Side Effects of Chantix Source: FDA

Nausea occurs commonly in people taking varenicline. Other less common side effects include headache, difficulty sleeping, and abnormal dreams. Rare side effects reported by people taking varenicline compared to placebo include change in taste, vomiting, abdominal pain, flatulence, and constipation.

In November 2007, the FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. It is unknown whether the psychiatric symptoms are related to the drug or to nicotine withdrawal symptoms, although not all patients had stopped smoking. FDA is aware of the highly-publicized case of Carter Albrecht who was shot to death by his neighbour after, in the apparent state of delirium, hitting his girlfriend and trying to force the entry in the neighbor's house.Although in this case the delirium appeared to be caused by taking varenicline with a high dose of alcohol, FDA asked Pfizer for additional cases that might be similar. The FDA also recommended that health care professionals and patients watch for behavioral and mood changes. March 13, 2008 an article was published in Diabetes Medicine about an insulin-dependent diabetic who had multiple episodes of hypoglycemia which she had not had before taking varenicline and which stopped when varenicline was stopped.

Following is a list of 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 lifethreatening.

BLOOD AND LYMPHATIC SYSTEM DISORDERS.
Infrequent: Anemia, Lymphadenopathy. Rare: Leukocytosis, Thrombocytopenia, Splenomegaly.

CARDIAC DISORDERS.
Infrequent: Angina pectoris, Arrhythmia, Bradycardia, Ventricular extrasystoles, Myocardial infarction, Palpitations, Tachycardia. Rare: Atrial fibrillation, Cardiac flutter, Coronary artery disease, Cor pulmonale, Acute coronary syndrome.

EAR AND LABYRINTH DISORDERS.
Infrequent: Tinnitus, Vertigo. Rare: Deafness, Meniere’s disease.

ENDOCRINE DISORDERS.
Infrequent: Thyroid gland disorders.

EYE DISORDERS.
Infrequent: Conjunctivitis, Dry eye, Eye irritation, Vision blurred, Visual disturbance, Eye pain. Rare: Acquired night blindness, Blindness transient, Cataract subcapsular, Ocular vascular disorder, Photophobia, Vitreous floaters.

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.

HEPATOBILIARY DISORDERS.
Infrequent: Gall bladder disorder.

IMMUNE SYSTEM DISORDERS.
Infrequent: Hypersensitivity. Rare: Drug hypersensitivity.

INVESTIGATIONS.
Frequent: Liver function test abnormal, Weight increased. Infrequent: Electrocardiogram abnormal, Muscle enzyme increased, Urine analysis abnormal.

METABOLISM AND NUTRITION DISORDERS.
Infrequent: Diabetes mellitus, Hyperlipidemia, Hypokalemia. Rare: Hyperkalemia, Hypoglycemia.

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.