Icatibant side effects: what 3,242 FDA adverse event reports show

Icatibant · 210 reaction terms · 7,845 drug–reaction co-reports · data 2026-09-14

Drug class

Bradykinin b2 receptor antagonist

FDA label, Indications wording

Who reports

3,242 reports · 72% serious · 133 with death outcome · 74% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. ( 1 )

FDA label, Indications and Usage

What it is

Icatibant injection (icatibant) is a synthetic decapeptide with five non-proteinogenic amino acids.

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 40 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 11Not in label — unassessed 26

What the badges mean

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. 170 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	1,177	817.3 777.5–859.2ROR 1,282.4 · χ² 850,378 / p <1e-300	716.1 EB05 682.4 · IC025 +9.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 561.4	no trial data cached
Pharyngeal swelling	93	63.4 51.9–77.6ROR 65.3 · χ² 5,598 / p <1e-300	62.0 EB05 52.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=50 · ♀ 97% (drug 74%)	no trial data cached
Insurance issue	144	63.3 53.9–74.3ROR 66.2 · χ² 8,685 / p <1e-300	62.2 EB05 54.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 92.2 · 80% consumer	no trial data cached
Product availability issue	135	39.2 33.2–46.2ROR 40.8 · χ² 4,958 / p <1e-300	38.7 EB05 33.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 59.0 · 78% consumer	no trial data cached
Body height decreased	46	27.6 20.7–36.8ROR 28.0 · χ² 1,149 / p 3e-252	27.2 EB05 21.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=45 · 91% consumer	no trial data cached
Poor venous access	41	25.8 19.0–35.0ROR 26.1 · χ² 949 / p 1e-208	25.4 EB05 19.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=38 · 76% consumer	no trial data cached
Pregnancy	73	23.4 18.7–29.4ROR 23.9 · χ² 1,540 / p <1e-300	23.2 EB05 19.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.8 · ♀ 100% (drug 74%) · 75% consumer	no trial data cached
Product prescribing error	73	20.0 15.9–25.1ROR 20.4 · χ² 1,296 / p 5e-284	19.8 EB05 16.3 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 30.4 · 88% consumer	no trial data cached
Weight fluctuation	32	19.9 14.1–28.1ROR 20.1 · χ² 555 / p 6e-123	19.6 EB05 14.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=21 · 72% consumer	no trial data cached
Angioedema (deep swelling of face/throat)	119	17.5 14.6–20.9ROR 18.1 · χ² 1,831 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications	serious PRR 14.2	no trial data cached
Stress	191	17.2 15.0–19.8ROR 18.2 · χ² 2,903 / p <1e-300	17.1 EB05 15.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.8 · 81% consumer	no trial data cached
Seasonal allergy	37	17.0 12.3–23.4ROR 17.2 · χ² 540 / p 1e-119	16.8 EB05 12.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=23 · 89% consumer	no trial data cached
Infusion site pain	29	14.7 10.2–21.1ROR 14.8 · χ² 356 / p 8e-80	14.3 EB05 10.2 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=22	no trial data cached
Ligament sprain	22	14.4 9.5–21.9ROR 14.5 · χ² 262 / p 4e-59	13.9 EB05 9.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=19 · 77% consumer	no trial data cached
Limb injury	60	14.4 11.2–18.4ROR 14.6 · χ² 731 / p 2e-161	14.2 EB05 11.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · 83% consumer	no trial data cached
Treatment noncompliance	101	12.0 9.9–14.6ROR 12.4 · χ² 1,012 / p 2e-222	11.9 EB05 10.0 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 14.0 · 90% consumer	no trial data cached
Expired product administered	58	11.3 8.8–14.6ROR 11.5 · χ² 535 / p 1e-118	11.0 EB05 8.7 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=55 · 83% consumer	no trial data cached
Appendicitis	16	11.1 6.8–18.2ROR 11.2 · χ² 138 / p 4e-32	9.9 EB05 6.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Skin laceration	18	10.8 6.8–17.1ROR 10.8 · χ² 150 / p 8e-35	9.7 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Product dose omission in error	38	9.2 6.7–12.6ROR 9.3 · χ² 268 / p 1e-60	8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 23.4 · 76% consumer	no trial data cached
Product use issue	261	9.0 8.0–10.2ROR 9.7 · χ² 1,872 / p <1e-300	8.9 EB05 8.1 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.7 · 83% consumer	no trial data cached
Accident	16	8.7 5.3–14.2ROR 8.7 · χ² 101 / p 4e-24	7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Weight increased (weight gain)	282	8.2 7.3–9.2ROR 8.9 · χ² 1,791 / p <1e-300	8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.7 · 76% consumer	no trial data cached
Influenza	141	8.2 6.9–9.6ROR 8.5 · χ² 883 / p 3e-194	8.0 EB05 6.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · 79% consumer	no trial data cached
Joint dislocation	13	8.0 4.6–13.8ROR 8.0 · χ² 73 / p 8e-18	6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Inability to afford medication	12	7.9 4.5–13.9ROR 7.9 · χ² 66 / p 3e-16	6.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Pharyngitis	15	7.8 4.7–12.9ROR 7.8 · χ² 82 / p 7e-20	6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Product prescribing issue	24	7.6 5.1–11.4ROR 7.7 · χ² 132 / p 8e-31	6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 14.6 · 88% consumer	no trial data cached
