- nausea (may persist for several months),
- stomach pain,
- unusual dreams,
- sleep problems (insomnia),
- headache, dry mouth, or
- unpleasant taste in your mouth.
Chantix is not addictive and is not a controlled substance; however, some patients may experience irritability and sleep disturbance if Chantix is abruptly discontinued. Patients may experience psychiatric symptoms such as behavioral changes, agitation, depressed mood, and suicidal behavior while using Chantix. Tell your doctor if you have serious side effects of Chantix including
- burning feeling in feet/toes, or
- unusual pain in the legs when walking.
The recommended dose of Chantix is 0.5 mg daily for 3 days followed by 0.5 mg twice daily for 4 days, then 1 mg twice daily for the remainder of the treatment period. Duration of therapy is 12 weeks. If treatment is successful, continue for an additional 12 weeks in order increase the chance of long-term abstinence. There are no adequate studies in pregnant women and it is not known whether Chantix is excreted in breast milk.
Our Chantix (varenicline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Your family or other caregivers should also be alert to changes in your mood or behavior.
Call your doctor at once if you have any of these other serious side effects:
- chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder, vomiting, sweating, general ill feeling;
- feeling light-headed or short of breath;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- easy bruising, unusual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
- the first sign of any blistering type of skin rash, no matter how mild.
Less serious side effects may include:
- nausea (may persist for several months);
- stomach pain, indigestion, constipation, gas;
- weakness, tired feeling;
- dry mouth, unpleasant taste in your mouth;
- headache; or
- sleep problems (insomnia) or unusual dreams.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Chantix (Varenicline)
The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling:
- Neuropsychiatric Adverse Events including Suicidality [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Interaction with alcohol [see WARNINGS AND PRECAUTIONS]
- Accidental injury [see WARNINGS AND PRECAUTIONS]
- Cardiovascular events [see WARNINGS AND PRECAUTIONS]
- Somnambulism [see WARNINGS AND PRECAUTIONS]
- Angioedema and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Serious skin reactions [see WARNINGS AND PRECAUTIONS]
In the placebo-controlled premarketing studies, the most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting.
The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for CHANTIX, compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates that are higher than placebo for the most common adverse events in CHANTIX-treated patients were as follows: nausea (3% vs. 0.5% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo).
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During the premarketing development of CHANTIX, over 4500 subjects 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.
The most common adverse event associated with CHANTIX treatment is nausea, occurring in 30% of patients treated at the recommended dose, compared with 10% in patients taking a comparable placebo regimen [see WARNINGS AND PRECAUTIONS].
Table 3 shows the adverse events for CHANTIX and placebo in the 12- week fixed dose premarketing studies with titration in the first week [Studies 2 (titrated arm only), 4, and 5]. Adverse events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1).
MedDRA High Level Group Terms (HLGT) reported in ≥ 5% of patients in the CHANTIX 1 mg twice daily 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.
Table 3: Common Treatment Emergent AEs (%) in the
Fixed-Dose, Placebo- Controlled Studies (HLGTs ≥ 5% of patients in the 1
mg BID CHANTIX Group and more commonly than Placebo and PT ≥ 1% in the 1
mg BID CHANTIX Group, and 1 mg BID CHANTIX at least 0.5% more than Placebo)
|SYSTEM ORGAN CLASS High Level Group Term Preferred Term||CHANTIX 0.5 mg BID
|CHANTIX 1 mg BID
|GI Signs and Symptoms|
|Abdominal Pain *||5||7||5|
|GI Motility/Defecation Conditions|
|Gastroesophageal reflux disease||1||1||0|
|Salivary Gland Conditions|
|Neurological Disorders NEC|
|General Disorders NEC|
|Respiratory Disorders NEC|
|Upper Respiratory Tract Disorder||7||5||4|
|Epidermal and Dermal Conditions|
|METABOLISM & NUTRITION|
|Appetite/General mNutrition Disorders|
|*Includes PTs Abdominal (pain, pain upper, pain lower,
discomfort, tenderness, distension) and Stomach discomfort
†Includes PTs Insomnia/Initial insomnia/Middle insomnia/Early morning awakening
The overall pattern and frequency of adverse events during the longer-term premarketing trials was similar to those described in Table 3, though several of the most common events were reported by a greater proportion of patients with long-term use (e.g., nausea was reported in 40% of patients treated with CHANTIX 1 mg twice daily 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 premarketing clinical trials and updated based on pooled data from 18 placebo-controlled preand post-marketing studies, including approximately 5,000 patients treated with varenicline. Adverse events were categorized using MedDRA, Version 16.0. 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.
Cardiac Disorders. Infrequent: angina pectoris, myocardial infarction, palpitations, tachycardia. Rare: acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, ventricular extrasystoles.
