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Drug · FAERS side-effect profile with label screen

Doxorubicin side effects: what 88,587 FDA adverse event reports show

Doxorubicin · Doxorubicin Hydrochloride · 1,277 reaction terms · 268,568 drug–reaction co-reports · data 2026-09-14

Drug class

Anthracycline topoisomerase inhibitor

FDA label, Indications wording

Brand names

Doxorubicin Hydrochloride

openFDA label

Who reports

88,587 reports · 96% serious · 16,873 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Doxorubicin hydrochloride for injection is an anthracycline topoisomerase inhibitor indicated: as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ).

FDA label, Indications and Usage

What it is

Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius.

FDA label, Description section

Boxed warning

CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride.

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 adverse reaction 1Labeled (related wording) 2Likely indication confounding 19Not in label — unassessed 18

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.
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.
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). 1,237 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
Desmoplastic small round cell tumour	47	273.3 179.3–416.6ROR 273.4 · calibrated p 1e-10 ✓	120.1 EB05 94.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=47 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma recurrent	1,127	264.0 242.4–287.4ROR 267.4 · calibrated p 3e-11 ✓	123.9 EB05 118.0 · IC025 +6.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,123	no trial arm names this drug
B-cell lymphoma refractory	44	227.4 150.1–344.6ROR 227.5 · calibrated p 6e-10 ✓	110.1 EB05 85.4 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=44 · ♀ 0% (drug 54%)	no trial arm names this drug
B-cell lymphoma recurrent	244	195.0 164.5–231.2ROR 195.6 · calibrated p 6e-10 ✓	105.7 EB05 95.0 · IC025 +6.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=244	no trial arm names this drug
Diffuse large b-cell lymphoma refractory	348	142.0 124.3–162.2ROR 142.6 · calibrated p 8e-9 ✓	88.1 EB05 80.6 · IC025 +6.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=348 · 91% clinician	no trial arm names this drug
Mantle cell lymphoma recurrent	147	123.9 101.4–151.3ROR 124.1 · calibrated p 3e-8 ✓	80.4 EB05 70.0 · IC025 +5.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=147 · ♀ 31% (drug 54%) · 95% clinician	no trial arm names this drug
Follicular lymphoma	233	89.0 76.5–103.5ROR 89.2 · calibrated p 3e-7 ✓	64.3 EB05 57.7 · IC025 +5.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=228 · 93% clinician	no trial arm names this drug
High-grade b-cell lymphoma	48	80.9 58.3–112.3ROR 80.9 · calibrated p 1e-6 ✓	58.9 EB05 46.2 · IC025 +4.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=48 · 100% clinician	no trial arm names this drug
Refractory cancer	55	80.5 59.2–109.3ROR 80.5 · calibrated p 1e-6 ✓	58.9 EB05 46.9 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=55 · ♀ 0% (drug 54%)	no trial arm names this drug
Lymphoma transformation	91	79.9 62.9–101.3ROR 79.9 · calibrated p 8e-7 ✓	59.0 EB05 49.5 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=91	no trial arm names this drug
Central hypothyroidism	77	78.5 60.7–101.7ROR 78.6 · calibrated p 1e-6 ✓	58.2 EB05 48.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=77	no trial arm names this drug
Meningitis tuberculous	121	64.7 52.9–79.1ROR 64.8 · calibrated p 3e-6 ✓	50.5 EB05 43.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=121 · ♀ 0% (drug 54%) · 92% clinician	no trial arm names this drug
Diffuse large b-cell lymphoma stage iv	67	61.8 47.2–81.0ROR 61.9 · calibrated p 5e-6 ✓	48.4 EB05 39.5 · IC025 +4.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=67 · ♀ 0% (drug 54%) · 93% clinician	no trial arm names this drug
Hepatitis b reactivation	606	55.7 51.0–60.8ROR 56.1 · calibrated p 7e-6 ✓	45.1 EB05 42.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=597	no trial arm names this drug
Neutropenic infection	179	53.7 45.7–63.2ROR 53.8 · calibrated p 1e-5 ✓	43.6 EB05 38.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=178 · ♀ 78% (drug 54%) · 97% clinician	no trial arm names this drug
Remission not achieved	102	46.5 37.6–57.5ROR 46.6 · calibrated p 3e-5 ✓	38.7 EB05 32.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=102 · 100% consumer	no trial arm names this drug
Anaplastic large-cell lymphoma	39	46.0 32.7–64.9ROR 46.1 · calibrated p 4e-5 ✓	37.9 EB05 29.0 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=38 · ♀ 0% (drug 54%)	no trial arm names this drug
Diffuse large b-cell lymphoma	1,209	44.5 41.8–47.3ROR 45.1 · calibrated p 3e-5 ✓	37.5 EB05 35.7 · IC025 +5.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 22.6 · 93% clinician	no trial arm names this drug
