Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Chantix
  2. Chantix Starter Pack
  3. Chantix Starting Month Box
  4. Chantix Start Month Pak


Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of varenicline in children older than 16 years of age. Use is not recommended in children 16 years of age and younger. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varenicline in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving varenicline.


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Angina (severe chest pain), history of or
  • Heart attack, history of or
  • Heart or blood vessel problems or
  • Stroke, history of—May increase risk for more serious side effects.
  • Depression, history of or
  • Mental problems (eg, psychosis), history of or
  • Seizures, or history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use this medicine. This will make it easier for you to quit smoking.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You should set a date to stop smoking. Start using varenicline 1 week before this date.

Your doctor may also tell you to start using this medicine anytime and then to stop smoking between days 8 and 35 of treatment.

You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.

Take this medicine after eating, and with a full glass of water.

If you are motivated to quit smoking and did not succeed treatment with this medicine previously, or if you returned to smoking after using varenicline, talk with your doctor about whether another course of varenicline treatment may be right for you.


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • To stop smoking:
      • Adults and children 17 years of age and older—
        • Days 1 to 3: 0.5 milligram (mg) once a day.
        • Days 4 to 7: 0.5 mg 2 times per day.
        • Days 8 to end of treatment: 1 mg 2 times per day.
      • Children 16 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.


It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you use this medicine. This will allow for changes in your dose and to help reduce any side effects. Blood and urine tests may also be needed to check for unwanted effects.

This medicine may increase the risk of having a heart attack, especially in patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, pain in your legs when walking, sweating, or troubled breathing.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause serious types of allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing or swallowing, or chest tightness while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause some people to become drowsy or dizzy, or to have problems with concentration. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Tell your doctor if you have nausea or sleeping problems (trouble sleeping, or unusual dreams) while you are using this medicine. The dose of this medicine may need to be adjusted.

While you are using this medicine be careful to limit the amount of alcohol that you drink.

Sleepwalking may occur while you are using this medicine. This can sometimes lead to a behavior that is harmful to you or other people, or to property. Check with your doctor right away if you start sleepwalking.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Anxiety
  2. black, tarry stools
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. bloody stools
  5. blurred vision
  6. burning feeling in the chest or stomach
  7. chest pain or discomfort
  8. chills
  9. cold hands and feet
  10. cold sweats
  11. confusion
  12. cool, pale skin cough
  13. deep or fast breathing with dizziness
  14. difficult or labored breathing
  15. dizziness
  16. dry mouth
  17. fainting
  18. fast, pounding, or irregular heartbeat or pulse
  19. flushed, dry skin
  20. fruit-like breath odor
  21. headache
  22. headache, severe and throbbing
  23. increased hunger
  24. increased thirst
  25. increased urination
  26. indigestion
  27. loss of consciousness
  28. nausea
  29. nervousness
  30. nightmares
  31. noisy breathing
  32. nosebleed
  33. numbness of the feet, hands and around the mouth
  34. pain or discomfort in the arms, jaw, back, or neck
  35. pale skin
  36. pounding in the ears
  37. rapid weight gain
  38. seizures
  39. shakiness
  40. slow heartbeat
  41. slurred speech
  42. stomach pain or upset
  43. sweating
  44. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  45. tenderness in the stomach area
  46. tightness in the chest
  47. tingling of the hands or feet
  48. tremor
  49. troubled breathing with exertion
  50. unexplained weight loss
  51. unusual bleeding or bruising
  52. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  53. unusual weight gain or loss
  54. vomiting
  55. vomiting of blood or material that looks like coffee grounds


  1. Agitation
  2. bleeding gums
  3. bloating
  4. blood in the urine or stools
  5. constipation
  6. dark urine
  7. decrease in height
  8. decreased awareness or responsiveness
  9. difficulty in swallowing
  10. eye pain
  11. feeling of fullness
  12. fever
  13. frequent urination
  14. general feeling of illness
  15. heartburn
  16. hostility
  17. increased sensitivity of the skin to sunlight
  18. increased volume of pale, dilute urine
  19. irritability
  20. itching, skin rash
  21. loss of appetite
  22. mood changes
  23. muscle pain, cramps, or twitching
  24. numbness or tingling in the hands, feet, or lips
  25. pain or burning in the throat
  26. pains in the stomach, side, or abdomen, possibly radiating to the back
  27. pinpoint red spots on the skin
  28. red, scaling, or crusted skin
  29. redness or other discoloration of the skin
  30. severe sleepiness
  31. severe stomach pain
  32. severe sunburn
  33. sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  34. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  35. uncontrolled eye movements
  36. yellow eyes or skin

Incidence not known

  1. Anger
  2. anxiety
  3. behavior changes
  4. discouragement
  5. feeling sad or empty
  6. feelings of panic
  7. irregular heartbeat
  8. loss of interest or pleasure
  9. mood swings
  10. restlessness
  11. seeing, hearing, or feeling things that are not there
  12. sleepwalking
  13. thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Abnormal dreams
  2. absence of menstruation
  3. change in taste
  4. diarrhea
  5. difficulty having a bowel movement
  6. difficulty in moving
  7. excess air or gas in the stomach or bowels
  8. joint pain or swelling
  9. lack or loss of strength
  10. loss of taste
  11. muscle stiffness
  12. painful menstruation
  13. passing gas
  14. toothache
  15. trouble sleeping

Less common

  1. Belching
  2. body aches or pain
  3. burning, dry, or itching eyes
  4. continuing ringing or buzzing or other unexplained noise in the ears
  5. decreased interest in sexual intercourse
  6. discharge, excessive tearing
  7. ear congestion
  8. feeling of constant movement of self or surroundings
  9. feeling of warmth
  10. hearing loss
  11. inability to have or keep an erection
  12. increased appetite
  13. increased urge to urinate during the night
  14. loss in sexual ability, desire, drive, or performance
  15. loss of voice
  16. nightmares
  17. redness in the joints
  18. redness of the face, neck, arms and occasionally, upper chest
  19. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  20. sensation of spinning
  21. sleepiness or unusual drowsiness
  22. sneezing
  23. sore throat
  24. stomach discomfort
  25. stuffy or runny nose
  26. transient, mild, pleasant aromatic odor
  27. trouble concentrating
  28. waking to urinate at night


  1. Change in color vision
  2. difficulty seeing at night
  3. increased sensitivity of the eyes to sunlight
  4. night blindness
  5. seeing floating dark spots or material before the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.