Camptosar (irinotecan hydrochloride) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Irinotecan hydrochloride
Class: Topoisomerase inhibitor

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 2,535 adverse event reports that name Camptosar. In these reports the drug is a suspect or interacting product.

In the same period, 746 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 110 reports in the 12 months to June 2026 and 100 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, 110 (under 0.1%) name Camptosar. Reports from consumers or other non-health professionals were 10% of the reports that name Camptosar 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 Camptosar 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 13 reports that name Camptosar.
In January to March 2026, FDA received 27.
In April to June 2025, FDA received 25.

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 237 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 2,535 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 237 terms.

Reaction terms in the reports that name Camptosar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,535 reports
Diarrhoealoose or frequent stools	447	17.6%
Vomitingbeing sick	245	9.7%
Nauseafeeling sick	238	9.4%
Deaththe patient died; cause not stated by this term	206	8.1%
Disease progressionthe disease advanced	186	7.3%
Dehydration	180	7.1%
Pyrexiafever	154	6.1%
Abdominal painstomach or belly pain	148	5.8%
Neutropenialow neutrophils, a type of white blood cell	137	5.4%
Astheniaweakness or lack of energy	126	5%
Fatiguetiredness	118	4.7%
Anaemialow red blood cells	85	3.4%
Febrile neutropeniafever with low white blood cells	83	3.3%
Haemoglobin decreasedlow haemoglobin	78	3.1%
Pulmonary embolisma blood clot in the lung	78	3.1%
Sepsisa severe body-wide response to infection	68	2.7%
Hypotensionlow blood pressure	64	2.5%
Thrombocytopenialow platelets	64	2.5%
Weight decreasedweight loss	64	2.5%
Leukopenialow white blood cells	61	2.4%
Hypokalaemialow blood potassium	60	2.4%
Dyspnoeashortness of breath	56	2.2%
White blood cell count decreasedlow white cell count	55	2.2%
Painpain, site not specified	53	2.1%
Pneumonialung infection	53	2.1%
Chillschills or shivering	50	2%
Decreased appetitereduced appetite	48	1.9%
Off label useused for a purpose or in a way not on the label	47	1.9%
Malaisegeneral feeling of being unwell	44	1.7%
Tachycardiafast heart rate	44	1.7%
Malignant neoplasm progression	43	1.7%
Hypophagia	41	1.6%
Neoplasm progression	41	1.6%
Stomatitissore mouth	41	1.6%
Dizzinesslight-headedness or unsteadiness	39	1.5%
Neutrophil count decreased	39	1.5%
Rashskin rash	39	1.5%
Colon cancer	36	1.4%
Falla fall	36	1.4%
Platelet count decreasedlow platelet count	35	1.4%
Anorexia	32	1.3%
Hypertensionhigh blood pressure	32	1.3%
Septic shockshock arising from infection	31	1.2%
Confusional stateconfusion	30	1.2%
Deep vein thrombosisa blood clot in a deep vein	30	1.2%
General physical health deteriorationgeneral decline in health	29	1.1%
Neuropathy peripheralnerve damage in hands or feet	27	1.1%
Atrial fibrillationan irregular heart rhythm	26	1%
Blood bilirubin increased	26	1%
Hyponatraemialow blood sodium	25	1%

Download all 237 terms of Camptosar (CSV)

The counts add to more than 2,535 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Irinotecan with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Irinotecan	Generic name	20,237
Irinotecan hydrochloride	Generic name	6,095
Camptosar (this page)	Brand name	2,535
Onivyde	Brand name	1,911

Sum of the separately reported names: 30,778. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Camptosar, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	288	275	76	40	186	8	0	63	13
2005	104	100	18	6	66	4	0	32	4
2006	103	98	19	4	58	3	0	40	5
2007	174	140	22	10	87	1	0	54	34
2008	154	131	27	7	67	5	0	50	23
2009	191	182	79	11	81	4	1	42	9
2010	173	164	57	13	79	2	0	53	9
2011	138	124	30	13	61	3	0	50	14
2012	66	33	24	0	5	1	0	7	33
2013	85	46	35	0	8	1	0	8	39
2014	57	39	24	0	12	0	0	6	18
2015	84	62	35	0	26	0	0	14	22
2016	67	51	26	1	30	0	0	14	16
2017	93	81	19	0	66	0	0	5	12
2018	93	80	14	0	64	0	0	10	13
2019	74	55	15	2	35	0	0	16	19
2020	63	47	16	3	20	0	0	21	16
2021	69	57	11	0	45	0	0	11	12
2022	159	146	19	7	102	1	0	52	13
2023	46	32	2	0	27	0	0	7	14
2024	84	67	6	0	63	0	0	4	17
2025	130	119	5	2	113	1	0	6	11
2026	40	37	2	0	36	0	0	1	3

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 Camptosar, 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 Camptosar, by the year in which FDA received them
Year	Reports
2004	274
2005	100
2006	100
2007	144
2008	109
2009	186
2010	263
2011	141
2012	80
2013	81
2014	59
2015	81
2016	67
2017	92
2018	102
2019	85
2020	74
2021	72
2022	128
2023	44
2024	83
2025	130
2026	40

Reports that name Camptosar, 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 Camptosar
Age	Reports	Share
Under 2	20	0.8%
2 to 11	83	3.3%
12 to 17	33	1.3%
18 to 44	149	5.9%
45 to 64	738	29.1%
65 to 74	482	19%
75 and over	158	6.2%
Age not given	872	34.4%

Sex of the patient in the reports that name Camptosar
Sex	Reports	Share
Female	936	36.9%
Male	1,375	54.2%
Unknown or not given	224	8.8%

Type of reporter in the reports that name Camptosar
Reporter	Reports	Share
Physician	954	37.6%
Pharmacist	130	5.1%
Other health professional	637	25.1%
Lawyer	0	0%
Consumer or non-health professional	254	10%
Not given	560	22.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 65.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Camptosar record
Indication as recorded (MedDRA)	Reports	Share
Colon cancer	227	9%
Colorectal cancer	129	5.1%
Colorectal cancer metastatic	80	3.2%
Colon cancer metastatic	77	3%
Rectal cancer	67	2.6%
Gastric cancer	49	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,535 reports.

Drugs in the same reports

Other drugs that the reports of Camptosar name, in any role, in order of name
Drug	Reports that name the two
Avastin	202
Bevacizumab	120
Cisplatin	120
Cyclophosphamide	111
Dactinomycin	114
Eloxatin	468
Erbitux	221
Fluorouracil	809
Leucovorin calcium	593
Vincristine sulfate	131

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

Irinotecan same ingredient
Irinotecan hydrochloride same ingredient
Onivyde same ingredient
Etopophos same class
Etoposide same class
Etoposide phosphate same class
Campto next in the A to Z list
Camrelizumab next in the A to Z list
Campral next in the A to Z list
Camzyos next in the A to Z list
Campath next in the A to Z list
Canagliflozin next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for CamptosarThe 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. Camptosar: adverse event reports that FDA received. https://reportedreactions.com/drug/camptosar/ 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 Camptosar as a suspect or interacting product. The 746 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 Camptosar 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 Camptosar?

No. It is a count of what people reported to FDA: 2,535 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?

Physician (37.6%), other health professional (25.1%) and consumer or non-health professional (10%). 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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