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TRAZODONE

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Trazodone Adverse Events Reported to the FDA Over Time

How are Trazodone adverse event reports trending over time?

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

Most Common Trazodone Adverse Events Reported to the FDA

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

Completed Suicide
812 (4.9%)
Cardiac Arrest
341 (2.06%)
Respiratory Arrest
318 (1.92%)
Drug Toxicity
210 (1.27%)
Depression
206 (1.24%)
Drug Ineffective
205 (1.24%)
Cardio-respiratory Arrest
203 (1.22%)
Insomnia
196 (1.18%)
Drug Interaction
195 (1.18%)
Overdose
185 (1.12%)
Somnolence
184 (1.11%)
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Suicide Attempt
170 (1.03%)
Anxiety
166 (1%)
Death
141 (.85%)
Tremor
125 (.75%)
Nausea
124 (.75%)
Dizziness
123 (.74%)
Headache
121 (.73%)
Confusional State
119 (.72%)
Poisoning
119 (.72%)
Serotonin Syndrome
118 (.71%)
Multiple Drug Overdose
113 (.68%)
Suicidal Ideation
113 (.68%)
Priapism
110 (.66%)
Hypotension
105 (.63%)
Loss Of Consciousness
105 (.63%)
Convulsion
104 (.63%)
Vomiting
104 (.63%)
Fatigue
103 (.62%)
Drug Abuse
98 (.59%)
Intentional Overdose
98 (.59%)
Fall
97 (.59%)
Electrocardiogram Qt Prolonged
94 (.57%)
Agitation
92 (.56%)
Feeling Abnormal
86 (.52%)
Multiple Drug Overdose Intentional
81 (.49%)
Pain
81 (.49%)
Constipation
77 (.46%)
Coma
75 (.45%)
Intentional Drug Misuse
74 (.45%)
Tachycardia
72 (.43%)
Weight Increased
72 (.43%)
Decreased Appetite
70 (.42%)
Drug Withdrawal Syndrome
70 (.42%)
Medication Error
70 (.42%)
Neuroleptic Malignant Syndrome
70 (.42%)
Memory Impairment
69 (.42%)
Amnesia
63 (.38%)
Diarrhoea
63 (.38%)
Condition Aggravated
62 (.37%)
Lethargy
62 (.37%)
Hyperhidrosis
61 (.37%)
Mental Status Changes
61 (.37%)
Dyspnoea
60 (.36%)
Palpitations
60 (.36%)
Delirium
59 (.36%)
Asthenia
58 (.35%)
Dry Mouth
58 (.35%)
Chest Pain
57 (.34%)
Depressed Level Of Consciousness
57 (.34%)
Disorientation
56 (.34%)
Hypertension
56 (.34%)
Malaise
56 (.34%)
Dehydration
55 (.33%)
Weight Decreased
55 (.33%)
Gait Disturbance
54 (.33%)
Pyrexia
54 (.33%)
Syncope
54 (.33%)
Drug Exposure During Pregnancy
50 (.3%)
Unresponsive To Stimuli
50 (.3%)
Aggression
49 (.3%)
Dyskinesia
47 (.28%)
Myocardial Infarction
47 (.28%)
Nightmare
45 (.27%)
Incorrect Dose Administered
44 (.27%)
Sedation
44 (.27%)
Alanine Aminotransferase Increased
42 (.25%)
Aspartate Aminotransferase Increase...
42 (.25%)
Irritability
42 (.25%)
Nervousness
42 (.25%)
Abdominal Pain
40 (.24%)
Rash
40 (.24%)
Hallucination
38 (.23%)
Rhabdomyolysis
38 (.23%)
Abnormal Behaviour
37 (.22%)
Disturbance In Attention
37 (.22%)
Flushing
37 (.22%)
Blood Creatine Phosphokinase Increa...
36 (.22%)
Drug Effect Decreased
36 (.22%)
Dysarthria
36 (.22%)
Grand Mal Convulsion
36 (.22%)
Torsade De Pointes
36 (.22%)
Hallucination, Visual
35 (.21%)
Muscle Spasms
35 (.21%)
Paraesthesia
35 (.21%)
Pneumonia
35 (.21%)
Renal Failure
35 (.21%)
Speech Disorder
35 (.21%)
Withdrawal Syndrome
35 (.21%)
Heart Rate Increased
34 (.21%)
Muscle Twitching
34 (.21%)

