tobramycin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 2684 32986-56-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vantobra
  • tobramycin
  • Nebramycin 6
  • Nebramycin VI
  • tobracin
  • tobradistin
  • tobralex
  • tobramaxin
  • tobramicin
  • tobramycetin
  • tobramycin sulfate
  • nebcin
  • Tobi Podhaler
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.
  • Molecular weight: 467.52
  • Formula: C18H37N5O9
  • CLOGP: -3.44
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 10
  • TPSA: 268.17
  • ALOGS: -0.94
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.11 g Inhal.powder
0.30 g Inhal.solution
0.24 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 93 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.25 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 20, 2011 EMA MYLAN IRELAND LIMITED
June 11, 1975 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 1810.75 14.39 433 17397 8384 63462808
Hospitalisation 560.31 14.39 329 17501 84752 63386440
Cystic fibrosis 383.56 14.39 103 17727 3193 63467999
Pulmonary function test decreased 259.33 14.39 79 17751 3868 63467324
Pseudomonas infection 245.76 14.39 99 17731 11114 63460078
Haemoptysis 191.01 14.39 112 17718 28614 63442578
Acute kidney injury 171.91 14.39 283 17547 263132 63208060
Cough 150.18 14.39 283 17547 292460 63178732
Pneumonia 130.98 14.39 350 17480 456417 63014775
Anti-neutrophil cytoplasmic antibody positive vasculitis 116.64 14.39 40 17790 2859 63468333
Renal tubular necrosis 111.05 14.39 58 17772 11820 63459372
Death 90.56 14.39 270 17560 374111 63097081
Ventilation perfusion mismatch 88.57 14.39 22 17808 496 63470696
Forced expiratory volume decreased 82.45 14.39 36 17794 4932 63466260
Sputum increased 80.10 14.39 29 17801 2430 63468762
Cystic fibrosis respiratory infection suppression 78.59 14.39 18 17812 283 63470909
Corneal perforation 77.51 14.39 20 17810 528 63470664
Bronchiectasis 77.03 14.39 51 17779 16091 63455101
Cystic fibrosis lung 76.02 14.39 15 17815 109 63471083
Ototoxicity 71.62 14.39 23 17807 1339 63469853
Hypopyon 67.22 14.39 19 17811 713 63470479
Proteinuria 66.93 14.39 50 17780 19095 63452097
Aplastic anaemia 65.39 14.39 38 17792 9531 63461661
Disease complication 62.33 14.39 26 17804 3183 63468009
Conjunctival hyperaemia 59.07 14.39 23 17807 2356 63468836
Staphylococcal infection 58.76 14.39 65 17765 41191 63430001
Corneal oedema 57.73 14.39 20 17810 1473 63469719
Bronchospasm 55.70 14.39 43 17787 17237 63453955
Infection 54.99 14.39 165 17665 229008 63242184
Antibiotic level above therapeutic 54.61 14.39 14 17816 360 63470832
Drug resistance 52.90 14.39 47 17783 22886 63448306
Dysphonia 52.82 14.39 66 17764 47548 63423644
Vasculitis 51.59 14.39 42 17788 18167 63453025
Endophthalmitis 49.94 14.39 23 17807 3569 63467623
Lung disorder 48.90 14.39 73 17757 62188 63409004
Tinnitus 48.79 14.39 55 17775 35573 63435619
Pneumonia pseudomonal 47.45 14.39 20 17810 2513 63468679
Systemic lupus erythematosus 46.84 14.39 3 17827 208915 63262277
Lung transplant 46.55 14.39 21 17809 3107 63468085
Drug level increased 45.43 14.39 43 17787 22693 63448499
Corneal infiltrates 45.29 14.39 10 17820 132 63471060
Off label use 44.88 14.39 333 17497 674129 62797063
Dyspnoea 43.71 14.39 326 17504 660987 62810205
Pneumothorax 42.93 14.39 36 17794 16225 63454967
Synovitis 40.98 14.39 3 17827 186915 63284277
Pseudomonas test positive 40.84 14.39 13 17817 735 63470457
Glossodynia 38.84 14.39 3 17827 178873 63292319
Deafness 37.88 14.39 35 17795 17922 63453270
SLE arthritis 37.86 14.39 12 17818 669 63470523
Eye irritation 37.28 14.39 38 17792 21933 63449259
Abdominal discomfort 37.23 14.39 22 17808 320863 63150329
Wound 34.72 14.39 3 17827 163260 63307932
Overlap syndrome 34.63 14.39 12 17818 884 63470308
Aphonia 34.54 14.39 26 17804 10037 63461155
Acute generalised exanthematous pustulosis 34.43 14.39 27 17803 11072 63460120
Chest discomfort 34.08 14.39 87 17743 109882 63361310
Arthropathy 33.57 14.39 12 17818 234780 63236412
Burkholderia cepacia complex infection 33.50 14.39 8 17822 152 63471040
Ulcerative keratitis 33.50 14.39 16 17814 2694 63468498
Productive cough 33.35 14.39 62 17768 63146 63408046
Pain 32.92 14.39 103 17727 740525 62730667
