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Avandia Side Effects

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Common Avandia Side Effects


The most commonly reported Avandia side effects (click to view or check a box to report):

Myocardial Infarction (16249)
Cardiac Failure Congestive (10752)
Cerebrovascular Accident (6205)
Coronary Artery Disease (4631)
Cardiac Disorder (3399)
Death (2077)
Cardiovascular Disorder (1801)
Dyspnoea (1581)
Chest Pain (1348)
Myocardial Ischaemia (1297)
Pain (1144)
Transient Ischaemic Attack (1133)
Heart Injury (1079)
Atrial Fibrillation (1068)
Coronary Artery Bypass (1023)
Hypertension (999)
Acute Myocardial Infarction (963)
Cardiac Arrest (944)
Stent Placement (862)
Weight Increased (848)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Avandia Side Effects Reported to FDA



Avandia Side Effect Report#9996317
Myocardial Infarction, Cerebrovascular Accident, Transient Ischaemic Attack, Coronary Artery Disease
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction, Cerebrovascular Accident, Transient Ischaemic Attack, Coronary Artery Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in male patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Avandia Side Effect Report#9992381
Sick Sinus Syndrome
This report suggests a potential Avandia Sick Sinus Syndrome side effect(s) that can have serious consequences. A 89-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: 8mg Per Day) starting 200504. After starting Avandia the patient began experiencing various side effects, including: Sick Sinus SyndromeAdditional drugs used concurrently: NA.The patient was hospitalized. Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sick Sinus Syndrome, may still occur.
Avandia Side Effect Report#9992373
Adverse Event
This Adverse Event problem was reported by a health professional from US. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Avandia (dosage: NA). The following drugs were being taken at the same time: NA. When using Avandia, the patient experienced the following unwanted symptoms/side effects: Adverse EventAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Adverse Event, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9992372
Adverse Event
This Adverse Event side effect was reported by a pharmacist from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Avandia (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Avandamet
.After starting to take Avandia the consumer reported adverse symptoms, such as: Adverse EventThese side effects may potentially be related to Avandia.
Avandia Side Effect Report#9992370
Adverse Event, Myocardial Infarction, Arrhythmia
This is a report of a 84-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Adverse Event, Myocardial Infarction, Arrhythmia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in male patients, resulting in Adverse Event side effect.
Avandia Side Effect Report#9992369
Adverse Event, Cardiac Failure Congestive, Acute Myocardial Infarction
This report suggests a potential Avandia Adverse Event side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: NA) starting 200110. After starting Avandia the patient began experiencing various side effects, including: Adverse Event, Cardiac Failure Congestive, Acute Myocardial InfarctionAdditional drugs used concurrently: NA. Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adverse Event, may still occur.
Avandia Side Effect Report#9992367
Adverse Event, Acute Myocardial Infarction, Aortic Aneurysm, Ventricular Tachycardia, Atrial Fibrillation
This Adverse Event problem was reported by a health professional from US. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Avandia (dosage: 8mg Per Day). The following drugs were being taken at the same time: NA. When using Avandia, the patient experienced the following unwanted symptoms/side effects: Adverse Event, Acute Myocardial Infarction, Aortic Aneurysm, Ventricular Tachycardia, Atrial FibrillationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Adverse Event, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9992321
Acute Myocardial Infarction, Myocardial Ischaemia, Cardiac Stress Test Abnormal, Cardiac Flutter, Coronary Artery Disease, Cardiac Disorder, Myocardial Infarction, Cor Pulmonale Chronic
This Acute Myocardial Infarction side effect was reported by a physician from US. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Avandia (drug dosage: 8mg Per Day), which was initiated on 2005. Concurrently used drugs:
  • Prevacid (30mg Per Day)
  • Atenolol (25mg Per Day)
  • Lipitor (10mg Per Day)
  • Aspirin (81mg Per Day)
  • Glucophage (1000mg Twice Per Day)
  • Amaryl
  • Metoprolol
  • Januvia
.After starting to take Avandia the consumer reported adverse symptoms, such as: Acute Myocardial Infarction, Myocardial Ischaemia, Cardiac Stress Test Abnormal, Cardiac Flutter, Coronary Artery Disease, Cardiac Disorder, Myocardial Infarction, Cor Pulmonale ChronicThese side effects may potentially be related to Avandia. The patient was hospitalized.
Avandia Side Effect Report#9983792
Adverse Event
This is a report of a 55-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: NA, start time: 200004), combined with: NA. and developed a serious reaction and side effect(s): Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in male patients, resulting in Adverse Event side effect.
Avandia Side Effect Report#9983776
Adverse Event
This report suggests a potential Avandia Adverse Event side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: NA) starting NS. After starting Avandia the patient began experiencing various side effects, including: Adverse EventAdditional drugs used concurrently: NA. Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adverse Event, may still occur.
Avandia Side Effect Report#9983752
Myocardial Infarction, Angina Unstable, Acute Coronary Syndrome
This Myocardial Infarction problem was reported by a physician from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Avandia (dosage: 4mg Per Day). The following drugs were being taken at the same time: NA. When using Avandia, the patient experienced the following unwanted symptoms/side effects: Myocardial Infarction, Angina Unstable, Acute Coronary SyndromeThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9974106
Adverse Event, Angina Unstable
This Adverse Event side effect was reported by a pharmacist from US. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Avandia (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Avandia the consumer reported adverse symptoms, such as: Adverse Event, Angina UnstableThese side effects may potentially be related to Avandia.
Avandia Side Effect Report#9974098
Adverse Event, Cardiac Failure Congestive
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: 4mg Twice Per Day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Adverse Event, Cardiac Failure Congestive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in female patients, resulting in Adverse Event side effect.
