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MYSLEE

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Myslee Adverse Events Reported to the FDA Over Time

How are Myslee adverse event reports trending over time?

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

Most Common Myslee Adverse Events Reported to the FDA

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

Delirium
177 (6.05%)
Amnesia
65 (2.22%)
Fall
54 (1.85%)
Depressed Level Of Consciousness
52 (1.78%)
Altered State Of Consciousness
44 (1.5%)
Loss Of Consciousness
38 (1.3%)
Road Traffic Accident
37 (1.26%)
Suicide Attempt
37 (1.26%)
Liver Disorder
35 (1.2%)
Pyrexia
35 (1.2%)
Restlessness
35 (1.2%)
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Erythema Multiforme
32 (1.09%)
Multiple Drug Overdose Intentional
32 (1.09%)
Hepatitis Fulminant
31 (1.06%)
Overdose
31 (1.06%)
Abnormal Behaviour
29 (.99%)
Hepatic Function Abnormal
28 (.96%)
Neuroleptic Malignant Syndrome
28 (.96%)
Rhabdomyolysis
28 (.96%)
Dizziness
27 (.92%)
Insomnia
27 (.92%)
Convulsion
26 (.89%)
Anterograde Amnesia
25 (.85%)
Drug Exposure During Pregnancy
25 (.85%)
Respiratory Depression
25 (.85%)
Somnolence
25 (.85%)
Intentional Overdose
22 (.75%)
Aggression
20 (.68%)
Coma
20 (.68%)
Renal Failure Acute
20 (.68%)
Drug Toxicity
19 (.65%)
Somnambulism
19 (.65%)
Agranulocytosis
18 (.62%)
Asthenia
17 (.58%)
Blood Creatine Phosphokinase Increa...
16 (.55%)
Drug Interaction
16 (.55%)
Drug Ineffective
15 (.51%)
Drug Withdrawal Syndrome Neonatal
15 (.51%)
Gamma-glutamyltransferase Increased
15 (.51%)
Sepsis
15 (.51%)
Stevens-johnson Syndrome
15 (.51%)
Disorientation
14 (.48%)
Hepatitis
14 (.48%)
Hyponatraemia
14 (.48%)
Inappropriate Antidiuretic Hormone ...
14 (.48%)
Malaise
14 (.48%)
Pruritus
14 (.48%)
Confusional State
13 (.44%)
Nausea
13 (.44%)
Platelet Count Decreased
13 (.44%)
Poriomania
13 (.44%)
Tremor
13 (.44%)
Vomiting
13 (.44%)
Alanine Aminotransferase Increased
12 (.41%)
Aspartate Aminotransferase Increase...
12 (.41%)
Blood Alkaline Phosphatase Increase...
12 (.41%)
Completed Suicide
12 (.41%)
Pneumonia
12 (.41%)
Tachypnoea
12 (.41%)
Cardio-respiratory Arrest
11 (.38%)
Condition Aggravated
11 (.38%)
Death
11 (.38%)
Blood Lactate Dehydrogenase Increas...
10 (.34%)
Electrocardiogram Qrs Complex Prolo...
10 (.34%)
Jaundice
10 (.34%)
Off Label Use
10 (.34%)
Urinary Incontinence
10 (.34%)
Agitation
9 (.31%)
Bradycardia
9 (.31%)
Gait Disturbance
9 (.31%)
Hallucination
9 (.31%)
Hyperkalaemia
9 (.31%)
Hypoglycaemia
9 (.31%)
Mania
9 (.31%)
Memory Impairment
9 (.31%)
Ventricular Tachycardia
9 (.31%)
Visual Field Defect
9 (.31%)
Apnoeic Attack
8 (.27%)
Blood Pressure Immeasurable
8 (.27%)
Cardiac Arrest
8 (.27%)
Cerebral Infarction
8 (.27%)
Constipation
8 (.27%)
Developmental Delay
8 (.27%)
Drug Abuse
8 (.27%)
Drug Withdrawal Syndrome
8 (.27%)
Fracture
8 (.27%)
Hepatic Neoplasm Malignant
8 (.27%)
Multiple Drug Overdose
8 (.27%)
Oedema Peripheral
8 (.27%)
Pancreatitis Acute
8 (.27%)
Psychiatric Symptom
8 (.27%)
Pulmonary Embolism
8 (.27%)
White Blood Cell Count Decreased
8 (.27%)
Accidental Overdose
7 (.24%)
Anaemia
7 (.24%)
Blood Cholesterol Decreased
7 (.24%)
Caesarean Section
7 (.24%)
Diabetes Insipidus
7 (.24%)
Diabetic Ketoacidosis
7 (.24%)
Dysuria
7 (.24%)
Eyelid Ptosis
7 (.24%)

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

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

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

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

Insomnia
1258
Drug Use For Unknown Indication
254
Depression
72
Product Used For Unknown Indication
49
Prophylaxis
28
Sleep Disorder
23
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Neurosis
15
Schizophrenia
10
Ill-defined Disorder
10
Suicide Attempt
9
Rheumatoid Arthritis
7
Drug Exposure During Pregnancy
7
Pain
6
Accidental Overdose
6
Intentional Overdose
6
Metastatic Renal Cell Carcinoma
5
Major Depression
5
Multiple Drug Overdose Intentional
5
Overdose
5
Anxiety
5
Anxiety Disorder
4
Preoperative Care
4
Dementia Alzheimers Type
3
Drug Prescribing Error
3
Circadian Rhythm Sleep Disorder
3
Obsessive-compulsive Disorder
3
Liver Disorder
2
Multiple Drug Overdose
2
Affective Disorder
2
Drug Abuse
2
Dissociative Disorder
2
Intentional Misuse
2
Dysthymic Disorder
2
Psychotic Disorder Due To A General...
2
Bipolar Disorder
2
Bipolar I Disorder
2
Sleep Disorder Therapy
1
Renal Impairment
1
Accidental Exposure
1
Delirium
1
Aplastic Anaemia
1
Drug Abuser
1
Mental Disorder
1
Myelofibrosis
1
Drug Dependence
1
Post Herpetic Neuralgia
1
Panic Disorder
1
Aortic Dissection
1
Cyclopia
1
Chemical Poisoning
1
Schizoaffective Disorder
1

Myslee Case Reports

What Myslee 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 Myslee. 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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