Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions

Ann Allergy Asthma Immunol. 2005 Dec;95(6):593-9. doi: 10.1016/S1081-1206(10)61024-1.


Background: Polyoxyethylene-sorbitan-20-monooleate (also known as polysorbate 80 and Tween 80) is a solubilizing agent ubiquitously used in nutritives, creams, ointments, lotions, and multiple medical preparations (e.g., vitamin oils, vaccines, and anticancer agents) and as an additive in tablets. Whereas its relevance as a contact allergen has declined during the past decades, it is of current relevance as a "hidden" inductor of anaphylactoid reactions.

Objective: To identify polysorbate 80 (generally believed to be an inert vehicle) as an inductor of a severe anaphylactoid reaction.

Methods: Skin prick testing, enzyme-linked immunosorbent assay, IgE immunoblotting, and flow cytometric detection of basophil activation were performed in controls and in a patient with a medical history of anaphylactic shock due to intravenous administration of a multivitamin product during pregnancy.

Results: Polysorbate 80 was identified as the causative agent for the anaphylactoid reaction of nonimmunologic origin in the patient. Polysorbate specific IgE antibodies were not identified in enzyme-linked immunosorbent assay and immunoblot examinations, confirming the nonimmunologic nature of the anaphylactoid reaction.

Conclusions: Polysorbate 80 is a ubiquitously used solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions.

MeSH terms

  • Anaphylaxis / chemically induced*
  • Anaphylaxis / immunology
  • Basophils / immunology
  • Drug-Related Side Effects and Adverse Reactions
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Flow Cytometry
  • Humans
  • Immunoblotting
  • Immunoglobulin E / blood
  • Pharmaceutical Preparations / chemistry
  • Polysorbates / adverse effects*
  • Polysorbates / chemistry
  • Pregnancy
  • Skin Tests
  • Surface-Active Agents / adverse effects*
  • Surface-Active Agents / chemistry
  • Vitamins / administration & dosage
  • Vitamins / adverse effects*
  • Vitamins / chemistry*


  • Pharmaceutical Preparations
  • Polysorbates
  • Surface-Active Agents
  • Vitamins
  • Immunoglobulin E