Avandia Side Effect Report#9974039
Myocardial Infarction, Atrial Fibrillation
This report suggests a potential Avandia Myocardial Infarction side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: NA) starting NS. After starting Avandia the patient began experiencing various side effects, including: Myocardial Infarction, Atrial FibrillationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Avandia Side Effect Report#9974038
Myocardial Infarction, Acute Coronary Syndrome
This Myocardial Infarction problem was reported by a pharmacist from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On
Aug 08, 2006 this consumer started treatment with Avandia (dosage: 2mg Per Day). The following drugs were being taken at the same time:
  • Pravachol
  • Methotrexate
  • Plaquenil
  • Lexapro
  • Zebeta
  • Amaryl
  • Lisinopril
When using Avandia, the patient experienced the following unwanted symptoms/side effects: Myocardial Infarction, Acute Coronary SyndromeThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9964305
Myocardial Infarction, Cardiac Failure Congestive
This Death side effect was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Avandia (drug dosage: 4mg Per Day), which was initiated on 2000. Concurrently used drugs: NA..After starting to take Avandia the consumer reported adverse symptoms, such as: Myocardial Infarction, Cardiac Failure CongestiveThese side effects may potentially be related to Avandia. The patient was hospitalized.
Avandia Side Effect Report#9964297
Myocardial Infarction, Cerebrovascular Accident
This is a report of a 60-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: 4mg Per Day, start time: 200403), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction, Cerebrovascular Accident after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in female patients, resulting in Myocardial Infarction side effect. The patient was hospitalized.
Avandia Side Effect Report#9964032
Adverse Event, Myocardial Infarction, Cardiac Failure Congestive, Pulmonary Oedema
This report suggests a potential Avandia Adverse Event side effect(s) that can have serious consequences. A 48-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: NA) starting NS. After starting Avandia the patient began experiencing various side effects, including: Adverse Event, Myocardial Infarction, Cardiac Failure Congestive, Pulmonary OedemaAdditional drugs used concurrently:
  • Avandamet
Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adverse Event, may still occur.
Avandia Side Effect Report#9963995
Respiratory Failure, Ischaemic Cardiomyopathy, Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive
This Respiratory Failure problem was reported by a pharmacist from US. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 200701 this consumer started treatment with Avandia (dosage: 4mg Twice Per Day). The following drugs were being taken at the same time:
  • Furosemide
  • Aldactone
  • Advair (1puff Twice Per Day)
  • Combivent
  • Albuterol
  • Amitriptyline (25mg At Night)
  • Aspirin (325mg Per Day)
  • Lipitor (40mg Per Day)
When using Avandia, the patient experienced the following unwanted symptoms/side effects: Respiratory Failure, Ischaemic Cardiomyopathy, Chronic Obstructive Pulmonary Disease, Cardiac Failure CongestiveThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Failure, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9943123
Myocardial Infarction, Cerebrovascular Accident
This Myocardial Infarction side effect was reported by a consumer or non-health professional from US. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Avandia (drug dosage: 8mg Twice Per Day), which was initiated on 1999. Concurrently used drugs: NA..After starting to take Avandia the consumer reported adverse symptoms, such as: Myocardial Infarction, Cerebrovascular AccidentThese side effects may potentially be related to Avandia. The patient was hospitalized.
Avandia Side Effect Report#9943122
Cerebrovascular Accident, Coronary Artery Disease
This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: 4mg Per Day, start time: 2003), combined with: NA. and developed a serious reaction and side effect(s): Cerebrovascular Accident, Coronary Artery Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in female patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.
Avandia Side Effect Report#9943119
Myocardial Infarction
This report suggests a potential Avandia Myocardial Infarction side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: diabetes mellitus and used Avandia (dosage: 2mg Twice Per Day) starting 200011. After starting Avandia the patient began experiencing various side effects, including: Myocardial InfarctionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Avandia demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Infarction, may still occur.
Avandia Side Effect Report#9943107
Transient Ischaemic Attack, Myocardial Infarction, Coronary Artery Bypass, Cerebrovascular Accident
This Transient Ischaemic Attack problem was reported by a pharmacist from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On 200111 this consumer started treatment with Avandia (dosage: 4mg Per Day). The following drugs were being taken at the same time: NA. When using Avandia, the patient experienced the following unwanted symptoms/side effects: Transient Ischaemic Attack, Myocardial Infarction, Coronary Artery Bypass, Cerebrovascular AccidentThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Transient Ischaemic Attack, may become evident only after a product is in use by the general population.
Avandia Side Effect Report#9943102
Myocardial Infarction, Injury
This Myocardial Infarction side effect was reported by a pharmacist from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Avandia (drug dosage: 4mg Per Day), which was initiated on 2000. Concurrently used drugs: NA..After starting to take Avandia the consumer reported adverse symptoms, such as: Myocardial Infarction, InjuryThese side effects may potentially be related to Avandia. The patient was hospitalized.
Avandia Side Effect Report#9943098
Cerebrovascular Accident, Myocardial Infarction, Transient Ischaemic Attack, Renal Failure Acute, Renal Failure Chronic, Cardiac Failure Congestive, Macular Oedema, Retinopathy, Tibia Fracture
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Avandia (dosage: NA, start time: 199608), combined with:
  • Lasix
  • Prevacid
  • Gemfibrozil
  • Levoxyl
  • Trileptal
  • Spironolactone
  • Klor-con
  • Elavil
and developed a serious reaction and side effect(s): Cerebrovascular Accident, Myocardial Infarction, Transient Ischaemic Attack, Renal Failure Acute, Renal Failure Chronic, Cardiac Failure Congestive, Macular Oedema, Retinopathy, Tibia Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Avandia treatment in female patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.


