Orladeyo Side Effects

Generic name: berotralstat

Medically reviewed by Drugs.com. Last updated on Mar 2, 2024.

Note: This document provides detailed information about Orladeyo Side Effects associated with berotralstat. Some dosage forms listed on this page may not apply specifically to the brand name Orladeyo.

Applies to berotralstat: oral capsule.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may increase your risk for heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you or your child have dizziness, fainting, or fast or irregular heartbeat.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Common 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:

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:

For healthcare professionals

Applies to berotralstat: oral capsule.

General adverse events

• 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

See also:

Frequently asked questions

• How effective is Orladeyo?

Further information

Orladeyo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer