Varenicline Side Effects

Medically reviewed by Drugs.com. Last updated on May 20, 2025.

Applies to varenicline: nasal spray.

Other dosage forms:

• oral tablet

Precautions

It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure the medicine is working properly and to check for unwanted effects.

Common side effects of varenicline

Some side effects of varenicline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of varenicline

Along with its needed effects, varenicline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

See also:

For healthcare professionals

Applies to varenicline: nasal spray, oral tablet.

General adverse events

The most commonly reported side effects included nausea, headache, insomnia, and abnormal dreams.^[Ref]

Psychiatric

• 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]

Gastrointestinal

• 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]

Nervous system

• 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]

Respiratory

• 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]

Local

• Very common (10% or more): Application site pruritus (up to 11%)^[Ref]

Cardiovascular

• 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]

Metabolic

• 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]

Musculoskeletal

• 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]

Other

• 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]

Dermatologic

• Common (1% to 10%): Pruritus, rash
• 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]

Genitourinary

• Common (1% to 10%): Menstrual disorder
• 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]

Immunologic

• Common (1% to 10%): Influenza
• Uncommon (0.1% to 1%): Fungal infection, influenza like illness, viral infection^[Ref]

Hepatic

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

Ocular

• 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]

Hematologic

• Uncommon (0.1% to 1%): Anemia, lymphadenopathy
• Rare (less than 0.1%): Leukocytosis, platelet count decreased, splenomegaly, thrombocytopenia^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Thyroid gland disorders^[Ref]

Renal

• Rare (less than 0.1%): Acute renal failure, nephrolithiasis, urine analysis abnormal^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Angioedema
• Frequency not reported: Hypersensitivity reactions^[Ref]

Frequently asked questions

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Further information

Varenicline side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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