VENCLEXTA FDA MedWatch Direct Reports Summary

These tables and charts are created from 604 voluntary U.S. reports for VENCLEXTA (VENETOCLAX) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS VENCLEXTA Report.

Top Adverse Effects Associated with VENCLEXTA (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEATH	259
2	THERAPY INTERRUPTED	44
3	HOSPITALIZATION	42
4	FATIGUE	26
5	NAUSEA	23
6	PNEUMONIA	21
7	LACK OF STRENGTH AND ENERGY (ASTHENIA)	19
8	DIARRHEA	17
9	FALL	14
10	PLATELET COUNT DECREASED	14
11	LOW WHITE BLOOD CELL COUNTS	12
12	THERAPY CESSATION	12
13	WHITE BLOOD CELL COUNT DECREASED	12
14	DISEASE PROGRESSION	10
15	FEVER	10
16	FEBRILE NEUTROPENIA	9
17	COVID-19	8
18	HOSPICE CARE	8
19	ILLNESS	8
20	INFECTION	8
21	PAIN	8
22	CONSTIPATION	7
23	DRUG INEFFECTIVE	7
24	FEELING ABNORMAL	7
25	STROKE	6

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VENCLEXTA Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
351	236	17	604

Medwatch Reporter Type	Count
Consumer	169
Physician	18
Pharmacist	62
Other Health Professional	77

Top Indications

Acute myeloid leukaemia
Chronic lymphocytic leukaemia
Product used for unknown indication
Myelodysplastic syndrome
Plasma cell myeloma

Type of Outcome Reported
Serious: 552
Not Serious: 52
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 604
Concomitant Drugs: 114
Note: A single MedWatch report can list more than one drug. This summary includes VENCLEXTA identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

VENCLEXTA (VENETOCLAX) Rx Drug:
FDA Safety-related Labeling Changes

New combination regimen Venclexta in combination with acalabrutinib; neutropenia, clinical trial results

Have experience (good or bad) with VENCLEXTA? Rate VENCLEXTA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.