BEVACIZUMAB

85/100 · Critical

Manufactured by Genentech, Inc.

Bevacizumab Adverse Events: High Seriousness and Diverse Reactions

204,762 FDA adverse event reports analyzed

Last updated: 2026-05-12

About BEVACIZUMAB

BEVACIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 204,762 FDA adverse event reports, BEVACIZUMAB has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for BEVACIZUMAB include OFF LABEL USE, DEATH, DISEASE PROGRESSION, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BEVACIZUMAB.

AI Safety Analysis

Bevacizumab has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 204,762 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..

The most commonly reported adverse events include Off Label Use, Death, Disease Progression. Of classified reports, 91.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Bevacizumab reports include a high percentage of serious adverse events, with death being one of the most common.

The drug is associated with a wide range of reactions, including gastrointestinal, hematological, and respiratory issues. Fatigue, nausea, and diarrhea are among the most frequently reported non-serious adverse events.

Patients taking Bevacizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 85/100

Bevacizumab received a safety concern score of 85/100 (high concern). This is based on a 91.1% serious event ratio across 118,680 classified reports. The score accounts for 204,762 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Top Adverse Reactions

OFF LABEL USE13,542 reports
DEATH12,987 reports
DISEASE PROGRESSION7,200 reports
DIARRHOEA7,113 reports
NAUSEA6,315 reports
FATIGUE6,126 reports
HYPERTENSION5,689 reports
VOMITING4,825 reports
ANAEMIA4,274 reports
PYREXIA3,948 reports
NEUTROPENIA3,871 reports
ASTHENIA3,438 reports
DECREASED APPETITE3,328 reports
DYSPNOEA3,315 reports
THROMBOCYTOPENIA3,228 reports
DRUG INEFFECTIVE3,136 reports
PROTEINURIA2,945 reports
ABDOMINAL PAIN2,786 reports
NEUROPATHY PERIPHERAL2,756 reports
MALIGNANT NEOPLASM PROGRESSION2,589 reports
HEADACHE2,327 reports
RASH2,273 reports
CONSTIPATION2,255 reports
NO ADVERSE EVENT2,216 reports
PAIN2,210 reports
INTENTIONAL PRODUCT USE ISSUE2,190 reports
PLATELET COUNT DECREASED2,177 reports
FEBRILE NEUTROPENIA2,109 reports
EPISTAXIS2,099 reports
DEHYDRATION2,011 reports
MYELOSUPPRESSION1,961 reports
PULMONARY EMBOLISM1,953 reports
PNEUMONIA1,943 reports
WEIGHT DECREASED1,910 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,836 reports
WHITE BLOOD CELL COUNT DECREASED1,736 reports
MALAISE1,729 reports
NEUTROPHIL COUNT DECREASED1,622 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME1,553 reports
SEPSIS1,484 reports
STOMATITIS1,465 reports
ASCITES1,431 reports
LEUKOPENIA1,402 reports
BLOOD PRESSURE INCREASED1,381 reports
COUGH1,370 reports
DIZZINESS1,354 reports
ARTHRALGIA1,348 reports
MUCOSAL INFLAMMATION1,344 reports
HAEMORRHAGE1,334 reports
INTERSTITIAL LUNG DISEASE1,290 reports
PLEURAL EFFUSION1,267 reports
INFECTION1,235 reports
ALOPECIA1,230 reports
DEEP VEIN THROMBOSIS1,220 reports
BACK PAIN1,197 reports
NEOPLASM PROGRESSION1,180 reports
HAEMOGLOBIN DECREASED1,148 reports
ENDOPHTHALMITIS1,144 reports
HYPOTENSION1,134 reports
METASTASES TO LIVER1,096 reports
URINARY TRACT INFECTION1,095 reports
VISUAL IMPAIRMENT1,091 reports
ACUTE KIDNEY INJURY1,087 reports
GASTROINTESTINAL PERFORATION1,077 reports
BLINDNESS1,071 reports
FALL1,014 reports
INTESTINAL OBSTRUCTION1,008 reports
BONE MARROW FAILURE1,007 reports
CHEST PAIN1,002 reports
CONFUSIONAL STATE992 reports
RENAL FAILURE984 reports
CEREBROVASCULAR ACCIDENT967 reports
RENAL IMPAIRMENT945 reports
HYPERSENSITIVITY940 reports
HEPATIC FUNCTION ABNORMAL932 reports
HYPOKALAEMIA930 reports
ALANINE AMINOTRANSFERASE INCREASED926 reports
PAIN IN EXTREMITY926 reports
INTESTINAL PERFORATION918 reports
PRURITUS912 reports
OEDEMA PERIPHERAL907 reports
ASPARTATE AMINOTRANSFERASE INCREASED906 reports
BLOOD CREATININE INCREASED875 reports
PARAESTHESIA875 reports
ABDOMINAL PAIN UPPER874 reports
ERYTHEMA874 reports
HYPONATRAEMIA853 reports
THROMBOSIS845 reports
HYPOAESTHESIA831 reports
GASTROINTESTINAL HAEMORRHAGE822 reports
CARDIAC FAILURE816 reports
METASTASES TO LUNG812 reports
VISUAL ACUITY REDUCED794 reports
TOXICITY TO VARIOUS AGENTS781 reports
HEPATIC FAILURE774 reports
CONDITION AGGRAVATED770 reports
VISION BLURRED747 reports
NEUROTOXICITY739 reports
THERAPY PARTIAL RESPONDER735 reports
COLITIS733 reports

