Crizanlizumab side effects: what 1,389 FDA adverse event reports show

Crizanlizumab · Adakveo · 12 reaction terms · 1,163 drug–reaction co-reports · data 2026-09-14

Drug class

Selectin Blocker

FDA label (Established Pharmacologic Class)

Brand names

Adakveo

openFDA label

Who reports

1,389 reports · 54% serious · 55 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

FDA label, Indications and Usage

What it is

Crizanlizumab-tmca is a P-selectin blocker humanized IgG2 kappa monoclonal antibody that binds to P-selectin. Crizanlizumab-tmca is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.

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 11 strongest signals

Labeled adverse reaction 2Labeled (related wording) 2Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 3

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.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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.

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
Sickle cell anaemia with crisis	360	352.1 321.7–385.4ROR 474.9 · χ² 122,867 / p <1e-300	337.8 EB05 309.5 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	serious PRR 459.6	no trial data cached
Infusion related reaction (reaction during infusion)	131	30.0 25.5–35.3ROR 33.0 · χ² 3,647 / p <1e-300	29.8 EB05 25.8 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 23.2	no trial data cached
Infusion site pain	9	10.6 5.5–20.4ROR 10.7 · χ² 69 / p 4e-17	8.3 EB05 4.2 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Back pain	150	9.7 8.4–11.3ROR 10.8 · χ² 1,181 / p 4e-259	9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8	no trial data cached
Pain	352	8.6 7.9–9.5ROR 11.2 · χ² 2,441 / p <1e-300	8.6 EB05 7.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Blood lactate dehydrogenase increased	9	8.5 4.4–16.4ROR 8.6 · χ² 52 / p 2e-13	6.5 EB05 3.5 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 9.6	no trial data cached
Haemoglobin decreased	50	7.3 5.6–9.6ROR 7.6 · χ² 269 / p 1e-60	6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 6.7	no trial data cached
Bone pain	26	6.7 4.6–9.8ROR 6.8 · χ² 121 / p 2e-28	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 96% (drug 62%)	no trial data cached
Therapy interrupted	28	6.1 4.2–8.8ROR 6.2 · χ² 115 / p 3e-27	5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Product storage error	32	5.6 4.0–7.9ROR 5.7 · χ² 116 / p 2e-27	5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Osteonecrosis (bone death)	11	5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8	4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	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
Sickle cell anaemia with crisis	360	352.1 321.7–385.4ROR 474.9 · χ² 122,867 / p <1e-300	337.8 EB05 309.5 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	serious PRR 459.6	no trial data cached
Pain	352	8.6 7.9–9.5ROR 11.2 · χ² 2,441 / p <1e-300	8.6 EB05 7.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Back pain	150	9.7 8.4–11.3ROR 10.8 · χ² 1,181 / p 4e-259	9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8	no trial data cached
Infusion related reaction (reaction during infusion)	131	30.0 25.5–35.3ROR 33.0 · χ² 3,647 / p <1e-300	29.8 EB05 25.8 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 23.2	no trial data cached
Haemoglobin decreased	50	7.3 5.6–9.6ROR 7.6 · χ² 269 / p 1e-60	6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 6.7	no trial data cached
Product storage error	32	5.6 4.0–7.9ROR 5.7 · χ² 116 / p 2e-27	5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Therapy interrupted	28	6.1 4.2–8.8ROR 6.2 · χ² 115 / p 3e-27	5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Bone pain	26	6.7 4.6–9.8ROR 6.8 · χ² 121 / p 2e-28	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 96% (drug 62%)	no trial data cached
Osteonecrosis (bone death)	11	5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8	4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Blood lactate dehydrogenase increased	9	8.5 4.4–16.4ROR 8.6 · χ² 52 / p 2e-13	6.5 EB05 3.5 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 9.6	no trial data cached
Infusion site pain	9	10.6 5.5–20.4ROR 10.7 · χ² 69 / p 4e-17	8.3 EB05 4.2 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Abortion spontaneous	5	1.9 0.8–4.5ROR 1.9 · χ² 1 / p 0.130	1.8 EB05 0.9 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.6	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.

Sickle cell anaemia with crisis — n=360, PRR 352.1
Bone pain — n=26, PRR 6.7

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 Crizanlizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Crizanlizumab are sickle cell anaemia with crisis, pain, back pain, infusion related reaction, haemoglobin decreased, bone pain. 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 Crizanlizumab have an FDA boxed warning?

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

Do FAERS signals prove that Crizanlizumab 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 b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6, effective 20260604; matched on openfda.generic_name.exact:"CRIZANLIZUMAB")
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, 12 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.