Quick answers
- What is Trisodium citrate dihydrate used for?
- The FDA-approved label (Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, January 24, 2025) says: “SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. […] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Trisodium citrate dihydrate?
- The “Adverse Reactions” section of the FDA label (Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, January 24, 2025) begins: “Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trisodium citrate dihydrate have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trisodium citrate dihydrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trisodium citrate dihydrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trisodium citrate dihydrate?
- 5 companies list prescription products of Trisodium citrate dihydrate in the FDA NDC Directory, including Fenwal, Inc., Terumo BCT, Ltd and Citra Labs LLC.
What Trisodium citrate dihydrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. […] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.
— FDA label: Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, effective January 24, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Trisodium citrate dihydrate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity.
Read more of this section
The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. (6) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, effective January 24, 2025. Read the full label on DailyMed →
Trisodium citrate dihydrate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. (2) SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. (2.1) Follow the directions for connecting the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP bag to the apheresis system.
Read more of this section
(2.2) 2.1 General Dosing Information SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion. For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual. 2.2 Administration Ensure solution is the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP and is within the expiration date. Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Use only if solution is clear and free of particulate matter. Protect from sharp objects. Directions for connecting the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP bag to the apheresis device. At the prompt to connect anticoagulant to the apheresis device tubing set: Remove the overwrap by pulling down at the notch, and remove the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP bag. Before use, perform the following checks [see Warnings and Precautions (5)]: Check for leaks by gently squeezing the bag. If leaks are found, discard the bag. Ensure that the solution is the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP and is within the expiration date. Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used. Remove the protective cap from the port on the bag. Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution. Proceed according to the apheresis device operator's manual. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
— FDA label: Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, effective January 24, 2025. Read the full label on DailyMed →
When Trisodium citrate dihydrate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. (4)
— FDA label: Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, effective January 24, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution · Injection, solution |
|---|---|
| Route | Intravenous · Extracorporeal |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Sodium Citrate Blood-Pack Units, (Pl 146 Plastic), Anticoagulant Sodium Citrate, Tricitrasol, Sodium Citrate 4% W/V Anticoagulant, Sodium Citrate W/V Anticoagulant |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fenwal, Inc.3 products
- Terumo BCT, Ltd2 products
- Citra Labs LLC1 product
- Baxter Healthcare Corporation1 product
- Laboratorios Grifols SA1 product
FDA approval history
No Drugs@FDA application is linked to these products.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | c9d0e9c8-379f-4895-b272-329efab575c4 |
|---|---|
| FDA labels (SPL) | 8 |
| Active ingredients (FDA) | TRISODIUM CITRATE DIHYDRATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- triCitrasolBrand page: products, maker and price
- Fenwal, Inc.Maker or distributor
- Terumo BCT, LtdMaker or distributor
- Citra Labs LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sodium Citrate w/v Anticoagulant, Terumo BCT, Ltd, effective January 24, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →