- ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
- An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO
- For pregnant individuals: To avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
- Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury due to fainting
- Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
- Vaccination with ABRYSVO may not protect all people
- In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
- In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea
- In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.3% placebo) and jaundice (7.3% ABRYSVO versus 6.9% placebo)
Ask your healthcare provider about the risks and benefits of ABRYSVO. Only a healthcare provider can decide if ABRYSVO is right for you. Always talk to your healthcare provider about any side effects you may experience.
You are encouraged to report side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.
Individuals who received ABRYSVO during pregnancy are encouraged to enroll in a pregnancy exposure registry at 1-800-616-3791. The registry will monitor pregnancy outcomes.
Please see full Prescribing Information for ABRYSVO.