Reslizumab side effects: what 683 FDA adverse event reports show
Drug class
Interleukin-5 Antagonist
Brand names
Cinqair
Who reports
683 reports · 64% serious · 17 with death outcome · 62% female
Used for
CINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype . Limitation of Use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus .
What it is
CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa.
Boxed warning
ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening.
Causality screen of the 10 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 1 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 |
|---|---|---|---|---|---|---|
| Asthma | 95 | 26.0 21.6–31.4ROR 30.1 · χ² 2,273 / p <1e-300 | 25.9 EB05 21.8 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 27.3 | no trial data cached |
| Wheezing | 40 | 20.8 15.4–28.1ROR 22.0 · χ² 735 / p 4e-162 | 20.6 EB05 15.7 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 19.3 · 70% consumer | no trial data cached |
| Secretion discharge | 8 | 19.9 10.0–39.6ROR 20.1 · χ² 125 / p 2e-29 | 18.0 EB05 8.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Throat tightness | 13 | 14.8 8.6–25.3ROR 15.0 · χ² 154 / p 1e-35 | 13.6 EB05 7.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 | no trial data cached |
| Sinus congestion | 6 | 13.6 6.1–30.2ROR 13.7 · χ² 58 / p 1e-14 | 10.0 EB05 4.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Rebound effect | 5 | 13.5 5.7–32.4ROR 13.6 · χ² 46 / p 5e-12 | 9.1 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 | no trial data cached |
| Eosinophilia | 7 | 12.3 5.9–25.7ROR 12.4 · χ² 62 / p 2e-15 | 9.2 EB05 4.1 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.9 | no trial data cached |
| Incorrect dose administered | 83 | 11.3 9.3–13.9ROR 12.8 · χ² 780 / p 6e-172 | 11.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 36.0 | no trial data cached |
| Sleep disorder due to a general medical condition | 5 | 9.5 4.0–22.7ROR 9.6 · χ² 30 / p 2e-8 | 6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Injection site warmth | 6 | 8.9 4.0–19.8ROR 9.0 · χ² 35 / p 2e-9 | 6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=6 | 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 |
|---|---|---|---|---|---|---|
| Asthma | 95 | 26.0 21.6–31.4ROR 30.1 · χ² 2,273 / p <1e-300 | 25.9 EB05 21.8 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 27.3 | no trial data cached |
| Incorrect dose administered | 83 | 11.3 9.3–13.9ROR 12.8 · χ² 780 / p 6e-172 | 11.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 36.0 | no trial data cached |
| Wheezing | 40 | 20.8 15.4–28.1ROR 22.0 · χ² 735 / p 4e-162 | 20.6 EB05 15.7 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 19.3 · 70% consumer | no trial data cached |
| Throat tightness | 13 | 14.8 8.6–25.3ROR 15.0 · χ² 154 / p 1e-35 | 13.6 EB05 7.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 | no trial data cached |
| Secretion discharge | 8 | 19.9 10.0–39.6ROR 20.1 · χ² 125 / p 2e-29 | 18.0 EB05 8.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Eosinophilia | 7 | 12.3 5.9–25.7ROR 12.4 · χ² 62 / p 2e-15 | 9.2 EB05 4.1 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.9 | no trial data cached |
| Injection site warmth | 6 | 8.9 4.0–19.8ROR 9.0 · χ² 35 / p 2e-9 | 6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Sinus congestion | 6 | 13.6 6.1–30.2ROR 13.7 · χ² 58 / p 1e-14 | 10.0 EB05 4.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Sleep disorder due to a general medical condition | 5 | 9.5 4.0–22.7ROR 9.6 · χ² 30 / p 2e-8 | 6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Rebound effect | 5 | 13.5 5.7–32.4ROR 13.6 · χ² 46 / p 5e-12 | 9.1 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 | no trial data cached |
| Caesarean section | 4 | 10.4 3.9–27.8ROR 10.5 · χ² 25 / p 2e-7 | 6.1 EB05 2.3 · IC025 +0.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | 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 Reslizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Reslizumab are asthma, wheezing, throat tightness, secretion discharge, eosinophilia, injection site warmth. 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 Reslizumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening.
Do FAERS signals prove that Reslizumab 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 053b9158-2a5b-48b9-bf47-5fa78a35ec33, effective 20200229; matched on
openfda.generic_name.exact:"RESLIZUMAB") - 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, 11 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.