Reported Reactions

Drugs › Vascular endothelial growth factor inhibitor

Generic name

Bevacizumab: adverse event reports filed with FDA

54,611 reports list it as a suspect or interacting product, 2004–2026. Class: Vascular endothelial growth factor inhibitor. Also reported as Bevacizumab 7 5, Bevacizumab Injection.

54,611
reports as suspect product
0.3% of all reports · about 2,446 a year
6,049
reports, 12 months to June 2026
4,988 in the 12 months before
96.4%
marked serious by the reporter
87.6% across the class
18.8%
record death among outcomes, as reported
10,292 reports · not verified by FDA

54,611 adverse event reports received by FDA list bevacizumab, a generic name as a suspect or interacting product, from March 2004 to June 2026. A further 5,420 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 6,049 reports listed it, up 21% from 4,988 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 2,446 reports a year and 0.3% of the 20,646,523 reports in the database, and 31% of the reports for the vascular endothelial growth factor inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.

The reactions recorded most often are off label use (12.1%), diarrhoea (7.6%) and hypertension (6.4%). A report can list several reactions, so shares add to more than 100%; 3,059 different terms appear across these reports. Off label use is recorded in 12.1% of these reports, a larger share than in the median vascular endothelial growth factor inhibitor drug (8.7%).

96.4% of the reports are marked serious by the reporter (87.6% across the class); 18.8% record death among the outcomes and 39.9% record hospitalisation, as reported. 50.8% of the reports came from physicians, and the largest patient age group is 45 to 64 (26.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

0284567Jul 2021: 295Aug 2021: 348Sep 2021: 350Oct 2021: 343Nov 2021: 354Dec 2021: 3782022Jan 2022: 270Feb 2022: 307Mar 2022: 323Apr 2022: 381May 2022: 458Jun 2022: 391Jul 2022: 343Aug 2022: 425Sep 2022: 377Oct 2022: 438Nov 2022: 374Dec 2022: 4262023Jan 2023: 383Feb 2023: 389Mar 2023: 428Apr 2023: 419May 2023: 334Jun 2023: 467Jul 2023: 504Aug 2023: 497Sep 2023: 481Oct 2023: 424Nov 2023: 403Dec 2023: 3762024Jan 2024: 418Feb 2024: 436Mar 2024: 341Apr 2024: 420May 2024: 385Jun 2024: 312Jul 2024: 404Aug 2024: 319Sep 2024: 481Oct 2024: 388Nov 2024: 422Dec 2024: 4802025Jan 2025: 484Feb 2025: 370Mar 2025: 445Apr 2025: 417May 2025: 390Jun 2025: 388Jul 2025: 530Aug 2025: 531Sep 2025: 492Oct 2025: 567Nov 2025: 457Dec 2025: 5622026Jan 2026: 498Feb 2026: 473Mar 2026: 496Apr 2026: 512May 2026: 467Jun 2026: 464

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

02,8175,6332004: 3820042005: 1362006: 2132007: 95820072008: 1,6242009: 1,6722010: 1,63520102011: 1,6482012: 1,9622013: 2,07120132014: 1,6272015: 1,7982016: 2,02020162017: 1,8702018: 3,0852019: 2,67420192020: 2,9472021: 3,6662022: 4,51320222023: 5,1052024: 4,8062025: 5,63320252026: 2,910

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Bevacizumab reports recording the termmedian drug in vascular endothelial growth factor inhibitor

  1. Off label useused for a purpose or in a way not on the label12.1%6,599
  2. Diarrhoealoose or frequent stools7.6%4,125
  3. Hypertensionhigh blood pressure6.4%3,491
  4. Nauseafeeling sick6.1%3,305
  5. Fatiguetiredness6.1%3,304
  6. Deaththe patient died; cause not stated by this term6%3,271
  7. Anaemialow red blood cells5.4%2,971
  8. Disease progressionthe disease advanced5.3%2,894
  9. Neutropenialow neutrophils, a type of white blood cell5.1%2,777
  10. Vomitingbeing sick4.8%2,626
  11. Thrombocytopenialow platelets4.1%2,244
  12. Pyrexiafever4%2,177
  13. Proteinuriaprotein in the urine3.5%1,906
  14. Decreased appetitereduced appetite3.2%1,750
  15. Neuropathy peripheralnerve damage in hands or feet3%1,651
  16. Astheniaweakness or lack of energy2.9%1,570
  17. Dyspnoeashortness of breath2.8%1,552
  18. Febrile neutropeniafever with low white blood cells2.7%1,485
  19. Abdominal painstomach or belly pain2.6%1,446
  20. Drug ineffectivethe medicine did not work as expected2.6%1,442
  21. Pulmonary embolisma blood clot in the lung2.1%1,169
  22. Dehydrationdehydration2.1%1,145
  23. General physical health deteriorationgeneral decline in health2.1%1,139
  24. Pneumonialung infection2.1%1,139
  25. Platelet count decreasedlow platelet count2%1,101
  26. Rashskin rash2%1,076
  27. Constipationconstipation1.9%1,064
  28. Intentional product use issuedeliberate use not as intended1.9%1,047

