Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tivozanib
Drug ID BADD_D02600
Description Renal cell carcinoma (RCC) is responsible for 3% of cancer cases[A231314] and is one of the 10 most common cancers in adults. The average age of diagnosis is between age 65 to 74.[L32529] Tivozanib, also known as FOTIVDA, is a kinase inhibitor developed to treat adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) after prior failed systemic therapies. It was approved on March 10, 2021 by the FDA. Marketed by Aveo Oncology, tivozanib is a promising therapy for individuals with RCC who have not been treated successfully with other therapies.[L32524]
Indications and Usage Tivozanib is approved in the USA for the treatment of relapsed or refractory renal cell carcinoma in adult patients who have undergone two or more systemic therapies.[L32524] In the UK and other countries, is indicated as first line therapy of adults with advanced renal cell carcinoma (RCC) and VEGFR and mTOR pathway inhibitor-naïve patients after disease progression following one previous treatment with cytokine therapy for advanced disease.[L17180]
Marketing Status approved; investigational
ATC Code L01EK03
DrugBank ID DB11800
KEGG ID D09683
MeSH ID C553176
PubChem ID 9911830
TTD Drug ID D0W7JZ
NDC Product Code 45629-134; 11014-0470; 45629-089; 11014-0457; 11014-0458; 11014-0471
UNII 172030934T
Synonyms tivozanib | AV 951 | AV951 cpd | AV-951 | fotivda | KRN 951 | KRN951 | KRN-951
Chemical Information
Molecular Formula C22H19ClN4O5
CAS Registry Number 475108-18-0
SMILES CC1=CC(=NO1)NC(=O)NC2=C(C=C(C=C2)OC3=C4C=C(C(=CC4=NC=C3)OC)OC)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)
Arthralgia15.01.02.0010.000381%
Asthenia08.01.01.0010.000492%-
Constipation07.02.02.0010.000437%
Death08.04.01.0010.000168%
Dehydration14.05.05.0010.000112%
Diarrhoea07.02.01.0010.000168%
Dysphonia17.02.08.004; 19.19.03.002; 22.12.03.0060.001063%
Fatigue08.01.01.0020.000851%
Headache17.14.01.0010.000246%
Hypertension24.08.02.0010.000246%
Nausea07.01.07.0010.001063%
Pain08.01.08.0040.000302%
Palmar-plantar erythrodysaesthesia syndrome17.02.07.009; 23.03.05.0090.000437%
Rash23.03.13.0010.000627%-
Stomatitis07.05.06.0050.000246%
Vomiting07.01.07.0030.000873%
Malignant neoplasm progression16.16.01.0050.000246%-
Decreased appetite08.01.09.028; 14.03.01.0050.000604%
Adverse drug reaction08.06.01.0090.000246%-
Disease progression08.01.03.0380.000929%
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