FDA-filed SPL labeling · retrieved through openFDA

Venetoclax

Venetoclax is a targeted cancer medicine used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and certain cases of newly diagnosed acute myeloid leukemia (AML) in adults.

Brand name Venclexta
Drug class ⓘ Bcl-2 Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 20, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2016
FDA-listed product records ⓘ24
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Venetoclax at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Venetoclax (Venclexta) is a once-daily oral targeted therapy for CLL, SLL, and certain cases of AML that works by restoring the natural death process in cancer cells. Its most critical risk is tumor lysis syndrome, a potentially life-threatening reaction that requires careful dose ramp-up, preventive hydration, and close monitoring at the start of treatment. Many drug and food interactions can significantly change how much venetoclax your body absorbs, so always review your full medication list with your care team.

📖 Venetoclax: Patient Information Guide

A plain-language walkthrough of Venetoclax — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Venetoclax is a targeted oral cancer medicine approved for adults with certain blood cancers. Here are the conditions it is used for:

  • Chronic lymphocytic leukemia (CLL) — Venclexta treats adult patients with CLL, either alone (monotherapy) or in combination with obinutuzumab, rituximab, or acalabrutinib
  • Small lymphocytic lymphoma (SLL) — Venclexta treats adult patients with SLL, using the same combinations as for CLL
  • Acute myeloid leukemia (AML) — newly diagnosed — Venclexta is used in combination with azacitidine, or decitabine, or low-dose cytarabine, specifically in adults aged 75 or older, or those who cannot tolerate intensive induction chemotherapy due to other health conditions
⚙️How it works▾

Venetoclax targets a protein called BCL-2, which acts like a survival switch for cancer cells — it blocks them from dying naturally. In CLL and AML, cancer cells overproduce BCL-2, helping them survive and resist chemotherapy. Venetoclax binds directly to BCL-2, displacing other proteins (like BIM) that normally trigger cell death. This restarts the programmed cell death process — called apoptosis — and causes the cancer cells to self-destruct.

Because cancer cells in CLL and AML rely so heavily on BCL-2 to survive, selectively blocking it can kill them while limiting damage to normal cells that don't depend on BCL-2 in the same way.

💊How it's taken▾

Venclexta tablets are taken once daily by mouth with a meal and water. Food is required — it significantly increases how much of the drug your body absorbs, so never take it on an empty stomach. Treatment always begins with a gradual dose ramp-up over several weeks to reduce the risk of tumor lysis syndrome; the ramp-up schedule differs between CLL/SLL and AML.

  • For CLL/SLL, the ramp-up takes 5 weeks, starting at a low dose and increasing weekly
  • For AML, the ramp-up is shorter (3–4 days), with the full dose reached quickly and continued throughout each 28-day cycle alongside the partner medicine
  • Venclexta tablets can be crushed without affecting how the drug is absorbed
  • If a dose is interrupted and then restarted, follow your prescriber's guidance on how to resume safely
🤒Side effects — in detail▾

Some side effects are very common with venetoclax, especially affecting blood counts. Here's what to expect:

  • Neutropenia (low white blood cells) — very common; raises infection risk
  • Thrombocytopenia (low platelets) — can cause bruising or bleeding
  • Anemia (low red blood cells) — may cause fatigue or weakness
  • Diarrhea and nausea — common, especially in the early weeks
  • Vomiting and constipation — particularly noted in AML treatment
  • Fatigue — reported across all uses
  • Upper respiratory infections and cough — common in CLL/SLL treatment
  • Muscle and bone pain — reported across treatment settings

Seek medical help right away for signs of serious infection (fever, chills, shortness of breath), or any symptoms of tumor lysis syndrome such as muscle cramps, confusion, rapid heartbeat, or very little urination — these are urgent.

