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Bevacizumab side effects: what 123,107 FDA adverse event reports show

Bevacizumab · Avastin · 1,301 reaction terms · 375,061 drug–reaction co-reports · data 2026-09-14
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Drug class

Vascular Endothelial Growth Factor Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Avastin

openFDA label

Who reports

123,107 reports · 91% serious · 28,193 with death outcome · 54% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Avastin 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 c.

FDA label, Indications and Usage

What it is

Bevacizumab is a vascular endothelial growth factor inhibitor. Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab 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 40 strongest signals

Labeled adverse reaction 6Labeled (related wording) 11Likely indication confounding 9Reporting / coding artifact 2Not in label — unassessed 12
What the badges mean

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. 1,261 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Bacterial endophthalmitis8281.1
62.3–105.5ROR 81.1 · χ² 4,312 / p <1e-300
54.3 EB05 45.1 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=81 · 100% cliniciannot reported in cached trials
Urogenital fistula6869.7
52.5–92.5ROR 69.7 · χ² 3,200 / p <1e-300
48.8 EB05 39.8 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=67 · ♀ 100% (drug 54%) · 100% cliniciannot reported in cached trials
Gastrointestinal perforation1,09060.5
56.5–64.8ROR 61.1 · χ² 46,802 / p <1e-300
44.7 EB05 42.5 · IC025 +5.4
3/3 methods agree
Labeled adverse reaction
exact term
serious n=1,082 · 93% clinicianNCT00112918: 1/1,145 (0.1%) on Bevacizumab (serious AE)
Colorectal cancer metastatic56756.0
50.9–61.6ROR 56.3 · χ² 22,906 / p <1e-300
42.1 EB05 39.3 · IC025 +5.2
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=564 · 93% cliniciannot reported in cached trials
Hepatic atrophy10753.0
42.7–65.9ROR 53.1 · χ² 4,107 / p <1e-300
40.2 EB05 34.2 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=107 · ♀ 100% (drug 54%) · 100% cliniciannot reported in cached trials
Pseudocirrhosis7247.7
36.7–62.0ROR 47.8 · χ² 2,526 / p <1e-300
37.0 EB05 30.4 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=72 · ♀ 100% (drug 54%) · 100% cliniciannot reported in cached trials
Diabetic retinal oedema10845.7
36.9–56.5ROR 45.7 · χ² 3,671 / p <1e-300
35.9 EB05 30.5 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=106not reported in cached trials
Retinal pigment epithelial tear13943.6
36.2–52.5ROR 43.6 · χ² 4,552 / p <1e-300
34.6 EB05 30.0 · IC025 +4.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=138 · 100% cliniciannot reported in cached trials
Endophthalmitis1,19942.4
39.8–45.2ROR 42.8 · χ² 38,665 / p <1e-300
34.0 EB05 32.4 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=1,179 · 91% cliniciannot reported in cached trials
Anastomotic leak13942.4
35.2–51.0ROR 42.4 · χ² 4,446 / p <1e-300
33.9 EB05 29.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=138 · ♀ 34% (drug 54%) · 100% clinicianNCT00433511: 1/1,168 (0.1%) on Bevacizumab (serious AE)
Detachment of retinal pigment epithelium17141.5
35.1–49.0ROR 41.5 · χ² 5,377 / p <1e-300
33.3 EB05 29.3 · IC025 +4.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=170not reported in cached trials
Subretinal fluid20741.4
35.6–48.2ROR 41.5 · χ² 6,510 / p <1e-300
33.3 EB05 29.7 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=205 · 100% cliniciannot reported in cached trials
Anastomotic complication5833.6
25.4–44.6ROR 33.7 · χ² 1,502 / p <1e-300
27.9 EB05 22.4 · IC025 +4.1
