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Nucynta ER Warnings and Precautions

If your healthcare provider prescribes Nucynta ER, he or she needs to know if you have a history of drug or alcohol abuse, lung problems of any kind, or certain allergies. It is also important to understand the safety precautions for Nucynta ER, including warnings of potentially serious complications this medicine may cause. Some of these problems include a dangerous group of symptoms known as serotonin syndrome.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Nucynta® ER (tapentadol ER) if you have:
 
  • A history of drug or alcohol dependence
  • Liver disease, such as cirrhosis, liver failure, or hepatitis
  • Kidney disease, such as kidney failure (renal failure)
  • Gallbladder or pancreatic disease
  • Lung disease of any sort
  • A head injury or high intracranial pressure
  • Severe abdominal (stomach) pain
  • Seizures or epilepsy
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Nucynta ER

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • Do not take Nucynta ER tablets that have been crushed, split, broken, or dissolved. Examine every tablet before you take it to make sure it is not damaged. This could easily cause a fatal overdose. Also, make sure to keep this medication out of the reach of children or pets.
 
  • You must not consume alcohol in any form (including in foods or medications) while taking Nucynta ER. Alcohol changes the rate at which the tablets release the medication, perhaps leading to a potentially fatal overdose.
 
  • Nucynta ER is approved to treat moderate-to-severe pain that requires continuous, around-the-clock treatment. It is a strong, long-acting narcotic painkiller that should not be used to treat mild or short-term pain.
 
  • Nucynta ER is a narcotic medication with significant potential for abuse. It is not a good choice for people who have a history of alcohol or drug abuse. Do not take the drug more frequently, longer, or at a higher dose than prescribed. If you feel you may be developing a problem with abuse, please seek help from your healthcare provider.
 
  • Like any other narcotic, this drug can cause dizziness and drowsiness, and may increase the risk for falls, particularly in elderly people.
 
  • Do not drive or operate heavy machinery until you know how Nucynta ER affects you. Your reflexes and reaction times may be significantly affected, even if you feel fine.
 
  • This medicine can cause slow and irregular breathing, especially at high doses. In severe situations, this can lead to life-threatening complications. This may be especially dangerous in people with lung problems.
 
  • This medication can cause problems in people with head injuries or high intracranial pressure. Nucynta ER should only be used with extreme caution in such circumstances.
 
  • Nucynta ER can interfere with the diagnosis of many conditions that cause severe abdominal (stomach) pain.
 
 
  • This drug can cause a dangerous group of symptoms known as serotonin syndrome. This problem is most common when Nucynta ER is combined with antidepressants or other medications that affect serotonin (see Nucynta ER Drug Interactions). Seek immediate medical attention if you develop signs of serotonin syndrome, such as:
 
    • Confusion or other mental changes
    • A rapid heartbeat
    • Nausea
    • Vomiting
    • Diarrhea
    • Hallucinations
    • Blood pressure changes
    • Overactive reflexes
    • Fever
    • Shivering
    • Shakiness
    • Agitation
    • Sweating
    • Seizures
    • Coma.
 
 
  • This product is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Nucynta ER and Pregnancy).
 
  • It is unknown if Nucynta ER passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking this drug (see Nucynta ER and Breastfeeding).
 
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