Condition aggravated 32.82 14.39 209 17621 402008 63069184
Swelling 31.76 14.39 19 17811 275359 63195833
Retinopathy of prematurity 31.53 14.39 9 17821 350 63470842
Drug reaction with eosinophilia and systemic symptoms 29.95 14.39 42 17788 33794 63437398
Ocular hyperaemia 29.73 14.39 36 17794 25108 63446084
Infusion related reaction 29.66 14.39 16 17814 245505 63225687
Nephropathy toxic 29.27 14.39 23 17807 9456 63461736
Visual acuity reduced 28.70 14.39 33 17797 21793 63449399
Elbow deformity 28.50 14.39 12 17818 1503 63469689
Stenotrophomonas infection 28.24 14.39 13 17817 2014 63469178
Keratitis fungal 28.09 14.39 7 17823 160 63471032
Sweat test abnormal 28.05 14.39 5 17825 19 63471173
Pathogen resistance 27.62 14.39 19 17811 6379 63464813
Corneal epithelium defect 27.25 14.39 8 17822 344 63470848
Infective exacerbation of bronchiectasis 27.23 14.39 8 17822 345 63470847
Pneumonia staphylococcal 26.55 14.39 14 17816 2906 63468286
Hypoxia 25.91 14.39 54 17776 59738 63411454
Drug ineffective 25.33 14.39 181 17649 1044584 62426608
Corneal neovascularisation 25.28 14.39 6 17824 111 63471081
Therapeutic product effect incomplete 24.77 14.39 3 17827 125053 63346139
Lipogranuloma 24.67 14.39 4 17826 7 63471185
Mobility decreased 23.77 14.39 3 17827 121156 63350036
Sputum discoloured 23.69 14.39 26 17804 16321 63454871
Injection site pain 23.64 14.39 4 17826 129796 63341396
Increased bronchial secretion 23.59 14.39 11 17819 1755 63469437
Peripheral swelling 23.51 14.39 24 17806 265918 63205274
Rhinovirus infection 23.29 14.39 15 17815 4514 63466678
Eyelid oedema 23.22 14.39 21 17809 10458 63460734
Alopecia 23.08 14.39 37 17793 337499 63133693
Vitritis 22.56 14.39 9 17821 983 63470209
Jaw fracture 22.18 14.39 12 17818 2622 63468570
Ocular hypertension 22.06 14.39 9 17821 1041 63470151
Distal intestinal obstruction syndrome 21.74 14.39 7 17823 411 63470781
Corneal opacity 21.38 14.39 8 17822 735 63470457
Respirovirus test positive 20.66 14.39 4 17826 26 63471166
Corneal thinning 20.33 14.39 5 17825 108 63471084
Corneal disorder 20.28 14.39 10 17820 1804 63469388
Product administered to patient of inappropriate age 19.77 14.39 12 17818 3256 63467936
Respiratory tract infection bacterial 19.74 14.39 6 17824 291 63470901
Retinal detachment 19.55 14.39 15 17815 5954 63465238
Pancreatic failure 19.06 14.39 8 17822 995 63470197
Keratitis bacterial 18.87 14.39 4 17826 43 63471149
Therapy cessation 18.79 14.39 32 17798 30425 63440767
Sinonasal papilloma 18.70 14.39 4 17826 45 63471147
Discomfort 18.66 14.39 12 17818 167362 63303830
Foreign body sensation in eyes 18.32 14.39 10 17820 2224 63468968
Bronchopulmonary aspergillosis allergic 18.22 14.39 10 17820 2248 63468944
Anterior chamber fibrin 18.03 14.39 4 17826 54 63471138
Contusion 17.78 14.39 10 17820 150034 63321158
Fall 17.76 14.39 54 17776 392280 63078912
Eye pain 17.59 14.39 33 17797 33821 63437371
Clubbing 17.34 14.39 6 17824 440 63470752
Bronchial disorder 17.12 14.39 8 17822 1282 63469910
Pupillary block 16.71 14.39 3 17827 12 63471180
Spirometry abnormal 16.58 14.39 5 17825 236 63470956
Respiratory disorder 16.58 14.39 35 17795 39047 63432145
Respiration abnormal 16.51 14.39 14 17816 6403 63464789
Aspergilloma 16.24 14.39 5 17825 253 63470939
Overdose 16.23 14.39 6 17824 115072 63356120
Bronchial wall thickening 15.98 14.39 8 17822 1491 63469701
Intentional product use issue 15.92 14.39 8 17822 127884 63343308
Renal failure 15.63 14.39 70 17760 117582 63353610
Lower respiratory tract infection 15.42 14.39 9 17821 132298 63338894
Bartter's syndrome 15.18 14.39 3 17827 22 63471170
Blastomycosis 15.14 14.39 5 17825 318 63470874
Confusional state 15.14 14.39 27 17803 236353 63234839
Intraocular pressure increased 15.10 14.39 13 17817 6065 63465127
Perineal necrosis 14.92 14.39 4 17826 123 63471069
Forced expiratory volume increased 14.84 14.39 3 17827 25 63471167
Central nervous system fungal infection 14.82 14.39 4 17826 126 63471066
Multiple organ dysfunction syndrome 14.65 14.39 42 17788 56710 63414482
Tracheostomy infection 14.54 14.39 3 17827 28 63471164

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 1581.22 16.65 401 14604 6400 34935526
Hospitalisation 444.40 16.65 286 14719 56616 34885310
