Medication Guide App

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
  • shortness of breath
  • tightness in the chest
  • wheezing
Incidence not known
  • Anger
  • anxiety
  • behavior changes
  • depression
  • discouragement
  • feeling sad or empty
  • feelings of panic
  • hallucinations
  • irregular heartbeats
  • irritability
  • loss of interest or pleasure
  • mood swings
  • nervousness
  • restlessness
  • 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
  • sleeplessness
  • stomach pain
  • trouble sleeping
  • unable to sleep
  • 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
  • loss of appetite
  • loss of voice
  • nightmares
  • rash
  • runny nose
  • sleepiness or unusual drowsiness
  • sneezing or sore throat
  • stomach discomfort or upset
  • stuffy nose
  • trouble concentrating
  • unusual drowsiness, dullness, or feeling of sluggishness
  • vomiting

For Healthcare Professionals

Applies to varenicline: oral tablet

Gastrointestinal

Gastrointestinal (GI) side effects have frequently included nausea (7.2% to 40%), flatulence (6% to 9%), constipation (5% to 8.5%), upper abdominal pain (2% to 7.7%), dry mouth (4% to 6%), abdominal pain (5%), dyspepsia (5%), vomiting (1% to 5%), and GI reflux disease (1%). Diarrhea, gingivitis, dysphagia, enterocolitis, eructation, gastritis, GI hemorrhage, mouth ulceration, esophagitis, gastric ulcer, intestinal obstruction, acute pancreatitis, and gall bladder disease have been reported. At least one case of cholecystitis has also been reported, in addition to case of peritonitis and a case of hemorrhoids and rectal prolapse.

The most common side effect associated with varenicline in clinical trials was nausea. Nausea was typically transient and described as mild or moderate in intensity; however, some patients experienced persistent nausea throughout treatment.

Psychiatric

A 63-year-old male with stable bipolar disorder experienced a manic episode coincident with varenicline (the active ingredient contained in Champix) therapy. The patient was admitted to an inpatient psychiatric unit and met criteria for a manic episode. He began exhibiting manic symptoms one week after initiating therapy with varenicline 1 mg twice daily for smoking cessation. Varenicline was stopped upon admission. Within one week of admission, he was euthymic, without manic or psychotic symptoms.

A 42-year-old female with a 17-year history of schizophrenia experienced exacerbation of schizophrenia coincident with varenicline therapy. She had been prescribed varenicline 2 mg for 5-days to help her stop smoking. The patient's mother reported a 5-day psychotic episode that began with increased activity. After she was advised to discontinue varenicline, she had no further exacerbation.

Psychiatric side effects have included insomnia (19%), abnormal dreams (9% to 13%), sleep disorder (2%), and nightmare (2%). Anxiety, depression, emotional disorder, irritability, restlessness, aggression, agitation, disorientation, dissociation, decreased libido, mood swings, abnormal thinking, bradyphrenia, euphoric mood, hallucination, psychotic disorder, suicidal ideation, and erratic behavior have also been reported. Depressed mood, agitation, changes in behavior, and suicide have been reported during postmarketing experience. At least one case of varenicline-induced manic episode has also been reported, in addition to a case of exacerbation of schizophrenia.

Nervous system

Nervous system side effects have frequently included headaches (10.3% to 19%), dysgeusia (8%), fatigue, malaise, asthenia, somnolence, and lethargy. Attention disturbances, dizziness, sensory disturbance, amnesia, migraine, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder, cerebrovascular accident, convulsion, dysarthria, facial palsy, mental impairment, multiple sclerosis, nystagmus, impairment of psychomotor skills, transient ischemic attack, visual field defect, and drowsiness have been reported.

The New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) identified a series of 13 reports of memory impairment in patients taking varenicline. This case series adds to cases of memory impairment reported by the Institute for Safe Medication Practices (ISMP) from FDA datasets who postulated that vasoconstriction or vasodilation could be the underlying mechanism.

Respiratory

Respiratory side effects have frequently included influenza (3.2% to 5.8%), rhinorrhea, dyspnea, and upper respiratory tract disorder. Epistaxis, respiratory disorders, asthma, pleurisy, and pulmonary embolism have also been reported.

Dermatologic

Dermatologic side effects have frequently included rash and pruritus. Hyperhidrosis, acne, dermatitis, dry skin, eczema, erythema, psoriasis, urticaria, and photosensitivity reaction have also been reported.

Metabolic

Metabolic side effects have frequently included increased or decreased appetite and anorexia. Hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, and increased weight have also been reported.

Hematologic

Hematologic side effects have included anemia, lymphadenopathy, leukocytosis, thrombocytopenia, and splenomegaly.

Cardiovascular

Cardiovascular side effects have included angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, myocardial infarction, palpitations, tachycardia, atrial fibrillation, cardiac flutter, coronary artery disease, cor pulmonale, abnormal electrocardiogram, acute coronary syndrome, hypertension, hypotension, peripheral ischemia, and thrombosis.

Endocrine

Endocrine side effects have included thyroid gland disorders and diabetes mellitus. At least one case of pituitary hemorrhage has also been reported.

Ocular

Ocular side effects have included conjunctivitis, dry eye, eye irritation, blurred vision, visual disturbance, eye pain, acquired night blindness, transient blindness, cataract subcapsular, ocular vascular disorder, photophobia, and vitreous floaters.

Hypersensitivity

Hypersensitivity side effects including seasonal allergy (2.6% to 5.9%) have been reported.

Genitourinary

Genitourinary side effects have included abnormal urine analysis, polyuria, nocturia, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction, and sexual dysfunction. At least one case of ovarian hematoma has also been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, back pain, muscle cramp, musculoskeletal pain, myalgia, arthritis, osteoporosis, and myositis.

Renal

Renal side effects have included nephrolithiasis, urethral syndrome, and acute renal failure. At least one case of elevated blood creatinine has also been reported.

Immunologic

Immunologic side effects commonly reported have included nasopharyngitis (35.9% to 51%), bronchitis, sinusitis, fungal infection, and viral infection.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported.

Other

Other side effects have included tinnitus, vertigo, deafness, Meniere's disease, chest pain, influenza-like symptoms, edema, thirst, chest discomfort, chills, pyrexia, increased muscle enzyme, and hot flash. At least one case of feeling abnormal has been reported, in addition to a case of elevated aspartate aminotransferase, two cases of elevated alanine aminotransferase, and one case of elevated blood bilirubin.

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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