Etoposide side effects: what 73,088 FDA adverse event reports show

Etoposide · 1,244 reaction terms · 234,517 drug–reaction co-reports · data 2026-09-14

Drug class

Topoisomerase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

73,088 reports · 97% serious · 17,814 with death outcome · 41% 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 40 strongest signals

Labeled — boxed warning 1Likely indication confounding 2Lab value / disease marker 1Not in label — unassessed 36

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.
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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,204 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
Lymphoid tissue hypoplasia	144	13,540.8 4,316.3–42,479.5ROR 13,567.6 · calibrated p 5e-21 ✓	267.5 EB05 232.8 · IC025 +6.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=144 · ♀ 0% (drug 41%)	no trial arm names this drug
Thymus hypoplasia	148	1,897.8 1,212.7–2,969.7ROR 1,901.6 · calibrated p 4e-19 ✓	238.9 EB05 208.3 · IC025 +6.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=148 · ♀ 0% (drug 41%)	no trial arm names this drug
Human bocavirus infection	133	682.2 498.3–933.9ROR 683.4 · calibrated p 8e-15 ✓	194.7 EB05 168.5 · IC025 +6.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=133 · ♀ 100% (drug 41%)	no trial arm names this drug
Ovarian germ cell teratoma	37	242.7 156.4–376.7ROR 242.9 · calibrated p 4e-10 ✓	122.8 EB05 93.0 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=37 · ♀ 100% (drug 41%) · 100% clinician	no trial arm names this drug
Basal ganglion degeneration	34	157.2 103.4–239.2ROR 157.3 · calibrated p 1e-8 ✓	96.0 EB05 71.8 · IC025 +4.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=34 · ♀ 100% (drug 41%) · 100% consumer	no trial arm names this drug
Medulloblastoma recurrent	40	154.6 105.1–227.3ROR 154.7 · calibrated p 1e-8 ✓	95.7 EB05 73.3 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=40 · 92% clinician	no trial arm names this drug
Renal salt-wasting syndrome	136	151.0 122.7–186.0ROR 151.3 · calibrated p 6e-9 ✓	97.4 EB05 84.4 · IC025 +5.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=136 · 100% clinician	no trial arm names this drug
Nephroblastoma	42	139.4 96.3–201.7ROR 139.5 · calibrated p 2e-8 ✓	89.9 EB05 69.3 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=42 · 100% clinician	no trial arm names this drug
Cystitis bacterial	110	137.3 109.3–172.4ROR 137.5 · calibrated p 1e-8 ✓	91.3 EB05 77.8 · IC025 +5.7 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=110	no trial arm names this drug
Malignant transformation	138	127.6 104.4–156.0ROR 127.9 · calibrated p 2e-8 ✓	87.2 EB05 75.6 · IC025 +5.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=138 · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma refractory	283	125.7 109.3–144.6ROR 126.2 · calibrated p 2e-8 ✓	86.8 EB05 78.6 · IC025 +6.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=283	no trial arm names this drug
Norovirus test positive	97	122.7 96.7–155.7ROR 122.9 · calibrated p 4e-8 ✓	84.4 EB05 71.2 · IC025 +5.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Lab value / disease marker	serious n=97	no trial arm names this drug
Neuroblastoma recurrent	59	118.9 87.7–161.1ROR 119.0 · calibrated p 6e-8 ✓	81.8 EB05 65.7 · IC025 +5.2 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=59 · ♀ 0% (drug 41%) · 100% clinician	no trial arm names this drug
Teratoma	57	103.1 76.1–139.6ROR 103.2 · calibrated p 2e-7 ✓	74.0 EB05 59.2 · IC025 +5.1 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=57 · ♀ 100% (drug 41%) · 100% clinician	no trial arm names this drug
Treatment related secondary malignancy	53	99.7 72.9–136.3ROR 99.7 · calibrated p 2e-7 ✓	72.1 EB05 57.2 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=53	no trial arm names this drug
Mycobacterium chelonae infection	181	93.5 79.1–110.6ROR 93.7 · calibrated p 2e-7 ✓	70.0 EB05 61.8 · IC025 +5.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=181	no trial arm names this drug
High-grade b-cell lymphoma	45	90.0 64.4–125.9ROR 90.1 · calibrated p 5e-7 ✓	66.6 EB05 51.8 · IC025 +4.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=45 · 100% clinician	no trial arm names this drug
Medulloblastoma	35	87.4 59.8–127.7ROR 87.4 · calibrated p 7e-7 ✓	64.7 EB05 48.6 · IC025 +4.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=34 · 100% clinician	no trial arm names this drug
Refractory cancer	50	86.0 62.7–118.0ROR 86.1 · calibrated p 6e-7 ✓	64.6 EB05 50.9 · IC025 +4.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Likely indication confounding term in indications	serious n=50 · ♀ 0% (drug 41%)	no trial arm names this drug
