandil side effect(s):
  • Fall
  • Femur Fracture
  • Agitation
A 89-year-old male patient from JAPAN (weight: NA) presented with the following condition: NA and received a treatment with Nicorandil (dosage: 10 Mg, Unk) starting: Mar 09, 2012.The following concurrently used drugs could have generated interactions:
  • Exelon (9 Mg, Daily)
  • Amlodipine (5 Mg, Unk)
  • Exelon (4.5 Mg Daily)
The patient was hospitalized.This report suggests that a Nicorandil treatment could be associated with the listed above side effect(s).

No Adverse Event
This Nicorandil report was submitted by a 88-year-old female consumer from UNITED KINGDOM (weight: NA). The patient was diagnosed with: angina pectoris,anaemia,infection and Nicorandil was administered (dosage: NA) starting: Mar 30, 2012. The consumer developed a set of symptoms:
  • No Adverse Event
Other drugs used simultaneously:
  • Ferrous Sulfate Tab
  • Teicoplanin
  • Ismn
  • Acetaminophen (1 G Qds)
  • Finasteride
  • Lansoprazole
  • Lactulose
  • Simvastatin (Nocte)
Those unexpected symptoms could be linked to a Nicorandil treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Vascular Pseudoaneurysm
This is a report of a possible correlation between Nicorandil use and the following symptoms/side effect(s):
  • Vascular Pseudoaneurysm
which could contribute to an assessment of Nicorandil risk profile.A 73-year-old male consumer from JAPAN (weight: NA) was suffering from atrial fibrillation,hypertension and was treated with Nicorandil (dosage: Daily Dose 50 Mg) starting Jan 01, 2007.Other concurrent medications:
  • Nitrendipine (Daily Dose 10 Mg)
  • Aspirin (Daily Dose 100 Mg)
  • Pilsicainide Hydrochloride (Daily Dose 50 Mg)
The patient was hospitalized.

Pain In Extremity
A 65-year-old male patient from (weight: NA) presented with the following symptoms: NA and after a treatment with Nicorandil (nicorandil) (dosage: NA) experienced the following side effect(s):
  • Pain In Extremity
The treatment was started on Dec 12, 2011. Nicorandil (nicorandil) was used in combination with the following drugs:
  • Isosorbide Mononitrate
  • Tilidiem La (diltiazem Hydrochloride)
  • Omeprazole
  • Simvastatin (1 Dosage Forms (1 Dosage Forms,1 In 1 D),oral)
  • Levemir
  • Novolog
  • Clopidogrel
  • Levothyroxine Sodium
This report could alert potential Nicorandil (nicorandil) consumers.

Rash Maculo-papular, Product Contamination Microbial, Pruritus, Paraesthesia, Papule, Rash Erythematous, Skin Warm
In this report, a 71-year-old female patient from UNITED KINGDOM (weight: NA) was affected by a possible Nicorandil (nicorandil) side effect.The patient was diagnosed with NA. After a treatment with Nicorandil (nicorandil) (dosage: NA, start date: Jan 11, 2012), the patient experienced the following side effect(s):
  • Rash Maculo-papular
  • Product Contamination Microbial
  • Pruritus
  • Paraesthesia
  • Papule
  • Rash Erythematous
  • Skin Warm
The following simultaneously used drugs could have led to this reaction:
  • Teicoplanin (teicoplanin)
  • Aspirin
  • Nitrofurantoin
  • Magnesium L-aspartate Hydrochloride (magnesium Aspartate) (10 Millimol, 1 In 1 D, Oral)
  • Atorvastatin
  • Bisoprolol Fumarate
  • Ciprofloxacin (750 Mg, 2 In 1 D, Oral)
  • Piperacillin And Tazobactam (4.5 Gm, Intravenous Drip)
The findings here stress that side effects should be taken into consideration when evaluating a Nicorandil (nicorandil) treatment.

Chest Pain, Electrocardiogram St Segment Elevation
This is a report of a patient from INDIA (weight: NA), who used Nicorandil (dosage: 2 Cc/hr) for a treatment of NA. After starting a treatment on Oct 13, 2011, the patient experienced the following side effect(s):
  • Chest Pain
  • Electrocardiogram St Segment Elevation
The following drugs could possibly have interacted with the Nicorandil treatment
  • Acetylsalicylic Acid Srt
  • Enoxaparin Sodium (60 Units Every Half An Hour)
  • Metalyse
  • Clopidogrel (plavix) (8 Tabs Administered)
  • Atorvastatin
Taken together, these observations suggest that a Nicorandil treatment could be related to side effect(s), such as Chest Pain, Electrocardiogram St Segment Elevation.

