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ONGLYZA

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Onglyza Adverse Events Reported to the FDA Over Time

How are Onglyza adverse event reports trending over time?

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

Most Common Onglyza Adverse Events Reported to the FDA

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

Pancreatitis
151 (3.79%)
Rash
126 (3.16%)
Blood Glucose Increased
113 (2.84%)
Headache
110 (2.76%)
Nausea
110 (2.76%)
Drug Ineffective
90 (2.26%)
Oedema Peripheral
90 (2.26%)
Diarrhoea
68 (1.71%)
Urticaria
58 (1.46%)
Dizziness
55 (1.38%)
Vomiting
52 (1.31%)
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Pruritus
49 (1.23%)
Weight Increased
47 (1.18%)
Pancreatitis Acute
45 (1.13%)
Angioedema
43 (1.08%)
Abdominal Pain
38 (.95%)
Abdominal Pain Upper
35 (.88%)
Hypoglycaemia
34 (.85%)
Fatigue
33 (.83%)
Swelling Face
33 (.83%)
Dyspnoea
31 (.78%)
Urinary Tract Infection
29 (.73%)
Abdominal Discomfort
28 (.7%)
Anaphylactic Shock
28 (.7%)
Medication Error
28 (.7%)
Renal Failure
27 (.68%)
Dehydration
26 (.65%)
Weight Decreased
26 (.65%)
Myalgia
25 (.63%)
Oedema
25 (.63%)
Constipation
24 (.6%)
Fluid Retention
24 (.6%)
Malaise
23 (.58%)
Vision Blurred
23 (.58%)
Chest Pain
22 (.55%)
Gastrointestinal Disorder
22 (.55%)
Liver Function Test Abnormal
22 (.55%)
Blood Creatinine Increased
21 (.53%)
Gamma-glutamyltransferase Increased
21 (.53%)
Hypersensitivity
21 (.53%)
Lip Swelling
21 (.53%)
Arthralgia
20 (.5%)
Eye Swelling
20 (.5%)
Renal Failure Acute
20 (.5%)
Asthenia
19 (.48%)
Hyperglycaemia
19 (.48%)
Swollen Tongue
19 (.48%)
Transaminases Increased
19 (.48%)
Adverse Event
18 (.45%)
Muscle Spasms
18 (.45%)
Blood Glucose Abnormal
17 (.43%)
Death
17 (.43%)
Hyperhidrosis
17 (.43%)
Upper Respiratory Tract Infection
17 (.43%)
Ascites
16 (.4%)
Face Oedema
16 (.4%)
Pancreatic Carcinoma
16 (.4%)
Abdominal Distension
15 (.38%)
Blood Albumin Decreased
15 (.38%)
Blood Bilirubin Increased
15 (.38%)
Blood Glucose Decreased
15 (.38%)
Cardiac Failure
15 (.38%)
Glycosylated Haemoglobin Increased
15 (.38%)
Nasopharyngitis
15 (.38%)
Oedema Mouth
15 (.38%)
Blood Glucose Fluctuation
14 (.35%)
Cough
14 (.35%)
Hepatic Enzyme Increased
14 (.35%)
Leukocytosis
14 (.35%)
Pain
14 (.35%)
Rash Generalised
14 (.35%)
Anaphylactic Reaction
13 (.33%)
Cholelithiasis
13 (.33%)
Diabetes Mellitus Inadequate Contro...
13 (.33%)
Dyspepsia
13 (.33%)
Lipase Increased
13 (.33%)
Renal Impairment
13 (.33%)
Acute Lymphocytic Leukaemia
12 (.3%)
Burning Sensation
12 (.3%)
Swelling
12 (.3%)
Tremor
12 (.3%)
Alopecia
11 (.28%)
Arrhythmia
11 (.28%)
Back Pain
11 (.28%)
Blood Pressure Increased
11 (.28%)
Bronchitis
11 (.28%)
Decreased Appetite
11 (.28%)
Depression
11 (.28%)
Tubulointerstitial Nephritis
11 (.28%)
Cardiac Disorder
10 (.25%)
Chest Discomfort
10 (.25%)
Discomfort
10 (.25%)
Dysphagia
10 (.25%)
Insomnia
10 (.25%)
Musculoskeletal Pain
10 (.25%)
Myocardial Infarction
10 (.25%)
Paraesthesia
10 (.25%)
Rhabdomyolysis
10 (.25%)
Alanine Aminotransferase Increased
9 (.23%)
Anxiety
9 (.23%)
Blister
9 (.23%)

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This graph shows the top adverse events submitted to the FDA for Onglyza, 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 Onglyza 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 Onglyza

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

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This graph shows the top categories of adverse events submitted to the FDA for Onglyza, 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 Onglyza 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 Onglyza According to Those Reporting Adverse Events

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

Type 2 Diabetes Mellitus
465
Diabetes Mellitus
451
Product Used For Unknown Indication
47
Diabetes Mellitus Inadequate Contro...
9
Hyperglycaemia
5
Hypertension
4
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Blood Glucose
4
Type 1 Diabetes Mellitus
4
Glucose Tolerance Impaired
4
Overweight
3
Blood Glucose Increased
3
Glycosylated Haemoglobin Increased
3
Blood Glucose Decreased
3
Drug Use For Unknown Indication
3
Blood Glucose Abnormal
2
Glycosylated Haemoglobin Decreased
1
Diabetes Prophylaxis
1
Pruritus
1
Skin Burning Sensation
1
Insulin Resistance
1
Blood Pressure Management
1
Blood Pressure Increased
1
Metabolic Syndrome
1
Metabolic Disorder
1

Drug Labels

LabelLabelerEffective
OnglyzaE.R. Squibb & Sons, L.L.C.16-DEC-11
OnglyzaPhysicians Total Care, Inc.09-JAN-12

Onglyza Case Reports

What Onglyza 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 Onglyza. 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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