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Nicorandil Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 43 

Gastrointestinal Disorder, Pneumonia (8474911-4)
on Jun 14, 2012 Male from JAPAN , 61 years of age, was treated with Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: gastrointestinal disorder, pneumonia. Nicorandil (nicorandil) dosage: N/A.
Associated medications used:
  • Lasix /0032601/ (furosemide)
  • Risedronate Sodium (17.5 Mg Weekly, Oral)
  • Aspirin
  • Famotidine
  • Lipitor
  • Aldactone
  • Carvedilol
  • Selbex (teprenone)
Patient was hospitalized.

Rhabdomyolysis (8457622-0)
Patient was taking Nicorandil. Patient felt the following Nicorandil side effects: rhabdomyolysis on Jun 08, 2012 from UNITED KINGDOM Additional patient health information: Male , 80 years of age, weighting 154.3 lb, was diagnosed with
  • angina pectoris
  • blood cholesterol increased
  • poor peripheral circulation
  • gastrooesophageal reflux disease
  • localised infection
and. Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Simvastatin
  • Cilostazol (Indication: Circulation)
  • Omeprazole
  • Fusidic Acid
  • Flucloxacillin
Patient was hospitalized.

Skin Exfoliation, Chest Pain, Atrial Fibrillation (8447209-8)
Adverse event was reported on May 30, 2012 by a Female taking Nicorandil (nicorandil) (Dosage: (df Oral)) . Location: JAPAN , 79 years of age, After Nicorandil was administered, patient encountered several Nicorandil side effects: skin exfoliation, chest pain, atrial fibrillation.
Multiple concurrent drugs taken:
  • Amiodarone Hcl ((df))
  • Diltiazem Hydrochloride ((df Oral))
  • Warfarin Sodium ((df Oral))


Fall, Tendon Rupture, Tendon Pain (8422250-X)
on May 25, 2012 Female from UNITED KINGDOM , 67 years of age, was treated with Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: fall, tendon rupture, tendon pain. Nicorandil (nicorandil) dosage: N/A.
Associated medications used:
  • 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 (8407240-5)
on May 14, 2012 Female from DENMARK , 72 years of age, was treated with Nicorandil. Patient felt the following Nicorandil side effects: swelling face. Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Amlodipine
  • Valproic Acid
  • Omeprazole
  • Tramadol Hcl
  • Simvastatin
  • Quinine Sulfate
  • Moviprep
  • Doxycycline Hyclate (100 Mg; Po)


Fall, Agitation, Femur Fracture (8376092-4)
Patient was taking Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: fall, agitation, femur fracture on May 14, 2012 from JAPAN Additional patient health information: Male , 89 years of age, . Nicorandil dosage: 10 Mg, Unk.
Multiple concurrent drugs taken:
  • Exelon (4.5 Mg Daily)
  • Exelon (9 Mg, Daily)
  • Amlodipine Besylate (5 Mg, Unk)
Patient was hospitalized.

Fall, Femur Fracture, Agitation (8303833-4)
Adverse event was reported on Apr 16, 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, femur fracture, agitation.
Associated medications used:
  • Exelon (9 Mg, Daily)
  • Amlodipine (5 Mg, Unk)
  • Exelon (4.5 Mg Daily)
Patient was hospitalized.

No Adverse Event (8260896-2)
on Apr 03, 2012 Female from UNITED KINGDOM , 88 years of age, was diagnosed with
  • angina pectoris
  • anaemia
  • infection
and was treated with Nicorandil. Patient felt the following Nicorandil side effects: no adverse event. Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Ferrous Sulfate Tab
  • Teicoplanin
  • Ismn
  • Acetaminophen (1 G Qds)
  • Finasteride
  • Lansoprazole
  • Lactulose
  • Simvastatin (Nocte)


Vascular Pseudoaneurysm (8240955-0)
on Mar 21, 2012 Male from JAPAN , 73 years of age, weighting 143.3 lb, was diagnosed with
  • atrial fibrillation
  • hypertension
and was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: vascular pseudoaneurysm. Nicorandil dosage: Daily Dose 50 Mg.
Multiple concurrent drugs taken:
  • Nitrendipine (Daily Dose 10 Mg)
  • Aspirin (Daily Dose 100 Mg)
  • Pilsicainide Hydrochloride (Daily Dose 50 Mg)
Patient was hospitalized.