⚠️Warnings & precautions▾
  • Tumor lysis syndrome (TLS): The most serious risk. When venetoclax kills cancer cells rapidly, their contents can flood the bloodstream and cause kidney failure or death. TLS can begin within hours of the first dose. A careful ramp-up schedule, preventive hydration, and anti-hyperuricemic medicines (to reduce uric acid) are required before and during early treatment. Patients at higher risk may need hospitalization and IV fluids.
  • Severe neutropenia: Most patients develop very low white blood cell counts, raising the risk of life-threatening infections including pneumonia and sepsis. Blood counts are monitored throughout treatment, and dose pauses or adjustments may be needed.
  • Serious infections: Fatal infections have occurred. Report any fever, chills, or signs of illness to your care team immediately.
  • Live vaccines: Do not receive any live vaccines during or after venetoclax treatment until your B-cells (immune cells) have recovered. All vaccines may be less effective during treatment.
  • Embryo-fetal toxicity: Venetoclax can harm an unborn baby. Women who can become pregnant must use effective contraception during treatment and for 30 days after the last dose.
  • Multiple myeloma caution: Venclexta is NOT recommended for multiple myeloma in combination with bortezomib and dexamethasone outside of clinical trials — a clinical study showed increased deaths with this combination.
🔀What it interacts with▾

Venetoclax is sensitive to many drug and food interactions that can make it too strong or too weak:

  • Strong CYP3A inhibitors (e.g., certain antifungals like ketoconazole, some antibiotics like clarithromycin) — significantly raise venetoclax levels; contraindicated at treatment start and during ramp-up in CLL/SLL patients; dose adjustment required in AML
  • Moderate CYP3A inhibitors and P-gp inhibitors — also raise venetoclax levels and increase side effect risk; dose adjustments are needed
  • Strong or moderate CYP3A inducers (e.g., rifampin, certain anti-seizure medicines) — lower venetoclax levels and reduce its effectiveness; avoid combining with venetoclax
  • Warfarin — venetoclax raises warfarin levels, increasing bleeding risk; INR (blood-thinning level) must be checked more often
  • P-gp substrate medicines — venetoclax raises their levels; if unavoidable, take the P-gp substrate at least 6 hours before venetoclax
  • Grapefruit, Seville oranges, and starfruit — naturally contain CYP3A inhibitors; avoid all forms (fruit, juice) throughout treatment

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Tell your doctor about all medicines, supplements, and herbal products you take — many common drugs interact with venetoclax
  • Patients with reduced kidney function are at higher risk of tumor lysis syndrome and require extra precautions and monitoring
  • Patients with severe liver impairment require a dose reduction — tell your doctor about any liver problems
  • Venetoclax is not approved for children; its safety and effectiveness have not been established in pediatric patients
  • Pregnancy must be ruled out before starting treatment; women of childbearing age must use effective contraception during treatment and for 30 days after the last dose
  • Do not breastfeed during treatment or for 1 week after the last dose
  • Men should be aware that venetoclax may impair fertility based on animal studies
  • Older adults (65+) with CLL/SLL: no major differences in effectiveness, but fatal side effects may be slightly more frequent in those 65 and older — close monitoring is important
  • Do not use venetoclax combined with bortezomib and dexamethasone for multiple myeloma outside of a clinical trial — this combination increased deaths in a clinical study
🚑If you take too much▾

There is no specific antidote if too much venetoclax is taken. If an overdose occurs, medical staff will monitor closely and provide supportive care. During the dose ramp-up phase, the drug should be stopped and the patient monitored carefully for tumor lysis syndrome and other serious effects. Because venetoclax binds extensively to proteins in the blood and distributes widely in the body, dialysis is not expected to remove meaningful amounts of the drug.

📡Pharmacodynamics — effects in the body▾

Higher levels of venetoclax in the blood are associated with a greater likelihood of response in both CLL/SLL and AML patients. In AML patients, higher drug exposure is also linked to a greater chance of certain side effects. Studies showed no meaningful effect on the heart's electrical conduction (QTc interval) even at doses twice the maximum approved amount, suggesting venetoclax does not carry a significant cardiac rhythm risk.

