Bevacizumab-Bvzr side effects: what 688 FDA adverse event reports show

Bevacizumab-Bvzr · Zirabev · 14 reaction terms · 238 drug–reaction co-reports · data 2026-09-14

Drug class

Vascular Endothelial Growth Factor Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Zirabev

openFDA label

Who reports

688 reports · 80% serious · 206 with death outcome · 52% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) • Metastatic colorect.

FDA label, Indications and Usage

What it is

Bevacizumab-bvzr is a vascular endothelial growth factor inhibitor. Bevacizumab-bvzr is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-bvzr has an approximate molecular weight of 149 kDa.

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 11 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 5

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.
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.
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. 3 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
Neoplasm progression	82	71.4 58.2–87.5ROR 80.9 · χ² 5,614 / p <1e-300	70.1 EB05 58.2 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 56.0	no trial data cached
Poor venous access	16	47.3 29.1–76.8ROR 48.4 · χ² 679 / p 5e-150	44.9 EB05 29.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Blood pressure systolic increased	26	40.5 27.8–59.1ROR 42.0 · χ² 962 / p 2e-211	39.4 EB05 28.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 30.5 · 92% clinician	no trial data cached
Blood pressure fluctuation	26	33.0 22.6–48.1ROR 34.2 · χ² 774 / p 1e-170	32.2 EB05 23.1 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 29.9 · 92% clinician	no trial data cached
Intestinal perforation	12	32.6 18.6–57.1ROR 33.1 · χ² 336 / p 2e-75	31.1 EB05 18.9 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.4	no trial data cached
Weight fluctuation	10	29.3 15.8–54.2ROR 29.7 · χ² 245 / p 1e-55	27.8 EB05 15.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Lymphocyte count decreased	13	22.4 13.1–38.4ROR 22.8 · χ² 245 / p 2e-55	21.6 EB05 13.2 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 19.7	no trial data cached
Hemiparesis	9	16.1 8.4–30.8ROR 16.3 · χ² 113 / p 1e-26	14.2 EB05 6.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Myelodysplastic syndrome	5	10.5 4.4–25.2ROR 10.6 · χ² 34 / p 3e-9	6.7 EB05 2.8 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Colon cancer	5	10.2 4.3–24.4ROR 10.3 · χ² 33 / p 5e-9	6.5 EB05 2.7 · IC025 +0.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 7.4	no trial data cached
Malignant neoplasm progression	22	6.6 4.4–9.9ROR 6.8 · χ² 99 / p 1e-23	5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4	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
Neoplasm progression	82	71.4 58.2–87.5ROR 80.9 · χ² 5,614 / p <1e-300	70.1 EB05 58.2 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 56.0	no trial data cached
Blood pressure fluctuation	26	33.0 22.6–48.1ROR 34.2 · χ² 774 / p 1e-170	32.2 EB05 23.1 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious PRR 29.9 · 92% clinician	no trial data cached
Blood pressure systolic increased	26	40.5 27.8–59.1ROR 42.0 · χ² 962 / p 2e-211	39.4 EB05 28.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious PRR 30.5 · 92% clinician	no trial data cached
Malignant neoplasm progression	22	6.6 4.4–9.9ROR 6.8 · χ² 99 / p 1e-23	5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4	no trial data cached
Poor venous access	16	47.3 29.1–76.8ROR 48.4 · χ² 679 / p 5e-150	44.9 EB05 29.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Lymphocyte count decreased	13	22.4 13.1–38.4ROR 22.8 · χ² 245 / p 2e-55	21.6 EB05 13.2 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 19.7	no trial data cached
Intestinal perforation	12	32.6 18.6–57.1ROR 33.1 · χ² 336 / p 2e-75	31.1 EB05 18.9 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.4	no trial data cached
Weight fluctuation	10	29.3 15.8–54.2ROR 29.7 · χ² 245 / p 1e-55	27.8 EB05 15.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Hemiparesis	9	16.1 8.4–30.8ROR 16.3 · χ² 113 / p 1e-26	14.2 EB05 6.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Colon cancer	5	10.2 4.3–24.4ROR 10.3 · χ² 33 / p 5e-9	6.5 EB05 2.7 · IC025 +0.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 7.4	no trial data cached
Myelodysplastic syndrome	5	10.5 4.4–25.2ROR 10.6 · χ² 34 / p 3e-9	6.7 EB05 2.8 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Metastases to lung	4	10.6 4.0–28.1ROR 10.6 · χ² 26 / p 2e-7	6.1 EB05 2.3 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Posterior reversible encephalopathy syndrome	4	12.8 4.8–34.0ROR 12.9 · χ² 33 / p 6e-9	7.6 EB05 2.6 · IC025 +0.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2	no trial data cached
Brain neoplasm	4	13.3 5.0–35.3ROR 13.3 · χ² 34 / p 3e-9	7.9 EB05 2.7 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	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.

Neoplasm progression — n=82, PRR 71.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Bevacizumab ↔ Hypertension.

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 Bevacizumab-Bvzr?

In FDA FAERS, the most frequently co-reported reaction terms for Bevacizumab-Bvzr are neoplasm progression, blood pressure fluctuation, blood pressure systolic increased, poor venous access, lymphocyte count decreased, intestinal perforation. 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 Bevacizumab-Bvzr have an FDA boxed warning?

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

Do FAERS signals prove that Bevacizumab-Bvzr 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 aa27acbd-d117-4350-aeee-17bc2e2c0ca4, effective 20260721; matched on openfda.generic_name.exact:"BEVACIZUMAB-BVZR")
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, 14 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.