Drug · FAERS side-effect profile with label screen
Belantamab Mafodotin side effects: what 2,907 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
2,907 reports · 88% serious · 993 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 4Lab value / disease marker 2Outcome field, not a reaction 1No label text to screen 33
What the badges mean
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 23 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 |
|---|---|---|---|---|---|---|
| Visual acuity reduced | 773 | 170.2 160.1–181.0ROR 231.4 · χ² 127,028 / p <1e-300 | 165.6 EB05 156.0 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 98.8 | no trial data cached |
| Plasma cell myeloma | 431 | 80.3 73.6–87.7ROR 94.1 · χ² 33,357 / p <1e-300 | 79.1 EB05 73.1 · IC025 +6.0 3/3 methods agree | No label text to screen | serious PRR 55.8 | no trial data cached |
| Photophobia (light sensitivity) | 187 | 72.9 63.4–83.8ROR 77.8 · χ² 13,061 / p <1e-300 | 71.6 EB05 63.4 · IC025 +5.7 3/3 methods agree | No label text to screen | serious PRR 35.1 | no trial data cached |
| Dry eye | 393 | 58.9 53.7–64.6ROR 67.9 · χ² 22,179 / p <1e-300 | 58.3 EB05 53.6 · IC025 +5.6 3/3 methods agree | No label text to screen | serious PRR 64.6 | no trial data cached |
| Ocular discomfort | 45 | 30.0 22.4–40.1ROR 30.4 · χ² 1,227 / p 5e-269 | 29.5 EB05 23.0 · IC025 +4.0 3/3 methods agree | No label text to screen | serious n=43 · ♀ 72% (drug 42%) · 84% consumer | no trial data cached |
| Hospice care | 37 | 27.2 19.7–37.4ROR 27.5 · χ² 903 / p 1e-198 | 26.7 EB05 20.2 · IC025 +3.8 3/3 methods agree | No label text to screen | serious PRR 23.5 | no trial data cached |
| Eye disorder | 87 | 19.2 15.6–23.6ROR 19.7 · χ² 1,478 / p <1e-300 | 19.0 EB05 15.9 · IC025 +3.8 3/3 methods agree | No label text to screen | serious PRR 15.9 | no trial data cached |
| Diplopia (double vision) | 64 | 17.8 14.0–22.7ROR 18.2 · χ² 996 / p 6e-219 | 17.7 EB05 14.3 · IC025 +3.6 3/3 methods agree | No label text to screen | serious PRR 9.4 | no trial data cached |
| Hypercalcaemia | 29 | 17.0 11.8–24.4ROR 17.1 · χ² 419 / p 2e-93 | 16.7 EB05 12.0 · IC025 +3.1 3/3 methods agree | No label text to screen | serious PRR 11.8 | no trial data cached |
| Blindness | 86 | 15.2 12.4–18.8ROR 15.7 · χ² 1,130 / p 4e-248 | 15.1 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious PRR 10.2 | no trial data cached |
| Cataract | 112 | 13.6 11.4–16.3ROR 14.1 · χ² 1,299 / p 9e-285 | 13.5 EB05 11.5 · IC025 +3.4 3/3 methods agree | No label text to screen | serious PRR 10.0 | no trial data cached |
| Therapy partial responder | 27 | 12.9 8.9–18.8ROR 13.0 · χ² 285 / p 3e-64 | 12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 · 100% clinician | no trial data cached |
| Cytokine release syndrome | 30 | 11.4 8.0–16.2ROR 11.5 · χ² 273 / p 1e-61 | 10.8 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 7.5 · ♀ 5% (drug 42%) | no trial data cached |
| Lacrimation increased | 41 | 9.9 7.3–13.4ROR 10.0 · χ² 319 / p 1e-71 | 9.4 EB05 7.1 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 15.5 | no trial data cached |
| Vision blurred (blurred vision) | 186 | 9.8 8.5–11.3ROR 10.4 · χ² 1,472 / p <1e-300 | 9.7 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen | serious PRR 10.1 | no trial data cached |
| Covid-19 pneumonia | 15 | 9.1 5.5–15.1ROR 9.1 · χ² 100 / p 7e-24 | 7.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen | serious PRR 6.0 | no trial data cached |
