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Tranxene Adverse Events Reported to the FDA Over Time

How are Tranxene adverse event reports trending over time?

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

Most Common Tranxene Adverse Events Reported to the FDA

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

Somnolence
51 (1.81%)
Coma
47 (1.67%)
Suicide Attempt
47 (1.67%)
Drug Exposure During Pregnancy
39 (1.39%)
Fall
36 (1.28%)
Hypotension
29 (1.03%)
Convulsion
27 (.96%)
Dizziness
26 (.92%)
Renal Failure Acute
26 (.92%)
Overdose
25 (.89%)
Drug Ineffective
24 (.85%)
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Confusional State
23 (.82%)
Malaise
22 (.78%)
Nausea
22 (.78%)
Anaemia
21 (.75%)
Asthenia
20 (.71%)
Bradycardia
19 (.68%)
Drug Interaction
19 (.68%)
Tachycardia
19 (.68%)
Agitation
18 (.64%)
Alanine Aminotransferase Increased
18 (.64%)
Anxiety
18 (.64%)
Colitis Ischaemic
18 (.64%)
Multiple Drug Overdose
18 (.64%)
Pyrexia
18 (.64%)
Thrombocytopenia
18 (.64%)
Aspartate Aminotransferase Increase...
17 (.6%)
Depressed Level Of Consciousness
17 (.6%)
Condition Aggravated
16 (.57%)
Disorientation
16 (.57%)
Gait Disturbance
16 (.57%)
Headache
16 (.57%)
Heart Rate Increased
16 (.57%)
Intentional Overdose
16 (.57%)
Diarrhoea
15 (.53%)
Premature Baby
15 (.53%)
Sepsis
14 (.5%)
Completed Suicide
13 (.46%)
Haemodialysis
13 (.46%)
Hepatitis Cholestatic
13 (.46%)
Abnormal Behaviour
12 (.43%)
Gastric Ulcer
12 (.43%)
General Physical Health Deteriorati...
12 (.43%)
Hypoxia
12 (.43%)
Interstitial Lung Disease
12 (.43%)
Lung Disorder
12 (.43%)
Metabolic Acidosis
12 (.43%)
Pain In Extremity
12 (.43%)
Renal Failure
12 (.43%)
Respiratory Distress
12 (.43%)
Serotonin Syndrome
12 (.43%)
Cardio-respiratory Arrest
11 (.39%)
Drug Toxicity
11 (.39%)
Dyspnoea
11 (.39%)
Hepatic Encephalopathy
11 (.39%)
Hypertension
11 (.39%)
Oedema Peripheral
11 (.39%)
Pancreatitis
11 (.39%)
Rhabdomyolysis
11 (.39%)
Death
10 (.36%)
Gastritis Haemorrhagic
10 (.36%)
Infection
10 (.36%)
Miosis
10 (.36%)
Pancytopenia
10 (.36%)
Abdominal Distension
9 (.32%)
Abdominal Pain
9 (.32%)
Blood Pressure Increased
9 (.32%)
Dehydration
9 (.32%)
Disturbance In Attention
9 (.32%)
Foetal Growth Retardation
9 (.32%)
Gamma-glutamyltransferase Increased
9 (.32%)
Pregnancy
9 (.32%)
Pruritus
9 (.32%)
Tachypnoea
9 (.32%)
Tremor
9 (.32%)
Blood Pressure Decreased
8 (.28%)
Electrocardiogram Qt Prolonged
8 (.28%)
Feeling Cold
8 (.28%)
Flushing
8 (.28%)
Haematemesis
8 (.28%)
Hyperkalaemia
8 (.28%)
Inflammation
8 (.28%)
Insomnia
8 (.28%)
Loss Of Consciousness
8 (.28%)
Myoclonus
8 (.28%)
Pancreatitis Acute
8 (.28%)
Thrombotic Microangiopathy
8 (.28%)
Toxic Epidermal Necrolysis
8 (.28%)
Visual Field Defect
8 (.28%)
Weight Decreased
8 (.28%)
Blood Amylase Increased
7 (.25%)
Blood Creatinine Increased
7 (.25%)
Cholestasis
7 (.25%)
Drug Abuser
7 (.25%)
Dysphagia
7 (.25%)
Hyponatraemia
7 (.25%)
Intestinal Ischaemia
7 (.25%)
Intestinal Obstruction
7 (.25%)
Jaundice Neonatal
7 (.25%)
Lipase Increased
7 (.25%)
Partial Seizures
7 (.25%)

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

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

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

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

Anxiety
276
Drug Use For Unknown Indication
183
Product Used For Unknown Indication
85
Depression
74
Insomnia
38
Ill-defined Disorder
38
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Epilepsy
31
Convulsion
25
Bipolar Disorder
17
Agitation
16
Sedation
13
Anxiolytic Therapy
12
Sleep Disorder
11
Panic Disorder
10
Panic Attack
10
Nervousness
9
Suicide Attempt
9
Alcohol Withdrawal Syndrome
8
Bone Disorder
8
Psychotic Disorder
7
Schizophrenia
7
Prophylaxis
7
Abnormal Behaviour
6
Anxiety Disorder
5
Tremor
5
Premedication
5
Mental Disorder
4
Muscle Spasms
4
Brief Psychotic Disorder With Marke...
4
Sleep Apnoea Syndrome
4
Drug Exposure During Pregnancy
4
Sinus Disorder
3
Prophylaxis Of Nausea And Vomiting
3
Intentional Overdose
3
Sleep Disorder Therapy
3
Initial Insomnia
3
Unevaluable Event
3
Partial Seizures
3
Weight Loss Diet
3
Dementia
3
Restlessness
2
Back Pain
2
Delirium
2
Drug Withdrawal Syndrome
2
Feeling Of Relaxation
2
Neuroleptic Malignant Syndrome
2
Blood Pressure
2
Vomiting
2
Cerebrovascular Accident
2
Generalised Anxiety Disorder
2
Convulsion Prophylaxis
2

Drug Labels

LabelLabelerEffective
Tranxenet-tabLundbeck Inc.25-JUN-10

Tranxene Case Reports

What Tranxene 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 Tranxene. 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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