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Chantix (Varenicline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Chantix (Varenicline) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (8032)
Death (210)
Life Threatening Events (44)
Disability (203)

Reports by Reaction Type

Depression (1644)Anxiety (1344)Abnormal Dreams (1126)Nausea (1078)Suicide Attempt (766)Insomnia (654)Aggression (608)Drug Ineffective (604)Suicidal Ideation (572)Feeling Abnormal (516)Malaise (423)Intentional Overdose (421)

Below are a few examples of reports where side effects / adverse reactions may be related to Chantix (Varenicline). For a complete list or a specific selection of reports, please use the links above.

Possible Chantix side effects in 65 year old female

Reported by a physician from Denmark on 2012-08-27

Patient: 65 year old female

Reactions: Cardiac Disorder, Suicidal Ideation, Malaise, Arthropathy, Palpitations, Dizziness, Memory Impairment, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Drug Ineffective, Hallucination, Visual

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Depression, Feeling Abnormal

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Renal Disorder

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 26 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 26 year old male

Reactions: Physical Assault, Suicide Attempt, Depression, Aggression

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 65 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Renal Function Test Abnormal, Drug Intolerance

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Indication: Smoking Cessation Therapy
    Start date: 2012-01-01
    End date: 2012-01-01

Chantix
    Dosage: unk
    Start date: 2012-01-01

Epzicom
    Dosage: 300 mg, daily
    Indication: HIV Infection
    End date: 2012-01-01



Possible Chantix side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 59 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Limb Discomfort, LIP Disorder, Headache

Drug(s) suspected as cause:
Chantix
    Dosage: 1 mg, daily
    Administration route: Oral
    Start date: 2012-08-01

Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-08-14
    End date: 2012-08-01

Chantix
    Dosage: 1 mg, 2x/day
    Administration route: Oral
    Start date: 2012-08-01
    End date: 2012-08-01



Possible Chantix side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Cough

Drug(s) suspected as cause:
Chantix
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-01
    End date: 2012-07-01

Chantix
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2011-08-01
    End date: 2012-01-01

Chantix
    Dosage: 1 mg, 2x/day
    Administration route: Oral
    Start date: 2012-07-01



Possible Chantix side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 76 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Abdominal Discomfort, Negative Thoughts, Mood Altered, Nausea, Gastrointestinal Disorder, Depressed Mood

Drug(s) suspected as cause:
Chantix
    Dosage: unk
    Administration route: Oral
    End date: 2012-08-01

Chantix
    Dosage: 1 mg, 2x/day
    Administration route: Oral

Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2011-01-01

Ibuprofen
    Dosage: unk
    Indication: Spinal Disorder

Other drugs received by patient: Lisinopril; Metoprolol Tartrate; Glipizide; Hydrochlorothiazide; Metformin Hydrochloride; Simvastatin



Possible Chantix side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 47 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Abnormal Dreams, Burning Sensation, Thinking Abnormal, Nausea, Trigeminal Neuralgia, Insomnia, Emotional Disorder, Multiple Sclerosis, Crying

Drug(s) suspected as cause:
Betaseron
    Dosage: unk
    Indication: Multiple Sclerosis
    Start date: 2004-01-01

Betaseron
    Indication: Trigeminal Neuralgia

Chantix
    Dosage: unk
    Administration route: Oral
    Indication: Smoking Cessation Therapy

Chantix
    Dosage: unk
    Administration route: Oral

Chantix
    Dosage: unk
    Administration route: Oral

Neurontin
    Dosage: 600 mg, daily
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2004-01-01

Neurontin
    Indication: Trigeminal Neuralgia

Rebif
    Dosage: 44 ug, 3x/week
    Indication: Multiple Sclerosis
    Start date: 2004-01-01

Rebif
    Indication: Trigeminal Neuralgia

Other drugs received by patient: Hydrocodone; Estradiol



Possible Chantix side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Cheilitis, Urticaria

Drug(s) suspected as cause:
Chantix
    Dosage: unk

Chantix
    Dosage: 0.5 mg, 2x/day



Possible Chantix side effects in

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 26 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 26 year old male, weighing 79.4 kg (174.6 pounds)

Reactions: Abnormal Dreams, Arthralgia, Pain in Extremity, Muscle Fatigue, Feeling Abnormal

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-07-01
    End date: 2012-07-01

Chantix
    Dosage: 0.5 mg, 2x/day
    Administration route: Oral
    Start date: 2012-07-01
    End date: 2012-07-12



Possible Chantix side effects in 80 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 80 year old male

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in female

Reported by a physician from Egypt on 2012-08-27

Patient: female

Reactions: Retroperitoneal Fibrosis

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 53 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Poor Quality Sleep, Depression

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 41 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 41 year old male, weighing 74.8 kg (164.6 pounds)

Reactions: Abnormal Dreams, Diarrhoea, Abdominal Pain Upper

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 58 year old male

Reported by a physician from United Kingdom on 2012-08-27

Patient: 58 year old male

Reactions: Confusional State, Emotional Distress, Mental Disorder, Violence-Related Symptom, Emotional Disorder, Crying

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Chantix

Other drugs received by patient: Rosuvastatin



Possible Chantix side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Hypersensitivity

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Abnormal Dreams

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 58 year old female

Reported by a physician from United Kingdom on 2012-08-27

Patient: 58 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Jaundice, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Blood Albumin Decreased

Drug(s) suspected as cause:
Chantix
    Dosage: starter pack
    Administration route: Oral
    Start date: 2012-03-09
    End date: 2012-01-01

Chantix
    Dosage: 1 mg
    Administration route: Oral
    Start date: 2012-03-26
    End date: 2012-04-13



Possible Chantix side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Abnormal Dreams, Pneumonia, Nausea, Sleep Disorder, Gastric Disorder

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Drug Administration Error, Feeling Abnormal

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 58 year old male, weighing 103.0 kg (226.6 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chantix

Other drugs received by patient: Nexium; Lisinopril; Crestor; Ventolin HFA; Symbicort



Possible Chantix side effects in 55 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 55 year old female

Reactions: Overwork, Road Traffic Accident, Sleep Disorder, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Abdominal Discomfort, Renal Pain

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, 1x/day
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-08-21
    End date: 2012-08-01

Chantix
    Dosage: 0.5 mg, 2x/day
    Administration route: Oral
    Start date: 2012-08-01



Possible Chantix side effects in 45 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 45 year old male, weighing 72.6 kg (159.6 pounds)

Reactions: Malaise, Skin Exfoliation, Expired Drug Administered

Drug(s) suspected as cause:
Chantix



Possible Chantix side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 49 year old female, weighing 86.2 kg (189.6 pounds)

Reactions: Abnormal Dreams

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, daily
    Start date: 2012-01-01
    End date: 2012-01-01

Chantix
    Dosage: unk
    Indication: Smoking Cessation Therapy



Possible Chantix side effects in 41 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 41 year old male, weighing 93.0 kg (204.5 pounds)

Reactions: Depression

Drug(s) suspected as cause:
Chantix
    Dosage: 0.5 mg, daily
    Administration route: Oral
    Indication: Smoking Cessation Therapy
    Start date: 2012-02-01

Chantix
    Dosage: unk
    Administration route: Oral
    End date: 2012-01-01



Possible Chantix side effects in female

Reported by a pharmacist from Japan on 2012-08-24

Patient: female

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
BUP-4
    Dosage: unk

Chantix
    Dosage: 1 mg, 2x/day
    Administration route: Oral

Vesicare
    Dosage: unk

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