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THERALENE

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Theralene Adverse Events Reported to the FDA Over Time

How are Theralene adverse event reports trending over time?

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

Most Common Theralene Adverse Events Reported to the FDA

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

Fall
17 (2.29%)
Drug Interaction
14 (1.89%)
Somnolence
13 (1.75%)
Coma
11 (1.48%)
Drug Exposure During Pregnancy
11 (1.48%)
Malaise
11 (1.48%)
Pyrexia
11 (1.48%)
Agitation
10 (1.35%)
Extrapyramidal Disorder
10 (1.35%)
Confusional State
9 (1.21%)
Drug Toxicity
9 (1.21%)
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Hypotension
9 (1.21%)
Tachycardia
9 (1.21%)
Dyskinesia
8 (1.08%)
Intentional Overdose
8 (1.08%)
Intra-uterine Death
8 (1.08%)
Suicide Attempt
8 (1.08%)
Cardio-respiratory Arrest
7 (.94%)
Cholestasis
7 (.94%)
General Physical Health Deteriorati...
7 (.94%)
Insomnia
7 (.94%)
Vomiting
7 (.94%)
Anxiety
6 (.81%)
Cytolytic Hepatitis
6 (.81%)
Hellp Syndrome
6 (.81%)
Hypothermia
6 (.81%)
Loss Of Consciousness
6 (.81%)
Neutropenia
6 (.81%)
Oxygen Saturation Decreased
6 (.81%)
Rhabdomyolysis
6 (.81%)
Sepsis
6 (.81%)
Altered State Of Consciousness
5 (.67%)
Asthenia
5 (.67%)
Blood Pressure Increased
5 (.67%)
Dysarthria
5 (.67%)
Factor V Deficiency
5 (.67%)
Fatigue
5 (.67%)
Hyponatraemia
5 (.67%)
Ileus Paralytic
5 (.67%)
Intestinal Obstruction
5 (.67%)
Leukopenia
5 (.67%)
Multiple Drug Overdose Intentional
5 (.67%)
Pancytopenia
5 (.67%)
Prothrombin Level Decreased
5 (.67%)
Thrombocytopenia
5 (.67%)
Visual Acuity Reduced
5 (.67%)
Abnormal Behaviour
4 (.54%)
Agranulocytosis
4 (.54%)
Antipsychotic Drug Level Above Ther...
4 (.54%)
Convulsion
4 (.54%)
Death
4 (.54%)
Delirium
4 (.54%)
Electrocardiogram Qt Prolonged
4 (.54%)
Foetal Distress Syndrome
4 (.54%)
Hepatitis Cholestatic
4 (.54%)
Neuroleptic Malignant Syndrome
4 (.54%)
Overdose
4 (.54%)
Pulmonary Embolism
4 (.54%)
Sleep Disorder
4 (.54%)
Sudden Death
4 (.54%)
Abdominal Abscess
3 (.4%)
Alcohol Use
3 (.4%)
Anaemia
3 (.4%)
Arrhythmia
3 (.4%)
Bone Marrow Failure
3 (.4%)
Constipation
3 (.4%)
Depressed Level Of Consciousness
3 (.4%)
Drug Level Increased
3 (.4%)
Dyspnoea
3 (.4%)
Gastrointestinal Obstruction
3 (.4%)
Headache
3 (.4%)
Hepatic Function Abnormal
3 (.4%)
Hyperbilirubinaemia
3 (.4%)
Hypotonia
3 (.4%)
Inflammation
3 (.4%)
Irritability
3 (.4%)
Leukocytoclastic Vasculitis
3 (.4%)
Lymphopenia
3 (.4%)
Myocardial Ischaemia
3 (.4%)
Nervousness
3 (.4%)
Pericarditis
3 (.4%)
Pulmonary Oedema
3 (.4%)
Renal Disorder
3 (.4%)
Renal Failure
3 (.4%)
Respiratory Depression
3 (.4%)
Weight Decreased
3 (.4%)
Abdominal Pain
2 (.27%)
Abortion Induced
2 (.27%)
Aggression
2 (.27%)
Alanine Aminotransferase Increased
2 (.27%)
Anuria
2 (.27%)
Aspartate Aminotransferase Increase...
2 (.27%)
Atrioventricular Block First Degree
2 (.27%)
Blood Creatine Phosphokinase Increa...
2 (.27%)
Blood Pressure Fluctuation
2 (.27%)
Bradycardia
2 (.27%)
Cardiac Failure
2 (.27%)
Cardiac Failure Acute
2 (.27%)
Catheter Related Infection
2 (.27%)
Condition Aggravated
2 (.27%)
Creatinine Renal Clearance Decrease...
2 (.27%)

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

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

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

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

Drug Use For Unknown Indication
58
Insomnia
32
Sleep Disorder
11
Bipolar I Disorder
8
Depression
6
Product Used For Unknown Indication
6
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Psychotic Disorder
6
Schizophrenia
4
Major Depression
4
Agitation
4
Anxiety
4
Suicide Attempt
2
Dysthymic Disorder
2
Bipolar Disorder
2
Epilepsy
2
Rheumatoid Arthritis
2
Overdose
2
Psychiatric Symptom
2
Mental Disorder
1
Abnormal Behaviour
1
Schizophrenia, Disorganised Type
1
Ill-defined Disorder
1
Autism
1
Sedative Therapy
1
Paranoia
1
Delusional Disorder, Persecutory Ty...
1
Delirium
1

Theralene Case Reports

What Theralene 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 Theralene. 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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