Note: This document contains side effect information about berotralstat. Some dosage forms listed on this page may not apply to the brand name Orladeyo.
Applies to berotralstat: oral capsule.
Serious side effects of Orladeyo
Along with its needed effects, berotralstat (the active ingredient contained in Orladeyo) 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 berotralstat:
Incidence not known
- Dizziness
- fainting
- fast or irregular heartbeat
Other side effects of Orladeyo
Some side effects of berotralstat 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
- Back pain
- diarrhea
- heartburn
- stomach pain
- vomiting
Less common
- Bloated
- excess air or gas in the stomach or bowels
- full feeling
- headache
- passing gas
- unusual tiredness or weakness
For Healthcare Professionals
Applies to berotralstat: oral capsule.
General
Common (1% to 10%): Headache, fatigue[Ref]
Cardiovascular
Frequency not reported: QT Prolongation (at higher than recommended dosage)[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain, vomiting, diarrhea, gastroesophageal reflux disease
Common (1% to 10%): Flatulence[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Maculopapular drug rash[Ref]
Musculoskeletal
Very common (10% or more): Back pain (10%)[Ref]
Nervous system
Very common (10% or more): Headache
