Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Phenylbutyric acid
Drug ID BADD_D01760
Description A monocarboxylic acid the structure of which is that of butyric acid substituted with a phenyl group at C-4. It is a histone deacetylase inhibitor that displays anticancer activity. It inhibits cell proliferation, invasion and migration and induces apoptosis in glioma cells. It also inhibits protein isoprenylation, depletes plasma glutamine, increases production of foetal haemoglobin through transcriptional activation of the γ-globin gene and affects hPPARγ activation.
Indications and Usage Adjunctive therapy for the management of chronic urea cycle disorders due to deficiencies in carbamylphosphate (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase. it is indicated in all neonatal- onset efficiency presenting within the first 28 days of life. Also indicated in patients with late-onset, presenting after the first month of life with a history of hyperammonemic encephalopathy.
Marketing Status approved; investigational
ATC Code A16AX03
DrugBank ID DB06819
KEGG ID D05868
MeSH ID C075773
PubChem ID 4775
TTD Drug ID D0P2GK
NDC Product Code Not Available
UNII 7WY7YBI87E
Synonyms 4-phenylbutyric acid | 4-phenylbutyric acid, calcium salt | Ammonaps | Buphenyl | 4-phenylbutyrate | 4-phenylbutyric acid, sodium salt | sodium 4-phenylbutanoate | sodium phenylbutyrate | sodium 4-phenylbutyrate
Chemical Information
Molecular Formula C10H12O2
CAS Registry Number 1821-12-1
SMILES C1=CC=C(C=C1)CCCC(=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)
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Pancreatitis07.18.01.001--
Pancreatitis chronic07.18.01.007--Not Available
Peptic ulcer07.04.07.001--Not Available
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal tubular acidosis20.05.03.003; 14.01.01.005--Not Available
Road traffic accident12.01.08.006--Not Available
Seizure17.12.03.0010.004312%
Shock24.06.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin odour abnormal23.03.03.012--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.001--Not Available
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Vomiting07.01.07.0030.018974%
Weight increased13.15.01.006--
Lymphatic disorder01.09.01.003--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Malnutrition14.03.02.004--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Blood disorder01.05.01.004--Not Available
Metabolic encephalopathy17.13.01.001; 14.11.01.013--Not Available
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