Active substance
Tramadol
- SFDA 14
- US FDA 42
- Health Canada 22
- US price lines 8
- NHS prices 10
- Safety 13
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MABRON | 50 mg/ml | Solution for injection/infusion · Intravenous use | 5 Ampoule | SAR 17.00 | Generic · Prescription | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY | Valid |
| NOMAL 50 MG CAPSULE | 50 mg | Capsule · Oral use | 10 Blister | SAR 7.10 | Generic · Prescription | THE ARAB PHARMACEUTICAL MANUFACTURING PSC | Valid |
| TRABILIN 100MG AMPOULES | 100 mg | Solution for injection · Intravenous use | 5 Ampoule | SAR 17.00 | Generic · Prescription | ACINO PHARMA AG | Valid |
| TRAMAL 50 MG CAPSULE | 50 mg | Capsule · Oral use | 30 Blister | SAR 34.95 | NCE · Prescription | STADA ARZNEIMITTEL GmbH | Valid |
| TRAMAL 50 MG CAPSULE | 50 mg | Capsule · Oral use | 10 Blister | SAR 15.55 | NCE · Prescription | STADA ARZNEIMITTEL GmbH | Valid |
| TRAMAL 50 MG-1 ML AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 18.15 | NCE · Prescription | STADA ARZNEIMITTEL GmbH | Valid |
| TRAMAL 50 MG-1 ML AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 31.90 | NCE · Prescription | STADA ARZNEIMITTEL GmbH | Valid |
| TRAMAL RETARD 100MG F.C TAB | 100 mg | Film-coated tablet · Oral use | 10 Blister | SAR 22.65 | NCE · Prescription | STADA ARZNEIMITTEL GmbH | Valid |
| TRAMADOL AWD 100MG-2ML AMPOULE | 50 mg/ml | Solution · Intravenous use | 5 Ampoule | SAR 20.95 | Generic · Prescription | BAXTER ONCOLOGY | Withdrawn by MAH · Not Marketed |
| TRAMADONE 50MG-ML(100MG-2ML) AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 18.90 | Generic · Prescription | APM | Withdrawn by MAH · Not Marketed |
| TRAMAL 100MG SUPPOSITORIES | 100 mg | Suppository · Rectal use | 5 Blister | SAR 15.20 | NCE · Prescription | GRUNENTHAL | Withdrawn by MAH · Not Marketed |
| TRAMAL 50 MG-1 ML AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 18.15 | NCE · Prescription | GRUNENTHAL | Withdrawn by MAH · Not Marketed |
| TRAMAL 50 MG-1 ML AMPOULE | 50 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 31.90 | NCE · Prescription | GRUNENTHAL | Withdrawn by MAH · Not Marketed |
| TRAMAL RETARD 100MG F.C TAB | 100 mg | Film-coated tablet · Oral use | 10 Blister | SAR 22.65 | NCE · Prescription | GRUNENTHAL | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE PANCREATITIS-PAIN MANAGEMENT; DIABETIC NEUROPATHY; ENDOMETRIOSIS; EPIDERMOLYSIS BULLOSA; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; SICKLE CELL DISEASE - PAIN MANAGEMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | SUN PHARM INDS INC | Prescription | 19 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | TEVA | Prescription | 19 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | AMNEAL PHARMS | Prescription | 20 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG; 100MG; 25MG | tablet · oral | GRAVITI PHARMS | Prescription | 25 Jun 2002 |
| CONZIP | 100MG; 200MG; 300MG | capsule, extended release · oral | CIPHER PHARMS INC | Prescription | 7 May 2010 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | SENORES PHARMS | Prescription | 31 Jan 2011 |
| TRAMADOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet, extended release · oral | LUPIN LTD | Prescription | 29 Aug 2011 |
| TRAMADOL HYDROCHLORIDE | 50MG; 25MG | tablet · oral | STRIDES PHARMA | Prescription | 28 Nov 2011 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | CSPC OUYI PHARM CO | Prescription | 29 Mar 2013 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 31 Mar 2014 |
| TRAMADOL HYDROCHLORIDE | 50MG; 100MG; 25MG; 75MG | tablet · oral | RUBICON RESEARCH | Prescription | 28 Jun 2019 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | UNICHEM | Prescription | 9 Aug 2019 |
| TRAMADOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet, extended release · oral | MACLEODS PHARMS | Prescription | 31 Jan 2025 |
| TRAMADOL HYDROCHLORIDE | 5MG/ML | solution · oral | NOVITIUM PHARMA | Prescription | 26 Jun 2026 |
| ULTRAM | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | JANSSEN PHARMS | Discontinued | 3 Mar 1995 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | ACTAVIS ELIZABETH | Discontinued | 19 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 20 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | MYLAN | Discontinued | 21 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | WATSON LABS | Discontinued | 24 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | SPECGX LLC | Discontinued | 25 Jun 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | PLIVA | Discontinued | 1 Jul 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 3 Jul 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | APOTEX | Discontinued | 10 Jul 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | ASTA | Discontinued | 12 Jul 2002 |
| TRAMADOL HYDROCHLORIDE | 50MG | tablet · oral | MYLAN PHARMS INC | Discontinued | 21 Nov 2002 |
