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SERZONE

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Serzone Adverse Events Reported to the FDA Over Time

How are Serzone adverse event reports trending over time?

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

Most Common Serzone Adverse Events Reported to the FDA

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

Nausea
35 (2%)
Drug Ineffective
34 (1.94%)
Fatigue
33 (1.88%)
Alanine Aminotransferase Increased
30 (1.71%)
Depression
30 (1.71%)
Insomnia
30 (1.71%)
Drug Interaction
29 (1.66%)
Medication Error
29 (1.66%)
Hepatic Enzyme Increased
27 (1.54%)
Dizziness
26 (1.48%)
Anxiety
24 (1.37%)
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Somnolence
23 (1.31%)
Aspartate Aminotransferase Increase...
22 (1.26%)
Hepatic Steatosis
22 (1.26%)
Malaise
22 (1.26%)
Tremor
21 (1.2%)
Hepatitis C
20 (1.14%)
Weight Increased
20 (1.14%)
Chromaturia
19 (1.09%)
Headache
19 (1.09%)
Liver Disorder
19 (1.09%)
Feeling Abnormal
18 (1.03%)
Anorexia
17 (.97%)
Suicidal Ideation
17 (.97%)
Drug Withdrawal Syndrome
15 (.86%)
Abdominal Pain
13 (.74%)
Asthenia
13 (.74%)
Lethargy
13 (.74%)
Abdominal Pain Upper
12 (.69%)
Drug Toxicity
12 (.69%)
Dry Mouth
12 (.69%)
Hepatic Failure
12 (.69%)
Pain
12 (.69%)
Panic Attack
12 (.69%)
Rhabdomyolysis
12 (.69%)
Vision Blurred
12 (.69%)
Blood Alkaline Phosphatase Increase...
11 (.63%)
Confusional State
11 (.63%)
Diarrhoea
11 (.63%)
Hepatic Cirrhosis
11 (.63%)
Constipation
10 (.57%)
Migraine
10 (.57%)
Weight Decreased
10 (.57%)
Agitation
9 (.51%)
Balance Disorder
9 (.51%)
Liver Function Test Abnormal
9 (.51%)
Loss Of Consciousness
9 (.51%)
Memory Impairment
9 (.51%)
Serotonin Syndrome
9 (.51%)
Vomiting
9 (.51%)
Hypersensitivity
8 (.46%)
Jaundice
8 (.46%)
Nervousness
8 (.46%)
Chills
7 (.4%)
Crying
7 (.4%)
Drug Dispensing Error
7 (.4%)
Dyskinesia
7 (.4%)
Dyspnoea
7 (.4%)
Dystonia
7 (.4%)
Hepatitis
7 (.4%)
Hyperhidrosis
7 (.4%)
Amnesia
6 (.34%)
Blood Glucose Increased
6 (.34%)
Cognitive Disorder
6 (.34%)
Dyspepsia
6 (.34%)
Gamma-glutamyltransferase Increased
6 (.34%)
Grand Mal Convulsion
6 (.34%)
Hypersomnia
6 (.34%)
Mental Status Changes
6 (.34%)
Musculoskeletal Stiffness
6 (.34%)
Myalgia
6 (.34%)
Oedema Peripheral
6 (.34%)
Overdose
6 (.34%)
Palpitations
6 (.34%)
Paraesthesia
6 (.34%)
Sedation
6 (.34%)
Anger
5 (.29%)
Blood Bilirubin Increased
5 (.29%)
Blood Pressure Increased
5 (.29%)
Choking
5 (.29%)
Convulsion
5 (.29%)
Coordination Abnormal
5 (.29%)
Decreased Appetite
5 (.29%)
Feeling Jittery
5 (.29%)
Hypoaesthesia
5 (.29%)
Mental Disorder
5 (.29%)
Mood Swings
5 (.29%)
Muscle Twitching
5 (.29%)
Muscular Weakness
5 (.29%)
Pollakiuria
5 (.29%)
Restlessness
5 (.29%)
Speech Disorder
5 (.29%)
Suicide Attempt
5 (.29%)
Syncope
5 (.29%)
Tachycardia
5 (.29%)
Tongue Disorder
5 (.29%)
Vertigo
5 (.29%)
Visual Impairment
5 (.29%)
Abnormal Behaviour
4 (.23%)
Alopecia
4 (.23%)
Back Pain
4 (.23%)

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

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

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

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

Depression
578
Anxiety
88
Drug Use For Unknown Indication
36
Product Used For Unknown Indication
15
Insomnia
14
Post-traumatic Stress Disorder
12
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Panic Attack
11
Major Depression
10
Migraine
9
Sleep Disorder
9
Panic Disorder
9
Fibromyalgia
8
Antidepressant Therapy
7
Obsessive-compulsive Disorder
7
Bipolar Disorder
6
Mental Disorder
5
Affective Disorder
4
Generalised Anxiety Disorder
4
Psychotic Disorder
3
Depressed Mood
3
Dysthymic Disorder
3
Bipolar I Disorder
3
Stress
3
Nervous System Disorder
3
Ill-defined Disorder
3
Nervousness
3
Mood Swings
2
Tourettes Disorder
2
Agoraphobia
2
Anger
2
Irritability
2
Dizziness
2
Hypertension
2
Muscle Tightness
2
Intentional Overdose
2
Headache
2
Medication Error
2
Anxiety Disorder
2
Attention Deficit/hyperactivity Dis...
2
Accidental Exposure
1
Schizophrenia
1
Psychiatric Symptom
1
Tachycardia
1
Suicidal Ideation
1
Pain
1
Dysphoria
1
Post Concussion Syndrome
1
Tension
1
Pain Management
1
Incontinence
1
Autonomic Nervous System Imbalance
1

Serzone Case Reports

What Serzone 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 Serzone. 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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