This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cilostazol and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (61)
Death (12)
Life Threatening Events (2)
Reports by Reaction Type
Tachycardia (8),
Drug Interaction (8),
Myocardial Infarction (5),
Toxic Epidermal Necrolysis (5),
Septic Shock (5),
Acinetobacter Test Positive (4),
Hyperhidrosis (4),
Malaise (4),
Staphylococcus Test Positive (4),
Interstitial Lung Disease (3),
Dizziness (3),
Stevens-Johnson Syndrome (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Cilostazol. For a complete list or a specific selection of reports, please use the links above.
Possible Cilostazol side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-27
Patient: 54 year old male
Reactions: General Physical Condition Abnormal, Perivascular Dermatitis, Cytolytic Hepatitis, Rash, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Lymphocytic Infiltration, Eosinophilia, Myalgia, Skin Lesion, Dermatitis Exfoliative, Rash Maculo-Papular, Leukocytosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Indication: Antiplatelet Therapy
Carbamazepine
Indication: Neuropathy Peripheral
Other drugs received by patient: Aspirin; Clopidegrel
Possible Cilostazol side effects in male
Reported by a pharmacist from United States on 2012-08-24
Patient: male, weighing 72.6 kg (159.7 pounds)
Reactions: Product Quality Issue, Stomatitis
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 66 year old male
Reported by a pharmacist from United States on 2012-08-22
Patient: 66 year old male, weighing 81.5 kg (179.3 pounds)
Reactions: Dyspnoea, Palpitations, Condition Aggravated
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Dosage: bid
Indication: Coronary Arterial Stent Insertion
Start date: 2012-02-10
Ticagrelor
Dosage: mg bid po
Administration route: Oral
Indication: Coronary Arterial Stent Insertion
Start date: 2012-02-11
End date: 2012-02-23
Possible Cilostazol side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-31
Patient: 59 year old male
Reactions: Condition Aggravated, Cerebral Artery Occlusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Lipilou (Atorvastatin Calcium Anhydrous)
Possible Cilostazol side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-31
Patient: 66 year old female
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Evening Primrose OIL (Evening Primrose Oil); Lercanidoine; Metformin Hydrochloride; Irbesartan
Possible Cilostazol side effects in 89 year old male
Reported by a pharmacist from United States on 2012-07-30
Patient: 89 year old male, weighing 59.2 kg (130.2 pounds)
Reactions: Abdominal Discomfort, Vomiting, Nausea, Blood Creatinine Increased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-26
Patient: 49 year old female
Reactions: Intraventricular Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Insulin Lispro (Insulin Lispro); Irbesartan; Metfformin Hydrochloride
Possible Cilostazol side effects in 30 year old male
Reported by a physician from Argentina on 2012-07-25
Patient: 30 year old male
Reactions: Ventricular Extrasystoles, Drug Ineffective, Atrial Fibrillation, Ventricular Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-07-17
Patient: 66 year old female
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-12
Patient: 63 year old male
Reactions: Abdominal Wall Haematoma, Drug Interaction, Haematoma
Drug(s) suspected as cause:
Cilostazol
Dosage: 100 mg milligram(s), bid, oral
Administration route: Oral
Indication: Intermittent Claudication
Start date: 2012-03-01
End date: 2012-05-28
Aspirin
Dosage: 100 mg milligram(s), unknown, oral
Administration route: Oral
Start date: 2012-03-01
Other drugs received by patient: Omeprazole (Omeprazole Sodium); Atorvastatin Calcium; Diclofenac Sodium; Enalapril + Hidroclorotiazida (Enalapril Maleate, Hydrochlorothiazide)
Possible Cilostazol side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-06-15
Patient: male
Reactions: Pain in Extremity, Hypotension, Hyperglycaemia, Drug Administration Error, Blood Glucose Fluctuation, Self-Medication
Drug(s) suspected as cause:
Benicar HCT
Dosage: 40/25 mg (1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2011-01-01
End date: 2012-02-01
Benicar HCT
Dosage: 40/25 mg (1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2006-01-01
End date: 2011-01-01
Benicar HCT
Dosage: 40/25 mg (1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-02-01
End date: 2012-02-01
Benicar HCT
Dosage: 40/25 mg (1 in 1 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-01-01
Cilostazol
Dosage: 200 mg, per oral
Administration route: Oral
Indication: Pain in Extremity
Start date: 2007-01-01
Other drugs received by patient: Simvastatin; Medicine FOR Hyperglycaemia (Name Unknown)
Possible Cilostazol side effects in
Reported by a physician from China on 2012-05-29
Patient:
Reactions: Hepatic Failure
Drug(s) suspected as cause:
Probucol
Cilostazol
Possible Cilostazol side effects in 64 year old male
Reported by a physician from Japan on 2012-05-04
Patient: 64 year old male
