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Tapentadol Extended-Release: Uses, Side Effects and Dosage

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Prescription (Rx) Controlled substance Schedule II Boxed warning
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Tapentadol Extended-Release

tapentadol extended-release tablet is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain in adults that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them.
  • Also used in adults to manage severe and persistent pain from damaged nerves (neuropathic pain) that happens with diabetes, and that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not to be taken on an "as needed" basis.

Important information about tapentadol extended-release tablet:

  • Get emergency help or call 911 right away if you take too much tapentadol extended-release tablet (overdose). When you first start taking tapentadol extended-release tablet, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking tapentadol extended-release tablet with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your tapentadol extended-release tablet. They could die from taking it. Selling or giving away tapentadol extended-release tablet is against the law.
  • Store tapentadol extended-release tablet securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take tapentadol extended-release tablet if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking tapentadol extended-release tablet, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

  • noticing your pain getting worse. If your pain gets worse after you take tapentadol extended-release tablet, do not take more of tapentadol extended-release tablet without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking tapentadol extended-release tablet.
  • pregnant or planning to become pregnant. Use of tapentadol extended-release tablet for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with tapentadol extended-release tablet. It may harm your baby.
  • living in a household where there are small children or someone who has abused street or prescription drugs.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tapentadol extended-release tablet with certain other medicines can cause serious side effects.

When taking tapentadol extended-release tablet:

  • Do not change your dose. Take tapentadol extended-release tablet exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
  • Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
  • Swallow tapentadol extended-release tablet whole. Do not cut, break, chew, crush, dissolve, snort, or inject tapentadol extended-release tablet because this may cause you to overdose and die.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking tapentadol extended-release tablet without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused tapentadol extended-release tablet by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking tapentadol extended-release tablet DO NOT:

  • Drive or operate heavy machinery until you know how tapentadol extended-release tablet affects you. tapentadol extended-release tablet can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with tapentadol extended-release tablet may cause you to overdose and die.

The possible side effects of tapentadol extended-release tablet are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • agitation, hallucinations, coma, feeling overheated, or heavy sweating.

These are not all the possible side effects of tapentadol extended-release tablet. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by: Collegium Pharmaceutical, Inc., 100 Technology Center Drive Suite 300, Stoughton, MA, 02072

Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, www.hikma.com or call 1-800-962-8364.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 200533 · View the label on DailyMed

Revision date stated in the text: December 2023

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Tapentadol Extended-Release

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IISchedule II: high potential for abuse; abuse may lead to severe psychological or physical dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Opioid Agonist
Active ingredient Tapentadol hydrochloride
Dosage form Tablet, film coated, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) COLLEGIUM PHARM INC
FDA approval NDA AUTHORIZED GENERIC 200533NDA authorized generic Approved August 25, 2011
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg – 60 in 1 bottle, plastic NDC 0054-0936-21
100 mg – 60 in 1 bottle, plastic NDC 0054-0937-21
150 mg – 60 in 1 bottle, plastic NDC 0054-0938-21
200 mg – 60 in 1 bottle, plastic NDC 0054-0939-21
250 mg – 60 in 1 bottle, plastic NDC 0054-0940-21

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.