| Cytopenia | 14 | 8.4 5.0–14.2ROR 8.5 · χ² 85 / p 2e-20 | 7.0 EB05 4.3 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 5.3 | no trial data cached |
| Thrombocytopenia (low platelets) | 118 | 7.6 6.4–9.1ROR 7.9 · χ² 676 / p 2e-149 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 5.1 · 92% clinician | no trial data cached |
| Myelodysplastic syndrome | 15 | 7.5 4.5–12.4ROR 7.5 · χ² 78 / p 6e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 4.9 | no trial data cached |
| Visual impairment | 126 | 7.4 6.2–8.8ROR 7.7 · χ² 692 / p 7e-153 | 7.2 EB05 6.2 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 6.4 · ♀ 63% (drug 42%) | no trial data cached |
| Pneumocystis jirovecii pneumonia | 10 | 7.2 3.9–13.4ROR 7.2 · χ² 47 / p 3e-12 | 5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 4.7 | no trial data cached |
| Eye pain | 49 | 6.4 4.8–8.4ROR 6.5 · χ² 218 / p 1e-49 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 9.0 | no trial data cached |
| Bacteraemia | 10 | 6.1 3.3–11.4ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 4.0 | no trial data cached |
| Blood lactate dehydrogenase increased | 13 | 5.9 3.4–10.1ROR 5.9 · χ² 48 / p 2e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 | no trial data cached |
| Liver function test increased | 17 | 5.7 3.6–9.2ROR 5.8 · χ² 62 / p 2e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 5.9 | no trial data cached |
| Disease progression | 88 | 5.4 4.4–6.6ROR 5.5 · χ² 311 / p 7e-70 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 93% clinician | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 12 | 5.3 3.0–9.2ROR 5.3 · χ² 37 / p 5e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 5.0 | no trial data cached |
| Eye irritation | 37 | 4.8 3.5–6.6ROR 4.8 · χ² 107 / p 2e-25 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 12.6 | no trial data cached |
| Death | 570 | 4.8 4.4–5.1ROR 5.7 · χ² 1,766 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Bone pain | 36 | 4.4 3.2–6.1ROR 4.5 · χ² 92 / p 4e-22 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 5.1 | no trial data cached |
| Conjunctivitis | 11 | 4.3 2.4–7.8ROR 4.3 · χ² 25 / p 3e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen | serious PRR 4.3 | no trial data cached |
| Neurotoxicity | 10 | 4.1 2.2–7.7ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen | serious PRR 2.7 | no trial data cached |
| Platelet count decreased | 58 | 3.9 3.0–5.1ROR 4.0 · χ² 124 / p 4e-29 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 25 | 3.2 2.2–4.8ROR 3.3 · χ² 36 / p 8e-10 | 3.1 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 2.1 | no trial data cached |
| Neoplasm progression | 15 | 3.1 1.9–5.1ROR 3.1 · χ² 19 / p 6e-6 | 2.9 EB05 1.9 · IC025 +0.7 | No label text to screen | serious PRR 2.8 | no trial data cached |
| Hospitalisation | 63 | 3.0 2.3–3.8ROR 3.0 · χ² 81 / p 9e-20 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Ocular hyperaemia | 19 | 2.9 1.9–4.6ROR 2.9 · χ² 22 / p 1e-6 | 2.8 EB05 1.9 · IC025 +0.7 | No label text to screen | serious PRR 5.6 | no trial data cached |
| Eye pruritus | 12 | 2.6 1.5–4.6ROR 2.6 · χ² 10 / p 6e-4 | 2.5 EB05 1.5 · IC025 +0.3 | No label text to screen | serious PRR 3.2 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 48 | 2.6 1.9–3.4ROR 2.6 · χ² 44 / p 2e-11 | 2.5 EB05 2.0 · IC025 +0.8 | No label text to screen | serious PRR 1.7 · ♀ 21% (drug 42%) | no trial data cached |
