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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
on Jan 17, 2014 Female from GB , 64 years of age, weighting 205.0 lb, was treated with Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: urosepsis. Nicorandil dosage: N/A.
Associated medications used:
  • Salbutamol
  • Omeprazole
  • Amlodipine
  • Atorvastatin
  • Seretide
  • Aspirin
Patient was hospitalized.

Gastrointestinal Disorder, Pneumonia
Patient was taking Nicorandil (nicorandil). Patient felt the following Nicorandil side effects: gastrointestinal disorder, pneumonia on Jun 14, 2012 from JAPAN Additional patient health information: Male , 61 years of age, . Nicorandil (nicorandil) dosage: N/A.
Multiple prescriptions taken:
  • Lasix /0032601/ (furosemide)
  • Risedronate Sodium (17.5 Mg Weekly, Oral)
  • Aspirin
  • Famotidine
  • Lipitor
  • Aldactone
  • Carvedilol
  • Selbex (teprenone)
Patient was hospitalized.

Rhabdomyolysis
Adverse event was reported on Jun 08, 2012 by a Male taking Nicorandil (Dosage: N/A) was diagnosed with and. Location: UNITED KINGDOM , 80 years of age, weighting 154.3 lb, After Nicorandil was administered, patient encountered several Nicorandil side effects: rhabdomyolysis.
Multiple concurrent drugs taken:
  • Simvastatin
  • Cilostazol (Indication: Circulation)
  • Omeprazole
  • Fusidic Acid
  • Flucloxacillin
Patient was hospitalized.

Skin Exfoliation, Chest Pain, Atrial Fibrillation
on May 30, 2012 Female from JAPAN , 79 years of age, was treated with Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: skin exfoliation, chest pain, atrial fibrillation. Nicorandil (nicorandil) dosage: (df Oral).
Associated medications used:
  • Amiodarone Hcl ((df))
  • Diltiazem Hydrochloride ((df Oral))
  • Warfarin Sodium ((df Oral))



Fall, Tendon Rupture, Tendon Pain
on May 25, 2012 Female from UNITED KINGDOM , 67 years of age, was treated with Nicorandil (nicorandil). Patient felt the following Nicorandil side effects: fall, tendon rupture, tendon pain. Nicorandil (nicorandil) dosage: N/A.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Swelling Face
Patient was taking Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: swelling face on May 14, 2012 from DENMARK Additional patient health information: Female , 72 years of age, . Nicorandil dosage: N/A.
Multiple concurrent drugs taken:
  • Amlodipine
  • Valproic Acid
  • Omeprazole
  • Tramadol Hcl
  • Simvastatin
  • Quinine Sulfate
  • Moviprep
  • Doxycycline Hyclate (100 Mg; Po)


Fall, Agitation, Femur Fracture
Adverse event was reported on May 14, 2012 by a Male taking Nicorandil (Dosage: 10 Mg, Unk) . Location: JAPAN , 89 years of age, Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: fall, agitation, femur fracture.
Associated medications used:
  • Exelon (4.5 Mg Daily)
  • Exelon (9 Mg, Daily)
  • Amlodipine Besylate (5 Mg, Unk)
Patient was hospitalized.

Fall, Femur Fracture, Agitation
on Apr 16, 2012 Male from JAPAN , 89 years of age, was treated with Nicorandil. Patient felt the following Nicorandil side effects: fall, femur fracture, agitation. Nicorandil dosage: 10 Mg, Unk.
Multiple prescriptions taken:
  • Exelon (9 Mg, Daily)
  • Amlodipine (5 Mg, Unk)
  • Exelon (4.5 Mg Daily)
Patient was hospitalized.

No Adverse Event
on Apr 03, 2012 Female from UNITED KINGDOM , 88 years of age, was diagnosed with and was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: no adverse event. Nicorandil dosage: N/A.
Multiple concurrent drugs taken:
  • Ferrous Sulfate Tab
  • Teicoplanin
  • Ismn
  • Acetaminophen (1 G Qds)
  • Finasteride
  • Lansoprazole
  • Lactulose
  • Simvastatin (Nocte)


Vascular Pseudoaneurysm
Patient was taking Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: vascular pseudoaneurysm on Mar 21, 2012 from JAPAN Additional patient health information: Male , 73 years of age, weighting 143.3 lb, was diagnosed with and. Nicorandil dosage: Daily Dose 50 Mg.
Associated medications used:
  • Nitrendipine (Daily Dose 10 Mg)
  • Aspirin (Daily Dose 100 Mg)
  • Pilsicainide Hydrochloride (Daily Dose 50 Mg)
Patient was hospitalized.

