Amivantamab-Vmjw side effects: what 3,253 FDA adverse event reports show
Drug class
Bispecific egf receptor-directed and met receptor-directed antibody
Brand names
Rybrevant
Who reports
3,253 reports · 68% serious · 246 with death outcome · 63% female
Used for
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
What it is
Amivantamab-vmjw is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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.
- 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. 30 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 |
|---|---|---|---|---|---|---|
| Infusion related reaction (reaction during infusion) | 721 | 70.8 66.4–75.6ROR 90.6 · χ² 49,157 / p <1e-300 | 69.9 EB05 65.7 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 48.0 · 94% clinician | no trial data cached |
| Adverse reaction | 45 | 21.8 16.3–29.2ROR 22.1 · χ² 871 / p 8e-192 | 21.6 EB05 16.8 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=41 · ♀ 85% (drug 63%) · 96% clinician | no trial data cached |
| Cytopenia | 28 | 15.1 10.4–21.8ROR 15.2 · χ² 353 / p 4e-79 | 14.7 EB05 10.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · 100% clinician | no trial data cached |
| Mucosal inflammation | 60 | 14.8 11.5–19.0ROR 15.1 · χ² 758 / p 4e-167 | 14.6 EB05 11.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · 98% clinician | no trial data cached |
| Skin reaction | 30 | 13.7 9.6–19.6ROR 13.8 · χ² 340 / p 3e-76 | 13.3 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 | no trial data cached |
| Folliculitis | 21 | 13.1 8.5–20.0ROR 13.1 · χ² 222 / p 2e-50 | 12.3 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 95% clinician | no trial data cached |
| Myelosuppression | 66 | 12.5 9.8–15.8ROR 12.7 · χ² 685 / p 3e-151 | 12.3 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 94% clinician | no trial data cached |
| Skin disorder | 63 | 12.2 9.5–15.5ROR 12.4 · χ² 634 / p 3e-140 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.5 | no trial data cached |
| Pneumonitis | 51 | 12.1 9.2–15.9ROR 12.3 · χ² 509 / p 5e-113 | 11.8 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 90% clinician | no trial data cached |
| Scab | 21 | 11.9 7.8–18.2ROR 12.0 · χ² 199 / p 2e-45 | 11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Metastases to central nervous system | 21 | 10.5 6.9–16.1ROR 10.6 · χ² 172 / p 2e-39 | 9.6 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Oxygen saturation decreased | 82 | 9.4 7.6–11.7ROR 9.7 · χ² 611 / p 3e-135 | 9.2 EB05 7.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 91% clinician | no trial data cached |
| Tubulointerstitial nephritis | 25 | 8.6 5.8–12.7ROR 8.6 · χ² 160 / p 7e-37 | 7.7 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Hepatic cytolysis | 16 | 8.4 5.2–13.7ROR 8.4 · χ² 97 / p 3e-23 | 7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Haematotoxicity | 12 | 8.3 4.7–14.6ROR 8.3 · χ² 70 / p 3e-17 | 6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Stomatitis (mouth sores) | 76 | 8.0 6.4–10.1ROR 8.2 · χ² 463 / p 6e-103 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Oesophagitis | 12 | 7.0 4.0–12.4ROR 7.1 · χ² 56 / p 3e-14 | 5.7 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Rash | 475 | 7.0 6.5–7.6ROR 8.1 · χ² 2,503 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Skin haemorrhage | 15 | 6.7 4.0–11.1ROR 6.7 · χ² 67 / p 2e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Renal tubular necrosis | 10 | 6.5 3.5–12.1ROR 6.5 · χ² 41 / p 6e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Interstitial lung disease | 48 | 6.4 4.8–8.4ROR 6.5 · χ² 213 / p 2e-48 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 98% clinician | no trial data cached |
| Status epilepticus | 11 | 6.2 3.5–11.3ROR 6.3 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hypocalcaemia (low calcium) | 18 | 6.1 3.9–9.7ROR 6.2 · χ² 72 / p 1e-17 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Oedema | 45 | 5.3 4.0–7.1ROR 5.4 · χ² 155 / p 9e-36 | 5.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 98% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 31 / p 2e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Flushing | 76 | 4.8 3.8–6.0ROR 4.9 · χ² 224 / p 5e-51 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 71 | 4.8 3.8–6.0ROR 4.9 · χ² 209 / p 1e-47 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 94% clinician | no trial data cached |
| Skin lesion | 20 | 4.7 3.0–7.3ROR 4.7 · χ² 55 / p 6e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Ulcer | 11 | 4.4 2.5–8.0ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Skin fissures | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Drug intolerance | 65 | 4.3 3.4–5.5ROR 4.4 · χ² 164 / p 7e-38 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 98% clinician | no trial data cached |
