Garadacimab side effects: what 507 FDA adverse event reports show
Drug class
Activated factor xii (fxiia) inhibitor (monoclonal antibody)
Brand names
Andembry
Who reports
507 reports · 81% serious · 3 with death outcome · 78% female
Used for
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )
What it is
Garadacimab-gxii, an activated Factor XII (FXIIa) inhibitor, is a recombinant, fully human, monoclonal antibody (IgG4/ λ -light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of garadacimab-gxii is approximately 148 kDa.
Boxed warning
None in the current label
Causality screen of the 13 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 344 | 1,401.2 1,315.6–1,492.3ROR 4,356.1 · χ² 464,217 / p <1e-300 | 1,258.9 EB05 1,151.1 · IC025 +8.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 1,095.7 | no trial data cached |
| Insurance issue | 31 | 86.5 61.5–121.7ROR 92.0 · χ² 2,531 / p <1e-300 | 82.1 EB05 60.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 118.5 | no trial data cached |
| Pharyngeal swelling | 8 | 34.6 17.4–68.8ROR 35.1 · χ² 228 / p 7e-52 | 32.0 EB05 17.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Poor venous access | 7 | 28.1 13.4–58.6ROR 28.4 · χ² 157 / p 3e-36 | 25.7 EB05 12.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Stress | 46 | 26.5 20.1–34.9ROR 29.0 · χ² 1,105 / p 1e-242 | 26.2 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 | no trial data cached |
| Therapy change | 6 | 25.7 11.6–57.1ROR 26.0 · χ² 119 / p 5e-28 | 22.8 EB05 9.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Product dose omission in error | 16 | 24.7 15.2–39.9ROR 25.4 · χ² 340 / p 3e-76 | 24.0 EB05 15.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 60.4 | no trial data cached |
| Bladder disorder | 5 | 20.8 8.7–49.7ROR 21.0 · χ² 75 / p 2e-18 | 16.5 EB05 5.3 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Therapy interrupted | 33 | 19.8 14.2–27.5ROR 21.1 · χ² 572 / p 1e-126 | 19.6 EB05 14.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 31.1 | no trial data cached |
| Injection site irritation | 5 | 16.4 6.8–39.1ROR 16.5 · χ² 58 / p 2e-14 | 11.9 EB05 4.0 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Product availability issue | 6 | 11.1 5.0–24.5ROR 11.2 · χ² 45 / p 8e-12 | 7.6 EB05 3.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.6 | no trial data cached |
| Injection site swelling | 15 | 8.2 5.0–13.5ROR 8.4 · χ² 88 / p 3e-21 | 6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.1 | no trial data cached |
| Injection site erythema (redness where injected) | 15 | 5.0 3.1–8.3ROR 5.1 · χ² 45 / p 1e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 344 | 1,401.2 1,315.6–1,492.3ROR 4,356.1 · χ² 464,217 / p <1e-300 | 1,258.9 EB05 1,151.1 · IC025 +8.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 1,095.7 | no trial data cached |
| Stress | 46 | 26.5 20.1–34.9ROR 29.0 · χ² 1,105 / p 1e-242 | 26.2 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 | no trial data cached |
| Therapy interrupted | 33 | 19.8 14.2–27.5ROR 21.1 · χ² 572 / p 1e-126 | 19.6 EB05 14.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 31.1 | no trial data cached |
| Insurance issue | 31 | 86.5 61.5–121.7ROR 92.0 · χ² 2,531 / p <1e-300 | 82.1 EB05 60.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 118.5 | no trial data cached |
| Product dose omission in error | 16 | 24.7 15.2–39.9ROR 25.4 · χ² 340 / p 3e-76 | 24.0 EB05 15.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 60.4 | no trial data cached |
| Injection site erythema (redness where injected) | 15 | 5.0 3.1–8.3ROR 5.1 · χ² 45 / p 1e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | no trial data cached |
| Injection site swelling | 15 | 8.2 5.0–13.5ROR 8.4 · χ² 88 / p 3e-21 | 6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.1 | no trial data cached |
| Pharyngeal swelling | 8 | 34.6 17.4–68.8ROR 35.1 · χ² 228 / p 7e-52 | 32.0 EB05 17.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Poor venous access | 7 | 28.1 13.4–58.6ROR 28.4 · χ² 157 / p 3e-36 | 25.7 EB05 12.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Product availability issue | 6 | 11.1 5.0–24.5ROR 11.2 · χ² 45 / p 8e-12 | 7.6 EB05 3.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.6 | no trial data cached |
| Therapy change | 6 | 25.7 11.6–57.1ROR 26.0 · χ² 119 / p 5e-28 | 22.8 EB05 9.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Injection site irritation | 5 | 16.4 6.8–39.1ROR 16.5 · χ² 58 / p 2e-14 | 11.9 EB05 4.0 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Bladder disorder | 5 | 20.8 8.7–49.7ROR 21.0 · χ² 75 / p 2e-18 | 16.5 EB05 5.3 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Injection site rash | 4 | 5.5 2.1–14.5ROR 5.5 · χ² 10 / p 6e-4 | 3.6 EB05 1.6 · IC025 +0.1 | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Syringe issue | 3 | 7.1 2.3–21.9ROR 7.1 · χ² 10 / p 7e-4 | 3.9 EB05 1.5 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious n=3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Insurance issue — n=31, PRR 86.5
- Stress — n=46, PRR 26.5
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 Garadacimab?
In FDA FAERS, the most frequently co-reported reaction terms for Garadacimab are hereditary angioedema, stress, insurance issue, injection site erythema, injection site swelling, pharyngeal swelling. 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 Garadacimab have an FDA boxed warning?
No. The FDA label retrieved for Garadacimab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Garadacimab 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 07b0b671-db81-49f0-a402-0c0219db7fa2, effective 20250630; matched on
openfda.generic_name.exact:"GARADACIMAB") - 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, fieldpatient.drug.openfda.generic_name.exact, 15 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.