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Orladeyo Side Effects

Generic name: berotralstat

Medically reviewed by Last updated on Sep 18, 2022.

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

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

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.


Common (1% to 10%): Headache, fatigue[Ref]


Frequency not reported: QT Prolongation (at higher than recommended dosage)[Ref]


Very common (10% or more): Abdominal pain, vomiting, diarrhea, gastroesophageal reflux disease

Common (1% to 10%): Flatulence[Ref]


Uncommon (0.1% to 1%): Maculopapular drug rash[Ref]


Very common (10% or more): Back pain (10%)[Ref]

Nervous system

Very common (10% or more): Headache


1. "Product Information. Orladeyo (berotralstat)." BioCryst Pharmaceuticals Inc (2021):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.