Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Crofelemer
Drug ID BADD_D00536
Description Crofelemer, previously known as the investigational drug SP-303, is a novel proanthocyanidin purified from the bark latex of the Amazonian Croton tree Croton lechleri. It is marketed under the brand name Fulyzaq and indicated for the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy.
Indications and Usage For the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy.
Marketing Status approved
ATC Code A07XA06
DrugBank ID DB04941
KEGG ID D03605
MeSH ID C546704
PubChem ID 36511
TTD Drug ID D09VXM
NDC Product Code 66039-854; 70564-802
UNII PY79D6C8RX
Synonyms crofelemer | Fulyzaq
Chemical Information
Molecular Formula C63H98N18O13S
CAS Registry Number 33507-63-0
SMILES CC(C)CC(C(=O)NC(CCSC)C(=O)N)NC(=O)CNC(=O)C(CC1=CC=CC=C1)NC(=O)C(CC2=CC=CC=C2)NC( =O)C(CCC(=O)N)NC(=O)C(CCC(=O)N)NC(=O)C3CCCN3C(=O)C(CCCCN)NC(=O)C4CCCN4C(=O)C(CCC N=C(N)N)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 distension07.01.04.001--
Abdominal pain07.01.05.002--
Acne23.02.01.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.005--
Bilirubin conjugated increased13.03.04.014--Not Available
Blood bilirubin increased13.03.04.018--
Blood bilirubin unconjugated increased13.03.04.020--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Flatulence07.01.04.002--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Giardiasis11.06.06.001; 07.19.01.015--Not Available
Haemorrhoids07.15.03.001; 24.10.02.002--
Herpes zoster23.11.05.005; 11.05.02.003; 17.09.03.026--
Musculoskeletal pain15.03.04.007--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Pain in extremity15.03.04.010--
Pollakiuria20.02.02.007--
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