tapentadol



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What is tapentadol?

Tapentadol is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Tapentadol is used to treat moderate to severe pain.

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

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

You should not use this medication if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus.

Do not take tapentadol if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take tapentadol before the MAO inhibitor has cleared from your body.

Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Tapentadol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking tapentadol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more tapentadol than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tapentadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

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 liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus.

Do not take tapentadol if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take tapentadol before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • asthma, COPD, sleep apnea, or other breathing disorders
  • liver or kidney disease
  • curvature of the spine
  • a history of head injury or brain tumor
  • epilepsy or other seizure disorder
  • gallbladder disease or pancreas problems
  • mental illness; or
  • a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Tapentadol may cause breathing problems and addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Tapentadol can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking this medication.

Older adults may be more sensitive to the effects of this medicine.

Do not give tapentadol to a child.

Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Tapentadol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I take tapentadol?

Take this medication exactly as it was prescribed for you. Never take tapentadol in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Your doctor may occasionally change the timing of your dose to make sure you get the best results from this medication.

Take this medicine with a full glass of water.

You may take tapentadol with or without food.

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

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store tapentadol at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Tapentadol is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Ask a pharmacist about how to dispose of any unused pills after you have stopped taking tapentadol.

Never crush a tablet or other pill to mix into a liquid for snorting tapentadol or injecting the drug into your vein. This practice has resulted in death with the misuse of narcotic pain medicines and similar prescription drugs.

What happens if I miss a dose?

Since tapentadol is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of tapentadol can be fatal.

Overdose symptoms may include extreme drowsiness, blurred vision, confusion, vomiting, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking tapentadol?

Do not drink alcohol while you are using tapentadol. Dangerous side effects or death can occur when alcohol is combined with tapentadol. Check your food and medicine labels to be sure these products do not contain alcohol.

Tapentadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of tapentadol?

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

Call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing, weak pulse, slow heartbeat
  • seizure (convulsions)
  • severe drowsiness or dizziness;
  • confusion, problems with speech or balance; or
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • mild nausea or vomiting
  • constipation
  • mild dizziness, drowsiness
  • dry mouth
  • itching; or
  • increased sweating.

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?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by tapentadol. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicines.

This list is not complete and there may be other drugs that can interact with tapentadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.