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SYMBYAX

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Symbyax Adverse Events Reported to the FDA Over Time

How are Symbyax adverse event reports trending over time?

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

Most Common Symbyax Adverse Events Reported to the FDA

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

Weight Increased
69 (3.65%)
Completed Suicide
55 (2.91%)
Convulsion
46 (2.43%)
Depression
28 (1.48%)
Diabetes Mellitus
28 (1.48%)
Loss Of Consciousness
26 (1.37%)
Hypertension
24 (1.27%)
Overdose
24 (1.27%)
Fall
23 (1.22%)
Somnolence
23 (1.22%)
Off Label Use
22 (1.16%)
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Drug Ineffective
20 (1.06%)
Syncope
20 (1.06%)
Fatigue
19 (1%)
Anxiety
18 (.95%)
Dizziness
18 (.95%)
Blood Glucose Increased
17 (.9%)
Cerebrovascular Accident
16 (.85%)
Mania
16 (.85%)
Suicidal Ideation
16 (.85%)
Road Traffic Accident
15 (.79%)
Suicide Attempt
14 (.74%)
Dyspnoea
13 (.69%)
Feeling Abnormal
13 (.69%)
Insomnia
13 (.69%)
Myocardial Infarction
13 (.69%)
Pancreatitis
13 (.69%)
Blood Triglycerides Increased
12 (.63%)
Headache
12 (.63%)
Intentional Overdose
12 (.63%)
Treatment Noncompliance
12 (.63%)
Aggression
11 (.58%)
Confusional State
11 (.58%)
Medication Error
11 (.58%)
Tremor
11 (.58%)
Vomiting
11 (.58%)
Abnormal Behaviour
10 (.53%)
Blood Cholesterol Increased
10 (.53%)
Death
10 (.53%)
Drug Withdrawal Syndrome
10 (.53%)
Oedema Peripheral
10 (.53%)
Grand Mal Convulsion
9 (.48%)
Hallucination
9 (.48%)
Hyperglycaemia
9 (.48%)
Memory Impairment
9 (.48%)
Obesity
9 (.48%)
Alanine Aminotransferase Increased
8 (.42%)
Asthenia
8 (.42%)
Blood Cholesterol Abnormal
8 (.42%)
Blood Pressure Increased
8 (.42%)
Coma
8 (.42%)
Condition Aggravated
8 (.42%)
Hypoaesthesia
8 (.42%)
Increased Appetite
8 (.42%)
Malaise
8 (.42%)
Palpitations
8 (.42%)
Pneumonia
8 (.42%)
Pyrexia
8 (.42%)
White Blood Cell Count Increased
8 (.42%)
Amnesia
7 (.37%)
Blood Alkaline Phosphatase Increase...
7 (.37%)
Diabetic Ketoacidosis
7 (.37%)
Disturbance In Attention
7 (.37%)
Drug Interaction
7 (.37%)
Intentional Self-injury
7 (.37%)
Paraesthesia
7 (.37%)
Renal Failure
7 (.37%)
Self Injurious Behaviour
7 (.37%)
Weight Decreased
7 (.37%)
Acute Myocardial Infarction
6 (.32%)
Alcohol Use
6 (.32%)
Cardiac Failure Congestive
6 (.32%)
Contusion
6 (.32%)
Cough
6 (.32%)
Delirium
6 (.32%)
Diarrhoea
6 (.32%)
Drug Intolerance
6 (.32%)
Electrolyte Imbalance
6 (.32%)
Fear
6 (.32%)
Gun Shot Wound
6 (.32%)
Hyperhidrosis
6 (.32%)
Hypersomnia
6 (.32%)
Low Density Lipoprotein Increased
6 (.32%)
Mood Swings
6 (.32%)
Nausea
6 (.32%)
Pulmonary Embolism
6 (.32%)
Type 2 Diabetes Mellitus
6 (.32%)
Anger
5 (.26%)
Aspartate Aminotransferase Increase...
5 (.26%)
Asphyxia
5 (.26%)
Blood Potassium Increased
5 (.26%)
Blood Sodium Decreased
5 (.26%)
Brain Oedema
5 (.26%)
Cerebral Haematoma
5 (.26%)
Eye Movement Disorder
5 (.26%)
Hepatic Enzyme Increased
5 (.26%)
Hepatic Steatosis
5 (.26%)
Injury
5 (.26%)
Irritability
5 (.26%)
Jaundice
5 (.26%)
Migraine
5 (.26%)

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

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

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

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

Bipolar Disorder
85
Depression
79
Bipolar I Disorder
67
Anxiety
21
Major Depression
12
Schizophrenia
10
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Affective Disorder
8
Drug Use For Unknown Indication
7
Aggression
5
Psychotic Disorder
5
Impulse-control Disorder
4
Insomnia
4
Hallucination
3
Impulsive Behaviour
2
Mania
2
Schizoaffective Disorder
2
Weight Increased
2
Stress
2
Attention Deficit/hyperactivity Dis...
1
Paraphilia
1
Obsessive-compulsive Disorder
1
Gastrointestinal Pain
1
Agitation
1
Mood Swings
1
Personality Disorder
1
Hallucination, Auditory
1
Borderline Personality Disorder
1
Schizophrenia, Paranoid Type
1
Somnolence
1
Irritability
1
Oppositional Defiant Disorder
1
Depressive Symptom
1
Bipolar Ii Disorder
1
Anger
1
Drug Withdrawal Syndrome
1

Drug Labels

LabelLabelerEffective
SymbyaxEli Lilly and Company03-JAN-13

Symbyax Case Reports

What Symbyax 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 Symbyax. 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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