Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gemifloxacin
Drug ID BADD_D01013
Description Gemifloxacin is a quinolone antibacterial agent with a broad-spectrum activity that is used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. It is available in oral formulations. Gemifloxacin acts by inhibiting DNA synthesis through the inhibition of both DNA gyrase and topoisomerase IV, which are essential for bacterial growth.
Indications and Usage For the treatment of bacterial infection caused by susceptible strains such as S. pneumoniae, H. influenzae, H. parainfluenzae, or M. catarrhalis, S. pneumoniae (including multi-drug resistant strains [MDRSP]), M. pneumoniae, C. pneumoniae, or K. pneumoniae.
Marketing Status approved; investigational
ATC Code J01MA15
DrugBank ID DB01155
KEGG ID D08012
MeSH ID D000077735
PubChem ID 5464436
TTD Drug ID D0VR7W
NDC Product Code Not Available
UNII OKR68Y0E4T
Synonyms Gemifloxacin | 7-(3-aminomethyl-4-methoxyimino-pyrrolidine-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-(1,8)-naphthyridine-3-carboxylic acid | Factive | Gemifloxacin Mesylate | SB-265805 | SB265805 | SB 265805 | LB 20304 | LB-20304 | LB20304
Chemical Information
Molecular Formula C18H20FN5O4
CAS Registry Number 210353-54-1
SMILES CON=C1CN(CC1CN)C2=C(C=C3C(=O)C(=CN(C3=N2)C4CC4)C(=O)O)F
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)
Headache17.14.01.001--
Hepatitis cholestatic09.01.01.002---
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
Hypercalcaemia05.04.01.002; 14.04.01.003--
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hyponatraemia14.05.04.002--
Hypovolaemia14.05.05.002---
Immune system disorder10.02.01.001---
Insomnia17.15.03.002; 19.02.01.002--
Jaundice hepatocellular09.01.01.006---
Leukopenia01.02.02.001---
Loss of consciousness17.02.04.004---
Megacolon07.02.05.002---
Menopausal symptoms21.02.02.002---
Mouth ulceration07.05.06.004---
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myasthenia gravis10.04.05.001; 15.05.08.001; 17.05.04.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Nervousness19.06.02.003---
Neuropathy peripheral17.09.03.003---
Neutrophil count decreased13.01.06.010--
Neutrophil count increased13.01.06.011---
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oral mucosal blistering07.05.05.017---
Pain08.01.08.004--
Palpitations02.11.04.012--
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