FDA Adverse Events Reports (FAERS) Summary for ONGLYZA

These tables and charts are based on 7,450 total reports for ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 7,271 pharmaceutical company-submitted and non-U.S. FAERS reports and 179 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 179 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ONGLYZA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with ONGLYZA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	BLOOD GLUCOSE INCREASED	409
2	CONGESTIVE HEART FAILURE	404
3	HEART FAILURE	381
4	DRUG INEFFECTIVE	327
5	NAUSEA	325
6	DIARRHEA	297
7	HEADACHE	250
8	WEIGHT DECREASED	248
9	FATIGUE	237
10	DEATH	236
11	DIZZINESS	229
12	RASH	214
13	PANCREATITIS	205
14	VOMITING	181
15	SHORTNESS OF BREATH	170
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	165
17	CARDIOVASCULAR DISORDER	163
18	ITCHING	163
19	KIDNEY FAILURE	160
20	PNEUMONIA	155
21	CHRONIC KIDNEY DISEASE	148
22	ACUTE KIDNEY INJURY	146
23	FALL	143
24	JOINT PAIN	142
25	MALAISE	138
26	DRUG DOSE OMISSION	135
27	OFF LABEL USE	133
28	SWELLING OF LIMBS	132
29	HEART ATTACK (MYOCARDIAL INFARCTION)	130
30	CONSTIPATION	128
31	WEIGHT INCREASED	122
32	PAIN	119
33	ABDOMINAL PAIN	114
34	ABDOMINAL PAIN UPPER	114
35	DECREASED APPETITE	114
36	PAIN IN EXTREMITY	108
37	URINARY TRACT INFECTION	103
38	BACK PAIN	101
39	HIGH BLOOD PRESSURE	99
40	PANCREATIC CANCER	96
41	BLOOD GLUCOSE INCREASED	95
42	LOW BLOOD SUGAR	94
43	DEHYDRATION	92
44	INJECTION SITE PAIN	92
45	BLOOD GLUCOSE DECREASED	90
46	CHEST PAIN	90
47	DIABETES MELLITUS	90
48	COUGH	89
49	ANEMIA	84
50	ABDOMINAL DISCOMFORT	81
51	INDIGESTION	81
52	HIVES	79
53	PANCREATITIS ACUTE	77
54	DEPRESSION	76
55	INSOMNIA	75
56	FEVER	75
57	MUSCLE PAIN	74
58	FEELING ABNORMAL	71
59	HIGH BLOOD SUGAR	71
60	CORONARY ARTERY DISEASE	70
61	KIDNEY IMPAIRMENT	69
62	MUSCLE SPASMS	68
63	BLOOD PRESSURE INCREASED	67
64	ANXIETY	64
65	LOWER LIMBS SWELLING	64
66	VISION BLURRED	63
67	GAIT DISTURBANCE	62
68	DROWSINESS	61
69	STROKE	59
70	BLADDER CANCER	58
71	TREMOR	58
72	BLOOD CREATININE INCREASED	57
73	DIABETES MELLITUS INADEQUATE CONTROL	57
74	LOW BLOOD PRESSURE	57
75	COMMON COLD	56
76	NUMBNESS	55
77	HAIR LOSS	54
78	ATRIAL FIBRILLATION	54
79	SKIN REDNESS	54
80	ACUTE LEFT VENTRICULAR FAILURE	53
81	DRUG INTERACTION	52
82	GENERAL PHYSICAL HEALTH DETERIORATION	52
83	VISUAL IMPAIRMENT	52
84	GASTROOESOPHAGEAL REFLUX DISEASE	51
85	INTENTIONAL PRODUCT MISUSE	51
86	BLOOD GLUCOSE ABNORMAL	50
87	DIFFICULTY SWALLOWING	50
88	HYPERSENSITIVITY	49
89	HEART ATTACK	48
90	BRONCHITIS	48
91	GASTROINTESTINAL BLEEDING	48
92	KIDNEY DISORDER	48
93	SINUSITIS	48
94	DRUG HYPERSENSITIVITY	47
95	LACTIC ACIDOSIS	47
96	ABDOMINAL DISTENSION	46
97	URINATION DIFFICULTY	45
98	INCORRECT DOSE ADMINISTERED	44
99	INJECTION SITE HAEMORRHAGE	44
100	SWELLING	44

Latest Known Outcomes for Reactions Reported for ONGLYZA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3365
2	Patient recovered	1429
3	Patient has not recovered/symtoms have not resolved	1284
4	Patient is recovering/symptoms resolving	709
5	Patient died	529
6	Patient has recovered but has consequent health issues	72

Search all MedWatch and FAERS by keyword:

ONGLYZA Total Reports

Male	Female	Unknown	Total
3115	3557	778	7,450

Top Countries Reporting

	Country	Number of Reports
1	United States	3557
2	Japan	547
3	Canada	326
4	France	294
5	Brazil	220
6	Germany	124
7	United Kingdom	55
8	China	53
9	Italy	27
10	Belgium	26

Outcomes for Reports

Serious: 4656
Not Serious: 2793
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Type 2 diabetes mellitus
Diabetes mellitus

Top Companies Reporting

ALEXION PHARMACEUTICALS

Safety-Related FDA Updates

FDA Approval Date: 2009-07-31

ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE) Rx Drug:
Because insulin and insulin secretagogues (such as glipizide) are known to cause hypoglycemia (low blood sugar), lower dosages of these may be required when taken along with Onglyza. Approved in 2009. Safety-related Labeling Changes

Have experience (good or bad) with ONGLYZA? Rate ONGLYZA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for ONGLYZA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.