Etoposide Phosphate side effects: what 1,605 FDA adverse event reports show

Etoposide Phosphate · 63 reaction terms · 1,362 drug–reaction co-reports · data 2026-09-14

Drug class

Topoisomerase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,605 reports · 91% serious · 283 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Etoposide Injection is indicated in the management of the following neoplasms: Refractory Testicular Tumors Etoposide Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.

FDA label, Indications and Usage

What it is

DESCRIPTION Etoposide Injection, USP (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside].

FDA label, Description section

Boxed warning

Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

FDA label

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 39 strongest signals

Labeled adverse reaction 3Labeled (related wording) 4Reporting / coding artifact 7Lab value / disease marker 3Not in label — unassessed 22

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. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Urosepsis	19	27.0 17.2–42.2ROR 27.3 · χ² 449 / p 6e-100	26.3 EB05 17.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.1	no trial data cached
Bone marrow failure	42	26.9 19.9–36.2ROR 27.6 · χ² 1,019 / p 6e-224	26.5 EB05 20.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Mucosal inflammation	51	25.6 19.5–33.6ROR 26.4 · χ² 1,181 / p 4e-259	25.4 EB05 20.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.2 · 92% clinician	no trial data cached
Blood lactate dehydrogenase increased	30	24.6 17.3–35.1ROR 25.1 · χ² 656 / p 6e-145	24.2 EB05 17.8 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 16.6 · 97% clinician	no trial data cached
Myelodysplastic syndrome	26	23.5 16.1–34.4ROR 23.9 · χ² 537 / p 3e-119	23.1 EB05 16.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.0 · ♀ 12% (drug 43%) · 96% clinician	no trial data cached
Encephalopathy	41	21.9 16.2–29.6ROR 22.5 · χ² 797 / p 1e-175	21.7 EB05 16.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.9	no trial data cached
Disease progression	163	18.1 15.6–20.9ROR 20.0 · χ² 2,624 / p <1e-300	18.0 EB05 15.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8 · 98% clinician	no trial data cached
Cytopenia	16	17.5 10.8–28.5ROR 17.7 · χ² 233 / p 8e-53	16.9 EB05 10.6 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4	no trial data cached
Multiple organ dysfunction syndrome	37	17.3 12.6–23.9ROR 17.7 · χ² 554 / p 1e-122	17.1 EB05 12.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Hepatotoxicity (liver damage)	25	14.7 10.0–21.8ROR 15.0 · χ² 307 / p 5e-69	14.3 EB05 9.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 87% (drug 43%)	no trial data cached
Agranulocytosis (severe loss of white cells)	20	14.1 9.2–21.9ROR 14.3 · χ² 231 / p 2e-52	13.5 EB05 8.8 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.0	no trial data cached
Septic shock	44	13.3 9.9–17.8ROR 13.7 · χ² 489 / p 1e-108	13.1 EB05 10.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · ♀ 21% (drug 43%)	no trial data cached
Acute respiratory distress syndrome	18	13.3 8.4–21.1ROR 13.4 · χ² 193 / p 4e-44	12.5 EB05 7.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Pancytopenia (all blood cells low)	56	13.1 10.2–17.0ROR 13.6 · χ² 617 / p 2e-136	12.9 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.4 · ♀ 66% (drug 43%)	no trial data cached
Cytokine release syndrome	19	13.0 8.3–20.4ROR 13.2 · χ² 199 / p 1e-45	12.2 EB05 7.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Febrile neutropenia	65	12.8 10.1–16.3ROR 13.3 · χ² 699 / p 2e-154	12.7 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1 · 95% clinician	no trial data cached
Incorrect product storage	13	12.8 7.4–21.9ROR 12.8 · χ² 129 / p 3e-30	11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Therapy partial responder	13	11.3 6.6–19.4ROR 11.4 · χ² 112 / p 2e-26	9.7 EB05 5.5 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.6	no trial data cached
Blood bilirubin increased	22	10.6 7.0–16.1ROR 10.8 · χ² 182 / p 8e-42	9.7 EB05 6.4 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 7.7	no trial data cached
Cardiomyopathy	12	10.6 6.0–18.6ROR 10.7 · χ² 95 / p 1e-22	8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Hypomagnesaemia	11	10.4 5.8–18.7ROR 10.4 · χ² 84 / p 3e-20	8.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Mass	11	10.3 5.7–18.5ROR 10.3 · χ² 83 / p 4e-20	8.4 EB05 4.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Hepatocellular injury	11	10.1 5.6–18.2ROR 10.2 · χ² 81 / p 9e-20	8.2 EB05 4.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Thrombocytopenia (low platelets)	82	9.6 7.8–11.9ROR 10.1 · χ² 627 / p 1e-138	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 91% clinician	no trial data cached
Respiratory distress	20	9.5 6.1–14.6ROR 9.6 · χ² 143 / p 3e-33	8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Ascites	21	9.3 6.1–14.3ROR 9.4 · χ² 148 / p 2e-34	8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Product storage error	61	9.2 7.2–11.8ROR 9.5 · χ² 440 / p 5e-98	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	95% clinician	no trial data cached
