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TRADJENTA

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Tradjenta Adverse Events Reported to the FDA Over Time

How are Tradjenta adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Tradjenta, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Tradjenta is flagged as the suspect drug causing the adverse event.

Most Common Tradjenta Adverse Events Reported to the FDA

What are the most common Tradjenta adverse events reported to the FDA?

Pancreatitis
81 (5.13%)
Blood Glucose Increased
80 (5.07%)
Nausea
80 (5.07%)
Rash
58 (3.67%)
Diarrhoea
42 (2.66%)
Dizziness
36 (2.28%)
Headache
30 (1.9%)
Drug Ineffective
28 (1.77%)
Vomiting
28 (1.77%)
Abdominal Discomfort
26 (1.65%)
Abdominal Pain
25 (1.58%)
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Lip Swelling
24 (1.52%)
Constipation
21 (1.33%)
Urticaria
20 (1.27%)
Oedema Peripheral
19 (1.2%)
Rhinorrhoea
19 (1.2%)
Abdominal Pain Upper
17 (1.08%)
Oropharyngeal Pain
17 (1.08%)
Rash Generalised
17 (1.08%)
Hyperglycaemia
16 (1.01%)
Hypersensitivity
15 (.95%)
Pruritus
15 (.95%)
Arthralgia
14 (.89%)
Asthenia
14 (.89%)
Glycosylated Haemoglobin Increased
14 (.89%)
Renal Failure Acute
14 (.89%)
Weight Increased
14 (.89%)
Blood Glucose Abnormal
13 (.82%)
Fatigue
13 (.82%)
Pancreatitis Acute
13 (.82%)
Paraesthesia
13 (.82%)
Weight Decreased
11 (.7%)
Chest Pain
10 (.63%)
Confusional State
10 (.63%)
Dyspnoea
10 (.63%)
Cough
9 (.57%)
Feeling Abnormal
9 (.57%)
Hypoglycaemia
9 (.57%)
Pain In Extremity
9 (.57%)
Renal Failure
9 (.57%)
Swollen Tongue
9 (.57%)
Visual Impairment
9 (.57%)
Diabetes Mellitus Inadequate Contro...
8 (.51%)
Palpitations
8 (.51%)
Skin Exfoliation
8 (.51%)
Vision Blurred
8 (.51%)
Anxiety
7 (.44%)
Blister
7 (.44%)
Feeling Hot
7 (.44%)
Gait Disturbance
7 (.44%)
Hypotension
7 (.44%)
Swelling
7 (.44%)
Tachycardia
7 (.44%)
Angioedema
6 (.38%)
Back Pain
6 (.38%)
Blood Glucose Decreased
6 (.38%)
Cerebrovascular Accident
6 (.38%)
Dehydration
6 (.38%)
Drug Intolerance
6 (.38%)
Dyspepsia
6 (.38%)
Erythema
6 (.38%)
Hepatic Enzyme Increased
6 (.38%)
Oedema
6 (.38%)
Tremor
6 (.38%)
Abdominal Distension
5 (.32%)
Anaemia
5 (.32%)
Blood Pressure Increased
5 (.32%)
Chills
5 (.32%)
Death
5 (.32%)
Decreased Appetite
5 (.32%)
Face Oedema
5 (.32%)
Glossodynia
5 (.32%)
Heart Rate Increased
5 (.32%)
Incorrect Dose Administered
5 (.32%)
Insomnia
5 (.32%)
Nasal Congestion
5 (.32%)
Pancreatic Enzymes Increased
5 (.32%)
Swelling Face
5 (.32%)
Tinnitus
5 (.32%)
Adverse Drug Reaction
4 (.25%)
Alanine Aminotransferase Increased
4 (.25%)
Aspartate Aminotransferase Increase...
4 (.25%)
Blood Creatinine Increased
4 (.25%)
Chromaturia
4 (.25%)
Dermatitis Allergic
4 (.25%)
Eczema
4 (.25%)
Epistaxis
4 (.25%)
Eye Haemorrhage
4 (.25%)
Gallbladder Disorder
4 (.25%)
Hearing Impaired
4 (.25%)
Lipase Increased
4 (.25%)
Local Swelling
4 (.25%)
Musculoskeletal Stiffness
4 (.25%)
Myalgia
4 (.25%)
Nasopharyngitis
4 (.25%)
Nervousness
4 (.25%)
Pharyngeal Oedema
4 (.25%)
Rash Pruritic
4 (.25%)
Rectal Haemorrhage
4 (.25%)
Renal Impairment
4 (.25%)
Somnolence
4 (.25%)

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This graph shows the top adverse events submitted to the FDA for Tradjenta, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tradjenta is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Tradjenta

What are the most common Tradjenta adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Tradjenta, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tradjenta is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Tradjenta According to Those Reporting Adverse Events

Why are people taking Tradjenta, according to those reporting adverse events to the FDA?

Type 2 Diabetes Mellitus
441
Diabetes Mellitus
122
Glycosylated Haemoglobin Increased
4
Renal Failure Chronic
4
Product Used For Unknown Indication
3
Type 1 Diabetes Mellitus
3
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Diabetes Mellitus Inadequate Contro...
2
Blood Glucose Increased
2
Renal Function Test Abnormal
2
Glycosylated Haemoglobin
2
Diabetes Mellitus Management
1
Blood Glucose Abnormal
1
Renal Impairment
1
Glucose Tolerance Impaired
1

Drug Labels

LabelLabelerEffective
TradjentaBoehringer Ingelheim Pharmaceuticals, Inc.10-SEP-12

Tradjenta Case Reports

What Tradjenta safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Tradjenta. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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