Pronunciation: ta PEN ta dol

Brand: Nucynta, Nucynta ER

Nucynta 100 mg

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Nucynta 50 mg

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Nucynta 75 mg

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What is the most important information I should know about tapentadol?

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

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tapentadol can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share tapentadol with another person.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tapentadol may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

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

What is tapentadol?

Tapentadol is an opioid pain medication. An opioid is sometimes called a narcotic.

Tapentadol is used to treat moderate to severe pain.

The extended-release form of this medicine (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.

What should I discuss with my healthcare provider before taking tapentadol?

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

  • severe asthma or breathing problems; or
  • a bowel obstruction called paralytic ileus.

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

Some medicines can interact with tapentadol and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure tapentadol is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;
  • a history of head injury, brain tumor, or seizures;
  • a history of drug abuse, alcohol addiction, or mental illness;
  • urination problems;
  • liver or kidney disease;
  • problems with your gallbladder, pancreas, or thyroid; or
  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Tapentadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

It is not known whether this medicine will harm an unborn baby. If you use tapentadol 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. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tapentadol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give tapentadol to a child.

How should I take tapentadol?

Follow all directions on your prescription label. Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tapentadol may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away tapentadol is against the law.

Take this medicine with a full glass of water. Tapentadol can be taken with or without food.

Stop taking all other around-the-clock narcotic pain medications when you start taking tapentadol extended-release tablets.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

While using tapentadol, you may need frequent blood tests.

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tapentadol.

Never crush or break a tapentadol pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tapentadol and similar prescription drugs.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Tapentadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover tapentadol pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet.

What happens if I miss a dose?

Since tapentadol is used for pain, you are not likely to miss a dose. If you do miss a dose, take the medicine as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while taking tapentadol?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What are the possible side effects of tapentadol?

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

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

  • weak or shallow breathing, weak pulse, slow heartbeat;
  • a light-headed feeling, like you might pass out;
  • seizure (convulsions);
  • severe drowsiness or dizziness, confusion, problems with speech or balance;
  • infertility, missed menstrual periods;
  • impotence, sexual problems, loss of interest in sex; or
  • low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Tapentadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

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

What other drugs will affect tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications --opioid pain medicine or prescription cough medicine;
  • drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
  • drugs that affect serotonin levels in your body --medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about tapentadol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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