Varenicline

Side effects and indications

Whenever possible, frequency information about the side effects was extracted from the labels. Aggregated frequency information for the drug and, if available, placebo is shown. To the right, you can click on shaded boxes to be taken to mentions of the side effect on the label. (In some cases, the side effect cannot be highlighted due to conversion problems.) Information about indications was extracted from the indications and usage sections of the labels.

Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4 5
Anxiety def Anxiety def postmarketing, frequent x x x x x
Arthralgia def Arthralgia def frequent x x x x x
Musculoskeletal discomfort Arthralgia def frequent x x x x x
Myalgia def frequent x x x x x
Back pain def Back pain def frequent x x x x x
Chest pain def Chest pain def frequent x x x x x
Chest discomfort infrequent x x x x x
Diarrhoea def Diarrhoea def frequent x x x x x
Dizziness def Dizziness def frequent x x x x x
Syncope def infrequent x x x x x
Oedema def Oedema def frequent x x x x x
Epistaxis def Epistaxis def frequent x x x x x
Dermatitis def Rash def frequent x x x x x
Dermatitis def infrequent x x x x
Rash def Rash def frequent x x x x x
Flushing def Flushing def frequent x x x x x
Gingivitis def Gingivitis def frequent x x x x
Hyperhidrosis def Hyperhidrosis def frequent x x x x x
Sweating def infrequent x
Hypertension def Hypertension def frequent x x x x x
Influenza def Influenza def frequent x x x x x
Irritability def Irritability def frequent x x x x
Menstrual disorder def Menstrual disorder def frequent x x x x x
Muscle spasms def Cramp muscle def frequent x x x x x
Muscle spasms def infrequent x
Musculoskeletal pain def Musculoskeletal pain def frequent x x x x x
Pain def Pain def infrequent, frequent x x x x x
Polyuria def Polyuria def frequent x x x x x
Urine output increased Polyuria def frequent x x x x x
Respiratory disorder def Respiratory disorder def frequent x x x x x
Thirst def Thirst def frequent x x x x
Weight increased def Weight increased def frequent x x x x x
Agitation def Agitation def postmarketing — frequent x x x x x
Hyperkinesia def infrequent x x x x x
Liver function test abnormal Liver function test abnormal frequent x x x x x
Sensory disturbance def Sensory disturbance def frequent x x x x x
Malaise def Sickness postmarketing, frequent x x x x x
Malaise def x x x x x
Myalgia def Myalgia def frequent x x x x x
Disturbance in attention Disturbance in attention frequent x x x x x
Emotional disorder Emotional disorder frequent x x x x
Rash generalised Rash generalised frequent x
Influenza like illness Influenza like illness frequent x x x x
Menopausal symptoms def Hot flush def frequent x x x x x
Hot flush def Hot flush def frequent x x x x x
Somnolence def Somnolence def frequent x x x x x
Aggression def Aggression def postmarketing, infrequent x x x x x
Amnesia def Amnesia def infrequent x x x x x
Anaemia def Anaemia def infrequent x x x x x
Angina pectoris def Angina pectoris def infrequent x x x x x
Arrhythmia def Arrhythmia def infrequent x x x x x
Arthritis def Arthritis def infrequent x x x x x
Asthma def Asthma def infrequent x x x x x
Atrial fibrillation def Atrial fibrillation def rare, infrequent x x x x x
Bladder disorder def Bladder disorder def infrequent x x x x x
Bronchitis def Bronchitis def infrequent x
Musculoskeletal chest pain Chest wall pain def infrequent x
Tongue coated Tongue coated infrequent x
Conjunctivitis def Conjunctivitis def infrequent x x x x x
