Idecabtagene Vicleucel side effects: what 1,221 FDA adverse event reports show

Idecabtagene Vicleucel · Abecma · 21 reaction terms · 1,296 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Abecma

openFDA label

Who reports

1,221 reports · 91% serious · 172 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA is a.

FDA label, Indications and Usage

What it is

ABECMA is a BCMA-directed genetically modified autologous T cell immunotherapy product consisting of a patient's own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 chimeric antigen receptor (CAR) lentiviral vector (LVV).

FDA label, Description section

Boxed warning

CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders.

FDA 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 17 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 8Labeled (related wording) 1Lab value / disease marker 1Not in label — unassessed 4

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.
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.
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. 4 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
Cytokine release syndrome	696	651.3 619.1–685.3ROR 1,513.5 · χ² 434,990 / p <1e-300	616.6 EB05 579.1 · IC025 +8.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 391.8 · 91% clinician	no trial data cached
Neurotoxicity	77	76.4 61.5–94.9ROR 81.5 · χ² 5,637 / p <1e-300	74.7 EB05 61.7 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.6	no trial data cached
Cytopenia	47	67.8 51.2–89.8ROR 70.5 · χ² 3,017 / p <1e-300	65.8 EB05 51.5 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 44.2 · 98% clinician	no trial data cached
Myelodysplastic syndrome	36	42.8 31.0–59.1ROR 44.1 · χ² 1,426 / p <1e-300	41.8 EB05 31.6 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.3 · ♀ 10% (drug 43%) · 100% clinician	no trial data cached
Haematotoxicity	23	42.7 28.5–64.0ROR 43.5 · χ² 894 / p 1e-196	41.3 EB05 29.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 27.7 · ♀ 77% (drug 43%) · 100% clinician	no trial data cached
Parkinsonism	22	38.8 25.7–58.8ROR 39.5 · χ² 772 / p 3e-170	37.6 EB05 26.2 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.1 · 95% clinician	no trial data cached
Acute myeloid leukaemia	24	26.5 17.8–39.4ROR 27.0 · χ² 563 / p 8e-125	26.0 EB05 18.4 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.8 · 100% clinician	no trial data cached
Immunodeficiency	22	25.7 17.0–38.9ROR 26.1 · χ² 497 / p 2e-110	25.2 EB05 17.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.7	no trial data cached
Plasma cell myeloma	48	21.1 16.0–27.9ROR 21.9 · χ² 900 / p 5e-198	20.9 EB05 16.4 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.4 · 98% clinician	no trial data cached
Altered state of consciousness	20	16.0 10.3–24.6ROR 16.2 · χ² 266 / p 5e-60	15.4 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Aspartate aminotransferase increased	48	15.5 11.8–20.5ROR 16.1 · χ² 639 / p 2e-141	15.4 EB05 12.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	86	10.9 8.9–13.4ROR 11.7 · χ² 769 / p 2e-169	10.7 EB05 8.9 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · 99% clinician	no trial data cached
Pancytopenia (all blood cells low)	34	10.5 7.5–14.6ROR 10.8 · χ² 283 / p 9e-64	9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.5 · 97% clinician	no trial data cached
Bone marrow failure	12	10.1 5.7–17.7ROR 10.2 · χ² 89 / p 2e-21	8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Full blood count decreased	10	8.5 4.6–15.8ROR 8.6 · χ² 59 / p 8e-15	6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 7.8	no trial data cached
Thrombocytopenia (low platelets)	52	8.0 6.1–10.5ROR 8.3 · χ² 314 / p 2e-70	7.6 EB05 6.0 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2 · 98% clinician	no trial data cached
Mucosal inflammation	11	7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	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
Cytokine release syndrome	696	651.3 619.1–685.3ROR 1,513.5 · χ² 434,990 / p <1e-300	616.6 EB05 579.1 · IC025 +8.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 391.8 · 91% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	86	10.9 8.9–13.4ROR 11.7 · χ² 769 / p 2e-169	10.7 EB05 8.9 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · 99% clinician	no trial data cached
Neurotoxicity	77	76.4 61.5–94.9ROR 81.5 · χ² 5,637 / p <1e-300	74.7 EB05 61.7 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 45.6	no trial data cached
Thrombocytopenia (low platelets)	52	8.0 6.1–10.5ROR 8.3 · χ² 314 / p 2e-70	7.6 EB05 6.0 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2 · 98% clinician	no trial data cached
Aspartate aminotransferase increased	48	15.5 11.8–20.5ROR 16.1 · χ² 639 / p 2e-141	15.4 EB05 12.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	no trial data cached
Plasma cell myeloma	48	21.1 16.0–27.9ROR 21.9 · χ² 900 / p 5e-198	20.9 EB05 16.4 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.4 · 98% clinician	no trial data cached
Cytopenia	47	67.8 51.2–89.8ROR 70.5 · χ² 3,017 / p <1e-300	65.8 EB05 51.5 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 44.2 · 98% clinician	no trial data cached
Myelodysplastic syndrome	36	42.8 31.0–59.1ROR 44.1 · χ² 1,426 / p <1e-300	41.8 EB05 31.6 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.3 · ♀ 10% (drug 43%) · 100% clinician	no trial data cached
Pancytopenia (all blood cells low)	34	10.5 7.5–14.6ROR 10.8 · χ² 283 / p 9e-64	9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.5 · 97% clinician	no trial data cached
Acute myeloid leukaemia	24	26.5 17.8–39.4ROR 27.0 · χ² 563 / p 8e-125	26.0 EB05 18.4 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.8 · 100% clinician	no trial data cached
Haematotoxicity	23	42.7 28.5–64.0ROR 43.5 · χ² 894 / p 1e-196	41.3 EB05 29.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 27.7 · ♀ 77% (drug 43%) · 100% clinician	no trial data cached
Immunodeficiency	22	25.7 17.0–38.9ROR 26.1 · χ² 497 / p 2e-110	25.2 EB05 17.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.7	no trial data cached
Parkinsonism	22	38.8 25.7–58.8ROR 39.5 · χ² 772 / p 3e-170	37.6 EB05 26.2 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.1 · 95% clinician	no trial data cached
Altered state of consciousness	20	16.0 10.3–24.6ROR 16.2 · χ² 266 / p 5e-60	15.4 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Bone marrow failure	12	10.1 5.7–17.7ROR 10.2 · χ² 89 / p 2e-21	8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	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.

Haematotoxicity — n=23, PRR 42.7
Altered state of consciousness — n=20, PRR 16.0

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 Idecabtagene Vicleucel?

In FDA FAERS, the most frequently co-reported reaction terms for Idecabtagene Vicleucel are cytokine release syndrome, neutropenia, neurotoxicity, thrombocytopenia, aspartate aminotransferase increased, plasma cell myeloma. 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 Idecabtagene Vicleucel have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders.

Do FAERS signals prove that Idecabtagene Vicleucel 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 b90c1fe7-f5cc-464e-958a-af36e9c26d7c, effective 20251125; matched on openfda.generic_name.exact:"IDECABTAGENE VICLEUCEL")
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, 21 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.