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IMOVANE

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Imovane Adverse Events Reported to the FDA Over Time

How are Imovane adverse event reports trending over time?

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

Most Common Imovane Adverse Events Reported to the FDA

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

Fall
77 (2.16%)
Somnolence
57 (1.6%)
Confusional State
53 (1.49%)
Coma
49 (1.37%)
Pyrexia
43 (1.21%)
Renal Failure
34 (.95%)
Dehydration
33 (.93%)
Drug Exposure During Pregnancy
31 (.87%)
Disorientation
27 (.76%)
Hypotension
26 (.73%)
Overdose
26 (.73%)
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Hyponatraemia
25 (.7%)
Pruritus
25 (.7%)
Renal Failure Acute
25 (.7%)
Cytolytic Hepatitis
24 (.67%)
Dysphagia
24 (.67%)
Gastrooesophageal Reflux Disease
24 (.67%)
Constipation
23 (.65%)
Rash Maculo-papular
23 (.65%)
Thrombocytopenia
23 (.65%)
Depression
22 (.62%)
Drug Rash With Eosinophilia And Sys...
22 (.62%)
Condition Aggravated
21 (.59%)
Drug Interaction
21 (.59%)
Toxic Epidermal Necrolysis
21 (.59%)
Oedema
20 (.56%)
Suicide Attempt
20 (.56%)
Abdominal Distension
19 (.53%)
Balance Disorder
19 (.53%)
Dyspepsia
19 (.53%)
Insomnia
19 (.53%)
Pancreatitis Acute
19 (.53%)
Vomiting
19 (.53%)
Eosinophilia
18 (.51%)
General Physical Health Deteriorati...
18 (.51%)
Skin Exfoliation
18 (.51%)
Urinary Retention
18 (.51%)
Alanine Aminotransferase Increased
17 (.48%)
Aspartate Aminotransferase Increase...
17 (.48%)
Cardiac Arrest
17 (.48%)
Cholestasis
17 (.48%)
Electrocardiogram Qt Prolonged
17 (.48%)
Jaundice
17 (.48%)
Malaise
17 (.48%)
Rash Morbilliform
17 (.48%)
Sleep Disorder
17 (.48%)
Cough
16 (.45%)
Faeces Hard
16 (.45%)
Headache
16 (.45%)
Neutropenia
16 (.45%)
Oxygen Saturation Decreased
16 (.45%)
Rhabdomyolysis
16 (.45%)
Urinary Tract Infection
16 (.45%)
Chills
15 (.42%)
Face Oedema
15 (.42%)
Gamma-glutamyltransferase Increased
15 (.42%)
Interstitial Lung Disease
15 (.42%)
Oedema Peripheral
15 (.42%)
Pulmonary Arterial Hypertension
15 (.42%)
Rectal Haemorrhage
15 (.42%)
Suicidal Ideation
15 (.42%)
Weight Decreased
15 (.42%)
Abdominal Pain
14 (.39%)
Abnormal Behaviour
14 (.39%)
Anaemia
14 (.39%)
Anxiety
14 (.39%)
C-reactive Protein Increased
14 (.39%)
Cerebral Haematoma
14 (.39%)
Decreased Appetite
14 (.39%)
Dyspnoea
14 (.39%)
Fatigue
14 (.39%)
Haemorrhoids
14 (.39%)
Altered State Of Consciousness
13 (.36%)
Disturbance In Attention
13 (.36%)
Hepatic Enzyme Increased
13 (.36%)
Multiple Drug Overdose
13 (.36%)
Rash Erythematous
13 (.36%)
Respiratory Distress
13 (.36%)
Toxic Skin Eruption
13 (.36%)
Agitation
12 (.34%)
Aortic Valve Incompetence
12 (.34%)
Convulsion
12 (.34%)
Inflammation
12 (.34%)
Intra-uterine Death
12 (.34%)
Loss Of Consciousness
12 (.34%)
Mitral Valve Incompetence
12 (.34%)
Orthostatic Hypotension
12 (.34%)
Pulmonary Embolism
12 (.34%)
Syncope
12 (.34%)
Tachycardia
12 (.34%)
Blood Alkaline Phosphatase Increase...
11 (.31%)
Caesarean Section
11 (.31%)
Depressed Level Of Consciousness
11 (.31%)
Diarrhoea
11 (.31%)
Nausea
11 (.31%)
Pregnancy
11 (.31%)
Agranulocytosis
10 (.28%)
Blood Pressure Increased
10 (.28%)
Chest Pain
10 (.28%)
Cognitive Disorder
10 (.28%)
Death
10 (.28%)

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

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

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

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

Insomnia
451
Drug Use For Unknown Indication
290
Product Used For Unknown Indication
165
Sleep Disorder
146
Depression
34
Ill-defined Disorder
25
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Anxiety
12
Suicide Attempt
10
Prophylaxis
10
Bipolar I Disorder
8
Sleep Disorder Therapy
6
Bipolar Disorder
6
Overdose
6
Psychotic Disorder
5
Sedative Therapy
5
Somnolence
5
Abnormal Behaviour
4
Renal Failure
4
Drug Exposure During Pregnancy
4
Mental Disorder
3
Intentional Overdose
3
Non-hodgkins Lymphoma
2
Dementia Alzheimers Type
2
Unevaluable Event
2
Hypnotherapy
2
Schizoaffective Disorder
2
Pain
2
Schizophrenia
2
Dysthymic Disorder
2
Fear
2
Major Depression
2
Bladder Repair
1
Dyspnoea
1
Behavioural And Psychiatric Symptom...
1
Drug Abuser
1
Relaxation Therapy
1
Cystocele
1
Premedication
1
Agitation
1
Nonspecific Reaction
1
Postpartum Depression
1
Generalised Anxiety Disorder
1
Post Procedural Complication
1
Rheumatoid Arthritis
1
Hypomania
1
Withdrawal Syndrome
1
Delirium
1
Sedation
1
General Symptom
1

Imovane Case Reports

What Imovane 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 Imovane. 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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