Varenicline (Oral)

Generic name: Varenicline

Usage of Varenicline (Oral)

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.

Varenicline (Oral) 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

  • Anxiety
  • black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody stools
  • blurred vision
  • burning feeling in the chest or stomach
  • chest pain or discomfort
  • chills
  • cold hands and feet
  • cold sweats
  • confusion
  • cool, pale skin cough
  • deep or fast breathing with dizziness
  • difficult or labored breathing
  • dizziness
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • headache, severe and throbbing
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • loss of consciousness
  • nausea
  • nervousness
  • nightmares
  • noisy breathing
  • nosebleed
  • numbness of the feet, hands and around the mouth
  • pain or discomfort in the arms, jaw, back, or neck
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • seizures
  • shakiness
  • slow heartbeat
  • slurred speech
  • stomach pain or upset
  • sweating
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tenderness in the stomach area
  • tightness in the chest
  • tingling of the hands or feet
  • tremor
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusual weight gain or loss
  • vomiting
  • vomiting of blood or material that looks like coffee grounds

    • Rare

  • Agitation
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • constipation
  • dark urine
  • decrease in height
  • decreased awareness or responsiveness
  • difficulty in swallowing
  • eye pain
  • feeling of fullness
  • fever
  • frequent urination
  • general feeling of illness
  • heartburn
  • hostility
  • increased sensitivity of the skin to sunlight
  • increased volume of pale, dilute urine
  • irritability
  • itching, skin rash
  • loss of appetite
  • mood changes
  • muscle pain, cramps, or twitching
  • numbness or tingling in the hands, feet, or lips
  • pain or burning in the throat
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • red, scaling, or crusted skin
  • redness or other discoloration of the skin
  • severe sleepiness
  • severe stomach pain
  • severe sunburn
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • uncontrolled eye movements
  • yellow eyes or skin

    • Incidence not known

  • Anger
  • anxiety
  • behavior changes
  • discouragement
  • feeling sad or empty
  • feelings of panic
  • irregular heartbeat
  • loss of interest or pleasure
  • mood swings
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sleepwalking
  • 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

  • Abnormal dreams
  • absence of menstruation
  • change in taste
  • diarrhea
  • difficulty having a bowel movement
  • difficulty in moving
  • excess air or gas in the stomach or bowels
  • joint pain or swelling
  • lack or loss of strength
  • loss of taste
  • muscle stiffness
  • painful menstruation
  • passing gas
  • toothache
  • trouble sleeping

    • Less common

  • Belching
  • body aches or pain
  • burning, dry, or itching eyes
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased interest in sexual intercourse
  • discharge, excessive tearing
  • ear congestion
  • feeling of constant movement of self or surroundings
  • feeling of warmth
  • hearing loss
  • inability to have or keep an erection
  • increased appetite
  • increased urge to urinate during the night
  • loss in sexual ability, desire, drive, or performance
  • loss of voice
  • nightmares
  • redness in the joints
  • redness of the face, neck, arms and occasionally, upper chest
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sneezing
  • sore throat
  • stomach discomfort
  • stuffy or runny nose
  • transient, mild, pleasant aromatic odor
  • trouble concentrating
  • waking to urinate at night

    • Rare

  • Change in color vision
  • difficulty seeing at night
  • increased sensitivity of the eyes to sunlight
  • night blindness
  • 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.

    Before taking Varenicline (Oral)

    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:

    Allergies

    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.

    Pediatric

    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.

    Geriatric

    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.

    Breast Feeding

    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.

    Interactions with Medicines

    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

    • Interactions with Food/Tobacco/Alcohol

    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.

    • How to use Varenicline (Oral)

    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.

    Dosing

    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.

    Storage

    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.

    Warnings

    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.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com'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. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com 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.

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