Pharmacologic class (EPC) · 7 drug pages

Anthracycline topoisomerase inhibitor: adverse event reports filed with FDA

109,832 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

109,832
reports across the class: 0.5% of all reports; 8,464
reports, 12 months to June 2026: 9,518 in the 12 months before; 97%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Anthracycline topoisomerase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 109,832 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

8,464 reports arrived in the 12 months to June 2026, down 11% from 9,518 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 97% of the class's reports are marked serious, 19.9% record death among the outcomes and 36.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are febrile neutropenia (10.7%), off label use (8.2%) and neutropenia (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
Doxorubicin	generic	54,401	4,879	97.9%	Febrile neutropenia
Doxorubicin hydrochloride	generic	35,913	2,172	96.9%	Febrile neutropenia
Epirubicin hydrochloride	generic	6,411	594	99.3%	Myelosuppression
DoxilDoxorubicin hydrochloride	brand	4,921	28	89.5%	Febrile neutropenia
Daunorubicin hydrochloride	generic	3,431	118	96.2%	Febrile neutropenia
Idarubicin hydrochloride	generic	2,456	112	98.1%	Febrile neutropenia
Vyxeos(daunorubicin and cytarabine) liposome	brand	2,299	561	87.4%	Febrile 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

Febrile neutropeniafever with low white blood cells10.7%11,806
Off label useused for a purpose or in a way not on the label8.2%8,965
Neutropenialow neutrophils, a type of white blood cell7%7,676
Disease progressionthe disease advanced6.1%6,742
Pyrexiafever4.9%5,397
Drug ineffectivethe medicine did not work as expected4.5%4,905
Anaemialow red blood cells4.1%4,474
Thrombocytopenialow platelets4%4,397
Nauseafeeling sick3.9%4,272
Sepsisa severe body-wide response to infection3.5%3,846
Pneumonialung infection3.3%3,673
Vomitingbeing sick3.2%3,546
Deaththe patient died; cause not stated by this term3.2%3,498
Diarrhoealoose or frequent stools3.1%3,360
Product use in unapproved indicationused for a purpose not on the label3%3,313
Pancytopenialow counts of all blood cells2.6%2,885
Infectionan infection, type not specified2.5%2,749
Fatiguetiredness2.5%2,748
Mucosal inflammation2.3%2,521
Dyspnoeashortness of breath2.2%2,414
Malignant neoplasm progression2.2%2,388
Myelosuppression2.2%2,362
Neuropathy peripheralnerve damage in hands or feet2.1%2,267
White blood cell count decreasedlow white cell count2.1%2,260
Leukopenialow white blood cells1.9%2,110

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death19.9%21,891

Life-threatening8%8,770

Hospitalisation (initial or prolonged)36.2%39,804

Disability1.3%1,431

Congenital anomaly0.3%298

Other serious65.7%72,199

Not serious3%3,275

Patient age

Under 20.9%1,027

2 to 114.2%4,570

12 to 173.1%3,442

18 to 4413.4%14,733

45 to 6424.5%26,938

65 to 7413.6%14,934

75 and over5.9%6,531

Age not given34.3%37,657

Who reported

Physician44.7%49,099

Pharmacist3.9%4,263

Other health professional40.8%44,839

Lawyer0.2%215

Consumer or non-health professional5.7%6,276

Not given4.7%5,140

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 Anthracycline topoisomerase inhibitor reports

Which drugs are in the Anthracycline topoisomerase inhibitor class on this site?

Doxorubicin, Doxorubicin hydrochloride, Epirubicin hydrochloride, Doxil, Daunorubicin hydrochloride and Idarubicin hydrochloride and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

109,832 reports through June 2026, 8,464 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?

febrile neutropenia (10.7%), off label use (8.2%), neutropenia (7%), disease progression (6.1%) and pyrexia (4.9%).

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.