Top 30 of 3,059 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 10 drugs in the vascular endothelial growth factor inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death18.8%10,292
Life-threatening5.3%2,892
Hospitalisation (initial or prolonged)39.9%21,768
Disability1.2%644
Congenital anomaly0%24
Other serious58.3%31,830
Not serious3.6%1,962

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 176,429 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.2%111
2 to 111%539
12 to 170.6%354
18 to 446.5%3,541
45 to 6426.7%14,589
65 to 7418.9%10,298
75 and over8.8%4,801
Age not given37.3%20,378

Patient sex

Female40.5%22,140
Male35.1%19,185
Not given24.3%13,286

Who reported

Physician50.8%27,737
Pharmacist2.7%1,476
Other health professional38.2%20,848
Lawyer0%7
Consumer or non-health professional6.1%3,315
Not given2.2%1,228

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 27% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Colorectal cancer metastatic4,5158.3%
Hepatocellular carcinoma4,4158.1%
Non-small cell lung cancer3,3526.1%
Ovarian cancer2,7945.1%
Colon cancer1,8843.4%
Colorectal cancer1,6793.1%

The indication field is filled in by the reporter and is often blank; shares are of all 54,611 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Bevacizumab reports
Carboplatin10,10918.5%
Paclitaxel9,57417.5%
Oxaliplatin9,39117.2%
Fluorouracil8,73416%
Atezolizumab7,80514.3%
Capecitabine5,90510.8%
Irinotecan5,2219.6%
Dexamethasone2,9055.3%
Cisplatin2,8575.2%
Leucovorin2,6574.9%

Other products listed in reports where Bevacizumab is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

MeasureBevacizumabVascular endothelial growth factor inhibitorAll reports
Reports as suspect product54,611176,42920,646,523
Share of that pool—31%0.3%
Reports, latest 12 months6,049—1,332,454
Marked serious96.4%87.6%57.4%
Death recorded among outcomes, per 1,000 reports18823791
Hospitalisation recorded, per 1,000 reports399269213
Consumer-filed share6.1%24.9%45.8%
Top term, share of reportsOff label use 12.1%median 8.7%4.1%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the vascular endothelial growth factor inhibitor class

DrugName typeReportsLatest 12 monthsMarked serious
Avastinbrand60,5102,19887.3%
Eyleabrand25,82696881.5%
Lucentisbrand20,41720382.9%
Ranibizumabgeneric4,86211997.4%
Mvasibrand4,50854227.9%
Afliberceptgeneric2,77222797.3%
Zaltrapbrand1,2272293.3%
Eylea Hdbrand1,09141166.8%
Zirabevbrand6055381%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about Bevacizumab reports

How many adverse event reports has FDA received for Bevacizumab?

54,611 reports list Bevacizumab as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 6,049 of them arrived in the latest 12 months. Another 5,420 list it only as a concomitant medication.

What reactions are recorded in Bevacizumab reports?

off label use (12.1%), diarrhoea (7.6%), hypertension (6.4%), nausea (6.1%) and fatigue (6.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Bevacizumab was responsible.

How serious are the reports?

96.4% are marked serious by the reporter. Among the outcomes recorded, 18.8% of reports include death and 39.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

physician (50.8%), other health professional (38.2%) and consumer or non-health professional (6.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Bevacizumab rising?

6,049 reports in the 12 months to June 2026, up 21% from 4,988 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Bevacizumab was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Bevacizumab?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Bevacizumab as a suspect or interacting product; reports listing it only as a concomitant medication (5,420) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.