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FAZACLO ODT

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Fazaclo Odt Adverse Events Reported to the FDA Over Time

How are Fazaclo Odt adverse event reports trending over time?

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

Most Common Fazaclo Odt Adverse Events Reported to the FDA

What are the most common Fazaclo Odt adverse events reported to the FDA?

Death
148 (11.15%)
Agranulocytosis
40 (3.01%)
Pneumonia
39 (2.94%)
Myocardial Infarction
37 (2.79%)
Cardiac Arrest
28 (2.11%)
Convulsion
25 (1.88%)
Choking
18 (1.36%)
Chronic Obstructive Pulmonary Disea...
18 (1.36%)
Vomiting
16 (1.21%)
Acute Myocardial Infarction
15 (1.13%)
Cardiac Failure Congestive
15 (1.13%)
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Completed Suicide
15 (1.13%)
Fall
15 (1.13%)
Pneumonia Aspiration
14 (1.06%)
Respiratory Failure
14 (1.06%)
General Physical Health Deteriorati...
13 (.98%)
Lung Neoplasm Malignant
13 (.98%)
Cardio-respiratory Arrest
12 (.9%)
Pyrexia
12 (.9%)
Intestinal Obstruction
11 (.83%)
Acute Respiratory Failure
10 (.75%)
Leukopenia
10 (.75%)
Respiratory Arrest
10 (.75%)
Abnormal Behaviour
9 (.68%)
Arteriosclerosis Coronary Artery
9 (.68%)
Nausea
9 (.68%)
Pulmonary Embolism
9 (.68%)
Tachycardia
9 (.68%)
Weight Decreased
9 (.68%)
Agitation
8 (.6%)
Asphyxia
8 (.6%)
Drug Toxicity
8 (.6%)
Myocardial Ischaemia
8 (.6%)
Respiratory Distress
8 (.6%)
Sepsis
8 (.6%)
Accidental Death
7 (.53%)
Arrhythmia
7 (.53%)
Dementia
7 (.53%)
Diabetes Mellitus
7 (.53%)
Diarrhoea
7 (.53%)
Essential Hypertension
7 (.53%)
Head Injury
7 (.53%)
Oxygen Saturation Decreased
7 (.53%)
Unresponsive To Stimuli
7 (.53%)
Arteriosclerosis
6 (.45%)
Dyspnoea
6 (.45%)
Granulocytopenia
6 (.45%)
Influenza Like Illness
6 (.45%)
Lethargy
6 (.45%)
Loss Of Consciousness
6 (.45%)
Mental Status Changes
6 (.45%)
Sedation
6 (.45%)
Septic Shock
6 (.45%)
Sudden Death
6 (.45%)
Treatment Noncompliance
6 (.45%)
Anaemia
5 (.38%)
Cardiomegaly
5 (.38%)
Cough
5 (.38%)
Failure To Thrive
5 (.38%)
Lung Disorder
5 (.38%)
Mental Disorder
5 (.38%)
Neuroleptic Malignant Syndrome
5 (.38%)
Paranoia
5 (.38%)
Psychotic Disorder
5 (.38%)
Rash
5 (.38%)
Therapeutic Agent Toxicity
5 (.38%)
Acute Respiratory Distress Syndrome
4 (.3%)
Aspiration
4 (.3%)
Cardiac Disorder
4 (.3%)
Cerebrovascular Accident
4 (.3%)
Chest Pain
4 (.3%)
Condition Aggravated
4 (.3%)
Constipation
4 (.3%)
Dysphagia
4 (.3%)
Hyperlipidaemia
4 (.3%)
Malaise
4 (.3%)
Neoplasm Malignant
4 (.3%)
Overdose
4 (.3%)
Renal Failure Acute
4 (.3%)
Schizophrenia
4 (.3%)
Abdominal Distension
3 (.23%)
Accidental Poisoning
3 (.23%)
Aggression
3 (.23%)
Asthenia
3 (.23%)
Colitis
3 (.23%)
Depression
3 (.23%)
Disease Complication
3 (.23%)
Disease Progression
3 (.23%)
Drooling
3 (.23%)
Haematemesis
3 (.23%)
Headache
3 (.23%)
Hip Fracture
3 (.23%)
Hypertensive Heart Disease
3 (.23%)
Hypotension
3 (.23%)
Hypoxia
3 (.23%)
Intestinal Perforation
3 (.23%)
Metastases To Central Nervous Syste...
3 (.23%)
Metastasis
3 (.23%)
Multi-organ Failure
3 (.23%)
Myocarditis
3 (.23%)
Nervous System Disorder
3 (.23%)

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

What are the most common Fazaclo Odt adverse events reported to the FDA?

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

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

Schizophrenia
188
Schizoaffective Disorder
59
Schizophrenia, Paranoid Type
38
Bipolar Disorder
30
Psychotic Disorder
27
Dementia
22
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Drug Use For Unknown Indication
11
Product Used For Unknown Indication
9
Depression
5
Bipolar I Disorder
5
Agitation
4
Abnormal Behaviour
4
Aggression
4
Schizoaffective Disorder Bipolar Ty...
3
Delusion
3
Obsessive-compulsive Disorder
2
Affective Disorder
2
Borderline Personality Disorder
2
Attention Deficit/hyperactivity Dis...
2
Bipolar Ii Disorder
2
Senile Dementia
2
Mania
2
Paranoia
2
Dementia Alzheimers Type
2
Psychotic Behaviour
1
Intermittent Explosive Disorder
1
Catatonia
1
Cerebrovascular Accident
1
Suicidal Ideation
1
Major Depression
1
Schizophrenia, Residual Type
1
Schizophrenia, Catatonic Type
1
Suicide Attempt
1
Hallucination
1
Schizophrenia, Undifferentiated Typ...
1
Psychotic Disorder Due To A General...
1

Fazaclo Odt Case Reports

What Fazaclo Odt 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 Fazaclo Odt. 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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