Oncovin adverse event reports that FDA received

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

Name type: Product name as reported

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 January 2004 to June 2026, FDA received 3,134 adverse event reports that name Oncovin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,413 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 234 reports in the 12 months to June 2026 and 163 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, 234 (under 0.1%) name Oncovin. Reports from consumers or other non-health professionals were 7.7% of the reports that name Oncovin 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 Oncovin 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 76 reports that name Oncovin.
In January to March 2026, FDA received 75.
In April to June 2025, FDA received 33.

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 345 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 all 3,134 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 345 terms.

Reaction terms in the reports that name Oncovin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,134 reports
Febrile neutropeniafever with low white blood cells	267	8.5%
Disease progressionthe disease advanced	228	7.3%
Off label useused for a purpose or in a way not on the label	216	6.9%
Neutropenialow neutrophils, a type of white blood cell	192	6.1%
Drug ineffectivethe medicine did not work as expected	176	5.6%
Pyrexiafever	146	4.7%
Anaemialow red blood cells	139	4.4%
Sepsisa severe body-wide response to infection	133	4.2%
White blood cell count decreasedlow white cell count	122	3.9%
Platelet count decreasedlow platelet count	110	3.5%
Pneumonialung infection	104	3.3%
Diarrhoealoose or frequent stools	103	3.3%
Neuropathy peripheralnerve damage in hands or feet	99	3.2%
Dyspnoeashortness of breath	89	2.8%
Malignant neoplasm progression	75	2.4%
Septic shockshock arising from infection	73	2.3%
Bone marrow failure	72	2.3%
Neutrophil count decreased	71	2.3%
Product use in unapproved indicationused for a purpose not on the label	71	2.3%
Thrombocytopenialow platelets	70	2.2%
Deaththe patient died; cause not stated by this term	69	2.2%
Pancytopenialow counts of all blood cells	65	2.1%
Nauseafeeling sick	64	2%
Fatiguetiredness	61	1.9%
Vomitingbeing sick	61	1.9%
Hepatitis B reactivation	59	1.9%
Infectionan infection, type not specified	58	1.9%
Mucosal inflammation	54	1.7%
Tumour lysis syndrome	54	1.7%
Cardiac failureheart failure	52	1.7%
Interstitial lung diseasescarring or inflammation of lung tissue	51	1.6%
Blood lactate dehydrogenase increased	50	1.6%
Respiratory failurethe lungs could not supply enough oxygen	48	1.5%
Lung disordera lung problem, type not specified	47	1.5%
Constipation	46	1.5%
Acute myeloid leukaemia	45	1.4%
Headachehead pain	45	1.4%
Decreased appetitereduced appetite	42	1.3%
Malaisegeneral feeling of being unwell	42	1.3%
Diffuse large B-cell lymphoma recurrent	41	1.3%
Leukopenialow white blood cells	39	1.2%
Myelodysplastic syndrome	39	1.2%
Pleural effusionfluid around the lung	39	1.2%
Covid-19COVID-19 infection	37	1.2%
Lymphomaa cancer of the lymphatic system	37	1.2%
Pain in extremitypain in an arm or leg	37	1.2%
Posterior reversible encephalopathy syndrome	37	1.2%
Abdominal painstomach or belly pain	36	1.1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	36	1.1%
Arthralgiajoint pain	36	1.1%

Download all 345 terms of Oncovin (CSV)

The counts add to more than 3,134 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.

Outcomes by year

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

Outcomes in the reports that name Oncovin, 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	Other Serious (Important Medical Events)	Not serious
2004	163	162	37	15	68	7	88	1
2005	104	104	34	16	35	3	60	0
2006	58	58	16	9	23	2	21	0
2007	71	71	19	19	37	9	17	0
2008	69	69	16	8	32	1	38	0
2009	89	89	22	9	46	1	41	0
2010	44	43	9	8	22	4	16	1
2011	65	63	12	8	31	4	30	2
2012	80	80	19	7	37	3	45	0
2013	122	121	26	13	35	7	83	1
2014	85	85	25	8	32	9	44	0
2015	181	178	64	21	42	3	124	3
2016	118	116	25	5	45	1	85	2
2017	150	143	28	27	80	4	98	7
2018	161	158	37	13	72	9	110	3
2019	195	192	19	19	69	2	151	3
2020	169	168	18	27	66	2	136	1
2021	193	188	34	21	78	2	141	5
2022	252	250	39	24	85	10	195	2
2023	272	268	43	30	87	0	221	4
2024	143	136	30	13	42	1	102	7
2025	169	165	42	23	51	0	138	4
2026	181	175	28	32	60	10	156	6

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 Oncovin, 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 Oncovin, by the year in which FDA received them
Year	Reports
2004	151
2005	109
2006	65
2007	72
2008	71
2009	98
2010	50
2011	69
2012	104
2013	123
2014	100
2015	178
2016	129
2017	147
2018	179
2019	192
2020	158
2021	198
2022	243
2023	250
2024	136
2025	161
2026	151

Reports that name Oncovin, 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 Oncovin
Age	Reports	Share
Under 2	27	0.9%
2 to 11	164	5.2%
12 to 17	121	3.9%
18 to 44	416	13.3%
45 to 64	777	24.8%
65 to 74	573	18.3%
75 and over	309	9.9%
Age not given	747	23.8%

Sex of the patient in the reports that name Oncovin
Sex	Reports	Share
Female	1,099	35.1%
Male	1,569	50.1%
Unknown or not given	466	14.9%

Type of reporter in the reports that name Oncovin
Reporter	Reports	Share
Physician	1,467	46.8%
Pharmacist	118	3.8%
Other health professional	1,153	36.8%
Lawyer	71	2.3%
Consumer or non-health professional	241	7.7%
Not given	84	2.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 17.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Oncovin record
Indication as recorded (MedDRA)	Reports	Share
Diffuse large b-cell lymphoma	597	19%
B-cell lymphoma	221	7.1%
Lymphoma	166	5.3%
Non-hodgkin's lymphoma	142	4.5%
Non-hodgkin's lymphoma	125	4%
Acute lymphocytic leukaemia	124	4%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,134 reports.

Drugs in the same reports

Other drugs that the reports of Oncovin name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	2,018
Cytarabine	482
Dexamethasone	472
Doxorubicin	723
Doxorubicin hydrochloride	679
Etoposide	727
Methotrexate	525
Prednisolone	826
Prednisone	1,292
Rituximab	1,187

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

Oncaspar next in the A to Z list
Ondansetron next in the A to Z list
Onbrez Breezhaler next in the A to Z list
Ondansetron Accord next in the A to Z list
Onbrez next in the A to Z list
Ondansetron hcl next in the A to Z list
Onapgo next in the A to Z list
Ondansetron hydrochloride next in the A to Z list
Omvoh next in the A to Z list
Ondexxya next in the A to Z list
Omnitrope next in the A to Z list
Onfi next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for OncovinThe 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. Oncovin: adverse event reports that FDA received. https://reportedreactions.com/drug/oncovin/ 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 Oncovin as a suspect or interacting product. The 1,413 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 Oncovin 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 Oncovin?

No. It is a count of what people reported to FDA: 3,134 reports from January 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?

Physician (46.8%), other health professional (36.8%) and consumer or non-health professional (7.7%). 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.

To the top of the page