Evrysdi Side Effects

Generic name: risdiplam

Medically reviewed by Drugs.com. Last updated on Jul 6, 2023.

Note: This document contains side effect information about risdiplam. Some dosage forms listed on this page may not apply to the brand name Evrysdi.

Applies to risdiplam: oral powder for solution.

Serious side effects of Evrysdi

Along with its needed effects, risdiplam (the active ingredient contained in Evrysdi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risdiplam:

More common

Body aches or pain
chest pain or tightness
chills
cough
ear congestion
fever
headache
loss of voice
runny or stuffy nose
sneezing
sore throat
trouble breathing
unusual tiredness or weakness

Less common

Bladder pain
bloody or cloudy urine
difficult, burning, or painful urination
frequent urge to urinate
lower back or side pain

Other side effects of Evrysdi

Some side effects of risdiplam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Canker sores
constipation
diarrhea
skin rash
sores, ulcers, or white spots on the lips or tongue or inside the mouth
vomiting

Less common

Difficulty in moving
joint pain
muscle pain or stiffness

For Healthcare Professionals

Applies to risdiplam: oral powder for reconstitution.

General

The most frequently reported side effects included fever, diarrhea, headache, and rash. Additionally, among patients with infantile-onset spinal muscular atrophy, upper respiratory tract infection, lower respiratory tract infection, constipation, vomiting, and cough were reported.^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 17%)

Common (1% to 10%): Eczema

Postmarketing reports: Cutaneous vasculitis

Rash included dermatitis, rash, erythema, maculo-papular rash, erythematous rash, popular rash, allergic dermatitis, acneiform dermatitis, and folliculitis.

Cutaneous vasculitis was identified during post-marketing experience.

Endocrine

Common (1% to 10%): Cryptorchism

Gastrointestinal

Very common (10% or more): Constipation (up to 25%), diarrhea (up to 17%), vomiting (up to 17%)

Common (1% to 10%): Mouth and aphthous ulcers, gastroesophageal reflux disease, gastroenteritis, nausea, upper abdominal pain

Genitourinary

Common (1% to 10%): Urinary tract infection

Urinary tract infection included urinary tract infection and cystitis.

Musculoskeletal

Common (1% to 10%): Arthralgia, joint dislocation

Nervous system

Very common (10% or more): Headache (20%)

Other

Pyrexia included fever and hyperpyrexia.

Very common (10% or more): Pyrexia (up to 54%), teething (up to 13%)

Common (1% to 10%): Ear infection

Respiratory

Upper respiratory tract infections included nasopharyngitis, respiratory tract infection, rhinitis, influenza, pharyngitis, viral respiratory tract infection, upper respiratory tract infection (bacterial and viral), and COVID-19.

Lower respiratory tract infection included pneumonia and bronchitis.

Very common (10% or more): Upper respiratory tract infection (up to 82%), pneumonia (up to 40%), cough (12.9%), bronchitis (up to 11%)

Common (1% to 10%): Respiratory failure, respiratory distress, acute respiratory failure, atelectasis

Frequency not reported: Lower respiratory tract infection