OpenClaim

Topotecan Side Effects

The most commonly reported side effects of topotecan include off label use, febrile neutropenia, and death, based on 6,959 FDA adverse event reports from 2004 to 2025. 4.1% of reports found the drug to be ineffective.

Topotecan side effects

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

1
Off Label Use7.9%552
2
Febrile Neutropenia7.1%496
3
Death6.8%476
4
Neutropenia5.6%389
5
Disease Progression5.6%388
6
Product Use In Unapproved Indication5.4%377
7
Anaemia5.4%374
8
Pyrexia4.4%308
9
Nausea4.2%290
10
Malignant Neoplasm Progression4.2%289
11
Thrombocytopenia4.1%284
12
Drug Ineffective4.1%282
13
Vomiting3.8%265
14
Fatigue3.5%243
15
Diarrhoea3.1%219

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

Report severity

91.7%Serious6,380 reports
37.9%Hospitalizations2,634 reports
24.1%Fatal1,676 reports

Seriousness is determined by the reporter, not by OpenClaim.

Topotecan drug interactions

Other drugs that appear in adverse event reports alongside topotecan. 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
Cyclophosphamide20.5%1,430
2
Carboplatin18.1%1,260
3
Etoposide13.8%963
4
Cisplatin11.8%818
5
Doxorubicin-hydrochloride11.5%803
6
Melphalan11.3%786
7
Vincristine-sulfate10.1%700
8
Bevacizumab8.3%579
9
Ifosfamide5.9%412
10
Paclitaxel5.8%407
11
Temozolomide5.8%404
12
Irinotecan-hydrochloride4.2%290
13
Gemcitabine4.0%280
14
Venetoclax3.5%247
15
Thiotepa3.2%223

Taken alongside

1
Ondansetron7.3%507
2
Dexamethasone6.2%432
3
Acetaminophen5.7%398
4
Carboplatin4.2%289
5
Etoposide3.2%220
6
Cisplatin3.1%219
7
Cyclophosphamide3.0%212
8
Oxycodone3.0%207
9
Doxorubicin-hydrochloride2.6%181
10
Filgrastim2.6%178
11
Vincristine-sulfate2.5%173
12
Sulfamethoxazole2.4%170
13
Trimethoprim2.3%161
14
Granisetron2.3%160
15
Levothyroxine-sodium2.3%159

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 topotecan side effects

49.9% of topotecan adverse event reports involve female patients and 32.9% involve male patients. The largest age group is adult at 38%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.9%
Male32.9%
Unknown17.2%

Age group

< 28.8%
2–1124.3%
12–175.4%
18–6438.0%
65+23.4%

What is topotecan used for

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

Acute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma Of The CervixAdenocarcinoma PancreasAdenoma BenignAdrenal AdenomaAdrenal Gland CancerAdult T-cell Lymphoma/leukaemia

Showing 15 of 509 indications

Topotecan brand names and reporting trend

Topotecan is sold under the brand name Hycamtin.

Brand names

Hycamtin1

Quarterly reports (20042025)

20052010201520202025

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

Taking topotecan with another medication?

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