Plasmablastic lymphoma	55	43.1 32.3–57.4ROR 43.1 · calibrated p 5e-5 ✓	36.1 EB05 28.8 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=55 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Myeloid leukaemia	77	42.4 33.3–54.1ROR 42.5 · calibrated p 5e-5 ✓	35.8 EB05 29.5 · IC025 +4.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=77 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Ovarian failure	82	42.3 33.4–53.5ROR 42.3 · calibrated p 5e-5 ✓	35.7 EB05 29.6 · IC025 +4.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=82 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Osteosarcoma	55	39.4 29.6–52.4ROR 39.4 · calibrated p 8e-5 ✓	33.5 EB05 26.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=55 · 100% clinician	no trial arm names this drug
Central nervous system lymphoma	193	38.6 33.2–45.0ROR 38.7 · calibrated p 7e-5 ✓	33.2 EB05 29.4 · IC025 +4.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=193 · ♀ 30% (drug 54%) · 95% clinician	no trial arm names this drug
Febrile neutropenia	9,167	37.9 37.2–38.8ROR 42.2 · calibrated p 4e-5 ✓	32.8 EB05 32.2 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 28.6 · serious PRR 19.6 · 97% clinician	no trial arm names this drug
Cardiotoxicity	1,221	37.7 35.5–40.1ROR 38.2 · calibrated p 7e-5 ✓	32.6 EB05 31.1 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.7 · 97% clinician	no trial arm names this drug
Peripheral t-cell lymphoma unspecified	80	37.3 29.5–47.2ROR 37.3 · calibrated p 1e-4 ✓	32.1 EB05 26.6 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=79 · ♀ 27% (drug 54%) · 96% clinician	no trial arm names this drug
Anaplastic large cell lymphoma t- and null-cell types	36	34.9 24.6–49.5ROR 34.9 · calibrated p 2e-4 ✓	30.0 EB05 22.7 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=36	no trial arm names this drug
Haematotoxicity	1,177	34.3 32.3–36.5ROR 34.8 · calibrated p 1e-4 ✓	30.0 EB05 28.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.4 · 99% clinician	no trial arm names this drug
Humoral immune defect	47	34.2 25.2–46.4ROR 34.2 · calibrated p 2e-4 ✓	29.6 EB05 23.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=37 · 100% clinician	no trial arm names this drug
Epstein-barr virus associated lymphoma	72	32.8 25.6–41.9ROR 32.8 · calibrated p 2e-4 ✓	28.7 EB05 23.5 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=72 · ♀ 32% (drug 54%) · 94% clinician	no trial arm names this drug
Congenital aplasia	35	32.4 22.8–46.2ROR 32.4 · calibrated p 3e-4 ✓	28.2 EB05 21.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=35 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Smooth muscle cell neoplasm	48	30.9 22.9–41.8ROR 30.9 · calibrated p 3e-4 ✓	27.2 EB05 21.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Malignant transformation	51	30.3 22.6–40.5ROR 30.3 · calibrated p 3e-4 ✓	26.7 EB05 21.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=51 · 100% clinician	no trial arm names this drug
Her2 positive breast cancer	41	29.5 21.3–40.9ROR 29.5 · calibrated p 4e-4 ✓	26.0 EB05 20.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious n=41 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Plasma cell leukaemia	66	29.2 22.6–37.8ROR 29.3 · calibrated p 4e-4 ✓	25.9 EB05 21.1 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=66 · 92% clinician	no trial arm names this drug
Acquired gene mutation	144	28.9 24.3–34.4ROR 28.9 · calibrated p 3e-4 ✓	25.7 EB05 22.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=139 · ♀ 26% (drug 54%) · 97% clinician	no trial arm names this drug
Azoospermia	42	28.6 20.8–39.5ROR 28.7 · calibrated p 5e-4 ✓	25.4 EB05 19.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=42 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Computerised tomogram thorax abnormal	75	28.5 22.4–36.2ROR 28.5 · calibrated p 4e-4 ✓	25.3 EB05 20.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=75 · ♀ 100% (drug 54%) · 94% clinician	no trial arm names this drug
Neutropenic colitis	214	27.4 23.8–31.5ROR 27.4 · calibrated p 4e-4 ✓	24.5 EB05 21.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=213 · 97% clinician	no trial arm names this drug
Pseudomonal bacteraemia	81	25.2 20.1–31.7ROR 25.2 · calibrated p 7e-4 ✓	22.7 EB05 18.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=81 · ♀ 27% (drug 54%) · 100% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Neutropenia / agranulocytosis	15,769	16.015.8–16.3	signal
Thrombocytopenia	5,089	5.65.4–5.7	signal
Interstitial lung disease	1,889	4.74.5–5.0	signal
Opportunistic infection	2,244	3.93.8–4.1	signal
Anaemia	4,655	3.73.6–3.8	signal
Heart failure	2,318	3.13.0–3.2	signal
Serious infection	9,200	2.82.8–2.9	signal
Liver injury	3,047	2.42.3–2.5	signal
Hyponatraemia	763	2.32.1–2.4	signal
Venous thromboembolism	1,879	2.12.0–2.2	raised
Arrhythmia / qt	1,359	1.71.6–1.8	raised
Kidney injury	3,186	1.71.6–1.7	raised
Osteonecrosis	311	1.31.1–1.4	raised
Pancreatitis	422	1.21.1–1.4	raised
Gi bleeding	853	1.11.0–1.2	raised
Seizure	655	0.80.7–0.9	lower than other drugs

