Bleomycin sulfate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Bleomycin sulfate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Cytoprotective agent
Also reported as: Bleomycin Sulfate For Injection Usp, Bleomycin Sulfate For Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 2,591 adverse event reports that name Bleomycin sulfate. In these reports the drug is a suspect or interacting product.

In the same period, 260 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 104 reports in the 12 months to June 2026 and 193 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 104 (under 0.1%) name Bleomycin sulfate. Reports from consumers or other non-health professionals were 8.3% of the reports that name Bleomycin sulfate and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Bleomycin sulfate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 18 reports that name Bleomycin sulfate.
In January to March 2026, FDA received 17.
In April to June 2025, FDA received 29.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 204 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,586 of the 2,591 reports (99.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 204 terms.

Reaction terms in the reports that name Bleomycin sulfate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,591 reports
Febrile neutropeniafever with low white blood cells	259	10%
Pulmonary toxicity	160	6.2%
Off label useused for a purpose or in a way not on the label	159	6.1%
Neutropenialow neutrophils, a type of white blood cell	143	5.5%
Acute myeloid leukaemia	102	3.9%
Second primary malignancy	100	3.9%
Pyrexiafever	99	3.8%
Vomitingbeing sick	93	3.6%
Sepsisa severe body-wide response to infection	91	3.5%
Nauseafeeling sick	90	3.5%
Anaemialow red blood cells	82	3.2%
Acute hepatic failure	74	2.9%
Respiratory failurethe lungs could not supply enough oxygen	73	2.8%
Hepatitis B reactivation	71	2.7%
Interstitial lung diseasescarring or inflammation of lung tissue	71	2.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	67	2.6%
Thrombocytopenialow platelets	66	2.5%
Acute respiratory distress syndrome	62	2.4%
Pancytopenialow counts of all blood cells	60	2.3%
Deaththe patient died; cause not stated by this term	59	2.3%
Fatiguetiredness	52	2%
Product use in unapproved indicationused for a purpose not on the label	51	2%
Dyspnoeashortness of breath	50	1.9%
Blood pressure decreaseda low blood pressure reading	49	1.9%
Mucosal inflammation	49	1.9%
Pneumonitis	48	1.9%
Pulmonary fibrosis	46	1.8%
Infectionan infection, type not specified	45	1.7%
Myelodysplastic syndrome	45	1.7%
Malignant neoplasm progression	42	1.6%
Neuropathy peripheralnerve damage in hands or feet	42	1.6%
Drug ineffectivethe medicine did not work as expected	41	1.6%
C-reactive protein increased	40	1.5%
Candida infectionthrush, a yeast infection	38	1.5%
Leukopenialow white blood cells	38	1.5%
Pulmonary embolisma blood clot in the lung	38	1.5%
Restlessness	38	1.5%
Neoplasm progression	34	1.3%
Back pain	33	1.3%
Brain oedema	33	1.3%
Chillschills or shivering	33	1.3%
Pleural effusionfluid around the lung	33	1.3%
Septic shockshock arising from infection	33	1.3%
Bone marrow failure	32	1.2%
Intentional product use issuedeliberate use not as intended	32	1.2%
Metastases to central nervous system	32	1.2%
Metastasis	32	1.2%
Myositis	32	1.2%
Metastases to lymph nodes	31	1.2%
Pneumonialung infection	31	1.2%

Download all 204 terms of Bleomycin sulfate (CSV)

The counts add to more than 2,591 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Bleomycin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Bleomycin	Generic name	6,341
Bleomycin sulfate (this page)	Generic name	2,591

Sum of the separately reported names: 8,932. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Bleomycin sulfate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	30	23	5	3	18	2	0	7	7
2005	23	23	5	0	14	0	0	9	0
2006	26	26	5	4	9	0	0	15	0
2007	17	16	3	0	7	0	0	7	1
2008	155	153	44	5	38	3	0	86	2
2009	145	144	49	17	47	6	0	73	1
2010	136	135	41	8	48	7	0	72	1
2011	301	300	53	8	75	3	0	203	1
2012	291	287	100	4	61	15	2	149	4
2013	30	29	8	4	9	0	0	11	1
2014	19	19	5	0	11	1	0	5	0
2015	30	30	7	2	7	0	0	23	0
2016	72	69	12	3	8	2	0	58	3
2017	55	54	25	4	6	0	0	44	1
2018	102	101	17	5	19	2	0	76	1
2019	201	198	73	11	33	2	1	123	3
2020	111	110	38	8	46	2	1	72	1
2021	105	105	37	11	47	1	0	56	0
2022	205	204	94	15	85	3	0	142	1
2023	134	133	41	31	69	5	0	85	1
2024	190	181	21	37	99	1	0	120	9
2025	168	167	21	38	75	2	4	136	1
2026	45	45	12	12	20	1	0	38	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Bleomycin sulfate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Bleomycin sulfate, by the year in which FDA received them
Year	Reports
2004	25
2005	30
2006	27
2007	16
2008	154
2009	145
2010	144
2011	304
2012	303
2013	40
2014	21
2015	34
2016	54
2017	58
2018	111
2019	197
2020	139
2021	121
2022	157
2023	125
2024	208
2025	143
2026	35

Reports that name Bleomycin sulfate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Bleomycin sulfate
Age	Reports	Share
Under 2	21	0.8%
2 to 11	61	2.4%
12 to 17	134	5.2%
18 to 44	870	33.6%
45 to 64	359	13.9%
65 to 74	177	6.8%
75 and over	40	1.5%
Age not given	929	35.9%

Sex of the patient in the reports that name Bleomycin sulfate
Sex	Reports	Share
Female	715	27.6%
Male	1,179	45.5%
Unknown or not given	697	26.9%

Type of reporter in the reports that name Bleomycin sulfate
Reporter	Reports	Share
Physician	793	30.6%
Pharmacist	151	5.8%
Other health professional	1,266	48.9%
Lawyer	1	under 0.1%
Consumer or non-health professional	216	8.3%
Not given	164	6.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Bleomycin sulfate record
Indication as recorded (MedDRA)	Reports	Share
Hodgkin's disease	558	21.5%
Hodgkin's disease	393	15.2%
Testis cancer	159	6.1%
Non-hodgkin's lymphoma	87	3.4%
Germ cell cancer	53	2%
Diffuse large b-cell lymphoma	36	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,591 reports.

Drugs in the same reports

Other drugs that the reports of Bleomycin sulfate name, in any role, in order of name
Drug	Reports that name the two
Cisplatin	725
Cyclophosphamide	823
Dacarbazine	740
Doxorubicin hydrochloride	1,047
Etoposide	1,256
Prednisone	617
Vinblastine	410
Vinblastine sulfate	451
Vincristine	396
Vincristine sulfate	501

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Bleomycin same ingredient
Dexrazoxane same class
Ethyol same class
Mesna same class
Blinatumomab next in the A to Z list
Blenrep next in the A to Z list
Blincyto next in the A to Z list
Bivigam next in the A to Z list
Blonanserin next in the A to Z list
Bivalirudin next in the A to Z list
Blopress next in the A to Z list
Bisoprolol hemifumarate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Bleomycin sulfateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Bleomycin sulfate: adverse event reports that FDA received. https://reportedreactions.com/drug/bleomycin-sulfate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Bleomycin sulfate as a suspect or interacting product. The 260 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Bleomycin sulfate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Bleomycin sulfate?

No. It is a count of what people reported to FDA: 2,591 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (48.9%), physician (30.6%) and consumer or non-health professional (8.3%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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