Does Humira (adalimumab) contain polysorbate 80, and are the amounts of polysorbate 80 in standard Humira doses equal to or greater than those in the Shingrix (recombinant zoster) vaccine?

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Last updated: October 20, 2026 • View editorial policy

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Polysorbate 80 Content in Humira vs. Shingrix

Yes, Humira contains polysorbate 80, and the standard adult dose of Humira contains significantly MORE polysorbate 80 than a single dose of Shingrix vaccine.

Polysorbate 80 Content in Humira

According to the FDA drug label, Humira formulations contain the following amounts of polysorbate 80 1:

  • 40 mg/0.4 mL formulation: 0.4 mg polysorbate 80 per dose
  • 40 mg/0.8 mL formulation: 0.8 mg polysorbate 80 per dose
  • 80 mg/0.8 mL formulation: 0.8 mg polysorbate 80 per dose
  • 20 mg/0.2 mL formulation: 0.2 mg polysorbate 80 per dose
  • 10 mg/0.1 mL formulation: 0.1 mg polysorbate 80 per dose

The most commonly used adult formulations (40 mg and 80 mg doses) contain 0.4-0.8 mg of polysorbate 80 per injection.

Polysorbate 80 Content in Shingrix

Shingrix does NOT contain polysorbate 80. The recombinant zoster vaccine uses a different adjuvant system (AS01B) and does not list polysorbate 80 among its excipients 2, 3. The vaccine consists of recombinant glycoprotein E combined with the AS01B adjuvant system in a 0.5 mL dose 2.

Direct Comparison

The comparison cannot be made as originally framed because Shingrix contains zero polysorbate 80. Standard Humira doses contain 0.4-0.8 mg of polysorbate 80, while Shingrix contains none.

Clinical Relevance

Polysorbate 80 Formulation Variations

Not all Humira formulations contain the same amount of polysorbate 80. The newer citrate-free formulations (40 mg/0.4 mL and 80 mg/0.8 mL) contain polysorbate 80 as an excipient 1. Adalimumab biosimilars also vary in their polysorbate 80 content - some biosimilars contain polysorbate 80 (FKB327, MSB11022) while others use different excipients entirely 4.

Safety Considerations

Polysorbate 80 has been associated with nonimmunologic anaphylactoid reactions 5, and macromolecular impurities in polysorbate 80 preparations can cause anaphylactoid reactions through histamine release 6. However, the amounts used in Humira (0.4-0.8 mg per dose) are within established safety parameters for subcutaneous administration.

Key Takeaway

If you are comparing these medications due to polysorbate 80 sensitivity concerns, Shingrix would be the safer choice as it contains no polysorbate 80, while Humira contains 0.4-0.8 mg per standard adult dose depending on formulation.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.