Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dexrazoxane hydrochloride
Drug ID BADD_D00634
Description An antimitotic agent with immunosuppressive properties. Dexrazoxane, the (+)-enantiomorph of razoxane, provides cardioprotection against anthracycline toxicity. It appears to inhibit formation of a toxic iron-anthracycline complex. [PubChem] The Food and Drug Administration has designated dexrazoxane as an orphan drug for use in the prevention or reduction in the incidence and severity of anthracycline-induced cardiomyopathy.
Indications and Usage For reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m^2 and would benefit from continued doxorubicin therapy. Also approved for the treatment of extravasation from intravenous anthracyclines.
Marketing Status approved; withdrawn
ATC Code V03AF02
DrugBank ID DB00380
KEGG ID D07807
MeSH ID D064730
PubChem ID 6918223
TTD Drug ID D07XVN
NDC Product Code 51991-942
UNII 5346058Q7S
Synonyms Dexrazoxane | Razoxane, (S)-Isomer | Cardioxane | Cardioxan | Zinecard | ICRF-187 | ICRF 187 | ICRF187 | NSC-169780 | NSC 169780 | NSC169780 | ADR-529 | ADR 529 | ADR529 | Dexrazoxane Hydrochloride | Hydrochloride, Dexrazoxane | Razoxane, (S)-Isomer, Hydrochloride
Chemical Information
Molecular Formula C11H17ClN4O4
CAS Registry Number 149003-01-0
SMILES CC(CN1CC(=O)NC(=O)C1)N2CC(=O)NC(=O)C2.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)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.04.011--
Blood bilirubin increased13.03.04.018--
Blood calcium increased13.11.01.003--Not Available
Blood creatinine abnormal13.13.01.002--Not Available
Blood creatinine increased13.13.01.004--
Blood lactate dehydrogenase increased13.04.02.002--
Blood sodium decreased13.11.01.012--Not Available
Blood urea abnormal13.13.01.005--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 02.11.04.006; 17.02.05.003--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001--Not Available
Extravasation08.01.03.008--Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Infection11.01.08.002--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site phlebitis24.12.03.003; 12.07.03.012; 08.02.03.011--Not Available
Insomnia19.02.01.002; 17.15.03.002--
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