Bortezomib side effects: what 88,896 FDA adverse event reports show

Bortezomib · 1,232 reaction terms · 250,859 drug–reaction co-reports · data 2026-09-14

Drug class

Proteasome Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

88,896 reports · 84% serious · 14,068 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bortezomib for Injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult patients with mantle cell lymphoma ( 1.2 ) 1.1 Multiple Myeloma Bortezomib for Injection is indicated for the treatment of adult patients with multiple myeloma.

FDA label, Indications and Usage

What it is

Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid.

FDA label, Description section

Boxed warning

None in the current 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 6Labeled (related wording) 6Likely indication confounding 6Lab value / disease marker 2Not in label — unassessed 20

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.
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). 1,192 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
Plasma cell myeloma refractory	744	322.3 288.4–360.1ROR 325.0 · calibrated p 5e-12 ✓	134.9 EB05 127.0 · IC025 +6.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=743 · 95% clinician	not reported in cached trials
Primary amyloidosis	132	259.2 202.2–332.3ROR 259.6 · calibrated p 7e-11 ✓	120.8 EB05 104.4 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=132 · 100% clinician	not reported in cached trials
Plasma cell myeloma recurrent	1,265	149.4 139.3–160.3ROR 151.5 · calibrated p 4e-9 ✓	91.1 EB05 87.0 · IC025 +6.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,227	not reported in cached trials
Leukaemia plasmacytic	57	125.8 91.1–173.7ROR 125.9 · calibrated p 4e-8 ✓	79.8 EB05 63.9 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=57 · 100% clinician	not reported in cached trials
Plasma cell leukaemia	205	123.1 103.9–145.8ROR 123.4 · calibrated p 3e-8 ✓	80.1 EB05 71.4 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=205 · 93% clinician	not reported in cached trials
Plasmacytoma	493	83.9 75.7–93.0ROR 84.4 · calibrated p 4e-7 ✓	61.7 EB05 57.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=483	not reported in cached trials
Blood stem cell harvest failure	38	80.8 55.8–116.9ROR 80.8 · calibrated p 1e-6 ✓	58.5 EB05 44.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=37 · 100% clinician	not reported in cached trials
Plasma cell myeloma	9,117	71.7 70.1–73.3ROR 79.8 · calibrated p 6e-7 ✓	55.0 EB05 54.0 · IC025 +5.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	age-adj. PRR 52.8 · serious PRR 39.4 · 92% clinician	not reported in cached trials
Light chain disease	34	71.0 48.3–104.2ROR 71.0 · calibrated p 3e-6 ✓	53.0 EB05 39.7 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 45%) · 100% clinician	not reported in cached trials
Hyperviscosity syndrome	64	66.8 50.6–88.2ROR 66.9 · calibrated p 3e-6 ✓	51.3 EB05 41.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=64 · 100% clinician	not reported in cached trials
Autonomic neuropathy	181	51.2 43.6–60.1ROR 51.3 · calibrated p 1e-5 ✓	41.9 EB05 37.0 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=180 · 91% clinician	not reported in cached trials
Monoclonal immunoglobulin increased	49	49.4 36.3–67.2ROR 49.4 · calibrated p 2e-5 ✓	40.3 EB05 31.7 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=38	not reported in cached trials
Light chain analysis increased	177	49.1 41.7–57.7ROR 49.2 · calibrated p 2e-5 ✓	40.5 EB05 35.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=117	not reported in cached trials
Plasmablastic lymphoma	56	43.8 33.0–58.3ROR 43.9 · calibrated p 4e-5 ✓	36.6 EB05 29.2 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=56 · 100% clinician	not reported in cached trials
Renal amyloidosis	38	43.2 30.5–61.0ROR 43.2 · calibrated p 5e-5 ✓	35.9 EB05 27.3 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=38 · 100% clinician	not reported in cached trials
Ivth nerve paralysis	34	41.5 28.8–59.7ROR 41.5 · calibrated p 7e-5 ✓	34.7 EB05 26.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 45%) · 100% clinician	not reported in cached trials
B-cell type acute leukaemia	104	39.8 32.4–49.0ROR 39.9 · calibrated p 6e-5 ✓	33.9 EB05 28.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=104 · 100% clinician	not reported in cached trials
Multiple myeloma	679	39.4 36.4–42.8ROR 39.7 · calibrated p 6e-5 ✓	33.8 EB05 31.7 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=675 · 97% clinician	not reported in cached trials
Mantle cell lymphoma	212	38.2 33.1–44.2ROR 38.3 · calibrated p 7e-5 ✓	32.9 EB05 29.3 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=209 · 94% clinician	not reported in cached trials
Monoclonal immunoglobulin present	104	37.0 30.1–45.5ROR 37.1 · calibrated p 1e-4 ✓	31.9 EB05 27.1 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=78	not reported in cached trials
Amyloidosis	230	36.1 31.5–41.5ROR 36.2 · calibrated p 1e-4 ✓	31.3 EB05 28.1 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=227	not reported in cached trials
Morganella infection	35	31.8 22.3–45.3ROR 31.8 · calibrated p 3e-4 ✓	27.7 EB05 20.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=35 · 100% clinician	not reported in cached trials
Paraproteinaemia	37	31.5 22.4–44.4ROR 31.5 · calibrated p 3e-4 ✓	27.5 EB05 20.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=36	not reported in cached trials
Cardiac amyloidosis	128	31.4 26.1–37.7ROR 31.4 · calibrated p 2e-4 ✓	27.7 EB05 23.9 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=128 · 94% clinician	not reported in cached trials
B precursor type acute leukaemia	44	30.0 21.9–41.0ROR 30.0 · calibrated p 4e-4 ✓	26.4 EB05 20.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=44 · 100% clinician	not reported in cached trials
Stem cell transplant	259	27.5 24.2–31.3ROR 27.6 · calibrated p 4e-4 ✓	24.7 EB05 22.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=247	not reported in cached trials
Osteolysis	198	25.1 21.7–29.1ROR 25.2 · calibrated p 7e-4 ✓	22.7 EB05 20.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=197	not reported in cached trials
Chalazion	61	25.0 19.2–32.6ROR 25.0 · calibrated p 8e-4 ✓	22.5 EB05 18.2 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious n=47 · 90% clinician	not reported in cached trials
Polyneuropathy	1,073	23.3 21.9–24.8ROR 23.6 · calibrated p 9e-4 ✓	21.3 EB05 20.2 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.7 · 93% clinician	not reported in cached trials
Peripheral sensorimotor neuropathy	111	23.1 19.0–28.1ROR 23.2 · calibrated p 0.001 ✓	21.1 EB05 18.0 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=110 · 100% clinician	not reported in cached trials
Monoclonal gammopathy	53	21.7 16.3–28.7ROR 21.7 · calibrated p 0.002 ✓	19.8 EB05 15.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=53	not reported in cached trials
Engraftment syndrome	45	19.5 14.4–26.4ROR 19.5 · calibrated p 0.003 ✓	17.9 EB05 13.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=45 · 100% clinician	not reported in cached trials
Meningitis listeria	39	19.4 14.0–26.9ROR 19.4 · calibrated p 0.003 ✓	17.8 EB05 13.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=39 · 100% clinician	not reported in cached trials
Herpes zoster disseminated	60	19.3 14.8–25.1ROR 19.3 · calibrated p 0.003 ✓	17.8 EB05 14.3 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=60 · 100% clinician	not reported in cached trials
Peripheral motor neuropathy	105	19.1 15.7–23.3ROR 19.1 · calibrated p 0.003 ✓	17.7 EB05 15.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=99 · 94% clinician	NCT01371981: 4/559 (0.7%) on Bortezomib
Peripheral sensory neuropathy	430	18.7 16.9–20.6ROR 18.7 · calibrated p 0.003 ✓	17.3 EB05 16.0 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=417 · 94% clinician	NCT01371981: 14/575 (2.4%) on Bortezomib (serious AE)
Neuropathy peripheral (nerve damage in hands/feet)	6,473	17.3 16.9–17.7ROR 18.6 · calibrated p 0.003 ✓	16.1 EB05 15.8 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 12.9 · serious PRR 10.9	NCT01371981: 14/575 (2.4%) on Bortezomib (serious AE)
Pneumonia pneumococcal	89	15.0 12.1–18.6ROR 15.0 · calibrated p 0.008 ✓	14.1 EB05 11.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=89 · 100% clinician	not reported in cached trials
Neuropathy	99	14.3 11.7–17.5ROR 14.3 · calibrated p 0.009 ✓	13.4 EB05 11.3 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=81	NCT01371981: 14/575 (2.4%) on Bortezomib (serious AE)
Bone lesion	206	14.2 12.4–16.4ROR 14.3 · calibrated p 0.009 ✓	13.4 EB05 11.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=190	not reported in cached trials