Endocrine Disorders. Infrequent: thyroid gland disorders.
Eye Disorders. Infrequent: conjunctivitis, eye irritation, eye pain, vision blurred, visual impairment.
Gastrointestinal Disorders. Frequent: diarrhea, toothache. Infrequent: dysphagia, eructation, gastritis, gastrointestinal hemorrhage, mouth ulceration. Rare: enterocolitis, esophagitis, gastric ulcer, intestinal obstruction, pancreatitis acute.
General Disorders and Administration Site Conditions. Frequent: chest pain. Infrequent: chest discomfort, chills, edema, influenza-like illness, pyrexia.
Hepatobiliary Disorders. Rare: gall bladder disorder.
Investigations. Frequent: liver function test abnormal, weight increased. Infrequent: electrocardiogram abnormal. Rare: muscle enzyme increased, urine analysis abnormal.
Nervous System Disorders. Frequent: disturbance in attention, dizziness. Infrequent: amnesia, convulsion, migraine, parosmia, syncope, tremor. Rare: balance disorder, cerebrovascular accident, dysarthria, mental impairment, multiple sclerosis, VII th �nerve paralysis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, sensory disturbance, transient ischemic attack, visual field defect.
Reproductive System and Breast Disorders. Frequent: menstrual disorder. Infrequent: erectile dysfunction. Rare: sexual dysfunction.
Respiratory, Thoracic and Mediastinal Disorders. Frequent: respiratory disorders. Infrequent: asthma, epistaxis, rhinitis allergic, upper respiratory tract inflammation. Rare: pleurisy, pulmonary embolism.
CHANTIX has also been studied in postmarketing trials including (1) a trial conducted in patients with chronic obstructive pulmonary disease (COPD), (2) a trial conducted in generally healthy patients (similar to those in the premarketing studies) in which they were allowed to select a quit date between days 8 and 35 of treatment (“alternative quit date instruction trial”), (3) a trial conducted in patients who did not succeed in stopping smoking during prior CHANTIX therapy, or who relapsed after treatment (“re-treatment trial”), (4) a trial conducted in patients with stable cardiovascular disease, (5) a trial conducted in patients with stable schizophrenia or schizoaffective disorder, (6) a trial conducted in patients with major depressive disorder, (7) a postmarketing neuropsychiatric safety outcome trial in patients without or with a history of psychiatric disorder, and (8) a trial in patients who were not able or willing to quit abruptly and who were instructed to quit gradually (“gradual approach to quitting smoking trial”).
Adverse events in the trial of patients with COPD, in the alternative quit date instruction trial, and in the gradual approach to quitting smoking trial were similar to those observed in premarketing studies. In the re-treatment trial, the profile of common adverse events was similar to that previously reported, but, in addition, varenicline-treated patients also commonly reported diarrhea (6% vs. 4% in placebo-treated patients), depressed mood disorders and disturbances (6% vs. 1%), and other mood disorders and disturbances (5% vs. 2%).
In the trial of patients with stable cardiovascular disease, more types and a greater number of cardiovascular events were reported compared to premarketing studies. Treatment-emergent (ontreatment or 30 days after treatment) cardiovascular events reported with a frequency ≥ 1% in either treatment group in this study were angina pectoris (3.7% and 2.0% for varenicline and placebo, respectively), chest pain (2.5% vs. 2.3%), peripheral edema (2.0% vs. 1.1%), hypertension (1.4% vs. 2.6%), and palpitations (0.6 % vs. 1.1%). Deaths and serious cardiovascular events occurring over the 52 weeks of the study (treatment emergent and non-treatment emergent) were adjudicated by a blinded, independent committee. The following treatment-emergent adjudicated events occurred with a frequency ≥ 1% in either treatment group: nonfatal MI (1.1% vs. 0.3% for varenicline and placebo, respectively), and hospitalization for angina pectoris (0.6% vs. 1.1%). During non-treatment follow-up to 52 weeks, the adjudicated events included need for coronary revascularization (2.0% vs. 0.6%), hospitalization for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%). Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal MI and hospitalization for angina. Cardiovascular death occurred in 0.3% of patients in the varenicline arm and 0.6% of patients in the placebo arm over the course of the 52-week study.
