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Drug · FAERS side-effect profile with label screen

Paclitaxel (Aibumin-Bound) side effects: what 81,715 FDA adverse event reports show

Paclitaxel (Aibumin-Bound) · Paclitaxel · 1,277 reaction terms · 251,295 drug–reaction co-reports · data 2026-09-14

Drug class

Microtubule Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Paclitaxel

openFDA label

Who reports

81,715 reports · 97% serious · 11,389 with death outcome · 74% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

FDA label, Indications and Usage

What it is

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor.

FDA label, Description section

Boxed warning

SEVERE MYELOSUPPRESSION Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ].

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 1Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 2Not in label — unassessed 32

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.
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
Computerised tomogram thorax	39	468.4 275.6–796.1ROR 468.6 · calibrated p 3e-12 ✓	152.4 EB05 116.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=39 · ♀ 100% (drug 74%) · 100% clinician	no trial arm names this drug
Pseudocirrhosis	129	166.8 133.6–208.4ROR 167.1 · calibrated p 3e-9 ✓	99.4 EB05 85.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=129 · ♀ 100% (drug 74%) · 96% clinician	no trial arm names this drug
Cervix carcinoma recurrent	45	92.3 65.6–129.8ROR 92.3 · calibrated p 4e-7 ✓	66.0 EB05 51.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 100% (drug 74%) · 100% clinician	no trial arm names this drug
Urogenital fistula	61	90.5 67.6–121.2ROR 90.6 · calibrated p 4e-7 ✓	65.6 EB05 52.9 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=61 · ♀ 100% (drug 74%) · 100% clinician	no trial arm names this drug
Pik3ca-activated mutation	72	72.6 55.9–94.4ROR 72.7 · calibrated p 2e-6 ✓	55.8 EB05 45.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=72 · 94% clinician	no trial arm names this drug
Immune-mediated adrenal insufficiency	164	71.2 59.9–84.7ROR 71.3 · calibrated p 2e-6 ✓	55.4 EB05 48.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=164 · 100% clinician	no trial arm names this drug
Immune-mediated hyperthyroidism	51	69.5 51.0–94.8ROR 69.6 · calibrated p 3e-6 ✓	53.7 EB05 42.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=51 · 100% clinician	no trial arm names this drug
Nail toxicity	63	68.8 52.1–90.9ROR 68.8 · calibrated p 3e-6 ✓	53.4 EB05 43.2 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious n=61 · ♀ 100% (drug 74%) · 94% clinician	no trial arm names this drug
Her2 positive breast cancer	63	52.8 40.2–69.3ROR 52.8 · calibrated p 1e-5 ✓	43.3 EB05 35.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=63 · ♀ 100% (drug 74%) · 100% clinician	no trial arm names this drug
Immune-mediated dermatitis	142	45.8 38.3–54.8ROR 45.9 · calibrated p 3e-5 ✓	38.7 EB05 33.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=142 · 97% clinician	no trial arm names this drug
Hepatic atrophy	68	45.6 35.2–59.1ROR 45.7 · calibrated p 3e-5 ✓	38.4 EB05 31.3 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=68 · ♀ 100% (drug 74%)	no trial arm names this drug
Immune-mediated hypothyroidism	161	45.1 38.2–53.3ROR 45.2 · calibrated p 3e-5 ✓	38.3 EB05 33.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=161 · 100% clinician	no trial arm names this drug
Immune-mediated hypophysitis	60	41.7 31.7–54.8ROR 41.7 · calibrated p 6e-5 ✓	35.5 EB05 28.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=60 · 100% clinician	no trial arm names this drug
Delusion of grandeur	56	36.6 27.6–48.4ROR 36.6 · calibrated p 1e-4 ✓	31.8 EB05 25.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=56 · ♀ 0% (drug 74%)	no trial arm names this drug
Immune-mediated pancreatitis	46	36.5 26.8–49.7ROR 36.5 · calibrated p 1e-4 ✓	31.6 EB05 24.7 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=46 · 100% clinician	no trial arm names this drug
Immune-mediated lung disease	214	35.7 31.0–41.2ROR 35.8 · calibrated p 1e-4 ✓	31.3 EB05 28.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=214 · ♀ 45% (drug 74%) · 100% clinician	no trial arm names this drug
Radiation oesophagitis	46	35.3 25.9–48.0ROR 35.3 · calibrated p 2e-4 ✓	30.7 EB05 24.0 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=46 · ♀ 0% (drug 74%) · 100% clinician	no trial arm names this drug
Metastases to the mediastinum	50	35.0 26.1–47.1ROR 35.1 · calibrated p 2e-4 ✓	30.6 EB05 24.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Glucocorticoid deficiency	49	34.2 25.4–46.1ROR 34.3 · calibrated p 2e-4 ✓	29.9 EB05 23.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 100% (drug 74%) · 94% clinician	no trial arm names this drug
Immune-mediated hepatic disorder	220	33.3 28.9–38.3ROR 33.4 · calibrated p 2e-4 ✓	29.5 EB05 26.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=219 · 100% clinician	no trial arm names this drug
Computerised tomogram thorax abnormal	80	33.2 26.3–41.9ROR 33.2 · calibrated p 2e-4 ✓	29.3 EB05 24.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=80 · ♀ 100% (drug 74%) · 95% clinician	no trial arm names this drug
Cystoid macular oedema	203	31.3 27.1–36.2ROR 31.4 · calibrated p 2e-4 ✓	27.9 EB05 24.8 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=203 · 97% clinician	no trial arm names this drug
Immune-mediated hepatitis	207	30.2 26.1–34.8ROR 30.2 · calibrated p 3e-4 ✓	27.0 EB05 24.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=207 · 99% clinician	no trial arm names this drug
Immune-mediated encephalitis	52	30.0 22.5–40.0ROR 30.0 · calibrated p 3e-4 ✓	26.7 EB05 21.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=52 · 100% clinician	no trial arm names this drug
Myelosuppression	3,421	28.6 27.6–29.6ROR 29.8 · calibrated p 3e-4 ✓	25.8 EB05 25.1 · IC025 +4.6 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 20.5 · serious PRR 15.3 · 96% clinician	no trial arm names this drug
Adrenocorticotropic hormone deficiency	86	28.0 22.4–35.0ROR 28.0 · calibrated p 4e-4 ✓	25.2 EB05 21.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=86 · 100% clinician	no trial arm names this drug
Immune-mediated thyroiditis	46	27.8 20.5–37.7ROR 27.8 · calibrated p 5e-4 ✓	24.9 EB05 19.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=46 · 100% clinician	no trial arm names this drug
Onycholysis	152	27.8 23.5–32.8ROR 27.8 · calibrated p 4e-4 ✓	25.0 EB05 21.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=148 · 97% clinician	no trial arm names this drug
Bronchopleural fistula	37	27.7 19.7–38.9ROR 27.7 · calibrated p 6e-4 ✓	24.8 EB05 18.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=36 · 100% clinician	no trial arm names this drug
Metastases to skin	100	27.7 22.5–34.0ROR 27.7 · calibrated p 5e-4 ✓	24.9 EB05 21.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=99 · 93% clinician	no trial arm names this drug
Immune-mediated nephritis	44	27.5 20.2–37.6ROR 27.6 · calibrated p 6e-4 ✓	24.7 EB05 19.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=44 · 100% clinician	no trial arm names this drug
Triple negative breast cancer	60	27.0 20.7–35.2ROR 27.0 · calibrated p 6e-4 ✓	24.3 EB05 19.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=60 · ♀ 100% (drug 74%) · 100% clinician	no trial arm names this drug
Metastases to pleura	99	26.9 21.8–33.1ROR 26.9 · calibrated p 5e-4 ✓	24.3 EB05 20.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=99 · 93% clinician	no trial arm names this drug
Immune-mediated renal disorder	36	25.9 18.4–36.6ROR 26.0 · calibrated p 8e-4 ✓	23.4 EB05 17.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=36 · 100% clinician	no trial arm names this drug
Peripheral sensory neuropathy	530	25.5 23.3–27.9ROR 25.7 · calibrated p 6e-4 ✓	23.2 EB05 21.6 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious n=524 · 96% clinician	no trial arm names this drug
Radiation pneumonitis	182	23.7 20.4–27.6ROR 23.8 · calibrated p 9e-4 ✓	21.7 EB05 19.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=180 · ♀ 42% (drug 74%) · 91% clinician	no trial arm names this drug
Ovarian cancer recurrent	135	23.6 19.8–28.1ROR 23.6 · calibrated p 1e-3 ✓	21.6 EB05 18.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=135 · ♀ 100% (drug 74%) · 95% clinician	no trial arm names this drug
Metastases to peritoneum	205	22.8 19.8–26.3ROR 22.9 · calibrated p 0.001 ✓	21.0 EB05 18.7 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=205 · 94% clinician	no trial arm names this drug
Infusion related hypersensitivity reaction	47	22.6 16.8–30.5ROR 22.6 · calibrated p 0.001 ✓	20.7 EB05 16.2 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=43 · 100% clinician	no trial arm names this drug
Immune-mediated enterocolitis	284	22.4 19.9–25.3ROR 22.5 · calibrated p 0.001 ✓	20.6 EB05 18.7 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=284 · 99% 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	8,879	9.59.3–9.7	signal
Interstitial lung disease	2,677	7.37.1–7.6	signal
Thrombocytopenia	3,721	4.44.3–4.5	signal
Anaemia	4,677	4.03.9–4.2	signal
Anaphylaxis / angioedema	1,483	3.12.9–3.2	signal
Hyponatraemia	926	3.02.8–3.2	signal
Liver injury	3,212	2.82.7–2.8	signal
Severe cutaneous reaction	653	2.32.1–2.4	signal
Heart failure	1,491	2.12.0–2.3	signal
Venous thromboembolism	1,696	2.01.9–2.1	raised
Osteonecrosis	417	1.91.7–2.0	raised
Serious infection	4,839	1.61.6–1.7	raised
Kidney injury	2,644	1.51.4–1.5	raised
Rhabdomyolysis / myopathy	412	1.31.2–1.4	raised
Gi bleeding	771	1.11.0–1.2	raised
Arrhythmia / qt	807	1.11.0–1.1	no difference

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Paclitaxel (Aibumin-Bound) (searched PACLITAXEL (AIBUMIN-BOUND).