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
Thrombocytopenia	5,860	6.46.3–6.6	signal
Neutropenia / agranulocytosis	4,573	4.44.3–4.5	signal
Opportunistic infection	1,763	3.12.9–3.2	signal
Anaemia	3,788	3.02.9–3.1	signal
Serious infection	8,457	2.62.5–2.7	signal
Osteonecrosis	630	2.62.4–2.8	signal
Venous thromboembolism	2,160	2.42.3–2.5	signal
Heart failure	1,716	2.32.2–2.4	signal
Hyponatraemia	766	2.32.1–2.4	signal
Kidney injury	4,027	2.12.0–2.2	signal
Severe cutaneous reaction	635	2.01.9–2.2	raised
Interstitial lung disease	794	2.01.8–2.1	raised
Arrhythmia / qt	1,595	1.91.9–2.0	raised
Liver injury	1,380	1.11.0–1.1	raised
Gi bleeding	760	1.00.9–1.1	no difference
Pancreatitis	328	1.00.9–1.1	no difference

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bortezomib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

NCT01371981 — Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (N=1645, PHASE3; 517 AE terms posted; arms: Arm A; Arm B; Arm C (Cohort 1); Arm C (Cohort 2))

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Plasma cell myeloma	9,117	71.7 70.1–73.3ROR 79.8 · calibrated p 6e-7 ✓	55.0 EB05 54.0 · IC025 +5.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	age-adj. PRR 52.8 · serious PRR 39.4 · 92% clinician	not reported in cached trials
Neuropathy peripheral (nerve damage in hands/feet)	6,473	17.3 16.9–17.7ROR 18.6 · calibrated p 0.003 ✓	16.1 EB05 15.8 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 12.9 · serious PRR 10.9	NCT01371981: 14/575 (2.4%) on Bortezomib (serious AE)
Off label use (used outside approved label)	6,424	1.8 1.7–1.8ROR 1.8 · calibrated p 0.836	1.7 EB05 1.7 · IC025 +0.8	Reporting / coding artifact	age-adj. PRR 1.8 · serious PRR 2.0	not reported in cached trials
Diarrhoea (diarrhea)	5,182	1.9 1.9–2.0ROR 2.0 · calibrated p 0.924	1.9 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.7	NCT01371981: 9/575 (1.6%) on Bortezomib (serious AE)
Fatigue (tiredness)	4,551	1.4 1.3–1.4ROR 1.4 · calibrated p 0.578	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.2	NCT01371981: 4/559 (0.7%) on Bortezomib
Death	4,194	1.1 1.1–1.2ROR 1.2 · calibrated p 0.411	1.1 EB05 1.1 · IC025 +0.1	Outcome field, not a reaction	age-adj. PRR 0.7 · serious PRR 0.8	NCT01371981: 38/559 (6.8%) on Bortezomib (serious AE)
Pneumonia (lung infection)	4,069	3.0 2.9–3.1ROR 3.1 · calibrated p 0.598	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.6 · serious PRR 2.1	not reported in cached trials
Drug ineffective (drug did not work)	3,750	0.7 0.7–0.7ROR 0.7 · calibrated p 0.109	0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 1.2	not reported in cached trials
Thrombocytopenia (low platelets)	3,710	8.1 7.8–8.3ROR 8.4 · calibrated p 0.057	7.8 EB05 7.6 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.1 · serious PRR 5.3 · 92% clinician	not reported in cached trials
Nausea	3,114	0.9 0.9–1.0ROR 0.9 · calibrated p 0.260	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 0.9	NCT01371981: 1/575 (0.2%) on Bortezomib (serious AE)
Pyrexia (fever)	2,866	2.0 1.9–2.0ROR 2.0 · calibrated p 0.940	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.9 · serious PRR 1.5	not reported in cached trials
Neutropenia (low neutrophils (infection-fighting cells))	2,717	4.8 4.6–5.0ROR 4.9 · calibrated p 0.243	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.7 · serious PRR 3.2 · 94% clinician	NCT01371981: 21/575 (3.7%) on Bortezomib (serious AE)
Anaemia (low red blood cells)	2,703	3.4 3.3–3.5ROR 3.4 · calibrated p 0.497	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 2.4	NCT01371981: 3/575 (0.5%) on Bortezomib (serious AE)
Rash	2,444	1.3 1.3–1.4ROR 1.3 · calibrated p 0.535	1.3 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.2	NCT01371981: 10/575 (1.7%) on Bortezomib (serious AE)
Disease progression	2,444	5.0 4.8–5.2ROR 5.1 · calibrated p 0.226	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.4 · serious PRR 3.8 · 93% clinician	not reported in cached trials

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.

Leukaemia plasmacytic — n=57, PRR 125.8
Plasma cell leukaemia — n=205, PRR 123.1
Plasmacytoma — n=493, PRR 83.9
Blood stem cell harvest failure — n=38, PRR 80.8
Light chain disease — n=34, PRR 71.0
Hyperviscosity syndrome — n=64, PRR 66.8
Autonomic neuropathy — n=181, PRR 51.2
Light chain analysis increased — n=177, PRR 49.1
Ivth nerve paralysis — n=34, PRR 41.5
B-cell type acute leukaemia — n=104, PRR 39.8

✓ A hand-written Bradford Hill causality assessment exists for this drug: Bortezomib (proteasome inhibitors) ↔ 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 Bortezomib?

In FDA FAERS, the most frequently co-reported reaction terms for Bortezomib are plasma cell myeloma, neuropathy peripheral, diarrhoea, fatigue, pneumonia, 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 Bortezomib have an FDA boxed warning?

No. The FDA label retrieved for Bortezomib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bortezomib 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 12500f21-8e2f-4bcd-861e-4dfca843da2e, effective 20220516; matched on openfda.generic_name.exact:"BORTEZOMIB")
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, 1,232 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 BORTEZOMIB, 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.