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Effient (Prasugrel) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Effient (Prasugrel) 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 (679)
Death (129)
Life Threatening Events (69)
Disability (10)

Reports by Reaction Type

Thrombosis in Device (77)Death (52)Acute Myocardial Infarction (36)Chest Pain (33)Haemorrhage (30)in-Stent Coronary Artery Restenosis (29)Dyspnoea (29)Haemorrhage Intracranial (28)Drug Dose Omission (26)Myocardial Infarction (26)Angina Pectoris (24)Stent Placement (23)

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

Possible Effient side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: female

Reactions: Back Pain, Fatigue, Dyspnoea, Dyspepsia, Chest Pain

Drug(s) suspected as cause:
Effient



Possible Effient side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Subdural Haematoma, Haemorrhage, Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Angiomax; Heparin Sodium; Integrilin



Possible Effient side effects in 52 year old male

Reported by a physician from United States on 2012-08-24

Patient: 52 year old male, weighing 90.7 kg (199.5 pounds)

Reactions: Gastrointestinal Haemorrhage, Gastric Ulcer

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Aspirin; Vicodin; Lipitor; Ranexa; Aspirin; Metoprolol Tartrate



Possible Effient side effects in 79 year old female

Reported by a physician from Germany on 2012-08-24

Patient: 79 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Abdominal Wall Haematoma, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient
    Dosage: 60 mg, qd
    Administration route: Oral
    Start date: 2011-01-23
    End date: 2011-01-23

Effient
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-01-24

Other drugs received by patient: Aspirin



Possible Effient side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Coronary Arterial Stent Insertion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient



Possible Effient side effects in male

Reported by a physician from France on 2012-08-23

Patient: male

Reactions: Gastrointestinal Haemorrhage, Presyncope, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Perindopril Erbumine; Acetaminophen and Tramadol HCL; Esomeprazole Sodium; Acebutolol; Nitroglycerin; Aspirin; Lamaline; Atorvastatin



Possible Effient side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Drug Dose Omission

Drug(s) suspected as cause:
Effient



Possible Effient side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Chest Pain, Laceration, Intentional Drug Misuse, Fall, Drug Dispensing Error, Device Occlusion, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Novolog; Triamterene and Hydrochlorothiazide; Tylenol (Caplet); Atenolol; Losartan Potassium; Aspirin; Amitriptyline Hydrochloride; Levemir; Requip; Benadryl; Nitroglycerin; Magnesium



Possible Effient side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Dyspnoea, Thinking Abnormal, Palpitations, Visual Acuity Reduced, Gait Disturbance, Asthenia, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Valium; Aspirin; Antihypertensives



Possible Effient side effects in 61 year old female

Reported by a pharmacist from United States on 2012-08-20

Patient: 61 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Dyspnoea, Throat Irritation, Cough, Rash Macular

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Metopralol; Rosuvastatin; Aspirin



Possible Effient side effects in 59 year old female

Reported by a physician from United States on 2012-08-17

Patient: 59 year old female

Reactions: Biopsy Lung

Drug(s) suspected as cause:
Effient



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Coronary Artery Bypass, Post Procedural Complication, Stent Placement, Scar

Drug(s) suspected as cause:
Effient



Possible Effient side effects in 84 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 84 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Death, Vomiting, Chest Pain, Rectal Haemorrhage, Musculoskeletal Pain, Pallor

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Metformin HCL; Lisinopril; Aspirin; Carvedilol; Tamsulosin HCL; Simvastatin



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Electrocardiogram ST Segment Depression, Incorrect Storage of Drug

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Coreg; Aspirin; Atorvastatin; Omeprazole



Possible Effient side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 55 year old male

Reactions: Drug Dose Omission, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient
    Dosage: unk
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-07-01
    End date: 2012-08-01

Effient
    Dosage: unk
    Start date: 2012-08-13



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Arterial Disorder, Chest Pain, Incorrect Product Storage, Arterial Occlusive Disease, Cardiovascular Disorder, Scar, High Density Lipoprotein Decreased

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Nexium; Metoprolol Tartrate; Isosorbide; Aspirin; Glucosamine; Fish OIL; Nitroglycerin; Vytorin; Niaspan; Percocet



Possible Effient side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 76 year old female

Reactions: Death, Myocardial Infarction, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Integrilin



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Drug Dose Omission, Thrombosis in Device

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Effient



Possible Effient side effects in 67 year old female

Reported by a physician from United States on 2012-08-15

Patient: 67 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Integrilin



Possible Effient side effects in 59 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 59 year old male

Reactions: Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Aspirin



Possible Effient side effects in 64 year old male

Reported by a physician from France on 2012-08-15

Patient: 64 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Atelectasis, Hypersensitivity, Hiatus Hernia, Neutropenia, Pyrexia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient
    Dosage: 10 mg, unknown
    Start date: 2012-05-23
    End date: 2012-05-25

Effient
    Dosage: 60 mg, single
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2012-05-22
    End date: 2012-05-22

Other drugs received by patient: Aspirin; Plavix



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Mouth Haemorrhage, Coma, Multimorbidity, Epistaxis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Effient
    Dosage: 10 mg, unknown

Effient
    Dosage: 60 mg, unknown
    Indication: Percutaneous Coronary Intervention



Possible Effient side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male

Reactions: Thrombocytopenia, Thrombosis in Device

Drug(s) suspected as cause:
Effient



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Gallbladder Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient



Possible Effient side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 87.5 kg (192.6 pounds)

Reactions: Syncope, non-Cardiac Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient
    Dosage: unk
    Indication: Prophylaxis
    Start date: 2012-01-21

Effient
    Dosage: 10 mg, qd

Other drugs received by patient: Spironolactone; Simvastatin; Nitroglycerin; Multi-Vitamin; Losartan Potassium; Aspirin; Carvedilol; Omeprazole



Possible Effient side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 55 year old male

Reactions: Coronary Artery Occlusion, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Effient
    Dosage: 60 mg, single
    Indication: Stent Placement
    Start date: 2012-07-01

Effient
    Dosage: 10 mg, unknown
    Start date: 2012-07-01

Other drugs received by patient: Aspirin; Angiomax



Possible Effient side effects in 65 year old male

Reported by a physician from United States on 2012-08-15

Patient: 65 year old male

Reactions: Head Injury, Haemorrhage Intracranial, Fall

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Aspirin



Possible Effient side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Fish OIL; Metoprolol Tartrate; Omeprazole; Coq10; Aspirin; Pitavastatin



Possible Effient side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Diabetic Ketoacidosis, Intentional Drug Misuse, Acute Myocardial Infarction, Epistaxis, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

Other drugs received by patient: Aspirin



Possible Effient side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effient

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