Varenicline (oral route)

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.

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

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

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.

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

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