Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levofloxacin
Drug ID BADD_D01275
Description Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic [ofloxacin].[A190663] It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin[A190663] and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer).[L11638] Levofloxacin, along with other quinolones such as [gatifloxacin] and [moxifloxacin], is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.[A31453,A190756] Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.[A190663]
Indications and Usage In oral and intravenous formulations, levofloxacin is indicated in adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate.[L11638,L11692] The oral formulation is also indicated in both adults and children 6 months of age and older for the post-exposure management of inhalational anthrax caused by _Bacillus anthracis_ and for the treatment and/or prophylaxis of plague caused by _Yersinia pestis_.[L11638] In its ophthalmic formulation, levofloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms.[L11641] An inhalational solution available in Canada is indicated for the management of cystic fibrosis patients aged 18 years or older with chronic pulmonary _Pseudomonas aeruginosa_ infections.[L11689]
Marketing Status approved; investigational
ATC Code J01MA12; S01AE05
DrugBank ID DB01137
KEGG ID D00588; D08120
MeSH ID D064704
PubChem ID 149096
TTD Drug ID D02RSN
NDC Product Code 0904-6353; 31722-723; 33342-532; 36000-294; 43063-457; 43063-637; 54288-140; 63187-004; 63187-384; 63187-438; 63187-514; 65841-693; 67296-1546; 70518-0968; 70518-3712; 72189-338; 0904-6352; 49587-102; 17478-107; 36000-045; 45865-758; 55154-5898; 63187-833; 63323-355; 68788-8340; 71335-0434; 72578-098; 0781-5791; 80425-0007; 80425-0008; 80425-0009; 82982-034; 53104-7550; 63415-0056; 33342-022; 36000-296; 0143-9720; 50090-4572; 51655-666; 61919-440; 61919-704; 67296-0744; 67296-0897; 67296-1393; 0409-0528; 70771-1079; 71205-058; 55111-281; 65841-691; 65862-537; 68083-416; 68180-242; 68382-989; 69097-287; 0527-1948; 70518-0453; 71335-0794; 53069-0600; 65862-488; 31722-721; 33342-021; 0143-9317; 43063-638; 67296-0972; 67296-0977; 67296-1400; 68071-3236; 68083-415; 70518-0719; 71335-0593; 72578-099; 0904-6351; 65862-536; 0143-9316; 50383-286; 70934-094; 71335-1208; 65862-538; 16571-150; 25021-132; 33342-023; 33342-531; 36000-048; 44567-436; 50090-3314; 51655-947; 55111-279; 63187-925; 67296-1325; 67296-1351; 67296-1535; 68071-4512; 68083-395; 68180-241; 70518-0587; 0781-5790; 0781-5792; 43235-0007; 31722-722; 36000-046; 43063-796; 0143-9721; 51407-428; 67296-0975; 67296-0985; 71205-002; 71205-234; 71335-0380; 72789-085; 72789-248; 17478-106; 0143-9315; 44567-437; 50090-4797; 53002-1350; 55111-280; 55150-156; 55150-157; 63187-003; 68083-414; 68788-6938; 72578-100; 80425-0077; 55525-0001; 36000-295; 44567-435; 50090-3214; 50090-3311; 51407-429; 51655-327; 61919-426; 65841-692; 68083-394; 68180-240; 80425-0076; 65977-0039; 33342-533; 36000-047; 42571-168; 43063-459; 0143-9722; 51407-430; 53002-2350; 55154-5897; 55700-729
UNII 6GNT3Y5LMF
Synonyms Levofloxacin | Ofloxacin, (S)-Isomer | Levofloxacin Anhydrous | Anhydrous, Levofloxacin | Quixin | Levaquin
Chemical Information
Molecular Formula C18H20FN3O4
CAS Registry Number 100986-85-4
SMILES CC1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=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)
Liver injury09.01.07.022; 12.01.17.0120.000304%-
Organising pneumonia22.01.02.0080.000042%-
Adverse reaction08.06.01.0180.000148%-
Oral disorder07.05.01.0050.000042%-
Vulvovaginal burning sensation21.08.02.0070.000114%-
Hypertransaminasaemia09.01.02.0050.000190%-
Anorectal discomfort07.03.03.0030.000042%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000084%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Vulvovaginal pain21.08.02.0090.000135%
Kounis syndrome02.02.02.020; 10.01.03.037; 24.04.04.0200.000822%-
Acute kidney injury20.01.03.0160.001484%
Osmotic demyelination syndrome17.16.02.0040.000127%-
Acute yellow liver atrophy09.01.07.026---
Posterior reversible encephalopathy syndrome17.13.02.0070.000063%
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001139%-
Peripheral artery thrombosis24.01.02.0100.000084%-
Granulomatosis with polyangiitis10.02.02.018; 20.05.01.013; 22.01.01.015; 24.12.04.0110.000232%-
White matter lesion17.11.01.009; 24.04.06.0270.000042%-
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.001455%-
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.0050.000063%-
Candida infection11.03.03.021--
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.020---
Neuropathic muscular atrophy15.05.03.029; 17.05.03.0130.000063%-
Cardiovascular symptom02.11.04.002; 24.03.02.0250.000042%-
Administration site discomfort08.02.04.010; 12.07.04.010---
Mucocutaneous haemorrhage08.01.06.018; 23.06.07.006; 24.07.06.0180.000042%-
Multiple organ dysfunction syndrome08.01.03.0570.000358%
Anal incontinence07.01.06.029; 17.05.01.0210.000042%
Depersonalisation/derealisation disorder19.14.01.0040.000105%-
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ADReCS-Target
Drug Name ADR Term Target
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