Talquetamab side effects: what 2,033 FDA adverse event reports show
Drug class
Bispecific gprc5d-directed cd3 t-cell engager
Brand names
Talvey
Who reports
2,033 reports · 71% serious · 225 with death outcome · 44% female
Used for
TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response .
What it is
Talquetamab-tgvs is a bispecific GPRC5D-directed CD3 T-cell engager. It is a humanized IgG4 proline, alanine, alanine (IgG4-PAA)-based bispecific antibody produced by Chinese hamster ovary (CHO) cells using recombinant DNA technology.
Boxed warning
CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS.
Causality screen of the 30 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.
- 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. 11 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 | 489 | 270.0 249.6–292.1ROR 354.5 · χ² 127,502 / p <1e-300 | 260.3 EB05 241.5 · IC025 +7.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 216.6 | no trial data cached |
| Ageusia (loss of taste) | 157 | 64.7 55.7–75.3ROR 70.0 · χ² 9,739 / p <1e-300 | 63.9 EB05 55.9 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 61.2 | no trial data cached |
| Taste disorder | 88 | 45.2 36.8–55.5ROR 47.2 · χ² 3,746 / p <1e-300 | 44.6 EB05 37.3 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.7 | no trial data cached |
| Plasma cell myeloma | 115 | 30.2 25.3–36.1ROR 32.0 · χ² 3,218 / p <1e-300 | 30.0 EB05 25.7 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 26.6 | no trial data cached |
| Dysgeusia (altered taste) | 192 | 26.4 23.1–30.2ROR 29.0 · χ² 4,674 / p <1e-300 | 26.3 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.4 | no trial data cached |
| Ataxia | 27 | 23.3 16.0–33.9ROR 23.6 · χ² 552 / p 2e-122 | 22.9 EB05 16.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.0 · 100% clinician | no trial data cached |
| Cytopenia | 27 | 23.2 15.9–33.8ROR 23.5 · χ² 551 / p 4e-122 | 22.8 EB05 16.4 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 19.6 · 93% clinician | no trial data cached |
| Skin exfoliation | 156 | 19.3 16.6–22.4ROR 20.8 · χ² 2,690 / p <1e-300 | 19.2 EB05 16.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.2 | no trial data cached |
| Dry mouth | 133 | 16.9 14.3–19.9ROR 18.0 · χ² 1,972 / p <1e-300 | 16.8 EB05 14.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.7 | no trial data cached |
| Mucosal inflammation | 34 | 13.4 9.6–18.7ROR 13.6 · χ² 377 / p 2e-84 | 13.0 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · ♀ 14% (drug 44%) · 100% clinician | no trial data cached |
| Neurotoxicity | 21 | 12.4 8.1–19.0ROR 12.5 · χ² 209 / p 1e-47 | 11.6 EB05 7.6 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 · 95% clinician | no trial data cached |
| Skin disorder | 38 | 11.7 8.5–16.1ROR 11.9 · χ² 362 / p 5e-81 | 11.3 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Product prescribing error | 27 | 11.7 8.0–17.0ROR 11.8 · χ² 254 / p 2e-57 | 11.1 EB05 7.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Skin reaction | 14 | 10.2 6.1–17.2ROR 10.3 · χ² 107 / p 2e-25 | 8.7 EB05 5.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 19 | 8.3 5.3–13.0ROR 8.4 · χ² 115 / p 3e-27 | 7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Hypercalcaemia | 10 | 8.3 4.5–15.4ROR 8.4 · χ² 57 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Lymphopenia | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Liver function test increased | 15 | 7.2 4.4–11.9ROR 7.3 · χ² 74 / p 4e-18 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 | no trial data cached |
| Anosmia (loss of smell) | 10 | 7.1 3.8–13.1ROR 7.1 · χ² 46 / p 5e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Dysphagia (difficulty swallowing) | 65 | 7.0 5.5–8.9ROR 7.2 · χ² 332 / p 2e-74 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Cytomegalovirus infection | 11 | 6.8 3.8–12.2ROR 6.8 · χ² 49 / p 2e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Weight decreased (weight loss) | 174 | 6.4 5.5–7.4ROR 6.9 · χ² 797 / p 1e-175 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.2 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 83 | 6.3 5.1–7.8ROR 6.5 · χ² 365 / p 9e-82 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 22% (drug 44%) | no trial data cached |
