Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tobramycin sulfate
Drug ID BADD_D02233
Description Aminoglycosides, many of which are derived directly from _Streptomyces_ spp., are concentration-dependent bactericidal antibiotics with a broad spectrum of activity against Gram-positive and Gram-negative organisms.[A232294] Inhaled tobramycin is notable for its use in treating chronic _Pseudomonas aeruginosa_ infections in cystic fibrosis patients, as _P. aeruginosa_ is notoriously inherently resistant to many antibiotics.[A232294, A232299, L32739] However, tobramycin can also be administered intravenously and topically to treat a variety of infections caused by susceptible bacteria.[L32744, L32749] Its use is limited in some cases by characteristic toxicities such as nephrotoxicity and ototoxicity, yet it remains a valuable option in the face of growing resistance to front-line antibiotics such as β-lactams and cephalosporins.[A232294, A232349, L32739, L32749] Tobramycin was approved by the FDA in 1975 and is currently available in a variety of forms for administration by inhalation, injection, and external application to the eye (ophthalmic).[L32739, L32744, L32749]
Indications and Usage For the treatment of pseudomonas aeruginosa lung infections. Also being investigated for use in the treatment of sinus infections.
Marketing Status Prescription; Discontinued
ATC Code J01GB01; S01AA12
DrugBank ID DB00684
KEGG ID D02542
MeSH ID D014031
PubChem ID 62005
TTD Drug ID D07BCT
NDC Product Code 42513-0009; 63323-306; 17478-114; 45932-0012; 63552-025; 0409-3578; 63323-303; 51552-0789; 63323-307; 63323-305; 62991-1351; 45932-0014; 10695-008; 49452-7821; 38779-0319
Synonyms Tobramycin | Nebramycin Factor 6 | Tobramycin Sulfate | Sulfate, Tobramycin | Obracin | Tobracin | Brulamycin | Nebcin | Nebicin
Chemical Information
Molecular Formula C18H39N5O13S
CAS Registry Number 49842-07-1
SMILES C1C(C(C(C(C1N)OC2C(C(C(C(O2)CO)O)N)O)O)OC3C(CC(C(O3)CN)O)N)N.OS(=O)(=O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Nephropathy toxicL-lactate dehydrogenase A chainP00338T15053Not Available
Nephropathy toxicBeta-hexosaminidaseP87258Not AvailableNot Available
Nephropathy toxicLysozyme CP61626T10586Not Available
Toxicity to various agents1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase beta-1Q9NQ66T26846Not Available
Toxicity to various agentsPhospholipase A2P04054T31479Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Alanine aminotransferase increased13.03.01.003--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.01.006--
Blood bilirubin increased13.03.01.008--
Blood calcium decreased13.11.01.002--Not Available
Blood creatine increased13.13.01.001--Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood magnesium decreased13.11.01.008--Not Available
Blood potassium decreased13.11.01.010--Not Available
Blood sodium decreased13.11.01.012--Not Available
Blood urea increased13.13.01.006--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Cylindruria20.02.01.004--Not Available
Deafness04.02.01.001--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Eosinophilia01.02.04.001--
Granulocytopenia01.02.03.003--Not Available
Headache17.14.01.001--
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Lethargy17.02.04.003; 19.04.04.004; 08.01.01.008--
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Nausea07.01.07.001--
Oliguria20.01.03.004--Not Available
Proteinuria20.02.01.011--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
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