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General Information ⬇

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IMPORTANT WARNING:

Tapentadol may be habit-forming. This may occur at recommended doses or if it is misused or abused. Take tapentadol exactly as directed. Do not take more of it, take it more often, stop taking it suddenly, or take it differently than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.

Tapentadol may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications, drinking alcohol, or using street drugs with tapentadol may increase the risk of serious, life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Swallow the extended-release tablets whole. Do not chew, break, divide, crush, or dissolve them as you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

Be sure that you know the dose in milliliters that your doctor has prescribed if you are taking a liquid product. Use the oral syringe and adapter provided with your medication to carefully measure the number of milliliters of solution that your doctor prescribed. Ask your doctor or pharmacist if you have any questions about how to measure your dose or how much medication you should take. You may experience serious or life-threatening side effects if you take a different amount of medication than prescribed by your doctor.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tapentadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Use ⬆ ⬇

WHY is this medicine prescribed?

Tapentadol is used for acute severe pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) and severe persistent neuropathic pain (pain caused by nerve damage) caused by diabetes. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

HOW should this medicine be used?

Tapentadol comes as an oral solution (liquid), immediate-release tablet, and an extended-release (long acting) tablet to take by mouth.

Take the oral solution or the immediate-release tablet with or without food every 4 to 6 hours as needed. Your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment.

Take the extended-release tablet with or without food every 12 hours. Swallow one whole tablet at a time, right after you put it in your mouth, with plenty of water. Take the medication at around the same times every day.

Your doctor may adjust your dose of tapentadol during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Tell your doctor if you feel that your pain is not controlled or if your pain becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with tapentadol. Do not take more of it, take it more often, or for a longer period of time than prescribed by your doctor.

Do not stop taking tapentadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tapentadol, you may experience withdrawal symptoms such as restlessness; anxiety; irritability; teary eyes; yawning; chills; sweating; difficulty falling asleep or staying asleep; shivering, uncontrollable shaking of a part of your body; muscle, back, or joint pain; weakness; nausea; vomiting; diarrhea; stomach cramps; loss of appetite; runny nose, sneezing, or coughing; hair on your skin standing on end; fast breathing; fast heartbeat; widening of the pupils (black circles in the middle of the eyes); or hallucinations (seeing things or hearing voices that do not exist).

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special ⬆ ⬇

What SPECIAL PRECAUTIONS should I follow?

Before taking tapentadol,

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If your doctor has told you to take tapentadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects ⬆ ⬇

What SIDE EFFECTS can this medicine cause?

Tapentadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS or IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment:

Tapentadol may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose ⬆ ⬇

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Talk to your doctor or pharmacist about having a rescue medication called naloxone or nalmefene. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program, over the counter, or with a prescription. Make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use the medication. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

Storage ⬆ ⬇

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store tapentadol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or how much solution (liquid), you have left so you will know if any is missing.

Dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication. You can also visit the FDA website (http://www.fda.gov/drugdisposal) to obtain more information about how to dispose of unused or outdated medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Miscellaneous ⬆

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking tapentadol.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication or if you continue to have pain after you finish the medication, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2026.