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Pletal (Cilostazol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pletal (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 (186)
Death (27)
Life Threatening Events (21)
Disability (3)

Reports by Reaction Type

Interstitial Lung Disease (12)Anaemia (12)Cerebral Infarction (11)Fall (9)Condition Aggravated (8)Headache (7)Cerebral Haemorrhage (7)Renal Failure Acute (7)Pneumonia (7)Hepatic Function Abnormal (6)Drug Interaction (6)Pyrexia (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Pletal (Cilostazol). For a complete list or a specific selection of reports, please use the links above.

Possible Pletal side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: White Blood Cell Count Decreased, Dermatitis Acneiform, Hospitalisation, Cerebral Infarction, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erlotinib Hydrochloride
    Dosage: 100 mg, uid/qd
    Administration route: Oral
    Indication: Adenocarcinoma Pancreas
    Start date: 2012-03-15
    End date: 2012-05-07

Erlotinib Hydrochloride
    Dosage: 100 mg, uid/qd
    Administration route: Oral
    Start date: 2012-07-05

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Indication: Adenocarcinoma Pancreas
    Start date: 2012-03-15
    End date: 2012-03-15

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-04-05
    End date: 2012-04-05

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-06-14
    End date: 2012-06-14

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-06-21
    End date: 2012-06-21

Gemcitabine Hydrochloride
    Dosage: 1000 mg, uid/qd
    Start date: 2012-07-05

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-03-22
    End date: 2012-03-22

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-04-28
    End date: 2012-04-28

Plavix
    Dosage: 75 mg, uid/qd
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2012-05-08

Pletal
    Dosage: 200 mg, uid/qd
    Administration route: Oral
    Start date: 2012-05-13

Pletal
    Dosage: 100 mg, uid/qd
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2012-05-08
    End date: 2012-05-12

Other drugs received by patient: Granisetron; Pravastatin; Dexamethasone Sodium Phosphate; Humalog; Lantus; Micardis



Possible Pletal side effects in 60 year old male

Reported by a pharmacist from Japan on 2012-08-06

Patient: 60 year old male

Reactions: Colitis Microscopic

Drug(s) suspected as cause:
Aspirin

Pletal
    Dosage: oral
    Administration route: Oral



Possible Pletal side effects in 61 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 61 year old male

Reactions: Procedural Haemorrhage

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 60 year old male

Reported by a pharmacist from Japan on 2012-08-03

Patient: 60 year old male

Reactions: Jaundice, Drug-Induced Liver Injury, Asthenia, Hepatitis Fulminant

Adverse event resulted in: death

Drug(s) suspected as cause:
Aspirin
    Dosage: unk
    Administration route: Oral
    Start date: 2012-05-01

Aspirin
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-03-01

Crestor
    Dosage: unk
    Administration route: Oral
    End date: 2012-03-01

Plavix
    Dosage: unk
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-05-01

Plavix
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-03-01

Pletal
    Dosage: unk
    Administration route: Oral
    End date: 2012-03-01

Other drugs received by patient: Heparin



Possible Pletal side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased

Drug(s) suspected as cause:
Amlodipine Besylate

Candesartan Cilexetil
    Administration route: Oral

Pletal
    Dosage: 100 mg, bid
    Administration route: Oral

Zocor
    Administration route: Oral



Possible Pletal side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-02

Patient: 72 year old male, weighing 59.5 kg (130.9 pounds)

Reactions: Haemoptysis, Eosinophilic Pneumonia, Pyrexia, Hyperhidrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Disopyramide Phosphate
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-05-25

Plavix
    Administration route: Oral
    Indication: Lacunar Infarction
    Start date: 2012-05-15
    End date: 2012-05-26

Plavix
    Administration route: Oral
    Start date: 2011-04-22
    End date: 2012-04-25

Plavix
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2012-05-15
    End date: 2012-05-26

Plavix
    Administration route: Oral
    Start date: 2011-04-22
    End date: 2012-04-25

Pletal
    Administration route: Oral
    Indication: Lacunar Infarction
    Start date: 2011-12-28
    End date: 2012-04-26

Pletal
    Administration route: Oral
    Start date: 2012-05-15
    End date: 2012-05-25

Tenormin
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-05-25

Verapamil HCL
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-05-25

Other drugs received by patient: Flomax; Epinastine Hydrochloride; Cetirizine HCL