Key Safety Signals

  • High percentage of serious adverse events (91.1%)
  • Multiple hematological issues like anemia, neutropenia, and thrombocytopenia
  • Significant respiratory issues including dyspnea and interstitial lung disease

Patient Demographics

Adverse event reports by sex: Female: 52,772, Male: 44,624, Unknown: 1,166. The most frequently reported age groups are age 65 (2,331 reports), age 70 (2,209 reports), age 60 (2,134 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 118,680 classified reports for BEVACIZUMAB:

  • Serious: 108,109 reports (91.1%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 10,571 reports (8.9%)
Serious 91.1%Non-Serious 8.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female52,772 (53.5%)
Male44,624 (45.3%)
Unknown1,166 (1.2%)

Reports by Age

Age 652,331 reports
Age 702,209 reports
Age 602,134 reports
Age 632,119 reports
Age 672,086 reports
Age 622,063 reports
Age 692,053 reports
Age 662,043 reports
Age 682,000 reports
Age 641,986 reports
Age 721,932 reports
Age 611,863 reports
Age 591,848 reports
Age 731,817 reports
Age 711,792 reports
Age 581,760 reports
Age 561,695 reports
Age 571,688 reports
Age 741,636 reports
Age 751,544 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat

What You Should Know

If you are taking Bevacizumab, here are important things to know. The most commonly reported side effects include off label use, death, disease progression, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and monitoring of vital signs are recommended to detect potential adverse events early. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

The FDA continues to monitor Bevacizumab for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines.

Frequently Asked Questions

How many adverse event reports has the FDA received for Bevacizumab?

The FDA has received approximately 204,762 adverse event reports associated with Bevacizumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What are the most commonly reported side effects of Bevacizumab?

The most frequently reported adverse events for Bevacizumab include Off Label Use, Death, Disease Progression, Diarrhoea, Nausea. By volume, the top reported reactions are: Off Label Use (13,542 reports), Death (12,987 reports), Disease Progression (7,200 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bevacizumab.

What percentage of Bevacizumab adverse event reports are serious?

Out of 118,680 classified reports, 108,109 (91.1%) were classified as serious and 10,571 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Bevacizumab (by sex)?

Adverse event reports for Bevacizumab break down by patient sex as follows: Female: 52,772, Male: 44,624, Unknown: 1,166. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Bevacizumab?

The most frequently reported age groups for Bevacizumab adverse events are: age 65: 2,331 reports, age 70: 2,209 reports, age 60: 2,134 reports, age 63: 2,119 reports, age 67: 2,086 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Bevacizumab?

The primary manufacturer associated with Bevacizumab adverse event reports is Genentech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Bevacizumab?

Beyond the most common reactions, other reported adverse events for Bevacizumab include: Fatigue, Hypertension, Vomiting, Anaemia, Pyrexia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Bevacizumab?

You can report adverse events from Bevacizumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Bevacizumab's safety score and what does it mean?

Bevacizumab has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Bevacizumab reports include a high percentage of serious adverse events, with death being one of the most common.

What are the key safety signals for Bevacizumab?

Key safety signals identified in Bevacizumab's adverse event data include: High percentage of serious adverse events (91.1%). Multiple hematological issues like anemia, neutropenia, and thrombocytopenia. Significant respiratory issues including dyspnea and interstitial lung disease. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Bevacizumab interact with other drugs?

Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bevacizumab.

What should patients know before taking Bevacizumab?

Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and monitoring of vital signs are recommended to detect potential adverse events early.

Are Bevacizumab side effects well-documented?

Bevacizumab has 204,762 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including gastrointestinal, hematological, and respiratory issues. The volume of reports for Bevacizumab reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Bevacizumab?

The FDA continues to monitor Bevacizumab for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to BEVACIZUMAB based on therapeutic use, drug class, or shared indications:

CisplatinPaclitaxelDocetaxelCarboplatinEtoposide
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.