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

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

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

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

Insomnia
1927
Depression
1676
Sleep Disorder
1455
Product Used For Unknown Indication
1099
Drug Use For Unknown Indication
1066
Anxiety
294
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Sleep Disorder Therapy
192
Bipolar Disorder
150
Pain
81
Ill-defined Disorder
72
Antidepressant Therapy
60
Fibromyalgia
55
Somnolence
53
Major Depression
48
Restless Legs Syndrome
45
Suicide Attempt
33
Affective Disorder
28
Schizophrenia
27
Post-traumatic Stress Disorder
23
Nervousness
23
Dementia
19
Mental Disorder
18
Agitation
17
Migraine
17
Sedative Therapy
17
Drug Exposure During Pregnancy
15
Bipolar I Disorder
13
Feeling Jittery
13
Schizoaffective Disorder
13
Dementia Alzheimers Type
13
Restlessness
13
Intentional Overdose
12
Sleep Apnoea Syndrome
11
Depressive Symptom
10
Overdose
10
Panic Disorder
10
Completed Suicide
9
Depressed Mood
9
Crohns Disease
9
Poor Quality Sleep
9
Arthritis
8
Drug Abuse
8
Sedation
8
Back Pain
7
Neuralgia
7
Psychotic Disorder
7
Suicidal Ideation
7
Obsessive-compulsive Disorder
6
Personality Disorder
6
Mood Swings
6
Analgesic Therapy
6

Drug Labels

LabelLabelerEffective
TrazodonePD-Rx Pharmaceuticals, Inc.21-MAR-08
TrazodonePD-Rx Pharmaceuticals, Inc.21-MAR-08
Trazodone HydrochlorideRebel Distributors Corp.01-JUN-09
Trazodone HydrochlorideContract Pharmacy Services-PA09-MAR-10
Trazodone HydrochlorideContract Pharmacy Services-PA11-AUG-10
Trazodone HydrochlorideREMEDYREPACK INC. 28-SEP-10
Trazodone Hydrochloride REMEDYREPACK INC. 26-OCT-10
Trazodone HydrochlorideKeltman Pharmaceuticals Inc.17-NOV-10
Trazodone HydrochlorideSTAT RX LLC USA29-NOV-10
Trazodone HydrochlorideApotex Corp10-DEC-10
Trazodone HydrochlorideUnit Dose Services18-JAN-11
Trazodone HydrochloridePD-Rx Pharmaceuticals, Inc.18-JAN-11
Trazodone HydrochlorideUnit Dose Services18-JAN-11
Trazodone HydrochlorideMedVantx, Inc.18-JAN-11
Trazodone HydrochlorideBryant Ranch Prepack20-JAN-11
Trazodone HydrochlorideCardinal Health24-MAY-11
Trazodone HydrochlorideBlenheim Pharmacal, Inc.08-JUN-11
Trazodone HydrochlorideDispensing Solutions, Inc.03-OCT-11
Trazodone HydrochlorideDispensing Solutions, Inc.03-OCT-11
Trazodone HydrochlorideQualitest Pharmaceuticals28-NOV-11
Trazodone HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLC14-DEC-11
Trazodone HydrochlorideGolden State Medical Supply, Inc.09-JAN-12
Trazodone HydrochlorideMcKesson Contract Packaging27-FEB-12
Trazodone HydrochloridePreferred Pharmaceuticals, Inc28-FEB-12
Trazodone HydrochloridePhysicians Total Care, Inc.04-MAR-12
Trazodone HydrochlorideSTAT Rx USA LLC14-MAR-12
Trazodone HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs26-APR-12
Trazodone HydrochlorideCardinal Health01-JUN-12
Trazodone HydrochlorideMutual Pharmaceutical Company, Inc.01-JUL-12
Trazodone HclMylan Pharmaceuticals Inc.31-JUL-12
Trazodone HydrochlorideQualitest Pharmaceuticals31-JUL-12
Trazodone HydrochlorideGoldline Laboratories, Inc.30-AUG-12
Trazodone HydrochlorideMajor Pharmaceuticals05-SEP-12
Trazodone HydrochlorideAmerican Health Packaging10-OCT-12
Trazodone HydrochlorideBryant Ranch Prepack12-OCT-12
Trazodone HydrochlorideAidarex Pharmaceuticals LLC12-OCT-12
Trazodone HydrochlorideBarr Laboratories Inc.16-OCT-12
Trazodone HydrochlorideBryant Ranch Prepack23-OCT-12
Oleptro Labopharm Inc.26-NOV-12
Trazodone HydrochloridePliva Inc.15-MAR-13
Trazodone HydrochlorideCardinal Health25-MAR-13
Trazodone HydrochlorideREMEDYREPACK INC. 27-MAR-13
Trazodone HydrochlorideREMEDYREPACK INC. 27-MAR-13
Trazodone HydrochlorideCardinal Health03-APR-13
Trazodone HydrochlorideCardinal Health19-APR-13
Trazodone HydrochlorideGoldline Laboratories, Inc.23-APR-13

Trazodone Case Reports

What Trazodone 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 Trazodone. 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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