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VARENICLINE TARTRATE

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Varenicline Tartrate Adverse Events Reported to the FDA Over Time

How are Varenicline Tartrate adverse event reports trending over time?

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

Most Common Varenicline Tartrate Adverse Events Reported to the FDA

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

Nausea
408 (3.23%)
Depression
298 (2.36%)
Feeling Abnormal
209 (1.65%)
Insomnia
205 (1.62%)
Dizziness
189 (1.5%)
Anxiety
186 (1.47%)
Suicidal Ideation
171 (1.35%)
Headache
167 (1.32%)
Depressed Mood
162 (1.28%)
Vomiting
149 (1.18%)
Aggression
130 (1.03%)
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Dyspnoea
129 (1.02%)
Blood Pressure Increased
124 (.98%)
Somnolence
124 (.98%)
Irritability
114 (.9%)
Abnormal Dreams
110 (.87%)
Decreased Appetite
109 (.86%)
Malaise
109 (.86%)
Nervousness
107 (.85%)
Road Traffic Accident
107 (.85%)
Agitation
105 (.83%)
Chest Pain
105 (.83%)
Hypertension
102 (.81%)
Weight Increased
102 (.81%)
Loss Of Consciousness
89 (.7%)
Mental Disorder
87 (.69%)
Tremor
87 (.69%)
Abnormal Behaviour
85 (.67%)
Abdominal Pain
73 (.58%)
Altered State Of Consciousness
73 (.58%)
Disturbance In Attention
73 (.58%)
Fatigue
70 (.55%)
Asthenia
67 (.53%)
Confusional State
67 (.53%)
Nightmare
67 (.53%)
Anger
66 (.52%)
Crying
66 (.52%)
Diarrhoea
66 (.52%)
Abdominal Pain Upper
64 (.51%)
Fall
63 (.5%)
Pruritus
63 (.5%)
Amnesia
60 (.47%)
Convulsion
59 (.47%)
Blood Glucose Increased
58 (.46%)
Dysgeusia
56 (.44%)
Sleep Disorder
56 (.44%)
Suicide Attempt
56 (.44%)
Death
55 (.44%)
Weight Decreased
55 (.44%)
Abdominal Distension
53 (.42%)
Apathy
53 (.42%)
Constipation
53 (.42%)
Palpitations
53 (.42%)
Stress
53 (.42%)
Hypersensitivity
52 (.41%)
Abdominal Discomfort
51 (.4%)
Epilepsy
49 (.39%)
Pain
48 (.38%)
Oedema Peripheral
47 (.37%)
Tobacco User
46 (.36%)
Psychotic Disorder
44 (.35%)
Rash
44 (.35%)
Drug Interaction
43 (.34%)
Emotional Disorder
42 (.33%)
Fear
42 (.33%)
Mood Altered
42 (.33%)
Throat Tightness
41 (.32%)
Drug Ineffective
40 (.32%)
Haematochezia
40 (.32%)
Heart Rate Increased
40 (.32%)
Hypotension
40 (.32%)
Mood Swings
39 (.31%)
Pyrexia
39 (.31%)
Vision Blurred
39 (.31%)
Gait Disturbance
38 (.3%)
Major Depression
38 (.3%)
Memory Impairment
38 (.3%)
Eating Disorder
37 (.29%)
Blood Pressure Decreased
36 (.28%)
Hypoaesthesia
36 (.28%)
Myocardial Infarction
36 (.28%)
Hallucination
35 (.28%)
Personality Change
35 (.28%)
Back Pain
34 (.27%)
Mania
34 (.27%)
Panic Attack
34 (.27%)
Pain In Extremity
33 (.26%)
Rash Generalised
31 (.25%)
Visual Impairment
31 (.25%)
Withdrawal Syndrome
31 (.25%)
Affect Lability
30 (.24%)
Psychiatric Symptom
30 (.24%)
Skin Exfoliation
30 (.24%)
Tachycardia
30 (.24%)
Blister
29 (.23%)
Emphysema
29 (.23%)
Hypersomnia
29 (.23%)
Paranoia
29 (.23%)
Swelling Face
29 (.23%)
Cardiac Disorder
28 (.22%)
Chest Discomfort
28 (.22%)

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

What are the most common Varenicline Tartrate 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 Tartrate, 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 Tartrate 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 Tartrate According to Those Reporting Adverse Events

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

Smoking Cessation Therapy
1499
Tobacco User
176
Nicotine Dependence
93
Tobacco Abuse
19
Product Used For Unknown Indication
14
Ex-tobacco User
13
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Drug Use For Unknown Indication
6
Restless Legs Syndrome
2
Alcoholism
2
Dependence
1
Fungal Infection
1
Drug Dependence
1
Suicide Attempt
1
Smoker
1
Deep Vein Thrombosis
1

Varenicline Tartrate Case Reports

What Varenicline Tartrate 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 Tartrate. 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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