Drug Safety Information for AVASTIN (Bevacizumab)

FDA Safety-related Labeling Changes for AVASTIN (BEVACIZUMAB) Biological Drug: Safety Information Link

Adverse Drug Reactions for AVASTIN* (Bevacizumab)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with AVASTIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death7561
2Disease progression3440
3Diarrhoea2822
4Nausea2602
5Off label use2370
6Vomiting2243
7Fatigue2216
8Pyrexia1674
9Dyspnoea1646
10Hypertension1632
11Dehydration1545
12Asthenia1449
13Abdominal pain1396
14Neoplasm malignant1310
15Anaemia1259
16Decreased appetite1250
17Neutropenia1205
18Pulmonary embolism1102
19Pain1031
20Thrombocytopenia950

* This side effect also appears in "Top 10 Side Effects of AVASTIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking AVASTIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Colorectal cancer metastatic9982
2Product used for unknown indication9038
3Non-small cell lung cancer8402
4Colon cancer7942
5Breast cancer7350
6Colorectal cancer5623
7Breast cancer metastatic5206
8Colon cancer metastatic4554
9Glioblastoma4430
10Ovarian cancer4164

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for AVASTIN

Total Reports Filed with FDA: 159253


Number of FDA Adverse Event Reports by Patient Age for AVASTIN

Total Reports Filed with FDA: 159253*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bevacizumab (Avastin)

Charts are based on 159253 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and AVASTIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.