Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Topotecan hydrochloride
Drug ID BADD_D02249
Description An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA topoisomerases, type I.
Indications and Usage For the treatment of advanced ovarian cancer in patients with disease that has recurred or progressed following therapy with platinum-based regimens. Also used as a second-line therapy for treatment-sensitive small cell lung cancer, as well as in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment with surgery and/or radiation therapy.
Marketing Status approved; investigational
ATC Code L01CE01
DrugBank ID DB01030
KEGG ID D02168
MeSH ID D019772
PubChem ID 60699
TTD Drug ID D0Z4XW
NDC Product Code 45963-615; 61187-001; 63323-762; 0078-0674; 29902-0001; 65129-1131; 16729-151; 55390-370
UNII 956S425ZCY
Synonyms Topotecan | 9-Dimethylaminomethyl-10-hydroxycamptothecin | 9 Dimethylaminomethyl 10 hydroxycamptothecin | Topotecan Hydrochloride | Hydrochloride, Topotecan | Nogitecan Hydrochloride | Hydrochloride, Nogitecan | Topotecan Monohydrochloride, (S)-Isomer | SK&F-104864-A | SK&F 104864 A | SK&F104864A | SKF-104864-A | SKF 104864 A | SKF104864A | Hycamtin | NSC-609699 | NSC 609699 | NSC609699 | Hycamtamine
Chemical Information
Molecular Formula C23H24ClN3O5
CAS Registry Number 119413-54-6
SMILES CCC1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dyspareunia19.08.05.004; 21.03.02.016--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Ear pain04.03.01.003--
Epistaxis22.04.03.001; 24.07.01.005--
Extravasation08.01.03.008---
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.004--
Feeling abnormal08.01.09.014---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Haemoglobin13.01.05.018---
Headache17.14.01.001--
Hepatic pain09.01.05.005--
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypoaesthesia17.02.06.023; 23.03.03.081---
Immune system disorder10.02.01.001---
Infection11.01.08.002---
Interstitial lung disease10.02.01.033; 22.01.02.003---
Intestinal obstruction07.13.01.002---
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.004--
Leukopenia01.02.02.001---
Lung disorder22.02.07.001---
Malaise08.01.01.003--
Mucosal inflammation08.01.06.002---
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nausea07.01.07.001--
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