Reactions: Activated Partial Thromboplastin Time Prolonged, Muscle Haemorrhage, Anaemia, Bone Swelling, Acquired Haemophilia, Factor Viii Inhibition, Factor Viii Deficiency
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Aspirin
Possible Cilostazol side effects in 74 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-04
Patient: 74 year old male
Reactions: Tachycardia, Drug Interaction
Drug(s) suspected as cause:
Omeprazole
Dosage: 20 mg milligram(s), daily dose, oral
Administration route: Oral
Start date: 2008-09-29
Cilostazol
Dosage: 50 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Intermittent Claudication
Start date: 2011-05-25
End date: 2011-05-26
Other drugs received by patient: Torsemide; Lexatin (Bromazepam); Atorvastatin Calcium; Cafinitrina (Caffeine Citrate, Glyceryl Trinitrate, Phenobarbital); Nitradisc (Glyceryl Trinitrate); Ventolin; Tarka 180 / 2 (Trandolapril, Verapamil Hydrochloride); Aspirin; Xalatan
Possible Cilostazol side effects in female
Reported by a physician from Japan on 2012-05-02
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Back Pain, Contusion, Constipation, Fall, Dysarthria, Malaise, Pollakiuria, Lower Gastrointestinal Haemorrhage, Gait Disturbance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac Sodium
Indication: Pain
Start date: 2011-10-10
End date: 2012-03-03
Cilostazol
Dosage: 100 mg
Administration route: Oral
Indication: Cerebral Infarction
Start date: 2004-02-06
End date: 2012-03-03
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-04-01
End date: 2012-01-01
Pradaxa
Dosage: 220 mg
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Verapamil HCL; Lanirapid; Gasmotin; Aderoxal
Possible Cilostazol side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-04-27
Patient: 59 year old male
Reactions: Clumsiness, Hemiparesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Gaslon-N (Irsogladine Maleate); Lipinon (Atorvastatin); Janumet; Glufast (Mitiglinide Calcium)
Possible Cilostazol side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-27
Patient: 73 year old male, weighing 116.0 kg (255.2 pounds)
Reactions: Arrhythmia
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 87 year old female
Reported by a physician from Japan on 2012-04-11
Patient: 87 year old female
Reactions: Cardiac Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Dosage: 200 mg
Administration route: Oral
Start date: 2012-03-26
End date: 2012-04-04
Trazenta
Dosage: 5 mg
Administration route: Oral
Indication: Diabetes Mellitus
Start date: 2012-03-30
End date: 2012-04-04
Possible Cilostazol side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-04
Patient: 60 year old male
Reactions: Malaise, Vomiting, Condition Aggravated, Convulsion
Drug(s) suspected as cause:
Cilostazol
Start date: 2011-10-01
End date: 2012-01-01
Retigabine (Retigabine)
Dosage: 50 mg milligram(s), 200 mg milligram(s), daily dose, 50 mg milligram(s), tid,
Indication: Convulsion
Start date: 2011-12-01
Retigabine (Retigabine)
Dosage: 50 mg milligram(s), 200 mg milligram(s), daily dose, 50 mg milligram(s), tid,
Indication: Convulsion
Start date: 2011-10-01
Retigabine (Retigabine)
Dosage: 50 mg milligram(s), 200 mg milligram(s), daily dose, 50 mg milligram(s), tid,
Indication: Convulsion
End date: 2012-03-01
Other drugs received by patient: Lamotrigine; Clopidogrel; Lansoprazole; Simvastatin
Possible Cilostazol side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from China on 2012-03-30
Patient: 67 year old male
Reactions: Upper Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clopidogrel
Dosage: 75 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2011-02-16
Lorelco
Dosage: 500 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2012-01-08
End date: 2012-01-12
Cilostazol
Dosage: 200 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2012-01-08
End date: 2012-01-12
Aspirin
Dosage: 0.1 g gram(s), daily dose, oral
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2011-02-16
End date: 2012-01-12
Other drugs received by patient: Atorvastatin Calcium
Possible Cilostazol side effects in 54 year old male
Reported by a physician from China on 2012-03-27
Patient: 54 year old male
Reactions: Blood Creatine Phosphokinase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Probucol
Dosage: 250 mg milligram(s), bid, oral
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2010-10-01
End date: 2011-09-01
Probucol
Dosage: 250 mg milligram(s), bid, oral
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2011-09-24
Cilostazol
Dosage: 100 mg milligram(s), bid, oral,
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2011-09-24
Cilostazol
Dosage: 100 mg milligram(s), bid, oral,
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2010-10-01
End date: 2011-09-01
Other drugs received by patient: Calcium Dobesilate (Calcium Dobesilate); Aspirin; Insulin Glargine (Insulin Glargine); Irbesartan; Nifedipine (Nifedipine) Tablet
Possible Cilostazol side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-22
Patient: 63 year old male
Reactions: Acute Pulmonary Oedema, Akinesia, Acute Coronary Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Dosage: 100 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Peripheral Circulatory Failure
