Venclextavenetoclax
According to the FDA label: VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
59,616 adverse event reports submitted to the FDA (2014–2026)
Top Reported Adverse Events
The most frequently reported events in association with Venclexta in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Death 9,996 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Off Label Use 6,655 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Neutropenia 3,339 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Febrile Neutropenia 3,033 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Platelet Count Decreased 2,723 reports
A blood test result showing a low level of platelets, the cells that help blood clot. This is the lab-measurement version of thrombocytopenia.
Full definition in the glossary →Pyrexia 2,658 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 2,605 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Fatigue 2,546 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Myelosuppression 2,438 reports
A decrease in the bone marrow's production of blood cells, which can lower red cells, white cells, and platelets. Common with some cancer treatments.
Full definition in the glossary →Diarrhoea 2,308 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →White Blood Cell Count Decreased 2,194 reports
A blood test result showing a low level of white blood cells, which help fight infection.
Full definition in the glossary →Nausea 2,060 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Thrombocytopenia 2,043 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Infection 1,926 reports
A general report of an infection, used when no more specific type is given.
Full definition in the glossary →Anaemia 1,881 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 33,154 |
| Female | 20,607 |
| Unknown | 2 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,018 |
| 18-34 | 1,130 |
| 35-49 | 1,851 |
| 50-64 | 7,302 |
| 65-74 | 11,528 |
| 75+ | 11,514 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Venclexta. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 26,907 |
| Hospitalization | 22,994 |
| Death | 16,938 |
| Non-Serious | 5,739 |
| Life-Threatening | 2,217 |
| Disability | 403 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Venclexta. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2014 | 4 |
| 2015 | 23 |
| 2016 | 691 |
| 2017 | 1,800 |
| 2018 | 3,586 |
| 2019 | 5,067 |
| 2020 | 5,630 |
| 2021 | 6,270 |
| 2022 | 11,152 |
| 2023 | 8,892 |
| 2024 | 7,505 |
| 2025 | 7,285 |
| 2026 (partial) | 1,711 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Venclexta
In FDA adverse event reports that mention Venclexta, these medications appeared most often in the same report.
- Azacitidine (12,033 reports)
- Azacitidine For (10,121 reports)
- Allopurinol (7,846 reports)
- Acyclovir (5,298 reports)
- Ibrutinib (4,550 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026