Active substance
Tranexamic acid
- SFDA 13
- US FDA 35
- Health Canada 13
- US price lines 2
- NHS prices 4
- WHO EML 2
- Safety 4
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Azeptil 100 mg/ml Injection | 100 mg/ml | Solution for injection · Intravenous use | 10 Ampoule | SAR 62.05 | Generic · Prescription | MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY | Valid |
| CYKLOKAPRON INJ 100MG-ML INJECTION | 100 mg/ml | Solution for injection · Intravenous use | 10 Ampoule | SAR 73.00 | NCE · Prescription | Pfizer Manufacturing Belgium N.V. | Valid |
| FEMIC | 500 mg | Film-coated tablet · Oral use | 60 Blister | SAR 127.70 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| Femic | 100 mg/ml | Solution for injection/infusion · Intravenous use | 10 Ampoule | SAR 62.00 | Generic · Prescription | SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| KAPRON | 500 mg | Tablet · Oral use | 20 Blister | SAR 23.30 | Generic · Prescription | Amoun Pharmaceutical Company | Valid |
| KAPRON 500 mg/5ml Injection | 100 mg/ml | Solution for injection · Intravenous use | 6 Ampoule | SAR 26.70 | Generic · Prescription | Amoun Pharmaceutical Company | Valid |
| LYSTEDA 650 mg Tablet | 650 mg | Tablet · Oral use | 30 Blister | SAR 88.95 | NCE · Prescription | Ferring Pharmaceuticals Inc./ USA | Valid |
| TRAPRON | 100 mg/ml | Solution for injection · Intravenous use | 10 Ampoule | SAR 52.80 | Generic · Prescription | PT. Novell Pharmaceutical Laboratories | Valid |
| Tranexamic Acid PSI 500 mg per 5 ml | 100 mg/ml | Solution for injection · Intravenous use | 5 Vial | SAR 31.00 | Generic · Prescription | Pharmaceutical Solution Industries (PSI) | Valid |
| Tranexamic acid BOS | 100 mg/ml | Solution for injection · Intravenous use | 1 Ampoule | SAR 12.40 | Generic · Prescription | Boston Oncology Arabia | Valid |
| CYKLOKAPRON INJ 100MG-ML 5ML | 100 mg/ml | Solution for injection · Intravenous use | 10 Ampoule | SAR 85.60 | NCE · Prescription | OCTAPHARMA | Withdrawn by MAH · Not Marketed |
| Gemotran | 100 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 31.00 | Generic · Prescription | JSC FARMAK | Suspended · Not Marketed |
| Gemotran | 100 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 62.00 | Generic · Prescription | JSC FARMAK | Suspended · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ MANAGEMENT OF BLEEDING; HEMOPHILIA A, HEMOPHILIA B, ACQUIRED HEMOPHILIA; MATERNAL AND CHILD HEALTHCARE- POSTPARTUM HEMORRHAGE; MENSTRUAL DISORDERS; POLYCYTHEMIA VERA -HEMORRHAGE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CYKLOKAPRON | 100MG/ML | injectable · injection | PFIZER | Prescription | 30 Dec 1986 |
| LYSTEDA | 650MG | tablet · oral | J MOLNER | Prescription | 13 Nov 2009 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 3 Nov 2011 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | EPIC PHARMA LLC | Prescription | 17 Nov 2011 |
| TRANEXAMIC ACID | 650MG | tablet · oral | ACTAVIS LABS FL INC | Prescription | 27 Dec 2012 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | PHARMOBEDIENT | Prescription | 14 Jun 2013 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | HERITAGE | Prescription | 11 Feb 2014 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | AVET LIFESCIENCES | Prescription | 12 Aug 2014 |
| TRANEXAMIC ACID | 650MG | tablet · oral | AUROBINDO PHARMA USA | Prescription | 21 Sep 2015 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | EUGIA PHARMA | Prescription | 14 Jan 2016 |
| TRANEXAMIC ACID | 650MG | tablet · oral | ANI PHARMS | Prescription | 25 Jul 2016 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | GLAND | Prescription | 13 Feb 2017 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | AMNEAL PHARMS CO | Prescription | 28 Feb 2017 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | MICRO LABS | Prescription | 27 Jun 2017 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | EXELA PHARMA | Prescription | 15 Apr 2019 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | CAPLIN | Prescription | 17 Jul 2019 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | MILLA PHARMS | Prescription | 17 Jul 2019 |
