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Valium Adverse Events Reported to the FDA Over Time

How are Valium adverse event reports trending over time?

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

Most Common Valium Adverse Events Reported to the FDA

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

Somnolence
173 (2.02%)
Overdose
140 (1.63%)
Insomnia
116 (1.35%)
Anxiety
110 (1.28%)
Drug Ineffective
109 (1.27%)
Nausea
97 (1.13%)
Coma
96 (1.12%)
Fall
96 (1.12%)
Depression
95 (1.11%)
Suicide Attempt
92 (1.07%)
Headache
81 (.94%)
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Dizziness
79 (.92%)
Suicidal Ideation
75 (.87%)
Weight Decreased
70 (.82%)
Vomiting
69 (.8%)
Confusional State
67 (.78%)
Drug Dependence
67 (.78%)
Drug Toxicity
66 (.77%)
Convulsion
64 (.75%)
Fatigue
63 (.73%)
Agitation
61 (.71%)
Asthenia
59 (.69%)
Drug Exposure During Pregnancy
59 (.69%)
Tremor
59 (.69%)
Loss Of Consciousness
58 (.68%)
Pain
55 (.64%)
Death
54 (.63%)
Dyspnoea
52 (.61%)
Feeling Abnormal
52 (.61%)
Malaise
50 (.58%)
Intentional Overdose
47 (.55%)
Hypotension
45 (.52%)
Rash
45 (.52%)
Diarrhoea
43 (.5%)
Amnesia
42 (.49%)
Drug Withdrawal Syndrome
42 (.49%)
Weight Increased
42 (.49%)
Drug Interaction
39 (.45%)
Chest Pain
36 (.42%)
Muscle Spasms
36 (.42%)
Abnormal Behaviour
35 (.41%)
Respiratory Depression
35 (.41%)
Tachycardia
35 (.41%)
Disturbance In Attention
33 (.38%)
Multiple Drug Overdose
33 (.38%)
Condition Aggravated
32 (.37%)
Palpitations
32 (.37%)
Road Traffic Accident
32 (.37%)
Back Pain
31 (.36%)
Depressed Level Of Consciousness
31 (.36%)
Hypertension
30 (.35%)
Abdominal Pain
29 (.34%)
Aggression
29 (.34%)
Drug Abuse
29 (.34%)
Hypotonia
29 (.34%)
Lethargy
29 (.34%)
Hallucination
28 (.33%)
Heart Rate Increased
28 (.33%)
Multiple Drug Overdose Intentional
28 (.33%)
Cough
27 (.31%)
Vision Blurred
27 (.31%)
Memory Impairment
26 (.3%)
Paranoia
26 (.3%)
Sedation
26 (.3%)
Accidental Overdose
25 (.29%)
Constipation
25 (.29%)
Orthostatic Hypotension
25 (.29%)
Cytolytic Hepatitis
24 (.28%)
Dehydration
24 (.28%)
Disorientation
24 (.28%)
Drug Effect Decreased
24 (.28%)
Dysarthria
24 (.28%)
Myocardial Infarction
24 (.28%)
Pyrexia
24 (.28%)
Completed Suicide
23 (.27%)
Gait Disturbance
23 (.27%)
Renal Failure Acute
23 (.27%)
Blood Creatine Phosphokinase Increa...
22 (.26%)
Oedema Peripheral
22 (.26%)
Pneumonia Aspiration
22 (.26%)
Respiratory Arrest
22 (.26%)
Tinnitus
22 (.26%)
Diabetes Mellitus
21 (.24%)
Drug Abuser
21 (.24%)
Sopor
21 (.24%)
Syncope
21 (.24%)
Activities Of Daily Living Impaired
20 (.23%)
Crying
20 (.23%)
Hypoaesthesia
20 (.23%)
Hypoglycaemia
20 (.23%)
Multiple Drug Overdose Accidental
20 (.23%)
Off Label Use
20 (.23%)
Panic Attack
20 (.23%)
Psychotic Disorder
20 (.23%)
Sleep Disorder
20 (.23%)
Substance Abuse
20 (.23%)
Drug Screen Positive
19 (.22%)
Drug Tolerance
19 (.22%)
Myalgia
19 (.22%)
Respiratory Distress
19 (.22%)
Respiratory Failure
19 (.22%)

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

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

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

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

Anxiety
1033
Drug Use For Unknown Indication
783
Product Used For Unknown Indication
480
Muscle Spasms
317
Depression
152
Insomnia
140
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Sleep Disorder
132
Pain
130
Convulsion
79
Muscle Relaxant Therapy
72
Back Pain
65
Nervousness
64
Panic Attack
58
Epilepsy
45
Agitation
44
Vertigo
43
Stress
40
Bipolar Disorder
35
Premedication
33
Sedation
31
Panic Disorder
24
Sleep Disorder Therapy
23
Anxiety Disorder
23
Tremor
23
Headache
22
Ill-defined Disorder
19
Restless Legs Syndrome
19
Vestibular Disorder
18
Migraine
18
Schizophrenia
18
Neck Pain
16
Myalgia
16
Feeling Of Relaxation
15
Suicide Attempt
15
Post-traumatic Stress Disorder
15
Surgery
14
Nervous System Disorder
12
Dizziness
12
Prophylaxis
12
Psychotic Disorder
11
Sarcoidosis
11
Aggression
10
Hypertension
10
Nerve Injury
10
Drug Abuser
9
Alcohol Withdrawal Syndrome
9
Fibromyalgia
9
Alcoholism
9
Mental Disorder
8
Delirium Tremens
8
Arrhythmia
8

Drug Labels

LabelLabelerEffective
ValiumPD-Rx Pharmaceuticals, Inc.02-APR-10
ValiumRoche Products Inc02-APR-10
ValiumCardinal Health26-APR-11
ValiumREMEDYREPACK INC. 28-NOV-12

Valium Case Reports

What Valium 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 Valium. 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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