Prescription medicine
Fondaparinux Brand names: Arixtra
Fondaparinux (Arixtra) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $44.82 per mL (Fondaparinux 10 mg/0.8 mL syringe) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fondaparinux FDA label on DailyMed (effective December 15, 2024, Mylan Institutional LLC); the NDA 21345 record on Drugs@FDA; every fondaparinux label on DailyMed.
Highlights of the record
FDA label of December 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SPINAL/EPIDURAL HEMATOMAS.
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
a history of traumatic or repeated epidural or spinal puncture
a history of spinal deformity or spinal surgery
Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7) ]. WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageFondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in adult patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery.
Forms and strengths
- 2.5 mg/.5ml
- 5 mg/.4ml
- 7.5 mg/.6ml
- 10 mg/.8ml
Injection (solution); injection.
On the market
- Earliest approval on file
- December 7, 2001 Arixtra, Mylan Ireland Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first July 11, 2011; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $44.82 per mL Fondaparinux 10 mg/0.8 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest September 30, 2022
- FAERS reports
- 8,047 through July 30, 2026
What is fondaparinux used for?
From the label: indications and usageFondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for:
Prophylaxis of deep vein thrombosis (DVT) in adult patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. ( 1.1 )
Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. ( 1.2 , 1.3 )
Treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg. […]
Conditions named in the indications of fondaparinux's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Factor Xa Inhibitor.
Source: FDA drug label (Fondaparinux Sodium), Mylan Institutional LLC, effective December 15, 2024 (SPL set 4b65f642-87f7-4da5-a9c9-02cd1f8d9d16), via openFDA; the full label on DailyMed
What does the patient leaflet for fondaparinux say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about fondaparinux sodium injection?Fondaparinux sodium injection may cause serious side effects, including: • Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like fondaparinux sodium injection, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: o a thin tube called an epidural catheter is placed in your back to give you certain medicine o you take non-steroidal anti-inflammatory drugs (NSAIDs) or a medicine to help prevent blood from clotting o you have a history of difficult or repeated epidural or spinal punctures o you have a history of problems with your spine or have had surgery on your spine If you use fondaparinux sodium injection and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), and loss of control of your bowels or bladder (incontinence). Because the risk of bleeding may be higher, tell your doctor before using fondaparinux sodium injection if you: o are also taking certain other medicines that affect blood clotting such as aspirin, an NSAID (for example, ibuprofen or naproxen), clopidogrel, or warfarin sodium o have bleeding problems o had problems in the past with pain medication given through the spine o have had surgery to your spine o have a spinal deformity See “What are the possible side effects of fondaparinux sodium injection?” for more information about side effects.
From the patient leaflet: How should I store Fondaparinux sodium injection?See the product label for complete instructions on how to store fondaparinux sodium injection. • Throw away (discard) fondaparinux sodium injection that is out of date (expired) or unused. Keep fondaparinux sodium injection and all medicines out of the reach of children.
Source: FDA drug label (Fondaparinux Sodium), Mylan Institutional LLC, effective December 15, 2024 (SPL set 4b65f642-87f7-4da5-a9c9-02cd1f8d9d16), via openFDA; the full label on DailyMed
Is there a generic for fondaparinux (Arixtra)?
The FDA approved the first generic fondaparinux on July 11, 2011. 6 generic applications are approved; 3 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 fondaparinux from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2001 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 fondaparinux (Arixtra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $44.82 per mL (Fondaparinux 10 mg/0.8 mL syringe), up 41% from $31.82 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Fondaparinux 2.5 mg/0.5 mL syringe (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fondaparinux 10 mg/0.8 mL syringe | Generic | $44.82 per mL | n/a | +41% |
| Fondaparinux 2.5 mg/0.5 mL syringe | Generic | $22.16 per mL | n/a | -16% |
| Fondaparinux 7.5 mg/0.6 mL syringe | Generic | $42.81 per mL | n/a | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fondaparinux been recalled?
The FDA's Enforcement Report lists 1 recall naming fondaparinux since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 30, 2022 | Class II | AuroMedics Pharma LLC | Subpotent Drug: Out of specification for assay |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fondaparinux label say about other medicines?
The fondaparinux label names 4 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Digoxin | drug interactions | DRUG INTERACTIONS In clinical studies performed with fondaparinux sodium, the concomitant use of oral anticoagulants (warfarin sodium), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. |
| Heparin | warnings and precautions | The activity of fondaparinux sodium is expressed in milligrams (mg) of the fondaparinux and cannot be compared with activities of heparin or low molecular weight heparins [see Clinical Pharmacology (12.2 , 12.3) ]. |
| Piroxicam | drug interactions | DRUG INTERACTIONS In clinical studies performed with fondaparinux sodium, the concomitant use of oral anticoagulants (warfarin sodium), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. |
| Warfarin | drug interactions | DRUG INTERACTIONS In clinical studies performed with fondaparinux sodium, the concomitant use of oral anticoagulants (warfarin sodium), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. |
Source: FDA drug label (Fondaparinux Sodium), Mylan Institutional LLC, effective December 15, 2024 (SPL set 4b65f642-87f7-4da5-a9c9-02cd1f8d9d16), via openFDA; the full label on DailyMed
What do FAERS reports show for fondaparinux?
The FDA Adverse Event Reporting System holds 8,047 reports that list fondaparinux among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,438 are coded as a death and 4,269 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
How does fondaparinux compare with medicines for the same use?
1 side-by-side page set fondaparinux beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other factor Xa inhibitors
- the pharmacologic class, with prices and generics
- Fondaparinux side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other