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The following safety information outlines important risks and precautions associated with the use of varenicline (Chantix). It is crucial to review these details carefully and discuss any concerns with your healthcare provider.

• Mental Health Changes and Risk of Suicide: Varenicline (Chantix) has been linked to changes in mental health, including depression, hallucinations, aggression, anxiety, and suicidal thoughts. These risks may be heightened by alcohol consumption or a history of mental health issues such as depression or bipolar disorder. Be vigilant for any unusual changes in mood, thoughts, or behavior, particularly at the start of treatment or if your dosage changes. Discontinue use and consult your healthcare provider immediately if you experience any of these symptoms.

• Heart Attacks and Strokes: Although rare, some individuals taking varenicline (Chantix) have experienced non-fatal heart attacks or strokes. It is uncertain if the medication increases the risk of these events. If you have existing heart problems, inform your healthcare provider about any worsening symptoms. Seek emergency medical attention if you experience heart attack symptoms (chest pain or discomfort) or stroke symptoms (difficulty walking, speaking, understanding, or numbness in the face, arms, or legs).

• Seizures: Seizures have occurred in some users of varenicline (Chantix), both in those with and without a prior history of seizures. They typically occur within the first month of treatment. Inform your healthcare provider if you have a history of seizures or are taking medications that may increase seizure risk. Stop taking varenicline (Chantix) and seek medical advice promptly if you suspect a seizure.

• Sleepwalking: Rare instances of sleepwalking or other sleep-related activities have been reported. These actions can be hazardous. If sleepwalking occurs, cease taking varenicline (Chantix) and contact your healthcare provider.

• Accidental Injuries: There have been reports of traffic accidents and other injuries while using varenicline (Chantix). The medication may cause drowsiness, dizziness, and impaired concentration. Ensure you understand how varenicline (Chantix) affects you before driving or engaging in activities that require full alertness.

• Allergic Reactions: Severe allergic reactions are possible, including life-threatening conditions like Stevens-Johnson syndrome (SJS) or anaphylaxis. Seek immediate medical help or call emergency services if you experience symptoms such as painful blisters, hives, rash, swelling of the lips or tongue, or difficulty breathing after taking varenicline (Chantix).

For any questions or further information, please contact your healthcare provider.

Common side effects:

• Nausea
• Trouble sleeping
• Headache
• Unusual dreams
• Constipation
• Tiredness
• Stomach pain
• Gas
• Dry mouth
• Vomiting
• Indigestion
• Changes in taste
• Drowsiness
• Itching
• Rash
• Trouble breathing
• Cold-like symptoms
• Changes in appetite

Serious side effects:

• Severe allergic reactions
• Severe skin reactions
• Symptoms of a heart attack or stroke
• Mental and mood changes
• Accidental injuries

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Bupropion