Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Panobinostat lactate
Drug ID BADD_D01667
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 approved; investigational
ATC Code L01XH03
DrugBank ID DB06603
KEGG ID D10019
MeSH ID D000077767
PubChem ID 23725423
TTD Drug ID D0E3SH
NDC Product Code 54893-0073
UNII HN0T99OO4V
Synonyms Panobinostat | LBH589 | NVP-LBH589 | NVP LBH589 | LBH 589 | Farydak
Chemical Information
Molecular Formula C24H29N3O5
CAS Registry Number 960055-56-5
SMILES CC1=C(C2=CC=CC=C2N1)CCNCC3=CC=C(C=C3)C=CC(=O)NO.CC(C(=O)O)O
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 distension07.01.04.001--
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Blood creatinine increased13.13.01.004--
Blood urea increased13.13.01.006--Not Available
Cheilitis23.03.03.025; 07.05.01.001--
Chills15.05.03.016; 08.01.09.001--
Colitis07.08.01.001--
Cough22.02.03.001--
Death08.04.01.001--
Dehydration14.05.05.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gastritis07.08.02.001--
Gastrointestinal pain07.01.05.005--
Glomerular filtration rate decreased13.13.01.009--Not Available
Headache17.14.01.001--
Hepatitis B09.01.09.003; 11.05.28.003--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
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