Hemiparesis	12	9.2 5.2–16.2ROR 9.3 · χ² 80 / p 2e-19	7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Ejection fraction decreased	10	8.4 4.5–15.6ROR 8.4 · χ² 58 / p 1e-14	6.5 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 5.8	no trial data cached
Cholestasis (bile flow blockage)	11	7.5 4.2–13.6ROR 7.6 · χ² 56 / p 4e-14	6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Malignant neoplasm progression	56	7.2 5.6–9.3ROR 7.4 · χ² 293 / p 5e-66	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Neoplasm progression	19	7.1 4.5–11.1ROR 7.1 · χ² 93 / p 2e-22	6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Disease recurrence	24	6.6 4.4–9.8ROR 6.7 · χ² 108 / p 1e-25	5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.9 · 92% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	61	5.9 4.6–7.5ROR 6.1 · χ² 244 / p 3e-55	5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9 · 95% clinician	no trial data cached
Electrocardiogram qt prolonged	16	5.8 3.6–9.5ROR 5.9 · χ² 59 / p 8e-15	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Liver function test abnormal	13	5.8 3.4–10.0ROR 5.8 · χ² 47 / p 3e-12	4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Hepatic failure	13	5.6 3.3–9.7ROR 5.7 · χ² 45 / p 1e-11	4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Coma	20	5.5 3.5–8.5ROR 5.5 · χ² 69 / p 5e-17	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.5 · ♀ 100% (drug 43%)	no trial data cached
Visual acuity reduced	10	3.9 2.1–7.2ROR 3.9 · χ² 19 / p 7e-6	3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	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
Disease progression	163	18.1 15.6–20.9ROR 20.0 · χ² 2,624 / p <1e-300	18.0 EB05 15.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8 · 98% clinician	no trial data cached
Thrombocytopenia (low platelets)	82	9.6 7.8–11.9ROR 10.1 · χ² 627 / p 1e-138	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 91% clinician	no trial data cached
Febrile neutropenia	65	12.8 10.1–16.3ROR 13.3 · χ² 699 / p 2e-154	12.7 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.1 · 95% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	61	5.9 4.6–7.5ROR 6.1 · χ² 244 / p 3e-55	5.6 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9 · 95% clinician	no trial data cached
Product storage error	61	9.2 7.2–11.8ROR 9.5 · χ² 440 / p 5e-98	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	95% clinician	no trial data cached
Malignant neoplasm progression	56	7.2 5.6–9.3ROR 7.4 · χ² 293 / p 5e-66	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Pancytopenia (all blood cells low)	56	13.1 10.2–17.0ROR 13.6 · χ² 617 / p 2e-136	12.9 EB05 10.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.4 · ♀ 66% (drug 43%)	no trial data cached
Mucosal inflammation	51	25.6 19.5–33.6ROR 26.4 · χ² 1,181 / p 4e-259	25.4 EB05 20.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.2 · 92% clinician	no trial data cached
Septic shock	44	13.3 9.9–17.8ROR 13.7 · χ² 489 / p 1e-108	13.1 EB05 10.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · ♀ 21% (drug 43%)	no trial data cached
Bone marrow failure	42	26.9 19.9–36.2ROR 27.6 · χ² 1,019 / p 6e-224	26.5 EB05 20.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.0	no trial data cached
Encephalopathy	41	21.9 16.2–29.6ROR 22.5 · χ² 797 / p 1e-175	21.7 EB05 16.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.9	no trial data cached
Multiple organ dysfunction syndrome	37	17.3 12.6–23.9ROR 17.7 · χ² 554 / p 1e-122	17.1 EB05 12.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Blood lactate dehydrogenase increased	30	24.6 17.3–35.1ROR 25.1 · χ² 656 / p 6e-145	24.2 EB05 17.8 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 16.6 · 97% clinician	no trial data cached
Myelodysplastic syndrome	26	23.5 16.1–34.4ROR 23.9 · χ² 537 / p 3e-119	23.1 EB05 16.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.0 · ♀ 12% (drug 43%) · 96% clinician	no trial data cached
Hepatotoxicity (liver damage)	25	14.7 10.0–21.8ROR 15.0 · χ² 307 / p 5e-69	14.3 EB05 9.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 87% (drug 43%)	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 marrow failure — n=42, PRR 26.9
Myelodysplastic syndrome — n=26, PRR 23.5
Encephalopathy — n=41, PRR 21.9
Multiple organ dysfunction syndrome — n=37, PRR 17.3
Hepatotoxicity — n=25, PRR 14.7
Septic shock — n=44, PRR 13.3
Respiratory distress — n=20, PRR 9.5
Ascites — n=21, PRR 9.3
Coma — n=20, PRR 5.5

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 Etoposide?

In FDA FAERS, the most frequently co-reported reaction terms for Etoposide are thrombocytopenia, febrile neutropenia, neutropenia, pancytopenia, mucosal inflammation, septic shock. 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 Etoposide have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Etoposide injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

Do FAERS signals prove that Etoposide 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 0dddbe44-b4f4-431f-9011-8a54abbd4cbf, effective 20260520; matched on openfda.generic_name.exact:"ETOPOSIDE")
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, field patient.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.