Mirvetuximab Soravtansine side effects: what 1,651 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Elahere
Who reports
1,651 reports · 56% serious · 196 with death outcome · 100% female
Used for
ELAHERE ® is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test .
What it is
Mirvetuximab soravtansine-gynx is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC) consisting of three components: 1) an anti-FRα monoclonal antibody of IgG1 subtype 2) the.
Boxed warning
OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] ..
Causality screen of the 20 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.
- 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. 13 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 |
|---|---|---|---|---|---|---|
| Pneumonitis | 88 | 41.5 33.8–50.8ROR 43.7 · χ² 3,428 / p <1e-300 | 41.0 EB05 34.3 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 33.8 | no trial data cached |
| Ovarian cancer | 24 | 33.0 22.2–49.1ROR 33.5 · χ² 711 / p 5e-157 | 32.2 EB05 22.7 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 34.1 | no trial data cached |
| Cataract | 85 | 18.2 14.8–22.4ROR 19.2 · χ² 1,369 / p 7e-300 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.7 | no trial data cached |
| Intestinal perforation | 15 | 17.0 10.3–28.1ROR 17.1 · χ² 210 / p 8e-48 | 16.2 EB05 9.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | no trial data cached |
| Small intestinal obstruction | 15 | 15.5 9.4–25.7ROR 15.7 · χ² 190 / p 2e-43 | 14.7 EB05 8.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.1 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 114 | 15.3 12.8–18.3ROR 16.4 · χ² 1,518 / p <1e-300 | 15.3 EB05 13.0 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.9 | no trial data cached |
| Dry eye | 55 | 14.4 11.1–18.7ROR 14.9 · χ² 675 / p 4e-149 | 14.3 EB05 11.3 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.2 | no trial data cached |
| Vision blurred (blurred vision) | 114 | 10.6 8.9–12.7ROR 11.3 · χ² 988 / p 4e-217 | 10.5 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.8 | no trial data cached |
| Eye disorder | 27 | 10.5 7.2–15.2ROR 10.6 · χ² 222 / p 2e-50 | 9.7 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Product preparation error | 17 | 10.4 6.5–16.7ROR 10.5 · χ² 136 / p 1e-31 | 9.2 EB05 5.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Photophobia (light sensitivity) | 15 | 10.2 6.2–16.9ROR 10.3 · χ² 116 / p 3e-27 | 8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.0 | no trial data cached |
| Disease progression | 94 | 10.1 8.3–12.3ROR 10.7 · χ² 768 / p 2e-169 | 9.9 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 43 | 8.3 6.2–11.1ROR 8.5 · χ² 268 / p 1e-60 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Interstitial lung disease | 31 | 8.2 5.8–11.6ROR 8.3 · χ² 188 / p 5e-43 | 7.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 · 100% clinician | no trial data cached |
| Blindness | 25 | 7.8 5.3–11.5ROR 7.9 · χ² 142 / p 6e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Intestinal obstruction | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 62 / p 1e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Visual acuity reduced | 15 | 5.7 3.4–9.4ROR 5.7 · χ² 53 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Visual impairment | 53 | 5.5 4.2–7.1ROR 5.6 · χ² 190 / p 1e-43 | 5.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.3 | no trial data cached |
| Eye irritation | 15 | 3.4 2.1–5.7ROR 3.4 · χ² 23 / p 7e-7 | 3.1 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Product storage error | 20 | 2.9 1.9–4.5ROR 3.0 · χ² 24 / p 6e-7 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Vision blurred (blurred vision) | 114 | 10.6 8.9–12.7ROR 11.3 · χ² 988 / p 4e-217 | 10.5 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.8 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 114 | 15.3 12.8–18.3ROR 16.4 · χ² 1,518 / p <1e-300 | 15.3 EB05 13.0 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.9 | no trial data cached |
| Disease progression | 94 | 10.1 8.3–12.3ROR 10.7 · χ² 768 / p 2e-169 | 9.9 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.0 | no trial data cached |
| Pneumonitis | 88 | 41.5 33.8–50.8ROR 43.7 · χ² 3,428 / p <1e-300 | 41.0 EB05 34.3 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 33.8 | no trial data cached |
| Cataract | 85 | 18.2 14.8–22.4ROR 19.2 · χ² 1,369 / p 7e-300 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.7 | no trial data cached |
| Dry eye | 55 | 14.4 11.1–18.7ROR 14.9 · χ² 675 / p 4e-149 | 14.3 EB05 11.3 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.2 | no trial data cached |
| Visual impairment | 53 | 5.5 4.2–7.1ROR 5.6 · χ² 190 / p 1e-43 | 5.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.3 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 43 | 8.3 6.2–11.1ROR 8.5 · χ² 268 / p 1e-60 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Interstitial lung disease | 31 | 8.2 5.8–11.6ROR 8.3 · χ² 188 / p 5e-43 | 7.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.5 · 100% clinician | no trial data cached |
| Eye disorder | 27 | 10.5 7.2–15.2ROR 10.6 · χ² 222 / p 2e-50 | 9.7 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Blindness | 25 | 7.8 5.3–11.5ROR 7.9 · χ² 142 / p 6e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Ovarian cancer | 24 | 33.0 22.2–49.1ROR 33.5 · χ² 711 / p 5e-157 | 32.2 EB05 22.7 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 34.1 | no trial data cached |
| Product storage error | 20 | 2.9 1.9–4.5ROR 3.0 · χ² 24 / p 6e-7 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | 95% clinician | no trial data cached |
| Intestinal obstruction | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 62 / p 1e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Product preparation error | 17 | 10.4 6.5–16.7ROR 10.5 · χ² 136 / p 1e-31 | 9.2 EB05 5.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=1 | 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.
- Blindness — n=25, PRR 7.8
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 Mirvetuximab Soravtansine?
In FDA FAERS, the most frequently co-reported reaction terms for Mirvetuximab Soravtansine are vision blurred, neuropathy peripheral, pneumonitis, cataract, dry eye, 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 Mirvetuximab Soravtansine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] ..
Do FAERS signals prove that Mirvetuximab Soravtansine 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 00c424b5-6ccd-48ab-9e88-1986451120e2, effective 20250714; matched on
openfda.generic_name.exact:"MIRVETUXIMAB SORAVTANSINE") - 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, 33 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.