Drugs › Topoisomerase inhibitor
Brand name · Topotecan
Hycamtin: adverse event reports filed with FDA
1,526 reports list it as a suspect or interacting product, 2004–2026. Class: Topoisomerase inhibitor.
- 1,526
- reports as suspect product
- 0% of all reports · about 68 a year
- 14
- reports, 12 months to June 2026
- 18 in the 12 months before
- 79.2%
- marked serious by the reporter
- 96.8% across the class
- 37.1%
- record death among outcomes, as reported
- 566 reports · not verified by FDA
1,526 adverse event reports received by FDA list the brand name Hycamtin (topotecan) as a suspect or interacting product, from January 2004 to June 2026. A further 71 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 14 reports listed it, down 22% from 18 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 68 reports a year and 0% of the 20,646,523 reports in the database, and 1.8% of the reports for the topoisomerase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are death (23.6%), anaemia (10.4%) and white blood cell count decreased (10.2%). A report can list several reactions, so shares add to more than 100%; 263 different terms appear across these reports. Death is recorded in 23.6% of these reports, a larger share than in the median topoisomerase inhibitor drug (2.8%).
79.2% of the reports are marked serious by the reporter (96.8% across the class); 37.1% record death among the outcomes and 30.1% record hospitalisation, as reported. 43.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (26.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Hycamtin reports recording the termmedian drug in topoisomerase inhibitor
- Deaththe patient died; cause not stated by this term23.6%360
- Anaemialow red blood cells10.4%159
- White blood cell count decreasedlow white cell count10.2%156
- Nauseafeeling sick9.8%149
- Platelet count decreasedlow platelet count8.7%133
- Neutrophil count decreased6.7%103
- Fatiguetiredness6%91
- Thrombocytopenialow platelets5.8%89
- Neutropenialow neutrophils, a type of white blood cell5.4%82
- Decreased appetitereduced appetite5.1%78
- Diarrhoealoose or frequent stools4.6%70
- Pyrexiafever4.6%70
- Disease progressionthe disease advanced4.5%69
- Vomitingbeing sick4.5%69
- Febrile neutropeniafever with low white blood cells4.4%67
- Haemoglobin decreasedlow haemoglobin2.8%43
- Pancytopenialow counts of all blood cells2.6%39
- Dyspnoeashortness of breath2.5%38
- Drug ineffectivethe medicine did not work as expected2.4%37
- Malaisegeneral feeling of being unwell2.2%33
- Abdominal painstomach or belly pain2.1%32
- Alopeciahair loss2.1%32
- Astheniaweakness or lack of energy2%31
- Interstitial lung diseasescarring or inflammation of lung tissue1.9%29
- Constipationconstipation1.8%28
- Alanine aminotransferase increasedraised liver enzyme (ALT)1.4%22
- Aspartate aminotransferase increasedraised liver enzyme (AST)1.4%22
- Leukopenialow white blood cells1.4%22
Top 30 of 263 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 60.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| 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 indication field is filled in by the reporter and is often blank; shares are of all 1,526 reports.
In context
| Measure | Hycamtin | Topoisomerase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,526 | 86,440 | 20,646,523 |
| Share of that pool | — | 1.8% | 0% |
| Reports, latest 12 months | 14 | — | 1,332,454 |
| Marked serious | 79.2% | 96.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 371 | 231 | 91 |
| Hospitalisation recorded, per 1,000 reports | 301 | 362 | 213 |
| Consumer-filed share | 43.8% | 6.8% | 45.8% |
| Top term, share of reports | Death 23.6% | median 2.8% | 4.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Etoposide | generic | 62,291 | 4,749 | 97.9% |
| Irinotecan hydrochloride | generic | 6,095 | 800 | 96.6% |
| Mitoxantrone | generic | 4,065 | 132 | 98.8% |
| Topotecan | generic | 3,668 | 187 | 96.6% |
| Camptosar | brand | 2,535 | 110 | 85.4% |
| Onivyde | brand | 1,911 | 614 | 92% |
| Mitoxantrone hydrochloride | generic | 1,213 | 39 | 97.1% |
| VePesid | brand | 900 | 20 | 96.7% |
| Topotecan hydrochloride | generic | 867 | 36 | 96.8% |
| Etoposide phosphate | generic | 747 | 63 | 96.5% |
| Etopophos | brand | 622 | 8 | 84.2% |
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.
Questions about Hycamtin reports
How many adverse event reports has FDA received for Hycamtin?
1,526 reports list Hycamtin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 14 of them arrived in the latest 12 months. Another 71 list it only as a concomitant medication.
What reactions are recorded in Hycamtin reports?
death (23.6%), anaemia (10.4%), white blood cell count decreased (10.2%), nausea (9.8%) and platelet count decreased (8.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Hycamtin was responsible.
How serious are the reports?
79.2% are marked serious by the reporter. Among the outcomes recorded, 37.1% of reports include death and 30.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (43.8%), physician (25.9%) and other health professional (15.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Hycamtin rising?
14 reports in the 12 months to June 2026, down 22% from 18 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Hycamtin was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Hycamtin?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Hycamtin as a suspect or interacting product; reports listing it only as a concomitant medication (71) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.