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This medication requires careful use due to several important safety concerns. Below is an overview of the associated risks and precautions. It's essential to follow your healthcare provider's instructions and consult them with any questions.

• Risk of Addiction and Misuse: Suboxone contains buprenorphine, an opioid with potential for misuse and dependence. Misuse can lead to addiction and serious side effects, including slowed breathing and overdose. Always take Suboxone exactly as prescribed. This risk is higher for individuals with a history of substance use disorder or those taking more than the prescribed dose.

• Respiratory Depression: Buprenorphine in Suboxone can cause dangerously slow breathing, which may be life-threatening. The risk increases when combined with substances like benzodiazepines, opioids, or alcohol. Those over 65, with COPD, or other conditions causing slow breathing, should be particularly cautious.

• Opioid Overdose Risk: Patients treated for opioid use disorder are at risk of relapse and overdose, which can occur even at prescribed doses. Children are particularly vulnerable to fatal overdose if they accidentally ingest Suboxone. Risk factors include previous opioid overdose, high opioid doses, concurrent use of sedatives, and alcohol consumption.

• Cognitive Impairment and Drowsiness: Suboxone may cause extreme drowsiness and difficulty concentrating. Alcohol and certain medications can exacerbate these effects. Older adults and those taking other sedatives should exercise caution.

• Pregnancy Risks: Opioids, including Suboxone, can pass through the bloodstream to an unborn baby, leading to dependency. Use during pregnancy should be closely monitored by a healthcare provider.

• Adrenal Insufficiency: Long-term use of Suboxone may reduce adrenal hormone levels, causing symptoms like nausea, fatigue, and dizziness. Immediate medical consultation is advised if these symptoms occur.

• Withdrawal Symptoms: Sudden cessation or rapid dose reduction of Suboxone can cause withdrawal symptoms. Gradual tapering under medical supervision is recommended for long-term users.

• Liver Damage: Buprenorphine may cause liver damage, ranging from mild to severe. Regular liver function tests are advised for those with a history of liver issues or hepatitis B or C.

• Dental Issues: Use of buprenorphine dissolved in the mouth may lead to dental problems, such as cavities and tooth loss.

• Heart Rhythm Concerns (QT Prolongation): Suboxone can prolong the QT interval, potentially leading to dangerous heart rhythms. Patients with heart conditions should be vigilant.

• Low Blood Pressure: Suboxone can cause significant drops in blood pressure, particularly when standing. Stand up slowly to prevent dizziness or fainting.

• Not for Opioid-Naïve Individuals: Suboxone is not suitable for pain management or individuals who have not previously taken opioids, as it may cause fatal overdoses.

Contraindications: Do not use Suboxone if you have a severe allergy to buprenorphine or naloxone. Always consult your healthcare provider before use if you have any contraindications.

Common side effects:

• drowsiness
• dizziness
• headache
• constipation
• nausea
• sweating
• trouble sleeping
• general pain

Less common but important to monitor:

• mouth numbness
• burning sensations in the mouth or tongue
• swelling in the hands or ankles
• body weakness
• back pain
• chills
• runny nose
• diarrhea
• vomiting
• signs of infection

Serious side effects:

• severe breathing problems
• heart rhythm issues
• opioid withdrawal symptoms
• serious liver disease
• allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• benzodiazepines (such as Diazepam)
• alcohol
• other depressants

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

• mixed opioid agonist-antagonists (such as Butorphanol, Nalbuphine, pentazocine)
• Naltrexone
• samidorphan
• marijuana (cannabis)
• antihistamines (such as Cetirizine, diphenhydramine)
• drugs for sleep or anxiety (such as Alprazolam, diazepam, Zolpidem)
• muscle relaxants (such as Carisoprodol, Cyclobenzaprine)
• other opioid pain relievers (such as codeine, hydrocodone)