Radiation: adverse event reports filed with FDA

610

reports as suspect product

0% of all reports · about 27 a year

0

reports, 12 months to June 2026

0 in the 12 months before

90%

marked serious by the reporter

70.4% across the class

15.4%

record death among outcomes, as reported

94 reports · not verified by FDA

Reports by month, five years

No report listing Radiation was received in the five years to June 2026; the latest was received in April 2021.

By year received

Reactions recorded in the reports

share of Radiation reports recording the termmedian drug in non-standardized food allergenic extract

1. Nauseafeeling sick14.1%86
2. Vomitingbeing sick12.6%77
3. Dehydrationdehydration11.1%68
4. Diarrhoealoose or frequent stools7.7%47
5. Dyspnoeashortness of breath7.5%46
6. Pyrexiafever7.4%45
7. Dysphagiadifficulty swallowing6.9%42
8. Fatiguetiredness6.1%37
9. Astheniaweakness or lack of energy5.6%34
10. Febrile neutropeniafever with low white blood cells4.6%28
11. Neutropenialow neutrophils, a type of white blood cell4.6%28
12. Pneumonialung infection4.6%28
13. Haemoglobin decreasedlow haemoglobin4.1%25
14. Hypotensionlow blood pressure4.1%25
15. Oesophagitis3.9%24
16. Weight decreasedweight loss3.9%24
17. White blood cell count decreasedlow white cell count3.9%24
18. Painpain, site not specified3.8%23
19. Abdominal painstomach or belly pain3.6%22
20. Anaemialow red blood cells3.6%22
21. Confusional stateconfusion3.4%21
22. Dizzinesslight-headedness or unsteadiness3.3%20
23. Malaisegeneral feeling of being unwell3.3%20
24. Pulmonary embolisma blood clot in the lung3.3%20
25. Headachehead pain2.8%17
26. Oral intake reduced2.8%17
27. Platelet count decreasedlow platelet count2.8%17
28. Pleural effusionfluid around the lung2.8%17
29. Mucosal inflammation2.6%16
30. Sepsisa severe body-wide response to infection2.6%16

Top 30 of 292 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the non-standardized food allergenic extract class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 2,328 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 60% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 610 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the non-standardized food allergenic extract class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Radiation as a suspect or interacting product; reports listing it only as a concomitant medication (454) are excluded. 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.