Hycamtin (topotecan) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Topotecan
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 June 2026, FDA received 1,526 adverse event reports that name Hycamtin. In these reports the drug is a suspect or interacting product.

In the same period, 71 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 14 reports in the 12 months to June 2026 and 18 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, 14 (under 0.1%) name Hycamtin. Reports for patients aged 18 to 44 were 2.9% of the reports that name Hycamtin and 12.3% 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 Hycamtin 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 4 reports that name Hycamtin.
In January to March 2026, FDA received 2.
In April to June 2025, FDA received 2.

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 98 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 1,520 of the 1,526 reports (99.6%).

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 98 terms.

Reaction terms in the reports that name Hycamtin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,526 reports
Deaththe patient died; cause not stated by this term	360	23.6%
Anaemialow red blood cells	159	10.4%
White blood cell count decreasedlow white cell count	156	10.2%
Nauseafeeling sick	149	9.8%
Platelet count decreasedlow platelet count	133	8.7%
Neutrophil count decreased	103	6.7%
Fatiguetiredness	91	6%
Thrombocytopenialow platelets	89	5.8%
Neutropenialow neutrophils, a type of white blood cell	82	5.4%
Red blood cell count decreased	79	5.2%
Decreased appetitereduced appetite	78	5.1%
Diarrhoealoose or frequent stools	70	4.6%
Pyrexiafever	70	4.6%
Disease progressionthe disease advanced	69	4.5%
Vomitingbeing sick	69	4.5%
Febrile neutropeniafever with low white blood cells	67	4.4%
Haemoglobin decreasedlow haemoglobin	43	2.8%
Pancytopenialow counts of all blood cells	39	2.6%
Dyspnoeashortness of breath	38	2.5%
Drug ineffectivethe medicine did not work as expected	37	2.4%
Malaisegeneral feeling of being unwell	33	2.2%
Abdominal painstomach or belly pain	32	2.1%
Alopeciahair loss	32	2.1%
Astheniaweakness or lack of energy	31	2%
Interstitial lung diseasescarring or inflammation of lung tissue	29	1.9%
Constipation	28	1.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	22	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	22	1.4%
Leukopenialow white blood cells	22	1.4%
Blood lactate dehydrogenase increased	20	1.3%
Malignant neoplasm progression	20	1.3%
Sepsisa severe body-wide response to infection	20	1.3%
Bone marrow failure	19	1.2%
Dizzinesslight-headedness or unsteadiness	19	1.2%
Weight decreasedweight loss	19	1.2%
Hospice care	16	1%
Protein total decreased	16	1%
General physical health deteriorationgeneral decline in health	15	1%
Product use in unapproved indicationused for a purpose not on the label	15	1%
Hospitalisationadmission to hospital	14	0.9%
C-reactive protein increased	13	0.9%
Condition aggravatedthe condition being treated got worse	13	0.9%
Blood sodium decreased	12	0.8%
Blood urea increased	12	0.8%
Drug toxicity	12	0.8%
Lymphocyte count decreased	12	0.8%
Painpain, site not specified	12	0.8%
Pneumonialung infection	12	0.8%
Anorexia	11	0.7%
Headachehead pain	11	0.7%

Download all 98 terms of Hycamtin (CSV)

The counts add to more than 1,526 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 Topotecan with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Topotecan	Generic name	3,668
Topotecan hydrochloride	Generic name	867
Hycamtin (this page)	Brand name	1,526

Sum of the separately reported names: 6,061. 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 Hycamtin, 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	63	52	19	4	22	1	19	11
2005	74	65	23	6	26	8	28	9
2006	33	26	3	2	9	2	17	7
2007	60	50	7	7	17	1	26	10
2008	48	42	14	3	27	1	10	6
2009	69	59	25	10	28	4	16	10
2010	66	61	25	6	30	2	18	5
2011	71	59	24	4	19	5	18	12
2012	104	90	35	7	34	6	22	14
2013	98	81	39	7	43	6	18	17
2014	127	89	42	6	42	3	30	38
2015	110	70	40	4	20	1	53	40
2016	89	77	55	2	18	1	16	12
2017	68	53	37	2	8	0	14	15
2018	74	56	27	3	20	0	24	18
2019	84	70	44	2	21	1	23	14
2020	81	63	32	1	21	0	14	18
2021	61	50	23	0	22	0	13	11
2022	63	45	24	0	16	0	10	18
2023	43	25	17	2	8	0	7	18
2024	20	10	5	1	3	0	5	10
2025	14	10	3	0	3	0	6	4
2026	6	5	3	0	3	0	3	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 Hycamtin, 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 Hycamtin, by the year in which FDA received them
Year	Reports
2004	52
2005	76
2006	34
2007	61
2008	50
2009	64
2010	73
2011	69
2012	123
2013	101
2014	112
2015	111
2016	90
2017	66
2018	77
2019	82
2020	82
2021	61
2022	61
2023	41
2024	19
2025	14
2026	6

Reports that name Hycamtin, 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 Hycamtin
Age	Reports	Share
Under 2	5	0.3%
2 to 11	46	3%
12 to 17	16	1%
18 to 44	44	2.9%
45 to 64	399	26.1%
65 to 74	277	18.2%
75 and over	126	8.3%
Age not given	613	40.2%

Sex of the patient in the reports that name Hycamtin
Sex	Reports	Share
Female	827	54.2%
Male	580	38%
Unknown or not given	119	7.8%

Type of reporter in the reports that name Hycamtin
Reporter	Reports	Share
Physician	395	25.9%
Pharmacist	131	8.6%
Other health professional	238	15.6%
Lawyer	0	0%
Consumer or non-health professional	668	43.8%
Not given	94	6.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 60.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hycamtin record
Indication as recorded (MedDRA)	Reports	Share
Lung neoplasm malignant	169	11.1%
Ovarian cancer	111	7.3%
Ovarian cancer recurrent	82	5.4%
Small cell lung cancer stage unspecified	53	3.5%
Small cell lung cancer	45	2.9%
Lung carcinoma cell type unspecified stage 0	42	2.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,526 reports.

Pages near this one

Topotecan same ingredient
Topotecan hydrochloride same ingredient
Etoposide phosphate same class
Irinotecan hydrochloride same class
Etoposide same class
Mitoxantrone same class
Etopophos same class
Mitoxantrone hydrochloride same class
Hyaluronidase Rituximab next in the A to Z list
Hydralazine next in the A to Z list
Hyaluronidase next in the A to Z list
Hydralazine hydrochloride 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 HycamtinThe 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. Hycamtin: adverse event reports that FDA received. https://reportedreactions.com/drug/hycamtin/ 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 Hycamtin as a suspect or interacting product. The 71 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 Hycamtin 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 Hycamtin?

No. It is a count of what people reported to FDA: 1,526 reports from January 2004 to June 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 (43.8%), physician (25.9%) and other health professional (15.6%). 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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