Cystic fibrosis 279.89 16.65 76 14929 1582 34940344
Pulmonary function test decreased 204.97 16.65 78 14927 4897 34937029
Pseudomonas infection 199.08 16.65 100 14905 12282 34929644
Choroiditis 178.75 16.65 50 14955 1165 34940761
Endophthalmitis 155.38 16.65 58 14947 3450 34938476
Eye pain 144.15 16.65 83 14922 13379 34928547
Intraocular pressure increased 141.10 16.65 61 14944 5322 34936604
Ototoxicity 128.00 16.65 43 14962 1874 34940052
Cough 120.36 16.65 224 14781 149916 34792010
Haemoptysis 118.35 16.65 107 14898 34899 34907027
Visual acuity reduced 110.69 16.65 75 14930 16074 34925852
Pneumonia 109.35 16.65 372 14633 362255 34579671
Condition aggravated 100.70 16.65 241 14764 191955 34749971
Cystic fibrosis respiratory infection suppression 90.35 16.65 21 14984 224 34941702
Infection 90.05 16.65 149 14856 90766 34851160
Uveitis 84.78 16.65 48 14957 7487 34934439
Sputum discoloured 83.16 16.65 48 14957 7764 34934162
Productive cough 80.57 16.65 90 14915 37723 34904203
Forced expiratory volume decreased 76.48 16.65 34 14971 3169 34938757
Sputum increased 69.20 16.65 29 14976 2341 34939585
Renal tubular necrosis 65.25 16.65 54 14951 15626 34926300
Disease complication 65.19 16.65 29 14976 2707 34939219
Painful respiration 64.24 16.65 23 14982 1213 34940713
Aplastic anaemia 61.55 16.65 43 14962 9673 34932253
Pathogen resistance 55.52 16.65 40 14965 9442 34932484
Lung disorder 54.89 16.65 71 14934 34625 34907301
Bronchospasm 53.28 16.65 41 14964 10690 34931236
Lung transplant 53.24 16.65 23 14982 2001 34939925
Chest injury 51.64 16.65 21 14984 1570 34940356
Dyspnoea 49.63 16.65 303 14702 376479 34565447
Walking aid user 47.79 16.65 21 14984 1903 34940023
Drug resistance 47.31 16.65 57 14948 25870 34916056
Retinopathy of prematurity 44.78 16.65 11 14994 151 34941775
Pancreatic failure 42.04 16.65 15 14990 783 34941143
Increased viscosity of bronchial secretion 41.34 16.65 11 14994 211 34941715
Linear IgA disease 41.21 16.65 18 14987 1608 34940318
Product administered to patient of inappropriate age 39.83 16.65 22 14983 3269 34938657
Hypoacusis 38.53 16.65 41 14964 16260 34925666
Cystic fibrosis related diabetes 38.39 16.65 10 14995 176 34941750
Nephropathy toxic 37.71 16.65 36 14969 12552 34929374
Respiratory tract irritation 36.46 16.65 10 14995 216 34941710
Pneumonia pseudomonal 36.24 16.65 22 14983 3900 34938026
Oxygen saturation decreased 35.34 16.65 74 14931 53744 34888182
Infective exacerbation of bronchiectasis 33.88 16.65 11 14994 430 34941496
Toxic epidermal necrolysis 33.76 16.65 44 14961 21602 34920324
Pseudomonas test positive 33.58 16.65 14 14991 1115 34940811
Deafness 33.33 16.65 32 14973 11233 34930693
Distal intestinal obstruction syndrome 31.97 16.65 10 14995 346 34941580
Tinnitus 31.54 16.65 41 14964 20077 34921849
Deafness neurosensory 31.51 16.65 18 14987 2853 34939073
Aphonia 31.37 16.65 19 14986 3354 34938572
Respiratory disorder 31.36 16.65 40 14965 19224 34922702
Bronchiectasis 31.21 16.65 29 14976 9772 34932154
Ill-defined disorder 31.14 16.65 34 14971 13875 34928051
Influenza 31.11 16.65 67 14938 49599 34892327
Vestibular disorder 30.50 16.65 13 14992 1094 34940832
Fall 29.78 16.65 26 14979 202859 34739067
Increased bronchial secretion 29.64 16.65 15 14990 1866 34940060
Somnolence 29.32 16.65 6 14999 111110 34830816
Arthralgia 28.52 16.65 19 14986 170022 34771904
Staphylococcal infection 27.53 16.65 50 14955 32710 34909216
Aortic aneurysm 27.47 16.65 23 14982 6756 34935170
Corneal epithelium defect 27.28 16.65 9 14996 370 34941556
Acute kidney injury 26.98 16.65 223 14782 304765 34637161
Death 26.63 16.65 274 14731 397775 34544151
Rhonchi 26.35 16.65 14 14991 1926 34940000
Cystic fibrosis lung 26.35 16.65 6 14999 58 34941868
Wheezing 26.10 16.65 56 14949 41346 34900580
Oral candidiasis 26.07 16.65 29 14976 12081 34929845
Rash morbilliform 25.19 16.65 16 14989 3071 34938855
Keratitis bacterial 24.87 16.65 6 14999 76 34941850
Product use issue 23.53 16.65 70 14935 63146 34878780
Toxic anterior segment syndrome 23.47 16.65 11 14994 1158 34940768
Rubber sensitivity 22.87 16.65 7 14998 225 34941701
Ulcerative keratitis 22.14 16.65 12 14993 1717 34940209
Chest discomfort 21.85 16.65 62 14943 54468 34887458
Mycobacterium chelonae infection 20.58 16.65 9 14996 806 34941120
