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BENZODIAZEPINE

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Benzodiazepine Adverse Events Reported to the FDA Over Time

How are Benzodiazepine adverse event reports trending over time?

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

Most Common Benzodiazepine Adverse Events Reported to the FDA

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

Completed Suicide
534 (6.71%)
Multiple Drug Overdose
273 (3.43%)
Cardiac Arrest
263 (3.3%)
Respiratory Arrest
247 (3.1%)
Coma
204 (2.56%)
Cardio-respiratory Arrest
199 (2.5%)
Drug Toxicity
177 (2.22%)
Somnolence
156 (1.96%)
Intentional Drug Misuse
119 (1.49%)
Hypotension
118 (1.48%)
Poisoning
118 (1.48%)
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Death
110 (1.38%)
Depressed Level Of Consciousness
106 (1.33%)
Agitation
96 (1.21%)
Drug Screen Positive
93 (1.17%)
Overdose
92 (1.16%)
Drug Abuse
89 (1.12%)
Lethargy
89 (1.12%)
Suicide Attempt
88 (1.11%)
Heart Rate Increased
75 (.94%)
Aspartate Aminotransferase Increase...
74 (.93%)
Vomiting
72 (.9%)
Multiple Drug Overdose Intentional
68 (.85%)
Tachycardia
68 (.85%)
Loss Of Consciousness
67 (.84%)
Oxygen Saturation Decreased
66 (.83%)
Alanine Aminotransferase Increased
61 (.77%)
Confusional State
60 (.75%)
Drug Abuser
60 (.75%)
Blood Creatine Phosphokinase Increa...
59 (.74%)
Respiratory Depression
58 (.73%)
Unresponsive To Stimuli
58 (.73%)
Convulsion
57 (.72%)
Sinus Tachycardia
54 (.68%)
Body Temperature Increased
48 (.6%)
Aspiration
47 (.59%)
Blood Potassium Decreased
45 (.57%)
Miosis
45 (.57%)
Rhabdomyolysis
45 (.57%)
Blood Glucose Increased
42 (.53%)
Pneumonia Aspiration
42 (.53%)
Drug Withdrawal Syndrome
41 (.52%)
Electrocardiogram Qt Prolonged
40 (.5%)
Blood Creatinine Increased
39 (.49%)
Intentional Overdose
39 (.49%)
Blood Pressure Decreased
37 (.46%)
Hypoxia
37 (.46%)
Respiratory Rate Decreased
36 (.45%)
Apnoea
35 (.44%)
White Blood Cell Count Increased
34 (.43%)
Aggression
33 (.41%)
Blood Ph Decreased
30 (.38%)
Respiratory Rate Increased
30 (.38%)
Blood Pressure Increased
29 (.36%)
Acidosis
28 (.35%)
Bradycardia
28 (.35%)
Hypertension
27 (.34%)
Disorientation
26 (.33%)
Mental Status Changes
25 (.31%)
Mydriasis
24 (.3%)
Prothrombin Time Prolonged
24 (.3%)
Renal Failure Acute
24 (.3%)
Blood Pressure Systolic Increased
23 (.29%)
Dyspnoea
23 (.29%)
Liver Function Test Abnormal
23 (.29%)
Pupillary Reflex Impaired
23 (.29%)
Abnormal Behaviour
22 (.28%)
Blood Potassium Increased
22 (.28%)
Dysarthria
21 (.26%)
Restlessness
21 (.26%)
Substance Abuse
21 (.26%)
Blood Urea Increased
20 (.25%)
Drug Dependence
20 (.25%)
Headache
20 (.25%)
Medication Error
20 (.25%)
Pneumonia
20 (.25%)
Pyrexia
20 (.25%)
Renal Failure
20 (.25%)
Body Temperature Decreased
19 (.24%)
Respiratory Failure
19 (.24%)
Blood Calcium Decreased
18 (.23%)
Heart Rate Decreased
18 (.23%)
Poisoning Deliberate
18 (.23%)
Suicidal Ideation
18 (.23%)
Tremor
18 (.23%)
Alcohol Use
17 (.21%)
Depression
17 (.21%)
Drug Ineffective
17 (.21%)
Electrocardiogram Qrs Complex Prolo...
17 (.21%)
Areflexia
16 (.2%)
Fall
16 (.2%)
Hyperhidrosis
16 (.2%)
Nausea
16 (.2%)
Blood Creatine Phosphokinase Mb Inc...
15 (.19%)
Blood Pressure Diastolic Decreased
15 (.19%)
Hypokalaemia
15 (.19%)
Myocardial Infarction
15 (.19%)
Pco2 Increased
15 (.19%)
Blood Alkaline Phosphatase Increase...
14 (.18%)
Blood Bicarbonate Decreased
14 (.18%)
Cyanosis
14 (.18%)

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

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

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

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

Drug Use For Unknown Indication
588
Product Used For Unknown Indication
284
Suicide Attempt
63
Ill-defined Disorder
25
Intentional Drug Misuse
19
Sedation
12
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Anxiety
12
Pain
11
Drug Abuse
9
Completed Suicide
9
Drug Abuser
8
Depression
8
Antidepressant Therapy
7
Psychotic Disorder
6
Sleep Disorder
6
Schizophrenia, Paranoid Type
5
Intentional Overdose
5
Bipolar Disorder
5
Status Epilepticus
4
Accidental Exposure
3
Panic Disorder
3
Nervousness
3
Dystonia
3
Premedication
3
Compulsions
2
Belligerence
2
Back Pain
2
Agitation
2
Brief Psychotic Disorder With Marke...
2
Alcohol Withdrawal Syndrome
2
Drug Dependence
2
Delusion
2
Schizophrenia
2
Multiple Drug Overdose
2
Major Depression
1
Life Support
1
Crush Injury
1
Mental Disorder
1
Endotracheal Intubation
1
Epilepsy
1
Unevaluable Event
1
Substance Use
1
Intentional Misuse
1
Arthritis
1
Anorexia Nervosa
1
Drug Administration Error
1
Neurosis
1
Convulsion
1
Rib Fracture
1
Wrong Drug Administered
1
Injury
1

Benzodiazepine Case Reports

What Benzodiazepine 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 Benzodiazepine. 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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