Cough def Cough def infrequent x
Cyst def Cyst def infrequent x
Libido decreased def Libido decreased def infrequent x x x x x
Disturbance in sexual arousal Libido decreased def infrequent x x x x x
Libido increased def infrequent x
Dysphagia def Dysphagia def infrequent x x x x x
Diabetes mellitus def Diabetes mellitus def infrequent x x x x x
Dysarthria def Dysarthria def rare, infrequent x x x x x
Osteoarthritis def Dysarthria def rare, infrequent x x x x x
Eczema def Eczema def infrequent x x x x x
Enterocolitis def Enterocolitis def infrequent x x x x x
Eructation def Eructation def infrequent x x x x x
Oesophagitis def Oesophagitis def infrequent x x x x x
Body temperature increased def Body temperature increased def infrequent x x x x x
Gallbladder disorder def Gallbladder disorder def infrequent x x x x x
Gastritis def Gastritis def infrequent x x x x x
Gastrointestinal haemorrhage def Gastrointestinal haemorrhage def infrequent x x x x x
Glycosuria def Glycosuria def infrequent x
Haematemesis def Haematemesis def infrequent x
Haematochezia def Haematochezia def infrequent x
Haemorrhage def Haemorrhage def infrequent x x x x x
Haemoglobin def Haemorrhage def infrequent x x x x x
Dysphonia def Hoarseness def infrequent x
Hyperlipidaemia def Hyperlipidaemia def infrequent x x x x x
Hypersensitivity def Hypersensitivity def rare — infrequent x x x x x
Hypoaesthesia def Hypoaesthesia def infrequent x
Hypocalcaemia def Hypocalcaemia def infrequent x
Calcium low infrequent x
Hypokalaemia def Hypokalaemia def infrequent x x x x x
Hypotension def Hypotension def infrequent x x x x
Libido increased def Libido increased def infrequent x
Infarction def Infarction def postmarketing, infrequent x x x x x
Infection def Infection def infrequent x
Ischaemia def Ischaemia def infrequent x x x x
Menorrhagia def Menorrhagia def infrequent x
Hypertonia def Hypertonia def infrequent x
Fungal infection def Fungal infection def infrequent x
Mydriasis def Mydriasis def infrequent x
Myocardial infarction def Myocardial infarction def postmarketing, infrequent x x x x x
Acute coronary syndrome def Myocardial infarction def postmarketing, infrequent x x x x x
Acute coronary syndrome def rare x x x x x
Myopia def Myopia def infrequent x
Nasopharyngitis def Nasopharyngitis def infrequent x
Rhinorrhoea def infrequent x x x x x
Night sweats def Night sweats def infrequent x
Nocturia def Nocturia def infrequent x x x x x
Osteoporosis def Osteoporosis def infrequent x x x x x
Palpitations def Palpitations def infrequent x x x x x
Panic reaction def Panic reaction def postmarketing, infrequent x x
Upper-airway cough syndrome Postnasal drip def infrequent x
Psoriasis def Psoriasis def infrequent x x x x x
Restless legs syndrome def Restless legs syndrome def infrequent x x x x x
Scotoma def Scotoma def rare, infrequent x x x x x
Sinusitis def Sinusitis def infrequent x
Snoring def Snoring def infrequent x
Stomatitis def Stomatitis def infrequent x
Mouth ulceration def infrequent x x x x x
Aphthous stomatitis def Aphthous stomatitis def infrequent x
Shock def Syncope def infrequent x x x x x
Syncope def Syncope def infrequent x x x x x
Loss of consciousness def Syncope def infrequent x x x x x
Tachycardia def Tachycardia def infrequent x x x x x
Thrombosis def Thrombosis def infrequent x x x x x
Thyroid disorder def Thyroid disorder def infrequent x x x x x
Costochondritis def Costochondritis def infrequent x
Tinnitus def Tinnitus def infrequent x x x x x
Tremor def Tremor def infrequent x x x x x
Ulcer def Ulcer def rare, infrequent x x x x x