Pain In Extremity (8233640-2)
Patient was taking Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: pain in extremity on Mar 12, 2012 from Additional patient health information: Male , 65 years of age, weighting 189.6 lb, . Nicorandil (nicorandil) dosage: N/A.
Associated medications used:
  • 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 (8223653-9)
Adverse event was reported on Mar 12, 2012 by a Female taking Nicorandil (nicorandil) (Dosage: N/A) . Location: UNITED KINGDOM , 71 years of age, Patient felt the following Nicorandil side effects: rash maculo-papular, product contamination microbial, pruritus, paraesthesia, papule, rash erythematous, skin warm.
Multiple prescriptions 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 (8215457-8)
on Mar 02, 2012 Patient from INDIA , weighting 132.3 lb, was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: chest pain, electrocardiogram st segment elevation. Nicorandil dosage: 2 Cc/hr.
Multiple concurrent drugs taken:
  • 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 (8164176-5)
on Feb 09, 2012 Female from , 83 years of age, was treated with Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: blood pressure decreased, dizziness, incorrect dose administered, heart rate decreased. Nicorandil (nicorandil) dosage: N/A.
Associated medications used:
  • 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 (8136177-4)
Patient was taking Nicorandil. Patient felt the following Nicorandil side effects: mastoiditis, ear infection on Feb 08, 2012 from FRANCE Additional patient health information: Male , 72 years of age, weighting 136.7 lb, . Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Clopidogrel Bisulfate
  • Januvia
  • Perindopril Erbumine
  • Januvia
  • Bromazepam
  • Atenolol
  • Aspirin Lysine
  • Pantoprazole Sodium
Patient was hospitalized.

Renal Mass, Renal Cell Carcinoma (8031629-X)
Adverse event was reported on Jan 05, 2012 by a Male taking Nicorandil (Dosage: N/A) . Location: UNITED KINGDOM , 66 years of age, After Nicorandil was administered, patient encountered several Nicorandil side effects: renal mass, renal cell carcinoma.
Multiple concurrent drugs taken:
  • Simvastatin
  • Humira (40 Mg, Biw)
  • Omeprazole
  • Methotrexate (5 Mg, Qw)
Patient was hospitalized.

Altered State Of Consciousness (8028017-9)
on Dec 22, 2011 Female from IRELAND , 83 years of age, was treated with Nicorandil (nicorandil). Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: altered state of consciousness. Nicorandil (nicorandil) dosage: Po.
Associated medications used:
  • 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 (8014044-4)
on Dec 19, 2011 Male from UNITED KINGDOM , 77 years of age, weighting 172.8 lb, was treated with Nicorandil. Patient felt the following Nicorandil side effects: condition aggravated, crepitations, exercise tolerance decreased, rectal haemorrhage, bronchopneumonia, dyspnoea, diarrhoea, fluid overload, oedema peripheral. Nicorandil dosage: N/A.
Multiple prescriptions taken:
  • Adizem Xl
  • Aspirin
  • Glyceryl Trinitrate
  • Isosorbide Mononitrate
  • Alendronic Acid
  • Calcichew D3
  • Finasteride
  • Rituximab


Rhabdomyolysis, Multi-organ Failure (7978325-2)
Patient was taking Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: rhabdomyolysis, multi-organ failure on Dec 01, 2011 from FRANCE Additional patient health information: Male , 34 years of age, weighting 136.7 lb, was diagnosed with
  • coronary artery disease
and. Nicorandil dosage: 10 Mg/day.
Multiple concurrent drugs taken:
  • 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 (7927006-X)
Adverse event was reported on Nov 14, 2011 by a Male taking Nicorandil (Dosage: N/A) . Location: UNITED KINGDOM , 63 years of age, weighting 207.2 lb, Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: diarrhoea.
Associated medications used:
  • Lansoprazole
  • Atenolol
  • Furosemide
  • Amitriptyline Hcl
  • Aspirin
  • Metformin Hcl
  • Hydrocortisone
  • Acetaminophen


Embolism, Ischaemia, Thrombosis (7801631-9)
on Sep 28, 2011 Female from UNITED KINGDOM , 70 years of age, was treated with Nicorandil. Patient felt the following Nicorandil side effects: embolism, ischaemia, thrombosis. Nicorandil dosage: Unk.
Multiple prescriptions taken:
  • Enbrel (25 Mg, 2x/week)
  • Aspirin (75 Mg, Unk)
  • Simvastatin (80 Mg, Unk)
  • Adizem (Unk)
  • Ramipril (10 Mg, Unk)


