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Brilinta (Ticagrelor) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Brilinta (Ticagrelor) 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 (763)
Death (87)
Life Threatening Events (40)
Disability (16)

Reports by Reaction Type

Dyspnoea (138)Myocardial Infarction (70)Off Label Use (53)Rash (34)Death (32)Chest Pain (30)Coronary Artery Occlusion (29)Malaise (28)Haemorrhage (27)Fatigue (27)Thrombosis in Device (26)Intentional Drug Misuse (22)

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

Possible Brilinta side effects in 71 year old male

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

Patient: 71 year old male, weighing 81.6 kg (179.5 pounds)

Reactions: Dyspnoea, Hiatus Hernia, Dilatation Ventricular, Headache, Joint Swelling, Oedema Peripheral, Gastrooesophageal Reflux Disease, Blood Creatinine Increased

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Indication: Stent Placement

Prilosec
    Dosage: generic
    Administration route: Oral

Prilosec
    Administration route: Oral
    Indication: Dyspepsia

Toprol-XL
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Other drugs received by patient: Xyzal; Vitamin D; Amlodipine; Donepezil HCL; Hydralazine HCL; Lipitor



Possible Brilinta side effects in 77 year old male

Reported by a physician from Bulgaria on 2012-08-27

Patient: 77 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Ventricular Fibrillation, Cardiogenic Shock, Thrombosis in Device

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient: Aspirin; Arixtra



Possible Brilinta side effects in male

Reported by a physician from Malaysia on 2012-08-27

Patient: male

Reactions: Atrioventricular Block

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27

Patient: 64 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in female

Reported by a pharmacist from NEW Zealand on 2012-08-24

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 79 year old male

Reactions: Chest Pain

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in female

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

Patient: female

Reactions: Cerebral Haematoma

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Angiomax
    Start date: 2012-08-10
    End date: 2012-08-10

Aspirin
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-08-10
    End date: 2012-08-10

Brilinta
    Dosage: 180 mg loading dose
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-08-10

Other drugs received by patient: Simvastatin; Isorbidmononitrat; Ramipril



Possible Brilinta side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 55 year old male

Reactions: Chest Pain

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 74 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-23

Patient: 74 year old male

Reactions: Coronary Artery Occlusion, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Start date: 2012-04-01

Crestor
    Administration route: Oral
    Start date: 2012-04-01

Metoprolol Succinate
    Administration route: Oral
    Start date: 2012-04-01



Possible Brilinta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in male

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

Patient: male

Reactions: Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-04-06

Brilinta
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-04-06

Placebo
    Dosage: once daily
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-04-06

Other drugs received by patient: Rhythmy; Sigmart; Magnesium Oxide



Possible Brilinta side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 63 year old male

Reactions: Palpitations, Pain

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Abdominal Discomfort, Nausea, Drug Intolerance

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in female

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

Patient: female

Reactions: Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 53 year old male, weighing 98.3 kg (216.3 pounds)

Reactions: Syncope, Hypotension, Bundle Branch Block, Atrioventricular Block First Degree

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 62 year old male

Reported by a pharmacist from Italy on 2012-08-23

Patient: 62 year old male

Reactions: Anaemia, Gastric Ulcer Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2008-01-01

Brilinta
    Dosage: 2 df, daily
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-01

Ramipril
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Atorvastatin; Glyceryl Trinitrate; Levetiracetam; Atenolol



Possible Brilinta side effects in

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

Patient:

Reactions: Transient Ischaemic Attack

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient: Simvastatin



Possible Brilinta side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 66 year old male, weighing 78.1 kg (171.8 pounds)

Reactions: Chest Pain, Cardiac Arrest

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Pain in Extremity, Liver Function Test Abnormal, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient possibly interacting with the suspect drug:
Zocor
    Dosage: unk
    Administration route: Oral

Zocor
    Dosage: unk

Other drugs received by patient: Metoprolol Tartrate; Ramipril; Aspirin



Possible Brilinta side effects in male

Reported by a physician from South Africa on 2012-08-22

Patient: male

Reactions: Ischaemic Stroke

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient: Ramipril; Bisoprolol Fumarate; Simvastatin; Aspirin



Possible Brilinta side effects in 78 year old female

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

Patient: 78 year old female

Reactions: Eye Swelling, Eye Pain

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral

Crestor
    Administration route: Oral



Possible Brilinta side effects in 70 year old female

Reported by a physician from United States on 2012-08-22

Patient: 70 year old female

Reactions: Feeling Jittery, Tachycardia

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 73 year old female

Reported by a physician from United States on 2012-08-21

Patient: 73 year old female

Reactions: Vomiting

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Indication: Thrombosis Prophylaxis

Brilinta
    Dosage: 180mg of the medication, one time 90mg dose, 12 hours later.
    Administration route: Oral



Possible Brilinta side effects in male

Reported by a physician from Brazil on 2012-08-20

Patient: male

Reactions: Haemorrhage Urinary Tract

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient: Enalapril Maleate; Isosorbide Mononitrate; Simvastatin; Atenolol; Aspirin



Possible Brilinta side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient:

Reactions: Thrombosis in Device

Drug(s) suspected as cause:
Angiomax

Brilinta
    Administration route: Oral



Possible Brilinta side effects in male

Reported by a physician from Italy on 2012-08-20

Patient: male

Reactions: Anaemia, Gastric Ulcer Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-01

Ramipril
    Administration route: Oral
    Indication: Hypertension

Salicylic Acid Acetyl
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2008-01-01

Other drugs received by patient: Atenololo (Atenolol); Nitroglicerina(nitroglycerine); Keppra; Atorvastatin



Possible Brilinta side effects in 77 year old male

Reported by a physician from Bulgaria on 2012-08-20

Patient: 77 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Ventricular Fibrillation, Thrombosis in Device

Adverse event resulted in: death

Drug(s) suspected as cause:
Brilinta

Other drugs received by patient: Aspirin; Arixtra



Possible Brilinta side effects in male

Reported by a physician from Brazil on 2012-08-20

Patient: male

Reactions: Off Label Use, Skin Discolouration, Atrial Fibrillation

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 70 year old male

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

Patient: 70 year old male

Reactions: Haemorrhage

Drug(s) suspected as cause:
Brilinta



Possible Brilinta side effects in 48 year old male

Reported by a physician from Malaysia on 2012-08-20

Patient: 48 year old male

Reactions: Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral
    Indication: Acute Coronary Syndrome

Brilinta
    Administration route: Oral
    Indication: Coronary Artery Bypass

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