Erythema def Erythema def postmarketing, infrequent x x x x x
Urticaria def Urticaria def infrequent x x x x x
Vertigo def Vertigo def infrequent x x x x x
Viral infection def Viral infection def infrequent x
Chills def Chills def infrequent x x x x x
Polydipsia def Polydipsia def infrequent x
Mood swings Mood swings infrequent x x x x x
Affect lability Mood swings infrequent x x x x x
Photophobia def Photophobia def rare, infrequent x x x x x
Dissociation Dissociation infrequent x x x x x
Mouth ulceration def Mouth ulceration def infrequent x x x x x
Migraine def Migraine def infrequent x x x x x
Ventricular extrasystoles def Ventricular extrasystoles def infrequent x x x x x
Eye pain def Eye pain def infrequent x x x x x
Dry skin def Dry skin def infrequent x x x x x
Hypogeusia Hypogeusia infrequent x
Sinus congestion Sinus congestion infrequent x
Lacrimation increased def Lacrimation increased def infrequent x
Lacrimation def infrequent x
Urethral syndrome Urethral syndrome infrequent x x x x x
Abnormal faeces Abnormal faeces infrequent x
Joint stiffness def Joint stiffness def infrequent x
Vaginal discharge def Vaginal discharge def infrequent x
Cardiac fibrillation Cardiac fibrillation rare, infrequent x x x x x
Disorientation Disorientation infrequent x x x x x
Dysphoria Dysphoria infrequent x
Thinking abnormal Thinking abnormal infrequent x x x x x
Mental disability Thinking abnormal infrequent x x x x x
Mental disability rare x x x x x
Discomfort def Discomfort def infrequent x x x x x
Malaise def x x x x x
Feeling cold Feeling cool infrequent x
Eye irritation Eye irritation infrequent x x x x x
Peripheral ischaemia def Peripheral ischaemia def infrequent x x x x
Urine abnormality Urine abnormality infrequent x x x x x
Urine analysis abnormal Urine abnormality infrequent x x x x x
Urine analysis abnormal infrequent x x x x x
Chest discomfort Chest discomfort infrequent x x x x x
Semen analysis abnormal Semen abnormal infrequent x
Gingival pain def Gingival pain def infrequent x
Erectile dysfunction def Erectile dysfunction def infrequent x x x x x
Change of bowel habit Change of bowel habit infrequent x
Dry eye Dry eye infrequent x x x x x
Extrasystoles def Extrasystoles def infrequent x x x x x
Vision blurred def Vision blurred def infrequent x x x x x
Platelet count decreased Platelet count decreased infrequent x
Nephrolithiasis def Nephrolithiasis def infrequent x x x x x
Hyperkinesia def Hyperkinesia def infrequent x x x x x
Musculoskeletal stiffness Stiffness infrequent x
Bradycardia def Bradycardia def infrequent x x x x x
Electrocardiogram ST segment Electrocardiogram ST segment infrequent x
Electrocardiogram T wave amplitude decreased Electrocardiogram T wave amplitude decreased infrequent x
Lymphadenopathy def Lymphadenopathy def infrequent x x x x x
Blood pressure increased Blood pressure increased infrequent x
Electrocardiogram ST segment depression def Electrocardiogram ST segment depression def infrequent x
Coordination abnormal Coordination abnormal infrequent x
Electrocardiogram abnormal Electrocardiogram abnormal infrequent x x x x x
Visual impairment def Visual disturbance infrequent x x x x x
Sexual dysfunction Sexual dysfunction rare, infrequent x x x x x
Bradyphrenia Bradyphrenia rare, infrequent x x x x x
Throat irritation Throat irritation infrequent x
Acne def Acne def infrequent x x x x x
Sleep disorder def Sleep disorder def infrequent x x x x x
Sleep disturbance x x x
Oropharyngeal pain Pharyngolaryngeal pain def infrequent x
