Bevacizumab-Awwb side effects: what 4,613 FDA adverse event reports show

Bevacizumab-Awwb · Mvasi · 68 reaction terms · 3,543 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

Mvasi

openFDA label

Who reports

4,613 reports · 29% serious · 129 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

MVASI 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 colorectal can.

FDA label, Indications and Usage

What it is

Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb 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 38 strongest signals

Labeled adverse reaction 7Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 16Lab value / disease marker 2Not in label — unassessed 6

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.
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. 30 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
Circumstance or information capable of leading to medication error	346	47.4 42.8–52.4ROR 51.1 · χ² 15,517 / p <1e-300	46.8 EB05 42.8 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Product storage error	437	23.1 21.1–25.2ROR 25.4 · χ² 9,195 / p <1e-300	22.9 EB05 21.2 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Intercepted product preparation error	54	20.2 15.5–26.4ROR 20.5 · χ² 965 / p 4e-212	20.0 EB05 15.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Proteinuria	69	16.7 13.2–21.1ROR 16.9 · χ² 999 / p 1e-219	16.5 EB05 13.5 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · ♀ 81% (drug 60%) · 96% clinician	no trial data cached
Hospice care	30	13.9 9.7–19.8ROR 14.0 · χ² 345 / p 3e-77	13.5 EB05 9.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.6	no trial data cached
Product preparation error	62	13.6 10.7–17.5ROR 13.8 · χ² 713 / p 3e-157	13.5 EB05 10.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Laboratory test abnormal	60	9.3 7.2–11.9ROR 9.4 · χ² 434 / p 1e-96	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 97% clinician	no trial data cached
Disease progression	193	7.5 6.5–8.6ROR 7.7 · χ² 1,076 / p 3e-236	7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 95% clinician	no trial data cached
Adverse event	145	7.2 6.1–8.4ROR 7.4 · χ² 765 / p 1e-168	7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 0.9 · 98% clinician	no trial data cached
Intentional dose omission	42	7.0 5.2–9.4ROR 7.0 · χ² 210 / p 8e-48	6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 95% clinician	no trial data cached
Ill-defined disorder	91	6.8 5.6–8.4ROR 6.9 · χ² 446 / p 2e-99	6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · 97% clinician	no trial data cached
Neutrophil count decreased	53	6.0 4.6–7.8ROR 6.0 · χ² 214 / p 1e-48	5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	100% clinician	no trial data cached
Ovarian cancer	12	5.9 3.3–10.4ROR 5.9 · χ² 44 / p 2e-11	4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Platelet count decreased	127	5.4 4.6–6.4ROR 5.6 · χ² 456 / p 2e-101	5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.8 · 91% clinician	no trial data cached
Blood pressure increased	178	5.3 4.6–6.1ROR 5.5 · χ² 618 / p 1e-136	5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.6 · 93% clinician	no trial data cached
Wound	31	5.1 3.6–7.2ROR 5.1 · χ² 97 / p 3e-23	4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 0.4 · 94% clinician	no trial data cached
Tooth extraction	13	4.7 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9	4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hypertension (high blood pressure)	213	4.6 4.0–5.2ROR 4.7 · χ² 596 / p 7e-132	4.5 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7 · 96% clinician	no trial data cached
Therapy partial responder	15	4.5 2.7–7.5ROR 4.5 · χ² 38 / p 4e-10	4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.1	no trial data cached
Unevaluable event	74	4.4 3.5–5.6ROR 4.5 · χ² 195 / p 1e-44	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4 · 97% clinician	no trial data cached
Accidental exposure to product	89	4.1 3.3–5.0ROR 4.1 · χ² 202 / p 3e-46	4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Blood pressure abnormal	17	3.9 2.4–6.3ROR 3.9 · χ² 34 / p 3e-9	3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 1.3	no trial data cached
Surgery	49	3.8 2.9–5.1ROR 3.9 · χ² 101 / p 6e-24	3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 98% clinician	no trial data cached
Sars-cov-2 test positive	11	3.7 2.1–6.8ROR 3.8 · χ² 19 / p 5e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Lab value / disease marker	serious n=2	no trial data cached
Tooth disorder	17	3.5 2.2–5.6ROR 3.5 · χ² 27 / p 9e-8	3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 0.7	no trial data cached
Adverse reaction	10	3.4 1.8–6.4ROR 3.4 · χ² 15 / p 6e-5	3.0 EB05 1.8 · IC025 +0.5	Reporting / coding artifact	serious n=2	no trial data cached
Blood test abnormal	10	3.2 1.7–6.0ROR 3.2 · χ² 13 / p 1e-4	2.9 EB05 1.7 · IC025 +0.5	Reporting / coding artifact	serious PRR 3.9	no trial data cached
