Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Neomycin sulfate
Drug ID BADD_D01552
Description Neomycin is a broad-spectrum aminoglycoside antibiotic drug that is derived from the metabolic products of _Streptomyces fradiae_.[L11979] Neomycin is a complex comprised of three components, neomycin A, B, and C.[A191529] Neomycin B, also known as [framycetin], is the most active component of the complex and neomycin C is the isomer of neomycin B, making these two stereoisomers the active components of neomycin.[A175042,A191529] Neomycin A, or [neamine], is a moiety that conjoins two molecules of neomycin B and C together.[A175042] Neomycin is active against both gram-positive and gram-negative organisms and mediates its pharmacological action by binding to bacterial ribosomes and inhibiting protein synthesis, which is crucial for the survival of bacteria.[L11985] Neomycin sulfate is the most common form for pharmaceutical preparations; because the compound is a complex, the amount of neomycin in products is measured in units.[A191529] Neomycin sulfate as monotherapy is available in an oral solution for adjunct use in the treatment of hepatic coma.[L11979] It is also used in combination with [polymyxin B] sulfates and [hydrocortisone] in otic suspensions for use in the treatment of bacterial infections in the external auditory canal, including infections caused by medical procedures in the ear.[L10532] Neomycin is also used in combination with [polymyxin B] sulfates and [dexamethasone] in ophthalmic preparations for use in the treatment of inflammatory conditions and infections in the eye.[L10716] Neomycin is also available in over-the-counter topical products to prevent minor skin infections.
Indications and Usage Oral neomycin sulfate is indicated as an adjunctive therapy in hepatic coma (portal-system encephalopathy) by reducing ammonia-forming bacteria in the intestinal tract. It is strongly recommended that oral neomycin is only used in infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the risk of the development of drug-resistant bacteria.[L11979] Neomycin, in combination with polymyxin B sulfates and hydrocortisone in otic suspensions, is used in the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the antibiotics. This otic formulation is also used in the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.[L10532] The ophthalmic solution containing neomycin in combination with polymyxin B sulfates and dexamethasone is used to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.[L10716]
Marketing Status approved; vet_approved
ATC Code S01AA03; A01AB08; R02AB01; S02AA07; A07AA01; J01GB05; B05CA09; S03AA01; D06AX04
DrugBank ID DB00994
KEGG ID D01618
MeSH ID D009355
PubChem ID 24978553
TTD Drug ID D05JNI
NDC Product Code 65876-0005; 54312-019; 51551-0303; 55718-162; 39822-0310; 0009-5238; 51671-0010; 65876-0003; 49452-4830; 51927-1167; 55718-163; 66405-0005; 79572-024; 62991-1202; 65876-0004; 69988-0031; 53145-056; 55550-730; 38779-0348; 51551-0307; 51552-0969; 63629-8352; 55718-145; 0093-1177; 73473-901; 0924-5620; 65876-0002; 48201-103; 61010-6700; 55718-147
UNII 057Y626693
Synonyms Neomycin | Neomycin Sulfate | Fradiomycin Sulfate | Neomycin Palmitate
Chemical Information
Molecular Formula C23H52N6O25S3
CAS Registry Number 1404-04-2
SMILES C1C(C(C(C(C1N)OC2C(C(C(C(O2)CN)O)O)N)OC3C(C(C(O3)CO)OC4C(C(C(C(O4)CN)O)O)N)O)O)N .OS(=O)(=O)O.OS(=O)(=O)O.OS(=O)(=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)
Carotene decreased13.02.05.005---
Diarrhoea07.02.01.001--
Faecal fat increased13.05.02.002---
Malabsorption07.17.01.001; 14.02.01.004--
Nausea07.01.07.001--
Nephropathy toxic12.03.01.010; 20.05.03.002---
Neuromuscular blockade17.05.04.003---
Ototoxicity04.03.01.004; 12.03.01.012---
Vomiting07.01.07.003--
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