Possible Pletal side effects in 87 year old male

Reported by a physician from Japan on 2012-08-01

Patient: 87 year old male

Reactions: Extravasation, Colon Cancer, International Normalised Ratio Increased, Shock Haemorrhagic, Anaemia, Lower Gastrointestinal Haemorrhage, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal
    Dosage: 200 mg milligram(s), daily dose, oral
    Administration route: Oral

Warfarin Sodium
    Dosage: 2 mg milligram(s), daily dose, oral
    Administration route: Oral

Other drugs received by patient: Nicorandil (Nicorandil) Tablet



Possible Pletal side effects in 17 year old male

Reported by a physician from Japan on 2012-07-31

Patient: 17 year old male

Reactions: Condition Aggravated, Aneurysm

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in female

Reported by a consumer/non-health professional from Japan on 2012-07-31

Patient: female

Reactions: Diplopia, Ophthalmoplegia

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27

Patient: 77 year old male

Reactions: Leukocytoclastic Vasculitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: 2.5 mg (2.5 mg,1 in 1 d) per oral
    Administration route: Oral
    Indication: LOW Density Lipoprotein Increased
    Start date: 2012-05-17
    End date: 2012-05-31

Lansoprazole
    Dosage: 15 mg (15 mg,1 in 1 d) per oral
    Administration route: Oral
    Indication: Ulcer
    Start date: 2012-05-17
    End date: 2012-05-31

Pletal
    Dosage: 200 mg (100 mg,2 in 1 d) per oral
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-05-29
    End date: 2012-05-31



Possible Pletal side effects in 80 year old male

Reported by a pharmacist from United States on 2012-07-27

Patient: 80 year old male, weighing 82.7 kg (181.9 pounds)

Reactions: Iron Deficiency Anaemia, Duodenal Ulcer, Upper Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 325 mg daily po chronic
    Administration route: Oral
    Indication: Coronary Artery Disease

Pletal
    Dosage: 100mg bid po chronic
    Administration route: Oral
    Indication: Coronary Artery Disease

Other drugs received by patient: M.v.i.; Tylenol; Fish OIL; Vitamin B-12; Lipitor; Lotrel; Altace; VIT C; VIT B6; Lasix



Possible Pletal side effects in 90 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 90 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Unresponsive To Stimuli, Haemorrhagic Anaemia, Haematemesis, Gastritis, Mallory-Weiss Syndrome, Oesophagitis, Dizziness, Upper Gastrointestinal Haemorrhage, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plavix
    Dosage: 75mg daily po chronic
    Administration route: Oral
    Indication: Cerebrovascular Accident

Pletal
    Dosage: 100mg bid po chronic
    Indication: Cerebrovascular Accident

Other drugs received by patient: Glipizide; Cholecalciferol; Apap W / Codeine; Olmesartan Medoxomil; Rosuvastatin; Santyl; Meclizine; Colchicine; Latanoprost; Amlodipine



Possible Pletal side effects in 70 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 70 year old female, weighing 60.5 kg (133.1 pounds)

Reactions: Upper Gastrointestinal Haemorrhage, Device Dislocation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 2tabs q4 prn po recent
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease

Aspirin
    Dosage: 81mg qpm po recent
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease

Fosamax
    Dosage: 70mg qwk chronic
    Indication: Osteoporosis

Plavix
    Dosage: 75mg daily po recent
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease

Pletal
    Dosage: 50mg bid po recent
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease

Other drugs received by patient: VIT B; Cholecalciferol; Ziac; Vitamin B-12; Lovaza; M.v.i.; Lipitor; Protonix; Librax; OR DYE Drugs



Possible Pletal side effects in 17 year old male

Reported by a physician from Japan on 2012-07-26

Patient: 17 year old male

Reactions: Aneurysm, Disease Progression

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in

Reported by a pharmacist from Japan on 2012-07-26

Patient:

Reactions: Colitis Microscopic

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-26

Patient: female

Reactions: Overdose, Drug Interaction, Acute Coronary Syndrome, Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 2 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 2 year old male, weighing 15.0 kg (33.0 pounds)

Reactions: NO Adverse Event, Accidental Drug Intake by Child

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 71 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 71 year old male

Reactions: Interstitial Lung Disease, Ventricular Tachycardia

Adverse event resulted in: death

Drug(s) suspected as cause:
Pletal
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Start date: 2012-05-25

Zithromax
    Dosage: 500 mg, 1x/day
    Indication: Pneumonia
    Start date: 2012-05-25
    End date: 2012-05-31

