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TEMAZEPAM

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Temazepam Adverse Events Reported to the FDA Over Time

How are Temazepam adverse event reports trending over time?

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

Most Common Temazepam Adverse Events Reported to the FDA

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

Completed Suicide
314 (4.87%)
Death
244 (3.79%)
Drug Toxicity
170 (2.64%)
Cardiac Arrest
110 (1.71%)
Overdose
106 (1.64%)
Loss Of Consciousness
94 (1.46%)
Respiratory Arrest
89 (1.38%)
Somnolence
88 (1.37%)
Drug Interaction
85 (1.32%)
Multiple Drug Overdose
79 (1.23%)
Confusional State
78 (1.21%)
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Anxiety
75 (1.16%)
Amnesia
72 (1.12%)
Suicide Attempt
71 (1.1%)
Hypotension
69 (1.07%)
Cardio-respiratory Arrest
62 (.96%)
Poisoning
61 (.95%)
Drug Ineffective
58 (.9%)
Metabolic Acidosis
58 (.9%)
Hypoxia
56 (.87%)
Multiple Drug Overdose Intentional
51 (.79%)
Vomiting
50 (.78%)
Drug Abuse
48 (.74%)
Intentional Overdose
48 (.74%)
Headache
45 (.7%)
Malaise
45 (.7%)
Unresponsive To Stimuli
45 (.7%)
Insomnia
44 (.68%)
Fall
42 (.65%)
Depression
40 (.62%)
Dizziness
40 (.62%)
Heart Rate Increased
40 (.62%)
Musculoskeletal Stiffness
40 (.62%)
Accidental Overdose
38 (.59%)
Mesothelioma
38 (.59%)
Tachycardia
38 (.59%)
Dysarthria
37 (.57%)
Agitation
32 (.5%)
Lung Neoplasm Malignant
32 (.5%)
Dyspnoea
31 (.48%)
Abdominal Pain
29 (.45%)
Fatigue
29 (.45%)
Pulmonary Congestion
29 (.45%)
Suicidal Ideation
29 (.45%)
Therapeutic Agent Toxicity
29 (.45%)
Pulmonary Oedema
28 (.43%)
Chills
27 (.42%)
Pruritus
27 (.42%)
Respiratory Depression
27 (.42%)
Memory Impairment
26 (.4%)
Pneumonia
26 (.4%)
Blood Pressure Decreased
25 (.39%)
Depressed Level Of Consciousness
25 (.39%)
Diarrhoea
25 (.39%)
Medication Error
25 (.39%)
Weight Decreased
25 (.39%)
Abnormal Dreams
24 (.37%)
Back Pain
24 (.37%)
Crystalluria
24 (.37%)
Drug Withdrawal Syndrome
24 (.37%)
Hallucination
24 (.37%)
Nervousness
24 (.37%)
Jaundice
23 (.36%)
Imprisonment
22 (.34%)
Palpitations
22 (.34%)
Pancreatic Carcinoma
22 (.34%)
Photophobia
22 (.34%)
Vision Blurred
22 (.34%)
Cerebrovascular Accident
21 (.33%)
Drug Dependence
21 (.33%)
Dry Mouth
21 (.33%)
Duodenal Ulcer
21 (.33%)
Gastritis
21 (.33%)
Pneumonia Aspiration
21 (.33%)
Blood Creatine Phosphokinase Increa...
20 (.31%)
Coma
20 (.31%)
Intentional Drug Misuse
20 (.31%)
Pyrexia
20 (.31%)
Sexual Abuse
20 (.31%)
Gastrointestinal Disorder
19 (.29%)
Hypertension
19 (.29%)
Mood Altered
19 (.29%)
Reflux Oesophagitis
19 (.29%)
Feeling Abnormal
18 (.28%)
Mental Status Changes
18 (.28%)
Alanine Aminotransferase Increased
17 (.26%)
Electrocardiogram Qt Prolonged
17 (.26%)
Hepatic Encephalopathy
17 (.26%)
Hypersensitivity
17 (.26%)
Lower Respiratory Tract Infection
17 (.26%)
Sedation
17 (.26%)
Accidental Death
16 (.25%)
Asthma
16 (.25%)
Drug Effect Decreased
16 (.25%)
Drug Level Increased
16 (.25%)
Multiple Drug Overdose Accidental
16 (.25%)
Nausea
16 (.25%)
Oesophageal Haemorrhage
16 (.25%)
Oxygen Saturation Decreased
16 (.25%)
Snoring
16 (.25%)
Abnormal Behaviour
15 (.23%)

