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SAXAGLIPTIN

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Saxagliptin Adverse Events Reported to the FDA Over Time

How are Saxagliptin adverse event reports trending over time?

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

Most Common Saxagliptin Adverse Events Reported to the FDA

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

Pancreatitis
117 (3.79%)
Hypoglycaemia
98 (3.17%)
Renal Failure Acute
96 (3.11%)
Nausea
66 (2.14%)
Pneumonia
59 (1.91%)
Diarrhoea
50 (1.62%)
Abdominal Pain Upper
47 (1.52%)
Pancreatitis Acute
46 (1.49%)
Dizziness
45 (1.46%)
Vomiting
44 (1.42%)
Abdominal Pain
41 (1.33%)
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Loss Of Consciousness
33 (1.07%)
Hypotension
32 (1.04%)
Syncope
30 (.97%)
Blood Glucose Increased
29 (.94%)
Chest Pain
28 (.91%)
Orthostatic Hypotension
28 (.91%)
Cholelithiasis
27 (.87%)
Drug Ineffective
27 (.87%)
Dyspnoea
27 (.87%)
Jaundice
27 (.87%)
Anaemia
26 (.84%)
Constipation
24 (.78%)
Dehydration
24 (.78%)
Pulmonary Oedema
23 (.74%)
Abdominal Discomfort
22 (.71%)
Asthenia
22 (.71%)
Blood Creatinine Increased
21 (.68%)
Headache
21 (.68%)
Hyperkalaemia
21 (.68%)
Myalgia
21 (.68%)
Blood Urea Increased
20 (.65%)
Angioedema
18 (.58%)
Atrial Fibrillation
18 (.58%)
Hepatic Function Abnormal
18 (.58%)
Malaise
18 (.58%)
Pleural Effusion
18 (.58%)
Rash
18 (.58%)
Urticaria
18 (.58%)
Asthma
17 (.55%)
Bronchitis
17 (.55%)
Pancreatitis Chronic
17 (.55%)
Non-cardiac Chest Pain
16 (.52%)
Oedema Peripheral
16 (.52%)
Haematuria
15 (.49%)
Medication Residue
15 (.49%)
Pulmonary Congestion
15 (.49%)
Viith Nerve Paralysis
15 (.49%)
Cholecystitis Acute
14 (.45%)
Gastroenteritis
14 (.45%)
Renal Impairment
14 (.45%)
Urosepsis
14 (.45%)
Bladder Cancer
13 (.42%)
Bundle Branch Block Left
13 (.42%)
Gastritis
13 (.42%)
Pyrexia
13 (.42%)
Thrombocytopenia
13 (.42%)
Ascites
12 (.39%)
Cellulitis
12 (.39%)
Glycosylated Haemoglobin Increased
12 (.39%)
Inguinal Hernia
12 (.39%)
Pancreatic Carcinoma Metastatic
12 (.39%)
Portal Vein Thrombosis
12 (.39%)
Biliary Polyp
11 (.36%)
Fatigue
11 (.36%)
Gastrointestinal Disorder
11 (.36%)
Pruritus
11 (.36%)
Sudden Cardiac Death
11 (.36%)
Vision Blurred
11 (.36%)
Acute Respiratory Failure
10 (.32%)
Condition Aggravated
10 (.32%)
Face Oedema
10 (.32%)
Mental Status Changes
10 (.32%)
Renal Failure Chronic
10 (.32%)
Sepsis
10 (.32%)
Sick Sinus Syndrome
10 (.32%)
Suicidal Ideation
10 (.32%)
Urinary Tract Infection
10 (.32%)
Alanine Aminotransferase Increased
9 (.29%)
Angina Pectoris
9 (.29%)
Aortic Aneurysm
9 (.29%)
Azotaemia
9 (.29%)
Drug Interaction
9 (.29%)
Fluid Overload
9 (.29%)
Gastric Ulcer
9 (.29%)
Hiv Infection
9 (.29%)
Hyperglycaemia
9 (.29%)
Hyperhidrosis
9 (.29%)
Pneumocystis Jiroveci Pneumonia
9 (.29%)
Qrs Axis Abnormal
9 (.29%)
Skin Ulcer
9 (.29%)
Abdominal Distension
8 (.26%)
Cardiac Failure Congestive
8 (.26%)
Cholangitis Acute
8 (.26%)
Depression
8 (.26%)
Diabetes Mellitus Inadequate Contro...
8 (.26%)
Erythema
8 (.26%)
Fall
8 (.26%)
Hepatitis
8 (.26%)
International Normalised Ratio Incr...
8 (.26%)
Irritable Bowel Syndrome
8 (.26%)

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

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

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

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

Type 2 Diabetes Mellitus
805
Diabetes Mellitus
87
Product Used For Unknown Indication
13
Diabetes Mellitus Non-insulin-depen...
5
Blood Glucose Increased
4
Diabetes Mellitus Management
1
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Blood Pressure Increased
1
Pancreatitis
1
Glycosylated Haemoglobin Increased
1
Blood Glucose
1
Glucose Tolerance Impaired
1
Type 1 Diabetes Mellitus
1
Hyperglycaemia
1

Drug Labels

LabelLabelerEffective
OnglyzaE.R. Squibb & Sons, L.L.C.16-DEC-11
OnglyzaPhysicians Total Care, Inc.09-JAN-12
KombiglyzexrE.R. Squibb & Sons, L.L.C.07-MAR-12

Saxagliptin Case Reports

What Saxagliptin 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 Saxagliptin. 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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