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Byetta Adverse Events Reported to the FDA Over Time

How are Byetta adverse event reports trending over time?

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

Most Common Byetta Adverse Events Reported to the FDA

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

Blood Glucose Increased
16938 (8.57%)
Weight Decreased
14768 (7.47%)
Nausea
13827 (7%)
Decreased Appetite
6650 (3.37%)
Blood Glucose Decreased
6553 (3.32%)
Vomiting
5144 (2.6%)
Pancreatitis
3597 (1.82%)
Diarrhoea
3161 (1.6%)
Dizziness
3062 (1.55%)
Headache
2248 (1.14%)
Drug Ineffective
2088 (1.06%)
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Fatigue
1899 (.96%)
Injection Site Pain
1882 (.95%)
Asthenia
1877 (.95%)
Feeling Abnormal
1877 (.95%)
Tremor
1796 (.91%)
Drug Effect Decreased
1713 (.87%)
Incorrect Dose Administered
1663 (.84%)
Malaise
1640 (.83%)
Dyspepsia
1559 (.79%)
Injection Site Haemorrhage
1557 (.79%)
Abdominal Pain Upper
1531 (.77%)
Abdominal Distension
1498 (.76%)
Off Label Use
1484 (.75%)
Weight Increased
1309 (.66%)
Pancreatitis Acute
1304 (.66%)
Constipation
1299 (.66%)
Hyperhidrosis
1298 (.66%)
Abdominal Pain
1156 (.59%)
Anorexia
1097 (.56%)
Feeling Jittery
1089 (.55%)
Eructation
934 (.47%)
Dyspnoea
899 (.46%)
Glycosylated Haemoglobin Increased
876 (.44%)
Fall
834 (.42%)
Medication Error
769 (.39%)
Blood Glucose Fluctuation
756 (.38%)
Early Satiety
744 (.38%)
Dysgeusia
714 (.36%)
Somnolence
706 (.36%)
Flatulence
701 (.35%)
Hypoglycaemia
694 (.35%)
Dehydration
693 (.35%)
Back Pain
690 (.35%)
Renal Failure
684 (.35%)
Pain
680 (.34%)
Gastrooesophageal Reflux Disease
675 (.34%)
Blood Glucose Abnormal
673 (.34%)
Chest Pain
671 (.34%)
Cholelithiasis
631 (.32%)
Chills
615 (.31%)
Pain In Extremity
596 (.3%)
Nervousness
585 (.3%)
Pyrexia
577 (.29%)
Injection Site Irritation
561 (.28%)
Increased Appetite
559 (.28%)
Oedema Peripheral
554 (.28%)
Nasopharyngitis
550 (.28%)
Hunger
534 (.27%)
Blood Pressure Increased
530 (.27%)
Therapeutic Response Unexpected
530 (.27%)
Injection Site Erythema
529 (.27%)
Loss Of Consciousness
528 (.27%)
Cough
527 (.27%)
Arthralgia
525 (.27%)
Vision Blurred
512 (.26%)
Renal Failure Acute
499 (.25%)
Injection Site Urticaria
495 (.25%)
Feeling Cold
494 (.25%)
Insomnia
488 (.25%)
Heart Rate Increased
474 (.24%)
Muscle Spasms
460 (.23%)
Stress
456 (.23%)
Myocardial Infarction
451 (.23%)
Anxiety
437 (.22%)
Pneumonia
431 (.22%)
Urinary Tract Infection
414 (.21%)
Accidental Overdose
413 (.21%)
Confusional State
408 (.21%)
Pruritus
397 (.2%)
Injection Site Pruritus
396 (.2%)
Palpitations
393 (.2%)
Injection Site Rash
376 (.19%)
Urticaria
374 (.19%)
Condition Aggravated
358 (.18%)
Feeling Hot
344 (.17%)
Hypertension
342 (.17%)
Contusion
340 (.17%)
Hypoaesthesia
335 (.17%)
Drug Ineffective For Unapproved Ind...
329 (.17%)
Depression
322 (.16%)
Rash
322 (.16%)
Pancreatic Carcinoma
319 (.16%)
Energy Increased
316 (.16%)
Influenza
303 (.15%)
Injection Site Extravasation
302 (.15%)
Cold Sweat
301 (.15%)
Abdominal Discomfort
298 (.15%)
Retching
295 (.15%)
Anaemia
293 (.15%)
Arthritis
293 (.15%)

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

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

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

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

Diabetes Mellitus Non-insulin-depen...
17510
Type 2 Diabetes Mellitus
13996
Diabetes Mellitus
3184
Drug Use For Unknown Indication
2941
Insulin-requiring Type 2 Diabetes M...
439
Product Used For Unknown Indication
277
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Glucose Tolerance Impaired
246
Weight Decreased
215
Insulin-requiring Type Ii Diabetes ...
171
Diabetes Mellitus Insulin-dependent
138
Type 1 Diabetes Mellitus
135
Insulin Resistance
123
Weight Control
105
Obesity
62
Insulin Resistant Diabetes
42
Metabolic Syndrome
35
Blood Glucose Increased
31
Diabetes Mellitus Inadequate Contro...
26
Polycystic Ovaries
17
Hypoglycaemia
13
Blood Glucose Abnormal
13
Hyperglycaemia
13
Overweight
11
Blood Glucose
8
Blood Insulin Increased
7
Decreased Appetite
6
Glycosylated Haemoglobin Increased
5
Neuropathy Peripheral
5
Metabolic Disorder
4
Diabetes Prophylaxis
4
Latent Autoimmune Diabetes In Adult...
3
Weight Increased
3
Hyperinsulinaemia
3
Blood Glucose Fluctuation
3
Nausea
3
Premedication
3
Appetite Disorder
2
Increased Appetite
2
Weight
2
Blood Pressure
2
Thyroid Disorder
2
Blood Triglycerides Increased
2
Hypertension
2
Prophylaxis
2
Headache
2
Accidental Needle Stick
2
Prader-willi Syndrome
2
Renal Disorder
1
Gastric Disorder
1
Psoriasis
1
Factor Ii Mutation
1

Drug Labels

LabelLabelerEffective
ByettaAmylin Pharmaceuticals, Inc.31-DEC-11
ByettaPhysicians Total Care, Inc.12-MAR-12

Byetta Case Reports

What Byetta 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 Byetta. 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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