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MIANSERIN

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Mianserin Adverse Events Reported to the FDA Over Time

How are Mianserin adverse event reports trending over time?

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

Most Common Mianserin Adverse Events Reported to the FDA

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

Depression
34 (1.95%)
Fall
27 (1.55%)
Drug Interaction
25 (1.44%)
Constipation
23 (1.32%)
Suicide Attempt
23 (1.32%)
Abdominal Distension
21 (1.21%)
Dyspepsia
21 (1.21%)
Gastrooesophageal Reflux Disease
20 (1.15%)
Suicidal Ideation
20 (1.15%)
Hypotension
19 (1.09%)
Insomnia
19 (1.09%)
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Agitation
18 (1.03%)
Faeces Hard
18 (1.03%)
Oedema
18 (1.03%)
Rectal Haemorrhage
18 (1.03%)
Anxiety
17 (.98%)
Overdose
17 (.98%)
Somnolence
17 (.98%)
Delirium
16 (.92%)
Haemorrhoids
16 (.92%)
Convulsion
15 (.86%)
Death
15 (.86%)
Drug Ineffective
15 (.86%)
Coma
14 (.8%)
Condition Aggravated
14 (.8%)
Serotonin Syndrome
14 (.8%)
Loss Of Consciousness
13 (.75%)
Syncope
13 (.75%)
Confusional State
12 (.69%)
Hepatic Function Abnormal
12 (.69%)
Irritability
11 (.63%)
Pyrexia
11 (.63%)
Abnormal Behaviour
10 (.57%)
Aggression
10 (.57%)
Agranulocytosis
10 (.57%)
Cardiac Failure
10 (.57%)
Headache
10 (.57%)
Tremor
10 (.57%)
Asthenia
9 (.52%)
Drug Toxicity
9 (.52%)
Face Oedema
9 (.52%)
Gait Disturbance
9 (.52%)
Malaise
9 (.52%)
Oedema Peripheral
9 (.52%)
Renal Failure Acute
9 (.52%)
Vomiting
9 (.52%)
Alanine Aminotransferase Increased
8 (.46%)
Bradycardia
8 (.46%)
C-reactive Protein Increased
8 (.46%)
Multiple Drug Overdose Intentional
8 (.46%)
Neck Pain
8 (.46%)
Renal Failure
8 (.46%)
Thrombocytopenia
8 (.46%)
Aspartate Aminotransferase Increase...
7 (.4%)
Blood Iron Decreased
7 (.4%)
Brugada Syndrome
7 (.4%)
Dehydration
7 (.4%)
Electrocardiogram Qt Prolonged
7 (.4%)
Hypertension
7 (.4%)
Hyponatraemia
7 (.4%)
Nausea
7 (.4%)
Pneumonia
7 (.4%)
Pulmonary Embolism
7 (.4%)
Therapeutic Agent Toxicity
7 (.4%)
Acute Respiratory Failure
6 (.34%)
Altered State Of Consciousness
6 (.34%)
Anaemia
6 (.34%)
Cholestasis
6 (.34%)
Diarrhoea
6 (.34%)
Diplopia
6 (.34%)
Disturbance In Attention
6 (.34%)
Drug Exposure During Pregnancy
6 (.34%)
Haemoglobin Decreased
6 (.34%)
Haemolytic Anaemia
6 (.34%)
Hepatic Enzyme Increased
6 (.34%)
Inflammation
6 (.34%)
Normochromic Normocytic Anaemia
6 (.34%)
Swelling Face
6 (.34%)
Tachycardia
6 (.34%)
Abdominal Pain
5 (.29%)
Activation Syndrome
5 (.29%)
Anorexia
5 (.29%)
Blood Alkaline Phosphatase Increase...
5 (.29%)
Cognitive Disorder
5 (.29%)
Completed Suicide
5 (.29%)
Cytolytic Hepatitis
5 (.29%)
Depressed Level Of Consciousness
5 (.29%)
Disorientation
5 (.29%)
Dysphagia
5 (.29%)
Dyspnoea
5 (.29%)
Electroencephalogram Abnormal
5 (.29%)
Fatigue
5 (.29%)
Gastric Polyps
5 (.29%)
General Physical Health Deteriorati...
5 (.29%)
Hyperhidrosis
5 (.29%)
Intra-abdominal Haematoma
5 (.29%)
Mental Disorder
5 (.29%)
Myoclonus
5 (.29%)
Orthostatic Hypotension
5 (.29%)
Restless Legs Syndrome
5 (.29%)
Restlessness
5 (.29%)

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

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

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

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

Depression
154
Product Used For Unknown Indication
41
Drug Use For Unknown Indication
41
Insomnia
16
Delirium
7
Sleep Disorder
7
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Ill-defined Disorder
7
Anxiety
5
Dysthymic Disorder
4
Sleep Disorder Therapy
4
Depressive Symptom
3
Alcoholism
3
Dementia Alzheimers Type
3
Mental Disorder
3
Major Depression
3
Antidepressant Therapy
2
Failure To Thrive
2
Prophylaxis
2
Neurosis
1
Restlessness
1
Abnormal Behaviour
1
Bipolar I Disorder
1
Adverse Event
1
Post-traumatic Stress Disorder
1
Death Of Spouse
1
Dementia
1

Mianserin Case Reports

What Mianserin 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 Mianserin. 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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