What the label lists and what reports show
Berotralstat side effects
Berotralstat's FDA label: “Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.” FAERS holds 856 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (62 reports).
- No generic listed
Check it at the source: the berotralstat FDA label on DailyMed (effective August 20, 2026, BioCryst Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ORLADEYO?Taking more than 1 dose of ORLADEYO a day may cause serious side effects, including: heart rhythm problems. A heart rhythm problem called QTc interval prolongation can happen in people who take more than 1 dose of ORLADEYO a day. This condition can cause an abnormal heart beat. Do not take more than 1 dose of ORLADEYO a day. The most common side effects of ORLADEYO include: abdominal pain vomiting diarrhea back pain heartburn Less common side effects include increases in liver function tests. Rarely, some people had a brief, itchy rash. These are not all of the possible side effects of ORLADEYO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, BioCryst Pharmaceuticals, Inc., effective August 20, 2026 (SPL set 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
Table 2: Adverse Reactions Observed in ≥10% of Adult and Pediatric Patients Aged 12 Years and Older with HAE in Any ORLADEYO Treatment Group (Trial 1)
| Reaction | n (%) | n (%) | n (%) | n (%) |
|---|---|---|---|---|
| Abdominal Pain includes Abdominal pain, Abdominal discomfort, Abdominal pain upper, and… | 4 (10) | 4 (10) | 9 (23) | 13 (16) |
| Vomiting | 1 (3) | 4 (10) | 6 (15) | 10 (12) |
| Diarrhea includes Diarrhea and Frequent bowel movements | 0 | 4 (10) | 6 (15) | 10 (12) |
| Back Pain | 1 (3) | 1 (2) | 4 (10) | 5 (6) |
| Gastroesophageal Reflux Disease | 0 | 4 (10) | 2 (5) | 6 (7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reaction is described elsewhere in the labeling: QTc Interval Prolongation [see Warnings and Precautions (5.1) ]. Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients 12 Years of Age and Older The safety of ORLADEYO is primarily based on 24-week (Part 1) data from a 3-part, double-blind, parallel-group, placebo-controlled trial (Trial 1) in 120 patients with Type I or II HAE who were randomized and dosed with either ORLADEYO 110 mg, 150 mg, or placebo, once daily with food. After Week 24, patients who continued in the study received active treatment through 48 weeks. In Trial 1, a total of 81 patients aged 12 years and older with HAE received at least one dose of ORLADEYO in Part 1. …
Source: FDA drug label, BioCryst Pharmaceuticals, Inc., effective August 20, 2026 (SPL set 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb), via openFDA; the full label on DailyMed
What do FAERS reports show?
856 reports list berotralstat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 209 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Berotralstat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions