Isosulfan Blue is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Taken
- Subcutaneous
- Label
- Devatis, Inc., revised July 1, 2026 · full label on DailyMed
- Generic
- FDA-approved (7 companies) · details
What it is used for
Isosulfan blue injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities ( 1.1 ).
1.1 Lymphatic Vessel Delineation Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.
Forms and strengths
1% aqueous solution (isosulfan blue) 1% aqueous solution (isosulfan blue)( 3 )
Who should not take it (contraindications)
Isosulfan blue injection is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds. Hypersensitivity to triphenylmethane or related compounds ( 4 ).
Warnings and precautions
Life threatening anaphylactic reactions have occurred after isosulfan blue injection administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection ( 5.1 ). The admixture of isosulfan blue injection with local anesthetics results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe for anesthetics ( 5.2 ). Isosulfan blue injection interferes with measurements in peripheral blood pulse oximetry. Arterial blood gas analysis may be needed ( 5.3 ).
5.1 Hypersensitivity Reactions Life threatening anaphylactic reactions (respiratory distress, shock, angio-edema) have occurred after isosulfan blue injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1%. Trained personnel should be available to administer emergency care including resuscitation.
5.2 Precipitation of Isosulfan Blue Injection by Lidocaine The admixture of isosulfan blue injection 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe to administer a local anesthetic.
5.3 Interference with Oxygen Saturation and Methemoglobin Measurements Isosulfan blue injection 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen. Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, cooximetry may be needed to verify methemoglobin level.
Side effects (adverse reactions)
Hypersensitivity Reactions: Hypersensitivity reactions occur in approximately 2% of patients and include life threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following IV administration of a similar compound ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Devatis, Inc. at 1-833-534-4406 or druginfo@devatis.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Post-Marketing Experience Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5) ]. Laboratory Tests: Isosulfan blue injection interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5) ]. Skin: transient or long-term (tattooing) blue coloration.
Drug interactions
No drug interactions have been identified with isosulfan blue injection. No drug interactions have been identified for isosulfan blue injection ( 7 ).
Pregnancy, breastfeeding, children and older adults
Caution should be exercised when isosulfan blue injection 1% is administered to nursing mothers ( 8.3 ). Safety and effectiveness of isosulfan blue injection 1% in children has not been established ( 8.4 ).
8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isosulfan blue injection 1% is administered to a nursing mother.
8.4 Pediatric Use Safety and effectiveness of isosulfan blue injection 1% in children have not been established.
Is there a generic Isosulfan Blue?
Yes. The FDA has approved generic Isosulfan Blue from 7 companies whose approvals are active. The earliest of these was approved in 2010.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Am Regent, Eugia Pharma, Meitheal, Msn, Mylan Institutional, Saba Ilay Sanayi, Somerset Theraps Llc
Brand-name versions
- Lymphazurin Covidien, approved 1981 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Isosulfan blue in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID aa6260da-0acd-4552-a215-07df8da1031c.