| Malignant neoplasm progression | 34 | 2.4 1.7–3.4ROR 2.4 · χ² 27 / p 1e-7 | 2.4 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.6 | 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 |
|---|---|---|---|---|---|---|
| Visual acuity reduced | 773 | 170.2 160.1–181.0ROR 231.4 · χ² 127,028 / p <1e-300 | 165.6 EB05 156.0 · IC025 +7.1 3/3 methods agree | No label text to screen | serious PRR 98.8 | no trial data cached |
| Death | 570 | 4.8 4.4–5.1ROR 5.7 · χ² 1,766 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Plasma cell myeloma | 431 | 80.3 73.6–87.7ROR 94.1 · χ² 33,357 / p <1e-300 | 79.1 EB05 73.1 · IC025 +6.0 3/3 methods agree | No label text to screen | serious PRR 55.8 | no trial data cached |
| Dry eye | 393 | 58.9 53.7–64.6ROR 67.9 · χ² 22,179 / p <1e-300 | 58.3 EB05 53.6 · IC025 +5.6 3/3 methods agree | No label text to screen | serious PRR 64.6 | no trial data cached |
| Photophobia (light sensitivity) | 187 | 72.9 63.4–83.8ROR 77.8 · χ² 13,061 / p <1e-300 | 71.6 EB05 63.4 · IC025 +5.7 3/3 methods agree | No label text to screen | serious PRR 35.1 | no trial data cached |
| Vision blurred (blurred vision) | 186 | 9.8 8.5–11.3ROR 10.4 · χ² 1,472 / p <1e-300 | 9.7 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen | serious PRR 10.1 | no trial data cached |
| Visual impairment | 126 | 7.4 6.2–8.8ROR 7.7 · χ² 692 / p 7e-153 | 7.2 EB05 6.2 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 6.4 · ♀ 63% (drug 42%) | no trial data cached |
| Thrombocytopenia (low platelets) | 118 | 7.6 6.4–9.1ROR 7.9 · χ² 676 / p 2e-149 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 5.1 · 92% clinician | no trial data cached |
| Cataract | 112 | 13.6 11.4–16.3ROR 14.1 · χ² 1,299 / p 9e-285 | 13.5 EB05 11.5 · IC025 +3.4 3/3 methods agree | No label text to screen | serious PRR 10.0 | no trial data cached |
| Disease progression | 88 | 5.4 4.4–6.6ROR 5.5 · χ² 311 / p 7e-70 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 93% clinician | no trial data cached |
| Eye disorder | 87 | 19.2 15.6–23.6ROR 19.7 · χ² 1,478 / p <1e-300 | 19.0 EB05 15.9 · IC025 +3.8 3/3 methods agree | No label text to screen | serious PRR 15.9 | no trial data cached |
| Blindness | 86 | 15.2 12.4–18.8ROR 15.7 · χ² 1,130 / p 4e-248 | 15.1 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious PRR 10.2 | no trial data cached |
| Diplopia (double vision) | 64 | 17.8 14.0–22.7ROR 18.2 · χ² 996 / p 6e-219 | 17.7 EB05 14.3 · IC025 +3.6 3/3 methods agree | No label text to screen | serious PRR 9.4 | no trial data cached |
| Hospitalisation | 63 | 3.0 2.3–3.8ROR 3.0 · χ² 81 / p 9e-20 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Platelet count decreased | 58 | 3.9 3.0–5.1ROR 4.0 · χ² 124 / p 4e-29 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Belantamab Mafodotin?
In FDA FAERS, the most frequently co-reported reaction terms for Belantamab Mafodotin are visual acuity reduced, plasma cell myeloma, dry eye, photophobia, vision blurred, visual impairment. 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 Belantamab Mafodotin have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Belantamab Mafodotin 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 63 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.