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TEMESTA

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Temesta Adverse Events Reported to the FDA Over Time

How are Temesta adverse event reports trending over time?

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

Most Common Temesta Adverse Events Reported to the FDA

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

Fall
68 (2.94%)
Confusional State
46 (1.99%)
Somnolence
37 (1.6%)
Suicide Attempt
32 (1.38%)
Disorientation
31 (1.34%)
Drug Interaction
31 (1.34%)
Condition Aggravated
29 (1.25%)
Drug Exposure During Pregnancy
29 (1.25%)
Drug Withdrawal Syndrome
27 (1.17%)
Fatigue
27 (1.17%)
Intentional Overdose
25 (1.08%)
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Malaise
25 (1.08%)
Anxiety
23 (.99%)
Hyponatraemia
23 (.99%)
Amnesia
20 (.87%)
Loss Of Consciousness
20 (.87%)
Completed Suicide
19 (.82%)
Dyskinesia
18 (.78%)
Orthostatic Hypotension
18 (.78%)
Suicidal Ideation
18 (.78%)
Vertigo
18 (.78%)
Agitation
17 (.74%)
Coma
17 (.74%)
Renal Failure
17 (.74%)
Sedation
17 (.74%)
Asthenia
16 (.69%)
Tachycardia
16 (.69%)
Delirium
14 (.61%)
Hallucination
14 (.61%)
Hypotension
14 (.61%)
Depressed Level Of Consciousness
13 (.56%)
Dizziness
13 (.56%)
Dysstasia
13 (.56%)
Hypersomnia
13 (.56%)
Insomnia
13 (.56%)
Muscular Weakness
13 (.56%)
Pyrexia
13 (.56%)
Sleep Disorder
13 (.56%)
Aspartate Aminotransferase Increase...
12 (.52%)
Cardiac Arrest
12 (.52%)
Dyspnoea
12 (.52%)
Hallucination, Visual
12 (.52%)
Presyncope
12 (.52%)
Syncope
12 (.52%)
Alanine Aminotransferase Increased
11 (.48%)
Dehydration
11 (.48%)
Drug Level Increased
11 (.48%)
Epilepsy
11 (.48%)
Extrapyramidal Disorder
11 (.48%)
Pulmonary Embolism
11 (.48%)
Rhabdomyolysis
11 (.48%)
Speech Disorder
11 (.48%)
Tongue Disorder
11 (.48%)
Vomiting
11 (.48%)
Gait Disturbance
10 (.43%)
Mydriasis
10 (.43%)
Restlessness
10 (.43%)
Blood Creatinine Increased
9 (.39%)
Crying
9 (.39%)
Disturbance In Attention
9 (.39%)
Foetal Growth Retardation
9 (.39%)
Paraesthesia
9 (.39%)
Abnormal Behaviour
8 (.35%)
Cardiac Failure
8 (.35%)
Drug Ineffective
8 (.35%)
Hyperreflexia
8 (.35%)
Miosis
8 (.35%)
Multiple Drug Overdose Intentional
8 (.35%)
Myoclonus
8 (.35%)
Overdose
8 (.35%)
Ventricular Extrasystoles
8 (.35%)
Agranulocytosis
7 (.3%)
Alcohol Use
7 (.3%)
Alopecia
7 (.3%)
Blood Alkaline Phosphatase Increase...
7 (.3%)
Cholestasis
7 (.3%)
Encephalopathy
7 (.3%)
Hair Texture Abnormal
7 (.3%)
Headache
7 (.3%)
Multiple Drug Overdose
7 (.3%)
Musculoskeletal Chest Pain
7 (.3%)
Nausea
7 (.3%)
Septic Shock
7 (.3%)
Thrombocytopenia
7 (.3%)
Aggression
6 (.26%)
Anaemia
6 (.26%)
Apnoea
6 (.26%)
Bladder Tamponade
6 (.26%)
Blood Creatine Phosphokinase Increa...
6 (.26%)
Cerebral Atrophy
6 (.26%)
Coordination Abnormal
6 (.26%)
Decreased Appetite
6 (.26%)
Dysarthria
6 (.26%)
Gamma-glutamyltransferase Increased
6 (.26%)
Head Injury
6 (.26%)
Hepatitis Cholestatic
6 (.26%)
Hypoxia
6 (.26%)
International Normalised Ratio Incr...
6 (.26%)
Leukocytosis
6 (.26%)
Oxygen Saturation Decreased
6 (.26%)
Peripheral Ischaemia
6 (.26%)

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

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

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

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

Drug Use For Unknown Indication
152
Anxiety
113
Insomnia
45
Depression
38
Product Used For Unknown Indication
36
Sleep Disorder
18
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Anxiety Disorder
17
Agitation
11
Bipolar Disorder
11
Restlessness
9
Bipolar I Disorder
9
Psychotic Disorder
7
Unevaluable Event
6
Mental Disorder
5
Ill-defined Disorder
5
Anxiolytic Therapy
4
Aggression
4
Nausea
4
Simple Partial Seizures
2
Schizophrenia, Paranoid Type
2
Schizophrenia
2
Schizophrenia, Undifferentiated Typ...
2
Mania
2
Sedative Therapy
2
Tension
2
Drug Exposure During Pregnancy
2
Sedation
2
Personality Change
2
Panic Attack
2
Affective Disorder
2
Suicide Attempt
1
Conduct Disorder
1
Schizoaffective Disorder
1
Confusional State
1
Somnolence
1
Antisocial Behaviour
1
Neurosis
1
Prophylaxis Of Nausea And Vomiting
1
Computerised Tomogram
1
Epilepsy
1
Hypertension
1
Suicidal Ideation
1
Catatonia
1
Acute Psychosis
1
Initial Insomnia
1
Dyspnoea
1
Obsessive-compulsive Disorder
1
Personality Disorder
1
Hyperventilation
1
Prophylaxis
1
Convulsion
1

Temesta Case Reports

What Temesta 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 Temesta. 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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