Generic Name: varenicline (var-EN-i-kleen)
Brand Name: Chantix
Serious mental or mood problems (including depression, suicidal thoughts, suicidal attempts) and completed suicides have been reported in patients taking varenicline. Nicotine withdrawal may also have contributed to some of these events. However, these events have also occurred in patients who continued to smoke. These events have occurred both in patients with and without a history of mental or mood problems. Safety and effectiveness of varenicline in patients with a history of certain mental or mood problems (eg, schizophrenia, bipolar disorder, severe depression) have not been confirmed.
Watch patients who take varenicline closely. Stop taking varenicline and contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, hostility or agitation, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Discuss the benefits and the risks of varenicline with your doctor. Discuss any other questions or concerns with your doctor.
Varenicline is used for:
Helping people to quit smoking cigarettes.
Varenicline is a smoking cessation agent. It works in the brain by blocking the pleasurable effects of smoking. This helps to decrease your desire to smoke.
Do NOT use varenicline if:
- you are allergic to any ingredient in varenicline or you have developed a skin reaction (eg, red, swollen, blistered, or peeling skin) from taking it
Contact your doctor or health care provider right away if this applies to you.
Before using varenicline:
Some medical conditions may interact with varenicline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems or dialysis, heart or blood vessel problems, mental or mood problems (eg, bipolar disorder, depression, schizophrenia), or suicidal thoughts or actions
- if you have tried to quit smoking before and experienced any unusual symptoms or side effects
- if you are using other medicines to quit smoking
Some MEDICINES MAY INTERACT with varenicline. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Nicotine replacement therapy because the risk of nausea, headache, vomiting, dizziness, stomach upset, and tiredness may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if varenicline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use varenicline:
Use varenicline as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Varenicline comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get varenicline refilled.
- Set a date to quit smoking. Start treatment with varenicline 1 week before your quit date unless your doctor directs you otherwise.
- Take varenicline by mouth after a meal with a full glass (8 oz [240 mL]) of water.
- Take varenicline on a regular schedule to get the most benefit from it. Taking it at the same time each day will help you remember to take it.
- Even if you smoke after your quit date, continue to try to quit.
- If you miss a dose of varenicline, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use varenicline.
Important safety information:
- Varenicline may cause drowsiness, dizziness, fainting, or vision changes. It may also cause trouble concentrating, hallucinations, muscle cramps, or seizures. These effects may be worse if you take it with alcohol or certain medicines. Use caution if you drive or perform other possibly unsafe tasks while you are taking varenicline.
- Varenicline may be used as a part of a treatment program that includes a variety of treatment measures (eg, educational materials, counseling).
- Tell your doctor about any other medicines that you take. If you are taking certain other medicines (eg, insulin, theophylline, warfarin), quitting smoking may affect their actions or side effects. Your dose of these medicines may need to be changed. Discuss any questions or concerns with your doctor.
- Some patients have experienced changes in behavior or mood while taking varenicline. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; aggressive, agitated, or abnormal behavior; personality change; thoughts of hurting other people; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- People who try to quit smoking may experience symptoms that could be caused by nicotine withdrawal. These may include the urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, trouble concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some patients may experience worsening of mental health problems they already have, such as depression. Be sure to tell your doctor if you have a history of any of these problems. Discuss any questions or concerns with your doctor.
- Stroke and heart attack have been reported rarely in patients using varenicline. However, smoking may also increase the risk for these events. Most of the reported cases occurred in patients who had a history of heart or certain blood vessel problems. Contact your doctor right away if you develop symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech, vision problems) or a heart attack (eg, chest, jaw, or left arm pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes). Contact your doctor right away if you develop any symptoms of new or worsening heart or blood vessel problems.
- Lab tests, including kidney function, may be performed while you use varenicline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use varenicline with caution in the ELDERLY; they may be more sensitive to its effects.
- Varenicline should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using varenicline while you are pregnant. It is not known if varenicline is found in breast milk. Do not breast-feed while taking varenicline.
Possible side effects of varenicline:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; gas; headache; increased appetite; nausea; stomach upset; taste changes; trouble sleeping; vivid, strange, or unusual dreams; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); behavior changes; chest, jaw, or left arm pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; memory loss; new or worsening mental or mood problems (eg, aggression, agitation, anger, anxiety, depression, nervousness, thoughts of hurting other people); numbness of an arm of leg; one-sided weakness; persistent trouble sleeping; red, swollen, blistered, or peeling skin; seizures; severe headache; severe or persistent nausea; slurred speech; shortness of breath; suicidal thoughts or actions; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of varenicline:
Store varenicline at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep varenicline out of the reach of children and away from pets.
- If you have any questions about varenicline, please talk with your doctor, pharmacist, or other health care provider.
- Varenicline is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take varenicline or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about varenicline. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to varenicline. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using varenicline.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.