Most of them stem from the mechanism of action of varenicline. What is the risk associated with Champix? Not everybody is affected by symptoms of nicotine withdrawal. Very common: may affect more than 1 in 10 people Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache, Download PDF Copy; Dec 2 2008. So far, no long-term Champix side effects have been reliably identified although there are some indications that impact on mood can be prolonged even after the stopping of the treatment. It is also recommended that you notify your friends and family members of this possibility in advance so they can monitor your behaviour and let you know if there are some noticeable changes in your mood or usual behaviour. So, similar to the more common side effects, they are considered to be rather mild and almost never lead to cessation of the treatment. How does this medication work? In that case, it is best to immediately contact your doctor and consult with him about the continuance or eventual termination of the treatment. However, most of the patients experience just a few or none Champix side effects. In very rare cases, due to varenicline’s mechanism of action, an unexpected dopamine interaction can occur and lead to mood and behaviour changes. A very small fraction of patients reported the feelings of depression and unusual and vivid dreams for weeks after the stopping of the Champix treatment. The high success rate and unprecedented effectiveness of Champix don’t come without certain risks. Call your doctor for medical advice about side effects. Furthermore, they are rather mild and usually disappear after the patient’s organism is adjusted to the presence of varenicline. Previously in May 2006, the FDA also approved the drug. [Ref], 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], 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], 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], 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], Very common (10% or more): Application site pruritus (up to 11%)[Ref], 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], 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], 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], 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], 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], 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], Uncommon (0.1% to 1%): Fungal infection, influenza like illness, viral infection[Ref], Common (1% to 10%): Liver function test abnormal[Ref], 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], Uncommon (0.1% to 1%): Anemia, lymphadenopathy, Rare (less than 0.1%): Leukocytosis, platelet count decreased, splenomegaly, thrombocytopenia[Ref], Uncommon (0.1% to 1%): Thyroid gland disorders[Ref], Rare (less than 0.1%): Acute renal failure, nephrolithiasis, urine analysis abnormal[Ref], Frequency not reported: Hypersensitivity reactions[Ref], 1. 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