Orladeyo (Berotralstat) – Side Effects, Interactions, Uses, Dosage, Warnings

Berotralstat is used to prevent attacks of hereditary angioedema (HAE) in adults and children at least 12 years old.

Berotralstat is not for use in treating an HAE attack that has already begun.

Berotralstat may also be used for purposes not listed in this medication guide.


What is Orladeyo (Berotralstat) used for?

  • Angioedema


What is the most important information I should know about Orladeyo (Berotralstat)?

Tell your doctor if you have ever had:

  • liver disease;
  • kidney disease (or if you are on dialysis); or
  • heart rhythm problems.

Tell your doctor if you are pregnant or breastfeeding.

Berotralstat is not approved for use by anyone younger than 12 years old.

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Side Effects

What are the side effects of Orladeyo (Berotralstat)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • stomach pain, heartburn, vomiting;
  • diarrhea; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Orladeyo (Berotralstat) if I’m pregnant or breastfeeding?

Tell your doctor if you are pregnant or breastfeeding.


What drugs and food should I avoid while taking Orladeyo (Berotralstat)?

Do not share this medicine with another person, even if they have HAE.

Dosage Guidelines & Tips

How to take Orladeyo (Berotralstat)?

Use Orladeyo (Berotralstat) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Berotralstat is usually taken once per day with food.

Follow your doctor's dosing instructions very carefully. Taking too much of this medicine can cause serious heart rhythm problems.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you are ready to take a pill.

What should I do if I missed a dose of Orladeyo (Berotralstat)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Overdose Signs

What happens if I overdose on Orladeyo (Berotralstat)?

If you think you or someone else may have overdosed on: Orladeyo (Berotralstat),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn't breathing after taking Orladeyo (Berotralstat), call 911



No image available

BCX, 110

Color: blue

Shape: capsule

Imprint: BCX, 110

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BCX, 150

Color: blue/white

Shape: capsule

Imprint: BCX, 150

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