Irinotecan hydrochloride: adverse event reports filed with FDA

6,095

reports as suspect product

0% of all reports · about 272 a year

800

reports, 12 months to June 2026

876 in the 12 months before

96.6%

marked serious by the reporter

96.8% across the class

12.9%

record death among outcomes, as reported

788 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Irinotecan hydrochloride reports recording the termmedian drug in topoisomerase inhibitor

1. Diarrhoealoose or frequent stools12.5%760
2. Myelosuppression10.4%634
3. Off label useused for a purpose or in a way not on the label9.4%572
4. Febrile neutropeniafever with low white blood cells7.4%449
5. Nauseafeeling sick6.8%416
6. Neutropenialow neutrophils, a type of white blood cell5.7%347
7. Vomitingbeing sick5.7%346
8. Neuropathy peripheralnerve damage in hands or feet5.2%316
9. Neoplasm progression5.1%312
10. Fatiguetiredness4.1%247
11. White blood cell count decreasedlow white cell count3.8%232
12. Neutrophil count decreased3.7%224
13. Pyrexiafever3.4%209
14. Disease progressionthe disease advanced3.3%204
15. Malignant neoplasm progression3.1%187
16. Anaemialow red blood cells3%181
17. Astheniaweakness or lack of energy2.9%178
18. Deaththe patient died; cause not stated by this term2.9%174
19. Product use in unapproved indicationused for a purpose not on the label2.8%172
20. Abdominal painstomach or belly pain2.8%169
21. Decreased appetitereduced appetite2.7%165
22. Drug ineffectivethe medicine did not work as expected2.7%165
23. Thrombocytopenialow platelets2.7%165
24. Stomatitissore mouth2.3%143
25. Dyspnoeashortness of breath2%122
26. Hypertensionhigh blood pressure1.9%113
27. Platelet count decreasedlow platelet count1.9%113
28. Interstitial lung diseasescarring or inflammation of lung tissue1.8%110
29. Sepsisa severe body-wide response to infection1.7%104
30. Dehydrationdehydration1.6%98

Top 30 of 792 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 12 drugs in the topoisomerase inhibitor 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 86,440 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. 16.7% 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 6,095 reports.

Drugs most often listed in the same reports

Other products listed in reports where Irinotecan hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 topoisomerase inhibitor 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 Irinotecan hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,543) 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.