varenicline

What is the most important information I should know about varenicline?

What is varenicline?

Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Varenicline may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking varenicline?

• 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.

Tell your doctor if you have ever had:

• depression or mental illness;
• a seizure;
• kidney disease (or if you are on dialysis);
• heart or blood vessel problems; or
• if you drink alcohol.

Tell your doctor if you are pregnant. It is not known whether varenicline will harm an unborn baby if you use the medicine during pregnancy. However, smoking while you are pregnant can harm the unborn baby or cause birth defects.

How should I take varenicline?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

When you first start taking varenicline, you will take a low dose and then gradually increase it over the first several days of treatment. Take varenicline regularly to get the most benefit.

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. 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, and 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.

Smoking cessation may also cause new or worsening mental health problems, such as depression.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking varenicline?

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.

What are the possible side effects of varenicline?

• 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;
• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; o
• stroke symptoms --sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

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;
• constipation, gas;
• 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.

What other drugs will affect varenicline?

After you stop smoking, your doctor may need to adjust the doses of certain medicines you take on a regular basis.

Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about varenicline.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 10.01. Revision date: 8/8/2018.