Active substance
Tapentadol
- US FDA 7
- Health Canada 8
- US price lines 6
- NHS prices 17
- Safety 7
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NUCYNTA | EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | tablet · oral | COLLEGIUM PHARM INC | Prescription | 20 Nov 2008 |
| NUCYNTA ER | EQ 50MG BASE; EQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASE; EQ 250MG BASE | tablet, extended release · oral | COLLEGIUM PHARM INC | Prescription | 25 Aug 2011 |
| TAPENTADOL HYDROCHLORIDE | EQ 20MG BASE/ML | solution · oral | NOVITIUM PHARMA | Prescription | 26 Jan 2026 |
| TAPENTADOL HYDROCHLORIDE | EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | tablet · oral | EPIC PHARMA LLC | Prescription | 27 Jan 2026 |
| TAPENTADOL HYDROCHLORIDE | EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | tablet · oral | MSN | Prescription | 3 Sep 2026 |
| NUCYNTA | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · oral | COLLEGIUM PHARM INC | Discontinued | 15 Oct 2012 |
| TAPENTADOL HYDROCHLORIDE | EQ 50MG BASE; EQ 75MG BASE; EQ 100MG BASE | tablet · oral | HIKMA PHARMS | Discontinued | 10 Feb 2026 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| NUCYNTA EXTENDED-RELEASE | 02415577 | 50 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA EXTENDED-RELEASE | 02415585 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA EXTENDED-RELEASE | 02415593 | 150 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA EXTENDED-RELEASE | 02415607 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA EXTENDED-RELEASE | 02415615 | 250 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA IR | 02378272 | 50 MG | TABLET (IMMEDIATE-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA IR | 02378280 | 75 MG | TABLET (IMMEDIATE-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| NUCYNTA IR | 02378299 | 100 MG | TABLET (IMMEDIATE-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TAPENTADOL ER 100 MG TABLET | $21.48667 | per EA | 23 Sep 2026 |
| US NADAC | TAPENTADOL ER 200 MG TABLET | $35.31226 | per EA | 23 Sep 2026 |
| US NADAC | TAPENTADOL ER 50 MG TABLET | $12.36583 | per EA | 23 Sep 2026 |
| US NADAC | TAPENTADOL HCL 100 MG TABLET | $14.47951 | per EA | 23 Sep 2026 |
| US NADAC | TAPENTADOL HCL 50 MG TABLET | $8.85429 | per EA | 23 Sep 2026 |
| US NADAC | TAPENTADOL HCL 75 MG TABLET | $10.6496 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tapentadol 100mg modified-release capsules | £42.35 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 100mg modified-release tablets | £15.24 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 150mg modified-release capsules | £63.52 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 150mg modified-release tablets | £20.25 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 200mg modified-release capsules | £84.69 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 200mg modified-release tablets | £30.99 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 20mg/ml oral solution sugar free | £17.80 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 250mg modified-release capsules | £105.87 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 250mg modified-release tablets | £124.55 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 25mg modified-release tablets | £8.72 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 50mg modified-release capsules | £10.59 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tapentadol 50mg modified-release capsules | £21.17 | 56 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 NUCYNTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 NUCYNTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 NUCYNTA ER — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 9 Jan 2019 Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressants. - EMA PRAC 9 Jan 2014 PRAC signal: Suicidal ideation
Action for MAH: update of the product information: No - EMA PRAC 10 Oct 2013 PRAC signal: Suicidal ideation
Action for MAH: update of the product information: No - EMA PRAC 16 May 2013 PRAC signal: Suicidal ideation
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.