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 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 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 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 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 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 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 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 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 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 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 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 2012-08-15
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 50 year old male
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 50 year old male
Reactions: Drug Dose Omission, Cardiovascular Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Effient
Possible Effient side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-14
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
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