Venetoclax Brand names: Venclexta

What is venetoclax used for?

From the label: indications and usage

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. […]

Conditions named in the indications of venetoclax's FDA labels, with every medicine labeled for each:

• Leukemia, lymphoma and myeloma

FDA pharmacologic class: BCL-2 Inhibitor.

What does the patient leaflet for venetoclax say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with VENCLEXTA, including: ○ fever ○ chills ○ nausea ○ vomiting ○ confusion ○ shortness of breath ○ seizures ○ irregular heartbeat ○ dark or cloudy urine ○ unusual tiredness ○ muscle or joint pain Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS . Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose. See " What are the possible side effects of VENCLEXTA? " for more information about side effects.

From the patient leaflet: What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit during treatment with VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

From the patient leaflet: How should I store VENCLEXTA?

Store VENCLEXTA at or below 86°F (30°C). Keep VENCLEXTA in its original packaging or container to protect from moisture. Keep VENCLEXTA and all medicines out of reach of children.

Is there a generic for venetoclax (Venclexta)?

The FDA approved the first generic venetoclax on May 15, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

The Orange Book lists 10 patents for Venclexta tablets: the compound patent runs to January 29, 2032, and the last listed entry to September 6, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What does the venetoclax label say about other medicines?

The venetoclax label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name venetoclax. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name venetoclax

• Cedazuridine and decitabine
• Itraconazole
• Posaconazole
• Ritonavir
• Voriconazole

Check venetoclax against other medicines

What do FAERS reports show for venetoclax?

The FDA Adverse Event Reporting System holds 61,220 reports that list venetoclax among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17,332 are coded as a death and 23,668 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 691
• 1,800
• 3,586
• 5,067
• 5,630
• 6,270
• 11,152
• 8,891
• 7,507
• 7,297
• 3,302

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Death (an outcome recorded in the report)10,178
• Off Label Use (a use or a product term, not a reaction)6,840
• Neutropenia (named in the label)3,427
• Febrile Neutropenia (named in the label)3,114
• Platelet Count Decreased2,824
• Pyrexia (named in the label)2,765
• Pneumonia (named in the label)2,672
• Myelosuppression2,662

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as venetoclax?

37 other medicines are given the same way (oral) and in the same FDA class as venetoclax or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

What next?

Venetoclax side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other