Blood Pressure Decreased, Dizziness, Incorrect Dose Administered, Heart Rate Decreased
This blood pressure decreased side effect was reported by a health professional from . A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Nicorandil (nicorandil) (dosage: NA), which was started on Oct 01, 2011. Concurrently used drugs:
  • Bisoprolol Fumarate
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Monomil Xl (isosorbide Mononitrate)
When starting to take Nicorandil (nicorandil) the consumer reported the following symptoms:
  • Blood Pressure Decreased
  • Dizziness
  • Incorrect Dose Administered
  • Heart Rate Decreased
The patient was hospitalized. These side effects may potentially be related to Nicorandil (nicorandil).

Mastoiditis, Ear Infection
This is a Nicorandil side effect report of a 72-year-old male patient (weight:NA) from FRANCE, suffering from the following symptoms/conditions: NA, who was treated with Nicorandil (dosage:NA, start time: Jan 26, 2012), combined with:
  • Clopidogrel Bisulfate
  • Januvia
  • Perindopril Erbumine
  • Januvia
  • Bromazepam
  • Atenolol
  • Aspirin Lysine
  • Pantoprazole Sodium
, and developed a serious reaction and a mastoiditis side effect. The patient presented with:
  • Mastoiditis
  • Ear Infection
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Nicorandil treatment in male patients suffering from NA, resulting in mastoiditis.

Renal Mass, Renal Cell Carcinoma
This report suggests a potential Nicorandil renal mass side effect(s) that can have serious consequences. A 66-year-old male patient from UNITED KINGDOM (weight:NA) was diagnosed with the following health condition(s): NA and used Nicorandil (dosage: NA) starting Aug 01, 2011. Soon after starting Nicorandil the patient began experiencing various side effects, including:
  • Renal Mass
  • Renal Cell Carcinoma
Drugs used concurrently:
  • Simvastatin
  • Humira (40 Mg, Biw)
  • Omeprazole
  • Methotrexate (5 Mg, Qw)
The patient was hospitalized. Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as renal mass, may still occur.

Altered State Of Consciousness
This altered state of consciousness problem was reported by a pharmacist from IRELAND. A 83-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Oct 26, 2011 a consumer started treatment with Nicorandil (nicorandil) (dosage: Po). The following drugs/medications were being taken at the same time:
  • Vancomycin (Iv)
  • Levocetirizine Dihydrochloride (2.5 Mg;qd;po)
  • Streptococcus Faecalis (streptococcus Faecalis) (Po)
  • Cefepime (Iv)
When commencing Nicorandil (nicorandil), the patient experienced the following unwanted symptoms /side effects:
  • Altered State Of Consciousness
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as altered state of consciousness, may become evident only after a product is in use by the general population.

Condition Aggravated, Crepitations, Exercise Tolerance Decreased, Rectal Haemorrhage, Bronchopneumonia, Dyspnoea, Diarrhoea, Fluid Overload, Oedema Peripheral
This is a Nicorandil side effect report of a 77-year-old male patient (weight: NA) from UNITED KINGDOM. The patient developed the following symptoms/conditions: NA and was treated with Nicorandil (dosage: NA) starting Aug 25, 2011. Concurrently used drugs:
  • Adizem Xl
  • Aspirin
  • Glyceryl Trinitrate
  • Isosorbide Mononitrate
  • Alendronic Acid
  • Calcichew D3
  • Finasteride
  • Rituximab
Soon after that, the consumer experienced the following of symptoms:
  • Condition Aggravated
  • Crepitations
  • Exercise Tolerance Decreased
  • Rectal Haemorrhage
  • Bronchopneumonia
  • Dyspnoea
  • Diarrhoea
  • Fluid Overload
  • Oedema Peripheral
This opens a possibility that Nicorandil could cause condition aggravated and that some male patients may be more susceptible.

Rhabdomyolysis, Multi-organ Failure
A 34-year-old male patient (weight: NA) from FRANCE with the following symptoms: coronary artery disease started Nicorandil treatment (dosage: 10 Mg/day) on Oct 01, 2009. Soon after starting Nicorandil treatment, the consumer experienced several side effects, including:
  • Rhabdomyolysis
  • Multi-organ Failure
. Concurrently used drugs:
  • Cotrim (400 Mg/80 Mg 3 Tablets Per Week)
  • Cholecalciferol (880 Iu/day)
  • Colimycin (2 Sprayers Per Day)
  • Alpha-tocoferol (500 Mg/day)
  • Cyclosporine (170 Mg, Bid)
  • Colchicine (1 Mg, Qd)
  • Pancreatin Triple Strength Cap (250000 Iu/day)
  • Ferrous Ascorbate (66 Mg/day)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Nicorandil side effects, such as rhabdomyolysis.

