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 approved
ATC Code A16AX09
DrugBank ID DB08909
KEGG ID D10127
MeSH ID C570223
PubChem ID 10482134
TTD Drug ID D0E0BD
NDC Product Code 75987-050; 14501-0097; 58159-034; 67262-0008; 45941-3054; 65977-0121; 67262-0009
UNII ZH6F1VCV7B
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
*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)
Hypertension24.08.02.0010.004312%
Hyponatraemia14.05.04.0020.008625%
Irritability19.04.02.013; 08.01.03.0110.042261%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.024581%
Malaise08.01.01.0030.006469%
Memory impairment19.20.01.003; 17.03.02.0030.009487%
Menstruation irregular21.01.01.005; 05.05.01.0080.014662%
Mental impairment19.21.02.003; 17.03.03.0020.009487%Not Available
Metabolic acidosis14.01.01.0030.017249%Not Available
Migraine24.03.05.003; 17.14.02.0010.016818%Not Available
Mood altered19.04.02.0070.014662%Not Available
Nasal congestion22.04.04.0010.006469%
Nausea07.01.07.0010.057786%
Nervous system disorder17.02.10.001--Not Available
Pain in extremity15.03.04.0100.009487%
Palpitations02.11.04.0120.009487%
Pancreatitis07.18.01.0010.004312%
Pyrexia08.05.02.0030.015093%
Rash23.03.13.0010.038811%Not Available
Rhinorrhoea22.12.03.0210.004312%
Screaming19.04.02.020; 08.01.03.0990.009487%Not Available
Seizure17.12.03.0010.019406%
Skin odour abnormal23.03.03.0120.021993%
Somnolence19.02.05.003; 17.02.04.0060.047005%
Steatorrhoea07.17.01.0020.009487%Not Available
Thirst08.01.09.021; 14.03.02.0070.021993%Not Available
Thrombocytopenia01.08.01.0020.004312%Not Available
Tremor17.01.06.0020.004312%
Vomiting07.01.07.0030.076760%
Vomiting projectile07.01.07.0120.009487%Not Available
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