Drug Safety Information for GLUCOTROL (Glipizide)

Safety-related Labeling Changes for GLUCOTROL (GLIPIZIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for GLUCOTROL XL (GLIPIZIDE) Rx Drug: FDA Link

Adverse Drug Reactions for GLUCOTROL* (Glipizide)

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 GLUCOTROL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased4027
2Nausea2614
3Weight decreased1810
4Drug ineffective*1506
5Blood glucose decreased1408
6Dizziness1314
7Myocardial infarction1314
8Diarrhoea1275
9Decreased appetite1262
10Dyspnoea1255
11Vomiting1245
12Fatigue1159
13Cardiac failure congestive1133
14Asthenia1119
15Pain*1019
16Headache958
17Hypoglycaemia*796
18Diabetes mellitus772
19Chest pain756
20Cerebrovascular accident750

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

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

Reason # of FDA Reports
1Diabetes mellitus*14377
2Type 2 diabetes mellitus6808
3Product used for unknown indication5983
4Blood glucose increased327
5Blood glucose abnormal281
6Ill-defined disorder215
7Type 1 diabetes mellitus172
8Hyperglycaemia87
9Insulin-requiring type 2 diabetes mellitus84
10Blood glucose83

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


Types of Adverse Events for GLUCOTROL

Total Reports Filed with FDA: 123288


Number of FDA Adverse Event Reports by Patient Age for GLUCOTROL

Total Reports Filed with FDA: 123288*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Glipizide (Ozidia, Glipizideer, Minodiab, Mindiab, Minidiab, Glibenese, Melizide, Glipizide xl, Glucotrol xl, Glucotrol, Glipizide)

Charts are based on 123288 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 GLUCOTROL 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.