Chantix Side Effects

Generic Name: varenicline

Please note - some side effects for Chantix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Chantix - for the Consumer

Chantix

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Chantix:

Constipation; gas; headache; increased appetite; nausea; stomach upset; strange dreams; taste changes; trouble sleeping; vivid, strange, or unusual dreams; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; chest pain; fast, slow, or irregular heartbeat; hallucinations; memory loss; new or worsening mental or mood problems (eg, aggression, agitation, anger, anxiety, depression, nervousness, thoughts of hurting other people); red, swollen, blistered, or peeling skin; seizures; severe or persistent nausea; suicidal thoughts or actions; vision changes.

Chantix Side Effects - for the Professional

Chantix

During the premarketing development of Chantix, over 4500 individuals were exposed to Chantix, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less.

In Phase 2 and 3 placebo-controlled studies, the treatment discontinuation rate due to adverse events in patients dosed with 1 mg BID was 12% for Chantix compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates for the most common adverse events in Chantix treated patients were as follows: nausea (3% vs. 0.5% for placebo), headache (0.6% vs. 0.9% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo).

Adverse Events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1).

The most common adverse events associated with Chantix (>5% and twice the rate seen in placebo-treated patients) were nausea, sleep disturbance, constipation, flatulence, and vomiting.

Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms.

The most common adverse event associated with Chantix treatment is nausea. For patients treated to the maximum recommended dose of 1 mg BID following initial dosage titration, the incidence of nausea was 30% compared with 10% in patients taking a comparable placebo regimen. In patients taking Chantix 0.5 mg BID following initial titration, the incidence was 16% compared with 11% for placebo. Nausea was generally described as mild or moderate and often transient; however, for some subjects, it was persistent throughout the treatment period.

Table 3 shows the adverse events for Chantix and placebo in the 12 week fixed dose studies with titration in the first week (Studies 2 (titrated arm only), 4, and 5). MedDRA High Level Group Terms (HLGT) reported in ≥ 5% of patients in the Chantix 1 mg BID dose group, and more commonly than in the placebo group, are listed, along with subordinate Preferred Terms (PT) reported in ≥ 1% of Chantix patients (and at least 0.5% more frequent than placebo). Closely related Preferred Terms such as 'Insomnia', 'Initial insomnia', 'Middle insomnia', 'Early morning awakening' were grouped, but individual patients reporting two or more grouped events are only counted once.

The overall pattern, and the frequency of adverse events during the longer-term trials was very similar to that described in Table 3, though several of the most common events were reported by a greater proportion of patients. Nausea, for instance, was reported in 40% of patients treated with Chantix 1 mg BID in a one-year study, compared to 8% of placebo-treated patients.

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.

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.

Post-Marketing Experience

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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of depression, mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed 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.

There have been reports of hypersensitivity reactions, including angioedema.

There have also been reports of serious skin reactions, including Stevens Johnson Syndrome and Erythema Multiforme in patients taking Chantix.

Side Effects by Body System

Gastrointestinal

Gastrointestinal (GI) side effects have frequently included nausea (7.2% to 40%), flatulence (6% to 9%), constipation (5% to 8.5%), upper abdominal pain (2% to 7.7%), dry mouth (4% to 6%), abdominal pain (5%), dyspepsia (5%), vomiting (1% to 5%), and GI reflux disease (1%). Diarrhea, gingivitis, dysphagia, enterocolitis, eructation, gastritis, GI hemorrhage, mouth ulceration, esophagitis, gastric ulcer, intestinal obstruction, acute pancreatitis, and gall bladder disease have been reported. At least one case of cholecystitis has also been reported, in addition to case of peritonitis and a case of hemorrhoids and rectal prolapse.

The most common side effect associated with varenicline in clinical trials was nausea. Nausea was typically transient and described as mild or moderate in intensity; however, some patients experienced persistent nausea throughout treatment.

