C1 Esterase Inhibitor Recombinant side effects: what 6,234 FDA adverse event reports show

C1 Esterase Inhibitor Recombinant · 125 reaction terms · 7,390 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

6,234 reports · 34% serious · 24 with death outcome · 82% 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. 85 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	1,014	359.9 339.0–382.1ROR 429.6 · χ² 327,219 / p <1e-300	322.8 EB05 306.4 · IC025 +8.0 3/3 methods agree	No label text to screen	serious PRR 393.4	no trial data cached
Pharyngeal swelling	360	131.4 118.7–145.6ROR 139.4 · χ² 44,723 / p <1e-300	125.6 EB05 115.1 · IC025 +6.6 3/3 methods agree	No label text to screen	serious n=143	no trial data cached
Weight fluctuation	156	51.1 43.7–59.8ROR 52.4 · χ² 7,503 / p <1e-300	50.1 EB05 43.8 · IC025 +5.2 3/3 methods agree	No label text to screen	serious n=20 · 96% consumer	no trial data cached
Drug ineffective for unapproved indication	510	31.1 28.6–33.8ROR 33.7 · χ² 14,705 / p <1e-300	30.7 EB05 28.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 93% consumer	no trial data cached
Intentional product use issue	764	29.5 27.6–31.5ROR 33.4 · χ² 20,887 / p <1e-300	29.2 EB05 27.5 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 20.0 · 82% consumer	no trial data cached
Insurance issue	126	28.8 24.2–34.2ROR 29.3 · χ² 3,323 / p <1e-300	28.4 EB05 24.5 · IC025 +4.4 3/3 methods agree	No label text to screen	serious PRR 55.4 · 81% consumer	no trial data cached
Incorrect route of product administration	53	10.6 8.1–13.9ROR 10.7 · χ² 452 / p 1e-100	10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9 · 92% consumer	no trial data cached
Poor venous access	32	10.5 7.4–14.8ROR 10.5 · χ² 264 / p 1e-59	9.8 EB05 7.1 · IC025 +2.6 3/3 methods agree	No label text to screen	serious n=25 · 72% consumer	no trial data cached
Complication associated with device	38	9.7 7.1–13.3ROR 9.7 · χ² 287 / p 1e-64	9.1 EB05 6.8 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 12.8 · 84% consumer	no trial data cached
Device related infection	43	9.4 7.0–12.7ROR 9.5 · χ² 314 / p 2e-70	8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 15.7 · 77% consumer	no trial data cached
Underdose	158	7.3 6.2–8.5ROR 7.5 · χ² 852 / p 1e-187	7.1 EB05 6.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0 · 89% consumer	no trial data cached
Stress	154	7.2 6.2–8.4ROR 7.4 · χ² 819 / p 2e-180	7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 8.9 · 84% consumer	no trial data cached
Seasonal allergy	29	6.9 4.8–10.0ROR 6.9 · χ² 141 / p 9e-33	6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	No label text to screen	serious n=4 · 93% consumer	no trial data cached
Drug effect incomplete	71	6.5 5.2–8.2ROR 6.6 · χ² 324 / p 8e-73	6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 30.3 · 93% consumer	no trial data cached
Maternal exposure during pregnancy	160	6.1 5.2–7.1ROR 6.2 · χ² 680 / p 3e-150	6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 71% consumer	no trial data cached
Product use in unapproved indication	406	5.6 5.1–6.2ROR 5.9 · χ² 1,544 / p <1e-300	5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 80% consumer	no trial data cached
Infusion site pain	21	5.5 3.6–8.5ROR 5.6 · χ² 74 / p 5e-18	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	No label text to screen	serious n=10 · 81% consumer	no trial data cached
Condition aggravated	428	4.8 4.4–5.2ROR 5.1 · χ² 1,290 / p 1e-282	4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · 92% consumer	no trial data cached
Gastroenteritis viral	25	4.6 3.1–6.9ROR 4.7 · χ² 68 / p 8e-17	4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree	No label text to screen	serious PRR 2.4 · 88% consumer	no trial data cached
Pharyngeal oedema	20	4.3 2.8–6.7ROR 4.3 · χ² 48 / p 2e-12	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 7.3	no trial data cached
Kidney infection	25	4.3 2.9–6.3ROR 4.3 · χ² 60 / p 5e-15	4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 8.2 · 88% consumer	no trial data cached
Ligament sprain	12	4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	No label text to screen	serious n=9	no trial data cached
Tooth extraction	15	4.1 2.4–6.7ROR 4.1 · χ² 32 / p 1e-8	3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree	No label text to screen	serious PRR 2.5	no trial data cached
Road traffic accident	48	3.9 2.9–5.1ROR 3.9 · χ² 99 / p 1e-23	3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree	No label text to screen	serious PRR 3.9 · 83% consumer	no trial data cached
Knee operation	11	3.8 2.1–6.9ROR 3.8 · χ² 20 / p 4e-6	3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6	no trial data cached
Product use complaint	17	3.7 2.3–5.9ROR 3.7 · χ² 31 / p 1e-8	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Weight increased (weight gain)	230	3.5 3.1–3.9ROR 3.6 · χ² 407 / p 9e-91	3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen	serious PRR 5.6 · 80% consumer	no trial data cached
Spinal operation	12	3.3 1.9–5.9ROR 3.3 · χ² 17 / p 2e-5	3.0 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 3.1	no trial data cached