17 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-TRAMADOL | 02426153 | 50 MG | TABLET · ORAL | APOTEX INC |
| AURO-TRAMADOL | 02479672 | 50 MG | TABLET · ORAL | AURO PHARMA INC |
| DURELA | 02373017 | 100 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | CIPHER PHARMACEUTICALS INC |
| DURELA | 02373025 | 200 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | CIPHER PHARMACEUTICALS INC |
| DURELA | 02373033 | 300 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | CIPHER PHARMACEUTICALS INC |
| JAMP TRAMADOL HCL | 02518759 | 50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-TRAMADOL | 02480859 | 50 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| RALIVIA | 02299194 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | BAUSCH HEALTH, CANADA INC. |
| RALIVIA | 02299208 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | BAUSCH HEALTH, CANADA INC. |
| RALIVIA | 02299216 | 300 MG | TABLET (EXTENDED-RELEASE) · ORAL | BAUSCH HEALTH, CANADA INC. |
| TARO-TRAMADOL ER | 02450429 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | TARO PHARMACEUTICALS INC |
| TARO-TRAMADOL ER | 02450437 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | TARO PHARMACEUTICALS INC |
| TARO-TRAMADOL ER | 02450445 | 300 MG | TABLET (EXTENDED-RELEASE) · ORAL | TARO PHARMACEUTICALS INC |
| TRIDURAL | 02296381 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| TRIDURAL | 02296403 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| TRIDURAL | 02296411 | 300 MG | TABLET (EXTENDED-RELEASE) · ORAL | KNIGHT THERAPEUTICS INC. |
| ZYTRAM XL | 02286424 | 150 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| ZYTRAM XL | 02286432 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| ZYTRAM XL | 02286440 | 300 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| ZYTRAM XL | 02286459 | 400 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| ZYTRAM XL | 02360322 | 75 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
| ZYTRAM XL | 02360349 | 100 MG | TABLET (EXTENDED-RELEASE) · ORAL | PURDUE PHARMA |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TRAMADOL HCL 100 MG TABLET | $1.08258 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL 25 MG TABLET | $3.36652 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL 50 MG TABLET | $0.0248 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL ER 100 MG CAPSULE | $7.73637 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL ER 100 MG TABLET | $0.89431 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL ER 200 MG CAPSULE | $9.35893 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL ER 200 MG TABLET | $1.25071 | per EA | 23 Sep 2026 |
| US NADAC | TRAMADOL HCL ER 300 MG TABLET | $2.16038 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tramadol 100mg modified-release capsules | £14.47 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 100mg/2ml solution for injection ampoules | £4.00 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 150mg modified-release capsules | £21.71 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 200mg modified-release capsules | £28.93 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg capsules | £0.91 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg capsules | £3.03 | 100 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg modified-release capsules | £7.24 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg modified-release tablets | £4.60 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg orodispersible tablets sugar free | £7.12 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tramadol 50mg soluble tablets sugar free | £13.33 | 100 tablet | 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 CONZIP — 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 QDOLO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Nov 2024 SEGLENTIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Feb 2023 ULTRACET — 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 13 Feb 2023 ULTRAM — 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 - EMA PRAC 6 May 2021 PRAC signal: Serotonin syndrome
Action for MAH: update of the product information: Yes - EMA PRAC 14 Jan 2021 PRAC signal: Serotonin syndrome
Action for MAH: update of the product information: No - EMA PRAC 13 Feb 2020 PRAC signal: Hiccups
Action for MAH: update of the product information: No - US FDA 29 Aug 2017 ULTRAM 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 - EMA PRAC 8 Jul 2016 PRAC signal: Hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Action for MAH: update of the product information: No - EMA PRAC 17 Mar 2016 PRAC signal: Hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Action for MAH: update of the product information: No - EMA PRAC 13 Jun 2013 PRAC signal: Hypoglycaemia
Action for MAH: update of the product information: Yes - EMA PRAC 7 Feb 2013 PRAC signal: Hypoglycaemia
Action for MAH: update of the product information: No
Combinations containing Tramadol
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.