3/3 methods agree
Reporting / coding artifactserious n=58 · ♀ 0% (drug 54%) · 100% cliniciannot reported in cached trials
Glioblastoma27533.4
29.3–38.0ROR 33.5 · χ² 7,174 / p <1e-300
27.9 EB05 25.3 · IC025 +4.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=272not reported in cached trials
Proteinuria3,06633.0
31.7–34.2ROR 33.8 · χ² 79,398 / p <1e-300
27.7 EB05 26.9 · IC025 +4.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 18.0 · 94% clinicianNCT00433511: 20/1,168 (1.7%) on Bevacizumab (serious AE)
Nasal septum perforation10532.8
26.6–40.5ROR 32.9 · χ² 2,683 / p <1e-300
27.5 EB05 23.4 · IC025 +4.3
3/3 methods agree
Labeled adverse reaction
exact term
serious n=97 · ♀ 75% (drug 54%)not reported in cached trials
Rectal cancer metastatic5632.7
24.6–43.6ROR 32.7 · χ² 1,413 / p <1e-300
27.3 EB05 21.8 · IC025 +4.0
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=56 · ♀ 0% (drug 54%) · 100% cliniciannot reported in cached trials
Bleeding varicose vein8531.6
25.0–39.8ROR 31.6 · χ² 2,090 / p <1e-300
26.6 EB05 22.2 · IC025 +4.2
3/3 methods agree
Labeled adverse reaction
exact term
serious n=85 · ♀ 0% (drug 54%) · 100% cliniciannot reported in cached trials
Ovarian cancer recurrent24530.7
26.8–35.1ROR 30.7 · χ² 5,915 / p <1e-300
26.0 EB05 23.4 · IC025 +4.4
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=241 · ♀ 100% (drug 54%)not reported in cached trials
Glioma9629.9
24.0–37.1ROR 29.9 · χ² 2,248 / p <1e-300
25.4 EB05 21.4 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=95 · ♀ 0% (drug 54%) · 100% cliniciannot reported in cached trials
Perforation10826.7
21.8–32.7ROR 26.7 · χ² 2,277 / p <1e-300
23.0 EB05 19.6 · IC025 +4.1
3/3 methods agree
Labeled adverse reaction
exact term
serious n=104 · 100% clinicianNCT00433511: 1/972 (0.1%) control (serious AE)
Optical coherence tomography abnormal8926.6
21.3–33.3ROR 26.6 · χ² 1,869 / p <1e-300
23.0 EB05 19.2 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious n=89 · 100% cliniciannot reported in cached trials
Oesophageal varices haemorrhage29026.1
23.1–29.5ROR 26.1 · χ² 6,031 / p <1e-300
22.7 EB05 20.6 · IC025 +4.3
3/3 methods agree
Labeled adverse reaction
exact term
serious n=289 · ♀ 17% (drug 54%) · 97% cliniciannot reported in cached trials
Ileal perforation8223.8
18.9–30.0ROR 23.8 · χ² 1,549 / p <1e-300
20.9 EB05 17.4 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=82 · 100% clinicianNCT00112918: 1/1,145 (0.1%) on Bevacizumab (serious AE)
Cataract nuclear8123.8
18.9–30.1ROR 23.8 · χ² 1,530 / p <1e-300
20.9 EB05 17.3 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=79 · 90% cliniciannot reported in cached trials
Metastases to peritoneum30623.6
20.9–26.6ROR 23.7 · χ² 5,784 / p <1e-300
20.8 EB05 18.9 · IC025 +4.1
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=305not reported in cached trials
Duodenal perforation11823.4
19.3–28.4ROR 23.4 · χ² 2,201 / p <1e-300
20.6 EB05 17.7 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=117 · 91% cliniciannot reported in cached trials
Ovarian cancer metastatic10223.4
19.0–28.8ROR 23.4 · χ² 1,899 / p <1e-300
20.6 EB05 17.4 · IC025 +3.9
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=101 · ♀ 100% (drug 54%)not reported in cached trials
Colon cancer metastatic18321.8
18.7–25.4ROR 21.8 · χ² 3,195 / p <1e-300
19.4 EB05 17.1 · IC025 +4.0
3/3 methods agree
Likely indication confounding
term in indications
serious n=182not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bevacizumab 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 (8 of 40 signal terms matched).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Off label use (used outside approved label)14,4502.9
