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

Warnings
Do not use tapentadol if you have used a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use this medicine if you have severe breathing problems, or a bowel obstruction called paralytic ileus.

Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Tapentadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Tell your doctor if you are pregnant. Tapentadol may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use tapentadol with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine
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, rasagiline, selegiline, or tranylcypromine.