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Avandamet (Rosiglitazone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Avandamet (Rosiglitazone) 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 (1362)
Death (162)
Life Threatening Events (3)
Disability (21)

Reports by Reaction Type

Myocardial Infarction (617)Cardiac Failure Congestive (445)Coronary Artery Disease (319)Cerebrovascular Accident (312)Cardiac Disorder (195)Cardiovascular Disorder (157)Chest Pain (100)Transient Ischaemic Attack (79)Dyspnoea (77)Atrial Fibrillation (73)Coronary Artery Bypass (71)Stent Placement (62)

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

Possible Avandamet side effects in female

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

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Chest Discomfort, Dyspnoea Exertional, Coronary Ostial Stenosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Avandamet

Other drugs received by patient: Candesartan Cilexetil and Hydrochlorothiazide; Sotalol HCL; Ezetimibe; Galvus



Possible Avandamet side effects in 57 year old male

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

Patient: 57 year old male

Reactions: Myocardial Infarction, Cardiovascular Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus



Possible Avandamet side effects in 55 year old male

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

Patient: 55 year old male

Reactions: Hemiparesis, Cerebrovascular Accident, Paraesthesia

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-01-01



Possible Avandamet side effects in 64 year old male

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

Patient: 64 year old male, weighing 90.9 kg (200.0 pounds)

Reactions: Cardio-Respiratory Arrest, Pulmonary Oedema, Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Avandamet
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2002-06-01
    End date: 2002-08-01

Avandia
    Dosage: 8mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2002-06-01
    End date: 2007-06-01



Possible Avandamet side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Cardiac Operation, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2007-01-01
    End date: 2010-05-01

Avandia
    Dosage: 8mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-01-01
    End date: 2006-12-01



Possible Avandamet side effects in male

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

Patient: male

Reactions: Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2006-01-01
    End date: 2006-01-01

Avandia
    Dosage: 8mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2000-01-01
    End date: 2006-01-01



Possible Avandamet side effects in 53 year old female

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

Patient: 53 year old female

Reactions: Heart Rate Decreased, Palpitations, Chest Pain, Cardiac Failure Congestive, Cardiomegaly

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-01-01
    End date: 2006-01-01

Avandia
    Dosage: 8mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-01-01
    End date: 2006-04-01



Possible Avandamet side effects in 50 year old female

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

Patient: 50 year old female, weighing 150.0 kg (330.0 pounds)

Reactions: Thrombosis, Syncope, Pulmonary Embolism, Coronary Artery Disease, Cardiomyopathy, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-08-01
    End date: 2005-12-14

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2003-10-13
    End date: 2007-05-05

Other drugs received by patient: Vasotec; Prilosec; Lovenox; Hydrocodone; Carisoprodol; Protonix; Amaryl; Ultram



Possible Avandamet side effects in 38 year old male

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

Patient: 38 year old male

Reactions: Dyslipidaemia, Coronary Artery Disease, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet



Possible Avandamet side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Supraventricular Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2006-01-01

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus



Possible Avandamet side effects in 67 year old female

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

Patient: 67 year old female

Reactions: Renal Disorder, Anaemia, Macular Oedema

Drug(s) suspected as cause:
Avandamet
    Indication: Diabetes Mellitus
    Start date: 2005-01-01
    End date: 2005-03-01

Avandia
    Dosage: 4mg twice per day
    Indication: Diabetes Mellitus
    Start date: 2005-02-01
    End date: 2008-04-01



Possible Avandamet side effects in 61 year old male

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

Patient: 61 year old male

Reactions: Thrombosis, Pulmonary Embolism, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Avandia
    Dosage: 2mg twice per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-03-01



Possible Avandamet side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Pain in Extremity, Myocardial Infarction, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus

Avandia
    Dosage: 4mg twice per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 1999-06-01
    End date: 2006-03-31



Possible Avandamet side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Cardiac Failure Congestive, Cardiomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2002-01-01
    End date: 2004-01-01

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2000-01-01
    End date: 2002-01-01



Possible Avandamet side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Multiple Fractures, Myocardial Infarction, Cardiac Failure Congestive, Cardiomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-01-01
    End date: 2005-01-01

Avandia
    Dosage: 4mg twice per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2003-01-01
    End date: 2004-01-01