🔬Pharmacokinetics — how your body processes it▾

After taking venetoclax with food, peak blood levels are reached in about 5 to 8 hours. Food has a major effect on absorption — eating a low-fat meal increases exposure about 3-fold, and a high-fat meal increases it 5-fold compared to fasting, which is why venetoclax must always be taken with food. The drug binds very extensively to proteins in the blood and is primarily broken down by the liver (CYP3A enzyme system), with more than 99% eliminated through the feces. Venetoclax levels remain consistent over time — they do not increase or decrease with repeated dosing.

📦How to store it▾

Store in original container at or below 86°F (30°C). protect from moisture.

📄 Written from Venetoclax’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

144

Supplements & herbs that interact with Venetoclax

144 supplements and herbal products have documented interactions with Venetoclax in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 103
  • Minor · 38
Every supplement checked against Venetoclax — ranked by severity The full interaction hub: 3 major · 103 moderate · 38 minor · every one linked to its full report. Check Venetoclax against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Venetoclax — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is venetoclax and why has my doctor prescribed it? ▾
Venetoclax is a targeted cancer medicine that specifically attacks leukemia cells by blocking a protein called BCL-2, which those cells use to survive. Your doctor likely prescribed it because you have chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or a newly diagnosed form of acute myeloid leukemia (AML) — and it's approved for all of those. It works differently from traditional chemotherapy — instead of broadly attacking fast-dividing cells, it zeroes in on a specific survival mechanism that leukemia cells depend on.
Why do I have to start at such a low dose and increase it slowly? ▾
That gradual increase — called the ramp-up schedule — is one of the most important safety measures with this drug. When venetoclax starts killing leukemia cells, it can do so very quickly, and the contents of those dying cells can flood your bloodstream. This is called tumor lysis syndrome, and it can be dangerous or even life-threatening. Starting low and increasing slowly gives your body time to clear those byproducts safely. You'll also likely be given extra fluids and medicines to protect your kidneys during this time.
Do I have to take it with food every time? ▾
Yes, every single time. Taking venetoclax with a meal is not optional — food dramatically increases how much of the drug your body actually absorbs. Taking it on an empty stomach means your body gets far less of it, which could make treatment less effective. A regular meal — not necessarily a heavy one — is all you need. Just be sure to avoid grapefruit, Seville oranges, and starfruit in any form, because these fruits can raise drug levels too high and increase side effect risk.
What side effects should I actually watch out for and call about right away? ▾
The two most urgent things to watch for are signs of tumor lysis syndrome and signs of serious infection. For tumor lysis syndrome, look out for muscle cramps, confusion, irregular heartbeat, or a big drop in how much you're urinating — these can happen within hours of starting or increasing your dose. For infection, call your care team immediately if you develop a fever, chills, or feel suddenly very unwell — your white blood cell count will likely be low during treatment, which makes infections more dangerous. These aren't things to wait out.
Are there any medicines, foods, or supplements I need to avoid? ▾
Yes, and this is really important. Many common medicines can interfere with venetoclax — some raise its levels dangerously high (like certain antifungals and some antibiotics), and some lower it so much it may not work (like certain seizure medicines or rifampin). Even grapefruit juice can cause problems. Before starting venetoclax, share a complete list of everything you take — prescriptions, over-the-counter medicines, vitamins, and herbal products — with your care team. If your doctor ever adds a new medicine, double-check for interactions.
Is it safe to get vaccinated or to become pregnant while on this medicine? ▾
Live vaccines — like the live flu mist or certain travel vaccines — should not be given while you're on venetoclax or until your immune cells have recovered afterward, because the drug affects your immune system. Regular (non-live) vaccines may still be given but could be less effective. As for pregnancy: venetoclax can cause serious harm to a developing baby, so it's essential to use reliable contraception throughout treatment and for 30 days after your last dose. If you're pregnant or think you might be, tell your doctor immediately before starting.
Is Venetoclax available over the counter? ▾
Venetoclax is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Venetoclax first available? ▾
Venetoclax has been available in the United States since at least 2016, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Venetoclax? ▾
Venetoclax is supplied by 8 manufacturers listed in the FDA NDC Directory, including AbbVie Inc., AbbVie Ireland NL B.V., AbbVie Biotechnology LTD.