Disseminated aspergillosis	107	84.8 68.3–105.2ROR 84.9 · calibrated p 5e-7 ✓	64.7 EB05 55.1 · IC025 +5.3 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=107 · ♀ 0% (drug 41%)	no trial arm names this drug
Meningitis tuberculous	125	81.8 67.1–99.8ROR 82.0 · calibrated p 6e-7 ✓	63.1 EB05 54.3 · IC025 +5.4 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=125 · ♀ 0% (drug 41%)	no trial arm names this drug
Ovarian failure	118	80.2 65.4–98.4ROR 80.3 · calibrated p 7e-7 ✓	62.1 EB05 53.2 · IC025 +5.3 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=117 · ♀ 100% (drug 41%) · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma recurrent	464	79.0 71.3–87.6ROR 79.5 · calibrated p 6e-7 ✓	61.8 EB05 57.2 · IC025 +5.7 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=461 · 92% clinician	no trial arm names this drug
Secondary immunodeficiency	255	77.9 67.8–89.4ROR 78.1 · calibrated p 8e-7 ✓	61.0 EB05 54.9 · IC025 +5.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Labeled — boxed warning synonym match	serious n=255 · ♀ 100% (drug 41%)	no trial arm names this drug
Primary hypogonadism	33	76.3 51.9–112.1ROR 76.3 · calibrated p 2e-6 ✓	58.3 EB05 43.5 · IC025 +4.4 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=33 · ♀ 100% (drug 41%) · 100% clinician	no trial arm names this drug
Blood stem cell transplant failure	45	75.6 54.4–105.0ROR 75.6 · calibrated p 2e-6 ✓	58.4 EB05 45.4 · IC025 +4.7 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=45 · ♀ 0% (drug 41%) · 96% clinician	no trial arm names this drug
Abscess bacterial	70	69.8 53.7–90.6ROR 69.8 · calibrated p 2e-6 ✓	55.3 EB05 45.3 · IC025 +4.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=70	no trial arm names this drug
Osteosarcoma	73	67.1 52.0–86.6ROR 67.1 · calibrated p 3e-6 ✓	53.7 EB05 44.1 · IC025 +4.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=73 · 100% clinician	no trial arm names this drug
Sweat gland tumour	44	66.0 47.6–91.7ROR 66.1 · calibrated p 4e-6 ✓	52.5 EB05 40.8 · IC025 +4.6 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=42 · 100% clinician	no trial arm names this drug
T-cell type acute leukaemia	37	62.9 44.0–89.8ROR 62.9 · calibrated p 6e-6 ✓	50.3 EB05 38.1 · IC025 +4.4 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=37 · 100% clinician	no trial arm names this drug
B-cell lymphoma recurrent	95	60.9 48.8–76.0ROR 61.0 · calibrated p 5e-6 ✓	49.8 EB05 41.9 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=95	no trial arm names this drug
Neuroblastoma	66	60.6 46.5–79.1ROR 60.7 · calibrated p 6e-6 ✓	49.4 EB05 40.2 · IC025 +4.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=65 · 94% clinician	no trial arm names this drug
Central nervous system fungal infection	37	59.6 41.8–85.0ROR 59.7 · calibrated p 8e-6 ✓	48.3 EB05 36.6 · IC025 +4.4 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=37 · ♀ 0% (drug 41%) · 95% clinician	no trial arm names this drug
Hepatosplenic t-cell lymphoma	64	59.4 45.4–77.8ROR 59.4 · calibrated p 6e-6 ✓	48.6 EB05 39.4 · IC025 +4.7 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=64 · ♀ 100% (drug 41%) · 92% clinician	no trial arm names this drug
Caecitis	78	59.2 46.3–75.5ROR 59.2 · calibrated p 6e-6 ✓	48.5 EB05 40.1 · IC025 +4.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=75	no trial arm names this drug
Corona virus infection	71	55.8 43.3–72.0ROR 55.8 · calibrated p 9e-6 ✓	46.2 EB05 37.9 · IC025 +4.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=71	no trial arm names this drug
Engraftment syndrome	88	50.5 40.2–63.3ROR 50.5 · calibrated p 2e-5 ✓	42.6 EB05 35.6 · IC025 +4.8 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=88 · 100% clinician	no trial arm names this drug
Neutropenic infection	136	46.9 39.1–56.2ROR 47.0 · calibrated p 2e-5 ✓	40.1 EB05 34.8 · IC025 +4.9 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=136 · 98% clinician	no trial arm names this drug
Pseudomonal sepsis	240	45.2 39.4–51.8ROR 45.3 · calibrated p 3e-5 ✓	39.0 EB05 35.0 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=240	no trial arm names this drug
Central hypothyroidism	42	45.1 32.5–62.4ROR 45.1 · calibrated p 4e-5 ✓	38.4 EB05 29.6 · IC025 +4.2 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Not in label — unassessed	serious n=42 · ♀ 100% (drug 41%) · 93% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Etoposide only as a background or rescue medication (NCT02883049, NCT00025259); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Off label use (used outside approved label)	8,247	2.7 2.7–2.8ROR 3.0 · calibrated p 0.638	2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 37.3 (34.0–40.9)	Reporting / coding artifact	serious PRR 2.9 · 95% clinician	no trial arm names this drug