Pain In Extremity
Adverse event was reported on Mar 12, 2012 by a Male taking Nicorandil (nicorandil) (Dosage: N/A) . Location: , 65 years of age, weighting 189.6 lb, Patient felt the following Nicorandil side effects: pain in extremity.
Multiple prescriptions taken:
  • Isosorbide Mononitrate
  • Tilidiem La (diltiazem Hydrochloride)
  • Omeprazole
  • Simvastatin (1 Dosage Forms (1 Dosage Forms,1 In 1 D),oral)
  • Levemir
  • Novolog
  • Clopidogrel
  • Levothyroxine Sodium


Rash Maculo-papular, Product Contamination Microbial, Pruritus, Paraesthesia, Papule, Rash Erythematous, Skin Warm
on Mar 12, 2012 Female from UNITED KINGDOM , 71 years of age, was treated with Nicorandil (nicorandil). After Nicorandil was administered, patient encountered several Nicorandil side effects: rash maculo-papular, product contamination microbial, pruritus, paraesthesia, papule, rash erythematous, skin warm. Nicorandil (nicorandil) dosage: N/A.
Multiple concurrent drugs taken:
  • 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)


Chest Pain, Electrocardiogram St Segment Elevation
on Mar 02, 2012 Patient from INDIA , weighting 132.3 lb, was treated with Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: chest pain, electrocardiogram st segment elevation. Nicorandil dosage: 2 Cc/hr.
Associated medications used:
  • Acetylsalicylic Acid Srt
  • Enoxaparin Sodium (60 Units Every Half An Hour)
  • Metalyse
  • Clopidogrel (plavix) (8 Tabs Administered)
  • Atorvastatin


Blood Pressure Decreased, Dizziness, Incorrect Dose Administered, Heart Rate Decreased
Patient was taking Nicorandil (nicorandil). Patient felt the following Nicorandil side effects: blood pressure decreased, dizziness, incorrect dose administered, heart rate decreased on Feb 09, 2012 from Additional patient health information: Female , 83 years of age, . Nicorandil (nicorandil) dosage: N/A.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Mastoiditis, Ear Infection
Adverse event was reported on Feb 08, 2012 by a Male taking Nicorandil (Dosage: N/A) . Location: FRANCE , 72 years of age, weighting 136.7 lb, After Nicorandil was administered, patient encountered several Nicorandil side effects: mastoiditis, ear infection.
Multiple concurrent drugs taken:
  • Clopidogrel Bisulfate
  • Januvia
  • Perindopril Erbumine
  • Januvia
  • Bromazepam
  • Atenolol
  • Aspirin Lysine
  • Pantoprazole Sodium
Patient was hospitalized.

Renal Mass, Renal Cell Carcinoma
on Jan 05, 2012 Male from UNITED KINGDOM , 66 years of age, was treated with Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: renal mass, renal cell carcinoma. Nicorandil dosage: N/A.
Associated medications used:
  • Simvastatin
  • Humira (40 Mg, Biw)
  • Omeprazole
  • Methotrexate (5 Mg, Qw)
Patient was hospitalized.

Altered State Of Consciousness
on Dec 22, 2011 Female from IRELAND , 83 years of age, was treated with Nicorandil (nicorandil). Patient felt the following Nicorandil side effects: altered state of consciousness. Nicorandil (nicorandil) dosage: Po.
Multiple prescriptions taken:
  • Vancomycin (Iv)
  • Levocetirizine Dihydrochloride (2.5 Mg;qd;po)
  • Streptococcus Faecalis (streptococcus Faecalis) (Po)
  • Cefepime (Iv)


