FDA Adverse Events Reports (FAERS) Summary for TRADJENTA

These tables and charts are based on 9,193 total reports for TRADJENTA (LINAGLIPTIN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 8,685 pharmaceutical company-submitted and non-U.S. FAERS reports and 508 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 508 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch TRADJENTA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	BLOOD GLUCOSE INCREASED	702
2	NAUSEA	488
3	DIARRHEA	481
4	DRUG INEFFECTIVE	383
5	FATIGUE	375
6	DEATH	338
7	CHRONIC KIDNEY DISEASE	333
8	DIZZINESS	328
9	KIDNEY FAILURE	300
10	PANCREATITIS	298
11	SHORTNESS OF BREATH	283
12	RASH	265
13	FALL	246
14	LACK OF STRENGTH AND ENERGY (ASTHENIA)	245
15	OFF LABEL USE	243
16	HEADACHE	233
17	VOMITING	233
18	WEIGHT DECREASED	230
19	ACUTE KIDNEY INJURY	228
20	JOINT PAIN	218
21	ABDOMINAL PAIN UPPER	204
22	ITCHING	202
23	ABDOMINAL PAIN	189
24	CONSTIPATION	187
25	PAIN	187
26	BLOOD GLUCOSE INCREASED	183
27	DECREASED APPETITE	177
28	MALAISE	177
29	ABDOMINAL DISCOMFORT	159
30	BACK PAIN	155
31	PNEUMONIA	149
32	COUGH	147
33	PAIN IN EXTREMITY	146
34	LOWER LIMBS SWELLING	146
35	URINARY TRACT INFECTION	145
36	BLOOD GLUCOSE DECREASED	133
37	STROKE	125
38	BLOOD GLUCOSE ABNORMAL	120
39	CHEST PAIN	117
40	HEART ATTACK (MYOCARDIAL INFARCTION)	113
41	INSOMNIA	112
42	WEIGHT INCREASED	111
43	ANXIETY	109
44	KIDNEY FAILURE	109
45	GAIT DISTURBANCE	108
46	CONGESTIVE HEART FAILURE	107
47	DEHYDRATION	104
48	HIGH BLOOD PRESSURE	104
49	LOW BLOOD SUGAR	100
50	KIDNEY IMPAIRMENT	99
51	DRUG DOSE OMISSION	96
52	HIVES	95
53	FEELING ABNORMAL	92
54	BLOOD PRESSURE INCREASED	91
55	LOW BLOOD PRESSURE	91
56	DROWSINESS	91
57	SWELLING OF LIMBS	89
58	DIABETES MELLITUS	88
59	THROAT PAIN	87
60	INJECTION SITE PAIN	85
61	TREMOR	85
62	ANEMIA	83
63	MUSCLE SPASMS	83
64	PRODUCT DOSE OMISSION ISSUE	83
65	DEPRESSION	82
66	HAEMOGLOBIN DECREASED	82
67	COMMON COLD	82
68	FEVER	82
69	VISION BLURRED	81
70	HAIR LOSS	79
71	KIDNEY DISORDER	79
72	GASTROOESOPHAGEAL REFLUX DISEASE	77
73	HIGH BLOOD SUGAR	77
74	SEPSIS	76
75	EXCESS SWEATING	75
76	PANCREATIC CANCER	74
77	MUSCLE PAIN	73
78	COVID-19	72
79	MEMORY IMPAIRMENT	71
80	ATRIAL FIBRILLATION	69
81	NUMBNESS	68
82	NEPHROGENIC ANAEMIA	67
83	PINS AND NEEDLES	67
84	CONDITION AGGRAVATED	66
85	ABDOMINAL DISTENSION	65
86	RUNNY NOSE	65
87	HYPERSENSITIVITY	64
88	INCORRECT DOSE ADMINISTERED	64
89	VISUAL IMPAIRMENT	64
90	BLOOD CREATININE INCREASED	62
91	CONFUSIONAL STATE	60
92	PALPITATIONS	60
93	CATARACT	57
94	SKIN REDNESS	57
95	MUSCULAR WEAKNESS	57
96	PANCREATITIS ACUTE	57
97	KIIDNEY INJURY	57
98	HEART FAILURE	56
99	CARDIAC DISORDER	55
100	JOINT SWELLING	55

Latest Known Outcomes for Reactions Reported for TRADJENTA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4659
2	Patient has not recovered/symtoms have not resolved	2634
3	Patient recovered	2293
4	Patient is recovering/symptoms resolving	644
5	Patient died	575
6	Patient has recovered but has consequent health issues	62

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2006	1
2010	1
2011	202
2012	682
2013	528
2014	707
2015	994
2016	1138
2017	883
2018	883
2019	840
2020	630
2021	474
2022	343
2023	270
2024	252
2025	256
2026	109

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	80
11-20	8
21-30	28
31-40	94
41-50	335
51-60	938
61-70	1497
71-80	1439
81-90	660
91+	80

Based on 5159 reports that included a patient age.

TRADJENTA Total Reports

Male	Female	Unknown	Total
3909	4592	692	9,193

Top Countries Reporting

	Country	Number of Reports
1	United States	7718
2	Brazil	127
3	Canada	101
4	United Kingdom	51
5	Spain	45
6	Italy	37
7	Puerto Rico	36
8	Switzerland	30
9	Mexico	28
10	Japan	26

Outcomes for Reports

Serious: 4337
Not Serious: 4853
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
Product used for unknown indication
Diabetes mellitus management
Diabetes mellitus

Top Companies Reporting

BOEHRINGER INGELHEIM

Safety-Related FDA Updates

FDA Approval Date: 2011-05-02

TRADJENTA (LINAGLIPTIN) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with TRADJENTA? Rate TRADJENTA 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

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for TRADJENTA 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 July 30, 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.