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Cilostazol (Cilostazol) - Side Effect Reports to FDA

 
 



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 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 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 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 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



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

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