Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dalbavancin
Drug ID BADD_D00572
Description Dalbavancin is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin [A4072, A4073]. Modifications from these older glycoprotein classes facilitated a similar mechanism of action for dalbavancin but with increased activity and once-weekly dosing [FDA Label, F2356, A4072, A4073]. Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, S. dysgalactiae, the S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin susceptible strains) [FDA Label, F2356]. Dalbavancin acts by interfering with bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of nascent cell wall peptidoglycan and preventing cross-linking [FDA Label, F2356, A4072, A4073].
Indications and Usage Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, and S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus). It is administered as a 30 minute IV infusion in a two-dose regimen of 1000 mg followed by 500 mg one week later.
Marketing Status Prescription
ATC Code J01XA04
DrugBank ID DB06219
KEGG ID D03640
MeSH ID C469289
PubChem ID 16134627
TTD Drug ID D07QAR
NDC Product Code 57970-100; 82297-102
Synonyms dalbavancin | Zeven | BI-397 | BI397 | BI 397 | MDL 64,397 | MDL-64397 | Dalvance | A-A-1 antibiotic | Xydalba | VER-001 | VER001
Chemical Information
Molecular Formula C88H100Cl2N10O28
CAS Registry Number 171500-79-1
SMILES CC(C)CCCCCCCCC(=O)NC1C(C(C(OC1OC2=C3C=C4C=C2OC5=C(C=C(C=C5)C(C6C(=O)NC(C7=C(C(=C C(=C7)O)OC8C(C(C(C(O8)CO)O)O)O)C9=C(C=CC(=C9)C(C(=O)N6)NC(=O)C4NC(=O)C1C2=C(C(=C C(=C2)OC2=C(C=CC(=C2)C(C(=O)NC(CC2=CC=C(O3)C=C2)C(=O)N1)NC)O)O)Cl)O)C(=O)NCCCN(C )C)O)Cl)C(=O)O)O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hypersensitivity10.01.03.0030.001277%
Hypoglycaemia14.06.03.001; 05.06.03.001--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
International normalised ratio increased13.01.02.008--
Leukopenia01.02.02.001--Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Musculoskeletal pain15.03.04.0070.000213%
Nausea07.01.07.0010.000532%
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Pallor23.03.03.031; 08.01.03.032; 24.03.04.0010.000213%Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.0160.000213%Not Available
Phlebitis24.05.03.001; 12.02.01.002--
Pruritus23.03.12.0010.000958%
Pyrexia08.05.02.0030.000745%
Rash23.03.13.0010.001490%Not Available
Rash macular23.03.13.0030.000319%Not Available
Sepsis11.01.11.0030.000056%
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.0030.000319%Not Available
Swelling08.01.03.0150.000213%Not Available
Swelling face23.04.01.018; 10.01.05.0180.000213%Not Available
Throat irritation22.02.05.013; 07.05.03.0040.000213%Not Available
Thrombocytopenia01.08.01.0020.000213%Not Available
Thrombocytosis01.08.02.001--Not Available
Urine abnormality20.02.01.0130.000213%Not Available
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