Sacituzumab Govitecan side effects: what 4,518 FDA adverse event reports show
Drug class
Trop-2-directed antibody and topoisomerase inhibitor conjugate
Brand names
Trodelvy
Who reports
4,518 reports · 89% serious · 929 with death outcome · 94% female
Used for
TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.
What it is
Sacituzumab govitecan-hziy is a Trop-2 directed antibody and topoisomerase inhibitor conjugate, composed of the following three components: the humanized monoclonal antibody, hRS7 IgG1κ (also .
Boxed warning
NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment.
Causality screen of the 40 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.
- 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. 58 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 |
|---|---|---|---|---|---|---|
| Disease progression | 1,294 | 51.5 49.2–53.9ROR 71.8 · χ² 63,659 / p <1e-300 | 50.9 EB05 48.6 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 37.9 · 94% clinician | no trial data cached |
| Weight fluctuation | 87 | 39.1 31.7–48.2ROR 39.8 · χ² 3,164 / p <1e-300 | 38.5 EB05 32.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=86 · 94% clinician | no trial data cached |
| Metastases to central nervous system | 82 | 29.9 24.1–37.1ROR 30.4 · χ² 2,248 / p <1e-300 | 29.5 EB05 24.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.3 | no trial data cached |
| Metastases to liver | 71 | 18.9 15.0–23.8ROR 19.1 · χ² 1,179 / p 9e-259 | 18.7 EB05 15.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 90% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 510 | 17.5 16.2–19.0ROR 19.6 · χ² 7,956 / p <1e-300 | 17.5 EB05 16.2 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.4 · 96% clinician | no trial data cached |
| Breast cancer metastatic | 36 | 15.6 11.3–21.6ROR 15.7 · χ² 477 / p 5e-106 | 15.4 EB05 11.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.7 · 97% clinician | no trial data cached |
| Neutrophil count decreased | 132 | 15.2 12.8–18.0ROR 15.6 · χ² 1,730 / p <1e-300 | 15.1 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.3 · 97% clinician | no trial data cached |
| Febrile neutropenia | 203 | 14.3 12.5–16.3ROR 14.9 · χ² 2,492 / p <1e-300 | 14.2 EB05 12.6 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.2 · 98% clinician | no trial data cached |
| Metastases to lung | 33 | 13.3 9.5–18.7ROR 13.4 · χ² 362 / p 4e-81 | 12.9 EB05 9.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Pneumonitis | 70 | 12.0 9.5–15.2ROR 12.2 · χ² 697 / p 7e-154 | 11.8 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 91% clinician | no trial data cached |
| Haematotoxicity | 24 | 12.0 8.1–18.0ROR 12.1 · χ² 232 / p 1e-52 | 11.3 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 96% clinician | no trial data cached |
| Myelosuppression | 86 | 11.8 9.5–14.5ROR 12.0 · χ² 835 / p 6e-184 | 11.6 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 98% clinician | no trial data cached |
| Metastases to bone | 37 | 10.5 7.6–14.5ROR 10.6 · χ² 309 / p 2e-69 | 10.0 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Colitis | 78 | 9.6 7.7–12.0ROR 9.8 · χ² 594 / p 1e-131 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 94% clinician | no trial data cached |
| Electrolyte imbalance | 19 | 7.7 4.9–12.0ROR 7.7 · χ² 104 / p 1e-24 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cytopenia | 17 | 6.6 4.1–10.6ROR 6.6 · χ² 75 / p 2e-18 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Mucosal inflammation | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 170 / p 4e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 · 100% clinician | no trial data cached |
| Therapy partial responder | 21 | 6.5 4.2–9.9ROR 6.5 · χ² 92 / p 5e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 90% clinician | no trial data cached |
| Septic shock | 59 | 6.3 4.9–8.2ROR 6.4 · χ² 260 / p 7e-59 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 98% clinician | no trial data cached |
| Hepatic cytolysis | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 135 | 5.6 4.8–6.6ROR 5.8 · χ² 511 / p 2e-113 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 98% clinician | no trial data cached |
| Sars-cov-2 test positive | 16 | 5.6 3.4–9.1ROR 5.6 · χ² 55 / p 5e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Product preparation error | 24 | 5.4 3.6–8.0ROR 5.4 · χ² 81 / p 1e-19 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 62 | 5.2 4.0–6.6ROR 5.2 · χ² 205 / p 1e-46 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 97% clinician | no trial data cached |
| Tooth fracture | 12 | 5.1 2.9–8.9ROR 5.1 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Interstitial lung disease | 50 | 4.8 3.6–6.3ROR 4.8 · χ² 147 / p 4e-34 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 100% clinician | no trial data cached |
| Liver function test increased | 22 | 4.8 3.2–7.3ROR 4.8 · χ² 62 / p 2e-15 | 4.4 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Pneumothorax | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Inappropriate schedule of product administration | 170 | 4.5 3.9–5.2ROR 4.6 · χ² 457 / p 1e-101 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 95% clinician | no trial data cached |