Gingival Bleeding (7779025-4)
on Sep 24, 2011 Male from JAPAN , weighting 186.3 lb, was diagnosed with
  • ill-defined disorder
and was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: gingival bleeding. Nicorandil dosage: N/A.
Multiple concurrent drugs taken:
  • Potassium Chloride
  • Acetylsalicylic Acid W/aminoacetic Acid
  • Rivaroxaban
  • Rivaroxaban
  • Rosuvastatin
  • Magnesium Oxide
  • Aspirin
  • Famotidine
Patient was hospitalized.

Deafness Unilateral (7763583-X)
Patient was taking Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: deafness unilateral on Sep 07, 2011 from UNITED KINGDOM Additional patient health information: Male , 73 years of age, . Nicorandil dosage: N/A.
Associated medications used:
  • Aspirin
  • Atorvastatin
  • Chlorpheniramine Maleate
  • Levothyroxine Sodium
  • Nitroglycerin
  • Lansoprazole
  • Warfarin Sodium
  • Metoprolol Tartrate


Torsade De Pointes, Arteriosclerosis Coronary Artery (7761472-8)
Adverse event was reported on Jan 07, 2011 by a Male taking Nicorandil (nicorandil) (Dosage: N/A) . Location: FRANCE , 67 years of age, Patient felt the following Nicorandil side effects: torsade de pointes, arteriosclerosis coronary artery.
Multiple prescriptions taken:
  • Atenolol
  • Hexabrix
  • Molsidomine (molsidomine)
  • Bepridil (bepridil) (200 Mg (200 Mg, 1 In 1 D), Intracoronary)


Intestinal Obstruction, Granulocytopenia, Ovarian Cancer Recurrent (7755695-1)
on Sep 09, 2011 Female from JAPAN , weighting 97.00 lb, was diagnosed with
  • angina pectoris
and was treated with Nicorandil. After Nicorandil was administered, patient encountered several Nicorandil side effects: intestinal obstruction, granulocytopenia, ovarian cancer recurrent. Nicorandil dosage: N/A.
Multiple concurrent drugs taken:
  • Warfarin Sodium
  • Primperan Tab
  • Dai-kenchu-to
  • Doxorubicin Hcl (Course 1)
  • Aspirin
  • Betamethasone
  • Famotidine
  • Azunol
Patient was hospitalized and became disabled.

Rash Macular, Obstructive Airways Disorder (7709799-X)
on Aug 18, 2011 Female from UNITED KINGDOM , 52 years of age, weighting 165.3 lb, was treated with Nicorandil. Directly after, patient experienced the unwanted or unexpected Nicorandil side effects: rash macular, obstructive airways disorder. Nicorandil dosage: N/A.
Associated medications used:
  • Sulfasalazine (500 Mg, 6x/1 Day)
  • Diclofenac
  • Hydroxychloroquine (400 Mg, 1x/day)
  • Alendronic Acid
  • Simvastatin
  • Ranitidine
  • Diazepam
  • Gabapentin
Patient was hospitalized.

Showing 1-25 of 43 

Nicorandil Health Episodes

How Can Nicorandil Affect You?

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dizziness, nausea, severe headache all over entire head, extreme tiredness and ...Keep Reading

DEVELOPED NECK PAIN AND HEADACHE AFTER TAKING NICRONADIL FOR FIVE DAYS. PAIN AROUND SHOULDER ...Keep Reading

Iam using 5mg two tablets morning and night. I have felt no side effects....Keep Reading

Diagnosed with Angina last week commenced tablets on Wednesday by Friday had nausea and ...Keep Reading

I have been on Nicorandil, 10mg morning and night for unstable angina, ...Keep Reading

Initially, in first day 6 episodes of dizziness and near fainting and gradulaly ...Keep Reading

I was given Nicorandil for Unstable Angina in conjunction with beta blocker,statins and ....Keep Reading

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Nicorandil Information

More About Nicorandil

Side Effects reported to FDA: 43. View Nicorandil Adverse Reports

Nicorandil safety alerts: No

Reported deaths: 12

Reported hospitalizations: 18

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