Drug Safety Information for DIABETA (Glyburide)

Safety-related Labeling Changes for DIABETA (GLYBURIDE) Rx Drug: FDA Link

Skin reactions Safety label updated

Safety-related Labeling Changes for GLUCOVANCE (GLYBURIDE; METFORMIN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for DIABETA* (Glyburide)

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 DIABETA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased2727
2Nausea*1821
3Weight decreased1305
4Hypoglycaemia1212
5Blood glucose decreased*1132
6Myocardial infarction1048
7Dyspnoea1019
8Dizziness998
9Decreased appetite*991
10Drug ineffective941
11Diarrhoea938
12Vomiting934
13Asthenia902
14Cardiac failure congestive821
15Fatigue*801
16Pain716
17Headache699
18Oedema peripheral663
19Cerebrovascular accident594
20Chest pain564

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

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

Reason # of FDA Reports
1Diabetes mellitus*12191
2Type 2 diabetes mellitus5801
3Product used for unknown indication4726
4Hyperglycaemia156
5Blood glucose increased144
6Blood glucose abnormal118
7Ill-defined disorder102
8Suicide attempt89
9Type 1 diabetes mellitus80
10Gestational diabetes78

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


Types of Adverse Events for DIABETA

Total Reports Filed with FDA: 100215


Number of FDA Adverse Event Reports by Patient Age for DIABETA

Total Reports Filed with FDA: 100215*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Glyburide (Daonil, Glycron, Glyburide, Maninil, Euglucon, Euglucon n, Glynase, Diabeta, Micronase)

Charts are based on 100215 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 DIABETA Reviews and Review Summary .

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.

Visit   DrugInformer.com more on DIABETA's side effects.