Avastin: adverse event reports filed with FDA

60,510

reports as suspect product

0.3% of all reports · about 2,690 a year

2,198

reports, 12 months to June 2026

2,427 in the 12 months before

87.3%

marked serious by the reporter

87.6% across the class

27.9%

record death among outcomes, as reported

16,904 reports · not verified by FDA

Reports by month, five years

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

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

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

1. Deaththe patient died; cause not stated by this term15.8%9,540
2. Off label useused for a purpose or in a way not on the label11.9%7,212
3. Disease progressionthe disease advanced7%4,245
4. Diarrhoealoose or frequent stools4.7%2,826
5. Fatiguetiredness4.5%2,700
6. Nauseafeeling sick4.4%2,669
7. Hypertensionhigh blood pressure3.6%2,206
8. Vomitingbeing sick3.3%2,024
9. No adverse eventno adverse event was reported3.2%1,910
10. Astheniaweakness or lack of energy3%1,801
11. Pyrexiafever2.7%1,662
12. Decreased appetitereduced appetite2.5%1,531
13. Dyspnoeashortness of breath2.4%1,468
14. Drug ineffectivethe medicine did not work as expected2.4%1,436
15. Painpain, site not specified2.2%1,355
16. Abdominal painstomach or belly pain2.1%1,291
17. Headachehead pain2.1%1,282
18. Anaemialow red blood cells2%1,204
19. Intentional product use issuedeliberate use not as intended1.9%1,177
20. Constipationconstipation1.8%1,119
21. Proteinuriaprotein in the urine1.8%1,101
22. Weight decreasedweight loss1.8%1,065
23. Neuropathy peripheralnerve damage in hands or feet1.8%1,061
24. Rashskin rash1.7%1,043
25. Epistaxisnosebleed1.7%1,042
26. Malaisegeneral feeling of being unwell1.7%1,034
27. Neutropenialow neutrophils, a type of white blood cell1.7%1,009
28. Blood pressure increaseda raised blood pressure reading1.6%998
29. Platelet count decreasedlow platelet count1.6%984
30. Malignant neoplasm progression1.5%880

Top 30 of 2,895 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

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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 39.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 60,510 reports.

Drugs most often listed in the same reports

Other products listed in reports where Avastin 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

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

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.

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 Avastin as a suspect or interacting product; reports listing it only as a concomitant medication (5,216) 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.