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VARENICLINE

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Varenicline Adverse Events Reported to the FDA Over Time

How are Varenicline adverse event reports trending over time?

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

Most Common Varenicline Adverse Events Reported to the FDA

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

Nausea
777 (4.41%)
Depression
621 (3.52%)
Vomiting
433 (2.46%)
Suicidal Ideation
356 (2.02%)
Insomnia
326 (1.85%)
Anxiety
280 (1.59%)
Abnormal Dreams
272 (1.54%)
Dizziness
270 (1.53%)
Headache
262 (1.49%)
Nightmare
260 (1.47%)
Feeling Abnormal
259 (1.47%)
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Agitation
245 (1.39%)
Irritability
194 (1.1%)
Depressed Mood
189 (1.07%)
Aggression
180 (1.02%)
Dyspnoea
175 (.99%)
Somnolence
161 (.91%)
Malaise
138 (.78%)
Blood Pressure Increased
130 (.74%)
Chest Pain
121 (.69%)
Fatigue
120 (.68%)
Decreased Appetite
117 (.66%)
Anger
116 (.66%)
Nervousness
116 (.66%)
Tremor
116 (.66%)
Confusional State
115 (.65%)
Road Traffic Accident
115 (.65%)
Weight Increased
113 (.64%)
Hypertension
111 (.63%)
Diarrhoea
108 (.61%)
Abnormal Behaviour
107 (.61%)
Mood Swings
103 (.58%)
Asthenia
98 (.56%)
Loss Of Consciousness
98 (.56%)
Mental Disorder
96 (.54%)
Abdominal Pain
93 (.53%)
Constipation
93 (.53%)
Pruritus
92 (.52%)
Abdominal Pain Upper
90 (.51%)
Disturbance In Attention
88 (.5%)
Hallucination
88 (.5%)
Rash
87 (.49%)
Abdominal Discomfort
86 (.49%)
Palpitations
82 (.46%)
Convulsion
79 (.45%)
Mood Altered
79 (.45%)
Sleep Disorder
79 (.45%)
Altered State Of Consciousness
75 (.43%)
Crying
74 (.42%)
Suicide Attempt
74 (.42%)
Dysgeusia
73 (.41%)
Amnesia
68 (.39%)
Fall
67 (.38%)
Pain
67 (.38%)
Weight Decreased
66 (.37%)
Drug Ineffective
65 (.37%)
Drug Interaction
65 (.37%)
Psychotic Disorder
62 (.35%)
Abdominal Distension
61 (.35%)
Blood Glucose Increased
60 (.34%)
Hypersensitivity
60 (.34%)
Stress
60 (.34%)
Apathy
59 (.33%)
Death
56 (.32%)
Oedema Peripheral
56 (.32%)
Paranoia
54 (.31%)
Epilepsy
53 (.3%)
Panic Attack
51 (.29%)
Emotional Disorder
50 (.28%)
Fear
50 (.28%)
Mania
50 (.28%)
Tobacco User
49 (.28%)
Gait Disturbance
48 (.27%)
Vision Blurred
48 (.27%)
Flatulence
47 (.27%)
Back Pain
46 (.26%)
Heart Rate Increased
46 (.26%)
Memory Impairment
46 (.26%)
Haematochezia
45 (.26%)
Myalgia
45 (.26%)
Pyrexia
45 (.26%)
Rash Generalised
44 (.25%)
Hypotension
43 (.24%)
Personality Change
42 (.24%)
Throat Tightness
42 (.24%)
Hypoaesthesia
41 (.23%)
Major Depression
41 (.23%)
Myocardial Infarction
41 (.23%)
Swelling Face
41 (.23%)
Eating Disorder
40 (.23%)
Hyperhidrosis
40 (.23%)
Lethargy
40 (.23%)
Pain In Extremity
40 (.23%)
Skin Exfoliation
40 (.23%)
Thinking Abnormal
40 (.23%)
Blood Pressure Decreased
38 (.22%)
Syncope
38 (.22%)
Chest Discomfort
37 (.21%)
Condition Aggravated
37 (.21%)
Dry Mouth
37 (.21%)
Tachycardia
36 (.2%)

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

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

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

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

Smoking Cessation Therapy
2745
Tobacco User
205
Nicotine Dependence
135
Tobacco Abuse
71
Ex-tobacco User
55
Ex-smoker
27
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Drug Use For Unknown Indication
25
Product Used For Unknown Indication
22
Depression
6
Pain
4
Vascular Operation
3
Hypertension
3
Restless Legs Syndrome
2
Alcoholism
2
Suicide Attempt
2
Schizoaffective Disorder
2
Ear Pain
2
Schizophrenia, Paranoid Type
2
Fungal Infection
2
Drug Dependence
2
Prophylaxis
1
Sinusitis
1
Hallucination, Auditory
1
Bipolar I Disorder
1
Dyspepsia
1
Diabetes Mellitus
1
Cardiovascular Disorder
1
Hyperlipidaemia
1
Asthma
1
Deep Vein Thrombosis
1
Dependence
1
Withdrawal Syndrome
1
Smoker
1

Drug Labels

LabelLabelerEffective
ChantixRebel Distributors Corp23-SEP-10
ChantixRebel Distributors Corp20-JUL-11
ChantixRebel Distributors Corp20-JUL-11
ChantixPhysicians Total Care, Inc.19-DEC-11
ChantixLake Erie Medical & Surgical Supply DBA Quality Care Products LLC05-JAN-12
ChantixLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-FEB-12
ChantixLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-FEB-12
ChantixCardinal Health25-OCT-12
ChantixPfizer Laboratories Div Pfizer Inc15-FEB-13
ChantixCardinal Health22-APR-13

Varenicline Case Reports

What Varenicline 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 Varenicline. 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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