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

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

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

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

Insomnia
1007
Drug Use For Unknown Indication
667
Product Used For Unknown Indication
574
Sleep Disorder
484
Anxiety
96
Sleep Disorder Therapy
61
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Depression
39
Pain
31
Somnolence
29
Ill-defined Disorder
29
Sedation
27
Suicide Attempt
19
Poor Quality Sleep
18
Sedative Therapy
14
Prophylaxis
13
Overdose
12
Drug Withdrawal Syndrome
10
Abdominal Pain
9
Post-traumatic Stress Disorder
9
Bipolar Disorder
8
Anaesthesia
6
Agitation
6
Asthma
6
Back Pain
4
Dependence
4
Analgesic Effect
4
Musculoskeletal Stiffness
4
Muscle Spasms
4
Premedication
4
Intentional Overdose
4
Abdominal Pain Upper
4
Myalgia
4
Generalised Anxiety Disorder
3
Drug Abuse
3
Sciatica
3
Nervousness
3
Restless Legs Syndrome
3
Stress
2
Nausea
2
Spondylitis
2
Major Depression
2
Arthritis
2
Initial Insomnia
2
Incorrect Dose Administered
2
Muscle Relaxant Therapy
2
Intervertebral Disc Protrusion
2
Substance Abuse
2
Completed Suicide
2
Musculoskeletal Discomfort
2
Myocardial Infarction
2
Supraventricular Tachycardia
2

Drug Labels

LabelLabelerEffective
TemazepamBryant Ranch Prepack21-APR-87
TemazepamBryant Ranch Prepack21-APR-87
TemazepamActavis Elizabeth LLC01-JAN-08
Temazepam Unit Dose Services01-JAN-08
Temazepam Unit Dose Services01-JAN-08
TemazepamPhysicians Total Care, Inc.04-SEP-09
TemazepamMylan Pharmaceuticals Inc.17-FEB-10
TemazepamKAISER FOUNDATION HOSPITALS26-MAR-10
TemazepamRebel Distributors Corp01-DEC-10
TemazepamRebel Distributors Corp01-DEC-10
TemazepamUDL Laboratories, Inc.17-DEC-10
TemazepamMallinckrodt, Inc.20-DEC-10
TemazepamMutual Pharmaceutical Company, Inc. 18-JAN-11
Temazepam PD-Rx Pharmaceuticals, Inc.05-MAR-11
TemazepamCardinal Health17-MAY-11
RestorilMallinckrodt, Inc.11-JUL-11
RestorilPhysicians Total Care, Inc.11-JUL-11
RestorilCardinal Health10-AUG-11
TemazepamSandoz Inc21-OCT-11
TemazepamLake Erie Medical Surgical & Supply DBA Quality Care Products LLC28-DEC-11
TemazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-FEB-12
TemazepamPreferred Pharmaceuticals, Inc28-FEB-12
TemazepamSTAT Rx USA LLC08-MAR-12
TemazepamAmerican Health Packaging27-MAR-12
Temazepam H.J. Harkins Company, Inc.19-APR-12
TemazepamCardinal Health01-JUN-12
TemazepamAphena Pharma Solutions - Tennessee, Inc.16-JUL-12
TemazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLC24-JUL-12
TemazepamNovel Laboratories, Inc.09-AUG-12
TemazepamSTAT Rx USA LLC20-AUG-12
TemazepamMcKesson Contract Packaging13-SEP-12
TemazepamAscend Laboratories, LLC14-FEB-13
Temazepam Unit Dose Services14-FEB-13
TemazepamCardinal Health05-MAR-13
TemazepamREMEDYREPACK INC. 26-MAR-13
TemazepamCardinal Health15-APR-13
TemazepamAphena Pharma Solutions - Tennessee, LLC02-MAY-13

Temazepam Case Reports

What Temazepam 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 Temazepam. 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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