| Dry skin | 78 | 6.1 4.9–7.6ROR 6.3 · χ² 328 / p 1e-73 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Respiratory tract infection | 15 | 5.9 3.6–9.8ROR 6.0 · χ² 57 / p 3e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Diplopia (double vision) | 14 | 5.5 3.3–9.3ROR 5.6 · χ² 48 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Bone pain | 29 | 5.1 3.5–7.3ROR 5.1 · χ² 91 / p 7e-22 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Thrombocytopenia (low platelets) | 55 | 5.1 3.9–6.6ROR 5.2 · χ² 176 / p 2e-40 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 98% clinician | no trial data cached |
| Febrile neutropenia | 30 | 4.6 3.3–6.6ROR 4.7 · χ² 82 / p 6e-20 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · 97% clinician | no trial data cached |
| Inappropriate schedule of product administration | 62 | 3.6 2.8–4.6ROR 3.7 · χ² 114 / p 5e-27 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | 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 | 489 | 270.0 249.6–292.1ROR 354.5 · χ² 127,502 / p <1e-300 | 260.3 EB05 241.5 · IC025 +7.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 216.6 | no trial data cached |
| Dysgeusia (altered taste) | 192 | 26.4 23.1–30.2ROR 29.0 · χ² 4,674 / p <1e-300 | 26.3 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.4 | no trial data cached |
| Weight decreased (weight loss) | 174 | 6.4 5.5–7.4ROR 6.9 · χ² 797 / p 1e-175 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.2 | no trial data cached |
| Ageusia (loss of taste) | 157 | 64.7 55.7–75.3ROR 70.0 · χ² 9,739 / p <1e-300 | 63.9 EB05 55.9 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 61.2 | no trial data cached |
| Skin exfoliation | 156 | 19.3 16.6–22.4ROR 20.8 · χ² 2,690 / p <1e-300 | 19.2 EB05 16.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.2 | no trial data cached |
| Dry mouth | 133 | 16.9 14.3–19.9ROR 18.0 · χ² 1,972 / p <1e-300 | 16.8 EB05 14.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.7 | no trial data cached |
| Plasma cell myeloma | 115 | 30.2 25.3–36.1ROR 32.0 · χ² 3,218 / p <1e-300 | 30.0 EB05 25.7 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 26.6 | no trial data cached |
| Taste disorder | 88 | 45.2 36.8–55.5ROR 47.2 · χ² 3,746 / p <1e-300 | 44.6 EB05 37.3 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.7 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 83 | 6.3 5.1–7.8ROR 6.5 · χ² 365 / p 9e-82 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 22% (drug 44%) | no trial data cached |
| Dry skin | 78 | 6.1 4.9–7.6ROR 6.3 · χ² 328 / p 1e-73 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Dysphagia (difficulty swallowing) | 65 | 7.0 5.5–8.9ROR 7.2 · χ² 332 / p 2e-74 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Inappropriate schedule of product administration | 62 | 3.6 2.8–4.6ROR 3.7 · χ² 114 / p 5e-27 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 55 | 5.1 3.9–6.6ROR 5.2 · χ² 176 / p 2e-40 | 4.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 98% clinician | no trial data cached |
| Skin disorder | 38 | 11.7 8.5–16.1ROR 11.9 · χ² 362 / p 5e-81 | 11.3 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Mucosal inflammation | 34 | 13.4 9.6–18.7ROR 13.6 · χ² 377 / p 2e-84 | 13.0 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · ♀ 14% (drug 44%) · 100% 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.
- Bone pain — n=29, PRR 5.1
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 Talquetamab?
In FDA FAERS, the most frequently co-reported reaction terms for Talquetamab are cytokine release syndrome, dysgeusia, weight decreased, ageusia, skin exfoliation, dry mouth. 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 Talquetamab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS.
Do FAERS signals prove that Talquetamab 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 9001355e-003d-4d4e-b4ce-337e0fd14952, effective 20251008; matched on
openfda.generic_name.exact:"TALQUETAMAB") - 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, 41 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.