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.

Some side effects of Champix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to varenicline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking varenicline (the active ingredient contained in Champix) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any mood or behavior changes, confusion, anxiety, panic attacks, hallucinations, extreme fear, or if you feel impulsive, agitated, aggressive, restless, hostile, depressed, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Your family or other caregivers should also be alert to changes in your mood or behavior.

Call your doctor at once if you have any of these other serious side effects:

• chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder, vomiting, sweating, general ill feeling;

• feeling light-headed or short of breath;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• easy bruising, unusual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• the first sign of any blistering type of skin rash, no matter how mild.

Less serious side effects of varenicline may include:

• nausea (may persist for several months);

• stomach pain, indigestion, constipation, gas;

• weakness, tired feeling;

• dry mouth, unpleasant taste in your mouth;

• headache; or

• sleep problems (insomnia) or unusual dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

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.

A 63-year-old male with stable bipolar disorder experienced a manic episode coincident with varenicline 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.

Nervous system

The New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) identified a series of 13 reports of memory impairment in patients taking varenicline (the active ingredient contained in Champix) 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.

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.

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.

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