Psychiatric

Psychiatric side effects have included insomnia (19%), abnormal dreams (9% to 13%), sleep disorder (2%), and nightmare (2%). Anxiety, depression, emotional disorder, irritability, restlessness, aggression, agitation, disorientation, dissociation, decreased libido, mood swings, abnormal thinking, bradyphrenia, euphoric mood, hallucination, psychotic disorder, suicidal ideation, and erratic behavior have also been reported. Depressed mood, agitation, changes in behavior, and suicide have been reported during postmarketing experience. At least one case of varenicline-induced manic episode has also been reported, in addition to a case of exacerbation of schizophrenia.

A 63-year-old male with stable bipolar disorder experienced a manic episode coincident with varenicline therapy. The patient was admitted to an inpatient psychiatric unit and met criteria for a manic episode. He began exhibiting manic symptoms one week after initiating therapy with varenicline 1 mg twice daily for smoking cessation. Varenicline was stopped upon admission. Within one week of admission, he was euthymic, without manic or psychotic symptoms.

A 42-year-old female with a 17-year history of schizophrenia experienced exacerbation of schizophrenia coincident with varenicline therapy. She had been prescribed varenicline 2 mg for 5-days to help her stop smoking. The patient's mother reported a 5-day psychotic episode that began with increased activity. After she was advised to discontinue varenicline, she had no further exacerbation.

Nervous system

Nervous system side effects have frequently included headaches (10.3% to 19%), dysgeusia (8%), fatigue, malaise, asthenia, somnolence, and lethargy. Attention disturbances, dizziness, sensory disturbance, amnesia, migraine, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder, cerebrovascular accident, convulsion, dysarthria, facial palsy, mental impairment, multiple sclerosis, nystagmus, impairment of psychomotor skills, transient ischemic attack, visual field defect, and drowsiness have been reported.

Respiratory

Respiratory side effects have frequently included influenza (3.2% to 5.8%), rhinorrhea, dyspnea, and upper respiratory tract disorder. Epistaxis, respiratory disorders, asthma, pleurisy, and pulmonary embolism have also been reported.

Dermatologic

Dermatologic side effects have frequently included rash and pruritus. Hyperhidrosis, acne, dermatitis, dry skin, eczema, erythema, psoriasis, urticaria, and photosensitivity reaction have also been reported.

Metabolic

Metabolic side effects have frequently included increased or decreased appetite and anorexia. Hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, and increased weight have also been reported.

Hematologic

Hematologic side effects have included anemia, lymphadenopathy, leukocytosis, thrombocytopenia, and splenomegaly.

Cardiovascular

Cardiovascular side effects have included angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, myocardial infarction, palpitations, tachycardia, atrial fibrillation, cardiac flutter, coronary artery disease, cor pulmonale, abnormal electrocardiogram, acute coronary syndrome, hypertension, hypotension, peripheral ischemia, and thrombosis.

Endocrine

Endocrine side effects have included thyroid gland disorders and diabetes mellitus. At least one case of pituitary hemorrhage has also been reported.

Ocular

Ocular side effects have included conjunctivitis, dry eye, eye irritation, blurred vision, visual disturbance, eye pain, acquired night blindness, transient blindness, cataract subcapsular, ocular vascular disorder, photophobia, and vitreous floaters.

Hypersensitivity

Hypersensitivity side effects including seasonal allergy (2.6% to 5.9%) have been reported.

Genitourinary

Genitourinary side effects have included abnormal urine analysis, polyuria, nocturia, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction, and sexual dysfunction. At least one case of ovarian hematoma has also been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, back pain, muscle cramp, musculoskeletal pain, myalgia, arthritis, osteoporosis, and myositis.

Renal

Renal side effects have included nephrolithiasis, urethral syndrome, and acute renal failure. At least one case of elevated blood creatinine has also been reported.

Immunologic

Immunologic side effects commonly reported have included nasopharyngitis (35.9% to 51%), bronchitis, sinusitis, fungal infection, and viral infection.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported.

Other

Other side effects have included tinnitus, vertigo, deafness, Meniere's disease, chest pain, influenza-like symptoms, edema, thirst, chest discomfort, chills, pyrexia, increased muscle enzyme, and hot flash. At least one case of feeling abnormal has been reported, in addition to a case of elevated aspartate aminotransferase, two cases of elevated alanine aminotransferase, and one case of elevated blood bilirubin.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.