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ZOPICLONE

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Zopiclone Adverse Events Reported to the FDA Over Time

How are Zopiclone adverse event reports trending over time?

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

Most Common Zopiclone Adverse Events Reported to the FDA

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

Suicide Attempt
153 (2.03%)
Overdose
135 (1.79%)
Intentional Overdose
124 (1.64%)
Confusional State
123 (1.63%)
Malaise
104 (1.38%)
Multiple Drug Overdose Intentional
99 (1.31%)
Somnolence
95 (1.26%)
Drug Interaction
88 (1.17%)
Urinary Tract Infection
87 (1.15%)
Multiple Drug Overdose
81 (1.07%)
Completed Suicide
78 (1.03%)
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Pyrexia
75 (.99%)
Anxiety
74 (.98%)
Vomiting
74 (.98%)
Insomnia
73 (.97%)
Coma
70 (.93%)
Fall
70 (.93%)
Myalgia
63 (.83%)
Diarrhoea
62 (.82%)
Depression
60 (.79%)
Suicidal Ideation
60 (.79%)
Constipation
58 (.77%)
White Blood Cell Count Increased
56 (.74%)
Rhabdomyolysis
55 (.73%)
Aggression
54 (.72%)
Decreased Appetite
54 (.72%)
Hypertension
54 (.72%)
Sinus Tachycardia
54 (.72%)
Cardiac Murmur
53 (.7%)
Syncope
51 (.68%)
Loss Of Consciousness
50 (.66%)
Agitation
48 (.64%)
Diabetes Mellitus
47 (.62%)
Neutrophil Count Increased
47 (.62%)
Drug Toxicity
46 (.61%)
Nausea
46 (.61%)
Weight Decreased
46 (.61%)
Blood Creatine Phosphokinase Increa...
45 (.6%)
Pain
45 (.6%)
Anaemia
44 (.58%)
Dizziness
44 (.58%)
Hypotension
44 (.58%)
Staphylococcal Infection
44 (.58%)
Tremor
44 (.58%)
Abdominal Tenderness
43 (.57%)
Hiatus Hernia
42 (.56%)
Hyperhidrosis
42 (.56%)
Iron Deficiency Anaemia
41 (.54%)
Skin Disorder
41 (.54%)
Mean Cell Volume Decreased
40 (.53%)
Body Mass Index Decreased
38 (.5%)
Depressed Level Of Consciousness
37 (.49%)
Dysphagia
37 (.49%)
Monocyte Count Increased
37 (.49%)
Panic Attack
37 (.49%)
Electrocardiogram Qt Prolonged
35 (.46%)
Hypochondriasis
35 (.46%)
Muscle Twitching
35 (.46%)
Muscle Atrophy
34 (.45%)
Lethargy
33 (.44%)
Cardiac Arrest
31 (.41%)
Amnesia
30 (.4%)
Oral Discomfort
30 (.4%)
Tachycardia
30 (.4%)
Physical Assault
29 (.38%)
Dehydration
28 (.37%)
Condition Aggravated
27 (.36%)
Hypothermia
27 (.36%)
Disorientation
25 (.33%)
Fatigue
25 (.33%)
Respiratory Arrest
25 (.33%)
Hepatic Function Abnormal
24 (.32%)
White Blood Cell Disorder
24 (.32%)
Acidosis
23 (.3%)
Drug Ineffective
23 (.3%)
Pruritus
23 (.3%)
Balance Disorder
22 (.29%)
Blood Pressure Decreased
22 (.29%)
Feeling Abnormal
22 (.29%)
Oxygen Saturation Decreased
22 (.29%)
Pulmonary Oedema
22 (.29%)
Abnormal Behaviour
21 (.28%)
Blood Pressure Systolic Increased
21 (.28%)
Drug Dependence
21 (.28%)
Drug Exposure During Pregnancy
21 (.28%)
Renal Failure Acute
21 (.28%)
Respiratory Failure
21 (.28%)
Ventricular Fibrillation
21 (.28%)
Acute Pulmonary Oedema
20 (.26%)
Alanine Aminotransferase Increased
20 (.26%)
Convulsion
20 (.26%)
Multi-organ Failure
20 (.26%)
Pneumonia Aspiration
20 (.26%)
Rash Maculo-papular
20 (.26%)
Accidental Overdose
19 (.25%)
Chills
19 (.25%)
Treatment Noncompliance
19 (.25%)
Alcohol Use
18 (.24%)
Drug Withdrawal Syndrome
18 (.24%)
Oedema Peripheral
18 (.24%)
Priapism
18 (.24%)

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

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

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

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

Insomnia
975
Drug Use For Unknown Indication
543
Product Used For Unknown Indication
382
Sleep Disorder
325
Sedation
64
Ill-defined Disorder
56
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Depression
48
Anxiety
38
Intentional Overdose
34
Poor Quality Sleep
19
Sleep Disorder Therapy
17
Bipolar Disorder
17
Suicide Attempt
15
Hypnotherapy
15
Sedative Therapy
10
Stress
9
Schizophrenia
9
Drug Dependence
9
Mental Disorder
9
Prophylaxis
8
Pain
8
Hypersomnia
7
Fatigue
7
Major Depression
6
Psychotic Disorder
4
Neck Pain
4
Mania
4
Fibromyalgia
4
Completed Suicide
4
Restlessness
4
Overdose
4
Nervousness
3
Somnolence
3
Spinal Cord Compression
3
Panic Disorder
3
Epilepsy
3
Emotional Distress
3
Schizophrenia, Paranoid Type
3
Initial Insomnia
2
Off Label Use
2
Dementia Alzheimers Type
2
Depressed Mood
2
Rheumatoid Arthritis
2
Delirium
2
Gastroenteritis
2
Dependence
2
Psychosomatic Disease
2
Generalised Anxiety Disorder
2
Schizoaffective Disorder
2
Acute Sinusitis
2
Maternal Exposure Timing Unspecifie...
2

Zopiclone Case Reports

What Zopiclone 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 Zopiclone. 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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