| TRANEXAMIC ACID | 100MG/ML | injectable · injection | APOTEX | Prescription | 14 Jan 2020 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | AMNEAL | Prescription | 16 Oct 2023 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | NEXUS | Prescription | 16 Apr 2024 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | GLAND | Prescription | 16 Apr 2024 |
| TRANEXAMIC ACID | 650MG | tablet · oral | RUBICON RESEARCH | Prescription | 11 Jun 2024 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 15 Aug 2024 |
| TRANEXAMIC ACID | 1GM/100ML (10MG/ML) | solution · intravenous | HERITAGE | Prescription | 2 Jun 2025 |
| TRANEXAMIC ACID | 650MG | tablet · oral | APPCO | Prescription | 11 Jun 2025 |
10 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CYKLOKAPRON 100 MG/ML | 02064413 | 100 MG / ML | SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
| CYKLOKAPRON 500 MG | 02064405 | 500 MG | TABLET · ORAL | PFIZER CANADA ULC |
| GD-TRANEXAMIC ACID | 02409097 | 500 MG | TABLET · ORAL | GENMED A DIVISION OF PFIZER CANADA ULC |
| M-TRANEXAMIC ACID | 02549395 | 500 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-TRANEXAMIC ACID | 02496232 | 500 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| TRANEXAMIC ACID | 02519194 | 500 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| TRANEXAMIC ACID INJECTION | 02392763 | 100 MG / ML | SOLUTION · INTRAVENOUS | OMEGA LABORATORIES LIMITED |
| TRANEXAMIC ACID INJECTION | 02466015 | 100 MG / ML | SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| TRANEXAMIC ACID INJECTION | 02497328 | 100 MG / ML | SOLUTION · INTRAVENOUS | JAMP PHARMA CORPORATION |
| TRANEXAMIC ACID INJECTION | 02531194 | 100 MG / ML | SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| TRANEXAMIC ACID INJECTION | 02531208 | 100 MG / ML | SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| TRANEXAMIC ACID INJECTION BP | 02246365 | 100 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| TRANEXAMIC ACID TABLETS | 02401231 | 500 MG | TABLET · ORAL | STERIMAX INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TRANEXAMIC ACID 1,000 MG/10 ML | $0.40354 | per ML | 23 Sep 2026 |
| US NADAC | TRANEXAMIC ACID 650 MG TABLET | $0.83438 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Tranexamic acid 1g granules sachets | £14.95 | 12 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Tranexamic acid 500mg tablets | £4.13 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Tranexamic acid 500mg/5ml solution for injection ampoules | £7.50 | 5 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Tranexamic acid 500mg/5ml solution for injection ampoules | £15.47 | 10 ampoule | 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.
WHO WHO Model List of Essential Medicines (2025)
- 22.6. Other medicines administered to the mother · core
Postpartum haemorrhage
Parenteral > General injections > IV: 100 mg per mL in 10 mL ampoule - 10.2. Medicines affecting coagulation · core
Haemorrhage, not elsewhere classified
Parenteral > General injections > IV: 100 mg per mL in 10 mL ampoule
Safety signals and safety-related labeling changes
- US FDA 29 Aug 2025 CYKLOKAPRON — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions - EMA PRAC 1 Sep 2022 PRAC signal: Incorrect route of product administration
Action for MAH: update of the product information: No - US FDA 7 Dec 2020 LYSTEDA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 16 Jul 2020 TRANEXAMIC ACID — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations
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.