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Champix Side Effects

Generic Name: varenicline

Note: This document contains side effect information about varenicline. Some of the dosage forms listed on this page may not apply to the brand name Champix.

For the Consumer

Applies to varenicline: oral tablet

Along with its needed effects, varenicline (the active ingredient contained in Champix) 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 while taking varenicline:

Less Common

  • Difficult or labored breathing
  • hyperventilation
  • tightness in the chest

Incidence Not Known

  • Anger
  • anxiety
  • behavior changes
  • discouragement
  • feeling sad or empty
  • feelings of panic
  • irregular heartbeats
  • irritability
  • 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 of varenicline 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
  • bloated or full feeling
  • change in taste
  • difficulty having a bowel movement (stool)
  • dry mouth
  • excess air or gas in the stomach or intestines
  • general feeling of discomfort or illness
  • headache
  • lack or loss of strength
  • loss of taste
  • nausea
  • passing gas
  • stomach pain
  • trouble sleeping
  • unusual tiredness or weakness

Less Common

  • Acid or sour stomach
  • belching
  • body aches or pain
  • chills
  • cough
  • decreased appetite
  • dizziness
  • ear congestion
  • fever
  • heartburn
  • increased appetite
  • indigestion
  • itching skin or rash
  • loss of appetite
  • loss of voice
  • nightmares
  • sleepiness or unusual drowsiness
  • sneezing or sore throat
  • stomach discomfort or upset
  • stuffy or runny nose
  • trouble concentrating
  • unusual drowsiness, dullness, or feeling of sluggishness
  • vomiting

For Healthcare Professionals

Applies to varenicline: oral tablet

General

The most commonly reported side effects included nausea, headache, insomnia, and abnormal dreams.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 19%), abnormal dreams (up to 13%), depressed mood disorders and disturbances (up to 11%), irritability (up to 11%)

Common (1% to 10%): Agitation, anxiety, depressed mood, depression, hostility, middle insomnia, nervousness, nightmare, restlessness, sleep disorder, tension

Uncommon (0.1% to 1%): Aggression, dissociation, hallucinations, libido decreased, libido increased, mood swings, panic reaction, suicidal ideation, thinking abnormal

Rare (less than 0.1%): Abnormal behavior, bradyphrenia, disorientation, dysphoria, euphoric mood, psychosis, somnambulism

Frequency not reported: Early morning awakening, initial insomnia, neuropsychiatric adverse events, suicidality

Postmarketing reports: Aggressive behavior, changes in behavior, changes in thinking, delusions, completed suicide, exacerbation of underlying psychiatric illness, homicidal ideation, nicotine withdrawal symptoms, panic, suicide, suicide attempt[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 40%), vomiting (up to 11%)

Common (1% to 10%): Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, gastroesophageal reflux disease, toothache

Uncommon (0.1% to 1%): Aphthous stomatitis, change of bowel habit, dysphagia, eructation, gastritis, gastrointestinal hemorrhage, gingival pain, hematochezia, mouth ulceration

Rare (less than 0.1%): Abnormal feces, acute pancreatitis, enterocolitis, esophagitis, gallbladder disorder, gastric ulcer, hematemesis, intestinal obstruction, tongue coated[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)

Common (1% to 10%): Disturbance in attention, dizziness, dysgeusia, lethargy, somnolence

Uncommon (0.1% to 1%): Amnesia, convulsion, hypoesthesia, hypogeusia, migraine, parosmia, seizure, syncope, tremor, vertigo

Rare (less than 0.1%): Balance disorder, cerebrovascular accident, coordination abnormal, circadian rhythm sleep disorder, dysarthria, hypertonia, mental impairment, multiple sclerosis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, scotoma, sensory disturbance, transient ischemic attack, VIIth nerve paralysis, visual field defect

Frequency not reported: Transient loss of consciousness

Postmarketing reports: Blackouts, hemorrhagic cerebrovascular event, ischemic cerebrovascular event, loss of consciousness[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 11%)

Common (1% to 10%): Bronchitis, cough, dyspnea, oropharyngeal pain, respiratory disorders, rhinorrhea, upper respiratory tract disorder, upper respiratory tract infection

Uncommon (0.1% to 1%): Allergic rhinitis, asthma, dysphonia, epistaxis, respiratory tract congestion, sinus congestion, throat irritation, upper- airway cough syndrome, upper respiratory tract inflammation

Rare (less than 0.1%): Laryngeal pain, pleurisy, pulmonary embolism, snoring[Ref]

Local

Very common (10% or more): Application site pruritus (up to 11%)[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, chest pain, hospitalization for angina pectoris, hypertension, need for coronary revascularization, new diagnosis of peripheral vascular disease (PVD)/admission for a PVD procedure, nonfatal myocardial infarction, peripheral edema

Uncommon (0.1% to 1%): Blood pressure increased, chest discomfort, ECG abnormal, edema, heart rate increased, hospitalization for angina pectoris, hot flush, myocardial infarction, palpitations, tachycardia

Rare (less than 0.1%): Acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, thrombosis, ventricular extrasystoles

Frequency not reported: Cardiovascular events[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite, increased appetite, weight increased

Uncommon (0.1% to 1%): Diabetes mellitus, hyperglycemia, hypoglycemia

Rare (less than 0.1%): Blood calcium decreased, C-reactive protein increased, hyperlipidemia, hypokalemia, polydipsia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, myalgia, pain in extremity

Uncommon (0.1% to 1%): arthritis, muscle cramp, muscle spasms, musculoskeletal chest pain, musculoskeletal pain

Rare (less than 0.1%): costochondritis, joint stiffness, muscle enzyme increased, myositis, osteoporosis[Ref]

Other

Common (1% to 10%): Asthenia, fatigue, malaise

Uncommon (0.1% to 1%): Chills, pyrexia, tinnitus

Rare (less than 0.1%): Cyst, deafness, feeling cold, Meniere's disease

Frequency not reported: Accidental injury, interaction with alcohol[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Acne, dry skin, eczema, erythema, hyperhidrosis, night sweats, urticaria

Rare (less than 0.1%): Erythema multiforme, photosensitivity, psoriasis, severe cutaneous reactions, Stevens-Johnson Syndrome

Frequency not reported: Serious skin reactions[Ref]

Genitourinary

Common (1% to 10%): Menstrual disorder

Uncommon (0.1% to 1%): Erectile dysfunction, menorrhagia, nocturia, pollakiuria, polyuria, urine abnormality

Rare (less than 0.1%): Glycosuria, semen analysis abnormal, sexual dysfunction, urethral syndrome, urinary retention, vaginal discharge[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Fungal infection, influenza like illness, viral infection[Ref]

Hepatic

Common (1% to 10%): Liver function test abnormal[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, eye pain, eye irritation, vision blurred, visual disturbance

Rare (less than 0.1%): Blindness transient, cataract subcapsular, dry eye, lacrimation increased, mydriasis, myopia, night blindness, ocular vascular disorder, photophobia, scleral discoloration, vitreous floaters[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy

Rare (less than 0.1%): Leukocytosis, platelet count decreased, splenomegaly, thrombocytopenia[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid gland disorders[Ref]

Renal

Rare (less than 0.1%): Acute renal failure, nephrolithiasis, urine analysis abnormal[Ref]

Hypersensitivity

Rare (less than 0.1%): Angioedema

Frequency not reported: Hypersensitivity reactions[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Chantix (varenicline)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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