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Fanapt Adverse Events Reported to the FDA Over Time

How are Fanapt adverse event reports trending over time?

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

Most Common Fanapt Adverse Events Reported to the FDA

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

Dizziness
62 (3.34%)
Weight Increased
41 (2.21%)
Dyspnoea
40 (2.16%)
Nausea
36 (1.94%)
Tachycardia
31 (1.67%)
Oedema Peripheral
30 (1.62%)
Orthostatic Hypotension
30 (1.62%)
Vomiting
30 (1.62%)
Insomnia
29 (1.56%)
Dry Mouth
24 (1.29%)
Death
22 (1.19%)
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Drug Ineffective
22 (1.19%)
Gait Disturbance
22 (1.19%)
Somnolence
21 (1.13%)
Anxiety
19 (1.02%)
Fall
19 (1.02%)
Feeling Abnormal
19 (1.02%)
Headache
19 (1.02%)
Priapism
19 (1.02%)
Syncope
19 (1.02%)
Heart Rate Increased
18 (.97%)
Urinary Incontinence
18 (.97%)
Hypotension
17 (.92%)
Loss Of Consciousness
17 (.92%)
Nasal Congestion
17 (.92%)
Palpitations
17 (.92%)
Retrograde Ejaculation
17 (.92%)
Sedation
17 (.92%)
Confusional State
16 (.86%)
Dyskinesia
16 (.86%)
Fatigue
16 (.86%)
Dysarthria
13 (.7%)
Enuresis
13 (.7%)
Malaise
13 (.7%)
Cognitive Disorder
12 (.65%)
Lethargy
12 (.65%)
Psychotic Disorder
12 (.65%)
Pulmonary Embolism
12 (.65%)
Arthralgia
11 (.59%)
Blood Pressure Increased
11 (.59%)
Chest Discomfort
11 (.59%)
Swollen Tongue
11 (.59%)
Tremor
11 (.59%)
Diarrhoea
10 (.54%)
Disturbance In Attention
10 (.54%)
Dystonia
10 (.54%)
Ejaculation Disorder
10 (.54%)
Hallucination
10 (.54%)
Hallucination, Auditory
10 (.54%)
Hypoaesthesia
10 (.54%)
Abnormal Behaviour
9 (.48%)
Blood Pressure Decreased
9 (.48%)
Convulsion
9 (.48%)
Erectile Dysfunction
9 (.48%)
Overdose
9 (.48%)
Sexual Dysfunction
9 (.48%)
Agitation
8 (.43%)
Chest Pain
8 (.43%)
Concomitant Disease Progression
8 (.43%)
Depression
8 (.43%)
Disorientation
8 (.43%)
Ejaculation Failure
8 (.43%)
Electrocardiogram Qt Prolonged
8 (.43%)
Extrapyramidal Disorder
8 (.43%)
Muscle Rigidity
8 (.43%)
Musculoskeletal Stiffness
8 (.43%)
Nightmare
8 (.43%)
Oxygen Saturation Decreased
8 (.43%)
Psychomotor Hyperactivity
8 (.43%)
Rash
8 (.43%)
Thinking Abnormal
8 (.43%)
Akathisia
7 (.38%)
Coma
7 (.38%)
Constipation
7 (.38%)
Hyperhidrosis
7 (.38%)
Obsessive-compulsive Disorder
7 (.38%)
Restlessness
7 (.38%)
Tardive Dyskinesia
7 (.38%)
Thrombocytopenia
7 (.38%)
Amnesia
6 (.32%)
Blood Prolactin Increased
6 (.32%)
Brain Death
6 (.32%)
Cardiac Arrest
6 (.32%)
Dry Eye
6 (.32%)
Dysphonia
6 (.32%)
Galactorrhoea
6 (.32%)
Hypersensitivity
6 (.32%)
Oedema
6 (.32%)
Pain In Extremity
6 (.32%)
Road Traffic Accident
6 (.32%)
Suicidal Ideation
6 (.32%)
Thirst
6 (.32%)
Vision Blurred
6 (.32%)
Weight Decreased
6 (.32%)
Wrong Technique In Drug Usage Proce...
6 (.32%)
Aggression
5 (.27%)
Anorgasmia
5 (.27%)
Asthenia
5 (.27%)
Balance Disorder
5 (.27%)
Cyanosis
5 (.27%)
Dehydration
5 (.27%)

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

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

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

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

Schizophrenia
131
Bipolar Disorder
45
Psychotic Disorder
21
Schizoaffective Disorder
19
Paranoia
7
Bipolar I Disorder
5
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Product Used For Unknown Indication
5
Depression
4
Affective Disorder
4
Schizoaffective Disorder Bipolar Ty...
4
Major Depression
2
Schizophrenia, Paranoid Type
2
Abnormal Behaviour
2
Anxiety
2
Mania
2
Bipolar Ii Disorder
1
Attention Deficit/hyperactivity Dis...
1
Mental Disorder
1
Psychotic Behaviour
1
Hallucination
1
Agitation
1
Personality Disorder
1
Mood Altered
1
Convulsion
1
Delusion
1
Cardiac Failure
1
Hallucination, Auditory
1

Drug Labels

LabelLabelerEffective
FanaptVanda Pharmaceuticals Inc.21-MAR-11
FanaptNovartis Pharmaceuticals Corporation31-JAN-13

Fanapt Case Reports

What Fanapt 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 Fanapt. 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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