Varenicline is a prescription medicine used along with education to help people quit smoking. Varenicline is in a class of medications called partial cholinergic nicotinic agonists. While it does not contain nicotine, it works by stimulating nicotine receptors in the brain, reducing cravings for cigarettes. It also decreases the pleasurable effects of cigarettes.
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS
Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking varenicline. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking varenicline who continued to smoke.
All patients being treated with varenicline should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking varenicline in the postmarketing experience. When symptoms were reported, most were during varenicline treatment, but some were following discontinuation of varenicline therapy.
These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of varenicline, and the safety and efficacy of varenicline in such patients has not been established.
Advise patients and caregivers that the patient should stop taking varenicline and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of varenicline was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.
The risks of varenicline should be weighed against the benefits of its use. Varenicline has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.
Varenicline is a prescription medicine to help adults quit smoking.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Serious side effects of varenicline may include:
- New or worse mental health problems, which have been reported in some patients.
- New or worse heart or blood vessel (cardiovascular) problems in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with varenicline. Get emergency medical help right away if you have any of the following symptoms of a heart attack, including:
- chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back
- pain or discomfort in one or both arms, back, neck, jaw or stomach
- shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort
- The most common side effects of varenicline include:
- sleep problems (trouble sleeping or vivid, unusual, or strange dreams)
Tell your doctor about side effects that bother you or that do not go away.
These are not all the side effects of varenicline. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:
- asthma medicines
- blood thinners
- alcohol (Chantix can change the way people react to alcohol)
When you stop smoking, there may be a change in how these and other medicines work for you.
You should not use varenicline while using other medicines to quit smoking.
Serious side effects have been reported with varenicline including the following:
Serious cardiovascular events: Varenicline has been linked to increased risk of hospitalization for serious cardiovascular events – such as heart attack or arrhythmia.
Smoking is a major risk factor for cardiovascular disease, and varenicline may help you quit smoking. The health benefits of quitting smoking are immediate and substantial, including decreasing the chances of developing lung disease, heart disease, and some cancers.
Contact your health care professional if you experience new or worsening symptoms of cardiovascular disease while taking varenicline, for example:
- Shortness of breath or trouble breathing
- New or worsening chest pain
- New or worse pain in legs when walking
- Sudden onset of weakness, paralysis, numbness, or difficulty speaking or understanding speech
Serious neuropsychiatric events: Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking varenicline. Some people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using varenicline to help them quit smoking. Some people had these symptoms when they began taking varenicline, and others developed them after several weeks of treatment, or after stopping varenicline.
- thoughts about suicide or dying, or attempts to commit suicide
- new or worse depression, anxiety, or panic attacks
- feeling very agitated or restless
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- abnormal thoughts or sensations
- seeing or hearing things that are not there (hallucinations)
- feeling people are against you (paranoia)
- feeling confused
- other unusual changes in behavior or mood
When you try to quit smoking, with or without varenicline, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Before taking varenicline, tell your doctor if you have ever had depression or other mental health problems. You should also tell your doctor about any symptoms you had during other times you tried to quit smoking, with or without varenicline.
Allergic reactions: Some people can have allergic reactions to varenicline. Some of these allergic reactions can be life-threatening and include: swelling of the face, mouth (tongue, lips), and throat that can cause trouble breathing. If you have these symptoms, stop taking varenicline and get medical attention right away.
Serious skin reactions: Some people can have serious skin reactions while taking varenicline. These can include rash, swelling, redness, and peeling of the skin. Some of these reactions can become life-threatening. If you have a rash with peeling skin or blisters in your mouth, stop taking varenicline and see your doctor right away.
Seizures: Rare accounts of seizures in patients treated with Chantix have been reported. If you have a seizure while taking Chantix , you should stop the medicine and seek medical attention immediately.
Chantix can change the way people react to alcohol. Decrease the amount of alcohol you drink until patients know how Chantix affects your ability to tolerate alcohol.
Use caution driving or operating machinery until you know how varenicline may affect you. Some people who use varenicline may feel sleepy, dizzy, or have trouble concentrating, that can make it hard to drive or perform other activities safely.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of varenicline there are no specific foods that you must exclude from your diet when receiving varenicline.
Before you take varenicline, tell your doctor if you:
- have ever had depression or other mental health problems.
- have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of varenicline for you.
- are allergic to varenicline or any ingredients in varenicline.
- have any other medical conditions
- are pregnant or plan to become pregnant. Ask your doctor for help to stop smoking before you get pregnant because smoking during pregnancy puts you and your baby at risk for problems during pregnancy. Varenicline has not been studied in pregnant women. It is not known if varenicline will harm your unborn baby.
- are breastfeeding. Varenicline has not been studied in breastfeeding women. It is not known if varenicline passes into breast milk. You and your doctor should talk about the best way to feed your baby if you take varenicline.
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if varenicline is excreted in human breastmilk or if it will harm your nursing baby.
- Take varenicline exactly as prescribed by your doctor.
- Choose a quit date when you will stop smoking.
- Start taking varenicline 1 week (7 days) before your quit date. This lets varenicline build up in your body. You can keep smoking during this time. Make sure that you try and stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take varenicline for a few weeks for varenicline to work best.
- Take varenicline after eating and with a full glass (8 ounces) of water.
- Most people will take varenicline for up to 12 weeks. If you have completely quit smoking by 12 weeks, your doctor may prescribe varenicline for another 12 weeks to help you stay cigarette-free.
- Varenicline comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.
- Talk to your doctor if you are having side effects such as nausea, strange dreams, or sleep problems. Your doctor may want to reduce your dose.
- If you miss a dose of varenicline, take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next dose at your regular dose.
Take varenicline exactly as your doctor prescribes it. Follow the directions on your prescription label carefully.
The recommended dose of varenicline is 1 mg twice daily following a one week titration (gradual increase). Days 1 to 3, 0.5 mg once daily. Days 4 to 7, 0.5 mg twice daily. Day 8 to end of treatment, 1 mg twice daily.
Patients should be treated with varenicline for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks' treatment with varenicline is recommended to further increase the likelihood of long-term abstinence.
Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.
Consider a temporary or permanent dose reduction in patients who cannot tolerate the adverse effects of varenicline.
If you take too much varenicline call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
If varenicline is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
- Store varenicline at room temperature, 59 to 86°F (15 to 30°C).
- Safely dispose of varenicline that is out of date or no longer needed.
- Keep varenicline and all medicines out of the reach of children.
Choose a quit date when you will stop smoking. Start taking varenicline 1 week (7 days) before your quit date. You can keep smoking during this time. Make sure that you try and stop smoking on your quit date.
Varenicline comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.
Some people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using varenicline to help them quit smoking.
Talk to your doctor if you are having side effects such as nausea, strange dreams, or sleep problems. Your doctor may want to reduce your dose.