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Champix Side Effects

Generic Name: varenicline

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

Not all side effects for Champix may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to varenicline: oral tablet

In addition to its needed effects, some unwanted effects may be caused by varenicline (the active ingredient contained in Champix). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • thoughts of killing oneself

Some of the side effects that can occur with varenicline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Gastrointestinal

Very common (10% or more): Nausea (up to 30%)
Common (1% to 10%): Abdominal pain, flatulence, dyspepsia, vomiting, constipation, GI reflux disease, dry mouth, abdominal pain, diarrhea, abdominal distension, toothache, flatulence
Uncommon (0.1% to 1%): Hematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain, dysphagia, enterocolitis, esophagitis, GI hemorrhage, mouth ulceration
Rare (less than 0.1%): Hematemesis, abnormal feces, tongue coated, gastric ulcer, intestinal obstruction, acute pancreatitis
Frequency not reported: Gall bladder disease[Ref]

Psychiatric

Very common (10% or more): Abnormal dreams, insomnia
Common (1% to 10%): Sleep disorder, nightmare
Uncommon (0.1% to 1%): Panic reaction, thinking abnormal, restlessness, mood swings, depression, anxiety, hallucinations, libido increased, libido decreased, irritability, aggression, agitation, disorientation, dissociation
Rare (less than 0.1%): Dysphoria, bradyphrenia, manic episode
Frequency not reported: Suicidal ideation, psychosis, abnormal behavior, somnambulism[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Somnolence, dizziness, dysgeusia
Uncommon (0.1% to 1%): Seizure, tremor, lethargy, hypoesthesia, amnesia, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder convulsion, facial palsy
Rare (less than 0.1%): Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis
Common (1% to 10%): Bronchitis, sinusitis, dyspnea, cough
Uncommon (0.1% to 1%): Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upper- airway cough syndrome, rhinorrhea, hoarseness, asthma, pleurisy, postnasal drip, epistaxis
Rare (less than 0.1%): Laryngeal pain, snoring[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Erythema, acne, hyperhidrosis, night sweats, acne, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity
Frequency not reported: Severe cutaneous reactions, including Stevens Johnson Syndrome and Erythema Multiforme, angioedema[Ref]

Metabolic

Common (1% to 10%): Weight increased, decreased appetite, increased appetite, anorexia
Rare (less than 0.1%): Polydipsia, C-reactive protein increased, blood calcium decreased
Frequency not reported: Diabetes mellitus, hyperglycemia, hyperlipidemia, hyperkalemia, hypoglycemia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy, blood calcium decreased
Rare (less than 0.1%): Platelet count decreased, leukocytosis, splenomegaly, thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Angina pectoris, tachycardia, palpitations, heart rate increased, hypertension, hot flush, chest discomfort, arrhythmia, bradycardia, ventricular extrasystoles
Rare (less than 0.1%): Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, acute coronary syndrome, cardiac flutter, cor pulmonale, coronary artery disease
Frequency not reported: Myocardial infarction, hypotension, peripheral ischemia[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid gland disorders, diabetes mellitus
Very rare (less than 0.01%): Pituitary hemorrhage[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, eye pain, dry eye, eye irritation, vision blurred, visual disturbance
Rare (less than 0.1%): Scotoma, scleral discoloration, mydriasis, photophobia, myopia, lacrimation increased, acquired night blindness, blindness transient, cataract subcapsular, ocular vascular disorder, photophobia, vitreous floaters[Ref]

Hypersensitivity

Common (1% to 10%): Seasonal allergy[Ref]

Genitourinary

Uncommon (0.1% to 1%): Pollakiuria, nocturia, menorrhagia
Rare (less than 0.1%): Glycosuria, polyuria, vaginal discharge, sexual dysfunction Frequency not reported: Abnormal urine analysis, polyuria, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain
Uncommon (0.1% to 1%): Muscle spasms, musculoskeletal chest pain, arthritis, osteoporosis
Rare (less than 0.1%): Joint stiffness, costochondritis, asthenia[Ref]

Renal

Frequency not reported: Nephrolithiasis, urethral syndrome, acute renal failure[Ref]

Immunologic

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

Hepatic

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

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Tinnitus, pyrexia, asthenia, malaise
Rare (less than 0.1%): Feeling cold, cyst, semen analysis abnormal, deafness, Meniere's disease, thirst[Ref]

References

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

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

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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