Chondritis 20.53 16.65 6 14999 164 34941762
Scleromalacia 19.86 16.65 4 15001 20 34941906
Cronobacter infection 19.86 16.65 4 15001 20 34941906
Necrotising scleritis 19.82 16.65 5 15000 77 34941849
Flavobacterium infection 19.58 16.65 5 15000 81 34941845
Febrile convulsion 19.41 16.65 8 14997 619 34941307
Aspergillus infection 19.24 16.65 25 14980 12229 34929697
Chronic sinusitis 19.07 16.65 12 14993 2267 34939659
Malignant neoplasm progression 19.02 16.65 7 14998 88039 34853887
Feeling cold 18.76 16.65 23 14982 10616 34931310
Neuralgic amyotrophy 18.57 16.65 6 14999 231 34941695
Keratitis 18.39 16.65 10 14995 1441 34940485
Hypotony of eye 18.27 16.65 5 15000 107 34941819
Trichosporon infection 18.19 16.65 8 14997 726 34941200
Lipogranuloma 18.18 16.65 3 15002 3 34941923
Carbon dioxide increased 18.15 16.65 9 14996 1072 34940854
Malaise 18.08 16.65 139 14866 185686 34756240
Nausea 17.98 16.65 80 14925 339828 34602098
Device related thrombosis 17.59 16.65 9 14996 1146 34940780
Cholangitis infective 17.54 16.65 6 14999 276 34941650
Ocular hyperaemia 17.42 16.65 23 14982 11429 34930497
Tracheostomy 17.19 16.65 8 14997 829 34941097
Hypertension 17.13 16.65 20 14985 136423 34805503
Ocular hypertension 17.12 16.65 8 14997 836 34941090
Anaemia 16.94 16.65 48 14957 233287 34708639
Staphylococcal sepsis 16.91 16.65 21 14984 9823 34932103
Keratitis fungal 16.83 16.65 5 15000 145 34941781

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infective pulmonary exacerbation of cystic fibrosis 2553.67 13.59 633 25426 12218 79706111
Hospitalisation 719.04 13.59 423 25636 93813 79624516
Cystic fibrosis 501.46 13.59 136 25923 3744 79714585
Pulmonary function test decreased 351.40 13.59 121 25938 7516 79710813
Pseudomonas infection 277.96 13.59 136 25923 20767 79697562
Haemoptysis 252.59 13.59 181 25878 55818 79662511
Acute kidney injury 190.59 13.59 480 25579 518924 79199405
Renal tubular necrosis 189.44 13.59 112 25947 24927 79693402
Ototoxicity 178.72 13.59 59 26000 3215 79715114
Choroiditis 171.85 13.59 47 26012 1334 79716995
Endophthalmitis 170.64 13.59 68 25991 6360 79711969
Intraocular pressure increased 147.13 13.59 68 25991 9137 79709192
Pneumonia 144.43 13.59 508 25551 659738 79058591
Cough 133.19 13.59 338 25721 366451 79351878
Disease complication 126.79 13.59 51 26008 4886 79713443
Visual acuity reduced 125.40 13.59 92 25967 29377 79688952
Aplastic anaemia 124.82 13.59 76 25983 17829 79700500
Cystic fibrosis respiratory infection suppression 124.79 13.59 29 26030 415 79717914
Forced expiratory volume decreased 122.63 13.59 57 26002 7757 79710572
Sputum increased 119.67 13.59 48 26011 4565 79713764
Eye pain 115.89 13.59 97 25962 37481 79680848
Drug resistance 98.39 13.59 93 25966 42120 79676209
Cystic fibrosis lung 93.92 13.59 19 26040 134 79718195
Corneal perforation 90.46 13.59 25 26034 738 79717591
Death 86.53 13.59 390 25669 566124 79152205
Sputum discoloured 83.84 13.59 64 25995 21679 79696650
Anti-neutrophil cytoplasmic antibody positive vasculitis 83.76 13.59 35 26024 3694 79714635
Condition aggravated 83.36 13.59 354 25705 500770 79217559
Pathogen resistance 82.72 13.59 54 26005 14288 79704041
Ventilation perfusion mismatch 80.65 13.59 22 26037 618 79717711
Pneumonia pseudomonal 74.20 13.59 37 26022 5874 79712455
Lung transplant 73.84 13.59 34 26025 4527 79713802
Uveitis 72.62 13.59 53 26006 16777 79701552
Productive cough 71.59 13.59 114 25945 88217 79630112
Bronchiectasis 71.53 13.59 59 26000 22327 79696002
Ulcerative keratitis 70.88 13.59 31 26028 3658 79714671
Bronchospasm 70.16 13.59 61 25998 24798 79693531
Nephropathy toxic 69.85 13.59 56 26003 20363 79697966
Tinnitus 69.57 13.59 79 25980 44254 79674075
Hypopyon 68.07 13.59 22 26037 1120 79717209
Completed suicide 67.57 13.59 3 26056 245764 79472565
Corneal oedema 63.62 13.59 26 26033 2594 79715735
Staphylococcal infection 61.26 13.59 85 25974 58210 79660119
Drug level increased 61.10 13.59 70 25989 39581 79678748
Conjunctival hyperaemia 56.51 13.59 28 26031 4385 79713944
Antibiotic level above therapeutic 55.54 13.59 17 26042 723 79717606
Corneal infiltrates 55.11 13.59 14 26045 296 79718033
Infective exacerbation of bronchiectasis 54.79 13.59 17 26042 757 79717572
Dyspnoea 48.45 13.59 459 25600 856566 78861763