Circadian rhythm sleep disorder def Circadian rhythm sleep disorder def infrequent x
Muscle enzyme increased Muscle enzyme increased infrequent x x x x x
Rhinorrhoea def Rhinorrhoea def infrequent x x x x x
Parosmia def Parosmia def infrequent x x x x x
Pancreatitis acute def Pancreatitis acute def rare x x x x x
Angioedema def Angioedema def postmarketing x
Mental disorder def Mental disorder def postmarketing x x x x x
Cardiovascular disorder def Cardiovascular disorder def postmarketing x
Transient ischaemic attack def Transient ischaemic attack def rare x x x x x
Convulsion def Convulsion def rare x x x x x
Deafness def Deafness def rare x x x x x
Delusion def Delusion def postmarketing x
Drug hypersensitivity def Drug hypersensitivity def rare x x x x
Embolism def Embolism def rare x x x x x
Erythema multiforme def Erythema multiforme def postmarketing x
VIIth nerve paralysis Facial paralysis def rare x x x x x
Vitreous floaters def Vitreous floaters def rare x x x x x
Cardiac flutter Cardiac flutter rare x x x x x
Hallucination def Hallucination def rare, postmarketing x x x x x
Hostility def Hostility def postmarketing x x
Hyperkalaemia def Hyperkalaemia def rare x x x x
Hypoglycaemia def Hypoglycaemia def rare x x x x x
Intestinal obstruction def Intestinal obstruction def rare x x x x x
Renal failure acute def Renal failure acute def rare x x x x x
Leukocytosis def Leukocytosis def rare x x x x x
Multiple sclerosis def Multiple sclerosis def rare x x x x x
Myositis def Myositis def rare x x x x x
Night blindness def Night blindness def rare x x x x x
Acquired night blindness rare x x x x x
Nystagmus def Nystagmus def rare x x x x x
Obstruction def Obstruction def rare x x x x x
Pancreatitis def Pancreatitis def rare x x x x x
Pleurisy def Pleurisy def rare x x x x x
Psychotic disorder def Psychotic disorder def rare, postmarketing x x x x x
Paranoia def postmarketing x
Pulmonary embolism def Pulmonary embolism def rare x x x x x
Cor pulmonale def Cor pulmonale def rare x x x x x
Renal failure def Renal failure def rare x x x x x
Splenomegaly def Splenomegaly def rare x x x x x
Gastric ulcer def Gastric ulcer def rare x x x x x
Cerebrovascular accident def Cerebrovascular accident def rare, postmarketing x x x x x
Completed suicide Suicide def postmarketing, rare x x x x
Completed suicide postmarketing x
Suicide attempt def Suicide attempt def postmarketing x
Thrombocytopenia def Thrombocytopenia def rare x x x x x
Angiopathy def Angiopathy def rare x x x x x
Urinary retention def Urinary retention def rare x x x x x
Cataract def Cataract def rare x x x x x
Blindness transient Blindness transient rare x x x x x
Photosensitivity reaction def Photosensitivity reaction def rare x x x x x
Photosensitivity def rare x x x x x
Euphoric mood def Euphoric mood def rare x x x x x
Cataract subcapsular Cataract subcapsular rare x x x x x
Mania def Mania def postmarketing x
Depressed mood def Depressed mood def postmarketing x x x
Suicidal ideation def Suicidal ideation def rare, postmarketing x x x x x
Homicidal ideation Homicidal ideation postmarketing x
Blindness def Blindness def rare x x x x x
Paralysis def Paralysis def rare x x x x x
Balance disorder Balance disorder rare x x x x x
Arterial disorder def Arterial disorder def rare x x x x x
Psychomotor skills impaired Psychomotor skills impaired rare x x x x x
Ocular vascular disorder Ocular vascular disorder rare x x x x x
Mental retardation def Mental disability rare x x x x x
Paranoia def Paranoia def postmarketing x
