Pharmacologic class (EPC) · 2 drug pages

CD30-directed immunoconjugate: adverse event reports filed with FDA

10,107 reports list a drug in this class as a suspect or interacting product, 2011–2026.

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.

10,107
reports across the class: 0.1% of all reports; 892
reports, 12 months to June 2026: 1,462 in the 12 months before; 91.3%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

CD30-directed immunoconjugate 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 10,107 adverse event reports received by FDA, 0.1% of the database, from March 2011 to June 2026.

892 reports arrived in the 12 months to June 2026, down 39% from 1,462 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 91.3% of the class's reports are marked serious, 19.3% record death among the outcomes and 38.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (12.9%), febrile neutropenia (7.4%) and neuropathy peripheral (7%). 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
AdcetrisBrentuximab vedotin	brand	5,820	362	85.6%	Off label use
Brentuximab vedotin	generic	4,287	530	99.1%	Off label use

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

Off label useused for a purpose or in a way not on the label12.9%1,302
Febrile neutropeniafever with low white blood cells7.4%752
Neuropathy peripheralnerve damage in hands or feet7%707
Pyrexiafever7%703
Neutropenialow neutrophils, a type of white blood cell5.6%571
Deaththe patient died; cause not stated by this term5.6%570
Hodgkin's disease4.5%453
Nauseafeeling sick3.9%397
Diarrhoealoose or frequent stools3.9%393
Anaemialow red blood cells3.8%388
Thrombocytopenialow platelets3.5%358
Disease progressionthe disease advanced3.4%339
Pneumonialung infection3.3%333
Drug ineffectivethe medicine did not work as expected3.1%318
Weight decreasedweight loss3.1%314
Vomitingbeing sick3%308
Rashskin rash2.7%270
Sepsisa severe body-wide response to infection2.6%267
White blood cell count decreasedlow white cell count2.6%258
Fatiguetiredness2.5%255
Dyspnoeashortness of breath2.5%254
Malignant neoplasm progression2.4%246
Myelosuppression2.4%242
Abdominal painstomach or belly pain2.3%237
Astheniaweakness or lack of energy2.2%219

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

Death19.3%1,948

Life-threatening7.6%768

Hospitalisation (initial or prolonged)38.7%3,907

Disability2.4%246

Congenital anomaly0%1

Other serious66%6,675

Not serious8.7%880

Patient age

Under 20.1%6

2 to 110.7%71

12 to 172.8%281

18 to 4424.1%2,439

45 to 6418%1,823

65 to 7410.8%1,090

75 and over8.3%841

Age not given35.2%3,556

Who reported

Physician51.7%5,222

Pharmacist6.4%650

Other health professional27.4%2,772

Lawyer0%4

Consumer or non-health professional13%1,311

Not given1.5%148

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 CD30-directed immunoconjugate reports

Which drugs are in the CD30-directed immunoconjugate class on this site?

Adcetris and Brentuximab vedotin. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

10,107 reports through June 2026, 892 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?

off label use (12.9%), febrile neutropenia (7.4%), neuropathy peripheral (7%), pyrexia (7%) and neutropenia (5.6%).

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.