Fall 48.22 13.59 53 26006 487576 79230753
Aphonia 47.98 13.59 34 26025 10278 79708051
Corneal epithelium defect 47.59 13.59 15 26044 704 79717625
Painful respiration 47.48 13.59 23 26036 3430 79714899
Lung disorder 47.04 13.59 90 25969 80467 79637862
Pancreatic failure 45.93 13.59 18 26041 1610 79716719
Chest injury 45.57 13.59 21 26038 2800 79715529
Keratitis fungal 44.87 13.59 12 26047 312 79718017
Cystic fibrosis related diabetes 44.12 13.59 11 26048 215 79718114
Pseudomonas test positive 43.68 13.59 18 26041 1834 79716495
Ocular hypertension 43.56 13.59 17 26042 1503 79716826
Lipogranuloma 42.98 13.59 7 26052 10 79718319
Product administered to patient of inappropriate age 42.40 13.59 25 26034 5528 79712801
Increased viscosity of bronchial secretion 42.29 13.59 13 26046 561 79717768
Distal intestinal obstruction syndrome 42.22 13.59 14 26045 773 79717556
Linear IgA disease 40.48 13.59 20 26039 3112 79715217
Acute generalised exanthematous pustulosis 40.16 13.59 38 26021 17216 79701113
Therapeutic product effect decreased 39.22 13.59 4 26055 163859 79554470
Hypoacusis 37.89 13.59 48 26011 30102 79688227
Deafness neurosensory 37.42 13.59 25 26034 6873 79711456
Deafness 37.34 13.59 40 26019 20997 79697332
Infection 37.17 13.59 167 25892 241545 79476784
Corneal neovascularisation 37.17 13.59 9 26050 155 79718174
Pneumothorax 37.04 13.59 46 26013 28277 79690052
Increased bronchial secretion 36.45 13.59 19 26040 3308 79715021
Off label use 36.43 13.59 454 25605 906761 78811568
Ocular hyperaemia 35.59 13.59 45 26014 28161 79690168
Corneal opacity 34.96 13.59 13 26046 1007 79717322
Toxic epidermal necrolysis 34.01 13.59 56 26003 44525 79673804
Necrotising scleritis 33.55 13.59 9 26050 237 79718092
Pain 32.16 13.59 120 25939 703682 79014647
Keratitis bacterial 32.01 13.59 8 26051 158 79718171
Stenotrophomonas infection 31.50 13.59 18 26041 3755 79714574
Respiratory disorder 31.10 13.59 54 26005 44802 79673527
Swelling 31.08 13.59 16 26043 216695 79501634
Aortic aneurysm 30.68 13.59 24 26035 8422 79709907
Proteinuria 30.62 13.59 45 26014 32457 79685872
Rhinovirus infection 29.76 13.59 23 26036 7930 79710399
SLE arthritis 29.63 13.59 10 26049 583 79717746
Mobility decreased 29.19 13.59 3 26056 122172 79596157
Injection site pain 29.01 13.59 4 26055 129834 79588495
Systemic lupus erythematosus 28.88 13.59 3 26056 121146 79597183
Vasculitis 28.48 13.59 38 26021 25064 79693265
Scleromalacia 28.26 13.59 6 26053 55 79718274
Forced expiratory volume increased 28.17 13.59 6 26053 56 79718273
Trichosporon infection 27.92 13.59 11 26048 997 79717332
Syncope 27.64 13.59 12 26047 179437 79538892
Somnolence 27.04 13.59 23 26036 238958 79479371
Burkholderia cepacia complex infection 26.85 13.59 8 26051 310 79718019
Vestibular disorder 26.84 13.59 14 26045 2441 79715888
Mycobacterium chelonae infection 26.83 13.59 14 26045 2442 79715887
Bronchopulmonary aspergillosis allergic 26.62 13.59 15 26044 3046 79715283
Chest discomfort 26.39 13.59 102 25957 137942 79580387
Eyelid oedema 26.02 13.59 27 26032 13660 79704669
Arthropathy 25.50 13.59 13 26046 177098 79541231
Toxic anterior segment syndrome 25.28 13.59 14 26045 2750 79715579
Respiratory tract irritation 25.28 13.59 9 26050 616 79717713
Abdominal discomfort 25.02 13.59 27 26032 250700 79467629
Vitritis 24.82 13.59 12 26047 1782 79716547
Dysphonia 24.38 13.59 56 26003 56816 79661513
Overlap syndrome 24.31 13.59 10 26049 1014 79717315
Intentional overdose 24.31 13.59 3 26056 105957 79612372
Keratitis 24.25 13.59 16 26043 4306 79714023
Clubbing 24.10 13.59 9 26050 706 79717623
Hypotony of eye 24.02 13.59 7 26052 251 79718078
Infusion related reaction 23.87 13.59 24 26035 230213 79488116
Pericarditis 23.79 13.59 3 26056 104233 79614096
Oxygen saturation decreased 23.57 13.59 94 25965 128953 79589376
Glossodynia 23.52 13.59 3 26056 103334 79614995
Rash morbilliform 23.48 13.59 18 26041 6132 79712197
Aspergillus infection 23.28 13.59 30 26029 19131 79699198
Multiple organ dysfunction syndrome 23.11 13.59 89 25970 120157 79598172
Eye irritation 22.99 13.59 31 26028 20650 79697679
Wound 22.85 13.59 5 26054 116174 79602155
Rhonchi 22.79 13.59 15 26044 4021 79714308
Malignant neoplasm progression 22.75 13.59 8 26051 135982 79582347
