Applies to risdiplam: oral powder for solution.
Serious side effects of Risdiplam
Along with its needed effects, risdiplam 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 Risdiplam
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 reported adverse events have included fever, diarrhea, and rash; additionally, among patients with infantile-onset spinal muscular atrophy, upper respiratory tract infection, pneumonia, constipation, and vomiting were reported.[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (17%), constipation, vomiting
Common (1% to 10%): Mouth and aphthous ulcers
Other
Very common (10% or more): Fever (22%)
Dermatologic
Very common (10% or more): Rash (17%)
Rash includes reports of rash, erythema, rash maculo-papular, rash erythematous, rash popular, dermatitis allergic, and folliculitis.
Respiratory
Respiratory tract infection includes reports of nasopharyngitis, rhinitis, and respiratory tract infection.
Very common (10% or more): Upper respiratory tract infection, pneumonia
Musculoskeletal
Common (1% to 10%): Arthralgia
Genitourinary
Common (1% to 10%): Urinary tract infection
