Drug · FAERS side-effect profile with label screen
Isatuximab side effects: what 5,551 FDA adverse event reports show
Drug class
CD38-directed Cytolytic Antibody
FDA label (Established Pharmacologic Class)
Brand names
Sarclisa
openFDA label
Who reports
5,551 reports · 93% serious · 736 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
FDA label, Indications and Usage
What it is
Isatuximab-irfc, a CD38-directed cytolytic antibody, is a chimeric immunoglobulin G1 (IgG1) monoclonal antibody (mAb). Isatuximab-irfc is produced from a mammalian cell line (Chinese hamster ovary, CHO) using a fed-batch production process.
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 12Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 22
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. 114 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 |
|---|---|---|---|---|---|---|
| Plasma cell myeloma | 388 | 37.9 34.4–41.7ROR 40.6 · χ² 13,770 / p <1e-300 | 37.4 EB05 34.4 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.0 · 97% clinician | no trial data cached |
| Thrombotic microangiopathy | 70 | 27.5 21.8–34.7ROR 27.8 · χ² 1,748 / p <1e-300 | 27.1 EB05 22.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 94% clinician | no trial data cached |
| Covid-19 pneumonia | 78 | 24.9 20.0–31.1ROR 25.3 · χ² 1,758 / p <1e-300 | 24.6 EB05 20.4 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 · 97% clinician | no trial data cached |
| Lymphopenia | 74 | 20.0 15.9–25.1ROR 20.2 · χ² 1,308 / p 1e-286 | 19.8 EB05 16.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 100% clinician | no trial data cached |
| Cytopenia | 51 | 16.2 12.3–21.3ROR 16.3 · χ² 709 / p 2e-156 | 16.0 EB05 12.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · 96% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 253 | 14.5 12.9–16.4ROR 15.2 · χ² 3,169 / p <1e-300 | 14.4 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 515 | 14.4 13.3–15.6ROR 15.8 · χ² 6,429 / p <1e-300 | 14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 · 98% clinician | no trial data cached |
| Polyneuropathy | 42 | 13.4 9.9–18.1ROR 13.5 · χ² 467 / p 6e-104 | 13.1 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 98% clinician | no trial data cached |
| Neutrophil count decreased | 119 | 11.1 9.3–13.3ROR 11.3 · χ² 1,085 / p 3e-238 | 11.0 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · 97% clinician | no trial data cached |
| Cytokine release syndrome | 55 | 10.9 8.4–14.2ROR 11.0 · χ² 485 / p 7e-108 | 10.6 EB05 8.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · ♀ 87% (drug 45%) · 96% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 321 | 10.9 9.8–12.1ROR 11.5 · χ² 2,884 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 97% clinician | no trial data cached |
| Hepatic cytolysis | 34 | 10.5 7.5–14.7ROR 10.6 · χ² 283 / p 7e-64 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.5 · 100% clinician | no trial data cached |
| Respiratory tract infection | 70 | 10.2 8.1–12.9ROR 10.3 · χ² 571 / p 1e-126 | 9.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · 96% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 26 | 9.8 6.7–14.5ROR 9.9 · χ² 197 / p 4e-45 | 9.0 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · ♀ 14% (drug 45%) · 100% clinician | no trial data cached |
| Bacteraemia | 29 | 9.3 6.5–13.4ROR 9.4 · χ² 207 / p 3e-47 | 8.6 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 16% (drug 45%) · 100% clinician | no trial data cached |
| Basal cell carcinoma | 37 | 9.0 6.5–12.4ROR 9.0 · χ² 254 / p 2e-57 | 8.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 12% (drug 45%) · 97% clinician | no trial data cached |
| Hypercalcaemia | 29 | 8.9 6.2–12.8ROR 8.9 · χ² 195 / p 1e-44 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 97% clinician | no trial data cached |
| Therapy partial responder | 34 | 8.5 6.1–11.9ROR 8.6 · χ² 219 / p 9e-50 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 100% clinician | no trial data cached |
| Febrile neutropenia | 149 | 8.5 7.3–10.0ROR 8.7 · χ² 982 / p 9e-216 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 97% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 42 | 8.4 6.2–11.4ROR 8.5 · χ² 267 / p 3e-60 | 7.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 98% clinician | no trial data cached |
| Hypertensive crisis | 24 | 8.1 5.5–12.1ROR 8.2 · χ² 143 / p 3e-33 | 7.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 96% clinician | no trial data cached |
| Haematotoxicity | 19 | 7.8 4.9–12.2ROR 7.8 · χ² 105 / p 6e-25 | 6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Myelodysplastic syndrome | 28 | 7.3 5.1–10.6ROR 7.4 · χ² 146 / p 6e-34 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 100% clinician | no trial data cached |
| Gastroenteritis | 26 | 6.7 4.6–9.9ROR 6.8 · χ² 121 / p 1e-28 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 65% (drug 45%) · 100% clinician | no trial data cached |
| Covid-19 | 297 | 6.3 5.7–7.1ROR 6.7 · χ² 1,342 / p 4e-294 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 98% clinician | no trial data cached |
