Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Panobinostat
Drug ID BADD_D02454
Description Panobinostat is an oral deacetylace (DAC) inhibitor approved on February 23, 2015 by the FDA for the treatment of multiple myeloma. The approval was accelerated based on progression-free survival, therefore confirmatory trials by the sponsor to demonstrate clinical efficacy in multiple myeloma treatment are in progress of being conducted. Panobinostat is marketed by Novartis under the brand name Farydak. Panobinostat acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor) and it is the most potent DAC inhibiting agent available on the market.
Indications and Usage Panobinostat is indicated in the treatment of multiple myeloma in combination with dexamethasone and bortezomib in patients who have received 2 previous treatment regimens including bortezomib and an immunomodulatory agent. This indication is approved by accelerated approval based on progression free survival as of February 23, 2015.
Marketing Status Not Available
ATC Code L01XH03
DrugBank ID DB06603
KEGG ID D10319
MeSH ID D000077767
PubChem ID 6918837
TTD Drug ID D0E3SH
NDC Product Code 73116-101; 73116-100; 73116-102; 0078-0650; 0078-0652; 0078-0651
Synonyms Panobinostat | LBH589 | NVP-LBH589 | NVP LBH589 | LBH 589 | Farydak
Chemical Information
Molecular Formula C21H23N3O2
CAS Registry Number 404950-80-7
SMILES CC1=C(C2=CC=CC=C2N1)CCNCC3=CC=C(C=C3)C=CC(=O)NO
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain upper07.01.05.0030.001066%
Anaemia01.03.02.0010.001066%
Asthenia08.01.01.0010.001865%Not Available
Atrial fibrillation02.03.03.0020.000799%
Blood creatinine increased13.13.01.0040.000533%
Brain stem glioma16.30.02.005; 17.20.02.0050.000533%Not Available
Cardiac failure congestive02.05.01.002--Not Available
Chest discomfort02.02.02.009; 08.01.08.019; 22.02.08.0010.000533%Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.0030.000533%Not Available
Confusional state17.02.03.005; 19.13.01.0010.001332%
Constipation07.02.02.0010.001066%
Cough22.02.03.001--
Death08.04.01.0010.003475%
Dehydration14.05.05.0010.000533%
Diarrhoea07.02.01.0010.015452%
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dysphagia07.01.06.0030.000533%
Dyspnoea02.01.03.002; 22.02.01.004--
Electrocardiogram abnormal13.14.05.0010.000799%Not Available
Electrocardiogram QT prolonged13.14.05.0040.000799%
Enterocolitis07.08.03.0030.000533%
Fatigue08.01.01.0020.003996%
Feeling abnormal08.01.09.0140.000533%Not Available
Headache17.14.01.001--
Hypertension24.08.02.0010.001066%
Infection11.01.08.0020.000347%Not Available
Intestinal obstruction07.13.01.0020.000139%Not Available
Large intestine perforation07.04.06.005; 12.02.03.0050.000139%
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.0040.000533%
Loss of consciousness17.02.04.0040.000533%Not Available
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ADReCS-Target
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