Drug Safety Information for TRADJENTA (Linagliptin)

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

Safety-related Labeling Changes for JENTADUETO (LINAGLIPTIN; METFORMIN 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 linagliptin and empagliflozin 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 metformin, insulin, or metformin plus insulin. A second randomization will take place at week 12, with uptitration of empagliflozin dose (from 10 mg to 25 mg) for approximately half of the subjects with a hemoglobin A1C greater than or equal to 7%. Due Date: 2022-12-31

Original FDA Drug Approval Date for TRADJENTA: 2011-05-02

Adverse Drug Reactions for TRADJENTA* (Linagliptin)

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 TRADJENTA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Blood glucose increased	239
2	Pancreatitis	180
3	Nausea	172
4	Rash	123
5	Dizziness	121
6	Diarrhoea	111
7	Drug ineffective	101
8	Headache	78
9	Abdominal pain	77
10	Vomiting	76
11	Pruritus	71
12	Weight decreased	71
13	Dyspnoea	69
14	Fatigue	69
15	Abdominal pain upper	65
16	Abdominal discomfort	64
17	Renal failure	59
18	Hyperglycaemia	57
19	Asthenia	56
20	Hypoglycaemia	56

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

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

	Reason	# of FDA Reports
1	Type 2 diabetes mellitus	2211
2	Diabetes mellitus	1744
3	Product used for unknown indication	801
4	Diabetes mellitus management	44
5	Blood glucose abnormal	32
6	Type 1 diabetes mellitus	29
7	Diabetes mellitus inadequate control	20
8	Glucose tolerance impaired	18
9	Blood cholesterol abnormal	10
10	Hypothyroidism	9

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

Types of Adverse Events for TRADJENTA

Total Reports Filed with FDA: 6912

Number of FDA Adverse Event Reports by Patient Age for TRADJENTA

Total Reports Filed with FDA: 6912*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Linagliptin (Tradjenta)

Charts are based on 6912 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.

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.