Other drugs received by patient: Aldactone; Zosyn; Amoban; Famotidine; Levofloxacin; Loxonin; Lasix; Bisolvon; Olmesartan Medoxomil; Lansoprazole; Aspirin; Nitroglycerin; Dutasteride; Plavix; Warfarin; Rabeprazole Sodium; Coniel



Possible Pletal side effects in female

Reported by a individual with unspecified qualification from Japan on 2012-07-23

Patient: female

Reactions: Diplopia, Post Procedural Complication, Ophthalmoplegia

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-07-16

Patient: 79 year old female

Reactions: Cardiac Failure, Hyperglycaemia

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 59 year old male

Reported by a physician from Korea, Republic of on 2012-07-13

Patient: 59 year old male

Reactions: Cerebral Artery Occlusion

Drug(s) suspected as cause:
Pletal

Other drugs received by patient: Lipilou (Atrovastatin Calcium Anhydrous)



Possible Pletal side effects in 87 year old male

Reported by a physician from Japan on 2012-07-13

Patient: 87 year old male

Reactions: Shock Haemorrhagic, Lower Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal
    Dosage: 200 mg milligram(s), daily dose, oral
    Administration route: Oral

Warfarin Potassium (Warfarin Potassium)
    Dosage: 2 mg milligram(s), daily dose, oral
    Administration route: Oral

Other drugs received by patient: Nicorandil (Nicorandil) Tablet



Possible Pletal side effects in 81 year old female

Reported by a pharmacist from Spain on 2012-07-12

Patient: 81 year old female

Reactions: Vitreous Haemorrhage

Drug(s) suspected as cause:
Clopidogrel
    Dosage: 75 mg milligram(s), daily dose, unknown
    Indication: Intermittent Claudication
    Start date: 2008-01-01

Pletal
    Dosage: el medicamento lo ha tomado de forma intermitente a lo largo de todo este tiempo, unknown
    Indication: Intermittent Claudication
    Start date: 2009-01-01



Possible Pletal side effects in 94 year old female

Reported by a physician from Japan on 2012-07-12

Patient: 94 year old female

Reactions: Fracture, Interstitial Lung Disease, Marasmus, Fall

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 77 year old male

Reported by a physician from Japan on 2012-07-12

Patient: 77 year old male

Reactions: Malaise, Drug-Induced Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan
    Dosage: 80 mg, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-12

Pletal
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2011-11-24
    End date: 2012-06-01

Other drugs received by patient: Plavix



Possible Pletal side effects in 51 year old male

Reported by a physician from Germany on 2012-07-12

Patient: 51 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Ejection Fraction Decreased, Left Ventricular Failure, Sinus Tachycardia, Device Occlusion, Cardiomegaly

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Pletal

Other drugs received by patient: Plavix; Aspirin; Procoralan (Lvabradine Hydrochloride)



Possible Pletal side effects in 68 year old male

Reported by a physician from Spain on 2012-07-12

Patient: 68 year old male

Reactions: Ear Haemorrhage, Drug Interaction

Drug(s) suspected as cause:
Aspirin
    Dosage: 100 mg milligram(s), daily dose,oral
    Administration route: Oral
    Indication: Myocardial Ischaemia

Pletal
    Dosage: 1 df dosage form,oral
    Administration route: Oral
    Indication: Peripheral Ischaemia
    Start date: 2012-03-22
    End date: 2012-04-26

Other drugs received by patient: Bisoprolol Normon 10 MG Comprimidos Recubiertos Efg, 20 Comprimidos (B; Ramipril Acost 2.5 MG Comprimidos, 29 Comprimidos (Ramipril)



Possible Pletal side effects in 2 year old male

Reported by a physician from Japan on 2012-07-06

Patient: 2 year old male, weighing 15.0 kg (33.0 pounds)

Reactions: Accidental Drug Intake by Child

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal



Possible Pletal side effects in 75 year old male

Reported by a physician from Japan on 2012-07-06

Patient: 75 year old male

Reactions: Pneumonia, Cerebral Infarction, Atrial Fibrillation

Adverse event resulted in: death

Drug(s) suspected as cause:
Pletal

Other drugs received by patient: Nafamostat Mesilate (Nafamostat Mesilate) Injection; Adrenocortical Hormone Preparations; Heparin and Preparations (Heparin and Preparations) Injection; Warfarin Sodium



Possible Pletal side effects in 94 year old female

Reported by a physician from Japan on 2012-07-03

Patient: 94 year old female

Reactions: Fracture, Interstitial Lung Disease, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pletal

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