Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vorinostat
Drug ID BADD_D02370
Description Vorinostat (rINN) or suberoylanilide hydroxamic acid (SAHA), is a drug currently under investigation for the treatment of cutaneous T cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. It is the first in a new class of agents known as histone deacetylase inhibitors. A recent study suggested that vorinostat also possesses some activity against recurrent glioblastoma multiforme, resulting in a median overall survival of 5.7 months (compared to 4 - 4.4 months in earlier studies). Further brain tumor trials are planned using combinations of vorinostat with other drugs.
Indications and Usage For the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
Marketing Status approved; investigational
ATC Code L01XH01
DrugBank ID DB02546
KEGG ID D06320
MeSH ID D000077337
PubChem ID 5311
TTD Drug ID D0E7PQ
NDC Product Code 0006-0568; 63285-009
UNII 58IFB293JI
Synonyms Vorinostat | N1-Hydroxy-N8-phenyloctanediamide | N1 Hydroxy N8 phenyloctanediamide | NHNPODA | Suberoyl Anilide Hydroxamic Acid | Suberoylanilide Hydroxamic Acid | N-Hydroxy-N'-phenyloctanediamide | N Hydroxy N' phenyloctanediamide | Suberanilohydroxamic Acid | M344 | MK-0683 | MK 0683 | MK0683 | 18F-SAHA | 18F-Suberoylanilide Hydroxamic Acid | 18F Suberoylanilide Hydroxamic Acid | Zolinza
Chemical Information
Molecular Formula C14H20N2O3
CAS Registry Number 149647-78-9
SMILES C1=CC=C(C=C1)NC(=O)CCCCCCC(=O)NO
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)
Fistula15.03.02.001---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Guillain-Barre syndrome10.04.10.005; 11.07.01.001; 17.09.01.001--
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Headache17.14.01.0010.000358%
Hydrocephalus17.07.01.0010.000112%
Hyperglycaemia05.06.02.002; 14.06.02.0020.000168%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023; 23.03.03.0810.000437%-
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Infection11.01.08.002---
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.0040.000168%
Leukopenia01.02.02.001---
Loss of consciousness17.02.04.004---
Lung infiltration22.01.02.0040.000112%-
Muscle spasms15.05.03.0040.000381%
Myelodysplastic syndrome01.10.04.001; 16.01.04.0010.000112%
Myocardial infarction02.02.02.007; 24.04.04.0090.000112%
Nausea07.01.07.0010.000851%
Neoplasm malignant16.16.01.001---
Neuropathy peripheral17.09.03.0030.000224%-
Neutropenia01.02.03.004---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pancytopenia01.03.03.003---
Pelvi-ureteric obstruction20.01.05.003---
Pneumonia11.01.09.003; 22.07.01.003---
Proteinuria20.02.01.011--
Pruritus23.03.12.0010.000627%
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ADReCS-Target
Drug Name ADR Term Target
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