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Safety Information


Indications and Clinical Use:

CHAMPIX (varenicline tartrate) is indicated for smoking-cessation treatment in adults, in conjunction with smoking-cessation counselling.

Prior to a decision to prescribe non-nicotine treatment including CHAMPIX, consideration should be given to the treatment option of nicotine replacement therapy (NRT).

Not recommended for use in pediatric patients.

Care should be taken in geriatric patients with dosing and renal function monitoring may be useful.

Most serious warnings and precautions:

Psychiatric symptoms: Post-marketing reports of serious neuropsychiatric symptoms, including anxiety, depressed mood, agitation, aggression, hostility, changes in behavior, psychosis, suicide related events (ideation, behavior, attempted suicide and suicide), as well as worsening of pre-existing psychiatric disorder (previously diagnosed or not). Alcohol intake may increase the risk of psychiatric adverse events. Patients with concomitant, or a history of, psychiatric symptoms should be diligently monitored.

Other relevant warnings and precautions:

  • Patients with concomitant illnesses
  • Hypersensitivity reactions including angioedema
  • Rare but severe cutaneous reactions including Stevens-Johnson syndrome and erythema multiforme
  • Concomitant use with NRT may increase adverse events
  • Increased plasma levels of CYP1A2 substrates
  • Risk of nausea
  • Caution while driving and operating machinery
  • Cardiovascular events
  • Patients with epilepsy
  • Not recommended in pregnant women or during nursing
  • Patients with impaired renal function

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information.

CHAMPIX ® C.P. Pharmaceuticals International C.V. C/O, owner/Pfizer Canada Inc., Licensee