Coronary artery disease def Coronary artery disease def rare x x x x x
Abdominal pain def Abdominal pain def x x x x x
Gastrointestinal pain def Abdominal pain def x x x x x
Anger def Anger def x
Decreased appetite Anorexia def x x x x x
Decreased appetite x x x x x
Asthenia def Asthenia def x x x x x
Fatigue def x x x x x
Breast disorder def Breast disorder def x x x x x
Connective tissue disorder def Connective tissue disorder def x x x x x
Constipation def Constipation def x x x x x
Dysgeusia def Dysgeusia def x x x x x
Dyspepsia def Dyspepsia def x x x x x
Dyspnoea def Dyspnoea def x x x x x
Endocrine disorder def Endocrine disorder def x x x x x
Hormone level abnormal Endocrine disorder def x x x x x
Eye disorder def Eye disorder def x x x x x
Fatigue def Fatigue def x x x x x
Flatulence def Flatulence def x x x x x
Frustration def Frustration def x
Gastrooesophageal reflux disease def Gastrooesophageal reflux disease def x x x x x
Gastrointestinal disorder def Gastrointestinal disorder def x x x x x
Headache def Headache def x x x x x
Cardiac disorder def Cardiac disorder def x x x x x
Immune system disorder def Immune system disorder def x x x x
Lethargy def Lethargy def x x x x x
Lung disorder def Lung disorder def x
Chronic obstructive pulmonary disease def Chronic obstructive pulmonary disease def x
Mediastinal disorder def Mediastinal disorder def x x x x x
Nausea def Nausea def x x x x x
Nervous system disorder def Nervous system disorder def x x x x x
Nightmare def Nightmare def x x x x x
Pruritus def Pruritus def x x x x x
Gastric disorder def Gastric disorder def x x x x x
Urethral disorder def Urinary tract disorder def x x x x x
Urinary tract disorder def Urinary tract disorder def x x x x x
Vomiting def Vomiting def x x x x x
Dry mouth def Dry mouth def x x x x x
Peripheral vascular disorder def Peripheral vascular disorder def x
Oedema peripheral def Oedema peripheral def x
Feeling abnormal Malaise def x x x x x
Ill-defined disorder Malaise def x x x x x
Increased appetite Increased appetite x x x x x
Tenderness def Tenderness def x x x x x
Abnormal dreams Abnormal dreams x x x x x
Abdominal discomfort Upset stomach x x x x x
Hepatobiliary disease def Hepatobiliary disease def x x x x x
Initial insomnia Initial insomnia x x x x x
Middle insomnia Middle insomnia x x x x x
Terminal insomnia Terminal insomnia x x x x x
Obstructive airways disorder def Obstructive airways disorder def x
Aortic dissection def Dissecting aortic aneurysm, thoracic x x x x x
Infestation Infestation NOS x
Insomnia def Insomnia def x x x x x
Death Death x
Indication Labels
Function kidney decreased x
Renal impairment def x

Information

More information: STITCH, PubChem and possibly Wikipedia or Medpedia

ATC Code: N07BA03

Legend

Color scheme: standard – alternative

100%    
75%    
50%    
10%    
frequent (1% to 100%)    
infrequent (0.1% to 1%)    
rare (<0.1%)    
postmarketing    
0%    
no frequency information    
not found on label    

Labels

Labels were obtained from different sources and potentially contain different sets of side effects. If you click on the label name, a HTML version of the label will be shown with proteins, chemicals and side efffects highlighted using Reflect.

  1. VARENICLINE TARTRATE / CHANTIX : 207 side effects (Drugs@FDA)
  2. VARENICLINE TARTRATE / CHANTIX : 209 side effects (Drugs@FDA)
  3. VARENICLINE TARTRATE / CHANTIX : 209 side effects (Drugs@FDA)
  4. varenicline : 212 side effects (FDA XML label)
  5. VARENICLINE (VARENICLINE TARTRATE) / CHAMPIX : 267 side effects (Health Canada)