| Mass | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Hypercalcaemia | 11 | 4.1 2.3–7.5ROR 4.1 · χ² 23 / p 7e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Diarrhoea (diarrhea) | 561 | 4.1 3.7–4.4ROR 4.5 · χ² 1,325 / p 2e-290 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 · 91% clinician | no trial data cached |
| Alopecia (hair loss) | 170 | 4.0 3.5–4.7ROR 4.1 · χ² 385 / p 6e-86 | 4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Bacteraemia | 10 | 3.9 2.1–7.3ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Complication associated with device | 11 | 3.9 2.1–7.0ROR 3.9 · χ² 21 / p 3e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Ascites | 24 | 3.8 2.5–5.6ROR 3.8 · χ² 47 / p 4e-12 | 3.6 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 91 | 3.8 3.1–4.6ROR 3.8 · χ² 185 / p 2e-42 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · ♀ 65% (drug 94%) · 96% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 15 | 3.8 2.3–6.2ROR 3.8 · χ² 28 / p 7e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.4 | no trial data cached |
| White blood cell count decreased | 88 | 3.8 3.1–4.6ROR 3.8 · χ² 177 / p 1e-40 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Hypophagia | 19 | 3.5 2.2–5.4ROR 3.5 · χ² 31 / p 1e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | 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 |
|---|---|---|---|---|---|---|
| Disease progression | 1,294 | 51.5 49.2–53.9ROR 71.8 · χ² 63,659 / p <1e-300 | 50.9 EB05 48.6 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 37.9 · 94% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 561 | 4.1 3.7–4.4ROR 4.5 · χ² 1,325 / p 2e-290 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 · 91% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 510 | 17.5 16.2–19.0ROR 19.6 · χ² 7,956 / p <1e-300 | 17.5 EB05 16.2 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.4 · 96% clinician | no trial data cached |
| Death | 462 | 2.5 2.3–2.7ROR 2.7 · χ² 428 / p 2e-95 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.6 | no trial data cached |
| Asthenia (weakness) | 206 | 2.5 2.2–2.9ROR 2.6 · χ² 195 / p 1e-44 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 94% clinician | no trial data cached |
| Febrile neutropenia | 203 | 14.3 12.5–16.3ROR 14.9 · χ² 2,492 / p <1e-300 | 14.2 EB05 12.6 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.2 · 98% clinician | no trial data cached |
| Alopecia (hair loss) | 170 | 4.0 3.5–4.7ROR 4.1 · χ² 385 / p 6e-86 | 4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Inappropriate schedule of product administration | 170 | 4.5 3.9–5.2ROR 4.6 · χ² 457 / p 1e-101 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 95% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 135 | 5.6 4.8–6.6ROR 5.8 · χ² 511 / p 2e-113 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 98% clinician | no trial data cached |
| Neutrophil count decreased | 132 | 15.2 12.8–18.0ROR 15.6 · χ² 1,730 / p <1e-300 | 15.1 EB05 13.0 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.3 · 97% clinician | no trial data cached |
| Anaemia (low red blood cells) | 129 | 3.1 2.6–3.7ROR 3.2 · χ² 187 / p 6e-43 | 3.1 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.2 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 91 | 3.8 3.1–4.6ROR 3.8 · χ² 185 / p 2e-42 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · ♀ 65% (drug 94%) · 96% clinician | no trial data cached |
| White blood cell count decreased | 88 | 3.8 3.1–4.6ROR 3.8 · χ² 177 / p 1e-40 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Weight fluctuation | 87 | 39.1 31.7–48.2ROR 39.8 · χ² 3,164 / p <1e-300 | 38.5 EB05 32.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=86 · 94% clinician | no trial data cached |
| Myelosuppression | 86 | 11.8 9.5–14.5ROR 12.0 · χ² 835 / p 6e-184 | 11.6 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 98% 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.
- Weight fluctuation — n=87, PRR 39.1
- Metastases to liver — n=71, PRR 18.9
- Pneumonitis — n=70, PRR 12.0
- Haematotoxicity — n=24, PRR 12.0
- Myelosuppression — n=86, PRR 11.8
- Metastases to bone — n=37, PRR 10.5
- Thrombocytopenia — n=135, PRR 5.6
- Pancytopenia — n=62, PRR 5.2
- Liver function test increased — n=22, PRR 4.8
- Ascites — n=24, PRR 3.8
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 Sacituzumab Govitecan?
In FDA FAERS, the most frequently co-reported reaction terms for Sacituzumab Govitecan are diarrhoea, neutropenia, asthenia, febrile neutropenia, alopecia, thrombocytopenia. 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 Sacituzumab Govitecan have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment.
Do FAERS signals prove that Sacituzumab Govitecan 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 57a597d2-03f0-472e-b148-016d7169169d, effective 20260624; matched on
openfda.generic_name.exact:"SACITUZUMAB GOVITECAN") - 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, 98 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.