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FLURAZEPAM

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Flurazepam Adverse Events Reported to the FDA Over Time

How are Flurazepam adverse event reports trending over time?

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

Most Common Flurazepam Adverse Events Reported to the FDA

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

Completed Suicide
69 (3.59%)
Suicide Attempt
68 (3.53%)
Confusional State
39 (2.03%)
Coma
38 (1.98%)
Overdose
37 (1.92%)
Intentional Overdose
36 (1.87%)
Drug Toxicity
33 (1.72%)
Hypotension
31 (1.61%)
Multiple Drug Overdose
30 (1.56%)
Multiple Drug Overdose Intentional
28 (1.46%)
Amnesia
25 (1.3%)
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Renal Failure Acute
25 (1.3%)
Depression
24 (1.25%)
Anxiety
22 (1.14%)
Cardiac Arrest
22 (1.14%)
Abnormal Dreams
21 (1.09%)
Hallucination
21 (1.09%)
Loss Of Consciousness
21 (1.09%)
Nervousness
21 (1.09%)
Suicidal Ideation
21 (1.09%)
Dehydration
19 (.99%)
Somnolence
19 (.99%)
Mood Altered
18 (.94%)
Tachycardia
18 (.94%)
Bradycardia
17 (.88%)
Drug Ineffective
16 (.83%)
Electrocardiogram Qt Prolonged
16 (.83%)
Miosis
14 (.73%)
Respiratory Arrest
13 (.68%)
Self Injurious Behaviour
13 (.68%)
Sopor
13 (.68%)
Cardio-respiratory Arrest
12 (.62%)
Electrocardiogram Abnormal
12 (.62%)
Fall
12 (.62%)
Serotonin Syndrome
12 (.62%)
Blood Glucose Increased
11 (.57%)
Blood Pressure Decreased
11 (.57%)
Haemodialysis
11 (.57%)
Incorrect Dose Administered
11 (.57%)
Anaemia
10 (.52%)
Aspiration Bronchial
10 (.52%)
Blood Creatinine Increased
10 (.52%)
Decreased Appetite
10 (.52%)
Depressed Level Of Consciousness
10 (.52%)
Diarrhoea
10 (.52%)
Haemoglobin Decreased
10 (.52%)
Pulmonary Oedema
10 (.52%)
Thrombocytopenia
10 (.52%)
Aggression
9 (.47%)
Blood Creatine Phosphokinase Increa...
9 (.47%)
Gastritis Haemorrhagic
9 (.47%)
Gun Shot Wound
9 (.47%)
Haematemesis
9 (.47%)
Hallucination, Visual
9 (.47%)
Impaired Driving Ability
9 (.47%)
Piriformis Syndrome
9 (.47%)
Sleep Talking
9 (.47%)
Somnambulism
9 (.47%)
Vomiting
9 (.47%)
Brain Oedema
8 (.42%)
Hypoxia
8 (.42%)
Intentional Drug Misuse
8 (.42%)
Malaise
8 (.42%)
Mental Disorder
8 (.42%)
Mental Status Changes
8 (.42%)
Oedema Peripheral
8 (.42%)
Pulmonary Embolism
8 (.42%)
Pupil Fixed
8 (.42%)
Alcohol Use
7 (.36%)
Drug Interaction
7 (.36%)
Gastric Ulcer
7 (.36%)
Headache
7 (.36%)
Metabolic Acidosis
7 (.36%)
Mydriasis
7 (.36%)
Myoclonus
7 (.36%)
Pitting Oedema
7 (.36%)
Sedation
7 (.36%)
Adrenal Haemorrhage
6 (.31%)
Agitation
6 (.31%)
Aspartate Aminotransferase Increase...
6 (.31%)
Blood Cholesterol Decreased
6 (.31%)
Blood Creatine Increased
6 (.31%)
Drug Abuser
6 (.31%)
Heart Rate Increased
6 (.31%)
Petechiae
6 (.31%)
Status Epilepticus
6 (.31%)
Stupor
6 (.31%)
Syncope
6 (.31%)
Tachypnoea
6 (.31%)
Abdominal Distension
5 (.26%)
Aspiration
5 (.26%)
Blood Bicarbonate Decreased
5 (.26%)
Blood Calcium Decreased
5 (.26%)
Blood Potassium Decreased
5 (.26%)
Body Temperature Decreased
5 (.26%)
Drug Screen Positive
5 (.26%)
Drug Withdrawal Syndrome
5 (.26%)
General Physical Health Deteriorati...
5 (.26%)
Head Injury
5 (.26%)
Hepatic Function Abnormal
5 (.26%)
Hyperhidrosis
5 (.26%)

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

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

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

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

Insomnia
123
Drug Use For Unknown Indication
97
Sleep Disorder
70
Product Used For Unknown Indication
30
Pain
22
Anxiety
12
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Suicide Attempt
10
Sleep Disorder Therapy
8
Schizophrenia
8
Ill-defined Disorder
8
Depression
7
Overdose
6
Psychotic Disorder
5
Medication Error
5
Bipolar Disorder
3
Intentional Overdose
3
Suicidal Behaviour
3
Analgesic Effect
3
Initial Insomnia
2
Drug Exposure During Pregnancy
2
Muscle Spasms
2
Hypnotherapy
2
Tremor
1
Bipolar Ii Disorder
1
Epilepsy
1
Drug Abuser
1
Mental Disorder
1
Therapeutic Agent Toxicity
1
Intentional Misuse
1
Obsessive-compulsive Disorder
1
Personality Disorder
1
Aggression
1
Affect Lability
1
Pain In Extremity
1
Schizophrenia, Paranoid Type
1
Impulse-control Disorder
1
Sedative Therapy
1
Self Injurious Behaviour
1
Somnolence
1
Sedation
1
Anxiety Disorder
1
Suicidal Ideation
1
Stress
1
Back Pain
1
Sleep Terror
1

Drug Labels

LabelLabelerEffective
FlurazepamBryant Ranch Prepack08-DEC-86
Flurazepam HydrochlorideMylan Pharmaceuticals Inc.06-MAY-10
Flurazepam HydrochloridePD-Rx Pharmaceuticals, Inc.06-MAY-10
Flurazepam HydrochloridePhysicians Total Care, Inc.03-SEP-10
FlurazepamWest-ward Pharmaceutical Corp02-DEC-10
FlurazepamRebel Distributors Corp28-DEC-10
FlurazepamGolden State Medical Supply, Inc.01-JUL-11
FlurazepamH.J. Harkins Company, Inc.06-DEC-11
FlurazepamPreferred Pharmaceuticals, Inc27-JAN-12
FlurazepamBryant Ranch Prepack23-OCT-12
FlurazepamA-S Medication Solutions LLC01-MAY-13

Flurazepam Case Reports

What Flurazepam 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 Flurazepam. 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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