Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Linezolid
Drug ID BADD_D01295
Description Linezolid is a synthetic antibiotic which is used for the treatment of infections caused by aerobic Gram-positive bacteria. Its effects are bacteriostatic against both enterococci and staphylococci and bactericidal against most isolates of streptococci.[L32965] Linezolid exerts its antibacterial activity by inhibiting the initiation of bacterial protein synthesis - more specifically, it binds to the 23S ribosomal RNA of the 50S subunit[A11227,A199050] and, in doing so, prevents the formation of the 70S initiation complex which is essential for bacterial reproduction. Linezolid was initially approved in 2000 and was the first member of the oxazolidinone antibiotic class.[A233425] A second member of this class, [tedizolid], was approved by the FDA in 2014 and is considered generally more effective and tolerable than its predecessor.
Indications and Usage Linezolid is indicated in adults and children for the treatment of infections caused by susceptible Gram-positive bacteria, including nosocomial pneumonia, community-acquired pneumonia, skin and skin structure infections, and vancomycin-resistant _Enterococcus faecium_ infections.[L32965] Examples of susceptible bacteria include _Staphylococcus aureus_, _Streptococcus pneumoniae_, _Streptococcus pyogenes_, and _Streptococcus agalactiae_.[L32965] Linezolid is not indicated for the treatment of Gram-negative infections, nor has it been evaluated for use longer than 28 days.[L32965]
Marketing Status approved; investigational
ATC Code J01XX08
DrugBank ID DB00601
KEGG ID D00947
MeSH ID D000069349
PubChem ID 441401
TTD Drug ID D07UYO
NDC Product Code 0781-3433; 52562-019; 66022-0103; 73309-004; 73402-113; 46708-183; 63629-8576; 66794-236; 0009-7807; 57664-682; 65162-777; 66298-7131; 67457-324; 70771-1111; 66499-0047; 0009-5138; 0009-5140; 60687-309; 68382-413; 63323-713; 66794-219; 67877-419; 0409-4883; 70518-1226; 65427-821; 66022-0201; 62135-442; 62332-183; 66298-7807; 66039-825; 0143-9534; 0009-4992; 0054-0319; 0009-5157; 55111-947; 68724-5135; 31722-749; 0009-5136; 66298-5137; 62512-0032; 66022-0206; 73377-115; 25021-169; 0009-5137; 67457-843; 72606-001; 58032-2009; 58623-0129; 59762-1308; 0781-3431; 0904-6553; 59285-021; 65841-166; 68578-0009; 55150-242; 57664-683; 66298-5140; 31722-865; 59762-1307
UNII ISQ9I6J12J
Synonyms Linezolid | N-((3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide | Linezolide | Zyvox | U 100766 | 100766, U | PNU-100766 | PNU 100766 | PNU100766 | U-100766 | U100766
Chemical Information
Molecular Formula C16H20FN3O4
CAS Registry Number 165800-03-3
SMILES CC(=O)NCC1CN(C(=O)O1)C2=CC(=C(C=C2)N3CCOCC3)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)
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Wheezing22.03.01.0090.004940%
White blood cell count13.01.06.027--Not Available
Mental status changes19.07.01.0010.005763%Not Available
Tubulointerstitial nephritis20.05.02.0020.016466%Not Available
Infusion site erythema08.02.05.008; 23.03.06.016; 12.07.05.0090.003622%Not Available
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.0050.005763%Not Available
Localised oedema02.05.04.006; 14.05.06.009; 08.01.07.0110.003293%
Chapped lips07.05.01.0040.005598%Not Available
Lip blister23.03.01.016; 07.05.01.0070.003622%Not Available
Erythropoiesis abnormal01.07.02.0100.001647%Not Available
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Lipase13.05.01.011--Not Available
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.001647%
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.004116%Not Available
Haemodynamic instability24.03.02.0060.004116%Not Available
Catheter site erythema23.03.06.014; 12.07.02.003; 08.02.02.0030.004940%Not Available
Catheter site pain12.07.02.004; 08.02.02.004--Not Available
Catheter site phlebitis08.02.02.013; 24.12.03.001; 12.07.02.013--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.023875%Not Available
Mitochondrial toxicity12.03.01.009; 14.11.02.0010.011526%Not Available
Skin candida23.11.03.009; 11.03.03.010--Not Available
Haemorrhage24.07.01.002--Not Available
Red blood cell vacuolisation01.07.02.0070.001647%Not Available
Erythrosis23.03.03.055; 01.05.01.0140.003293%Not Available
Palpable purpura10.02.02.019; 24.12.04.018; 23.06.02.0060.001647%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.004116%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.006586%Not Available
Bicytopenia01.03.03.0100.011526%Not Available
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