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FLUNITRAZEPAM

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Flunitrazepam Adverse Events Reported to the FDA Over Time

How are Flunitrazepam adverse event reports trending over time?

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

Most Common Flunitrazepam Adverse Events Reported to the FDA

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

Rhabdomyolysis
57 (2.97%)
Overdose
46 (2.4%)
Suicide Attempt
45 (2.35%)
Somnolence
33 (1.72%)
Renal Failure Acute
32 (1.67%)
Drug Toxicity
30 (1.56%)
Loss Of Consciousness
29 (1.51%)
Drug Interaction
27 (1.41%)
Depressed Level Of Consciousness
26 (1.36%)
Coma
23 (1.2%)
Multiple Drug Overdose Intentional
23 (1.2%)
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Hepatic Function Abnormal
18 (.94%)
Pyrexia
18 (.94%)
Urine Colour Abnormal
18 (.94%)
Death
17 (.89%)
Intentional Overdose
17 (.89%)
Multiple Drug Overdose
17 (.89%)
Aspartate Aminotransferase Increase...
16 (.83%)
Completed Suicide
16 (.83%)
Convulsion
16 (.83%)
Delirium
16 (.83%)
Insomnia
16 (.83%)
Neuroleptic Malignant Syndrome
16 (.83%)
Gait Disturbance
15 (.78%)
Vomiting
15 (.78%)
Alanine Aminotransferase Increased
13 (.68%)
Aspiration
13 (.68%)
Confusional State
13 (.68%)
Fall
13 (.68%)
Dizziness
12 (.63%)
Drug Exposure During Pregnancy
12 (.63%)
Gamma-glutamyltransferase Increased
12 (.63%)
Platelet Count Decreased
11 (.57%)
Restlessness
11 (.57%)
Tremor
11 (.57%)
Brain Oedema
10 (.52%)
Dehydration
10 (.52%)
Electrocardiogram Qt Prolonged
10 (.52%)
Hallucination
10 (.52%)
Pneumonia Aspiration
10 (.52%)
Pulmonary Embolism
10 (.52%)
Septic Shock
10 (.52%)
Stevens-johnson Syndrome
10 (.52%)
White Blood Cell Count Decreased
10 (.52%)
Anaemia
9 (.47%)
Cardio-respiratory Arrest
9 (.47%)
Drug Abuse
9 (.47%)
Drug Ineffective
9 (.47%)
Drug Withdrawal Syndrome Neonatal
9 (.47%)
Liver Disorder
9 (.47%)
Pulmonary Oedema
9 (.47%)
Shock
9 (.47%)
Tachycardia
9 (.47%)
Altered State Of Consciousness
8 (.42%)
Cardiac Arrest
8 (.42%)
Cardiac Failure
8 (.42%)
Condition Aggravated
8 (.42%)
Dialysis
8 (.42%)
Irritability
8 (.42%)
Malaise
8 (.42%)
Respiratory Depression
8 (.42%)
Sudden Death
8 (.42%)
Ventricular Tachycardia
8 (.42%)
Anxiety
7 (.37%)
Cardiovascular Insufficiency
7 (.37%)
Drug Abuser
7 (.37%)
Haemoglobin Decreased
7 (.37%)
Hypertension
7 (.37%)
Nystagmus
7 (.37%)
Pain
7 (.37%)
Pulmonary Congestion
7 (.37%)
Renal Impairment
7 (.37%)
Respiratory Failure
7 (.37%)
Asthenia
6 (.31%)
Blood Cholesterol Decreased
6 (.31%)
Depression
6 (.31%)
Diabetes Mellitus
6 (.31%)
Drug Level Increased
6 (.31%)
Electrocardiogram Qrs Complex Prolo...
6 (.31%)
Erythema Multiforme
6 (.31%)
Hypoglycaemia
6 (.31%)
Pneumonia
6 (.31%)
Schizophrenia
6 (.31%)
Sepsis
6 (.31%)
Tachypnoea
6 (.31%)
Agitation
5 (.26%)
Blood Creatine Phosphokinase Increa...
5 (.26%)
Blood Creatinine Increased
5 (.26%)
Caesarean Section
5 (.26%)
Cellulitis
5 (.26%)
Fatigue
5 (.26%)
Femoral Neck Fracture
5 (.26%)
Hypertriglyceridaemia
5 (.26%)
Hyponatraemia
5 (.26%)
Nausea
5 (.26%)
Pancytopenia
5 (.26%)
Poisoning
5 (.26%)
Psychiatric Symptom
5 (.26%)
White Blood Cell Count Increased
5 (.26%)
Acute Hepatic Failure
4 (.21%)
Agranulocytosis
4 (.21%)

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

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

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

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

Insomnia
253
Drug Use For Unknown Indication
116
Depression
67
Schizophrenia
63
Product Used For Unknown Indication
48
Ill-defined Disorder
31
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Sleep Disorder
15
Schizophrenia, Paranoid Type
12
Sleep Disorder Therapy
11
Drug Dependence
7
Panic Disorder
7
Dysthymic Disorder
6
Suicide Attempt
6
Schizophrenia, Disorganised Type
6
Drug Withdrawal Syndrome
5
Anxiety
5
Anxiety Disorder
4
Adjustment Disorder
4
Schizophrenia, Undifferentiated Typ...
3
Intentional Overdose
3
Major Depression
3
Bipolar I Disorder
3
Sedation
3
Drug Abuse
3
Head Injury
2
Polysubstance Dependence
2
Feeling Abnormal
2
Overdose
2
Self Injurious Behaviour
2
Skin Test Positive
2
Frustration
2
Somatoform Disorder
2
Aplastic Anaemia
2
Premedication
2
Mental Disorder
2
Pain
2
Personality Disorder
2
Prophylaxis
2
Agitation
2
Hallucination
2
Bipolar Disorder
2
Mania
1
Drug Abuser
1
Unevaluable Event
1
Drug Exposure Via Breast Milk
1
Cervix Carcinoma
1
Drug Exposure During Pregnancy
1
Dissociative Amnesia
1
Gastritis Prophylaxis
1
Psychiatric Symptom
1
Anger
1

Flunitrazepam Case Reports

What Flunitrazepam 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 Flunitrazepam. 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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