Drug Safety Information for GLUCOVANCE (Glyburide; metformin hydrochloride)

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

Adverse Drug Reactions for GLUCOVANCE* (Glyburide; metformin hydrochloride)

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 GLUCOVANCE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased746
2Nausea*527
3Weight decreased379
4Blood glucose decreased*333
5Decreased appetite274
6Myocardial infarction236
7Diarrhoea236
8Dizziness221
9Drug ineffective205
10Vomiting199
11Dyspnoea174
12Asthenia165
13Cardiac failure congestive161
14Headache*159
15Hypoglycaemia*158
16Fatigue*149
17Pain142
18Diabetes mellitus138
19Weight increased132
20Cerebrovascular accident127

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

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

Reason # of FDA Reports
1Diabetes mellitus*2319
2Type 2 diabetes mellitus1198
3Product used for unknown indication591
4Diabetes mellitus management24
5Blood glucose increased21
6Renal lithiasis prophylaxis18
7Blood glucose14
8Insulin resistance13
9Blood glucose abnormal12
10Maternal exposure during pregnancy7

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


Types of Adverse Events for GLUCOVANCE

Total Reports Filed with FDA: 19033


Number of FDA Adverse Event Reports by Patient Age for GLUCOVANCE

Total Reports Filed with FDA: 19033*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Glyburide; metformin hydrochloride (Glucovance)

Charts are based on 19033 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 GLUCOVANCE 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.