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BROMAZEPAM

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Bromazepam Adverse Events Reported to the FDA Over Time

How are Bromazepam adverse event reports trending over time?

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

Most Common Bromazepam Adverse Events Reported to the FDA

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

Suicide Attempt
86 (2.85%)
Coma
57 (1.89%)
Somnolence
55 (1.83%)
Intentional Overdose
51 (1.69%)
Multiple Drug Overdose Intentional
47 (1.56%)
Fall
46 (1.53%)
Loss Of Consciousness
44 (1.46%)
Overdose
42 (1.39%)
Confusional State
33 (1.1%)
Hypotension
31 (1.03%)
Multiple Drug Overdose
31 (1.03%)
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Hyponatraemia
26 (.86%)
Depression
25 (.83%)
Circulatory Collapse
24 (.8%)
Renal Failure Acute
24 (.8%)
Pyrexia
23 (.76%)
Vomiting
23 (.76%)
Bradycardia
22 (.73%)
Drug Toxicity
22 (.73%)
Rhabdomyolysis
22 (.73%)
Tremor
22 (.73%)
Completed Suicide
21 (.7%)
Drug Interaction
20 (.66%)
Renal Failure
20 (.66%)
Depressed Level Of Consciousness
19 (.63%)
Dizziness
19 (.63%)
Drug Exposure During Pregnancy
18 (.6%)
Drug Ineffective
18 (.6%)
Thrombocytopenia
18 (.6%)
Disseminated Intravascular Coagulat...
17 (.56%)
Condition Aggravated
16 (.53%)
Cytolytic Hepatitis
16 (.53%)
Malaise
16 (.53%)
Agitation
15 (.5%)
Altered State Of Consciousness
15 (.5%)
Anxiety
15 (.5%)
Leukocytosis
15 (.5%)
Disorientation
14 (.46%)
Insomnia
14 (.46%)
Serotonin Syndrome
14 (.46%)
Constipation
13 (.43%)
Headache
13 (.43%)
Hyperhidrosis
13 (.43%)
Hypokalaemia
13 (.43%)
Pneumonia Aspiration
13 (.43%)
Bradykinesia
12 (.4%)
Cardiac Arrest
12 (.4%)
Sopor
12 (.4%)
Toxic Skin Eruption
12 (.4%)
Aggression
11 (.37%)
General Physical Health Deteriorati...
11 (.37%)
Hypertension
11 (.37%)
Nausea
11 (.37%)
Neuroleptic Malignant Syndrome
11 (.37%)
Pruritus
11 (.37%)
Respiratory Failure
11 (.37%)
Septic Shock
11 (.37%)
Shock
11 (.37%)
Blood Creatine Phosphokinase Increa...
10 (.33%)
Death
10 (.33%)
Disturbance In Attention
10 (.33%)
Electrocardiogram Qt Prolonged
10 (.33%)
Feeling Abnormal
10 (.33%)
Maternal Drugs Affecting Foetus
10 (.33%)
Poisoning Deliberate
10 (.33%)
Pulmonary Embolism
10 (.33%)
Respiratory Depression
10 (.33%)
Arrhythmia
9 (.3%)
Arthralgia
9 (.3%)
Asthenia
9 (.3%)
Atrial Fibrillation
9 (.3%)
Gait Disturbance
9 (.3%)
Hypoxia
9 (.3%)
Mydriasis
9 (.3%)
Blood Alkaline Phosphatase Increase...
8 (.27%)
Blood Glucose Increased
8 (.27%)
Blood Pressure Decreased
8 (.27%)
Bradypnoea
8 (.27%)
Caesarean Section
8 (.27%)
Cardiac Failure
8 (.27%)
Cholestasis
8 (.27%)
Dyspnoea
8 (.27%)
Incorrect Dose Administered
8 (.27%)
Irritability
8 (.27%)
Metabolic Acidosis
8 (.27%)
Pain
8 (.27%)
Sinus Tachycardia
8 (.27%)
Syncope
8 (.27%)
Ventricular Arrhythmia
8 (.27%)
Acute Respiratory Distress Syndrome
7 (.23%)
Alcohol Use
7 (.23%)
Amnesia
7 (.23%)
Anaemia
7 (.23%)
Bradyphrenia
7 (.23%)
Cardiogenic Shock
7 (.23%)
Chest Pain
7 (.23%)
Dehydration
7 (.23%)
Drug Withdrawal Syndrome
7 (.23%)
Dysarthria
7 (.23%)
Fatigue
7 (.23%)
Gamma-glutamyltransferase Increased
7 (.23%)

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

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

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

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

Drug Use For Unknown Indication
304
Anxiety
236
Product Used For Unknown Indication
129
Depression
106
Insomnia
83
Sleep Disorder
41
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Suicide Attempt
18
Schizophrenia
18
Sedative Therapy
17
Ill-defined Disorder
14
Sleep Disorder Therapy
14
Intentional Overdose
14
Agitation
13
Anxiety Disorder
10
Prophylaxis
9
Anxiolytic Therapy
9
Nervousness
7
Drug Exposure During Pregnancy
7
Nausea
6
Muscle Relaxant Therapy
5
Depressed Mood
5
Panic Attack
5
Major Depression
4
Relaxation Therapy
3
Panic Disorder
3
Sedation
3
Neurosis
3
Hypertension
3
Convulsion
3
Self Injurious Behaviour
3
Restlessness
3
Stress
2
Epilepsy
2
Tension
2
Stress At Work
2
Asthenia
2
Premedication
2
Bipolar I Disorder
2
Intentional Self-injury
2
Frustration
2
Obsessive-compulsive Disorder
2
Blood Pressure
2
Irritable Bowel Syndrome
2
Overdose
2
Diabetes Mellitus
2
Emotional Disorder
2
Poisoning Deliberate
2
Cardiac Failure
2
Feeling Abnormal
2
Parkinsons Disease
2
Abdominal Pain
2

Bromazepam Case Reports

What Bromazepam 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 Bromazepam. 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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