In the trial of patients with stable schizophrenia or schizoaffective disorder, 128 smokers on antipsychotic medication were randomized 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up. The most common adverse events in patients taking varenicline were nausea (24% vs. 14.0% on placebo), headache (11% vs. 19% on placebo) and vomiting (11% vs. 9% on placebo). Among reported neuropsychiatric adverse events, insomnia was the only event that occurred in either treatment group in ≥5% of subjects at a rate higher in the varenicline group than in placebo (10% vs. 5%). These common and neuropsychiatric adverse events occurred on treatment or within 30 days after the last dose of study drug. There was no consistent worsening of schizophrenia in either treatment group as measured by the Positive and Negative Syndrome Scale. There were no overall changes in extra-pyramidal signs, as measured by the Simpson-Angus Rating Scale. The Columbia-Suicide Severity Rating Scale was administered at baseline and at clinic visits during the treatment and non-treatment follow-up phases. Over half of the patients had a lifetime history of suicidal behavior and/or ideation (62% on varenicline vs. 51% on placebo), but at baseline, no patients in the varenicline group reported suicidal behavior and/or ideation vs. one patient in the placebo group (2%). Suicidal behavior and/or ideation were reported in 11% of the varenicline-treated and 9% of the placebo-treated patients during the treatment phase. During the post-treatment phase, suicidal behavior and/or ideation were reported in 11% of patients in the varenicline group and 5% of patients in the placebo group. Many of the patients reporting suicidal behavior and ideation in the follow-up phase had not reported such experiences in the treatment phase. However, no new suicidal ideation or behavior emerged in either treatment group shortly (within one week) after treatment discontinuation (a phenomenon noted in postmarketing reporting). There were no completed suicides. There was one suicide attempt in a varenicline-treated patient. The limited data available from this single smoking cessation study are not sufficient to allow conclusions to be drawn.
In the trial of patients with major depressive disorder, the most common adverse events (≥ 10%) in subjects taking varenicline were nausea (27% vs. 10% on placebo), headache (17 vs. 11%), abnormal dreams (11% vs. 8%), insomnia (11% vs. 5%) and irritability (11% vs. 8%). Additionally, the following psychiatric AEs were reported in ≥ 2% of patients in either treatment group (varenicline or placebo, respectively): anxiety (7% vs. 9%), agitation (7% vs. 4%), depressed mood disorders and disturbances (11% vs. 9%), tension (4% vs. 3%), hostility (2% vs. 0.4%) and restlessness (2% vs. 2%). Patients treated with varenicline were more likely than patients treated with placebo to report one of various events related to hostility and aggression (3% vs. 1%). Psychiatric scales showed no differences between the varenicline and placebo groups and no overall worsening of depression during the study in either treatment group. The percentage of subjects with suicidal ideation and/or behavior was similar between the varenicline and placebo groups during treatment (6% and 8%, respectively) and the nontreatment follow-up (6% and 6%, respectively). There was one event of intentional self-injury/possible suicide attempt during treatment (Day 73) in a subject in the placebo group. Suicide could not be ruled out in one subject who died by an overdose of illicit drugs 76 days after last dose of study drug in the varenicline group.
In the trial of patients without or with a history of psychiatric disorder, the most common adverse events in subjects treated with varenicline were similar to those observed in premarketing studies. Adverse events reported in ≥ 10% of subjects treated with varenicline in the entire study population were nausea (25% vs. 7% on placebo) and headache (12% vs. 10% on placebo). Additionally, the following psychiatric adverse events were reported in ≥ 2% of patients in either treatment group (varenicline vs. placebo) by cohort. For the non-psychiatric cohort, these adverse events were abnormal dreams (8% vs. 4%), agitation (3% vs. 3%), anxiety (5% vs. 6%), depressed mood (3% vs. 3%), insomnia (10% vs. 7%), irritability (3% vs. 4%), sleep disorder (3% vs. 2%). For the psychiatric cohort, these adverse events were abnormal dreams (12% vs. 5%), agitation (5% vs. 4%), anxiety (8% vs. 6%), depressed mood (5% vs. 5%), depression (5% vs. 5%), insomnia (9% vs. 7%), irritability (5% vs. 7%), nervousness (2% vs. 3%), sleep disorder (3% vs. 2%).
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 [see WARNINGS AND PRECAUTIONS].
There have been postmarketing reports of new or worsening seizures in patients treated with CHANTIX [see WARNINGS AND PRECAUTIONS].
There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX. Some reported neuropsychiatric events, including unusual and sometimes aggressive behavior [see WARNINGS AND PRECAUTIONS].
There have been reports of hypersensitivity reactions, including angioedema [see WARNINGS AND PRECAUTIONS].
There have also been reports of serious skin reactions, including Stevens-Johnson Syndrome and erythema multiforme, in patients taking CHANTIX [see WARNINGS AND PRECAUTIONS]. There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking CHANTIX. In the majority of the reported cases, patients had pre-existing cardiovascular disease and/or other risk factors. Although smoking is a risk factor for MI and CVA, based on temporal relationship between medication use and events, a contributory role of varenicline cannot be ruled out [see WARNINGS AND PRECAUTIONS].
There have been reports of hyperglycemia in patients following initiation of CHANTIX. There have been reports of somnambulism, some resulting in harmful behavior to self, others, or property in patients treated with CHANTIX [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Chantix (Varenicline)
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