Ciltacabtagene Autoleucel side effects: what 5,838 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Carvykti
Who reports
5,838 reports · 72% serious · 748 with death outcome · 42% female
Used for
CARVYKTI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
What it is
CARVYKTI ® (ciltacabtagene autoleucel) is a BCMA-directed genetically modified autologous T cell immunotherapy. CARVYKTI is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure.
Boxed warning
CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Do not administer CARVYKTI to patients with active infection or inflammatory disorders.
Causality screen of the 40 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.
- 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. 55 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 813 | 159.1 149.0–169.9ROR 184.5 · χ² 122,179 / p <1e-300 | 151.7 EB05 143.2 · IC025 +7.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 121.7 · 90% clinician | no trial data cached |
| Parkinsonism | 328 | 124.2 111.6–138.3ROR 131.5 · χ² 38,630 / p <1e-300 | 119.2 EB05 108.8 · IC025 +6.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 95.8 · 94% clinician | no trial data cached |
| Neurotoxicity | 192 | 39.9 34.7–45.9ROR 41.2 · χ² 7,162 / p <1e-300 | 39.3 EB05 34.8 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 31.9 | no trial data cached |
| Cytopenia | 94 | 28.3 23.1–34.6ROR 28.7 · χ² 2,429 / p <1e-300 | 27.9 EB05 23.5 · IC025 +4.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 23.3 · 93% clinician | no trial data cached |
| Full blood count abnormal | 49 | 16.7 12.6–22.0ROR 16.8 · χ² 703 / p 4e-155 | 16.5 EB05 12.9 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Bacterial infection | 79 | 15.2 12.2–19.0ROR 15.4 · χ² 1,034 / p 5e-227 | 15.1 EB05 12.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 · 91% clinician | no trial data cached |
| Myelodysplastic syndrome | 59 | 14.6 11.3–18.8ROR 14.7 · χ² 732 / p 2e-161 | 14.4 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.8 · 100% clinician | no trial data cached |
| Transfusion | 32 | 10.9 7.7–15.4ROR 10.9 · χ² 277 / p 2e-62 | 10.3 EB05 7.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 81% consumer | no trial data cached |
| Plasma cell myeloma | 115 | 10.5 8.8–12.6ROR 10.7 · χ² 981 / p 1e-215 | 10.3 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Colitis | 108 | 10.3 8.5–12.4ROR 10.4 · χ² 892 / p 2e-196 | 10.1 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.8 · 94% clinician | no trial data cached |
| Adverse event | 247 | 9.6 8.5–10.8ROR 10.0 · χ² 1,895 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 74% consumer | no trial data cached |
| Acute myeloid leukaemia | 38 | 8.7 6.4–12.0ROR 8.8 · χ² 252 / p 5e-57 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.0 · 100% clinician | no trial data cached |
| Laboratory test abnormal | 67 | 8.1 6.4–10.3ROR 8.2 · χ² 411 / p 9e-92 | 7.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 75% consumer | no trial data cached |
| Hospitalisation | 339 | 8.0 7.2–8.8ROR 8.4 · χ² 2,065 / p <1e-300 | 7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 86% consumer | no trial data cached |
| Brain fog | 32 | 7.8 5.5–11.1ROR 7.9 · χ² 184 / p 3e-42 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 88% consumer | no trial data cached |
| Bacteraemia | 23 | 7.0 4.6–10.5ROR 7.0 · χ² 112 / p 2e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 91% clinician | no trial data cached |
| Basal cell carcinoma | 30 | 6.9 4.8–9.8ROR 6.9 · χ² 144 / p 1e-33 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 100% clinician | no trial data cached |
| Viral infection | 47 | 5.1 3.8–6.7ROR 5.1 · χ² 149 / p 2e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Covid-19 pneumonia | 16 | 4.8 2.9–7.8ROR 4.8 · χ² 44 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Intestinal perforation | 15 | 4.8 2.9–7.9ROR 4.8 · χ² 41 / p 8e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Paralysis | 19 | 4.7 3.0–7.4ROR 4.7 · χ² 52 / p 3e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Adverse drug reaction | 113 | 4.5 3.8–5.4ROR 4.6 · χ² 306 / p 7e-69 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 82% consumer | no trial data cached |
| Nervous system disorder | 38 | 4.3 3.2–6.0ROR 4.4 · χ² 94 / p 1e-22 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Lymphopenia | 17 | 4.3 2.7–6.9ROR 4.3 · χ² 40 / p 1e-10 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Diplopia (double vision) | 31 | 4.3 3.0–6.1ROR 4.3 · χ² 74 / p 4e-18 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 14% (drug 42%) | no trial data cached |
| Illness | 117 | 4.2 3.5–5.0ROR 4.2 · χ² 279 / p 7e-63 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 79% consumer | no trial data cached |
| Clostridium difficile infection | 25 | 4.1 2.8–6.1ROR 4.1 · χ² 56 / p 4e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Haemorrhage intracranial | 17 | 4.0 2.5–6.5ROR 4.1 · χ² 36 / p 1e-9 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Pyrexia (fever) | 380 | 3.9 3.6–4.3ROR 4.1 · χ² 837 / p 3e-184 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 74% consumer | no trial data cached |
