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Fentanyl is a potent medication that requires careful handling due to its significant risks and potential for serious health consequences. Please review the following safety information and warnings carefully, and consult your healthcare provider if you have any questions or concerns.

• Risk of Abuse and Addiction: Fentanyl can lead to misuse, addiction, and overdose, potentially resulting in death. Those with a history of substance or alcohol abuse, or mental health conditions, are at higher risk. It is crucial to use the lowest effective dose for the shortest duration possible to minimize these risks.

• Respiratory Depression: This medication can cause severe and potentially fatal breathing difficulties, especially during the initial days of treatment or following a dosage increase. The risk is heightened in individuals who are opioid-intolerant, have severe lung conditions, or use other substances that depress respiration, such as alcohol or certain medications.

• Interactions with Other Medications: Combining fentanyl with specific drugs can amplify its effects or lead to withdrawal symptoms. Medications like erythromycin, ketoconazole, and ritonavir can increase fentanyl levels, while others like phenytoin and carbamazepine can decrease them. Always consult your healthcare provider before starting or stopping any medications.

• Potential for Overdose: Even at recommended doses, fentanyl can cause overdose, particularly if accidentally ingested by children or taken in higher quantities than prescribed. Ensure the medication is stored securely to prevent accidental ingestion.

• Impact on Brain Function: The use of fentanyl with alcohol or other sedative medications can significantly slow brain function, leading to extreme drowsiness or coma. Avoid operating machinery or driving until you understand how the medication affects you.

• Pregnancy and Newborn Withdrawal: Use during pregnancy can lead to neonatal opioid withdrawal syndrome, which can be life-threatening. If used long-term during pregnancy, inform your healthcare provider, and monitor newborns for withdrawal symptoms.

• Serotonin Syndrome: When combined with serotonergic medications, fentanyl can cause a dangerous condition known as serotonin syndrome. Be alert to symptoms like agitation, hallucinations, or rapid heart rate, and seek immediate medical attention if they occur.

• Adrenal Insufficiency: Long-term use can lead to low cortisol levels, affecting mood and stress response. Alert your healthcare provider if you experience symptoms like fatigue or dizziness.

• Blood Pressure and Heart Rate: Fentanyl may cause low blood pressure and a slowed heart rate. Individuals with heart problems or on medications for hypertension should exercise caution, especially when standing up quickly.

• Seizure Risk: Those with a history of seizures should be cautious, as fentanyl can exacerbate this condition.

• Application Site Reactions: Irritation or discomfort at the application site may occur but should improve over time.

Contraindications: Fentanyl should not be used by individuals who are not opioid-tolerant, those with severe respiratory depression, asthma, stomach or intestinal blockage, or for short-term pain management.

In case of an overdose, or if severe side effects like slowed breathing or extreme drowsiness occur, seek emergency medical help immediately. Always ensure fentanyl is used responsibly, adhering to prescribed guidelines, and stored securely to prevent misuse or accidental ingestion.

When taking this medication, some individuals may experience common side effects such as nausea, vomiting, tiredness, dizziness, or headache. These effects are often mild and may diminish as your body adjusts to the medication. Other common reactions include constipation, swelling of arms or legs, weakness, dehydration, and reactions at the application site, such as pain or irritation. To manage constipation, consider increasing your fiber intake, staying hydrated, and engaging in regular exercise. If dizziness occurs, rise slowly from sitting or lying positions.

Less common side effects might include drowsiness, low blood cell counts, stomach pain, diarrhea, low potassium levels, or respiratory issues like shortness of breath and cough. Some people may also experience changes in mood, such as confusion or depression, alongside trouble sleeping, weight loss, or poor appetite. If these issues persist or worsen, it's important to consult a healthcare provider.

Serious side effects, though rare, demand immediate medical attention. These include symptoms of overdose—such as slowed breathing, extreme drowsiness, or unresponsiveness—and signs of a severe allergic reaction, like hives, difficulty breathing, or swelling of the face and throat. Other critical conditions involve serotonin syndrome, marked by fast heartbeat, severe nausea, or hallucinations, and adrenal insufficiency, presenting as fatigue, dizziness, and low blood pressure. If you notice symptoms of withdrawal, such as restlessness, anxiety, or suicidal thoughts, seek urgent care. Always inform your healthcare provider if you experience any severe or concerning side effects.

This medication can interact with various other drugs, which may impact its effectiveness or increase the risk of severe side effects.

1. Pain Medications and Opioid Antagonists: Avoid combining this drug with certain pain relievers such as butorphanol, nalbuphine, pentazocine, and opioid antagonists like naltrexone and samidorphan, as interactions may occur.

2. Drugs Affecting Fentanyl Removal: Medications like azole antifungals (e.g., itraconazole, ketoconazole), some calcium channel blockers (e.g., diltiazem, verapamil), HIV protease inhibitors (e.g., nelfinavir), macrolide antibiotics (e.g., erythromycin), mifepristone, nefazodone, rifamycins (e.g., rifabutin), ritonavir, and certain anti-seizure drugs (e.g., carbamazepine, phenytoin) can alter how fentanyl is removed from your body, impacting its function.

3. MAO Inhibitors: Serious or life-threatening interactions can occur if this drug is taken with MAO inhibitors, such as isocarboxazid, linezolid, and others. MAO inhibitors should be avoided during and for two weeks before starting this medication. Consult your doctor for guidance on timing.

4. CNS Depressants: The risk of severe side effects like slow or shallow breathing, and extreme drowsiness or dizziness, increases if taken with other products causing drowsiness or respiratory issues. These include other opioids, alcohol, cannabis, sleep or anxiety medications (e.g., alprazolam, lorazepam), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), and antihistamines (e.g., cetirizine, diphenhydramine). Always check medication labels and consult your pharmacist to ensure safe usage.

5. Serotonin Syndrome Risk: The likelihood of serotonin syndrome, a potentially dangerous condition, increases when this drug is taken with other serotonin-elevating drugs. Examples include MDMA/"ecstasy," St. John’s wort, and certain antidepressants like SSRIs (e.g., fluoxetine, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), especially when starting or increasing doses.

6. Lab Tests: This medication might interfere with lab tests, such as amylase/lipase levels, leading to potentially false results. Ensure all healthcare providers are informed of your medication use.

Always discuss with your healthcare provider all the medications you take to manage these interactions appropriately.