Influenza 22.55 13.59 93 25966 129513 79588816
Pneumonia staphylococcal 22.51 13.59 16 26043 4858 79713471
Overdose 21.74 13.59 17 26042 184189 79534140
Pain in extremity 21.70 13.59 55 26004 364483 79353846
Arthralgia 21.47 13.59 105 25954 571698 79146631
Corneal thinning 21.40 13.59 6 26053 187 79718142
Respiratory distress 21.31 13.59 54 26005 58285 79660044
Walking aid user 21.08 13.59 21 26038 10127 79708202
Cronobacter infection 20.95 13.59 4 26055 20 79718309
Macular oedema 20.85 13.59 16 26043 5458 79712871
Wheezing 20.52 13.59 84 25975 116580 79601749
Bronchial wall thickening 20.45 13.59 12 26047 2629 79715700
Elbow deformity 20.36 13.59 10 26049 1537 79716792
Flavobacterium infection 20.04 13.59 5 26054 98 79718231
Discomfort 19.99 13.59 8 26051 125609 79592720
Gait disturbance 19.98 13.59 23 26036 207483 79510846
Respiration abnormal 19.76 13.59 18 26041 7770 79710559
Hypertension 19.65 13.59 50 26009 330942 79387387
Gastrointestinal haemorrhage 19.59 13.59 12 26047 147707 79570622
Anaemia 19.55 13.59 77 25982 444938 79273391
Therapeutic product effect incomplete 19.50 13.59 11 26048 141634 79576695
Hypoaesthesia 19.39 13.59 18 26041 179334 79538995
Sputum abnormal 19.14 13.59 9 26050 1256 79717073
Drug reaction with eosinophilia and systemic symptoms 18.99 13.59 55 26004 64189 79654140
Neuralgic amyotrophy 18.98 13.59 6 26053 284 79718045
Sweat test abnormal 18.62 13.59 4 26055 39 79718290
Oral candidiasis 18.40 13.59 34 26025 29594 79688735
Haemodialysis 18.34 13.59 26 26033 18142 79700187
Febrile convulsion 18.34 13.59 8 26051 938 79717391
Post procedural complication 18.26 13.59 30 26029 23799 79694530
Sinonasal papilloma 18.18 13.59 4 26055 44 79718285
Erythema of eyelid 18.14 13.59 11 26048 2559 79715770
Underweight 18.04 13.59 8 26051 975 79717354
Restrictive cardiomyopathy 17.85 13.59 8 26051 1000 79717329
Pulmonary haemorrhage 17.81 13.59 23 26036 14694 79703635
Chondritis 17.70 13.59 5 26054 160 79718169
Respiratory tract infection bacterial 17.58 13.59 10 26049 2067 79716262
Fatigue 17.57 13.59 207 25852 929520 78788809
Anterior chamber fibrin 17.38 13.59 5 26054 171 79718158
Stenotrophomonas test positive 17.38 13.59 6 26053 375 79717954
Therapy cessation 17.23 13.59 38 26021 37524 79680805
Muscle spasms 17.22 13.59 19 26040 174711 79543618
Contusion 17.21 13.59 14 26045 148762 79569567
Pyrexia 16.77 13.59 313 25746 678396 79039933
Corneal disorder 16.67 13.59 10 26049 2281 79716048
Surgical procedure repeated 16.59 13.59 7 26052 757 79717572
Staphylococcal sepsis 16.26 13.59 22 26037 14704 79703625
Psoriatic arthropathy 16.08 13.59 3 26056 77996 79640333
Bronchial disorder 15.91 13.59 10 26049 2479 79715850
Vitamin A deficiency 15.51 13.59 4 26055 90 79718239
Blood creatinine increased 15.42 13.59 95 25964 154962 79563367
Alopecia 15.28 13.59 33 26026 231322 79487007
Muscular weakness 15.27 13.59 18 26041 160711 79557618
Intentional product misuse 15.24 13.59 6 26053 95159 79623170
Interstitial lung disease 15.14 13.59 9 26050 112591 79605738
Vitamin E deficiency 15.11 13.59 3 26056 19 79718310
Infectious crystalline keratopathy 14.98 13.59 3 26056 20 79718309
Scedosporium infection 14.94 13.59 8 26051 1470 79716859
Osteoarthritis 14.83 13.59 5 26054 87304 79631025
Dermatitis exfoliative 14.82 13.59 18 26041 10811 79707518
Bacterial infection 14.75 13.59 32 26027 31248 79687081
Loss of consciousness 14.72 13.59 20 26039 167923 79550406
Herpes zoster 14.69 13.59 6 26053 93077 79625252
Bartter's syndrome 14.61 13.59 3 26056 23 79718306
Staphylococcus test positive 14.56 13.59 14 26045 6467 79711862
Carbon dioxide increased 14.32 13.59 9 26050 2231 79716098
Angle closure glaucoma 14.28 13.59 10 26049 2966 79715363
Jaw fracture 14.16 13.59 10 26049 3007 79715322
Injection site erythema 14.14 13.59 4 26055 78193 79640136
Hypoxia 14.13 13.59 69 25990 103174 79615155
Perineal necrosis 14.07 13.59 4 26055 131 79718198
Cholangitis infective 14.02 13.59 6 26053 671 79717658
Confusional state 13.97 13.59 55 26004 317942 79400387
Moaning 13.92 13.59 7 26052 1130 79717199
Osteopenia 13.91 13.59 23 26036 18341 79699988
Vitamin E decreased 13.90 13.59 3 26056 30 79718299
Respirovirus test positive 13.85 13.59 4 26055 139 79718190