Intestinal obstruction	25	3.0 2.1–4.5ROR 3.0 · χ² 32 / p 7e-9	2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.1	no trial data cached
Therapy interrupted	44	2.9 2.2–3.9ROR 2.9 · χ² 53 / p 2e-13	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.2 · 90% clinician	no trial data cached
Metastases to liver	11	2.9 1.6–5.1ROR 2.9 · χ² 11 / p 4e-4	2.6 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 5.7	no trial data cached
Liver function test increased	13	2.8 1.6–4.8ROR 2.8 · χ² 13 / p 2e-4	2.6 EB05 1.6 · IC025 +0.4	Not in label — unassessed	–	no trial data cached
Epistaxis (nosebleed)	43	2.6 1.9–3.5ROR 2.6 · χ² 41 / p 7e-11	2.6 EB05 2.0 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Off label use (used outside approved label)	489	2.6 2.4–2.8ROR 2.7 · χ² 484 / p 1e-107	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	13	2.5 1.5–4.3ROR 2.5 · χ² 11 / p 6e-4	2.4 EB05 1.5 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 2.6	no trial data cached
Product dose omission issue	158	2.5 2.2–2.9ROR 2.6 · χ² 146 / p 8e-34	2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	96% clinician	no trial data cached
Ascites	16	2.5 1.5–4.0ROR 2.5 · χ² 13 / p 2e-4	2.4 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 5.0	no trial data cached
Impaired healing	17	2.4 1.5–3.8ROR 2.4 · χ² 12 / p 3e-4	2.3 EB05 1.5 · IC025 +0.4	Reporting / coding artifact	serious PRR 1.3	no trial data cached
Thrombocytopenia (low platelets)	57	2.3 1.8–3.0ROR 2.3 · χ² 42 / p 5e-11	2.3 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 4.8 · ♀ 32% (drug 60%) · 96% clinician	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
Off label use (used outside approved label)	489	2.6 2.4–2.8ROR 2.7 · χ² 484 / p 1e-107	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8	no trial data cached
Product storage error	437	23.1 21.1–25.2ROR 25.4 · χ² 9,195 / p <1e-300	22.9 EB05 21.2 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Circumstance or information capable of leading to medication error	346	47.4 42.8–52.4ROR 51.1 · χ² 15,517 / p <1e-300	46.8 EB05 42.8 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Hypertension (high blood pressure)	213	4.6 4.0–5.2ROR 4.7 · χ² 596 / p 7e-132	4.5 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7 · 96% clinician	no trial data cached
Disease progression	193	7.5 6.5–8.6ROR 7.7 · χ² 1,076 / p 3e-236	7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 95% clinician	no trial data cached
Blood pressure increased	178	5.3 4.6–6.1ROR 5.5 · χ² 618 / p 1e-136	5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.6 · 93% clinician	no trial data cached
Product dose omission issue	158	2.5 2.2–2.9ROR 2.6 · χ² 146 / p 8e-34	2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	96% clinician	no trial data cached
Adverse event	145	7.2 6.1–8.4ROR 7.4 · χ² 765 / p 1e-168	7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 0.9 · 98% clinician	no trial data cached
Platelet count decreased	127	5.4 4.6–6.4ROR 5.6 · χ² 456 / p 2e-101	5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 1.8 · 91% clinician	no trial data cached
Ill-defined disorder	91	6.8 5.6–8.4ROR 6.9 · χ² 446 / p 2e-99	6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · 97% clinician	no trial data cached
Accidental exposure to product	89	4.1 3.3–5.0ROR 4.1 · χ² 202 / p 3e-46	4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Unevaluable event	74	4.4 3.5–5.6ROR 4.5 · χ² 195 / p 1e-44	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4 · 97% clinician	no trial data cached
Proteinuria	69	16.7 13.2–21.1ROR 16.9 · χ² 999 / p 1e-219	16.5 EB05 13.5 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · ♀ 81% (drug 60%) · 96% clinician	no trial data cached
Product preparation error	62	13.6 10.7–17.5ROR 13.8 · χ² 713 / p 3e-157	13.5 EB05 10.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Laboratory test abnormal	60	9.3 7.2–11.9ROR 9.4 · χ² 434 / p 1e-96	8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 97% clinician	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.

Hospice care — n=30, PRR 13.9
Ill-defined disorder — n=91, PRR 6.8

✓ 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-Awwb?

In FDA FAERS, the most frequently co-reported reaction terms for Bevacizumab-Awwb are circumstance or information capable of leading to medication error, hypertension, blood pressure increased, platelet count decreased, ill-defined disorder, proteinuria. 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-Awwb have an FDA boxed warning?

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

Do FAERS signals prove that Bevacizumab-Awwb 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 0a562b4e-67ce-4bab-852c-d9ee71e55fb8, effective 20260623; matched on openfda.generic_name.exact:"BEVACIZUMAB-AWWB")
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, 68 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.