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# FDA Requires Guillain-Barré Warning in Shingrix Labeling
- URL: https://www.fdaweb.com/fda-requires-guillain-barre-warning-in-shingrix-labeling/
- Published: 2021-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:52:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148963

FDA says it is requiring the addition of language in the Warnings and Precautions section of labeling for GlaxoSmithKline’s Shingrix (zoster vaccine recombinant, adjuvanted) describing the risk for Guillain-Barré Syndrome (GBS) following administration of the shingles vaccine. An agency [safety communication](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix?ref=fdaweb.com) says the new language reports that in a postmarketing observational study, an increased risk of GBS was observed during the 42 days following Shingrix vaccination.

The notice says the study shows an association of GBS with Shingrix but the available evidence is insufficient to establish a causal relationship. “FDA has determined that the benefits of vaccination with Shingrix continue to outweigh its risks,” it says.