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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ROSIGLITAZONE: 45,976 Adverse Event Reports & Safety Profile

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45,976
Total FAERS Reports
4,661 (10.1%)
Deaths Reported
23,675
Hospitalizations
45,976
As Primary/Secondary Suspect
29
Life-Threatening
30
Disabilities
Jan 25, 2013
FDA Approved
Discontinued
Status
Yes
Generic Available

Active Ingredient: ROSIGLITAZONE MALEATE · FDA Application: 021071 ·

First Report: 1978 · Latest Report: 20250428

What Are the Most Common ROSIGLITAZONE Side Effects?

#1 Most Reported
Myocardial infarction
17,018 reports (37.0%)
#2 Most Reported
Cardiac failure congestive
15,085 reports (32.8%)
#3 Most Reported
Cerebrovascular accident
7,899 reports (17.2%)

All ROSIGLITAZONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myocardial infarction 17,018 37.0% 2,557 8,748
Cardiac failure congestive 15,085 32.8% 1,596 8,220
Cerebrovascular accident 7,899 17.2% 700 3,880
Coronary artery disease 4,982 10.8% 610 4,277
Acute myocardial infarction 2,437 5.3% 388 2,178
Cardiac disorder 1,732 3.8% 169 389
Coronary arterial stent insertion 1,698 3.7% 47 994
Coronary artery bypass 1,181 2.6% 38 948
Chest pain 990 2.2% 21 760
Myocardial ischaemia 970 2.1% 125 583
Atrial fibrillation 784 1.7% 131 688
Angina unstable 759 1.7% 20 703
Hypertension 756 1.6% 86 503
Cardio-respiratory arrest 718 1.6% 686 343
Cardiac arrest 690 1.5% 580 356
Angina pectoris 680 1.5% 31 529
Transient ischaemic attack 585 1.3% 37 502
Injury 566 1.2% 10 44
Vascular graft 561 1.2% 29 303
Death 456 1.0% 371 152

Who Reports ROSIGLITAZONE Side Effects? Age & Gender Data

Gender: 42.8% female, 57.2% male. Average age: 60.2 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is ROSIGLITAZONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 710 80 654
2001 1,018 147 907
2002 1,358 194 1,196
2003 1,809 260 1,602
2004 2,141 287 1,929
2005 2,753 398 2,389
2006 3,085 481 2,644
2007 3,424 566 2,922
2008 2,909 427 2,521
2009 2,483 405 2,107
2010 2,282 371 1,935
2011 847 173 679
2012 182 78 104
2013 44 21 20
2014 23 5 16
2015 9 1 3
2016 1 0 0
2017 2 0 1
2018 2 0 1
2019 5 0 2
2020 1 0 0
2022 1 0 0
2023 2 0 2
2025 1 0 0

View full timeline →

What Is ROSIGLITAZONE Used For?

IndicationReports
Diabetes mellitus 45,088
Type 2 diabetes mellitus 605
Product used for unknown indication 188
Type 1 diabetes mellitus 10

ROSIGLITAZONE vs Alternatives: Which Is Safer?

ROSIGLITAZONE vs ROSUVASTATIN ROSIGLITAZONE vs ROSUVASTATIN\ROSUVASTATIN ROSIGLITAZONE vs ROTIGOTINE ROSIGLITAZONE vs ROXADUSTAT ROSIGLITAZONE vs ROXICODONE ROSIGLITAZONE vs ROXITHROMYCIN ROSIGLITAZONE vs ROZANOLIXIZUMAB ROSIGLITAZONE vs ROZANOLIXIZUMAB-NOLI ROSIGLITAZONE vs RUBIDIUM RB-82 ROSIGLITAZONE vs RUCAPARIB

Official FDA Label for ROSIGLITAZONE

Official prescribing information from the FDA-approved drug label.