Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sodium phenylbutyrate
Drug ID BADD_D02048
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 5258
TTD Drug ID D0P2GK
NDC Product Code 49629-043; 66326-504; 71770-200; 72542-600; 54382-120; 65571-0006; 66326-210; 71052-297; 72542-400; 49884-006; 72542-667; 75987-060; 66326-207; 73309-233; 72542-300; 75987-070; 38779-2549; 42794-086; 71770-210; 68462-853; 72542-500; 86036-004; 72542-200
UNII NT6K61736T
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 C10H11NaO2
CAS Registry Number 1716-12-7
SMILES C1=CC=C(C=C1)CCCC(=O)[O-].[Na+]
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 pain07.01.05.002--
Acidosis14.01.03.002--
Alkalosis14.01.02.001--
Anaemia01.03.02.001--
Aplastic anaemia01.03.03.002---
Arrhythmia02.03.02.001---
Constipation07.02.02.001--
Depression19.15.01.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Gastritis07.08.02.001--
Headache17.14.01.001--
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
Hyperchloraemia14.05.08.001---
Hypernatraemia14.05.04.001--
Hyperphosphataemia14.04.03.007--
Hyperuricaemia14.09.01.003--
Hypoalbuminaemia09.01.02.003; 14.10.01.002--
Hypokalaemia14.05.03.002--
Hypophosphataemia14.04.03.001--
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001---
Nausea07.01.07.001--
Oedema08.01.07.006; 14.05.06.010---
Pancreatitis07.18.01.001--
Peptic ulcer07.04.07.001---
Protein total decreased13.09.01.004---
Rash23.03.13.001---
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal tubular acidosis14.01.01.005; 20.05.03.003---
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