ORLADEYO® (berotralstat) has established safety

  • In the first 6 months of the clinical study (part 1), the most common side effects that occurred in at least 10% of people taking ORLADEYO and more frequently than in those taking placebo were abdominal pain, vomiting, diarrhea, back pain, and heartburn. These are not all of the possible side effects of ORLADEYO. For more information, ask your healthcare provider or pharmacist
    • Not everyone experienced gastrointestinal (GI) side effects. For those who did, they generally occurred early after starting treatment, became less frequent with time, and typically got better on their own
    • No one being treated with ORLADEYO 150 mg discontinued therapy due to GI side effects. One person being treated with ORLADEYO 110 mg discontinued
  • No new types of side effects were seen in those who continued ORLADEYO for 2 years

If you experience GI side effects that don’t go away, your healthcare provider may prescribe a reduced dosage of ORLADEYO (110 mg, once daily with food).

Another clinical study of 227 people looked at the safety of ORLADEYO and found results that support the findings from the previous study.

What to avoid when taking ORLADEYO

  • It is not known if ORLADEYO is safe and effective to treat an acute HAE attack; therefore ORLADEYO should not be used to treat an acute HAE attack
  • Do not take additional doses of ORLADEYO to treat an acute swelling attack
  • Do not take more than 1 capsule of ORLADEYO per day because extra doses can cause heart rhythm problems. If you do, call your healthcare provider right away
  • Do not start taking ORLADEYO without telling your healthcare provider about all the medicines you take. Taking ORLADEYO with certain other medicines may affect the way those medicines work and other medicines may affect how ORLADEYO works

Talk to your healthcare provider if you experience any side effects.