Medically reviewed on December 21, 2016
What is varenicline?
Varenicline may also be used for purposes not listed in this medication guide.
Do not drink large amounts alcohol. Varenicline can increase the effects of alcohol or change the way you react to it.
Before taking this medicine
You should not use varenicline if you used it in the past and had:
a serious allergic reaction--trouble breathing, swelling in your face (lips, tongue, throat) or neck; or
a serious skin reaction--blisters in your mouth, peeling skin rash.
To make sure varenicline is safe for you, tell your doctor if you have:
a history of depression or mental illness;
a history of seizures;
kidney disease (or if you are on dialysis);
heart disease, circulation problems; or
if you drink alcohol.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether varenicline passes into breast milk. However, if you breast-feed while using this medicine, your baby may spit up or vomit more than normal, and may have a seizure.
Varenicline is not approved for use by anyone younger than 18 years old.
How should I take varenicline?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
When you first start taking varenicline, you will take a low dose and then gradually increase it over the first several days of treatment. Follow your doctor's dosing instructions very carefully.
You may choose from 3 ways to use varenicline. Ask your doctor which method is best for you:
Set a date to quit smoking and start taking varenicline 1 week before that date. This will allow the drug to build up in your body. Make sure to quit smoking on your planned quit date. Take varenicline for a total of 12 weeks.
Start taking varenicline before you set a planned quit date. Once you start taking the medicine, choose a quit date that is between 8 and 35 days after you start treatment. Take varenicline for a total of 12 weeks.
Start taking varenicline and gradually reduce the number of cigarettes you smoke each day over a 12-week period, until you no longer smoke at all. Then take varenicline for another 12 weeks, for a total of 24 weeks.
Take varenicline after eating. Take the medicine with a full glass of water.
Use varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You should remain under the care of a doctor while taking varenicline.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
You may have nicotine withdrawal symptoms when you stop smoking, including: increased appetite, weight gain, trouble sleeping, trouble concentrating, slower heart rate, having the urge to smoke, and feeling anxious, restless, depressed, angry, frustrated, or irritated. These symptoms may occur with or without using medication such as varenicline.
Smoking cessation may also cause new or worsening mental health problems, such as depression.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking varenicline?
Do not drink large amounts alcohol while taking this medicine. Varenicline can increase the effects of alcohol or change the way you react to it. Some people taking varenicline have had unusual or aggressive behavior or forgetfulness while drinking alcohol.
Do not use other medicines to quit smoking, unless your doctor tells you to. Using varenicline while wearing a nicotine patch can cause unpleasant side effects.
This medicine may impair your thinking or reactions. You may also have mood or behavior changes when you quit smoking. Until you know how varenicline and the smoking cessation process are going to affect you, be careful if you drive or do anything that requires you to be cautious and alert.
Varenicline side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using varenicline and call your doctor at once if you have:
a seizure (convulsions);
thoughts about suicide or hurting yourself;
strange dreams, sleepwalking, trouble sleeping;
new or worsening mental health problems--mood or behavior changes, depression, agitation, hostility, aggression;
stroke symptoms--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance; or
severe skin reaction--swelling or redness of the skin, blisters in your mouth, or skin rash that spreads and causes blistering and peeling.
Your family or other caregivers should also be alert to changes in your mood or behavior.
Common side effects may include:
nausea (may persist for several months), vomiting;
sleep problems (insomnia); or
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.
See also: Side effects (in more detail)
Varenicline dosing information
Usual Adult Dose for Smoking Cessation:
Days 1 to 3: 0.5 mg orally once a day
Days 4 to 7: 0.5 mg orally twice a day
Days 8 to end of treatment: 1 mg orally twice a day
-The patient should set a date to stop smoking. Dosing should start 1 to 2 weeks before this date.
-Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
-In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Use: Smoking cessation
What other drugs will affect varenicline?
After you stop smoking, the doses of your other medications may need to be adjusted. Tell your doctor about all other medicines you use, especially:
This list is not complete. Other drugs may interact with varenicline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 8.03.
More about varenicline
- Varenicline Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- En Español
- 1302 Reviews
- Drug class: smoking cessation agents
Other brands: Chantix