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Irinotecan Side Effects

The most commonly reported side effects of irinotecan include diarrhoea, nausea, and neutropenia, based on 45,953 FDA adverse event reports from 2004 to 2025. 2.9% of reports found the drug to be ineffective.

Irinotecan side effects

Percentages show how often each reaction appears relative to total reports for irinotecan.

1
Diarrhoea11.6%5,318
2
Nausea6.7%3,073
3
Neutropenia6.6%3,026
4
Off Label Use6.4%2,962
5
Disease Progression6.2%2,860
6
Vomiting5.5%2,527
7
Fatigue4.4%2,041
8
Death4.3%1,988
9
Neuropathy Peripheral3.6%1,640
10
Febrile Neutropenia3.6%1,637
11
Thrombocytopenia3.4%1,544
12
Asthenia3.3%1,532
13
Anaemia3.3%1,512
14
Decreased Appetite3.2%1,471
15
Pyrexia3.2%1,458

These are voluntary reports and do not establish that irinotecan caused these reactions.

Report severity

95.0%Serious43,675 reports
39.6%Hospitalizations18,191 reports
18.4%Fatal8,463 reports

Seriousness is determined by the reporter, not by OpenClaim.

Irinotecan drug interactions

Other drugs that appear in adverse event reports alongside irinotecan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fluorouracil44.7%20,539
2
Bevacizumab28.9%13,274
3
Oxaliplatin25.9%11,901
4
Levoleucovorin13.1%6,029
5
Cetuximab11.2%5,127
6
Capecitabine8.8%4,040
7
Panitumumab8.0%3,685
8
Leucovorin-calcium7.5%3,437
9
Aflibercept5.5%2,527
10
Calcium5.3%2,458
11
Cisplatin4.3%1,966
12
Temozolomide4.0%1,831
13
Gemcitabine3.1%1,427
14
Carboplatin3.1%1,402
15
Vincristine-sulfate2.9%1,314

Taken alongside

1
Fluorouracil12.4%5,705
2
Dexamethasone8.8%4,052
3
Ondansetron6.1%2,826
4
Levoleucovorin5.6%2,576
5
Oxaliplatin5.6%2,562
6
Atropine4.1%1,893
7
Loperamide-hydrochloride3.7%1,722
8
Calcium3.5%1,627
9
Acetaminophen3.4%1,553
10
Leucovorin-calcium2.9%1,336
11
Pantoprazole-sodium2.8%1,306
12
Bevacizumab2.8%1,306
13
Palonosetron-hydrochloride2.7%1,243
14
Granisetron2.4%1,084
15
Omeprazole2.2%1,026

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports irinotecan side effects

34.5% of irinotecan adverse event reports involve female patients and 49.4% involve male patients. The largest age group is adult at 53%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.5%
Male49.4%
Unknown16.1%

Age group

< 20.5%
2–113.6%
12–171.8%
18–6452.6%
65+41.5%

What is irinotecan used for

Conditions and purposes for which patients were taking irinotecan when the adverse event was reported.

Abdominal NeoplasmAcinar Cell Carcinoma Of PancreasAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Promyelocytic LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma Of Colon Stage IvAdenocarcinoma Of The Gastroesophageal JunctionAdenocarcinoma Of The Prostate MetastaticAdenocarcinoma PancreasAdenoid Cystic Carcinoma

Showing 15 of 976 indications

Irinotecan brand names and reporting trend

Irinotecan is sold under the brand name Camptosar.

Brand names

Camptosar5

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking irinotecan with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.