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)
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.007739%Not Available
Drug resistance08.06.01.0050.083317%Not Available
Urine output increased13.13.03.002--Not Available
Haematotoxicity01.05.01.007; 12.03.01.0250.037048%Not Available
Ischaemia24.04.02.0040.001647%Not Available
Optic nerve disorder06.02.08.001; 17.04.05.004--
Optic neuropathy17.04.05.005; 06.02.08.0020.063393%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Skin degenerative disorder23.03.03.040--Not Available
Blood disorder01.05.01.0040.007410%Not Available
Disease recurrence08.01.03.0500.012514%Not Available
Pigmentation disorder23.05.03.0010.003622%Not Available
Metabolic encephalopathy17.13.01.001; 14.11.01.0130.003293%Not Available
Renal impairment20.01.03.0100.060100%Not Available
Infusion site extravasation12.07.05.008; 08.02.05.0070.006422%
Vulvovaginal mycotic infection11.03.05.004; 21.14.02.004--Not Available
Spontaneous haematoma24.07.01.054; 01.01.03.0060.002470%Not Available
Bone marrow failure01.03.03.0050.046927%
Post-tussive vomiting22.02.03.009; 07.01.07.011; 12.02.05.0420.001647%Not Available
Cytopenia01.03.03.0120.003293%Not Available
Treatment failure08.06.01.0170.032602%Not Available
Liver injury12.01.17.012; 09.01.07.0220.005763%Not Available
Hypertransaminasaemia09.01.02.0050.008233%Not Available
Acute kidney injury20.01.03.0160.036225%
Langerhans' cell histiocytosis22.01.01.016; 16.21.04.003; 15.09.03.008; 01.13.04.003; 09.01.08.0180.006586%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.002470%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.005763%Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.0210.017289%Not Available
Candida infection11.03.03.021--
Multiple organ dysfunction syndrome08.01.03.0570.009056%
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