Radiation Therapy adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Radiation Therapy Nos

This name is not the name of a medicine. The site published this page earlier and keeps it. Search engines do not index it. The counts are for the name as reporters wrote it.

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 May 2026, FDA received 2,192 adverse event reports that name Radiation Therapy. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 2,125 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 11 reports in the 12 months to June 2026 and 83 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, 11 (under 0.1%) name Radiation Therapy. Reports for male patients were 64.8% of the reports that name Radiation Therapy and 34.6% 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 Radiation Therapy 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 6 reports that name Radiation Therapy.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 8.

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 232 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 2,136 of the 2,192 reports (97.4%).

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 232 terms.

Reaction terms in the reports that name Radiation Therapy, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,192 reports
Fatiguetiredness	265	12.1%
Dehydration	262	12%
Hot flusha hot flush	222	10.1%
Nauseafeeling sick	221	10.1%
Vomitingbeing sick	176	8%
Diarrhoealoose or frequent stools	147	6.7%
Astheniaweakness or lack of energy	137	6.3%
Mucosal inflammation	134	6.1%
Dysphagiadifficulty swallowing	131	6%
Pyrexiafever	106	4.8%
Injection site painpain where the injection was given	102	4.7%
Stomatitissore mouth	99	4.5%
Weight decreasedweight loss	98	4.5%
Dyspnoeashortness of breath	82	3.7%
Febrile neutropeniafever with low white blood cells	79	3.6%
Oesophagitis	77	3.5%
Rashskin rash	77	3.5%
Pneumonialung infection	72	3.3%
Haemoglobin decreasedlow haemoglobin	71	3.2%
Neutropenialow neutrophils, a type of white blood cell	71	3.2%
Dizzinesslight-headedness or unsteadiness	65	3%
White blood cell count decreasedlow white cell count	65	3%
Dysuriapain on passing urine	63	2.9%
Anaemialow red blood cells	59	2.7%
Painpain, site not specified	58	2.6%
Infectionan infection, type not specified	55	2.5%
Hypotensionlow blood pressure	54	2.5%
Deaththe patient died; cause not stated by this term	53	2.4%
Decreased appetitereduced appetite	53	2.4%
Anorexia	49	2.2%
Radiation injury	47	2.1%
Sepsisa severe body-wide response to infection	46	2.1%
Hypokalaemialow blood potassium	45	2.1%
Injection site mass	44	2%
Radiation pneumonitis	44	2%
Weight increasedweight gain	43	2%
Constipation	42	1.9%
Lymphopenia	42	1.9%
Platelet count decreasedlow platelet count	42	1.9%
Arthralgiajoint pain	41	1.9%
Post procedural diarrhoea	41	1.9%
Radiation skin injury	41	1.9%
Malaisegeneral feeling of being unwell	39	1.8%
Neutrophil count decreased	39	1.8%
Pollakiuriapassing urine more often	39	1.8%
Headachehead pain	38	1.7%
Pulmonary embolisma blood clot in the lung	38	1.7%
Thrombocytopenialow platelets	38	1.7%
Hyponatraemialow blood sodium	37	1.7%
Leukopenialow white blood cells	36	1.6%

Download all 232 terms of Radiation Therapy (CSV)

The counts add to more than 2,192 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 Radiation Therapy, 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	144	142	37	9	75	1	65	2
2005	192	163	20	12	113	6	66	29
2006	169	159	34	9	106	5	57	10
2007	172	157	20	3	113	8	61	15
2008	242	228	42	12	157	2	79	14
2009	243	216	48	11	152	3	64	27
2010	236	201	33	16	139	1	77	35
2011	37	36	8	3	20	0	16	1
2012	53	52	25	1	8	0	32	1
2013	35	33	14	0	10	2	23	2
2014	50	47	13	1	16	0	28	3
2015	33	26	10	0	9	0	11	7
2016	9	9	2	1	3	0	7	0
2017	3	3	0	0	0	0	3	0
2018	11	11	2	0	2	0	10	0
2019	4	4	1	0	1	0	2	0
2020	14	14	2	0	9	0	8	0
2021	23	17	3	0	4	0	11	6
2022	92	53	8	0	16	0	41	39
2023	172	89	16	1	22	0	75	83
2024	169	94	5	0	18	0	87	75
2025	78	38	2	0	16	0	31	40
2026	11	10	3	2	2	0	10	1

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 Radiation Therapy, 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 Radiation Therapy, by the year in which FDA received them
Year	Reports
2004	117
2005	198
2006	184
2007	146
2008	251
2009	219
2010	240
2011	89
2012	59
2013	27
2014	49
2015	32
2016	6
2017	2
2018	11
2019	8
2020	15
2021	56
2022	149
2023	171
2024	123
2025	33
2026	7

Reports that name Radiation Therapy, 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 Radiation Therapy
Age	Reports	Share
Under 2	3	0.1%
2 to 11	37	1.7%
12 to 17	28	1.3%
18 to 44	153	7%
45 to 64	642	29.3%
65 to 74	453	20.7%
75 and over	234	10.7%
Age not given	642	29.3%

Sex of the patient in the reports that name Radiation Therapy
Sex	Reports	Share
Female	564	25.7%
Male	1,420	64.8%
Unknown or not given	208	9.5%

Type of reporter in the reports that name Radiation Therapy
Reporter	Reports	Share
Physician	483	22%
Pharmacist	20	0.9%
Other health professional	771	35.2%
Lawyer	2	0.1%
Consumer or non-health professional	810	37%
Not given	106	4.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 54% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Radiation Therapy record
Indication as recorded (MedDRA)	Reports	Share
Head and neck cancer	157	7.2%
Non-small cell lung cancer	149	6.8%
Prostate cancer	135	6.2%
Squamous cell carcinoma	103	4.7%
Neoplasm malignant	86	3.9%
Oesophageal carcinoma	76	3.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,192 reports.

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These links are for navigation. No count selected them.

Official pages

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. Radiation Therapy: adverse event reports that FDA received. https://reportedreactions.com/drug/radiation-therapy/ 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 Radiation Therapy as a suspect or interacting product. The 2,125 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 Radiation Therapy 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 Radiation Therapy?

No. It is a count of what people reported to FDA: 2,192 reports from January 2004 to May 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?

Consumer or non-health professional (37%), other health professional (35.2%) and physician (22%). 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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