Gastroenteritis	17	7.5 4.7–12.1ROR 7.6 · χ² 90 / p 1e-21	6.5 EB05 4.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Lymphoma	18	7.5 4.7–11.9ROR 7.6 · χ² 95 / p 8e-23	6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Inappropriate schedule of product administration	201	7.4 6.4–8.4ROR 7.8 · χ² 1,106 / p 8e-243	7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6 · 81% consumer	no trial data cached
Needle issue	32	7.2 5.1–10.2ROR 7.3 · χ² 166 / p 3e-38	6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=20 · 88% consumer	no trial data cached
Illness	108	7.0 5.8–8.4ROR 7.2 · χ² 547 / p 3e-121	6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 82% consumer	no trial data cached
Toothache	19	6.8 4.3–10.6ROR 6.8 · χ² 88 / p 3e-21	5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Gastroenteritis viral	19	6.8 4.3–10.6ROR 6.8 · χ² 88 / p 3e-21	5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Post procedural complication	20	6.7 4.3–10.4ROR 6.8 · χ² 92 / p 5e-22	5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8	no trial data cached
Product dose omission issue	295	6.7 6.0–7.5ROR 7.3 · χ² 1,444 / p <1e-300	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 16.8 · 78% consumer	no trial data cached
Covid-19	179	6.5 5.7–7.5ROR 6.9 · χ² 842 / p 2e-185	6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 78% consumer	no trial data cached
Ovarian cyst	10	6.4 3.5–11.9ROR 6.5 · χ² 41 / p 9e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Complication associated with device	13	6.4 3.7–10.9ROR 6.4 · χ² 53 / p 1e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	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	1,177	817.3 777.5–859.2ROR 1,282.4 · χ² 850,378 / p <1e-300	716.1 EB05 682.4 · IC025 +9.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 561.4	no trial data cached
Product dose omission issue	295	6.7 6.0–7.5ROR 7.3 · χ² 1,444 / p <1e-300	6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 16.8 · 78% consumer	no trial data cached
Weight increased (weight gain)	282	8.2 7.3–9.2ROR 8.9 · χ² 1,791 / p <1e-300	8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.7 · 76% consumer	no trial data cached
Weight decreased (weight loss)	274	6.4 5.7–7.1ROR 6.8 · χ² 1,246 / p 3e-273	6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 78% consumer	no trial data cached
Product use issue	261	9.0 8.0–10.2ROR 9.7 · χ² 1,872 / p <1e-300	8.9 EB05 8.1 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.7 · 83% consumer	no trial data cached
Malaise (feeling unwell)	217	3.2 2.8–3.6ROR 3.4 · χ² 331 / p 2e-74	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.6 · 85% consumer	no trial data cached
Injection site pain (pain where injected)	205	4.4 3.8–5.0ROR 4.6 · χ² 537 / p 5e-119	4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.8 · 75% consumer	no trial data cached
Inappropriate schedule of product administration	201	7.4 6.4–8.4ROR 7.8 · χ² 1,106 / p 8e-243	7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6 · 81% consumer	no trial data cached
Stress	191	17.2 15.0–19.8ROR 18.2 · χ² 2,903 / p <1e-300	17.1 EB05 15.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.8 · 81% consumer	no trial data cached
Covid-19	179	6.5 5.7–7.5ROR 6.9 · χ² 842 / p 2e-185	6.4 EB05 5.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 78% consumer	no trial data cached
Insurance issue	144	63.3 53.9–74.3ROR 66.2 · χ² 8,685 / p <1e-300	62.2 EB05 54.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 92.2 · 80% consumer	no trial data cached
Influenza	141	8.2 6.9–9.6ROR 8.5 · χ² 883 / p 3e-194	8.0 EB05 6.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · 79% consumer	no trial data cached
Product availability issue	135	39.2 33.2–46.2ROR 40.8 · χ² 4,958 / p <1e-300	38.7 EB05 33.6 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 59.0 · 78% consumer	no trial data cached
Angioedema (deep swelling of face/throat)	119	17.5 14.6–20.9ROR 18.1 · χ² 1,831 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	Likely indication confounding term in indications	serious PRR 14.2	no trial data cached
Illness	108	7.0 5.8–8.4ROR 7.2 · χ² 547 / p 3e-121	6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 82% consumer	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.

Pharyngeal swelling — n=93, PRR 63.4
Insurance issue — n=144, PRR 63.3
Body height decreased — n=46, PRR 27.6
Poor venous access — n=41, PRR 25.8
Pregnancy — n=73, PRR 23.4
Weight fluctuation — n=32, PRR 19.9
Stress — n=191, PRR 17.2
Seasonal allergy — n=37, PRR 17.0
Ligament sprain — n=22, PRR 14.4
Limb injury — n=60, PRR 14.4

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 Icatibant?

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

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

Do FAERS signals prove that Icatibant 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 8c149392-d281-4311-880f-3be2b4752f40, effective 20250627; matched on openfda.generic_name.exact:"ICATIBANT")
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, 210 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.