Tapentadol is an opioid medicine that is used to treat moderate to severe pain.

Tapentadol extended-release form (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Tapentadol may also be used for purposes not listed in this medication guide.

You should not use tapentadol if you are allergic to it, or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus); or
• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing that stops during sleep);
• a head injury, brain tumor, or seizures;
• alcoholism or drug addiction, mental illness;
• urination problems,
• liver or kidney disease; or
• problems with your gallbladder, pancreas, thyroid, or adrenal gland.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Do not give tapentadol to a child.

Use Nucynta ER (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;
• a light-headed feeling, like you might pass out;
• agitation, feeling hot;
• severe drowsiness or dizziness, confusion, problems with speech or balance;
• a seizure;
• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• constipation, nausea, vomiting, stomach pain;
• headache, feeling tired; or
• drowsiness, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.