Drug Safety Information for AVANDIA (Rosiglitazone maleate)

Safety-related Labeling Changes for AVANDIA (ROSIGLITAZONE MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for AVANDIA* (Rosiglitazone maleate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with AVANDIA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction36297
2Cardiac failure congestive26533
3Cerebrovascular accident15769
4Coronary artery disease9583
5Cardiac disorder6953
6Death6232
7Injury3694
8Acute myocardial infarction3413
9Cardiovascular disorder2780
10Chest pain2733
11Myocardial ischaemia2424
12Blood glucose increased2423
13Coronary artery bypass2351
14Dyspnoea*2266
15Atrial fibrillation2180
16Coronary arterial stent insertion2112
17Hypertension2059
18Transient ischaemic attack1937
19Nausea1829
20Cardiac arrest1723

* This side effect also appears in "Top 10 Side Effects of AVANDIA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking AVANDIA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diabetes mellitus*138717
2Type 2 diabetes mellitus22936
3Product used for unknown indication7182
4Type 1 diabetes mellitus362
5Ill-defined disorder270
6Blood glucose increased154
7Blood glucose100
8Glucose tolerance impaired86
9Insulin resistance*84
10Hyperglycaemia75

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for AVANDIA

Total Reports Filed with FDA: 253644


Number of FDA Adverse Event Reports by Patient Age for AVANDIA

Total Reports Filed with FDA: 253644*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rosiglitazone maleate (Rosiglitazone, Avandamet 4/500, Avandia)

Charts are based on 253644 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and AVANDIA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.