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The following safety information highlights crucial warnings associated with the use of varenicline (Chantix). Please read carefully and consult your healthcare provider if you have any questions or concerns.

• Mental Health Changes and Risk of Suicide: Individuals taking varenicline (Chantix) may experience alterations in mental health, including depression, hallucinations, aggression, anxiety, and suicidal thoughts. These side effects are more likely if you consume alcohol while on this medication or if you have 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 the treatment or if the dosage is altered. Discontinue use and consult your healthcare provider immediately if such changes occur. Increased risks include a history of mental health issues, alcohol consumption, and continued smoking while on varenicline (Chantix).

• Heart Attacks and Strokes: Although rare, some individuals have experienced non-fatal heart attacks or strokes while taking varenicline (Chantix). There is no clear evidence that this medication increases the risk of these events. If you have pre-existing heart conditions, monitor for any worsening symptoms and contact your healthcare provider if they occur. Seek immediate medical attention or call emergency services if you experience symptoms indicative of a heart attack (such as chest pain) or stroke (such as difficulty walking, speaking, or numbness in the face or limbs). A history of heart problems may increase these risks.

• Seizures: Seizures have been reported by some users of varenicline (Chantix), including those with no prior history. These typically occur within the first month of treatment. Inform your healthcare provider if you have a history of seizures or are on seizure medications before beginning varenicline (Chantix). If you suspect a seizure has occurred, stop taking the medication and contact your healthcare provider promptly. Risks are heightened for those with a history of seizures or those taking medications that increase seizure risk.

• Sleepwalking: In rare instances, varenicline (Chantix) users have experienced sleepwalking or other activities while asleep, posing potential danger to themselves and others. If sleepwalking is observed, discontinue the medication and notify your healthcare provider.

• Accidental Injuries: Some users have reported traffic accidents and other injuries while on varenicline (Chantix), possibly due to drowsiness or dizziness affecting concentration. Ensure you understand how the medication affects you before driving or engaging in activities that require full alertness.

• Allergic Reactions: Severe allergic reactions, including life-threatening conditions such as Stevens-Johnson syndrome (SJS) or anaphylaxis, may occur. If you experience symptoms like painful blisters, hives, rash, swelling of lips or tongue, or difficulty breathing, seek medical attention or call emergency services immediately.

When taking this medication, you might experience some common side effects, which are generally mild. These include nausea (30%), trouble sleeping (18%), headache (15%), and unusual dreams (13%). Other possible effects are constipation (8%), tiredness (7%), stomach pain (7%), gas (6%), dry mouth (6%), vomiting (5%), indigestion (5%), and changes in taste (5%). If any of these persist or become bothersome, it is advisable to consult your healthcare provider.

Additionally, some users have reported other side effects. These include drowsiness, itching, rash, trouble breathing, and cold-like symptoms. Changes in appetite, nightmares, and heartburn may also occur. It is important to monitor these symptoms and seek medical advice if they become severe or concerning.

Although rare, there are serious side effects that demand immediate medical attention. These include a severe allergic reaction characterized by swelling of the face or mouth, and breathing difficulties. A severe skin reaction may present as a rash with sores or bumps. Also, be cautious of accidental injuries if you feel tired, dizzy, or have trouble focusing during activities such as driving. If any of these serious side effects occur, seek urgent medical care promptly.