| Toxic skin eruption | 15 | 5.6 3.4–9.3ROR 5.6 · χ² 52 / p 2e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Anaemia (low red blood cells) | 278 | 5.5 4.9–6.2ROR 5.7 · χ² 1,029 / p 4e-226 | 5.5 EB05 4.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 96% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 70 | 5.3 4.2–6.7ROR 5.4 · χ² 240 / p 2e-54 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 94% clinician | no trial data cached |
| Mitral valve incompetence | 15 | 5.0 3.0–8.3ROR 5.0 · χ² 44 / p 1e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Spinal pain | 15 | 4.8 2.9–8.0ROR 4.9 · χ² 42 / p 5e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Septic shock | 52 | 4.5 3.5–6.0ROR 4.6 · χ² 141 / p 1e-32 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 114 | 4.5 3.8–5.4ROR 4.6 · χ² 309 / p 1e-69 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 98% clinician | no trial data cached |
| Urosepsis | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Bronchospasm (airway tightening) | 17 | 4.5 2.8–7.2ROR 4.5 · χ² 43 / p 3e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Flank pain | 11 | 4.4 2.5–8.0ROR 4.5 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Pneumonia (lung infection) | 379 | 4.4 4.0–4.9ROR 4.7 · χ² 1,019 / p 8e-224 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 95% clinician | no trial data cached |
| Squamous cell carcinoma | 11 | 4.4 2.4–8.0ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Disease progression | 137 | 4.4 3.7–5.2ROR 4.5 · χ² 357 / p 6e-80 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · ♀ 65% (drug 45%) · 94% clinician | no trial data cached |
| Platelet count decreased | 123 | 4.4 3.7–5.2ROR 4.4 · χ² 317 / p 3e-71 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 94% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 64 | 4.3 3.4–5.5ROR 4.4 · χ² 161 / p 3e-37 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Neutropenia (low neutrophils (infection-fighting cells)) | 515 | 14.4 13.3–15.6ROR 15.8 · χ² 6,429 / p <1e-300 | 14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 · 98% clinician | no trial data cached |
| Plasma cell myeloma | 388 | 37.9 34.4–41.7ROR 40.6 · χ² 13,770 / p <1e-300 | 37.4 EB05 34.4 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.0 · 97% clinician | no trial data cached |
| Pneumonia (lung infection) | 379 | 4.4 4.0–4.9ROR 4.7 · χ² 1,019 / p 8e-224 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 95% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 321 | 10.9 9.8–12.1ROR 11.5 · χ² 2,884 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 97% clinician | no trial data cached |
| Covid-19 | 297 | 6.3 5.7–7.1ROR 6.7 · χ² 1,342 / p 4e-294 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 98% clinician | no trial data cached |
| Pyrexia (fever) | 281 | 3.1 2.7–3.4ROR 3.2 · χ² 396 / p 2e-88 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 95% clinician | no trial data cached |
| Anaemia (low red blood cells) | 278 | 5.5 4.9–6.2ROR 5.7 · χ² 1,029 / p 4e-226 | 5.5 EB05 4.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 96% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 253 | 14.5 12.9–16.4ROR 15.2 · χ² 3,169 / p <1e-300 | 14.4 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 151 | 3.7 3.2–4.4ROR 3.8 · χ² 303 / p 3e-68 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 96% clinician | no trial data cached |
| Febrile neutropenia | 149 | 8.5 7.3–10.0ROR 8.7 · χ² 982 / p 9e-216 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · 97% clinician | no trial data cached |
| Infection | 142 | 3.7 3.2–4.4ROR 3.8 · χ² 282 / p 2e-63 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 99% clinician | no trial data cached |
| Disease progression | 137 | 4.4 3.7–5.2ROR 4.5 · χ² 357 / p 6e-80 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · ♀ 65% (drug 45%) · 94% clinician | no trial data cached |
| Platelet count decreased | 123 | 4.4 3.7–5.2ROR 4.4 · χ² 317 / p 3e-71 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 94% clinician | no trial data cached |
| Neutrophil count decreased | 119 | 11.1 9.3–13.3ROR 11.3 · χ² 1,085 / p 3e-238 | 11.0 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 118 | 4.0 3.3–4.8ROR 4.1 · χ² 263 / p 2e-59 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 97% 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.
- Thrombotic microangiopathy — n=70, PRR 27.5
- Lymphopenia — n=74, PRR 20.0
- Cytopenia — n=51, PRR 16.2
- Polyneuropathy — n=42, PRR 13.4
- Thrombocytopenia — n=321, PRR 10.9
- Bacteraemia — n=29, PRR 9.3
- Basal cell carcinoma — n=37, PRR 9.0
- Hypercalcaemia — n=29, PRR 8.9
- Hypocalcaemia — n=42, PRR 8.4
- Myelodysplastic syndrome — n=28, PRR 7.3
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 Isatuximab?
In FDA FAERS, the most frequently co-reported reaction terms for Isatuximab are neutropenia, plasma cell myeloma, pneumonia, thrombocytopenia, covid-19, pyrexia. 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 Isatuximab have an FDA boxed warning?
No. The FDA label retrieved for Isatuximab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Isatuximab 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 a0473462-6f9d-4eca-a5bf-8620aea68e8a, effective 20260707; matched on
openfda.generic_name.exact:"ISATUXIMAB") - 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, 154 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.