Dizziness 13.83 13.59 108 25951 526333 79191996
Conjunctival oedema 13.80 13.59 7 26052 1151 79717178
Cognitive disorder 13.77 13.59 3 26056 69923 79648406
Retinal detachment 13.69 13.59 16 26043 9231 79709098
Suicide attempt 13.66 13.59 5 26054 82927 79635402
Corneal erosion 13.60 13.59 5 26054 375 79717954
Lip haemorrhage 13.60 13.59 7 26052 1187 79717142

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01GB01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides
ATC S01AA12 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA CS M0000946 Aminoglycosides
FDA EPC N0000175477 Aminoglycoside Antibacterial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
CHEBI has role CHEBI:27026 toxins
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:33282 bactericides

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Staphylococcal pneumonia indication 22754005
Pneumonia due to Pseudomonas indication 41381004
Punctate keratitis indication 42513006 DOID:12197
Pneumonia due to Escherichia coli indication 51530003
Blepharoconjunctivitis indication 68659002 DOID:2456
Infection due to Escherichia coli indication 71057007
Bacterial infection due to Serratia indication 71120004
Rhinoscleroma indication 72409005 DOID:11336
Perforation of cornea indication 74895004
Dacryocystitis indication 85777005 DOID:9938
Corneal abrasion indication 85848002
Keratoconjunctivitis indication 88151007 DOID:9368
Bacterial meningitis indication 95883001 DOID:9470
Infection of bone indication 111253001
Bacterial conjunctivitis indication 128350005 DOID:9700
Uveitis indication 128473001 DOID:13141
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Bacterial peritonitis indication 197171003
Sepsis of the newborn indication 206376005
Neonatal meningitis indication 276674008
Escherichia coli urinary tract infection indication 301011002
Meibomianitis indication 309779001
Bacterial urinary infection indication 312124009
Infective blepharitis indication 312219000
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Infection due to Staphylococcus aureus indication 406602003
Anterior uveitis indication 410692006 DOID:1407
Nosocomial pneumonia indication 425464007
Osteomyelitis due to Staphylococcus aureus indication 428783003
Sepsis due to Pseudomonas indication 448813005
Allergic conjunctivitis indication 473460002 DOID:11204
Urinary tract infection caused by Klebsiella indication 369001000119100
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa indication
Synergy for Neonatal Meningitis indication
Klebsiella Pneumoniae Peritonitis indication
Proteus Mirabilis Osteomyelitis indication
E. Coli Osteomyelitis indication
Skin and Skin Structure Proteus Infection indication
Complicated UTI with Pseudomonas Aeruginosa indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Klebsiella Pneumoniae Osteomyelitis indication
Synergy for Staphylococcal Infections indication
Staphylococcus Aureus Complicated UTI indication
Complicated Proteus UTI indication
Citrobacter Complicated UTI indication
Enterobacter Osteomyelitis indication
Synergy for P. Aeruginosa Infection in Cystic Fibrosis indication
E. Coli Peritonitis indication
Complicated Urinary Tract Infections indication
Synergy for Bacterial Meningitis indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Enterobacter Pneumonia indication
Pseudomonas Aeruginosa Osteomyelitis indication
Serratia Complicated UTI indication
Providencia Complicated UTI indication
Pyrexia of unknown origin off-label use 7520000
Exposure keratoconjunctivitis off-label use 14366000 DOID:9461
Neuropathic corneal ulcer off-label use 231901007
Superficial Ocular Infection off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Hypocalcemia contraindication 5291005
Herpes simplex keratitis contraindication 9389005
Glaucoma contraindication 23986001 DOID:1686
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Tinnitus contraindication 60862001
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes zoster ophthalmicus contraindication 87513003
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Hypomagnesemia contraindication 190855004
Pregnancy, function contraindication 289908002
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Pseudomembranous enterocolitis contraindication 397683000
