"The US Food and Drug Administration (FDA) has changed the labeling on the smoking cessation drug varenicline (Chantix, Pfizer Inc) to reflect concerns that the drug may lower tolerance to alcohol and is linked to a rare risk for seizures"...
What is the most important information I should know about CHANTIX?
Some people have had serious side effects while using CHANTIX to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX.
Before taking CHANTIX, 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 CHANTIX.
Stop taking CHANTIX and call your doctor right away if you, your family, or caregiver notice agitation, hostility, depression or changes in your behavior or thinking that are not typical for you, or you develop any of the following symptoms:
- 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 CHANTIX, 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.
See “What are the possible side effects of CHANTIX?” for more information about other side effects.
What is CHANTIX?
CHANTIX is a prescription medicine to help people stop smoking.
Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking.
It is not known if CHANTIX is safe and effective in children.
It is not known if CHANTIX is safe and effective when used with other stop-smoking medicines.
Who should not take CHANTIX?
Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Symptoms may include:
- swelling of the face, mouth (tongue, lips, gums), throat or neck
- trouble breathing
- rash, with peeling skin
- blisters in your mouth
What should I tell my doctor before taking CHANTIX?
See “What is the most important information I should know about CHANTIX?”
Before you take CHANTIX, tell your doctor if you:
- use other treatments to quit smoking. Using CHANTIX with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than if you just use a nicotine patch alone.
- have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of CHANTIX for you.
- have a history of seizures
- drink alcohol
- have heart or blood vessel problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if CHANTIX will harm your unborn baby.
- are breastfeeding. It is not known if CHANTIX passes into breast milk. You and your doctor should decide if you will breastfeed or take CHANTIX. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Your doctor may need to change the dose of some of your medicines when you stop smoking.
You should not use CHANTIX while using other medicines to quit smoking. Tell your doctor if you use other treatments to quit smoking.
Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist when you get a new medicine.
How should I take CHANTIX?
- There are 2 ways that you can use CHANTIX to help you quit smoking. Talk to your doctor about the following 2 ways to use
Choose a quit date when you will stop smoking. Start taking CHANTIX 1 week (7 days) before your quit date.
Start taking CHANTIX before you choose a quit date. Pick a date to quit smoking that is between days 8 and 35 of treatment.
Starting CHANTIX before your quit date gives CHANTIX time to build up in your body. You can keep smoking during this time. Take CHANTIX exactly as prescribed by your doctor.
- CHANTIX 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. See the chart below for dosing instructions for adults.
|Day 1 to Day 3||
|Day 4 to Day 7||
|Day 8 to end of treatment||
- Make sure that you try to stop smoking on your quit date. If you slip-up and smoke, try again. Some people need to take CHANTIX for a few weeks for CHANTIX to work best.
- Most people will take CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, your doctor may prescribe CHANTIX for another 12 weeks to help you stay cigarette-free.
- Take CHANTIX after eating and with a full glass (8 ounces) of water.
- This dosing schedule may not be right for everyone. 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 CHANTIX, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take your next dose at your regular time.
What should I avoid while taking CHANTIX?
- Use caution when driving or operating machinery until you know how CHANTIX affects you. CHANTIX may make you feel sleepy, dizzy, or have trouble concentrating, making it hard to drive or perform other activities safely.
- Decrease the amount of alcoholic beverages that you drink
during treatment with CHANTIX until you know if CHANTIX affects your ability to
tolerate alcohol. Some people have experienced the following when drinking
alcohol during treatment with CHANTIX:
- increased drunkenness (intoxication)
- unusual or sometimes aggressive behavior
- no memory of things that have happened
What are the possible side effects of CHANTIX?
Serious side effects of CHANTIX may include:
- See “What is the most important information I should know about CHANTIX?”
- Seizures. Some people have had seizures during treatment with CHANTIX. In most cases, the seizures have happened during the first month of treatment with CHANTIX. If you have a seizure during treatment with CHANTIX, stop taking CHANTIX and contact your healthcare provider right away.
- New or worse heart or blood vessel (cardiovascular) problems, mostly in people, who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with CHANTIX.
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
- Allergic reactions can happen with CHANTIX. Some of these allergic reactions can be life-threatening.
- Serious skin reactions, including rash, swelling, redness, and peeling of the skin. Some of these skin reactions can become life-threatening.
Stop taking CHANTIX and get medical help right away if you have any of the following symptoms:
- swelling of the face, mouth (tongue, lips, and gums), throat or neck
- trouble breathing
- rash with peeling skin
- blisters in your mouth
The most common side effects of CHANTIX 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 CHANTIX. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CHANTIX?
- Store CHANTIX at room temperature, between 68°F to 77°F (20°C to 25°C).
- Keep CHANTIX and all medicines out of the reach of children.
General information about CHANTIX
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CHANTIX for a condition for which it was not prescribed. Do not give your CHANTIX to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CHANTIX that is written for healthcare professionals.
For more information about CHANTIX and tips on how to quit smoking, go to www.CHANTIX.com or call 1-877-242-6849.
What are the ingredients in CHANTIX?
Active ingredient: varenicline tartrate
Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry ® White (for 0.5 mg), Opadry ® Blue (for 1 mg), and Opadry® Clear.
Last reviewed on RxList: 10/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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