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Champix Adverse Events Reported to the FDA Over Time

How are Champix adverse event reports trending over time?

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

Most Common Champix Adverse Events Reported to the FDA

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

Nausea
899 (3.59%)
Depression
757 (3.03%)
Anxiety
477 (1.91%)
Insomnia
435 (1.74%)
Headache
403 (1.61%)
Suicidal Ideation
391 (1.56%)
Malaise
334 (1.34%)
Dizziness
324 (1.3%)
Depressed Mood
304 (1.22%)
Nervousness
289 (1.16%)
Aggression
269 (1.08%)
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Feeling Abnormal
259 (1.04%)
Vomiting
259 (1.04%)
Fatigue
253 (1.01%)
Abnormal Dreams
236 (.94%)
Dyspnoea
230 (.92%)
Agitation
225 (.9%)
Abnormal Behaviour
199 (.8%)
Tremor
185 (.74%)
Confusional State
179 (.72%)
Somnolence
179 (.72%)
Irritability
175 (.7%)
Blood Pressure Increased
164 (.66%)
Decreased Appetite
162 (.65%)
Abdominal Pain Upper
156 (.62%)
Memory Impairment
150 (.6%)
Drug Interaction
149 (.6%)
Diarrhoea
148 (.59%)
Nightmare
148 (.59%)
Crying
147 (.59%)
Disturbance In Attention
141 (.56%)
Abdominal Pain
138 (.55%)
Weight Increased
138 (.55%)
Suicide Attempt
135 (.54%)
Hypertension
134 (.54%)
Asthenia
131 (.52%)
Sleep Disorder
128 (.51%)
Anger
124 (.5%)
Paranoia
124 (.5%)
Chest Pain
123 (.49%)
Amnesia
122 (.49%)
Mental Disorder
121 (.48%)
Constipation
119 (.48%)
Weight Decreased
116 (.46%)
Rash
113 (.45%)
Mood Altered
110 (.44%)
Dysgeusia
109 (.44%)
Palpitations
108 (.43%)
Abdominal Distension
107 (.43%)
Mood Swings
106 (.42%)
Hyperhidrosis
102 (.41%)
Hypersensitivity
100 (.4%)
Loss Of Consciousness
99 (.4%)
Oedema Peripheral
98 (.39%)
Panic Attack
96 (.38%)
Blood Glucose Increased
94 (.38%)
Pain
94 (.38%)
Pruritus
91 (.36%)
Flatulence
90 (.36%)
Blood Pressure Decreased
88 (.35%)
Dyspepsia
88 (.35%)
Fall
87 (.35%)
Dry Mouth
86 (.34%)
Hallucination
86 (.34%)
Psychotic Disorder
86 (.34%)
Cough
79 (.32%)
Fear
78 (.31%)
Arthralgia
75 (.3%)
Tearfulness
75 (.3%)
Haematochezia
73 (.29%)
Paraesthesia
73 (.29%)
Vision Blurred
73 (.29%)
Apathy
72 (.29%)
Back Pain
72 (.29%)
Withdrawal Syndrome
72 (.29%)
Heart Rate Increased
71 (.28%)
Hypoaesthesia
69 (.28%)
Pyrexia
69 (.28%)
Restlessness
69 (.28%)
Syncope
69 (.28%)
Emotional Disorder
67 (.27%)
Disorientation
66 (.26%)
Muscle Spasms
66 (.26%)
Gait Disturbance
65 (.26%)
Pain In Extremity
65 (.26%)
Myalgia
64 (.26%)
Self-injurious Ideation
64 (.26%)
Bipolar Disorder
63 (.25%)
Personality Change
62 (.25%)
Thinking Abnormal
62 (.25%)
Tachycardia
61 (.24%)
Chest Discomfort
60 (.24%)
Speech Disorder
58 (.23%)
Erythema
57 (.23%)
Drug Ineffective
56 (.22%)
Road Traffic Accident
55 (.22%)
Urticaria
55 (.22%)
Activities Of Daily Living Impaired
53 (.21%)
Intentional Overdose
53 (.21%)
Vertigo
53 (.21%)
Death
51 (.2%)

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

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

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

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

Smoking Cessation Therapy
3365
Tobacco User
451
Nicotine Dependence
146
Ex-smoker
107
Tobacco Abuse
93
Ex-tobacco User
50
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Drug Use For Unknown Indication
20
Drug Withdrawal Syndrome
9
Product Used For Unknown Indication
8
Ill-defined Disorder
3
Fungal Infection
3
Tobacco Withdrawal Symptoms
3
Bronchitis
2
Nasopharyngitis
2
Smoker
2
Withdrawal Syndrome
2
Prophylaxis
2
Sinusitis
2
Premedication
1
Melaena
1
Depressed Mood
1
Ataxia
1

Champix Case Reports

What Champix 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 Champix. 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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