Start date: 2010-01-01
End date: 2011-05-09
Cilostazol
Dosage: 100 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Off Label Use
Start date: 2010-01-01
End date: 2011-05-09
Other drugs received by patient: Augmentine (Amoxicillin Sodium, Clavulanate Potassium); Aspirin; Ramipril; Ranitidine HCL; Simvastatin
Possible Cilostazol side effects in male
Reported by a individual with unspecified qualification from Brazil on 2012-03-20
Patient: male
Reactions: Pain in Extremity, Tachycardia, Hyperglycaemia, Hypotension, Blood Pressure Fluctuation
Drug(s) suspected as cause:
Cilostazol
Dosage: 200; 100 mg, per oral
Administration route: Oral
Indication: Pain in Extremity
Start date: 2007-01-01
Benicar HCT
Dosage: 40/25; 20/12.5 mg (1 in 1 d; 1 in 2 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2006-01-01
End date: 2011-01-01
Benicar HCT
Dosage: 40/25; 20/12.5 mg (1 in 1 d; 1 in 2 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2012-02-01
Benicar HCT
Dosage: 40/25; 20/12.5 mg (1 in 1 d; 1 in 2 d), per oral
Administration route: Oral
Indication: Hypertension
Start date: 2011-01-01
End date: 2012-02-01
Other drugs received by patient: Simvastatin; Medicine FOR Hyperglucaemia
Possible Cilostazol side effects in 60 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-03-19
Patient: 60 year old male
Reactions: Malaise, Vomiting, Convulsion
Drug(s) suspected as cause:
Potiga
Dosage: 50mg three times per day
Indication: Convulsion
Start date: 2011-10-01
End date: 2012-03-01
Cilostazol
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-01
End date: 2012-01-01
Other drugs received by patient: Clopidogrel; Simvastatin; Lansoprazole; Lamotrigine
Possible Cilostazol side effects in 63 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-09
Patient: 63 year old male
Reactions: Acute Pulmonary Oedema, Acute Coronary Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Dosage: 100 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Peripheral Circulatory Failure
Start date: 2010-01-01
End date: 2011-05-09
Cilostazol
Dosage: 100 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Off Label Use
Start date: 2010-01-01
End date: 2011-05-09
Simvastatin
Other drugs received by patient: Ranitidine HCL; Ramipril; Aspirin; Augmentine (Amoxicillin Sodium, Clavulanate Potassium)
Possible Cilostazol side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-21
Patient: 84 year old male
Reactions: Rectal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Cilostazol
Dosage: 200 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Arterial Insufficiency
Start date: 2011-11-17
End date: 2011-12-19
Cilostazol
Dosage: 200 mg milligram(s), daily dose, oral
Administration route: Oral
Indication: Off Label Use
Start date: 2011-11-17
End date: 2011-12-19
Other drugs received by patient: Pantoprazole; Torasemide (Torasemide)
Possible Cilostazol side effects in male
Reported by a physician from China on 2012-02-20
Patient: male, weighing 57.0 kg (125.4 pounds)
Reactions: Upper Gastrointestinal Haemorrhage, Acute Myocardial Infarction, Blood Creatinine Increased, Disease Progression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Blinded NO Treatment Received
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-16
Blinded Aliskiren
Dosage: code not broken
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-03-15
End date: 2011-01-19
Enalapril Maleate
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-16
Cilostazol
Enalapril Maleate
Dosage: code not broken
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-03-15
End date: 2011-01-19
Blinded NO Treatment Received
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-26
Blinded Aliskiren
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-16
Blinded Aliskiren
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-26
Blinded NO Treatment Received
Dosage: code not broken
Administration route: Oral
Indication: Cardiac Failure
Start date: 2010-03-15
End date: 2011-01-19
Enalapril Maleate
Dosage: code not broken
Administration route: Oral
Start date: 2011-05-26
Possible Cilostazol side effects in 54 year old male
Reported by a individual with unspecified qualification from Spain on 2012-02-16
Patient: 54 year old male
Reactions: Wrong Technique in Drug Usage Process, Dizziness, Fall, Loss of Consciousness
Drug(s) suspected as cause:
Cilostazol
Possible Cilostazol side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-10
Patient: 80 year old male
Reactions: Acute Pulmonary Oedema, Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cilostazol
Other drugs received by patient: Tiotropium Bromide (Tiotropium Bromide); Tamsulosin (Tamsulosin Hydrochloride); Salmeterol (Salmeterol); Fluticasone Propionate; Verapamil; Clopidogrel; Dutasteride (Dutasteride); Lansoprazole
Possible Cilostazol side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-10
Patient: 72 year old male
Reactions: Tachyarrhythmia
Drug(s) suspected as cause:
Cilostazol
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