Tafasitamab-Cxix side effects: what 894 FDA adverse event reports show

Tafasitamab-Cxix · Monjuvi · 19 reaction terms · 684 drug–reaction co-reports · data 2026-09-14

Drug class

Cd19-directed cytolytic antibody

FDA label, Indications wording

Brand names

Monjuvi

openFDA label

Who reports

894 reports · 74% serious · 130 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

FDA label, Indications and Usage

What it is

Tafasitamab-cxix is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. It is produced by recombinant DNA technology in mammalian cells (Chinese hamster ovary).

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 19 strongest signals

Labeled adverse reaction 3Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 10

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.
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. 0 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
Lymphoma	166	252.9 220.2–290.4ROR 310.0 · χ² 40,973 / p <1e-300	243.1 EB05 213.6 · IC025 +6.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 196.0 · 99% clinician	no trial data cached
Polyneuropathy	29	57.1 39.9–81.7ROR 58.9 · χ² 1,539 / p <1e-300	55.0 EB05 40.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 44.9 · 100% clinician	no trial data cached
Blood lactate dehydrogenase increased	38	55.8 40.8–76.2ROR 58.2 · χ² 1,986 / p <1e-300	54.2 EB05 41.2 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 43.8 · 100% clinician	no trial data cached
Cytopenia	26	50.9 34.8–74.4ROR 52.4 · χ² 1,221 / p 1e-267	49.1 EB05 35.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.6 · ♀ 90% (drug 45%) · 96% clinician	no trial data cached
Disease progression	239	47.4 42.5–52.9ROR 64.3 · χ² 10,853 / p <1e-300	47.2 EB05 42.3 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 35.3 · 96% clinician	no trial data cached
Haematotoxicity	10	25.2 13.6–46.7ROR 25.5 · χ² 209 / p 1e-47	23.9 EB05 13.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 18.2	no trial data cached
Hepatitis c	12	23.0 13.1–40.3ROR 23.3 · χ² 230 / p 2e-52	22.0 EB05 13.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.1	no trial data cached
Urosepsis	8	20.3 10.2–40.4ROR 20.5 · χ² 128 / p 6e-30	18.4 EB05 8.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Covid-19 pneumonia	10	19.7 10.6–36.4ROR 19.9 · χ² 159 / p 1e-36	18.4 EB05 9.7 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5	no trial data cached
Thrombotic microangiopathy	8	19.3 9.7–38.5ROR 19.5 · χ² 121 / p 2e-28	17.4 EB05 7.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Cytokine release syndrome	15	18.4 11.1–30.4ROR 18.7 · χ² 230 / p 3e-52	17.7 EB05 11.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.5	no trial data cached
Bacteraemia	9	17.9 9.3–34.2ROR 18.0 · χ² 127 / p 1e-29	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.0	no trial data cached
Cardiomyopathy	11	17.4 9.7–31.3ROR 17.6 · χ² 154 / p 1e-35	16.2 EB05 8.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Cytomegalovirus infection	12	16.9 9.6–29.6ROR 17.1 · χ² 163 / p 1e-37	15.8 EB05 8.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.3	no trial data cached
Neoplasm progression	19	12.6 8.1–19.7ROR 12.9 · χ² 192 / p 5e-44	11.8 EB05 7.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Metastases to lung	6	12.1 5.5–27.0ROR 12.2 · χ² 51 / p 5e-13	8.6 EB05 3.6 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Ill-defined disorder	23	8.8 5.9–13.2ROR 9.0 · χ² 152 / p 2e-35	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 91% clinician	no trial data cached
Malignant neoplasm progression	37	8.5 6.2–11.6ROR 8.8 · χ² 238 / p 6e-54	7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7 · 92% clinician	no trial data cached
Gastric cancer	6	5.5 2.5–12.1ROR 5.5 · χ² 18 / p 1e-5	4.0 EB05 2.0 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	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
Disease progression	239	47.4 42.5–52.9ROR 64.3 · χ² 10,853 / p <1e-300	47.2 EB05 42.3 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 35.3 · 96% clinician	no trial data cached
Lymphoma	166	252.9 220.2–290.4ROR 310.0 · χ² 40,973 / p <1e-300	243.1 EB05 213.6 · IC025 +6.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 196.0 · 99% clinician	no trial data cached
Blood lactate dehydrogenase increased	38	55.8 40.8–76.2ROR 58.2 · χ² 1,986 / p <1e-300	54.2 EB05 41.2 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 43.8 · 100% clinician	no trial data cached
Malignant neoplasm progression	37	8.5 6.2–11.6ROR 8.8 · χ² 238 / p 6e-54	7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7 · 92% clinician	no trial data cached
Polyneuropathy	29	57.1 39.9–81.7ROR 58.9 · χ² 1,539 / p <1e-300	55.0 EB05 40.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 44.9 · 100% clinician	no trial data cached
Cytopenia	26	50.9 34.8–74.4ROR 52.4 · χ² 1,221 / p 1e-267	49.1 EB05 35.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 34.6 · ♀ 90% (drug 45%) · 96% clinician	no trial data cached
Ill-defined disorder	23	8.8 5.9–13.2ROR 9.0 · χ² 152 / p 2e-35	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 91% clinician	no trial data cached
Neoplasm progression	19	12.6 8.1–19.7ROR 12.9 · χ² 192 / p 5e-44	11.8 EB05 7.5 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial data cached
Cytokine release syndrome	15	18.4 11.1–30.4ROR 18.7 · χ² 230 / p 3e-52	17.7 EB05 11.0 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.5	no trial data cached
Cytomegalovirus infection	12	16.9 9.6–29.6ROR 17.1 · χ² 163 / p 1e-37	15.8 EB05 8.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.3	no trial data cached
Hepatitis c	12	23.0 13.1–40.3ROR 23.3 · χ² 230 / p 2e-52	22.0 EB05 13.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.1	no trial data cached
Cardiomyopathy	11	17.4 9.7–31.3ROR 17.6 · χ² 154 / p 1e-35	16.2 EB05 8.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Covid-19 pneumonia	10	19.7 10.6–36.4ROR 19.9 · χ² 159 / p 1e-36	18.4 EB05 9.7 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.5	no trial data cached
Haematotoxicity	10	25.2 13.6–46.7ROR 25.5 · χ² 209 / p 1e-47	23.9 EB05 13.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 18.2	no trial data cached
Bacteraemia	9	17.9 9.3–34.2ROR 18.0 · χ² 127 / p 1e-29	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.0	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.

Polyneuropathy — n=29, PRR 57.1
Ill-defined disorder — n=23, PRR 8.8

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 Tafasitamab-Cxix?

In FDA FAERS, the most frequently co-reported reaction terms for Tafasitamab-Cxix are lymphoma, blood lactate dehydrogenase increased, polyneuropathy, cytopenia, ill-defined disorder, neoplasm progression. 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 Tafasitamab-Cxix have an FDA boxed warning?

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

Do FAERS signals prove that Tafasitamab-Cxix 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 9e0a220b-517f-4c86-b581-ffbab493fb58, effective 20250623; matched on openfda.generic_name.exact:"TAFASITAMAB-CXIX")
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, 19 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.