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This document outlines crucial safety and warning information regarding the use of nefazodone. It is essential to understand the potential risks and consult your healthcare provider if you have any concerns.

• Worsening Depression and Suicidal Thoughts: Nefazodone, like other antidepressants, may increase the risk of worsening depression and suicidal thoughts, particularly in individuals under 24 years of age. This risk is most significant during the initial months of treatment or following dosage adjustments. If you or someone you care for experiences mood changes, such as anxiety, irritability, panic attacks, aggression, or suicidal ideation, contact your healthcare provider immediately. The National Suicide Prevention Lifeline is available 24/7 at 988. Risk factors include a personal or family history of mental health conditions or suicide.

• Liver Issues: Nefazodone can cause severe liver damage, including failure, which may necessitate a transplant or result in death. It should not be used if you have existing liver problems. Prior to starting treatment, your healthcare provider may conduct liver function tests. Be alert for symptoms of liver damage such as jaundice, abdominal pain, loss of appetite, dark urine, nausea, vomiting, fatigue, or confusion, and contact your healthcare provider if these occur. Risk factors include a history of liver issues.

• Bipolar Disorder: Depression might be an early sign of bipolar disorder, characterized by mood fluctuations between depression and mania. Nefazodone should not be used alone for treating bipolar depression due to the risk of triggering mania. Consult your healthcare provider for a comprehensive assessment if you have a history of mood disorders.

• Eye Conditions: Nefazodone can cause pupil dilation, potentially leading to angle-closure glaucoma, a condition that increases eye pressure and may require surgical intervention. Inform your healthcare provider if you have concerns about eye health.

• Orthostatic Hypotension: Sudden changes in posture after sitting or lying down can cause a drop in blood pressure, leading to dizziness and falls. Rise slowly to mitigate this risk, especially if you are on blood pressure medications. Risk factors include a history of cardiovascular issues.

• Seizures: Use nefazodone cautiously if you have a history of seizures. Should you experience any seizure symptoms, such as convulsions, stiffness, or unconsciousness, seek emergency medical help immediately. Risk factors include a history of seizures or concurrent use of other seizure-inducing medications.

• Heart Conditions: Individuals with a history of heart disease or low heart rate should use nefazodone cautiously and may require close monitoring. Discuss your heart health with your healthcare provider before beginning treatment. Risk factors include existing heart conditions or medications affecting heart rate.

Contraindications: Avoid using nefazodone if you have previously experienced liver problems while taking it, or if you are using medications such as carbamazepine, triazolam, terfenadine, astemizole, cisapride, or pimozide. Always consult your healthcare provider if these conditions apply to you.

Common side effects:

• Headaches
• Sleepiness
• Dry mouth
• Nausea
• Dizziness
• Constipation
• Trouble sleeping
• Weakness
• Lightheadedness
• Blurred vision
• Indigestion

Less common but important to monitor:

• Diarrhea
• Infections
• Confusion
• Changes in vision
• Sore throat
• Increased appetite
• Memory issues
• Low blood pressure when standing up
• Feeling flushed or warm
• Burning or tingling sensation in the arms or legs

Serious side effects:

• Severe allergic reactions (hives, difficulty breathing, swelling of the face or throat)
• Liver problems (jaundice, abdominal pain, dark urine)
• Seizures
• Suicidal thinking or behavior