Lanadelumab-Flyo side effects: what 2 FDA adverse event reports show

Lanadelumab-Flyo · 136 reaction terms · 5,900 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

2 reports · 50% serious · 0 with death outcome · 100% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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 40 strongest signals

Reporting / coding artifact 14No label text to screen 26

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 96 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	1,197	853.6 812.7–896.6ROR 1,372.1 · χ² 901,309 / p <1e-300	746.0 EB05 711.2 · IC025 +9.1 3/3 methods agree	No label text to screen	–	no trial data cached
Pharyngeal swelling	121	84.8 71.1–101.1ROR 88.1 · χ² 9,814 / p <1e-300	82.7 EB05 71.0 · IC025 +5.7 3/3 methods agree	No label text to screen	–	no trial data cached
Weight fluctuation	84	53.8 43.6–66.5ROR 55.3 · χ² 4,270 / p <1e-300	52.8 EB05 44.0 · IC025 +5.0 3/3 methods agree	No label text to screen	–	no trial data cached
Insurance issue	113	50.8 42.3–60.9ROR 52.6 · χ² 5,426 / p <1e-300	50.0 EB05 42.7 · IC025 +5.1 3/3 methods agree	No label text to screen	–	no trial data cached
Product availability issue	79	23.4 18.8–29.1ROR 24.0 · χ² 1,669 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Body height decreased	32	19.7 13.9–27.8ROR 19.9 · χ² 547 / p 3e-121	19.4 EB05 14.3 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Poor venous access	30	19.3 13.5–27.6ROR 19.5 · χ² 501 / p 2e-111	19.0 EB05 13.9 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Stress	138	12.7 10.8–15.0ROR 13.3 · χ² 1,483 / p <1e-300	12.6 EB05 10.9 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Seasonal allergy	25	11.8 7.9–17.4ROR 11.8 · χ² 235 / p 2e-53	11.1 EB05 7.5 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Pregnancy	35	11.5 8.3–16.0ROR 11.6 · χ² 324 / p 9e-73	11.0 EB05 8.0 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Infusion site pain	22	11.4 7.5–17.3ROR 11.5 · χ² 199 / p 2e-45	10.6 EB05 7.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Treatment noncompliance	92	11.2 9.2–13.7ROR 11.5 · χ² 848 / p 8e-187	11.1 EB05 9.2 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Intentional product use issue	146	11.0 9.4–12.9ROR 11.5 · χ² 1,323 / p 6e-290	10.9 EB05 9.5 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product prescribing error	39	10.9 8.0–14.9ROR 11.1 · χ² 342 / p 1e-76	10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Complication associated with device	19	9.5 6.1–14.9ROR 9.6 · χ² 137 / p 7e-32	8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Drug effect less than expected	19	8.9 5.7–14.0ROR 9.0 · χ² 126 / p 1e-29	7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Limb injury	33	8.1 5.8–11.3ROR 8.2 · χ² 198 / p 3e-45	7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Ligament sprain	12	8.1 4.6–14.2ROR 8.1 · χ² 67 / p 1e-16	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy change	11	7.6 4.2–13.7ROR 7.6 · χ² 56 / p 3e-14	6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Inability to afford medication	11	7.4 4.1–13.4ROR 7.4 · χ² 55 / p 7e-14	5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Prescribed overdose	21	7.2 4.7–11.0ROR 7.2 · χ² 106 / p 4e-25	6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Weight increased (weight gain)	239	7.1 6.3–8.0ROR 7.6 · χ² 1,262 / p 1e-276	7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Product prescribing issue	21	6.8 4.5–10.5ROR 6.9 · χ² 99 / p 1e-23	6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site urticaria	25	6.8 4.6–10.1ROR 6.9 · χ² 119 / p 6e-28	6.2 EB05 4.4 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Inappropriate schedule of product administration	178	6.7 5.8–7.7ROR 7.0 · χ² 860 / p 3e-189	6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product dose omission issue	273	6.4 5.7–7.1ROR 6.9 · χ² 1,243 / p 1e-272	6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Skin laceration	10	6.1 3.3–11.4ROR 6.2 · χ² 38 / p 4e-10	4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree	No label text to screen	–	no trial data cached
