Prescription medicine
Tranexamic acid Brand names: Cyklokapron
Tranexamic acid (Cyklokapron) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.404 per mL (Tranexamic acid 1,000 mg/10 mL) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tranexamic acid FDA label on DailyMed (effective September 3, 2025, Pfizer Laboratories Div Pfizer Inc); the NDA 19281 record on Drugs@FDA; every tranexamic acid label on DailyMed.
Highlights of the record
FDA label of September 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION.
CYKLOKAPRON is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when CYKLOKAPRON was inadvertently administered via the neuraxial route [see Warnings and Precautions (5.1) ]. WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION See full prescribing information for complete boxed warning. CYKLOKAPRON is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when CYKLOKAPRON was inadvertently administered intrathecally via the neuraxial route.
Used for
From the label: indications and usageCYKLOKAPRON ® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Forms and strengths
- 650 mg
- 1 g/10ml
- 10 mg/ml
- 100 mg/ml
Injection (solution); tablet; injection; film-coated tablet.
On the market
- Earliest approval on file
- December 30, 1986 Cyklokapron, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 31 first August 10, 2011; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 34 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.404 per mL Tranexamic acid 1,000 mg/10 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 1 Class I among all firms' recalls; latest June 13, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 8,840 through July 30, 2026
What is tranexamic acid used for?
From the label: indications and usageCYKLOKAPRON ® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. CYKLOKAPRON is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
FDA pharmacologic class: Antifibrinolytic Agent.
Source: FDA drug label (Cyklokapron), Pfizer Laboratories Div Pfizer Inc, effective September 3, 2025 (SPL set 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5), via openFDA; the full label on DailyMed
Is there a generic for tranexamic acid (Cyklokapron)?
The FDA approved the first generic tranexamic acid on August 10, 2011. 31 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tranexamic acid from 34 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tranexamic acid (Cyklokapron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.404 per mL (Tranexamic acid 1,000 mg/10 mL), up 16% from $0.348 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tranexamic acid 1,000 mg/10 mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tranexamic acid 1,000 mg/10 mL | Generic | $0.404 per mL | n/a | +16% |
| Tranexamic acid 650 mg tablet | Generic | $0.834 per tablet | $25.03 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tranexamic acid been recalled?
The FDA's Enforcement Report lists 6 recalls naming tranexamic acid since 2013: 1 Class I (the most serious), 2 Class II, 3 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of tranexamic acid and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 13, 2023 | Class III | AVKARE LLC | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. |
| June 12, 2023 | Class III | Amring Pharmaceuticals Inc | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. |
| September 26, 2022 | Class III | AuroMedics Pharma LLC | Presence of Particulate Matter: Piece of metal found in a vial |
| August 17, 2020 | Class I | Mylan Institutional LLC | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled … |
| October 31, 2013 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tranexamic acid label say about other medicines?
The tranexamic acid label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name tranexamic acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlorpromazine | drug interactions | Chlorpromazine: May result in increased risk of bleeding ( 7.2 ). |
| Tretinoin | drug interactions | Acid (Oral Tretinoin) Tranexamic acid USP tablets are not recommended in patients with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid [see Warnings and Precautions (5.1) ]. |
Source: FDA drug label (Cyklokapron), Pfizer Laboratories Div Pfizer Inc, effective September 3, 2025 (SPL set 6e89a7d9-4da4-42aa-b7f8-c602c24eefe5), via openFDA; the full label on DailyMed
What do FAERS reports show for tranexamic acid?
The FDA Adverse Event Reporting System holds 8,840 reports that list tranexamic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,316 are coded as a death and 3,999 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antifibrinolytic agents
- the pharmacologic class, with prices and generics
- Tranexamic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other