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Varenicline Side Effects

In Summary

Commonly reported side effects of varenicline include: insomnia, nausea, and abnormal dreams. Other side effects include: constipation, dyspepsia, sleep disorder, vomiting, and flatulence. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to varenicline: oral tablet

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.

Check with your doctor immediately if any of the following side effects occur while taking varenicline:

Less Common

  • Difficult or labored breathing
  • hyperventilation
  • tightness in the chest

Incidence Not Known

  • Anger
  • anxiety
  • behavior changes
  • discouragement
  • feeling sad or empty
  • feelings of panic
  • irregular heartbeats
  • irritability
  • loss of interest or pleasure
  • mood swings
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • sleepwalking
  • thoughts of killing oneself

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:

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
  • stomach pain
  • trouble sleeping
  • 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 or rash
  • loss of appetite
  • loss of voice
  • nightmares
  • sleepiness or unusual drowsiness
  • sneezing or sore throat
  • stomach discomfort or upset
  • stuffy or runny nose
  • trouble concentrating
  • unusual drowsiness, dullness, or feeling of sluggishness
  • vomiting

For Healthcare Professionals

Applies to varenicline: oral tablet

Gastrointestinal

Very common (10% or more): Nausea (up to 30%)

Common (1% to 10%): Abdominal pain, flatulence, dyspepsia, vomiting, constipation, GI reflux disease, dry mouth, abdominal pain, diarrhea, abdominal distension, toothache, flatulence

Uncommon (0.1% to 1%): Hematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain, dysphagia, enterocolitis, esophagitis, GI hemorrhage, mouth ulceration

Rare (less than 0.1%): Hematemesis, abnormal feces, tongue coated, gastric ulcer, intestinal obstruction, acute pancreatitis

Frequency not reported: Gall bladder disease[Ref]

Psychiatric

Very common (10% or more): Abnormal dreams, insomnia

Common (1% to 10%): Sleep disorder, nightmare

Uncommon (0.1% to 1%): Panic reaction, thinking abnormal, restlessness, mood swings, depression, anxiety, hallucinations, libido increased, libido decreased, irritability, aggression, agitation, disorientation, dissociation

Rare (less than 0.1%): Dysphoria, bradyphrenia, manic episode

Frequency not reported: Suicidal ideation, psychosis, abnormal behavior, somnambulism[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)

Common (1% to 10%): Somnolence, dizziness, dysgeusia

Uncommon (0.1% to 1%): Seizure, tremor, lethargy, hypoesthesia, amnesia, parosmia, psychomotor hyperactivity, restless legs syndrome, syncope, tremor, balance disorder convulsion, facial palsy

Rare (less than 0.1%): Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis

Common (1% to 10%): Bronchitis, sinusitis, dyspnea, cough

Uncommon (0.1% to 1%): Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upper- airway cough syndrome, rhinorrhea, hoarseness, asthma, pleurisy, postnasal drip, epistaxis

Rare (less than 0.1%): Laryngeal pain, snoring[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Erythema, acne, hyperhidrosis, night sweats, acne, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity

Frequency not reported: Severe cutaneous reactions, including Stevens Johnson Syndrome and Erythema Multiforme, angioedema[Ref]

Metabolic

Common (1% to 10%): Weight increased, decreased appetite, increased appetite, anorexia

Rare (less than 0.1%): Polydipsia, C-reactive protein increased, blood calcium decreased

Frequency not reported: Diabetes mellitus, hyperglycemia, hyperlipidemia, hyperkalemia, hypoglycemia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy, blood calcium decreased

Rare (less than 0.1%): Platelet count decreased, leukocytosis, splenomegaly, thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Chest pain

Uncommon (0.1% to 1%): Angina pectoris, tachycardia, palpitations, heart rate increased, hypertension, hot flush, chest discomfort, arrhythmia, bradycardia, ventricular extrasystoles

Rare (less than 0.1%): Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, acute coronary syndrome, cardiac flutter, cor pulmonale, coronary artery disease

Frequency not reported: Myocardial infarction, hypotension, peripheral ischemia[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid gland disorders, diabetes mellitus

Very rare (less than 0.01%): Pituitary hemorrhage[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, eye pain, dry eye, eye irritation, vision blurred, visual disturbance

Rare (less than 0.1%): Scotoma, scleral discoloration, mydriasis, photophobia, myopia, lacrimation increased, acquired night blindness, blindness transient, cataract subcapsular, ocular vascular disorder, photophobia, vitreous floaters[Ref]

Hypersensitivity

Common (1% to 10%): Seasonal allergy[Ref]

Genitourinary

Uncommon (0.1% to 1%): Pollakiuria, nocturia, menorrhagia

Rare (less than 0.1%): Glycosuria, polyuria, vaginal discharge, sexual dysfunction Frequency not reported: Abnormal urine analysis, polyuria, urine abnormality, urinary retention, menstrual disorder, erectile dysfunction[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain

Uncommon (0.1% to 1%): Muscle spasms, musculoskeletal chest pain, arthritis, osteoporosis

Rare (less than 0.1%): Joint stiffness, costochondritis, asthenia[Ref]

Renal

Frequency not reported: Nephrolithiasis, urethral syndrome, acute renal failure[Ref]

Immunologic

Uncommon (0.1% to 1%): Fungal infection, viral infection, influenza like illness[Ref]

Hepatic

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

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Tinnitus, pyrexia, asthenia, malaise

Rare (less than 0.1%): Feeling cold, cyst, semen analysis abnormal, deafness, Meniere's disease, thirst[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Chantix (varenicline)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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