US Healthcare Professionals

Established safety profile in adults, children, and infants with SMA

Established safety profile in adults, children, and infants with SMA

Patients living with SMA

The most common side effects of Evrysdi include:

IN ADULTS AND CHILDREN

Type 2 or 3 SMA (later-onset)

  • fever
  • diarrhea
  • rash

IN INFANTS

Type 1 SMA (infantile-onset)

  • fever
  • diarrhea
  • rash
  • runny nose, sneezing, and sore throat (upper respiratory infection)
  • lung infection (lower respiratory infection)
  • constipation
  • vomiting
  • cough


The safety profile of Evrysdi in infants treated before symptoms of SMA appear (presymptomatic) was consistent with the safety profile of Evrysdi in infants with Type 1 SMA and adults and children with Type 2 or 3 SMA.

These are not all of the possible side effects of Evrysdi. For more information on the possible risks and benefits of Evrysdi, speak to your healthcare provider.

No one in the clinical studies stopped taking Evrysdi because of side effects of treatment*

*As of March 2022.

Initial safety findings from people who previously took other approved or investigational SMA medications have been consistent with the safety findings from studies in adults, children, and infants who only took Evrysdi.

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What is Evrysdi?

Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in children and adults.

  • Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you:
    • are pregnant or plan to become pregnant, as Evrysdi may harm your unborn baby. Ask your healthcare provider for advice before taking this medicine
    • are a woman who can become pregnant:
      • Before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy
      • Talk to your healthcare provider about birth control methods that may be right for you. Use birth control while on treatment and for at least 1 month after stopping Evrysdi
      • Pregnancy Registry. Talk to your healthcare provider right away if you become pregnant while taking Evrysdi. Ask about registering with the Evrysdi Pregnancy Registry, which was created to collect information about your health and your baby's health. Your healthcare provider can enroll you in this registry by calling 1-833-760-1098 or visiting www.evrysdipregnancyregistry.com
    • are an adult male. Evrysdi may affect a man’s ability to have children (fertility). Ask a healthcare provider for advice before taking this medicine
    • are breastfeeding or plan to breastfeed. It is not known if Evrysdi passes into breast milk and may harm your baby
  • Tell your healthcare provider about all the medicines you take
  • You should receive Evrysdi from the pharmacy as a liquid. If the medicine in the bottle is a powder, do not use it. Contact your pharmacist for a replacement
  • Avoid getting Evrysdi on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water
  • The most common side effects of Evrysdi include:
    • For later-onset SMA:
      • fever
      • diarrhea
      • rash
    • For infantile-onset SMA:            
      • fever
      • diarrhea
      • rash
      • runny nose, sneezing, and sore throat (upper respiratory infection)
      • lung infection (lower respiratory infection)
      • constipation
      • vomiting
      • cough

These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

    • Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.

      Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.