Apo-Varenicline Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Giving up smoking with or without treatment can cause various symptoms. These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Patients should be aware of the possible emergence of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during a quit attempt with or without APO-VARENICLINE and should be advised to contact a doctor or pharmacist if they experience such symptoms.
Serious side effects of either an uncommon or rare frequency have occurred in people attempting to quit smoking with APO-VARENICLINE: seizure, stroke, heart attack, suicidal thoughts, loss of contact with reality and unable to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggression and abnormal behaviour). There have also been reports of severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) and serious allergic reactions including angioedema (swelling of the face, mouth, or throat).
Very common: may affect more than 1 in 10 people: Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache; Nausea.
Common: may affect up to 1 in 10 people: Chest infection, inflammation of the sinuses; Increased weight, decreased appetite, increased appetite; Sleepiness, dizziness, changes in the way things taste; Shortness of breath, cough; Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache, indigestion, flatulence, dry mouth; Skin rash, itching; Joint ache, muscle ache, back pain; Chest pain, tiredness.
Uncommon: may affect up to 1 in 100 people: Fungal infection, viral infection; Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations, changes in sex drive; Seizure, tremor, feeling sluggish, less sensitive to touch; Conjunctivitis, eye pain; Ringing in the ears; Angina, rapid heart rate, palpitations, increased heart rate; Increased blood pressure, hot flush; Inflammation of nose, sinuses and throat, congestion of nose, throat and chest, hoarseness, hay fever, throat irritation, congested sinuses, excess mucous from nose causing cough, runny nose; Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, pain in the gums; Reddening of the skin, acne, increased sweating, night sweats; Muscle spasms, chest wall pain; Abnormally frequent urination, urination at night; Increased menstrual flow; Chest discomfort, flu like illness, fever, feeling weak or unwell; High blood sugar; Heart attack; Suicidal thoughts; Changes in thinking or behaviour (such as aggression).
Rare: may affect up to 1 in 1,000 people: Excessive thirst; Feeling unwell or unhappy, slow thinking; Stroke; Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern; Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light, shortsightedness, watery eyes; Irregular heart beat or heart rhythm disturbances; Throat pain, snoring; Blood in vomit, abnormal stools, coated tongue; Stiff joints, rib pain; Glucose in urine, increased urine volume and frequency; Vaginal discharge, changes in sexual ability; Feeling cold, cyst; Diabetes; Sleep walking; Loss of contact with reality and unable to think or judge clearly (psychosis); Abnormal behaviour; Severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals); Serious allergic reactions including angioedema (swelling of the face, mouth, or throat).
Not known: Transient loss of consciousness.
Reporting of side effects: In case of any side effects, advise the patient to talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. By reporting side effects, it can help provide more information on the safety of this medicine.
Result of a meta-analysis: Cardiovascular events: In a trial of patients with stable cardiovascular disease (CVD) certain cardiovascular events were reported more frequently in patients treated with varenicline. A meta-analysis of 15 clinical trials, which included the smoking cessation trial of patients with stable CVD, had similar results.
Subjects with Cardiovascular Disease: A meta-analysis of 15 clinical trials of ≥ 12 weeks treatment duration, including 7002 patients (4190 varenicline, 2812 placebo), was conducted to systematically assess the cardiovascular safety of varenicline. The study in patients with stable cardiovascular disease described previously was included in the meta-analysis. The key cardiovascular safety analysis included occurrence and timing of a composite endpoint of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, nonfatal MI, and nonfatal stroke. These events included in the endpoint were adjudicated by a blinded, independent committee. Overall, a small number of MACE occurred during treatment in the trials included in the meta-analysis (varenicline 7 [0.17%]; placebo 2 [0.07%]). Additionally, a small number of MACE occurred up to 30 days after treatment (varenicline 13 [0.31%]; placebo 6 [0.21%]).
The meta-analysis showed that exposure to Varenicline resulted in a hazard ratio for MACE of 2.83 (95% confidence interval from 0.76 to 10.55, p=0.12) for patients during treatment and 1.95 (95% confidence interval from 0.79 to 4.82, p=0.15) for patients up to 30 days after treatment. These are equivalent to an estimated increase of 6.5 MACE events and 6.3 MACE events per 1,000 patient-years, respectively of exposure. The hazard ratio for MACE was higher in patients with cardiovascular risk factors in addition to smoking compared with that in patients without cardiovascular risk factors other than smoking. There were similar rates of all-cause mortality (varenicline 6 [0.14%]; placebo 7 [0.25%]) and cardiovascular mortality (varenicline 2 [0.05%]; placebo 2 [0.07%]) in the varenicline arms compared with the placebo arms in the meta-analysis.