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Zyban Adverse Events Reported to the FDA Over Time

How are Zyban adverse event reports trending over time?

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

Most Common Zyban Adverse Events Reported to the FDA

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

Completed Suicide
1081 (3.86%)
Drug Ineffective
860 (3.07%)
Depression
744 (2.65%)
Anxiety
464 (1.66%)
Insomnia
440 (1.57%)
Suicidal Ideation
398 (1.42%)
Convulsion
390 (1.39%)
Headache
382 (1.36%)
Cardiac Arrest
350 (1.25%)
Nausea
317 (1.13%)
Dizziness
311 (1.11%)
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Product Substitution Issue
290 (1.03%)
Feeling Abnormal
288 (1.03%)
Agitation
284 (1.01%)
Respiratory Arrest
283 (1.01%)
Poisoning
275 (.98%)
Overdose
265 (.95%)
Tremor
245 (.87%)
Therapeutic Response Unexpected Wit...
234 (.83%)
Drug Toxicity
220 (.78%)
Aggression
206 (.73%)
Irritability
206 (.73%)
Fatigue
204 (.73%)
Urticaria
189 (.67%)
Drug Interaction
188 (.67%)
Cardio-respiratory Arrest
186 (.66%)
Vomiting
181 (.65%)
Condition Aggravated
179 (.64%)
Malaise
174 (.62%)
Pruritus
172 (.61%)
Rash
172 (.61%)
Grand Mal Convulsion
170 (.61%)
Loss Of Consciousness
161 (.57%)
Death
160 (.57%)
Confusional State
158 (.56%)
Suicide Attempt
155 (.55%)
Dyspnoea
151 (.54%)
Crying
150 (.54%)
Multiple Drug Overdose
150 (.54%)
Drug Exposure During Pregnancy
144 (.51%)
Hallucination
141 (.5%)
Disturbance In Attention
140 (.5%)
Palpitations
138 (.49%)
Product Quality Issue
137 (.49%)
Asthenia
131 (.47%)
Intentional Overdose
131 (.47%)
Hypotension
129 (.46%)
Dry Mouth
124 (.44%)
Heart Rate Increased
113 (.4%)
Hyperhidrosis
107 (.38%)
Somnolence
107 (.38%)
Tachycardia
107 (.38%)
Weight Increased
106 (.38%)
Anger
104 (.37%)
Hypersensitivity
100 (.36%)
Memory Impairment
99 (.35%)
Tinnitus
99 (.35%)
Depressed Mood
98 (.35%)
Amnesia
97 (.35%)
Arthralgia
97 (.35%)
Vision Blurred
93 (.33%)
Fall
90 (.32%)
Drug Effect Decreased
88 (.31%)
Chest Pain
85 (.3%)
Intentional Drug Misuse
85 (.3%)
Medication Error
85 (.3%)
Blood Pressure Increased
83 (.3%)
Panic Attack
82 (.29%)
Nervousness
81 (.29%)
Paraesthesia
80 (.29%)
Sleep Disorder
80 (.29%)
Multiple Drug Overdose Intentional
79 (.28%)
Hallucination, Visual
78 (.28%)
Lethargy
78 (.28%)
Constipation
75 (.27%)
Pyrexia
73 (.26%)
Mood Swings
72 (.26%)
Delirium
70 (.25%)
Weight Decreased
69 (.25%)
Decreased Appetite
67 (.24%)
Hypertension
67 (.24%)
Disorientation
66 (.24%)
Mood Altered
66 (.24%)
Depressed Level Of Consciousness
65 (.23%)
Diarrhoea
65 (.23%)
Restlessness
65 (.23%)
Bradycardia
64 (.23%)
Dysgeusia
64 (.23%)
Pain
64 (.23%)
Balance Disorder
63 (.22%)
Paranoia
63 (.22%)
Unresponsive To Stimuli
63 (.22%)
Abdominal Pain Upper
61 (.22%)
Erythema
61 (.22%)
Drug Abuse
60 (.21%)
Serotonin Syndrome
60 (.21%)
Adverse Event
58 (.21%)
Migraine
58 (.21%)
Psychotic Disorder
58 (.21%)
Myalgia
57 (.2%)
Cardiogenic Shock
56 (.2%)

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

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

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

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

Depression
2600
Drug Use For Unknown Indication
1336
Product Used For Unknown Indication
694
Smoking Cessation Therapy
601
Major Depression
255
Anxiety
216
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Ex-smoker
145
Bipolar Disorder
127
Ex-tobacco User
74
Attention Deficit/hyperactivity Dis...
73
Ill-defined Disorder
58
Suicide Attempt
43
Seasonal Affective Disorder
33
Bipolar I Disorder
31
Antidepressant Therapy
27
Affective Disorder
26
Overdose
24
Post-traumatic Stress Disorder
21
Migraine
19
Dysthymic Disorder
18
Completed Suicide
18
Depressive Symptom
17
Pain
16
Disturbance In Attention
14
Tobacco Abuse
14
Fatigue
14
Smoker
13
Nicotine Dependence
12
Mental Disorder
12
Tobacco User
12
Mood Swings
11
Asthenia
11
Bipolar Ii Disorder
10
Premenstrual Syndrome
10
Obsessive-compulsive Disorder
9
Depressed Mood
9
Intentional Overdose
8
Disease Recurrence
8
Fibromyalgia
8
Generalised Anxiety Disorder
8
Anxiety Disorder
8
Erectile Dysfunction
7
Stress
7
Panic Attack
7
Postpartum Depression
7
Suicidal Ideation
6
Accidental Exposure
5
Panic Disorder
5
Psychotic Disorder
5
Apathy
5
Mood Altered
5

Drug Labels

LabelLabelerEffective
ZybanGlaxoSmithKline LLC26-APR-12

Zyban Case Reports

What Zyban 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 Zyban. 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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