Pharmacologic class (EPC) · 3 drug pages

Cytoprotective agent: adverse event reports filed with FDA

13,325 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.

13,325
reports across the class: 0.1% of all reports; 781
reports, 12 months to June 2026: 946 in the 12 months before; 98.2%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Cytoprotective agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 13,325 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

781 reports arrived in the 12 months to June 2026, down 17% from 946 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 98.2% of the class's reports are marked serious, 22.8% record death among the outcomes and 36.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are febrile neutropenia (11.5%), off label use (7.6%) and neutropenia (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
Bleomycin	generic	6,341	352	98%	Off label use
Mesna	generic	4,393	325	98.3%	Febrile neutropenia
Bleomycin sulfate	generic	2,591	104	98.5%	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 cells11.5%1,534
Off label useused for a purpose or in a way not on the label7.6%1,015
Neutropenialow neutrophils, a type of white blood cell6%805
Pyrexiafever5.6%752
Vomitingbeing sick4.1%551
Drug ineffectivethe medicine did not work as expected3.9%521
Nauseafeeling sick3.7%498
Sepsisa severe body-wide response to infection3.7%497
Thrombocytopenialow platelets3.7%495
Anaemialow red blood cells3.6%475
Disease progressionthe disease advanced3.3%444
Pulmonary toxicity3%401
Pancytopenialow counts of all blood cells2.9%383
Product use in unapproved indicationused for a purpose not on the label2.8%377
Pneumonialung infection2.6%353
Respiratory failurethe lungs could not supply enough oxygen2.5%339
Deaththe patient died; cause not stated by this term2.5%329
Toxicity to various agentspoisoning or toxic effect of one or more substances2.3%310
Mucosal inflammation2.3%304
Dyspnoeashortness of breath2.3%303
Acute myeloid leukaemia2.3%300
Diarrhoealoose or frequent stools2.2%296
Fatiguetiredness2%271
Infectionan infection, type not specified2%271
Second primary malignancy1.9%258

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death22.8%3,035

Life-threatening8.2%1,086

Hospitalisation (initial or prolonged)36.8%4,905

Disability1.6%210

Congenital anomaly0.5%70

Other serious63.9%8,513

Not serious1.8%236

Patient age

Under 21.6%216

2 to 115%666

12 to 175.3%701

18 to 4429.6%3,938

45 to 6417.6%2,341

65 to 747%935

75 and over2.3%311

Age not given31.6%4,217

Who reported

Physician35.6%4,747

Pharmacist4.8%634

Other health professional48.5%6,463

Lawyer0.1%12

Consumer or non-health professional4.9%647

Not given6.2%822

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 Cytoprotective agent reports

Which drugs are in the Cytoprotective agent class on this site?

Bleomycin, Mesna and Bleomycin sulfate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

13,325 reports through June 2026, 781 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 (11.5%), off label use (7.6%), neutropenia (6%), pyrexia (5.6%) and vomiting (4.1%).

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.