| Immunodeficiency | 16 | 3.9 2.4–6.3ROR 3.9 · χ² 31 / p 1e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Septic shock | 43 | 3.6 2.6–4.8ROR 3.6 · χ² 76 / p 1e-18 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 95% clinician | no trial data cached |
| Encephalopathy | 24 | 3.5 2.3–5.2ROR 3.5 · χ² 40 / p 1e-10 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 95% clinician | no trial data cached |
| Ageusia (loss of taste) | 24 | 3.4 2.3–5.1ROR 3.4 · χ² 39 / p 2e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.0 · 71% consumer | no trial data cached |
| Clostridium difficile colitis | 10 | 3.4 1.8–6.2ROR 3.4 · χ² 14 / p 8e-5 | 3.0 EB05 1.8 · IC025 +0.5 | Labeled — boxed warning synonym match | serious PRR 2.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 126 | 3.3 2.8–3.9ROR 3.4 · χ² 203 / p 2e-46 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 60 | 3.2 2.5–4.2ROR 3.3 · χ² 91 / p 7e-22 | 3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Acute respiratory distress syndrome | 16 | 3.2 2.0–5.3ROR 3.2 · χ² 22 / p 1e-6 | 3.0 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Fungal infection | 30 | 3.2 2.3–4.6ROR 3.2 · χ² 44 / p 2e-11 | 3.1 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Sars-cov-2 test positive | 12 | 3.2 1.8–5.6ROR 3.2 · χ² 16 / p 3e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Lab value / disease marker | serious n=2 | no trial data cached |
| Thrombocytopenia (low platelets) | 99 | 3.2 2.6–3.9ROR 3.2 · χ² 146 / p 8e-34 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 813 | 159.1 149.0–169.9ROR 184.5 · χ² 122,179 / p <1e-300 | 151.7 EB05 143.2 · IC025 +7.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 121.7 · 90% clinician | no trial data cached |
| Pyrexia (fever) | 380 | 3.9 3.6–4.3ROR 4.1 · χ² 837 / p 3e-184 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 74% consumer | no trial data cached |
| Hospitalisation | 339 | 8.0 7.2–8.8ROR 8.4 · χ² 2,065 / p <1e-300 | 7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 86% consumer | no trial data cached |
| Parkinsonism | 328 | 124.2 111.6–138.3ROR 131.5 · χ² 38,630 / p <1e-300 | 119.2 EB05 108.8 · IC025 +6.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 95.8 · 94% clinician | no trial data cached |
| Adverse event | 247 | 9.6 8.5–10.8ROR 10.0 · χ² 1,895 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.7 · 74% consumer | no trial data cached |
| Malaise (feeling unwell) | 195 | 1.6 1.4–1.8ROR 1.6 · χ² 42 / p 4e-11 | 1.6 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 0.5 · 86% consumer | no trial data cached |
| Neurotoxicity | 192 | 39.9 34.7–45.9ROR 41.2 · χ² 7,162 / p <1e-300 | 39.3 EB05 34.8 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 31.9 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 126 | 3.3 2.8–3.9ROR 3.4 · χ² 203 / p 2e-46 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Infection | 122 | 3.0 2.5–3.6ROR 3.1 · χ² 164 / p 8e-38 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.6 | no trial data cached |
| Illness | 117 | 4.2 3.5–5.0ROR 4.2 · χ² 279 / p 7e-63 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 79% consumer | no trial data cached |
| Plasma cell myeloma | 115 | 10.5 8.8–12.6ROR 10.7 · χ² 981 / p 1e-215 | 10.3 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Adverse drug reaction | 113 | 4.5 3.8–5.4ROR 4.6 · χ² 306 / p 7e-69 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 82% consumer | no trial data cached |
| Colitis | 108 | 10.3 8.5–12.4ROR 10.4 · χ² 892 / p 2e-196 | 10.1 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.8 · 94% clinician | no trial data cached |
| Covid-19 | 99 | 2.0 1.6–2.4ROR 2.0 · χ² 49 / p 1e-12 | 2.0 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 99 | 3.2 2.6–3.9ROR 3.2 · χ² 146 / p 8e-34 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 94% clinician | 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.
- Brain fog — n=32, PRR 7.8
- Bacteraemia — n=23, PRR 7.0
- Basal cell carcinoma — n=30, PRR 6.9
- Clostridium difficile infection — n=25, PRR 4.1
- Septic shock — n=43, PRR 3.6
- Ageusia — n=24, PRR 3.4
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 Ciltacabtagene Autoleucel?
In FDA FAERS, the most frequently co-reported reaction terms for Ciltacabtagene Autoleucel are cytokine release syndrome, pyrexia, parkinsonism, malaise, neurotoxicity, neutropenia. 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 Ciltacabtagene Autoleucel have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Do not administer CARVYKTI to patients with active infection or inflammatory disorders.
Do FAERS signals prove that Ciltacabtagene Autoleucel 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 7d040b91-3fb8-41db-ba7f-60a36f06e2c2, effective 20251016; matched on
openfda.generic_name.exact:"CILTACABTAGENE AUTOLEUCEL") - 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, 95 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.