2.8–2.9ROR 3.1 · χ² 18,020 / p <1e-300
2.8 EB05 2.8 · IC025 +1.5
3/3 methods agree
Reporting / coding artifactserious PRR 2.7not reported in cached trials
Death13,2142.6
2.6–2.7ROR 2.8 · χ² 13,802 / p <1e-300
2.6 EB05 2.6 · IC025 +1.4
3/3 methods agree
Outcome field, not a reactionserious PRR 1.7NCT00433511: 1/1,168 (0.1%) on Bevacizumab (serious AE)
Disease progression7,37711.3
11.1–11.6ROR 12.0 · χ² 65,275 / p <1e-300
10.7 EB05 10.4 · IC025 +3.4
3/3 methods agree
Reporting / coding artifactserious PRR 7.4NCT00433511: 3/1,168 (0.3%) on Bevacizumab; 4/972 (0.4%) control (serious AE)
Diarrhoea (diarrhea)7,3492.0
1.9–2.0ROR 2.0 · χ² 3,506 / p <1e-300
1.9 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
serious PRR 2.1NCT00433511: 11/1,168 (0.9%) on Bevacizumab; 29/972 (3.0%) control (serious AE)
Nausea6,5251.4
1.4–1.4ROR 1.4 · χ² 808 / p 5e-178
1.4 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.6NCT00433511: 5/1,168 (0.4%) on Bevacizumab; 25/972 (2.6%) control (serious AE)
Fatigue (tiredness)6,4551.4
1.4–1.5ROR 1.4 · χ² 821 / p 8e-181
1.4 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.6NCT00433511: 31/1,168 (2.7%) on Bevacizumab; 66/972 (6.8%) control (serious AE)
Hypertension (high blood pressure)5,8514.8
4.7–4.9ROR 5.0 · χ² 17,314 / p <1e-300
4.7 EB05 4.6 · IC025 +2.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.4NCT00433511: 131/1,168 (11.2%) on Bevacizumab; 20/972 (2.1%) control (serious AE)
Vomiting4,9561.8
1.8–1.9ROR 1.8 · χ² 1,814 / p <1e-300
1.8 EB05 1.8 · IC025 +0.8Labeled adverse reaction
exact term
serious PRR 1.6NCT00433511: 8/1,168 (0.7%) on Bevacizumab; 15/972 (1.5%) control (serious AE)
Anaemia (low red blood cells)4,4364.0
3.9–4.1ROR 4.1 · χ² 9,955 / p <1e-300
4.0 EB05 3.9 · IC025 +1.9
3/3 methods agree
Not in label — unassessedserious PRR 2.7 · 90% clinicianNCT00433511: 5/1,168 (0.4%) on Bevacizumab; 15/972 (1.5%) control (serious AE)
Pyrexia (fever)4,0722.0
2.0–2.1ROR 2.0 · χ² 2,091 / p <1e-300
2.0 EB05 2.0 · IC025 +1.0Labeled adverse reaction
exact term
serious PRR 1.5NCT00112918: 20/1,126 (1.8%) on Bevacizumab (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))4,0155.2
5.0–5.3ROR 5.3 · χ² 13,188 / p <1e-300
5.0 EB05 4.9 · IC025 +2.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.3 · 94% clinicianNCT00433511: 4/1,942 (0.2%) on Bevacizumab; 6/972 (0.6%) control (serious AE)
Asthenia (weakness)3,5761.6
1.6–1.7ROR 1.6 · χ² 868 / p 5e-191
1.6 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.4NCT00112918: 3/1,145 (0.3%) on Bevacizumab (serious AE)
Decreased appetite (loss of appetite)3,4582.6
2.5–2.7ROR 2.6 · χ² 3,291 / p <1e-300
2.5 EB05 2.5 · IC025 +1.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.4NCT00112918: 1/1,145 (0.1%) on Bevacizumab (serious AE)
Dyspnoea (shortness of breath)3,4041.0
1.0–1.1ROR 1.0 · χ² 2 / p 0.072
1.0 EB05 1.0 · IC025 -0.0
PRR-only: not supported by EBGM or IC
Labeled adverse reaction
exact term
serious PRR 0.9NCT00433511: 18/1,168 (1.5%) on Bevacizumab; 32/972 (3.3%) control (serious AE)
Thrombocytopenia (low platelets)3,3665.3
5.1–5.5ROR 5.4 · χ² 11,351 / p <1e-300
5.1 EB05 5.0 · IC025 +2.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.3 · 92% clinicianNCT00112918: 1/1,135 (0.1%) on Bevacizumab (serious AE)

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.

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Bevacizumab are diarrhoea, nausea, fatigue, hypertension, vomiting, anaemia. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Bevacizumab 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

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.