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Ssri Adverse Events Reported to the FDA Over Time

How are Ssri adverse event reports trending over time?

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

Most Common Ssri Adverse Events Reported to the FDA

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

Multiple Drug Overdose
47 (3.79%)
Completed Suicide
43 (3.47%)
Somnolence
36 (2.9%)
Coma
31 (2.5%)
Agitation
30 (2.42%)
Depressed Level Of Consciousness
25 (2.02%)
Confusional State
21 (1.69%)
Drug Screen Positive
21 (1.69%)
Overdose
17 (1.37%)
Alanine Aminotransferase Increased
16 (1.29%)
Convulsion
16 (1.29%)
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Aspartate Aminotransferase Increase...
15 (1.21%)
Hypotension
15 (1.21%)
Heart Rate Increased
14 (1.13%)
Lethargy
14 (1.13%)
Drug Toxicity
13 (1.05%)
Suicide Attempt
13 (1.05%)
Tachycardia
13 (1.05%)
Blood Pressure Decreased
12 (.97%)
Drug Interaction
12 (.97%)
Serotonin Syndrome
12 (.97%)
Vomiting
12 (.97%)
Body Temperature Increased
11 (.89%)
Respiratory Arrest
11 (.89%)
Blood Glucose Increased
10 (.81%)
Blood Potassium Decreased
10 (.81%)
Cardiac Arrest
10 (.81%)
Electrocardiogram Qt Prolonged
10 (.81%)
Oxygen Saturation Decreased
10 (.81%)
Blood Creatine Phosphokinase Increa...
9 (.73%)
Drug Abuser
9 (.73%)
Sinus Tachycardia
9 (.73%)
Blood Creatinine Increased
8 (.65%)
Cardio-respiratory Arrest
8 (.65%)
Hyperhidrosis
8 (.65%)
Respiratory Rate Decreased
8 (.65%)
Aggression
7 (.56%)
Aspiration
7 (.56%)
Blood Pressure Increased
7 (.56%)
Electrocardiogram Qrs Complex Prolo...
7 (.56%)
Loss Of Consciousness
7 (.56%)
Miosis
7 (.56%)
Pneumonia Aspiration
7 (.56%)
Poisoning
7 (.56%)
Rhabdomyolysis
7 (.56%)
Tremor
7 (.56%)
Abdominal Pain
6 (.48%)
Areflexia
6 (.48%)
Body Temperature Decreased
6 (.48%)
Chest Pain
6 (.48%)
Death
6 (.48%)
Diarrhoea
6 (.48%)
Dysarthria
6 (.48%)
Hypertension
6 (.48%)
Medication Error
6 (.48%)
Mental Status Changes
6 (.48%)
Pyrexia
6 (.48%)
Respiratory Depression
6 (.48%)
Blood Bicarbonate Decreased
5 (.4%)
Blood Ph Decreased
5 (.4%)
Blood Ph Increased
5 (.4%)
Blood Potassium Increased
5 (.4%)
Blood Pressure Systolic Increased
5 (.4%)
Depression
5 (.4%)
Hallucination
5 (.4%)
Multiple Drug Overdose Intentional
5 (.4%)
Nausea
5 (.4%)
Pneumonia
5 (.4%)
Prothrombin Time Prolonged
5 (.4%)
Restlessness
5 (.4%)
Sinus Bradycardia
5 (.4%)
Abnormal Behaviour
4 (.32%)
Accidental Overdose
4 (.32%)
Acidosis
4 (.32%)
Asthenia
4 (.32%)
Blood Creatine Phosphokinase Mb Inc...
4 (.32%)
Blood Urea Increased
4 (.32%)
Bradycardia
4 (.32%)
Chromaturia
4 (.32%)
Dizziness
4 (.32%)
Dyspnoea
4 (.32%)
Heart Rate Decreased
4 (.32%)
Mania
4 (.32%)
Pain In Extremity
4 (.32%)
Po2 Increased
4 (.32%)
Sedation
4 (.32%)
Troponin Increased
4 (.32%)
Unresponsive To Stimuli
4 (.32%)
White Blood Cell Count Increased
4 (.32%)
Accidental Drug Intake By Child
3 (.24%)
Anger
3 (.24%)
Anxiety
3 (.24%)
Apnoea
3 (.24%)
Blood Alkaline Phosphatase Increase...
3 (.24%)
Blood Amylase Increased
3 (.24%)
Blood Magnesium Decreased
3 (.24%)
Blood Sodium Decreased
3 (.24%)
Cough
3 (.24%)
Disorientation
3 (.24%)
Drug Effect Decreased
3 (.24%)
Drug Ineffective
3 (.24%)

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

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

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

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

Drug Use For Unknown Indication
79
Depression
42
Product Used For Unknown Indication
23
Suicide Attempt
12
Anxiety
11
Ill-defined Disorder
6
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Intentional Drug Misuse
4
Schizophrenia
4
Psychotic Disorder
3
Accidental Drug Intake By Child
1
Mental Disorder
1
Drug Abuser
1
Major Depression
1
Diabetes Mellitus Non-insulin-depen...
1
Migraine Prophylaxis
1
Accidental Exposure
1
Psychiatric Symptom
1
Anorexia Nervosa
1
Mood Swings
1
Pain
1
Anorexia
1
Hot Flush
1
Sleep Apnoea Syndrome
1
Antidepressant Therapy
1
Delirium
1
Insomnia
1

Ssri Case Reports

What Ssri 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 Ssri. 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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