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Tapentadol

Palexia, Tapentadol G.L. · ATC code N02AX06

Brand names: Palexia, Tapentadol G.L., Tadomon, Tapenaxiro, Tapendolor, Nucynta, Nucynta ER

Key facts
Active substance
Tapentadol
Drug class
Opioid
ATC code
N02AX06
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Addiction, Abuse, and Misuse
Because the use of tapentadol tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [seeWarnings and Precautions (5.1)].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of tapentadol tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol tablets are essential [see Warnings and Precautions (5.2)].
Accidental Ingestion
Accidental ingestion of even one dose of tapentadol tablets, especially by children, can result in a fatal overdose of tapentadol [see Warnings and Precautions (5.2)].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of tapentadol tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)].
Neonatal Opioid Withdrawal Syndrome (NOWS)
Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)].

Key facts

Tapentadol is an opioid analgesic. Per the US prescribing information, it is used in adults for acute pain severe enough to require an opioid and for which alternative treatments are inadequate.

What it is used for

  • Acute pain in adults severe enough to require an opioid analgesic and for which alternatives are inadequate
  • Because of risks of addiction, abuse, overdose and death, reserve for patients in whom other options are ineffective, not tolerated or inadequate

Dosing

  • Use the lowest effective dosage for the shortest duration; many acute pain conditions need no more than a few days of an opioid
  • Start with 50 mg to 100 mg every 4 to 6 hours as needed; on the first day the second dose may be given as soon as one hour after the first
  • Then 50 mg, 75 mg or 100 mg every 4 to 6 hours; daily doses above 700 mg on the first day and 600 mg on later days are not studied and not recommended
  • Moderate hepatic impairment: start with 50 mg no more often than every 8 hours (maximum three doses in 24 hours); not recommended in severe hepatic or renal impairment
  • With or without food; inform patients about access to an opioid overdose reversal agent (e.g. naloxone)

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity to tapentadol or any ingredient
  • Concurrent MAOIs or MAOI use within the last 14 days

Important warnings

  • Boxed warning: addiction, abuse and misuse, with risk of overdose and death
  • Boxed warning: life-threatening respiratory depression, especially at initiation and after dose increases; accidental ingestion, especially by children, can be fatal
  • Boxed warning: use with benzodiazepines or other CNS depressants, including alcohol, may cause profound sedation, respiratory depression, coma and death
  • Boxed warning: neonatal opioid withdrawal syndrome with prolonged use in pregnancy
  • Serotonin syndrome, seizures, adrenal insufficiency, severe hypotension, withdrawal

Side effects

  • Most common: nausea (30%), dizziness (24%), vomiting (18%), somnolence (15%)
  • Constipation (8%), dry mouth, fatigue, decreased appetite
  • Serious: respiratory depression, addiction, serotonin syndrome, seizures

Interactions

  • Benzodiazepines and other CNS depressants including alcohol: respiratory depression, profound sedation, coma and death
  • Serotonergic drugs (e.g. SSRIs, SNRIs, TCAs, triptans): serotonin syndrome
  • MAOIs: contraindicated

Pregnancy and breastfeeding

  • Prolonged use in pregnancy may cause neonatal opioid withdrawal syndrome; data on birth defect risk are insufficient

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • PalexiaGrünenthal Österreich Gmbh · 3 register entries
  • Tapentadol G.L.G.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • PalexiaGrünenthal Gmbh, Pb Pharma Gmbh · 5 register entries
  • TadomonG.L. Pharma Gmbh · 2 register entries
  • TapenaxiroMedical Valley Invest Ab · 1 register entry
  • TapendolorTad Pharma Gmbh · 1 register entry
  • TapentadolAliud Pharma Gmbh, Betapharm Arzneimittel Gmbh, 1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Aachen-Pharma Grt Gmbh, Libra-Pharm Gmbh, Ratiopharm Gmbh, Neuraxpharm Arzneimittel Gmbh, Micro Labs Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Viatris Germany Gmbh, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Stadapharm Gmbh, G.L. Pharma Gmbh, Abz-Pharma Gmbh · 29 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

USA

  • NucyntaCollegium Pharmaceutical, Inc. · 1 register entry
  • Nucynta ERCollegium Pharmaceutical, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 22 more European countries
Belgium
Palexia, Tapentadol Laboratorios Liconsa
Croatia
Apeneta, Dolten, Palexia, Tadomon, Tapista, Wyvady
Cyprus
Dolten, Palexia
Czechia
Apeneta, Dolupren, Mabinovan, Palexia, Taboxea, Taxemba, Wyvady
Denmark
Palexia, Tapentadol G.L. Pharma, Tapentadol Krka, Tapentadol Medical Valley, Tapentadol Stada, Tapentadol Teva, Tapentadol Vivanta, Tapentadol Zentiva, Wyvady
Estonia
Tapemed Retard
Greece
Dolupren, Palexia
Hungary
Adoben
Iceland
Tapentadol Stada
Ireland
Apeneta, Palexia, Palexia® Sr, Tapentadol, Tapimio
Italy
Palexia, Taboxea, Tadomon, Tapelod, Tapentadolo Grünenthal, Tapentadolo Krka, Tapentadolo Teva, Tapentadolo Vivanta
Luxembourg
Palexia
Malta
Dolten, Tadomon
Netherlands
Palexia, Tapentadol
Norway
Palexia, Tapentadol G.L. Pharma, Tapentadol Krka, Tapentadol Medical Valley, Tapentadol Stada, Tapentadol Zentiva
Poland
Adoben, Binatta, Palexia, Tadomon
Portugal
Ationdo, Palexia, Tapentadol Bluepharma, Tapentadol Ciclum, Tapentadol Farmoz, Tapentadol Generis, Tapentadol Krka, Tapentadol Mylan, Tapentadol Retard Pharmakern, Tapentadol Teva, Tapentadol Zentiva
Romania
Dolten
Slovakia
Apeneta, Dolten, Mabinovan, Palexia, Taboxea, Tapestad, Wyvady
Slovenia
Apeneta, Palexia, Tapentadol Hcs, Wyvady
Spain
Palexia, Palgesic Retard, Tapentadol Krka, Tapentadol Retard Stada, Tapentadol Retard Zentiva, Tapentadol Sandoz, Tapentadol Teva, Tapimio, Yantil
Sweden
Palexia, Tapentadol, Tapimio Depot

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Tapentadol Hydrochloride (Novadoz Pharmaceuticals LLC) – Prescribing Information, 2026-09-03. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4c5938a-68f0-46d2-9bad-8988d5724b09
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  5. Wikidata (CC0): ATC N02AX.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.