Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Glycerol phenylbutyrate
Drug ID BADD_D01032
Description Glycerol phenylbutyrate is a nitrogen-binding agent. Chemically, it is a triglyceride in which three molecules of phenylbutyrate are linked to a glycerol backbone. FDA approved on February 1, 2013.
Indications and Usage Glycerol phenylbutyrate is a nitrogen-binding agent for the chronic management of adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Marketing Status Prescription
ATC Code A16AX09
DrugBank ID DB08909
KEGG ID D10127
MeSH ID C570223
PubChem ID 10482134
TTD Drug ID D0E0BD
NDC Product Code 58159-034; 75987-050; 65977-0121; 67262-0009; 14501-0097; 67262-0008; 45941-3054
Synonyms glycerol phenylbutyrate | HPN 100 | HPN100 | HPN-100 | Ravicti
Chemical Information
Molecular Formula C33H38O6
CAS Registry Number 611168-24-2
SMILES C1=CC=C(C=C1)CCCC(=O)OCC(COC(=O)CCCC2=CC=CC=C2)OC(=O)CCCC3=CC=CC=C3
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.021361%Not Available
Abdominal pain07.01.05.0020.074763%
Abdominal pain upper07.01.05.0030.042722%
Acute respiratory failure14.01.04.004; 22.02.06.0010.005572%Not Available
Aggression19.05.01.0010.053402%Not Available
Alopecia23.02.02.0010.021361%
Altered state of consciousness17.02.04.001; 19.07.01.0030.021361%Not Available
Ammonia increased13.03.01.0230.384497%Not Available
Anger19.04.02.0010.021361%Not Available
Anxiety19.06.02.002--
Asthenia08.01.01.001--Not Available
Blood glucose increased13.02.02.0020.021361%Not Available
Blood potassium decreased13.11.01.0100.032041%Not Available
Bone pain15.02.01.0010.021361%
Confusional state17.02.03.005; 19.13.01.0010.042722%
Constipation07.02.02.0010.042722%
Cough22.02.03.0010.064083%
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.0020.032041%Not Available
Death08.04.01.001--
Dehydration14.05.05.0010.064083%
Dermatitis23.03.04.002--Not Available
Developmental delay08.01.03.0370.021361%Not Available
Diarrhoea07.02.01.0010.096124%
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Dyspnoea02.01.03.002; 22.02.01.004--
Fatigue08.01.01.0020.117485%
Flatulence07.01.04.002--
Gastroenteritis07.19.03.001; 11.01.07.0040.021361%Not Available
Gastroenteritis viral07.19.03.005; 11.05.04.0050.021361%Not Available
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