Pharmacologic class (EPC) · 2 drug pages

BCL-2 inhibitor: adverse event reports filed with FDA

57,562 reports list a drug in this class as a suspect or interacting product, 2014–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

57,562
reports across the class: 0.3% of all reports; 6,424
reports, 12 months to June 2026: 6,532 in the 12 months before; 90.7%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

BCL-2 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 57,562 adverse event reports received by FDA, 0.3% of the database, from May 2014 to June 2026.

6,424 reports arrived in the 12 months to June 2026, close to the 6,532 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 90.7% of the class's reports are marked serious, 28.4% record death among the outcomes and 38.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (17.1%), off label use (11.1%) and neutropenia (5.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
VenclextaVenetoclax	brand	35,195	3,239	86.6%	Death
Venetoclax	generic	22,367	3,185	97.1%	Neutropenia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Deaththe patient died; cause not stated by this term17.1%9,842
Off label useused for a purpose or in a way not on the label11.1%6,364
Neutropenialow neutrophils, a type of white blood cell5.6%3,247
Febrile neutropeniafever with low white blood cells4.9%2,832
Platelet count decreasedlow platelet count4.6%2,661
Myelosuppression4.5%2,567
Pyrexiafever4.5%2,567
Fatiguetiredness4.4%2,505
Pneumonialung infection4.2%2,443
Diarrhoealoose or frequent stools3.9%2,234
White blood cell count decreasedlow white cell count3.8%2,185
Thrombocytopenialow platelets3.4%1,981
Nauseafeeling sick3.4%1,978
Infectionan infection, type not specified3.3%1,878
Anaemialow red blood cells3.1%1,806
Acute myeloid leukaemia2.9%1,697
Astheniaweakness or lack of energy2.9%1,693
Covid-19COVID-19 infection2.7%1,569
Haemoglobin decreasedlow haemoglobin2.7%1,537
Disease progressionthe disease advanced2.4%1,391
Drug ineffectivethe medicine did not work as expected2.4%1,353
Hospitalisationadmission to hospital2.3%1,310
Sepsisa severe body-wide response to infection2.1%1,209
Pancytopenialow counts of all blood cells2%1,166
Atrial fibrillationan irregular heart rhythm2%1,136

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death28.4%16,357

Life-threatening3.4%1,970

Hospitalisation (initial or prolonged)38.7%22,277

Disability0.6%371

Congenital anomaly0%14

Other serious44.5%25,609

Not serious9.3%5,358

Patient age

Under 20.1%54

2 to 110.7%402

12 to 170.5%316

18 to 443.3%1,923

45 to 6413.7%7,871

65 to 7419.3%11,093

75 and over19.5%11,209

Age not given42.9%24,694

Who reported

Physician36%20,720

Pharmacist2.5%1,415

Other health professional16.6%9,540

Lawyer0%3

Consumer or non-health professional44.3%25,528

Not given0.6%356

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about BCL-2 inhibitor reports

Which drugs are in the BCL-2 inhibitor class on this site?

Venclexta and Venetoclax. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

57,562 reports through June 2026, 6,424 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

death (17.1%), off label use (11.1%), neutropenia (5.6%), febrile neutropenia (4.9%) and platelet count decreased (4.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.