Sodium tetradecyl sulfate

What Sodium tetradecyl sulfate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Sodium tetradecyl sulfate injection is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit- to-risk ratio should be considered in selected patients who are great surgical risks.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, solution, intravenous), Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

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.

Sodium tetradecyl sulfate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug. (See WARNINGS section.) Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting.

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(See WARNINGS section.) At least six deaths have been reported with the use of sodium tetradecyl sulfate injection. Four cases of anaphylactic shock leading to death have been reported in patients who received sodium tetradecyl sulfate injection. One of these four patients reported a history of asthma, a contraindication to the administration of sodium tetradecyl sulfate injection. (See WARNINGS section.) One death has been reported in a patient who received sodium tetradecyl sulfate injection and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives. Cerebrovascular accident, myocardial infarction To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Sodium tetradecyl sulfate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with sodium tetradecyl sulfate injection. (See ADVERSE REACTIONS section.) Heparin should not be included in the same syringe as sodium tetradecyl sulfate injection, since the two are incompatible.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Sodium tetradecyl sulfate 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored. Sodium tetradecyl sulfate injection is for intravenous use only. The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities.

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The dosage should be kept small, using 0.5 mL to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Sodium tetradecyl sulfate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Teratogenic Effects Animal reproduction studies have not been conducted with sodium tetradecyl sulfate injection. It is also not known whether sodium tetradecyl sulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium tetradecyl sulfate injection should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Sodium tetradecyl sulfate and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

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 sodium tetradecyl sulfate injection is administered to a nursing woman.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

When Sodium tetradecyl sulfate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Sodium tetradecyl sulfate injection is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

— FDA label: Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024. Read the full label on DailyMed →

Forms and how it is given

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.

• Hikma Pharmaceuticals USA Inc.1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (1)

• ANDA209937Hikma · December 9, 2019

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Sodium Tetradecyl Sulfate, Hikma Pharmaceuticals USA Inc., effective June 26, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. 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 →

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