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Important Safety Information
and Possible Side Effects

What is the most important safety information about CHANTIX?

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Is there other important safety information?

Do not take CHANTIX if you have had a serious allergic or skin reaction to CHANTIX. Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

Before starting CHANTIX, tell your doctor if you have a history of heart or blood vessel problems. If you have new or worse heart or blood vessel symptoms during treatment, tell your doctor. Get emergency medical help right away if you have any symptoms of a heart attack or stroke.

Use caution driving or operating machinery until you know how CHANTIX may affect you.

You should not use CHANTIX while using other treatments to quit smoking. Tell your doctor if you use other treatments to quit smoking.

What are the most common side effects?

In clinical trials, the most common side effects of CHANTIX include:

  • Nausea (30%)
  • Sleep problems (trouble sleeping, changes in dreaming)
  • Constipation
  • Gas
  • Vomiting

These are not all the side effects of CHANTIX. Ask your doctor or pharmacist for more information.

A side effect is a negative or positive effect related to a medicine based upon clinical studies.

Tell your doctor about these side effects that bother you or that do not go away.

What should I tell my doctor before starting CHANTIX?

Tell your doctor about all your medical conditions, including if you:

  • Have ever had depression or other mental health problems, as these symptoms may worsen while taking CHANTIX.
  • Experienced nicotine withdrawal symptoms with prior quit attempts, with or without CHANTIX. Quitting smoking, with or without CHANTIX, can result in nicotine withdrawal symptoms (such as depressed mood, agitation) or a worsening of existing mental health problems, such as depression.
  • Have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of CHANTIX for you.
  • Have a history of heart or blood vessel problems before starting CHANTIX. If you have new or worse heart or blood vessel symptoms during treatment, tell your doctor. Get emergency medical help right away if you have any symptoms of a heart attack or stroke.
  • Are pregnant or plan to become pregnant. CHANTIX has not been studied in pregnant women. It is not known if CHANTIX will harm your unborn baby. It is best to stop smoking before you get pregnant.
  • Are breastfeeding. Although it was not studied, CHANTIX may pass into breast milk. You and your doctor should discuss alternative ways to feed your baby if you take CHANTIX.

Tell your doctor about all your other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take:

  • Insulin
  • Asthma medicines
  • Blood thinners

When you stop smoking, there may be a change in how these and other medicines work for you.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist.

Next: How Your Doctor Can Help