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Venetoclax Side Effects

The most commonly reported side effects of venetoclax include death, off label use, and neutropenia, based on 57,916 FDA adverse event reports from 2011 to 2025. 2.6% of reports found the drug to be ineffective.

Venetoclax side effects

Percentages show how often each reaction appears relative to total reports for venetoclax.

1
Death16.8%9,742
2
Off Label Use11.2%6,503
3
Neutropenia5.6%3,217
4
Febrile Neutropenia5.1%2,971
5
Platelet Count Decreased4.5%2,622
6
Pyrexia4.4%2,569
7
Pneumonia4.4%2,542
8
Fatigue4.3%2,482
9
Diarrhoea3.9%2,262
10
Myelosuppression3.7%2,143
11
White Blood Cell Count Decreased3.6%2,103
12
Nausea3.4%1,996
13
Thrombocytopenia3.4%1,964
14
Infection3.2%1,855
15
Anaemia3.2%1,843

These are voluntary reports and do not establish that venetoclax caused these reactions.

Report severity

90.2%Serious52,253 reports
38.7%Hospitalizations22,437 reports
28.5%Fatal16,525 reports

Seriousness is determined by the reporter, not by OpenClaim.

Venetoclax drug interactions

Other drugs that appear in adverse event reports alongside venetoclax. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Azacitidine13.5%7,811
2
Ibrutinib6.6%3,850
3
Rituximab6.2%3,593
4
Obinutuzumab4.6%2,691
5
Cyclophosphamide3.3%1,883
6
Cytarabine3.2%1,880
7
Dexamethasone2.7%1,547
8
Vincristine-sulfate2.3%1,337
9
Doxorubicin-hydrochloride2.2%1,298
10
Prednisone1.9%1,123
11
Decitabine1.9%1,087
12
Etoposide1.6%910
13
Fludarabine-phosphate1.5%848
14
Bendamustine-hydrochloride1.3%779
15
Methotrexate1.2%701

Taken alongside

1
Allopurinol13.7%7,962
2
Acyclovir12.0%6,954
3
Ondansetron8.5%4,897
4
Acetaminophen7.3%4,246
5
Azacitidine6.5%3,775
6
Pantoprazole-sodium5.0%2,902
7
Levofloxacin4.7%2,751
8
Ergocalciferol4.7%2,701
9
Levothyroxine-sodium4.6%2,652
10
Atorvastatin-calcium4.5%2,629
11
Metoprolol4.5%2,619
12
Aspirin4.2%2,444
13
Furosemide4.2%2,439
14
Omeprazole4.2%2,410
15
Sulfamethoxazole4.0%2,342

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports venetoclax side effects

34.6% of venetoclax adverse event reports involve female patients and 55.7% involve male patients. The largest age group is elderly at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.6%
Male55.7%
Unknown9.7%

Age group

< 20.2%
2–111.3%
12–170.9%
18–6431.4%
65+66.3%

What is venetoclax used for

Conditions and purposes for which patients were taking venetoclax when the adverse event was reported.

5q Minus Syndrome5q Minus SyndromeAbdominal LymphadenopathyAbdominal MassAbdominal PainAbnormal DreamsAbnormal Loss Of WeightAcute Biphenotypic LeukaemiaAcute Erythroid LeukaemiaAcute Graft Versus Host DiseaseAcute Kidney InjuryAcute Left Ventricular FailureAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic Leukaemia

Showing 15 of 854 indications

Venetoclax brand names and reporting trend

Venetoclax is sold under the brand name Venetoclax.

Brand names

Venetoclax46,548

Quarterly reports (20112025)

20112016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking venetoclax with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.