What the label lists and what reports show
Topotecan side effects
Topotecan's FDA label: “The most common Grade 3 or 4 hematologic adverse reactions (incidence > 5%) were neutropenia, anemia, thrombocytopenia, and febrile neutropenia.” FAERS holds 6,854 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (602 reports).
- Generic listed
- Boxed warning
Check it at the source: the topotecan FDA label on DailyMed (effective July 7, 2022, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of HYCAMTIN?HYCAMTIN may cause serious side effects, including: • See “What is the most important information I should know about HYCAMTIN?” • Lung problems that can cause death. Tell your healthcare provider right away if you have new or worse symptoms of coughing, fever, shortness of breath, or problems breathing. Your healthcare provider may tell you to stop taking HYCAMTIN capsules. The most common side effects of HYCAMTIN include: • decreased blood cell counts • diarrhea • hair loss • nausea • vomiting • fatigue Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking HYCAMTIN if you develop certain serious side effects during treatment with HYCAMTIN. HYCAMTIN may cause short-term and long-term fertility problems in females. This could affect your ability to become pregnant. HYCAMTIN may cause lower sperm count problems in men. […]
Source: FDA drug label (HYCAMTIN), Sandoz Inc, effective September 18, 2023 (SPL set b23b46f5-c276-47f5-8bbd-940680b3f579), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common Grade 3 or 4 hematologic adverse reactions (incidence > 5%) were neutropenia, anemia, thrombocytopenia, and febrile neutropenia.
Table 3. Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Cervical Cancer (Between-Arm Difference ≥ 2%) a in Study GOG 0179
| Adverse Reactions | HYCAMTIN for Injection With Cisplatin (n = 140) % | Cisplatin (n = 144) % |
|---|---|---|
| Grade 3 (< 1,000-500/mm 3 ) | 26 | 1 |
| Grade 4 (< 500/mm 3 ) | 48 | 1 |
| Grade 3 (Hgb < 8-6.5 g/dL) | 34 | 19 |
| Grade 4 (Hgb < 6.5 g/dL) | 6 | 3 |
| Grade 3 (< 50,000-10,000/mm 3 ) | 26 | 3 |
| Grade 4 (< 10,000/mm 3 ) | 7 | 0 |
| Constitutional d | 69 | 62 |
| Pain e | 59 | 50 |
| Vomiting | 40 | 37 |
| Stomatitis-pharyngitis | 6 | 0 |
| Other | 63 | 56 |
| Dermatology f | 48 | 20 |
| Febrile neutropenia f | 28 | 18 |
| Cardiovascular f | 25 | 15 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1)] Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.2)] Extravasation and Tissue Injury [see Warnings and Precautions (5.3)] Ovarian Cancer The most common Grade 3 or 4 hematologic adverse reactions (incidence > 5%) were neutropenia, anemia, thrombocytopenia, and febrile neutropenia. ( 6.1 ) The most common (incidence > 5%) non-hematologic adverse reactions (all Grades) were nausea, vomiting, fatigue, diarrhea, and dyspnea. ( 6.1 ) SCLC The most common Grade 3 or 4 hematologic adverse reactions were (incidence > 5%) neutropenia, anemia, thrombocytopenia, and febrile neutropenia. ( 6.1 ) The most common (incidence > 5%) non-hematologic adverse reactions (all Grades) were asthenia, dyspnea, nausea, pneumonia, abdominal pain, and fatigue. ( 6.1 ) Cervical Cancer The most common Grade 3 or 4 hematologic adverse reactions were (incidence > 5%) neutropenia, anemia, and thrombocytopenia. ( 6.1 ) The most common (incidence > 25% and ≥ 2% higher than cisplatin alone) non-hematologic adverse reactions were pain, vomiting, and infection/febrile neutropenia.
Source: FDA drug label, NDA020671 (Sandoz), as published by Novartis Pharmaceuticals Corporation, effective July 7, 2022 (SPL set eeee060c-a9ec-423e-a374-8484009f8524), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,854 reports list topotecan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,640 are coded as a death and 2,591 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Topotecan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions