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OXAZEPAM

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Oxazepam Adverse Events Reported to the FDA Over Time

How are Oxazepam adverse event reports trending over time?

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

Most Common Oxazepam Adverse Events Reported to the FDA

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

Somnolence
75 (1.85%)
Suicide Attempt
74 (1.82%)
Drug Toxicity
73 (1.8%)
Fall
67 (1.65%)
Drug Interaction
59 (1.45%)
Intentional Overdose
54 (1.33%)
Coma
51 (1.26%)
Overdose
50 (1.23%)
Confusional State
49 (1.21%)
Completed Suicide
44 (1.08%)
Drug Exposure During Pregnancy
41 (1.01%)
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Vomiting
38 (.94%)
Drug Abuse
36 (.89%)
Hypotension
36 (.89%)
Loss Of Consciousness
35 (.86%)
Multiple Drug Overdose
31 (.76%)
Multiple Drug Overdose Intentional
31 (.76%)
Pulmonary Oedema
30 (.74%)
Pneumonia Aspiration
28 (.69%)
Agitation
26 (.64%)
Disorientation
26 (.64%)
Cardiac Arrest
25 (.62%)
Bradycardia
24 (.59%)
Pyrexia
24 (.59%)
Aggression
23 (.57%)
Anxiety
22 (.54%)
Convulsion
21 (.52%)
Renal Failure Acute
21 (.52%)
Delirium
20 (.49%)
Hyponatraemia
20 (.49%)
Hypothermia
20 (.49%)
Dizziness
19 (.47%)
Drug Abuser
19 (.47%)
Maternal Drugs Affecting Foetus
19 (.47%)
Medication Error
19 (.47%)
Tachycardia
19 (.47%)
Depressed Level Of Consciousness
18 (.44%)
Drug Ineffective
18 (.44%)
Dyspnoea
18 (.44%)
Respiratory Depression
18 (.44%)
Tremor
18 (.44%)
Dehydration
17 (.42%)
Respiratory Failure
17 (.42%)
Sedation
17 (.42%)
Serotonin Syndrome
17 (.42%)
Cardio-respiratory Arrest
16 (.39%)
Cytolytic Hepatitis
16 (.39%)
Diarrhoea
16 (.39%)
General Physical Health Deteriorati...
16 (.39%)
Hypoglycaemia
16 (.39%)
Stevens-johnson Syndrome
16 (.39%)
Suicidal Ideation
16 (.39%)
Abnormal Behaviour
15 (.37%)
Condition Aggravated
15 (.37%)
Death
15 (.37%)
Head Injury
15 (.37%)
Hepatic Failure
15 (.37%)
Nausea
15 (.37%)
Respiratory Arrest
15 (.37%)
Accidental Overdose
14 (.34%)
Aspiration
14 (.34%)
Drug Dependence
14 (.34%)
Electrocardiogram Qt Prolonged
14 (.34%)
Insomnia
14 (.34%)
Toxic Epidermal Necrolysis
14 (.34%)
Brain Oedema
13 (.32%)
Drug Withdrawal Syndrome
13 (.32%)
Fatigue
13 (.32%)
Malaise
13 (.32%)
Syncope
13 (.32%)
Withdrawal Syndrome
13 (.32%)
Bronchitis
12 (.3%)
Eosinophilia
12 (.3%)
Pneumonia
12 (.3%)
Pruritus
12 (.3%)
Thrombocytopenia
12 (.3%)
Balance Disorder
11 (.27%)
Grand Mal Convulsion
11 (.27%)
Hyperkalaemia
11 (.27%)
Hypertension
11 (.27%)
Intentional Drug Misuse
11 (.27%)
Iron Deficiency Anaemia
11 (.27%)
Miosis
11 (.27%)
Poisoning
11 (.27%)
Pulmonary Congestion
11 (.27%)
Renal Failure
11 (.27%)
Speech Disorder
11 (.27%)
Weight Decreased
11 (.27%)
Weight Increased
11 (.27%)
Atrioventricular Block First Degree
10 (.25%)
Blood Pressure Increased
10 (.25%)
Circulatory Collapse
10 (.25%)
Depression
10 (.25%)
Extrapyramidal Disorder
10 (.25%)
Headache
10 (.25%)
Restlessness
10 (.25%)
Rhabdomyolysis
10 (.25%)
Shock
10 (.25%)
Alcohol Use
9 (.22%)
Asthenia
9 (.22%)
Blood Creatinine Increased
9 (.22%)

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

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

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

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

Product Used For Unknown Indication
283
Drug Use For Unknown Indication
270
Anxiety
248
Insomnia
140
Depression
66
Sleep Disorder
50
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Sedation
33
Ill-defined Disorder
24
Suicide Attempt
20
Prophylaxis
17
Sedative Therapy
17
Anxiolytic Therapy
17
Sleep Disorder Therapy
12
Abnormal Behaviour
10
Intentional Overdose
9
Pain
9
Drug Exposure During Pregnancy
9
Restlessness
8
Anxiety Disorder
8
Agitation
8
Foetal Exposure During Pregnancy
7
Panic Attack
7
Psychotic Disorder
6
Bipolar I Disorder
6
Drug Dependence
6
Personality Disorder
5
Nervousness
5
Drug Abuse
5
Schizophrenia
5
Drug Withdrawal Syndrome
5
Major Depression
5
Mania
4
Relaxation Therapy
4
Mental Disorder
4
Tension
4
Feeling Of Relaxation
4
Delirium
4
Multiple Myeloma
4
Personality Change Due To A General...
4
Somnolence
3
Agoraphobia
3
Generalised Anxiety Disorder
3
Hallucination
3
Completed Suicide
3
Dementia
3
Maternal Exposure During Pregnancy
3
Dependence
3
Alcohol Poisoning
2
Bipolar Disorder
2
Muscle Relaxant Therapy
2
Alcohol Detoxification
2

Drug Labels

LabelLabelerEffective
OxazepamPhysicians Total Care, Inc.01-DEC-09
OxazepamSTAT RX USA LLC15-DEC-09
OxazepamActavis Elizabeth LLC04-JUN-10
OxazepamREMEDYREPACK INC. 06-SEP-11
OxazepamSandoz Inc21-OCT-11
OxazepamAmerican Health Packaging16-JUL-12
OxazepamAphena Pharma Solutions - Tennessee, Inc.15-AUG-12
OxazepamIVAX Pharmaceuticals, Inc.13-SEP-12
OxazepamBryant Ranch Prepack12-OCT-12

Oxazepam Case Reports

What Oxazepam 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 Oxazepam. 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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