| Febrile neutropenia | 44 | 4.3 3.2–5.7ROR 4.3 · χ² 107 / p 2e-25 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 100% clinician | no trial data cached |
| Blood pressure decreased | 44 | 4.3 3.2–5.7ROR 4.3 · χ² 107 / p 3e-25 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 100% clinician | no trial data cached |
| Shock | 15 | 4.2 2.5–7.0ROR 4.2 · χ² 34 / p 3e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 35 | 4.1 2.9–5.7ROR 4.1 · χ² 79 / p 3e-19 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Pneumothorax | 10 | 4.0 2.2–7.5ROR 4.1 · χ² 20 / p 4e-6 | 3.5 EB05 2.1 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Pancytopenia (all blood cells low) | 35 | 4.0 2.9–5.6ROR 4.1 · χ² 77 / p 9e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 · 100% clinician | no trial data cached |
| Anaphylactic shock | 16 | 4.0 2.5–6.5ROR 4.0 · χ² 33 / p 4e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Adverse event | 57 | 4.0 3.1–5.1ROR 4.0 · χ² 124 / p 4e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Adverse drug reaction | 52 | 3.7 2.8–4.9ROR 3.8 · χ² 102 / p 3e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | 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 |
|---|---|---|---|---|---|---|
| Infusion related reaction (reaction during infusion) | 721 | 70.8 66.4–75.6ROR 90.6 · χ² 49,157 / p <1e-300 | 69.9 EB05 65.7 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 48.0 · 94% clinician | no trial data cached |
| Rash | 475 | 7.0 6.5–7.6ROR 8.1 · χ² 2,503 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Oxygen saturation decreased | 82 | 9.4 7.6–11.7ROR 9.7 · χ² 611 / p 3e-135 | 9.2 EB05 7.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 91% clinician | no trial data cached |
| Flushing | 76 | 4.8 3.8–6.0ROR 4.9 · χ² 224 / p 5e-51 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Stomatitis (mouth sores) | 76 | 8.0 6.4–10.1ROR 8.2 · χ² 463 / p 6e-103 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 71 | 4.8 3.8–6.0ROR 4.9 · χ² 209 / p 1e-47 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 94% clinician | no trial data cached |
| Myelosuppression | 66 | 12.5 9.8–15.8ROR 12.7 · χ² 685 / p 3e-151 | 12.3 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 94% clinician | no trial data cached |
| Drug intolerance | 65 | 4.3 3.4–5.5ROR 4.4 · χ² 164 / p 7e-38 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 98% clinician | no trial data cached |
| Skin disorder | 63 | 12.2 9.5–15.5ROR 12.4 · χ² 634 / p 3e-140 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.5 | no trial data cached |
| Mucosal inflammation | 60 | 14.8 11.5–19.0ROR 15.1 · χ² 758 / p 4e-167 | 14.6 EB05 11.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · 98% clinician | no trial data cached |
| Chest discomfort | 58 | 3.7 2.8–4.7ROR 3.7 · χ² 109 / p 6e-26 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Adverse event | 57 | 4.0 3.1–5.1ROR 4.0 · χ² 124 / p 4e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 55 | 2.6 2.0–3.4ROR 2.6 · χ² 53 / p 2e-13 | 2.6 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 96% clinician | no trial data cached |
| Adverse drug reaction | 52 | 3.7 2.8–4.9ROR 3.8 · χ² 102 / p 3e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Pneumonitis | 51 | 12.1 9.2–15.9ROR 12.3 · χ² 509 / p 5e-113 | 11.8 EB05 9.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 90% 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.
- Folliculitis — n=21, PRR 13.1
- Myelosuppression — n=66, PRR 12.5
- Scab — n=21, PRR 11.9
- Tubulointerstitial nephritis — n=25, PRR 8.6
- Skin lesion — n=20, PRR 4.7
- Febrile neutropenia — n=44, PRR 4.3
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 Amivantamab-Vmjw?
In FDA FAERS, the most frequently co-reported reaction terms for Amivantamab-Vmjw are infusion related reaction, rash, oxygen saturation decreased, flushing, stomatitis, pulmonary embolism. 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 Amivantamab-Vmjw have an FDA boxed warning?
No. The FDA label retrieved for Amivantamab-Vmjw has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amivantamab-Vmjw 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 1466c070-9f97-4fa4-a955-6a6b59981fb8, effective 20251111; matched on
openfda.generic_name.exact:"AMIVANTAMAB-VMJW") - 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, 70 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.