Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omadacycline
Drug ID BADD_D02575
Description Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.
Indications and Usage Omadacycline is indicated for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections caused by omadacycline-susceptible organisms in adults.[FDA Label]
Marketing Status approved; investigational
ATC Code J01AA15
DrugBank ID DB12455
KEGG ID D09647
MeSH ID C000591640
PubChem ID Not Available
TTD Drug ID D09GUJ
NDC Product Code 68225-111; 71715-001; 71715-002
UNII 090IP5RV8F
Synonyms omadacycline | nuzyra
Chemical Information
Molecular Formula Not Available
CAS Registry Number 389139-89-3
SMILES Not Available
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 discomfort07.01.06.0010.000190%-
Bronchiectasis22.03.02.0050.000049%-
Cough22.02.03.0010.000049%
Death08.04.01.0010.000194%
Diarrhoea07.02.01.0010.000165%
Drug ineffective08.06.01.0060.000073%-
Dyspnoea02.11.05.003; 22.02.01.0040.000049%
Eosinophilia01.02.04.0010.000330%
Hepatic function abnormal09.01.02.0010.000355%-
Hypersensitivity10.01.03.0030.000049%
Nausea07.01.07.0010.000578%
Rash papular23.03.13.0170.000165%-
Rash pruritic23.03.13.0300.000248%-
Retching07.01.07.0020.000107%-
Skin hyperpigmentation23.05.01.0030.000131%
Tooth discolouration07.09.02.0010.000330%
Urticaria10.01.06.001; 23.04.02.0010.000165%
Vomiting07.01.07.0030.000248%
Liver injury09.01.07.022; 12.01.17.0120.000049%-
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