This list is from the Pfizer/Chantix web site.
Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
- GASTROINTESTINAL DISORDERS. Frequent: Diarrhea, Gingivitis. Infrequent: Dysphagia, Enterocolitis, Eructation, Gastritis, Gastrointestinal hemorrhage, Mouth ulceration, Esophagitis. Rare: Gastric ulcer, Intestinal obstruction, Pancreatitis acute.
- GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS. Frequent: Chest pain, Influenza like illness, Edema, Thirst. Infrequent: Chest discomfort, Chills, Pyrexia.
- INVESTIGATIONS. Frequent: Liver function test abnormal, Weight increased. Infrequent: Electrocardiogram abnormal, Muscle enzyme increased, Urine analysis abnormal.
- MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS. Frequent: Arthralgia, Back pain, Muscle cramp, Musculoskeletal pain, Myalgia. Infrequent: Arthritis, Osteoporosis. Rare: Myositis.
- NERVOUS SYSTEM DISORDERS. Frequent: Disturbance in attention, Dizziness, Sensory disturbance. Infrequent: Amnesia, Migraine, Parosmia, Psychomotor hyperactivity, Restless legs syndrome, Syncope, Tremor. Rare: Balance disorder, Cerebrovascular accident, Convulsion, Dysarthria, Facial palsy, Mental impairment, Multiple sclerosis, Nystagmus, Psychomotor skills impaired, Transient ischemic attack, Visual field defect.
- PSYCHIATRIC DISORDERS. Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. Infrequent: Aggression, Agitation, Disorientation, Dissociation, Libido decreased, Mood swings, Thinking abnormal. Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation.
- RENAL AND URINARY DISORDERS. Frequent: Polyuria. Infrequent: Nephrolithiasis, Nocturia, Urine abnormality, Urethral syndrome. Rare: Renal failure acute, Urinary retention.
- REPRODUCTIVE SYSTEM AND BREAST DISORDERS. Frequent: Menstrual disorder. Infrequent: Erectile dysfunction. Rare: Sexual dysfunction.
- RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS. Frequent: Epistaxis, Respiratory disorders. Infrequent: Asthma. Rare: Pleurisy, Pulmonary embolism.
- SKIN AND SUBCUTANEOUS TISSUE DISORDERS. Frequent: Hyperhidrosis. Infrequent: Acne, Dermatitis, Dry skin, Eczema, Erythema, Psoriasis, Urticaria. Rare: Photosensitivity reaction.
- VASCULAR DISORDERS. Frequent: Hot flush, Hypertension. Infrequent: Hypotension, Peripheral ischemia, Thrombosis.
12. The following adverse events have been reported during post-approval use of Chantix. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
13. There have been reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix. Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had discontinued smoking. The role of Chantix in these reports is not known (see WARNINGS).