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
Nausea	4,618	1.5 1.5–1.5ROR 1.5 · calibrated p 0.665	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.7 · 93% clinician	no trial arm names this drug
Dyspnoea (shortness of breath)	4,592	2.1 2.0–2.2ROR 2.2 · calibrated p 0.973	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 1.9 · serious PRR 1.7 · 94% clinician	no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))	4,492	8.8 8.5–9.0ROR 9.2 · calibrated p 0.042 ✓	8.5 EB05 8.3 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 6.4 · serious PRR 5.2 · 95% clinician	no trial arm names this drug
Off label use (used outside approved label)	4,421	1.3 1.3–1.3ROR 1.3 · calibrated p 0.526	1.3 EB05 1.3 · IC025 +0.3	Reporting / coding artifact	age-adj. PRR 1.2 · serious PRR 1.4 · 92% clinician	no trial arm names this drug
Diarrhoea (diarrhea)	4,266	1.7 1.7–1.8ROR 1.7 · calibrated p 0.797	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.7 · 93% clinician	no trial arm names this drug
Anaemia (low red blood cells)	3,941	5.4 5.2–5.6ROR 5.6 · calibrated p 0.178	5.3 EB05 5.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.1 · serious PRR 3.4 · 95% clinician	no trial arm names this drug
Malignant neoplasm progression	3,781	9.9 9.5–10.2ROR 10.3 · calibrated p 0.029 ✓	9.5 EB05 9.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 8.1 · serious PRR 5.8	no trial arm names this drug
Myelosuppression	3,421	28.6 27.6–29.6ROR 29.8 · calibrated p 3e-4 ✓	25.8 EB05 25.1 · IC025 +4.6 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 20.5 · serious PRR 15.3 · 96% clinician	no trial arm names this drug
Disease progression	3,418	7.6 7.4–7.9ROR 7.9 · calibrated p 0.069	7.4 EB05 7.2 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 6.4 · serious PRR 5.0 · 96% clinician	no trial arm names this drug
Fatigue (tiredness)	3,395	1.1 1.1–1.2ROR 1.1 · calibrated p 0.391	1.1 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	age-adj. PRR 0.9 · serious PRR 1.2 · 91% clinician	no trial arm names this drug
Neuropathy peripheral (nerve damage in hands/feet)	3,277	9.2 8.9–9.5ROR 9.5 · calibrated p 0.038 ✓	8.9 EB05 8.6 · IC025 +3.1 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 8.2 · serious PRR 6.1 · 92% clinician	no trial arm names this drug
Pyrexia (fever)	3,156	2.4 2.3–2.4ROR 2.4 · calibrated p 0.854	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 1.7 · 93% clinician	no trial arm names this drug
Vomiting	3,117	1.7 1.7–1.8ROR 1.7 · calibrated p 0.793	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.5 · 93% clinician	no trial arm names this drug
Febrile neutropenia	3,112	12.6 12.2–13.1ROR 13.1 · calibrated p 0.012 ✓	12.1 EB05 11.7 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 9.8 · serious PRR 7.2 · 94% clinician	no trial arm names this drug
Drug ineffective (drug did not work)	2,592	0.5 0.5–0.5ROR 0.5 · calibrated p 0.045 ✓	0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.6 · serious PRR 0.8 · 95% 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.

Computerised tomogram thorax — n=39, PRR 468.4
Pseudocirrhosis — n=129, PRR 166.8
Cervix carcinoma recurrent — n=45, PRR 92.3
Urogenital fistula — n=61, PRR 90.5
Pik3ca-activated mutation — n=72, PRR 72.6
Immune-mediated adrenal insufficiency — n=164, PRR 71.2
Immune-mediated hyperthyroidism — n=51, PRR 69.5
Her2 positive breast cancer — n=63, PRR 52.8
Immune-mediated dermatitis — n=142, PRR 45.8
Hepatic atrophy — n=68, PRR 45.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Paclitaxel ↔ Peripheral neuropathy.

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 Paclitaxel (Aibumin-Bound)?

In FDA FAERS, the most frequently co-reported reaction terms for Paclitaxel (Aibumin-Bound) are nausea, dyspnoea, neutropenia, diarrhoea, anaemia, myelosuppression. 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 Paclitaxel (Aibumin-Bound) have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SEVERE MYELOSUPPRESSION Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ].

Do FAERS signals prove that Paclitaxel (Aibumin-Bound) 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 4df3fda6-0b29-420e-ab91-81441ce914ed, effective 20260211; matched on openfda.generic_name.exact:"PACLITAXEL (AIBUMIN-BOUND)")
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 PACLITAXEL (AIBUMIN-BOUND, 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.