Drug · FAERS side-effect profile with label screen
Icatibant Acetate side effects: what 5,836 FDA adverse event reports show
Drug class
Bradykinin b2 receptor antagonist
FDA label, Indications wording
Who reports
5,836 reports · 68% serious · 152 with death outcome · 79% 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 adverse reaction 3Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 11Not in label — unassessed 23
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. 181 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 2,547 | 1,154.6 1,113.0–1,197.6ROR 2,047.3 · χ² 2,214,395 / p <1e-300 | 865.4 EB05 837.5 · IC025 +9.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 702.8 | no trial data cached |
| Pharyngeal swelling | 158 | 60.3 51.6–70.4ROR 61.9 · χ² 9,001 / p <1e-300 | 58.9 EB05 51.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=95 | no trial data cached |
| Insurance issue | 173 | 42.3 36.5–49.0ROR 43.6 · χ² 6,860 / p <1e-300 | 41.6 EB05 36.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 | no trial data cached |
| Pharyngeal oedema | 128 | 29.7 25.0–35.3ROR 30.4 · χ² 3,497 / p <1e-300 | 29.4 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Prescribed overdose | 146 | 27.3 23.2–32.1ROR 28.0 · χ² 3,648 / p <1e-300 | 27.0 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 33.9 | no trial data cached |
| Poor venous access | 75 | 26.3 21.0–32.9ROR 26.6 · χ² 1,786 / p <1e-300 | 25.9 EB05 21.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=67 | no trial data cached |
| Weight fluctuation | 53 | 18.4 14.0–24.0ROR 18.5 · χ² 849 / p 7e-187 | 18.1 EB05 14.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Device related infection | 57 | 13.3 10.3–17.2ROR 13.4 · χ² 635 / p 2e-140 | 13.1 EB05 10.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 | no trial data cached |
| Product availability issue | 75 | 12.1 9.6–15.1ROR 12.2 · χ² 747 / p 7e-165 | 11.8 EB05 9.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 | no trial data cached |
| Stress | 206 | 10.3 9.0–11.8ROR 10.7 · χ² 1,724 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Swollen tongue | 88 | 10.1 8.2–12.5ROR 10.3 · χ² 715 / p 1e-157 | 9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Injection site irritation | 35 | 10.0 7.2–13.9ROR 10.0 · χ² 273 / p 2e-61 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=27 · 71% consumer | no trial data cached |
| Infusion site pain | 35 | 9.9 7.1–13.7ROR 9.9 · χ² 270 / p 7e-61 | 9.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 | no trial data cached |
| Product dose omission in error | 59 | 7.9 6.1–10.2ROR 8.0 · χ² 349 / p 4e-78 | 7.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 23.8 | no trial data cached |
| Inability to afford medication | 21 | 7.7 5.0–11.8ROR 7.7 · χ² 115 / p 3e-27 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=17 · 71% consumer | no trial data cached |
| Therapy change | 20 | 7.5 4.8–11.6ROR 7.5 · χ² 105 / p 5e-25 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Weight increased (weight gain) | 373 | 6.0 5.5–6.6ROR 6.4 · χ² 1,571 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Dermatitis contact | 19 | 6.0 3.8–9.4ROR 6.0 · χ² 74 / p 3e-18 | 5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Local swelling | 29 | 5.9 4.1–8.5ROR 5.9 · χ² 113 / p 1e-26 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Seasonal allergy | 23 | 5.9 3.9–8.8ROR 5.9 · χ² 88 / p 4e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Swelling face | 104 | 5.8 4.8–7.0ROR 5.8 · χ² 404 / p 3e-90 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pregnancy | 32 | 5.7 4.0–8.0ROR 5.7 · χ² 119 / p 5e-28 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 100% (drug 79%) · 81% consumer | no trial data cached |
| Pharyngitis streptococcal | 17 | 5.6 3.5–9.1ROR 5.7 · χ² 60 / p 4e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Product dose omission issue | 442 | 5.6 5.1–6.1ROR 6.0 · χ² 1,678 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Incorrect route of product administration | 26 | 5.6 3.8–8.2ROR 5.6 · χ² 93 / p 3e-22 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Kidney infection | 30 | 5.5 3.8–7.9ROR 5.5 · χ² 106 / p 4e-25 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 100% (drug 79%) · 80% consumer | no trial data cached |
| Injection site urticaria | 37 | 5.5 4.0–7.6ROR 5.5 · χ² 131 / p 1e-30 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=25 | no trial data cached |
