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DIAZEPAM

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Diazepam Adverse Events Reported to the FDA Over Time

How are Diazepam adverse event reports trending over time?

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

Most Common Diazepam Adverse Events Reported to the FDA

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

Completed Suicide
1134 (3.93%)
Cardiac Arrest
866 (3%)
Respiratory Arrest
805 (2.79%)
Drug Toxicity
549 (1.9%)
Overdose
486 (1.69%)
Cardio-respiratory Arrest
445 (1.54%)
Drug Abuse
407 (1.41%)
Death
391 (1.36%)
Multiple Drug Overdose
323 (1.12%)
Drug Interaction
313 (1.09%)
Suicide Attempt
311 (1.08%)
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Somnolence
276 (.96%)
Hypotension
258 (.89%)
Poisoning
242 (.84%)
Confusional State
226 (.78%)
Intentional Overdose
223 (.77%)
Loss Of Consciousness
216 (.75%)
Multiple Drug Overdose Intentional
216 (.75%)
Drug Ineffective
208 (.72%)
Anxiety
203 (.7%)
Intentional Drug Misuse
192 (.67%)
Malaise
187 (.65%)
Convulsion
183 (.63%)
Respiratory Depression
179 (.62%)
Vomiting
178 (.62%)
Dizziness
173 (.6%)
Depression
170 (.59%)
Insomnia
170 (.59%)
Pyrexia
168 (.58%)
Coma
165 (.57%)
Drug Exposure During Pregnancy
155 (.54%)
Tachycardia
154 (.53%)
Fatigue
153 (.53%)
Suicidal Ideation
151 (.52%)
Fall
149 (.52%)
Aggression
133 (.46%)
Tremor
133 (.46%)
Agitation
132 (.46%)
Serotonin Syndrome
132 (.46%)
Nystagmus
130 (.45%)
Nausea
129 (.45%)
Pain
125 (.43%)
Urinary Tract Infection
122 (.42%)
Pulmonary Oedema
119 (.41%)
Hyperhidrosis
113 (.39%)
Asthenia
111 (.39%)
Drug Dependence
109 (.38%)
Dyspnoea
106 (.37%)
Accidental Overdose
105 (.36%)
Neuroleptic Malignant Syndrome
104 (.36%)
Sedation
101 (.35%)
Depressed Level Of Consciousness
100 (.35%)
Developmental Delay
100 (.35%)
Weight Decreased
100 (.35%)
Syncope
99 (.34%)
Hypertension
98 (.34%)
Sinus Tachycardia
98 (.34%)
Visual Acuity Reduced
98 (.34%)
Constipation
97 (.34%)
White Blood Cell Count Increased
96 (.33%)
Headache
95 (.33%)
Hallucination
94 (.33%)
Diarrhoea
93 (.32%)
Drug Withdrawal Syndrome
93 (.32%)
Decreased Appetite
91 (.32%)
Congenital Nystagmus
89 (.31%)
Diabetes Mellitus
85 (.29%)
Aspiration
83 (.29%)
Electrocardiogram Qt Prolonged
83 (.29%)
Strabismus
82 (.28%)
Condition Aggravated
80 (.28%)
Abnormal Behaviour
79 (.27%)
Drug Abuser
78 (.27%)
Feeling Abnormal
78 (.27%)
Delirium
77 (.27%)
Pneumonia
77 (.27%)
Disorientation
76 (.26%)
Unresponsive To Stimuli
74 (.26%)
Panic Attack
72 (.25%)
Psychotic Disorder
72 (.25%)
Lethargy
71 (.25%)
Metabolic Acidosis
71 (.25%)
Memory Impairment
70 (.24%)
Myalgia
68 (.24%)
Pulmonary Congestion
68 (.24%)
Staphylococcal Infection
67 (.23%)
Blood Pressure Decreased
66 (.23%)
Dysarthria
64 (.22%)
Encephalopathy
64 (.22%)
Cardiac Murmur
63 (.22%)
Heart Rate Increased
62 (.22%)
Hypoxia
62 (.22%)
Neutrophil Count Increased
62 (.22%)
Grand Mal Convulsion
61 (.21%)
Anaemia
60 (.21%)
Circulatory Collapse
60 (.21%)
Mental Status Changes
60 (.21%)
Substance Abuse
60 (.21%)
Brain Oedema
59 (.2%)
Abdominal Tenderness
58 (.2%)
Hiatus Hernia
58 (.2%)

