Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Carglumic acid
Drug ID BADD_D00368
Description Carglumic acid is a drug used for the treatment of hyperammonemia in patients with a deficiency in N-acetyl glutamate synthase. This rare genetic disorder results in elevated blood levels of ammonia, which can eventually cross the blood–brain barrier and cause neurologic problems, cerebral edema, coma, and death. Carglumic acid was approved by the U.S. Food and Drug Administration (FDA) on 18 March 2010.
Indications and Usage For the treatment of acute and chronic hyperammonaemia in patients with N-acetylglutamate synthase (NAGS) deficiency. This enzyme is an important component of the urea cycle to prevent build up of neurotoxic ammonium in the blood.
Marketing Status approved
ATC Code A16AA05
DrugBank ID DB06775
KEGG ID D07130
MeSH ID C528449
PubChem ID 121396
TTD Drug ID D0Z0MG
NDC Product Code 76339-108; 46438-0658; 71863-114; 46016-1180; 52276-312; 68475-006; 43235-0011; 35573-459; 58159-053
UNII 5L0HB4V1EW
Synonyms carglumic acid | Carbaglu
Chemical Information
Molecular Formula C6H10N2O5
CAS Registry Number 1188-38-1
SMILES C(CC(=O)O)C(C(=O)O)NC(=O)N
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 distension07.01.04.0010.004312%
Abdominal pain07.01.05.0020.011643%
Abdominal pain upper07.01.05.0030.006469%
Acidosis14.01.03.0020.012937%
Acute respiratory failure22.02.06.001; 14.01.04.0040.004312%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.006469%Not Available
Anaemia01.03.02.001--
Asthenia08.01.01.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Cardiac arrest02.03.04.0010.006469%
Cardiac failure02.05.01.0010.004312%
Condition aggravated08.01.03.0040.010781%Not Available
Constipation07.02.02.0010.013800%
Death08.04.01.0010.028030%
Dehydration14.05.05.0010.008625%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.0010.047436%
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.0070.016818%
Dysgeusia17.02.07.003; 07.14.03.001--
Ear disorder04.03.01.001--Not Available
Ear infection11.01.05.001; 04.03.01.006--Not Available
Feeling abnormal08.01.09.0140.004312%Not Available
Flatulence07.01.04.0020.009487%
Gastritis07.08.02.0010.009487%
Gastrooesophageal reflux disease07.02.02.0030.016818%
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.0010.016818%
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