| Ligament sprain | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 50 / p 7e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Intentional product use issue | 132 | 5.4 4.6–6.4ROR 5.5 · χ² 470 / p 2e-104 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 76% consumer | no trial data cached |
| Weight decreased (weight loss) | 405 | 5.2 4.8–5.7ROR 5.5 · χ² 1,394 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Product use issue | 267 | 5.1 4.6–5.8ROR 5.3 · χ² 892 / p 3e-196 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Skin laceration | 15 | 5.0 3.0–8.3ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Inappropriate schedule of drug administration | 99 | 4.9 4.1–6.0ROR 5.0 · χ² 307 / p 5e-69 | 4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 | no trial data cached |
| Inappropriate schedule of product administration | 242 | 4.9 4.4–5.6ROR 5.1 · χ² 758 / p 4e-167 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Limb injury | 37 | 4.9 3.6–6.8ROR 4.9 · χ² 111 / p 2e-26 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 78% consumer | no trial data cached |
| Swelling | 126 | 4.9 4.1–5.8ROR 4.9 · χ² 383 / p 2e-85 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Abdominal distension (bloating) | 140 | 4.8 4.1–5.7ROR 4.9 · χ² 424 / p 1e-94 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Road traffic accident | 56 | 4.8 3.7–6.2ROR 4.8 · χ² 165 / p 4e-38 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Expired product administered | 43 | 4.7 3.5–6.3ROR 4.7 · χ² 120 / p 3e-28 | 4.4 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=30 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 57 | 4.6 3.6–6.0ROR 4.7 · χ² 159 / p 8e-37 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.7 | 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 | 2,547 | 1,154.6 1,113.0–1,197.6ROR 2,047.3 · χ² 2,214,395 / p <1e-300 | 865.4 EB05 837.5 · IC025 +9.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 702.8 | no trial data cached |
| Product dose omission issue | 442 | 5.6 5.1–6.1ROR 6.0 · χ² 1,678 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Weight decreased (weight loss) | 405 | 5.2 4.8–5.7ROR 5.5 · χ² 1,394 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Weight increased (weight gain) | 373 | 6.0 5.5–6.6ROR 6.4 · χ² 1,571 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Injection site pain (pain where injected) | 302 | 3.6 3.2–4.0ROR 3.7 · χ² 566 / p 3e-125 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.5 | no trial data cached |
| Product use issue | 267 | 5.1 4.6–5.8ROR 5.3 · χ² 892 / p 3e-196 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Inappropriate schedule of product administration | 242 | 4.9 4.4–5.6ROR 5.1 · χ² 758 / p 4e-167 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 | no trial data cached |
| Stress | 206 | 10.3 9.0–11.8ROR 10.7 · χ² 1,724 / p <1e-300 | 10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Condition aggravated | 197 | 2.3 2.0–2.7ROR 2.4 · χ² 153 / p 2e-35 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Malaise (feeling unwell) | 193 | 1.6 1.4–1.8ROR 1.6 · χ² 41 / p 7e-11 | 1.6 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Covid-19 | 191 | 3.9 3.4–4.5ROR 4.0 · χ² 409 / p 4e-91 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 73% consumer | no trial data cached |
| Insurance issue | 173 | 42.3 36.5–49.0ROR 43.6 · χ² 6,860 / p <1e-300 | 41.6 EB05 36.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 65.0 | no trial data cached |
| Fall | 168 | 1.8 1.6–2.1ROR 1.8 · χ² 62 / p 2e-15 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| No adverse event | 164 | 3.3 2.9–3.9ROR 3.4 · χ² 266 / p 4e-60 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 | no trial data cached |
| Pharyngeal swelling | 158 | 60.3 51.6–70.4ROR 61.9 · χ² 9,001 / p <1e-300 | 58.9 EB05 51.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=95 | 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=158, PRR 60.3
- Insurance issue — n=173, PRR 42.3
- Pharyngeal oedema — n=128, PRR 29.7
- Prescribed overdose — n=146, PRR 27.3
- Poor venous access — n=75, PRR 26.3
- Weight fluctuation — n=53, PRR 18.4
- Stress — n=206, PRR 10.3
- Swollen tongue — n=88, PRR 10.1
- Inability to afford medication — n=21, PRR 7.7
- Weight increased — n=373, PRR 6.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 decreased, weight increased, injection site pain, stress, malaise. 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, fieldpatient.drug.openfda.generic_name.exact, 221 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.