💬 Answers drafted from Venetoclax’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Venetoclax comes

Venetoclax is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Venclexta
How this form is used
What it may be used for
  • Venclexta tablets are used to treat adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), alone or with other medicines
  • Venclexta tablets are used in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults 75 or older, or those who cannot tolerate intensive chemotherapy
Important instructions
  • Venclexta tablets are taken by mouth once daily with a meal and water — do not take on an empty stomach
  • Venclexta is started at a low dose and increased gradually over several weeks (ramp-up schedule) to reduce the risk of tumor lysis syndrome — follow your prescriber's schedule exactly
  • Venclexta tablets may be crushed if needed without affecting the amount of drug absorbed
  • Avoid grapefruit, Seville oranges, and starfruit throughout Venclexta treatment, as they can raise drug levels to unsafe amounts
Available strengths 4 strengths
16 FDA-listed product records ⓘ

📊 Venetoclax across the U.S. market

How Venetoclax appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
8
Manufacturers
1
Brand names
24
FDA-listed product records ⓘ
2016
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (5) · Kit (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

AbbVie Inc.63%
AbbVie Ireland NL B.V.13%
AbbVie Biotechnology LTD4%
Dr. Reddy's Laboratories Limited4%
Fournier Laboratories Ireland LTD4%
Hetero Labs Limited4%
Other makers8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Venetoclax is used

A general measure of how commonly Venetoclax is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Venetoclax is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,880
Medicaid prescriptions filled (Q1–Q4 2025)
$32.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Venetoclax prescribed? Of the 1,597 medications we measure, Venetoclax ranks #1,133 by Medicaid prescriptions — more than 29% of them.

Where Venetoclax ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Venetoclax product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral tablet is the most-dispensed Venetoclax product — about 97% of these Medicaid prescriptions.

venetoclax 100 MG Oral Tablet Most dispensed

2,796 Medicaid prescriptions (Q1–Q4 2025) 97% of Venetoclax prescriptions shown $31.9M gross reimbursement (before rebates) ≈ $11,414 per prescription (gross)

Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1747561

venetoclax 50 MG Oral Tablet

31 Medicaid prescriptions (Q1–Q4 2025) 1% of Venetoclax prescriptions shown $40,864 gross reimbursement (before rebates) ≈ $1,318 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1747574

venetoclax 10 MG Oral Tablet

29 Medicaid prescriptions (Q1–Q4 2025) 1% of Venetoclax prescriptions shown $22,019 gross reimbursement (before rebates) ≈ $759 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1747572

Other Venetoclax products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

24 Medicaid prescriptions (Q1–Q4 2025) <1% of Venetoclax prescriptions shown $81,151 gross reimbursement (before rebates) ≈ $3,381 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Venetoclax, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 19 listed Venetoclax NDCs with Medicaid activity.

🔍 Compare Venetoclax products

A representative set of FDA-listed product records for Venetoclax — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Venetoclax NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Venetoclax RxCUI 1747556 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1747560 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 1747572 50 MG RxCUI 1747574 100 MG RxCUI 1747561

Look up RxCUI 1747556 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Venclexta

🏭 Manufacturers & labelers

AbbVie Inc. 15 AbbVie Ireland NL B.V. 3 AbbVie Biotechnology LTD 1 Dr. Reddy's Laboratories Limited 1 Fournier Laboratories Ireland LTD 1 Hetero Labs Limited 1 MSN Laboratories Private Limited 1 Natco Pharma Limited 1

RxNorm drug class

Venetoclax belongs to the BCL-2 Inhibitor class.

Pharmacologic class BCL-2 Inhibitor
Drug family (ATC) Other antineoplastic agents
How it works P-Glycoprotein Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Venetoclax.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Venetoclax after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
24
Distinct labelers/manufacturers represented
8
Linked representative label ⓘ
AbbVie Inc.
Linked label effective
May 20, 2026
Composite sections available
22
Linked SPL Set ID
b118a40d-6b56-cee3-10f6-ded821a97018
Linked SPL Document ID
5d893369-497c-46ee-9b64-ee737fab4225
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AbbVie Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.