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DULOXETIME

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Duloxetime Adverse Events Reported to the FDA Over Time

How are Duloxetime adverse event reports trending over time?

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

Most Common Duloxetime Adverse Events Reported to the FDA

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

Completed Suicide
74 (11.95%)
Cardio-respiratory Arrest
21 (3.39%)
Death
18 (2.91%)
Cardiac Arrest
15 (2.42%)
Respiratory Arrest
15 (2.42%)
Suicidal Ideation
14 (2.26%)
Nausea
12 (1.94%)
Drug Interaction
11 (1.78%)
Vomiting
11 (1.78%)
Poisoning
9 (1.45%)
Serotonin Syndrome
9 (1.45%)
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Intentional Drug Misuse
8 (1.29%)
Optic Neuritis
8 (1.29%)
Suicide Attempt
8 (1.29%)
Hypotension
7 (1.13%)
Medication Error
7 (1.13%)
Tremor
7 (1.13%)
Confusional State
6 (.97%)
Dizziness
6 (.97%)
Syncope
6 (.97%)
Agitation
5 (.81%)
Bezoar
5 (.81%)
Extrapyramidal Disorder
5 (.81%)
Intentional Overdose
5 (.81%)
Lethargy
5 (.81%)
Migraine
5 (.81%)
Off Label Use
5 (.81%)
Hepatic Enzyme Increased
4 (.65%)
Hot Flush
4 (.65%)
Hyperhidrosis
4 (.65%)
Insomnia
4 (.65%)
Loss Of Consciousness
4 (.65%)
Multiple System Atrophy
4 (.65%)
Parkinsonism
4 (.65%)
Stress Cardiomyopathy
4 (.65%)
Tachycardia
4 (.65%)
Vision Blurred
4 (.65%)
Cardiotoxicity
3 (.48%)
Decreased Appetite
3 (.48%)
Drug Withdrawal Syndrome
3 (.48%)
Dysphagia
3 (.48%)
Fall
3 (.48%)
Gait Disturbance
3 (.48%)
Hypertension
3 (.48%)
Hypoglycaemia
3 (.48%)
Hypokinesia
3 (.48%)
Inappropriate Antidiuretic Hormone ...
3 (.48%)
Mental Status Changes
3 (.48%)
Multiple Drug Overdose
3 (.48%)
Muscle Rigidity
3 (.48%)
Myoclonus
3 (.48%)
Oesophageal Obstruction
3 (.48%)
Pre-eclampsia
3 (.48%)
Premature Baby
3 (.48%)
Shock
3 (.48%)
Sopor
3 (.48%)
Weight Increased
3 (.48%)
Abdominal Pain
2 (.32%)
Adverse Event
2 (.32%)
Akathisia
2 (.32%)
Amenorrhoea
2 (.32%)
Anxiety
2 (.32%)
Arrhythmia
2 (.32%)
Balance Disorder
2 (.32%)
Blood Glucose Increased
2 (.32%)
Chills
2 (.32%)
Coma
2 (.32%)
Delirium
2 (.32%)
Disturbance In Attention
2 (.32%)
Drug Level Increased
2 (.32%)
Dyskinesia
2 (.32%)
Dyspnoea
2 (.32%)
Dystonia
2 (.32%)
Fatigue
2 (.32%)
Feeding Tube Complication
2 (.32%)
Gastrointestinal Sounds Abnormal
2 (.32%)
Gastrointestinal Tube Insertion
2 (.32%)
Gestational Diabetes
2 (.32%)
Hallucination
2 (.32%)
Headache
2 (.32%)
Hyperlipidaemia
2 (.32%)
Hyperreflexia
2 (.32%)
Idiopathic Thrombocytopenic Purpura
2 (.32%)
International Normalised Ratio Incr...
2 (.32%)
Motion Sickness
2 (.32%)
Multiple Drug Overdose Intentional
2 (.32%)
Muscular Weakness
2 (.32%)
Musculoskeletal Stiffness
2 (.32%)
Nystagmus
2 (.32%)
Oesophageal Ulcer
2 (.32%)
Pain
2 (.32%)
Photophobia
2 (.32%)
Poor Quality Sleep
2 (.32%)
Psychomotor Hyperactivity
2 (.32%)
Psychotic Disorder
2 (.32%)
Refusal Of Treatment By Patient
2 (.32%)
Self-medication
2 (.32%)
Somnolence
2 (.32%)
Speech Disorder
2 (.32%)
Stupor
2 (.32%)
Tardive Dyskinesia
2 (.32%)

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

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

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

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

Product Used For Unknown Indication
93
Depression
63
Hallucination, Auditory
7
Stress Urinary Incontinence
7
Pain
7
Anxiety
7
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Neuralgia
6
Agitated Depression
6
Suicide Attempt
5
Urinary Incontinence
5
Diabetic Neuropathy
5
Major Depression
5
Panic Disorder
4
Completed Suicide
4
Post Herpetic Neuralgia
3
Foetal Exposure During Pregnancy
2
Schizophrenia
2
Schizoaffective Disorder
1
Memory Impairment
1
Breakthrough Pain
1
Myelopathy
1
Psychotic Disorder
1
Depressive Symptom
1
Neuropathy Peripheral
1
Mental Disorder
1

Duloxetime Case Reports

What Duloxetime 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 Duloxetime. 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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