Febrile neutropenia	7,715	37.8 36.9–38.6ROR 42.1 · calibrated p 4e-5 ✓	33.4 EB05 32.8 · IC025 +5.0 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 21.7 (20.2–23.4)	Labeled (related wording) related wording	serious PRR 19.8 · 94% clinician	no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))	5,063	11.1 10.8–11.4ROR 11.9 · calibrated p 0.018 ✓	10.7 EB05 10.5 · IC025 +3.4 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 14.9 (13.8–16.1)	Labeled adverse reaction exact term	serious PRR 6.5 · 91% clinician	no trial arm names this drug
Drug ineffective (drug did not work)	4,719	1.0 1.0–1.1ROR 1.0 · calibrated p 0.326	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Topoisomerase Inhibitors: only this drug	Reporting / coding artifact	serious PRR 1.7 · 96% clinician	no trial arm names this drug
Disease progression	4,508	11.4 11.0–11.7ROR 12.0 · calibrated p 0.016 ✓	11.0 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 13.7 (12.7–14.8)	Reporting / coding artifact	serious PRR 7.3 · 94% clinician	no trial arm names this drug
Thrombocytopenia (low platelets)	4,107	10.9 10.6–11.3ROR 11.5 · calibrated p 0.019 ✓	10.6 EB05 10.3 · IC025 +3.3 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 13.9 (12.8–15.1)	Labeled adverse reaction exact term	serious PRR 6.4 · 90% clinician	no trial arm names this drug
Pyrexia (fever)	3,430	2.9 2.8–3.0ROR 3.0 · calibrated p 0.642	2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 21.8 (19.5–24.4)	Labeled — boxed warning synonym match	serious PRR 2.1 · 93% clinician	no trial arm names this drug
Anaemia (low red blood cells)	3,359	5.1 5.0–5.3ROR 5.3 · calibrated p 0.202	5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 9.5 (8.8–10.3)	Labeled adverse reaction exact term	serious PRR 3.3	no trial arm names this drug
Sepsis (blood infection)	3,036	8.0 7.7–8.3ROR 8.3 · calibrated p 0.059	7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 51.6 (43.2–61.7)	Not in label — unassessed	serious PRR 4.6 · 94% clinician	no trial arm names this drug
Product use in unapproved indication	2,981	3.5 3.4–3.7ROR 3.6 · calibrated p 0.452	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 19.5 (17.4–21.8)	Reporting / coding artifact	serious PRR 4.5 · 94% clinician	no trial arm names this drug
Death	2,840	0.9 0.9–1.0ROR 0.9 · calibrated p 0.270	0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Topoisomerase Inhibitors: PRR 6.4 (5.9–6.8)	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 0.6	no trial arm names this drug
Pancytopenia (all blood cells low)	2,761	14.9 14.4–15.5ROR 15.5 · calibrated p 0.006 ✓	14.2 EB05 13.8 · IC025 +3.8 3/3 methods agree vs other Topoisomerase Inhibitors: PRR 14.9 (13.4–16.5)	Labeled (related wording) related wording	serious PRR 8.5 · 94% clinician	no trial arm names this drug
Pneumonia (lung infection)	2,511	2.2 2.2–2.3ROR 2.3 · calibrated p 0.911	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Topoisomerase Inhibitors: only this drug	Labeled — boxed warning synonym match	serious PRR 1.4 · 94% clinician	no trial arm names this drug
Nausea	2,484	0.9 0.9–0.9ROR 0.9 · calibrated p 0.243	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Topoisomerase Inhibitors: PRR 12.1 (11.0–13.4)	Labeled adverse reaction exact term	serious PRR 1.0 · 93% clinician	no trial arm names this drug
Diarrhoea (diarrhea)	2,288	1.0 1.0–1.1ROR 1.0 · calibrated p 0.320	1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Topoisomerase Inhibitors: only this drug	Labeled adverse reaction exact term	serious PRR 1.0 · 91% clinician	no trial arm names this drug

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.

Lymphoid tissue hypoplasia — n=144, PRR 13,540.8
Thymus hypoplasia — n=148, PRR 1,897.8
Human bocavirus infection — n=133, PRR 682.2
Ovarian germ cell teratoma — n=37, PRR 242.7
Basal ganglion degeneration — n=34, PRR 157.2
Medulloblastoma recurrent — n=40, PRR 154.6
Renal salt-wasting syndrome — n=136, PRR 151.0
Nephroblastoma — n=42, PRR 139.4
Cystitis bacterial — n=110, PRR 137.3
Malignant transformation — n=138, PRR 127.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Etoposide ↔ Febrile neutropenia.

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 febrile neutropenia, neutropenia, thrombocytopenia, pyrexia, anaemia, sepsis. 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, 1,244 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
ClinicalTrials.gov API v2 (query ETOPOSIDE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.