Drug Safety Information for KOMBIGLYZE XR (Metformin hydrochloride; saxagliptin)

Safety-related Labeling Changes for KOMBIGLYZE XR (METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE) Rx Drug: FDA Link

Required post-approval safety study:

Conduct a 26-week randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the monotherapies saxagliptin and dapagliflozin for the treatment of pediatric patients ages 10 to < 18 years with type 2 diabetes mellitus, followed by a 26-week site- and subject-blinded safety extension period (weeks 26 to 52). Background therapy will consist of either metformin, insulin, or metformin plus insulin. A second randomization will take place at week 14, with uptitration of dose (saxagliptin may be increased from 2.5 mg to 5 mg dapagliflozin from 5 mg to 10 mg) for approximately half of the subjects with a hemoglobin A1C greater than or equal to 7%. Due Date: 2022-04-30

Original FDA Drug Approval Date for KOMBIGLYZE XR: 2010-11-05

Adverse Drug Reactions for KOMBIGLYZE XR* (Metformin hydrochloride; saxagliptin)

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 KOMBIGLYZE XR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea94
2Blood glucose increased73
3Nausea68
4Drug ineffective67
5Vomiting47
6Dizziness43
7Pancreatitis41
8Drug dose omission37
9Weight decreased35
10Rash32
11Headache31
12Abdominal discomfort27
13Abdominal pain26
14Malaise25
15Gastrointestinal disorder24
16Dyspnoea24
17Pruritus23
18Glycosylated haemoglobin increased23
19Abdominal pain upper21
20Hyperglycaemia20

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

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

Reason # of FDA Reports
1Diabetes mellitus429
2Type 2 diabetes mellitus414
3Product used for unknown indication93
4Blood glucose increased20
5Blood glucose10
6Diabetes mellitus inadequate control4
7Hyperglycaemia3
8Type 1 diabetes mellitus3
9Blood glucose abnormal2
10Glycosylated haemoglobin increased1

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


Types of Adverse Events for KOMBIGLYZE XR

Total Reports Filed with FDA: 2247


Number of FDA Adverse Event Reports by Patient Age for KOMBIGLYZE XR

Total Reports Filed with FDA: 2247*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Metformin hydrochloride; saxagliptin (Kombiglyze xr)

Charts are based on 2247 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 KOMBIGLYZE XR 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.