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REMERON

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Remeron Adverse Events Reported to the FDA Over Time

How are Remeron adverse event reports trending over time?

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

Most Common Remeron Adverse Events Reported to the FDA

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

Suicide Attempt
114 (1.71%)
Completed Suicide
101 (1.52%)
Drug Interaction
93 (1.4%)
Somnolence
86 (1.29%)
Depression
85 (1.28%)
Anxiety
78 (1.17%)
Insomnia
75 (1.13%)
Confusional State
73 (1.1%)
Agitation
71 (1.07%)
Overdose
69 (1.04%)
Nausea
67 (1.01%)
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Drug Ineffective
66 (.99%)
Weight Increased
61 (.92%)
Headache
57 (.86%)
Multiple Drug Overdose Intentional
52 (.78%)
Serotonin Syndrome
52 (.78%)
Suicidal Ideation
51 (.77%)
Condition Aggravated
50 (.75%)
Tachycardia
50 (.75%)
Asthenia
49 (.74%)
Tremor
49 (.74%)
Vomiting
49 (.74%)
Dizziness
46 (.69%)
Amnesia
45 (.68%)
Coma
45 (.68%)
Fatigue
43 (.65%)
Hyponatraemia
40 (.6%)
Pyrexia
40 (.6%)
Fall
39 (.59%)
Convulsion
38 (.57%)
Dyspnoea
38 (.57%)
Aggression
36 (.54%)
Diarrhoea
35 (.53%)
Oedema Peripheral
35 (.53%)
Loss Of Consciousness
34 (.51%)
Weight Decreased
34 (.51%)
Drug Exposure During Pregnancy
32 (.48%)
Electrocardiogram Qt Prolonged
32 (.48%)
Decreased Appetite
31 (.47%)
Restlessness
31 (.47%)
Blood Creatine Phosphokinase Increa...
29 (.44%)
Hallucination
29 (.44%)
Irritability
29 (.44%)
Dysarthria
28 (.42%)
Disorientation
26 (.39%)
Hypoaesthesia
26 (.39%)
Intentional Overdose
26 (.39%)
Intentional Self-injury
26 (.39%)
Malaise
26 (.39%)
Rhabdomyolysis
26 (.39%)
Chronic Obstructive Pulmonary Disea...
25 (.38%)
Drug Withdrawal Syndrome
24 (.36%)
Agranulocytosis
23 (.35%)
Hypokalaemia
23 (.35%)
Back Pain
22 (.33%)
Constipation
22 (.33%)
Dehydration
22 (.33%)
Feeling Abnormal
22 (.33%)
Hypotension
22 (.33%)
Memory Impairment
22 (.33%)
Myalgia
22 (.33%)
Emphysema
21 (.32%)
Grand Mal Convulsion
21 (.32%)
Hypertension
21 (.32%)
Poisoning
21 (.32%)
Altered State Of Consciousness
20 (.3%)
Bedridden
20 (.3%)
General Physical Health Deteriorati...
20 (.3%)
Hyperhidrosis
20 (.3%)
Neuroleptic Malignant Syndrome
20 (.3%)
Pain
20 (.3%)
Alanine Aminotransferase Increased
19 (.29%)
Aspartate Aminotransferase Increase...
19 (.29%)
Delirium
19 (.29%)
Disturbance In Attention
19 (.29%)
Gait Disturbance
19 (.29%)
Off Label Use
19 (.29%)
Pain In Extremity
19 (.29%)
Pulmonary Embolism
19 (.29%)
Renal Failure Acute
19 (.29%)
Sleep Disorder
19 (.29%)
Extrapyramidal Disorder
18 (.27%)
Heart Rate Increased
18 (.27%)
Oedema
18 (.27%)
Rash
18 (.27%)
Respiratory Failure
18 (.27%)
Syncope
18 (.27%)
Urinary Tract Infection
18 (.27%)
Dysphagia
17 (.26%)
Hepatic Function Abnormal
17 (.26%)
Incorrect Dose Administered
17 (.26%)
Multiple Drug Overdose
17 (.26%)
Sedation
17 (.26%)
Abnormal Behaviour
16 (.24%)
Balance Disorder
16 (.24%)
Blood Potassium Decreased
16 (.24%)
Depressed Level Of Consciousness
16 (.24%)
Drug Toxicity
16 (.24%)
Mania
16 (.24%)
Medication Error
15 (.23%)
Mental Status Changes
15 (.23%)

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

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

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

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

Depression
1258
Product Used For Unknown Indication
281
Drug Use For Unknown Indication
271
Insomnia
182
Anxiety
146
Sleep Disorder
137
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Major Depression
60
Bipolar Disorder
43
Antidepressant Therapy
29
Decreased Appetite
23
Sleep Disorder Therapy
22
Depressive Symptom
20
Post-traumatic Stress Disorder
17
Ill-defined Disorder
15
Schizoaffective Disorder
14
Bipolar I Disorder
12
Schizophrenia
12
Affective Disorder
12
Pain
10
Social Phobia
9
Depressed Mood
9
Generalised Anxiety Disorder
8
Appetite Disorder
8
Adjustment Disorder
8
Panic Attack
7
Dementia
7
Gastrointestinal Pain
7
Increased Appetite
6
Somatoform Disorder
6
Weight Increased
6
Attention Deficit/hyperactivity Dis...
6
Aggression
5
Somnolence
5
Drug Exposure During Pregnancy
5
Prophylaxis
5
Obsessive-compulsive Disorder
5
Schizophrenia, Paranoid Type
5
Suicidal Ideation
4
Panic Disorder
4
Suicide Attempt
4
Drug Dependence
4
Dysthymic Disorder
3
Anxiety Disorder
3
Initial Insomnia
3
Psychotic Disorder
3
Agitation
3
Weight Decreased
3
Intentional Overdose
3
Schizoaffective Disorder Depressive...
3
Parkinsons Disease
2
Bipolar Ii Disorder
2

Drug Labels

LabelLabelerEffective
RemeronPhysicians Total Care, Inc.17-FEB-12
RemeronOrganon Pharmaceuticals USA30-OCT-12

Remeron Case Reports

What Remeron 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 Remeron. 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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