Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dalbavancin hydrochloride
Drug ID BADD_D00573
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 86298757
TTD Drug ID D07QAR
NDC Product Code 42513-0017; 62227-017
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 C88H101Cl3N10O28
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.Cl
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)
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Clostridium difficile colitis11.02.02.004; 07.19.01.004--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Eosinophilia01.02.04.001--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009--Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Headache17.14.01.001--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
International normalised ratio increased13.01.02.008--
Leukopenia01.02.02.001--Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Nausea07.01.07.001--
Neutropenia01.02.03.004--Not Available
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Phlebitis12.02.01.002; 24.05.03.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Wound haemorrhage24.07.01.029; 12.01.08.017--Not Available
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
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