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 Inhaled tobramycin is indicated for the management of cystic fibrosis patients with _Pseudomonas aeruginosa_, but is not recommended in patients under six years of age, those with forced expiratory volume in 1 second (FEV1) <25 or >80% predicted, or in those with _Burkholderia cepacia_.[L32739] Tobramycin applied topically to the eyes is indicated for the treatment of external eye (and adjoining structure) infections by susceptible bacteria.[L32744] Tobramycin injection is indicated in adult and pediatric patients for the treatment of serious bacterial infections, including septicemia (caused by _P. aeruginosa_, _Escherichia coli_, and _Klebsiella_ spp.), lower respiratory tract infections (caused by _P. aeruginosa_, _Klebsiella_ spp., _Enterobacter_ spp., _Serratia_ spp., _E. coli_, and _Staphylococcus aureus_, both penicillinase and non-penicillinase-producing strains), serious central-nervous-system infections (meningitis, caused by susceptible organisms), intra-abdominal infections including peritonitis (caused by _E. coli_, _Klebsiella_ spp., and _Enterobacter_ spp.), skin, bone, and skin structure infections (caused by _P. aeruginosa_, _Proteus_ spp., _E. coli_, _Klebsiella_ spp., _Enterobacter_ spp., _Serratia_ spp. and _S. aureus_), and complicated and recurrent urinary tract infections (caused by _P. aeruginosa_, _Proteus_ spp., _E. coli_, _Klebsiella_ spp., _Enterobacter_ spp., _Serratia_ spp., _S. aureus_, _Providencia_ spp., and _Citrobacter_ spp.).[L32749] Aminoglycosides, including tobramycin, should generally not be used in uncomplicated urinary tract infections or staphylococcal infections unless less toxic antibiotics cannot be used and the bacteria in question are known to be sensitive to aminoglycosides.[L32749] As with all antibiotics, tobramycin use should be limited to cases where bacterial infections are known or strongly suspected to be caused by sensitive organisms, and the possible emergence of resistance should be monitored closely.[L32739, L32744, L32749]
Marketing Status approved; investigational
ATC Code S01AA12; J01GB01
DrugBank ID DB00684
KEGG ID D02542
MeSH ID D014031
PubChem ID 62005
TTD Drug ID D07BCT
NDC Product Code 63323-303; 45932-0014; 63323-305; 63323-306; 45932-0012; 42513-0009; 63323-307; 51552-0789; 63552-025; 38779-0319; 49452-7821; 62991-1351; 10695-008
UNII HJT0RXD7JK
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
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)
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.04.011--
Blood bilirubin increased13.03.04.018--
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--
Disorientation17.02.05.015; 19.13.01.002--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Eosinophilia01.02.04.001--
Granulocytopenia01.02.03.003--Not Available
Headache17.14.01.001--
Injection site pain08.02.03.010; 12.07.03.011--Not Available
Lethargy19.04.04.004; 17.02.04.003; 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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