Diarrhoea
This diarrhoea side effect was reported by a consumer or non-health professional from UNITED KINGDOM. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (dosage: NA), which was started on Aug 26, 2011. Concurrently used drugs:
  • Lansoprazole
  • Atenolol
  • Furosemide
  • Amitriptyline Hcl
  • Aspirin
  • Metformin Hcl
  • Hydrocortisone
  • Acetaminophen
.When starting to take Nicorandil the consumer reported symptoms, such as:
  • Diarrhoea
These side effects may potentially be related to Nicorandil.

Embolism, Ischaemia, Thrombosis
This is a report of a 70-year-old female patient (weight: NA) from UNITED KINGDOM, suffering from the following symptoms/conditions: NA, who was treated with Nicorandil (dosage: Unk, start time: Dec 01, 2008), combined with:
  • Enbrel (25 Mg, 2x/week)
  • Aspirin (75 Mg, Unk)
  • Simvastatin (80 Mg, Unk)
  • Adizem (Unk)
  • Ramipril (10 Mg, Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Embolism
  • Ischaemia
  • Thrombosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in embolism side effect.

Gingival Bleeding
This report suggests a potential Nicorandil Gingival Bleeding side effect(s) that can have serious consequences. A male patient (weight: NA) from JAPAN was diagnosed with the following symptoms/conditions: ill-defined disorder and used Nicorandil (dosage: NA) starting Sep 25, 2009. Soon after starting Nicorandil the patient began experiencing various side effects, including:
  • Gingival Bleeding
Drugs used concurrently:
  • Potassium Chloride
  • Acetylsalicylic Acid W/aminoacetic Acid
  • Rivaroxaban
  • Rivaroxaban
  • Rosuvastatin
  • Magnesium Oxide
  • Aspirin
  • Famotidine
The patient was hospitalized. Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gingival bleeding, may still occur.

Deafness Unilateral
This Deafness Unilateral problem was reported by a health professional from UNITED KINGDOM. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jan 01, 1998 this consumer started treatment with Nicorandil (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Atorvastatin
  • Chlorpheniramine Maleate
  • Levothyroxine Sodium
  • Nitroglycerin
  • Lansoprazole
  • Warfarin Sodium
  • Metoprolol Tartrate
When commencing Nicorandil, the patient experienced the following unwanted symptoms/side effects:
  • Deafness Unilateral
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as deafness unilateral, may become evident only after a product is in use by the general population.

Torsade De Pointes, Arteriosclerosis Coronary Artery
This is a report of a 67-year-old male patient (weight: NA) from FRANCE. The patient developed the following symptoms/conditions: NA and was treated with Nicorandil (nicorandil) (dosage: NA) starting NS. Concurrently used drugs:
  • Atenolol
  • Hexabrix
  • Molsidomine (molsidomine)
  • Bepridil (bepridil) (200 Mg (200 Mg, 1 In 1 D), Intracoronary)
Soon after that, the consumer experienced the following side effects:
  • Torsade De Pointes
  • Arteriosclerosis Coronary Artery
This opens a possibility that Nicorandil (nicorandil) treatment could cause the above reactions, including torsade de pointes, and some male subjects may be more susceptible.

Intestinal Obstruction, Granulocytopenia, Ovarian Cancer Recurrent
A female patient (weight: NA) from JAPAN with the following symptoms/conditions: angina pectoris started Nicorandil treatment (dosage: NA) on Jan 01, 2003. Soon after starting Nicorandil treatment, the subject experienced various side effects, including:
  • Intestinal Obstruction
  • Granulocytopenia
  • Ovarian Cancer Recurrent
Concurrently used drugs:
  • Warfarin Sodium
  • Primperan Tab
  • Dai-kenchu-to
  • Doxorubicin Hcl (Course 1)
  • Aspirin
  • Betamethasone
  • Famotidine
  • Azunol
The patient was hospitalized and became disabled. This finding indicates that some female patients could be more vulnerable to Nicorandil.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Nicorandil Side Effects

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    Yes, Moderate
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    How Effective is Nicorandil for You?

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