Drug · FAERS side-effect profile with label screen

Berotralstat side effects: what 854 FDA adverse event reports show

Berotralstat Hydrochloride · 23 reaction terms · 417 drug–reaction co-reports · data 2026-09-14

Drug class

Plasma kallikrein inhibitor

FDA label, Indications wording of the closest related product

Label matched

Berotralstat Hydrochloride (Orladeyo)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

854 reports · 49% serious · 28 with death outcome · 74% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ORLADEYO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older. ORLADEYO is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older. ( 1 ) Limitations of Use : ORLADEYO should not be used for treatment of acute HAE attacks.

FDA label, Indications and Usage

What it is

ORLADEYO (berotralstat) is a plasma kallikrein inhibitor. Berotralstat is presented as the dihydrochloride salt with the chemical name 1-[3-(aminomethyl)phenyl]- N -(5-{( R )-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1 H -pyrazole-5-carboxamide dihydrochloride.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 14 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 9

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 9 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hereditary angioedema	244	582.8 523.2–649.2ROR 814.8 · χ² 137,885 / p <1e-300	544.7 EB05 489.7 · IC025 +7.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 590.4	no trial data cached
Pharyngeal swelling	12	30.7 17.5–53.9ROR 31.2 · χ² 316 / p 6e-71	29.4 EB05 17.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Insurance issue	9	14.8 7.8–28.4ROR 15.0 · χ² 103 / p 2e-24	12.8 EB05 6.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 35.8	no trial data cached
Gastrointestinal disorder	50	13.9 10.6–18.1ROR 14.7 · χ² 586 / p 9e-130	13.7 EB05 10.7 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Poor venous access	5	11.9 5.0–28.5ROR 11.9 · χ² 39 / p 2e-10	7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Weight fluctuation	5	11.8 4.9–28.2ROR 11.8 · χ² 39 / p 2e-10	7.6 EB05 3.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Product use complaint	7	11.1 5.3–23.1ROR 11.1 · χ² 54 / p 8e-14	8.1 EB05 3.7 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Product dose omission in error	11	10.0 5.6–18.1ROR 10.2 · χ² 81 / p 1e-19	8.1 EB05 4.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 37.8	no trial data cached
Dysmenorrhoea	5	9.4 3.9–22.5ROR 9.4 · χ² 29 / p 3e-8	6.0 EB05 2.6 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Injection site urticaria	5	5.0 2.1–12.1ROR 5.1 · χ² 12 / p 2e-4	3.7 EB05 1.7 · IC025 +0.3	Not in label — unassessed	serious n=4	no trial data cached
Expired product administered	6	4.4 2.0–9.8ROR 4.5 · χ² 13 / p 2e-4	3.5 EB05 1.8 · IC025 +0.4	Reporting / coding artifact	serious n=6	no trial data cached
Injection site swelling	10	3.2 1.7–6.0ROR 3.3 · χ² 13 / p 1e-4	2.9 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 22.0	no trial data cached
Injection site bruising	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 22.0	no trial data cached
Injection site pruritus	7	2.6 1.2–5.4ROR 2.6 · χ² 5 / p 0.011	2.3 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 18.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hereditary angioedema	244	582.8 523.2–649.2ROR 814.8 · χ² 137,885 / p <1e-300	544.7 EB05 489.7 · IC025 +7.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 590.4	no trial data cached
Gastrointestinal disorder	50	13.9 10.6–18.1ROR 14.7 · χ² 586 / p 9e-130	13.7 EB05 10.7 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Pharyngeal swelling	12	30.7 17.5–53.9ROR 31.2 · χ² 316 / p 6e-71	29.4 EB05 17.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Product dose omission in error	11	10.0 5.6–18.1ROR 10.2 · χ² 81 / p 1e-19	8.1 EB05 4.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 37.8	no trial data cached
Injection site bruising	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 22.0	no trial data cached
Injection site swelling	10	3.2 1.7–6.0ROR 3.3 · χ² 13 / p 1e-4	2.9 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 22.0	no trial data cached
Insurance issue	9	14.8 7.8–28.4ROR 15.0 · χ² 103 / p 2e-24	12.8 EB05 6.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 35.8	no trial data cached
Injection site pruritus	7	2.6 1.2–5.4ROR 2.6 · χ² 5 / p 0.011	2.3 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 18.2	no trial data cached
Product use complaint	7	11.1 5.3–23.1ROR 11.1 · χ² 54 / p 8e-14	8.1 EB05 3.7 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Expired product administered	6	4.4 2.0–9.8ROR 4.5 · χ² 13 / p 2e-4	3.5 EB05 1.8 · IC025 +0.4	Reporting / coding artifact	serious n=6	no trial data cached
Injection site urticaria	5	5.0 2.1–12.1ROR 5.1 · χ² 12 / p 2e-4	3.7 EB05 1.7 · IC025 +0.3	Not in label — unassessed	serious n=4	no trial data cached
Dysmenorrhoea	5	9.4 3.9–22.5ROR 9.4 · χ² 29 / p 3e-8	6.0 EB05 2.6 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Weight fluctuation	5	11.8 4.9–28.2ROR 11.8 · χ² 39 / p 2e-10	7.6 EB05 3.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Poor venous access	5	11.9 5.0–28.5ROR 11.9 · χ² 39 / p 2e-10	7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Syringe issue	4	5.6 2.1–14.9ROR 5.6 · χ² 11 / p 5e-4	3.7 EB05 1.6 · IC025 +0.1	Not in label — unassessed	serious n=4	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Berotralstat?

In FDA FAERS, the most frequently co-reported reaction terms for Berotralstat are hereditary angioedema, gastrointestinal disorder, pharyngeal swelling, injection site bruising, injection site swelling, insurance issue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Berotralstat have an FDA boxed warning?

No. The FDA label retrieved for Berotralstat has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Berotralstat causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb, effective 20260820; matched on openfda.generic_name.exact:"BEROTRALSTAT HYDROCHLORIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 23 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.