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 for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin susceptible strains) [FDA Label, F2356]. Dalbavancin is not active against gram-negative bacteria; therefore, combination therapy may be clinically indicated if the ABSSSI is polymicrobial and includes a suspected or documented gram-negative pathogen [F2356]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin and other antibacterial drugs, dalbavancin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria [FDA Label, F2356]. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy [FDA Label, F2356]. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy [FDA Label, F2356].
Marketing Status approved; investigational
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
UNII 808UI9MS5K
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
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 pain07.01.05.002--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Bronchospasm10.01.03.012; 22.03.01.004--
Clostridium difficile colitis11.02.02.004; 07.19.01.004--Not Available
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Eosinophilia01.02.04.001--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Haematochezia07.12.02.003; 24.07.02.012--Not Available
Headache17.14.01.001--
Hepatitis viral11.05.04.011; 09.01.09.007--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hypoglycaemia05.06.03.001; 14.06.03.001--
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
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Oral candidiasis07.05.07.001; 11.03.03.004--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Phlebitis24.12.03.004; 12.02.01.002--
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