Possible Avandamet side effects in 57 year old male

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

Patient: 57 year old male

Reactions: Sick Sinus Syndrome, Oedema Peripheral, Atrial Fibrillation, Cerebrovascular Accident, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-05-01
    End date: 2006-02-01

Avandia
    Dosage: 2mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2005-06-01
    End date: 2005-07-01



Possible Avandamet side effects in female

Reported by a consumer/non-health professional from Croatia (Local Name: Hrvatska) on 2012-08-20

Patient: female

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Avandamet
    Indication: Diabetes Mellitus
    End date: 2010-02-15

Avandia
    Indication: Diabetes Mellitus
    Start date: 2000-01-01

Metformin Hydrochloride
    Indication: Diabetes Mellitus
    Start date: 2000-01-01



Possible Avandamet side effects in 64 year old male

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

Patient: 64 year old male

Reactions: Coma, Pulmonary Oedema, Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-01-01
    End date: 2009-12-15

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-12-01
    End date: 2010-02-01



Possible Avandamet side effects in male

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

Patient: male

Reactions: Dyspnoea, Hepatic Fibrosis, Bile Duct Stone, Cardiac Disorder, Blood Glucose Abnormal, Weight Increased, Iron Deficiency Anaemia, Palpitations, Pancreatitis Chronic, Asthenia, Nervousness, Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet

Other drugs received by patient: Venlafaxine Hydrochloride; Sulpirid; Mirtazapine; Ramipril



Possible Avandamet side effects in 59 year old female

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

Patient: 59 year old female

Reactions: Angina Unstable, Coronary Artery Disease, Depression, Cardiovascular Disorder, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Indication: Diabetes Mellitus
    Start date: 2003-01-01
    End date: 2007-01-01

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2005-01-01
    End date: 2009-01-01



Possible Avandamet side effects in 64 year old male

Reported by a pharmacist from United States on 2012-08-16

Patient: 64 year old male

Reactions: Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2006-01-13
    End date: 2006-11-01

Avandia
    Dosage: 2mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2006-05-12
    End date: 2006-06-12



Possible Avandamet side effects in 56 year old male

Reported by a pharmacist from United States on 2012-08-16

Patient: 56 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus



Possible Avandamet side effects in 64 year old male

Reported by a lawyer from United States on 2012-08-16

Patient: 64 year old male

Reactions: Thrombosis, Cardiovascular Disorder, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-04-01
    End date: 2006-11-14

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2006-04-24
    End date: 2006-08-17



Possible Avandamet side effects in female

Reported by a consumer/non-health professional from Costa Rica on 2012-08-16

Patient: female

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Avandamet
    Indication: Diabetes Mellitus
    End date: 2010-02-15

Avandia
    Indication: Diabetes Mellitus
    Start date: 2000-01-01

Metformin Hydrochloride
    Indication: Diabetes Mellitus
    Start date: 2000-01-01



Possible Avandamet side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 52 year old female, weighing 85.9 kg (189.0 pounds)

Reactions: Chest Pain, Coronary Artery Disease, Acute Coronary Syndrome, Cardiac Disorder, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Indication: Diabetes Mellitus
    End date: 2008-01-01

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus



Possible Avandamet side effects in 53 year old male

Reported by a physician from United States on 2012-08-16

Patient: 53 year old male

Reactions: Cardiomyopathy, Cardiovascular Disorder, Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-05-10
    End date: 2007-09-29

Avandia
    Dosage: 4mg twice per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2004-01-01
    End date: 2005-09-01



Possible Avandamet side effects in 57 year old male

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

Patient: 57 year old male, weighing 90.9 kg (200.0 pounds)

Reactions: Coronary Artery Disease, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2007-05-11
    End date: 2007-10-01

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2006-11-27
    End date: 2007-04-21



Possible Avandamet side effects in female

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

Patient: female

Reactions: Dyspnoea, Fatigue, Cerebrovascular Accident, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2005-12-01
    End date: 2010-05-01

Avandaryl
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2007-02-01
    End date: 2007-02-01

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2006-12-01
    End date: 2007-03-01



Possible Avandamet side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 49 year old male, weighing 97.7 kg (214.9 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet



Possible Avandamet side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: female, weighing 84.1 kg (185.0 pounds)

Reactions: Stent Placement, Device Malfunction, Myocardial Infarction, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avandamet
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2003-12-04
    End date: 2004-05-06

Avandia
    Dosage: 4mg per day
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2002-11-07
    End date: 2003-07-19

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