Brand Name: Nucynta
Tapentadol is used for:
Treating moderate to severe acute pain in certain patients.
Tapentadol is an analgesic. It works in certain areas of the brain and nervous system to decrease pain.
Do NOT use Tapentadol if:
- you are allergic to any ingredient in Tapentadol
- you have severe lung problems (eg, respiratory depression, acute or severe asthma or hypercapnia [high blood carbon dioxide levels])
- you have paralytic ileus (bowel paralysis)
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tapentadol:
Some medical conditions may interact with Tapentadol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver or kidney problems; bowel problems; gallbladder problems; metabolism problems; or pancreas problems (eg, pancreatitis)
- if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system
- if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], sleep apnea), or a seizure disorder (eg, epilepsy)
- if you have high blood carbon dioxide levels or low blood oxygen levels
- if you are in poor health or are severely overweight
- if you are going through withdrawal from alcohol or other substances or if you or a family member have a history of alcohol or other substance abuse
Some MEDICINES MAY INTERACT with Tapentadol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- MAOIs (eg, phenelzine), selective serotonin and norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because serotonin syndrome may occur
- Medicines used for anesthesia, mental or mood disorders, nausea, or sleep disorders; or other opioid pain medicines (eg, codeine, hydrocodone) because the risk of side effects, including excessive drowsiness, trouble breathing, or low blood pressure, may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tapentadol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tapentadol:
Use Tapentadol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tapentadol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tapentadol refilled.
- Take Tapentadol by mouth with or without food.
- Swallow Tapentadol whole. Do not break, crush, or chew before swallowing.
- If you miss a dose of Tapentadol and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tapentadol.
Important safety information:
- Tapentadol may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tapentadol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tapentadol; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Tapentadol may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take Tapentadol before you receive any medical or dental care, emergency care, or surgery.
- Tapentadol may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you drink a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Tapentadol.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Tapentadol. Your risk may be greater if you take Tapentadol with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Use Tapentadol with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, weakness or tiredness, and severe lightheadedness.
- Tapentadol should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Tapentadol has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tapentadol while you are pregnant. It is not known if Tapentadol is found in breast milk. Do not breast-feed while taking Tapentadol.
When used for long periods of time or at high doses, Tapentadol may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tapentadol stops working well. Do not take more than prescribed.
Some people who use Tapentadol for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Tapentadol, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Tapentadol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; dry mouth; itching; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; cold, clammy skin; confusion; difficult or increased urination; difficult, slow, or shallow breathing; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; headache; loss of coordination; mood or mental changes; numbness or tingling; seizures; severe dizziness, drowsiness, or lightheadedness; trouble talking, thinking, or walking; weakness or tiredness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (), or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult, slow, or shallow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat; vomiting.Proper storage of Tapentadol:
Store Tapentadol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tapentadol out of the reach of children and away from pets.
- If you have any questions about Tapentadol, please talk with your doctor, pharmacist, or other health care provider.
- Tapentadol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Tapentadol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.