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

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

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

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

Drug Use For Unknown Indication
1865
Product Used For Unknown Indication
1636
Anxiety
1384
Insomnia
289
Muscle Spasms
279
Depression
264
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Agitation
193
Convulsion
172
Pain
157
Sleep Disorder
144
Epilepsy
123
Sedation
116
Ill-defined Disorder
80
Schizophrenia
77
Nervousness
73
Back Pain
69
Suicide Attempt
62
Panic Attack
51
Muscle Relaxant Therapy
47
Premedication
46
Status Epilepticus
45
Anxiety Disorder
44
Drug Exposure During Pregnancy
44
Drug Dependence
43
Bipolar Disorder
39
Overdose
38
Stress
36
Sedative Therapy
36
Grand Mal Convulsion
36
Prophylaxis
35
Psychotic Disorder
34
Restlessness
31
Tremor
31
Mental Disorder
30
Schizophrenia, Paranoid Type
29
Nervous System Disorder
29
Anxiolytic Therapy
26
Dizziness
25
Panic Disorder
24
Sleep Disorder Therapy
23
Intentional Overdose
21
Cerebral Disorder
21
Menieres Disease
19
Headache
19
Foetal Exposure During Pregnancy
18
Muscle Disorder
17
Muscle Spasticity
17
Major Depression
16
Vertigo
16
Post-traumatic Stress Disorder
16
Dependence
15

Drug Labels

LabelLabelerEffective
DiazepamAtlantic Biologicals Corps03-APR-87
DiazepamUDL Laboratories, Inc.27-FEB-09
DiazepamAmerican Health Packaging13-OCT-09
DiazepamMylan Pharmaceuticals Inc.18-NOV-09
DiazepamPD-Rx Pharmaceuticals, Inc.01-JAN-10
DiazepamSTAT RX USA LLC22-FEB-10
DiazepamMcKesson Packaging Services Business Unit of McKesson Corporation02-MAR-10
DiazepamApotheca, Inc.15-MAR-10
ValiumPD-Rx Pharmaceuticals, Inc.02-APR-10
ValiumRoche Products Inc02-APR-10
DiazepamRebel Distributors Corp.15-SEP-10
DiazepamRedPharm Drug Inc.02-DEC-10
DiazepamRebel Distributors Corp20-DEC-10
DiazepamCardinal Health15-FEB-11
Diazepam General Injectables and Vaccines, Inc.26-APR-11
ValiumCardinal Health26-APR-11
DiazepamHospira, Inc.16-MAY-11
DiazepamUnit Dose Services06-JUN-11
DiazepamBlenheim Pharmacal, Inc.09-JUN-11
DiazepamContract Pharmacy Services-PA01-AUG-11
DiazepamPreferred Pharmaceuticals, Inc08-NOV-11
DiazepamPreferred Pharmaceuticals, Inc08-NOV-11
DiazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLC01-DEC-11
DiazepamPreferred Pharmaceuticals, Inc17-JAN-12
Diazepam General Injectables and Vaccines, Inc.07-FEB-12
DiazepamDispensing Solutions, Inc.09-FEB-12
DiazepamSTAT Rx USA LLC21-FEB-12
DiazepamPrecision Dose Inc.23-FEB-12
DiazepamCardinal Health15-MAR-12
DiazepamUnit Dose Services18-MAR-12
DiazepamPhysicians Total Care, Inc.03-APR-12
DiazepamCardinal Health10-APR-12
DiazepamHospira, Inc.31-MAY-12
DiazepamPD-Rx Pharmaceuticals, Inc.07-JUN-12
DiazepamPD-Rx Pharmaceuticals, Inc.07-JUN-12
DiazepamWatson Laboratories, Inc.07-JUN-12
DiazepamHospira, Inc.21-JUN-12
DiazepamHospira, Inc.21-JUN-12
DiazepamTeva Pharmaceuticals USA Inc20-JUL-12
DiazepamRoxane Laboratories, Inc30-JUL-12
Diazepam IntensolRoxane Laboratories, Inc30-JUL-12
DiazepamQualitest Pharmaceuticals31-JUL-12
DiazepamIVAX Pharmaceuticals Inc.10-AUG-12
DiazepamMajor Pharmaceuticals05-SEP-12
DiazepamMcKesson Contract Packaging13-SEP-12
DiazepamPhysicians Total Care, Inc.12-OCT-12
DiazepamBryant Ranch Prepack12-OCT-12
DiazepamBryant Ranch Prepack12-OCT-12
DiazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLC08-NOV-12
DiazepamCardinal Health15-NOV-12
DiazepamLake Erie Medical DBA Quality Care Products LLC31-JAN-13
DiazepamBryant Ranch Prepack13-FEB-13
DiazepamBryant Ranch Prepack13-FEB-13
DiazepamBarr Laboratories Inc.27-FEB-13
DiazepamCardinal Health08-MAR-13
DiazepamCardinal Health03-APR-13
DiazepamCardinal Health04-APR-13
DiazepamCardinal Health09-APR-13
DiazepamAphena Pharma Solutions - Tennessee, LLC24-APR-13
DiazepamAphena Pharma Solutions - Tennessee, LLC26-APR-13
DiazepamA-S Medication Solutions LLC01-MAY-13
DiazepamA-S Medication Solutions LLC01-MAY-13

Diazepam Case Reports

What Diazepam 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 Diazepam. 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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