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This document outlines critical safety information and warnings for the use of tramadol. It is essential to understand the potential risks and take necessary precautions when using this medication. Please review the following points carefully and consult with your healthcare provider if you have any questions or concerns.

• Potential for Abuse and Addiction: Tramadol is a controlled substance with a risk of addiction and misuse, which can lead to overdose and possible death. Use the medication strictly as prescribed by your healthcare provider, without altering the dose or frequency. Misuse can diminish its effectiveness and increase the risk of severe side effects like dangerously slow breathing and extreme drowsiness.

• Respiratory Depression: The use of tramadol can result in dangerously slow breathing, which can be life-threatening. This risk is heightened in individuals with specific genetic markers or medical conditions such as COPD, asthma, or head injury. Combining tramadol with certain medications, alcohol, or in older, frail individuals further increases this risk. If breathing issues arise, seek emergency medical assistance immediately.

• Overdose Risks: Overdosing on tramadol can occur if taken in excess or more frequently than prescribed. Signs of an overdose include unresponsiveness, extremely slowed breathing, severe drowsiness, slow heartbeat, or cold, clammy skin. Naloxone is often prescribed alongside tramadol to counteract an overdose. Ensure it is readily available and call 911 immediately if overdose symptoms occur.

• Pregnancy and Newborn Risk: Long-term use during pregnancy can lead to neonatal opioid withdrawal syndrome, causing symptoms such as high-pitched crying, poor feeding, and seizures in newborns. Pregnant women should only use tramadol if absolutely necessary and under medical supervision.

• Drug Interactions: Tramadol interacts with several medications, which can either increase its levels in the body, leading to severe side effects, or decrease its effectiveness. Notify your healthcare provider of all medications and supplements you are taking to avoid harmful interactions.

• Cognitive and Motor Impairment: Tramadol can cause extreme sleepiness and impair your ability to think clearly. Avoid activities requiring full attention, such as driving, until you know how tramadol affects you.

• Serotonin Syndrome: Tramadol may cause a potentially life-threatening condition called serotonin syndrome when taken with other medications that increase serotonin levels. Symptoms include fast heart rate, muscle stiffness, and confusion. Seek medical help immediately if these occur.

• Seizure Risk: Tramadol can increase the risk of seizures, particularly in individuals with a history of seizures or those taking medications that elevate seizure risk. Discuss your medical history with your provider before starting tramadol.

• Low Blood Pressure and Adrenal Hormone Levels: Tramadol can cause significant drops in blood pressure and, with long-term use, low adrenal hormone levels. If you experience symptoms such as dizziness, weakness, or nausea, inform your healthcare provider.

• Physical Dependence and Withdrawal: Regular use of tramadol can lead to physical dependence. Stopping suddenly can cause withdrawal symptoms such as sweating, anxiety, and irritability. Your provider will help you taper off the medication safely.

• Low Blood Sodium Levels: There have been reports of low sodium levels in individuals taking tramadol, particularly in females over 65. Symptoms include confusion and memory problems, which require immediate medical attention.

• Contraindications: Do not use tramadol if you are younger than 12 years, younger than 18 years with recent tonsil or adenoid surgery, have severe respiratory depression, severe asthma, or a blockage in the stomach passageway. It is also contraindicated if you have a severe allergy to tramadol or have taken an MAOI in the last 14 days.

Store tramadol securely to prevent theft, misuse, or accidental ingestion, especially by children or pets. If accidental ingestion occurs, seek emergency medical help right away. Always discuss any concerns or potential risks with your healthcare provider to ensure safe use of tramadol.

Common side effects:

• Constipation
• Nausea
• Dizziness
• Headache
• Drowsiness
• Vomiting
• Indigestion
• Diarrhea
• Dry mouth
• Itching
• Sweating
• Weakness
• Mood changes
• Difficulty sleeping

Serious side effects:

• Dangerously slow breathing
• Symptoms of overdose (extreme sleepiness or unresponsiveness)
• Signs of opioid withdrawal (anxiety and restlessness)
• Serotonin syndrome
• Serious allergic reaction (rash, hives, shortness of breath)
• Seizures
• Severe dizziness or fainting

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

• MAO inhibitors (isocarboxazid, Linezolid, Selegiline, etc.)

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

• Drugs that increase serotonin (MDMA, St. John's wort, SSRIs like Fluoxetine, SNRIs like Duloxetine)
• Certain antifungals (Itraconazole), antibiotics (Erythromycin), and seizure medications (Carbamazepine)
• Quinidine, Rifampin
• Other opioids (codeine, hydrocodone), alcohol, marijuana, sleep aids (Zolpidem), anxiety drugs (Alprazolam, Lorazepam)

Interactions with low risk that usually do not require a change in therapy:

• Certain pain medications (Butorphanol, Nalbuphine, pentazocine), Naltrexone, samidorphan