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SAROTEN

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Saroten Adverse Events Reported to the FDA Over Time

How are Saroten adverse event reports trending over time?

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

Most Common Saroten Adverse Events Reported to the FDA

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

Drug Interaction
6 (3.35%)
Pulmonary Embolism
5 (2.79%)
Dysarthria
4 (2.23%)
Somnolence
4 (2.23%)
Suicide Attempt
4 (2.23%)
Tremor
4 (2.23%)
Agitation
3 (1.68%)
Anxiety
3 (1.68%)
Breast Pain
3 (1.68%)
Cardiac Failure
3 (1.68%)
Confusional State
3 (1.68%)
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Deep Vein Thrombosis
3 (1.68%)
Disorientation
3 (1.68%)
Encephalitis
3 (1.68%)
Gait Disturbance
3 (1.68%)
Galactorrhoea
3 (1.68%)
Hallucination
3 (1.68%)
Hyperprolactinaemia
3 (1.68%)
Hypertensive Crisis
3 (1.68%)
Hyponatraemia
3 (1.68%)
Hypotension
3 (1.68%)
Restlessness
3 (1.68%)
Serotonin Syndrome
3 (1.68%)
Stevens-johnson Syndrome
3 (1.68%)
Stupor
3 (1.68%)
Urinary Retention
3 (1.68%)
Alcohol Use
2 (1.12%)
Balance Disorder
2 (1.12%)
Body Temperature Increased
2 (1.12%)
Bradyphrenia
2 (1.12%)
Cognitive Disorder
2 (1.12%)
Constipation
2 (1.12%)
Delirium
2 (1.12%)
Drug Exposure During Pregnancy
2 (1.12%)
Dysphagia
2 (1.12%)
Foetal Growth Retardation
2 (1.12%)
Hyperreflexia
2 (1.12%)
Hypochloraemia
2 (1.12%)
Hypokinesia
2 (1.12%)
Intentional Overdose
2 (1.12%)
Leukocytosis
2 (1.12%)
Long Qt Syndrome
2 (1.12%)
Micturition Disorder
2 (1.12%)
Multiple Drug Overdose Intentional
2 (1.12%)
Neuromyopathy
2 (1.12%)
Overdose
2 (1.12%)
Pollakiuria
2 (1.12%)
Renal Failure Acute
2 (1.12%)
Restless Legs Syndrome
2 (1.12%)
Sedation
2 (1.12%)
Sopor
2 (1.12%)
Speech Disorder
2 (1.12%)
Tachycardia
2 (1.12%)
Toxic Epidermal Necrolysis
2 (1.12%)
Vomiting
2 (1.12%)
Aspiration
1 (.56%)
Blister
1 (.56%)
Bradyarrhythmia
1 (.56%)
Cerebrovascular Disorder
1 (.56%)
Coma
1 (.56%)
Delusion
1 (.56%)
Depressed Level Of Consciousness
1 (.56%)
Diarrhoea
1 (.56%)
Dizziness
1 (.56%)
Drug Abuse
1 (.56%)
Drug Effect Increased
1 (.56%)
Drug Toxicity
1 (.56%)
Dry Mouth
1 (.56%)
Electrocardiogram Qt Prolonged
1 (.56%)
Fatigue
1 (.56%)
Heart Rate Increased
1 (.56%)
Hypothermia
1 (.56%)
Ileus
1 (.56%)
Inappropriate Antidiuretic Hormone ...
1 (.56%)
Medication Error
1 (.56%)
Multi-organ Failure
1 (.56%)
Multiple Drug Overdose
1 (.56%)
Mydriasis
1 (.56%)
Myoclonus
1 (.56%)
Pain Of Skin
1 (.56%)
Personality Change
1 (.56%)
Pneumonia
1 (.56%)
Prothrombin Time Prolonged
1 (.56%)
Pulmonary Infarction
1 (.56%)
Sepsis
1 (.56%)
Suicidal Ideation
1 (.56%)
Suspiciousness
1 (.56%)
Systemic Lupus Erythematosus Rash
1 (.56%)
Systolic Hypertension
1 (.56%)

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

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

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

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

Depression
27
Pain
17
Drug Use For Unknown Indication
10
Product Used For Unknown Indication
7
Ill-defined Disorder
2
Neuralgia
2
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Anxiety
2
Prophylaxis
1
Drug Exposure During Pregnancy
1
Mental Disorder
1
Personality Disorder
1
Schizoaffective Disorder
1
Schizophrenia
1
Antidepressant Therapy
1
Restlessness
1
Fibromyalgia
1

Saroten Case Reports

What Saroten 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 Saroten. 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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