Vertigo contraindication 399153001
Infant Botulism contraindication
Disorder of the 8th Cranial Nerve contraindication
Tobramycin Toxicity contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.15 acidic
pKa2 13.85 acidic
pKa3 8.34 Basic
pKa4 7.59 Basic
pKa5 6.94 Basic
pKa6 6.81 Basic
pKa7 5.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 11484671 Nov. 7, 2024 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8664187 June 20, 2025 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
0.05%;0.3% TOBRADEX ST EYEVANCE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 8101582 Dec. 19, 2027 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.05%;0.3% TOBRADEX ST EYEVANCE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 7795316 Aug. 3, 2028 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8869794 Sept. 12, 2028 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 10207066 Nov. 4, 2030 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Taste receptor type 2 member 20 GPCR AGONIST EC50 4.29 IUPHAR
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B) Enzyme Km 5.82 WOMBAT-PK

External reference:

IDSource
4018595 VUID
N0000146911 NUI
D00063 KEGG_DRUG
49842-07-1 SECONDARY_CAS_RN
4018595 VANDF
4018596 VANDF
C0040341 UMLSCUI
CHEBI:28864 CHEBI
TOY PDB_CHEM_ID
CHEMBL1747 ChEMBL_ID
CHEMBL3989564 ChEMBL_ID
CHEMBL1200780 ChEMBL_ID
D014031 MESH_DESCRIPTOR_UI
DB00684 DRUGBANK_ID
10930 IUPHAR_LIGAND_ID
2990 INN_ID
VZ8RRZ51VK UNII
36294 PUBCHEM_CID
10627 RXNORM
1090 MMSL
182011 MMSL
2138 MMSL
5590 MMSL
5591 MMSL
5606 MMSL
d00069 MMSL
002779 NDDF
002780 NDDF
13188003 SNOMEDCT_US
373548001 SNOMEDCT_US
89695009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 0065-0643 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 17 sections
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 0065-0643 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 17 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0065-0644 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0065-0644 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0647 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0647 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0648 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TOBI HUMAN PRESCRIPTION DRUG LABEL 1 0078-0494 SOLUTION 300 mg ORAL NDA 30 sections
TOBI HUMAN PRESCRIPTION DRUG LABEL 1 0078-0494 SOLUTION 300 mg ORAL NDA 30 sections
TOBI Podhaler HUMAN PRESCRIPTION DRUG LABEL 1 0078-0630 CAPSULE 28 mg ORAL NDA 29 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0078-0813 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0078-0813 OINTMENT 3 mg OPHTHALMIC NDA 16 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0876 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0876 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0876 OINTMENT 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0953 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0078-0953 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3750 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 30 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-3750 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 30 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 26 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 26 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7196 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3577 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3577 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3578 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 18 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3578 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 18 sections
TOBRAMYCIN AND DEXAMETHASONE HUMAN PRESCRIPTION DRUG LABEL 2 0574-4031 SUSPENSION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections
BETHKIS HUMAN PRESCRIPTION DRUG LABEL 1 10122-820 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 34 sections
BETHKIS HUMAN PRESCRIPTION DRUG LABEL 1 10122-820 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 34 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 10544-883 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 18 sections