Condition Aggravated, Crepitations, Exercise Tolerance Decreased, Rectal Haemorrhage, Bronchopneumonia, Dyspnoea, Diarrhoea, Fluid Overload, Oedema Peripheral
Patient was taking Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: condition aggravated, crepitations, exercise tolerance decreased, rectal haemorrhage, bronchopneumonia, dyspnoea, diarrhoea, fluid overload, oedema peripheral on Dec 19, 2011 from UNITED KINGDOM Additional patient health information: Male , 77 years of age, weighting 172.8 lb, . Nicorandil dosage: N/A.
Multiple concurrent drugs taken:
  • Adizem Xl
  • Aspirin
  • Glyceryl Trinitrate
  • Isosorbide Mononitrate
  • Alendronic Acid
  • Calcichew D3
  • Finasteride
  • Rituximab


Rhabdomyolysis, Multi-organ Failure
Adverse event was reported on Dec 01, 2011 by a Male taking Nicorandil (Dosage: 10 Mg/day) was diagnosed with and. Location: FRANCE , 34 years of age, weighting 136.7 lb, Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: rhabdomyolysis, multi-organ failure.
Associated medications used:
  • 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)
Patient was hospitalized.

Diarrhoea
on Nov 14, 2011 Male from UNITED KINGDOM , 63 years of age, weighting 207.2 lb, was treated with Nicorandil. Patient felt the following Nicorandil side effects: diarrhoea. Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Lansoprazole
  • Atenolol
  • Furosemide
  • Amitriptyline Hcl
  • Aspirin
  • Metformin Hcl
  • Hydrocortisone
  • Acetaminophen


Embolism, Ischaemia, Thrombosis
on Sep 28, 2011 Female from UNITED KINGDOM , 70 years of age, was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: embolism, ischaemia, thrombosis. Nicorandil dosage: Unk.
Multiple concurrent drugs taken:
  • Enbrel (25 Mg, 2x/week)
  • Aspirin (75 Mg, Unk)
  • Simvastatin (80 Mg, Unk)
  • Adizem (Unk)
  • Ramipril (10 Mg, Unk)


Gingival Bleeding
Patient was taking Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: gingival bleeding on Sep 24, 2011 from JAPAN Additional patient health information: Male , weighting 186.3 lb, was diagnosed with and. Nicorandil dosage: N/A.
Associated medications used:
  • Potassium Chloride
  • Acetylsalicylic Acid W/aminoacetic Acid
  • Rivaroxaban
  • Rivaroxaban
  • Rosuvastatin
  • Magnesium Oxide
  • Aspirin
  • Famotidine
Patient was hospitalized.

Deafness Unilateral
Adverse event was reported on Sep 07, 2011 by a Male taking Nicorandil (Dosage: N/A) . Location: UNITED KINGDOM , 73 years of age, Patient felt the following Nicorandil side effects: deafness unilateral.
Multiple prescriptions taken:
  • Aspirin
  • Atorvastatin
  • Chlorpheniramine Maleate
  • Levothyroxine Sodium
  • Nitroglycerin
  • Lansoprazole
  • Warfarin Sodium
  • Metoprolol Tartrate


Torsade De Pointes, Arteriosclerosis Coronary Artery
on Jan 07, 2011 Male from FRANCE , 67 years of age, was treated with Nicorandil (nicorandil). After Nicorandil was administered, patient encountered several Nicorandil side effects: torsade de pointes, arteriosclerosis coronary artery. Nicorandil (nicorandil) dosage: N/A.
Multiple concurrent drugs taken:
  • Atenolol
  • Hexabrix
  • Molsidomine (molsidomine)
  • Bepridil (bepridil) (200 Mg (200 Mg, 1 In 1 D), Intracoronary)


Intestinal Obstruction, Granulocytopenia, Ovarian Cancer Recurrent
on Sep 09, 2011 Female from JAPAN , weighting 97.00 lb, was diagnosed with and was treated with Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: intestinal obstruction, granulocytopenia, ovarian cancer recurrent. Nicorandil dosage: N/A.
Associated medications used:
  • Warfarin Sodium
  • Primperan Tab
  • Dai-kenchu-to
  • Doxorubicin Hcl (Course 1)
  • Aspirin
  • Betamethasone
  • Famotidine
  • Azunol
Patient was hospitalized and became disabled.

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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


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  • 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.

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