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The appearance of Avandia on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Avandia reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Avandia Safety Alerts, Active Ingredients, Usage Information

    NDC0173-0834
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAVANDIA
    Namerosiglitazone maleate
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20110525
    LabelerGlaxoSmithKline LLC
    Active Ingredient(s)ROSIGLITAZONE MALEATE
    Strength(s)2
    Unit(s)mg/1
    Pharma ClassPeroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Acti

    Avandia Dosage, Warnings, Usage.

    Side Effects reported to FDA: 33456

    Avandia safety alerts: 2011 2010 2008 2007 2006 2002

    Reported deaths: 6225

    Reported hospitalizations: 28009

    Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events

    includes Avandia, Avandamet, and Avandaryl

     

    [UPDATED 11/04/2011] Healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities after November 18, 2011.

    [UPDATED 05/18/2011] FDA notified healthcare professionals and the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. These medicines to treat type II diabetes are sold under the names Avandia, Avandamet, and Avandaryl. Healthcare providers and patients must enroll in a special program in order to prescribe and receive these drugs.

    FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.

     

    [UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

    Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

    In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

    • In patients already being treated with these medicines
    • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

     

    [Posted 09/23/2010]

    AUDIENCE: Endocrinology, Cardiology

    ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

    BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

    RECOMMENDATION: FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

    Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/04/2011 - Drug Safety Communication - FDA]
    [05/18/2011 - Drug Safety Communication - FDA]
    [02/03/2011 - Drug Safety Communication - FDA]
    [02/03/2011 - Prescribing Information/Medication Guide - GSK]

    [09/23/2010 - News Release - FDA]
    [09/23/2010 - Q&As - FDA]
    [09/23/2010 - Avandia Related Information - FDA]
     

    Latest Avandia clinical trials