Illness	99	3.3 2.7–4.0ROR 3.4 · χ² 158 / p 1e-36	3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 86% consumer	no trial data cached
Caesarean section	11	3.1 1.7–5.7ROR 3.2 · χ² 14 / p 9e-5	2.9 EB05 1.7 · IC025 +0.5	No label text to screen	serious PRR 5.0	no trial data cached
Skin laceration	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	No label text to screen	serious PRR 3.1	no trial data cached
Pharyngitis streptococcal	10	3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	No label text to screen	serious n=5	no trial data cached
Upper respiratory tract infection (cold/sinus infection)	42	3.1 2.3–4.1ROR 3.1 · χ² 56 / p 3e-14	3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree	No label text to screen	serious PRR 3.8 · 88% consumer	no trial data cached
Sinusitis	93	3.0 2.5–3.7ROR 3.1 · χ² 126 / p 1e-29	3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 3.3 · 85% consumer	no trial data cached
Ear infection	24	3.0 2.0–4.5ROR 3.1 · χ² 31 / p 1e-8	2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree	No label text to screen	serious PRR 4.0 · 83% consumer	no trial data cached
Viral infection	30	3.0 2.1–4.3ROR 3.0 · χ² 39 / p 2e-10	2.9 EB05 2.2 · IC025 +0.9 3/3 methods agree	No label text to screen	serious PRR 2.7 · 87% consumer	no trial data cached
Product availability issue	20	3.0 1.9–4.7ROR 3.0 · χ² 25 / p 3e-7	2.9 EB05 2.0 · IC025 +0.8	Reporting / coding artifact	serious PRR 8.0	no trial data cached
Joint injury	19	3.0 1.9–4.7ROR 3.0 · χ² 23 / p 7e-7	2.8 EB05 1.9 · IC025 +0.7	No label text to screen	serious PRR 3.9	no trial data cached
Weight decreased (weight loss)	245	3.0 2.6–3.3ROR 3.0 · χ² 319 / p 1e-71	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 4.2 · 79% consumer	no trial data cached
Injection site irritation	11	2.9 1.6–5.3ROR 2.9 · χ² 12 / p 3e-4	2.7 EB05 1.6 · IC025 +0.4	No label text to screen	serious n=4	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	1,014	359.9 339.0–382.1ROR 429.6 · χ² 327,219 / p <1e-300	322.8 EB05 306.4 · IC025 +8.0 3/3 methods agree	No label text to screen	serious PRR 393.4	no trial data cached
Intentional product use issue	764	29.5 27.6–31.5ROR 33.4 · χ² 20,887 / p <1e-300	29.2 EB05 27.5 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 20.0 · 82% consumer	no trial data cached
Drug ineffective for unapproved indication	510	31.1 28.6–33.8ROR 33.7 · χ² 14,705 / p <1e-300	30.7 EB05 28.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 93% consumer	no trial data cached
Condition aggravated	428	4.8 4.4–5.2ROR 5.1 · χ² 1,290 / p 1e-282	4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · 92% consumer	no trial data cached
Product use in unapproved indication	406	5.6 5.1–6.2ROR 5.9 · χ² 1,544 / p <1e-300	5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 80% consumer	no trial data cached
Pharyngeal swelling	360	131.4 118.7–145.6ROR 139.4 · χ² 44,723 / p <1e-300	125.6 EB05 115.1 · IC025 +6.6 3/3 methods agree	No label text to screen	serious n=143	no trial data cached
Weight decreased (weight loss)	245	3.0 2.6–3.3ROR 3.0 · χ² 319 / p 1e-71	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 4.2 · 79% consumer	no trial data cached
Product dose omission issue	241	2.8 2.5–3.2ROR 2.9 · χ² 291 / p 2e-65	2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.5 · 76% consumer	no trial data cached
Weight increased (weight gain)	230	3.5 3.1–3.9ROR 3.6 · χ² 407 / p 9e-91	3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen	serious PRR 5.6 · 80% consumer	no trial data cached
Maternal exposure during pregnancy	160	6.1 5.2–7.1ROR 6.2 · χ² 680 / p 3e-150	6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8 · 71% consumer	no trial data cached
Underdose	158	7.3 6.2–8.5ROR 7.5 · χ² 852 / p 1e-187	7.1 EB05 6.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0 · 89% consumer	no trial data cached
Weight fluctuation	156	51.1 43.7–59.8ROR 52.4 · χ² 7,503 / p <1e-300	50.1 EB05 43.8 · IC025 +5.2 3/3 methods agree	No label text to screen	serious n=20 · 96% consumer	no trial data cached
Stress	154	7.2 6.2–8.4ROR 7.4 · χ² 819 / p 2e-180	7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 8.9 · 84% consumer	no trial data cached
Covid-19	151	2.9 2.5–3.4ROR 2.9 · χ² 184 / p 4e-42	2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 4.7 · 81% consumer	no trial data cached
Insurance issue	126	28.8 24.2–34.2ROR 29.3 · χ² 3,323 / p <1e-300	28.4 EB05 24.5 · IC025 +4.4 3/3 methods agree	No label text to screen	serious PRR 55.4 · 81% consumer	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 C1 Esterase Inhibitor Recombinant?

In FDA FAERS, the most frequently co-reported reaction terms for C1 Esterase Inhibitor Recombinant are hereditary angioedema, pharyngeal swelling, weight decreased, weight increased, weight fluctuation, stress. 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 C1 Esterase Inhibitor Recombinant 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 C1 Esterase Inhibitor Recombinant 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, 125 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.