Expired product administered	30	6.0 4.2–8.6ROR 6.0 · χ² 120 / p 3e-28	5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Weight decreased (weight loss)	234	5.6 4.9–6.3ROR 5.9 · χ² 882 / p 5e-194	5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Product use issue	156	5.5 4.7–6.4ROR 5.8 · χ² 579 / p 3e-128	5.4 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Abdominal distension (bloating)	86	5.5 4.5–6.8ROR 5.6 · χ² 312 / p 4e-70	5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Kidney infection	16	5.4 3.3–8.8ROR 5.4 · χ² 53 / p 2e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Illness	81	5.3 4.3–6.6ROR 5.5 · χ² 283 / p 9e-64	5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product dose omission in error	21	5.2 3.4–7.9ROR 5.2 · χ² 67 / p 1e-16	4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Nephrolithiasis (kidney stones)	35	5.1 3.6–7.1ROR 5.1 · χ² 111 / p 4e-26	4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Dysmenorrhoea	10	5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	No label text to screen	–	no trial data cached
Influenza	84	5.0 4.0–6.2ROR 5.1 · χ² 264 / p 9e-60	4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Device related infection	11	4.7 2.6–8.5ROR 4.7 · χ² 29 / p 4e-8	4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Road traffic accident	29	4.6 3.2–6.6ROR 4.6 · χ² 78 / p 5e-19	4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Swelling face	44	4.5 3.3–6.0ROR 4.5 · χ² 116 / p 2e-27	4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree	No label text to screen	–	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	1,197	853.6 812.7–896.6ROR 1,372.1 · χ² 901,309 / p <1e-300	746.0 EB05 711.2 · IC025 +9.1 3/3 methods agree	No label text to screen	–	no trial data cached
Product dose omission issue	273	6.4 5.7–7.1ROR 6.9 · χ² 1,243 / p 1e-272	6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Weight increased (weight gain)	239	7.1 6.3–8.0ROR 7.6 · χ² 1,262 / p 1e-276	7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Weight decreased (weight loss)	234	5.6 4.9–6.3ROR 5.9 · χ² 882 / p 5e-194	5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Condition aggravated	182	4.0 3.5–4.6ROR 4.2 · χ² 411 / p 9e-92	4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Inappropriate schedule of product administration	178	6.7 5.8–7.7ROR 7.0 · χ² 860 / p 3e-189	6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product use issue	156	5.5 4.7–6.4ROR 5.8 · χ² 579 / p 3e-128	5.4 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site pain (pain where injected)	148	3.2 2.8–3.8ROR 3.3 · χ² 229 / p 5e-52	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Intentional product use issue	146	11.0 9.4–12.9ROR 11.5 · χ² 1,323 / p 6e-290	10.9 EB05 9.5 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Stress	138	12.7 10.8–15.0ROR 13.3 · χ² 1,483 / p <1e-300	12.6 EB05 10.9 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Pharyngeal swelling	121	84.8 71.1–101.1ROR 88.1 · χ² 9,814 / p <1e-300	82.7 EB05 71.0 · IC025 +5.7 3/3 methods agree	No label text to screen	–	no trial data cached
Product use in unapproved indication	114	3.1 2.6–3.7ROR 3.2 · χ² 161 / p 3e-37	3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Insurance issue	113	50.8 42.3–60.9ROR 52.6 · χ² 5,426 / p <1e-300	50.0 EB05 42.7 · IC025 +5.1 3/3 methods agree	No label text to screen	–	no trial data cached
No adverse event	110	4.1 3.4–4.9ROR 4.2 · χ² 258 / p 2e-58	4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Covid-19	104	3.9 3.2–4.7ROR 4.0 · χ² 223 / p 1e-50	3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree	No label text to screen	–	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 Lanadelumab-Flyo?

In FDA FAERS, the most frequently co-reported reaction terms for Lanadelumab-Flyo are hereditary angioedema, weight increased, weight decreased, injection site pain, stress, 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 Lanadelumab-Flyo have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Lanadelumab-Flyo 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 136 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.