Drug Safety Information for ONGLYZA (Saxagliptin hydrochloride)

Safety-related Labeling Changes for ONGLYZA (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 ONGLYZA: 2009-07-31

Adverse Drug Reactions for ONGLYZA* (Saxagliptin 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 ONGLYZA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased247
2Nausea244
3Drug ineffective191
4Pancreatitis184
5Diarrhoea170
6Rash*166
7Headache163
8Vomiting145
9Dizziness137
10Oedema peripheral121
11Weight decreased120
12Fatigue117
13Renal failure acute107
14Hypoglycaemia103
15Pruritus*101
16Dyspnoea97
17Asthenia94
18Abdominal pain89
19Abdominal pain upper86
20Pneumonia83

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus3319
2Diabetes mellitus*2402
3Product used for unknown indication875
4Blood glucose increased49
5Blood glucose abnormal48
6Type 1 diabetes mellitus28
7Blood glucose27
8Hyperglycaemia25
9Diabetes mellitus inadequate control23
10Blood glucose decreased18

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


Types of Adverse Events for ONGLYZA

Total Reports Filed with FDA: 11713


Number of FDA Adverse Event Reports by Patient Age for ONGLYZA

Total Reports Filed with FDA: 11713*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Saxagliptin hydrochloride (Onglyza)

Charts are based on 11713 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 ONGLYZA 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.