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Doxorubicin only as a background or rescue medication (NCT01190930, NCT02883049); 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
Febrile neutropenia	9,167	37.9 37.2–38.8ROR 42.2 · calibrated p 4e-5 ✓	32.8 EB05 32.2 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 28.6 · serious PRR 19.6 · 97% clinician	no trial arm names this drug
Off label use (used outside approved label)	8,867	2.4 2.4–2.5ROR 2.6 · calibrated p 0.774	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 2.6 · 95% clinician	no trial arm names this drug
Disease progression	6,508	13.8 13.4–14.1ROR 14.8 · calibrated p 0.007 ✓	13.1 EB05 12.8 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 11.0 · serious PRR 8.8 · 96% clinician	no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))	6,449	11.8 11.5–12.1ROR 12.6 · calibrated p 0.014 ✓	11.3 EB05 11.0 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 8.9 · serious PRR 6.9 · 97% clinician	no trial arm names this drug
Drug ineffective (drug did not work)	5,229	0.9 0.9–1.0ROR 0.9 · calibrated p 0.265	0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 1.3 · serious PRR 1.6 · 96% clinician	no trial arm names this drug
Pyrexia (fever)	4,098	2.8 2.7–2.9ROR 2.9 · calibrated p 0.655	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 2.3 · serious PRR 2.1 · 94% clinician	no trial arm names this drug
Anaemia (low red blood cells)	3,819	4.8 4.7–5.0ROR 5.0 · calibrated p 0.236	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.7 · serious PRR 3.1 · 96% clinician	no trial arm names this drug
Thrombocytopenia (low platelets)	3,812	8.3 8.1–8.6ROR 8.7 · calibrated p 0.052	8.1 EB05 7.9 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.0 · serious PRR 5.0 · 97% clinician	no trial arm names this drug
Nausea	3,179	1.0 0.9–1.0ROR 1.0 · calibrated p 0.276	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 1.1 · 92% clinician	no trial arm names this drug
Death	3,125	0.9 0.8–0.9ROR 0.9 · calibrated p 0.215	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction boxed warning mentions mortality	age-adj. PRR 0.6 · serious PRR 0.5 · 94% clinician	no trial arm names this drug
Product use in unapproved indication	2,995	2.9 2.8–3.0ROR 3.0 · calibrated p 0.628	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.6 · serious PRR 3.8 · 96% clinician	no trial arm names this drug
Pneumonia (lung infection)	2,890	2.1 2.1–2.2ROR 2.2 · calibrated p 0.969	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 2.0 · serious PRR 1.3 · 96% clinician	no trial arm names this drug
Sepsis (blood infection)	2,845	6.2 5.9–6.4ROR 6.3 · calibrated p 0.130	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 4.7 · serious PRR 3.6 · 95% clinician	no trial arm names this drug
Diarrhoea (diarrhea)	2,738	1.0 1.0–1.0ROR 1.0 · calibrated p 0.312	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 1.0 · 95% clinician	no trial arm names this drug
Vomiting	2,604	1.3 1.3–1.4ROR 1.3 · calibrated p 0.526	1.3 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.0 · serious PRR 1.1 · 93% 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.

Desmoplastic small round cell tumour — n=47, PRR 273.3
Refractory cancer — n=55, PRR 80.5
Central hypothyroidism — n=77, PRR 78.5
Meningitis tuberculous — n=121, PRR 64.7
Hepatitis b reactivation — n=606, PRR 55.7
Neutropenic infection — n=179, PRR 53.7
Remission not achieved — n=102, PRR 46.5
Osteosarcoma — n=55, PRR 39.4
Haematotoxicity — n=1,177, PRR 34.3
Humoral immune defect — n=47, PRR 34.2

✓ A hand-written Bradford Hill causality assessment exists for this drug: Doxorubicin (anthracyclines) ↔ Cardiotoxicity / cardiomyopathy.

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 Doxorubicin?

In FDA FAERS, the most frequently co-reported reaction terms for Doxorubicin are febrile neutropenia, neutropenia, pyrexia, anaemia, thrombocytopenia, nausea. 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 Doxorubicin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride.

Do FAERS signals prove that Doxorubicin 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 d928625e-c1ef-4f25-8d25-764c8c6aab67, effective 20240529; matched on openfda.generic_name.exact:"DOXORUBICIN")
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, 1,277 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 DOXORUBICIN, 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.