tobramycin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibiotics, produced by Streptomyces strains | 2684 | 32986-56-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.11 | g | Inhal.powder |
| 0.30 | g | Inhal.solution |
| 0.24 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 1000 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 93 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 19.25 µM/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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 18, 2019 | EMA | PARI PHARMA GMBH | |
| June 11, 1975 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 1813.11 | 14.84 | 432 | 16371 | 7725 | 56267539 |
| Cystic fibrosis | 962.98 | 14.84 | 220 | 16583 | 3224 | 56272040 |
| Hospitalisation | 534.87 | 14.84 | 312 | 16491 | 74688 | 56200576 |
| Pseudomonas infection | 264.31 | 14.84 | 103 | 16700 | 9968 | 56265296 |
| Pulmonary function test decreased | 257.66 | 14.84 | 78 | 16725 | 3513 | 56271751 |
| Haemoptysis | 184.92 | 14.84 | 109 | 16694 | 26451 | 56248813 |
| Acute kidney injury | 155.11 | 14.84 | 266 | 16537 | 240497 | 56034767 |
| Cough | 145.37 | 14.84 | 270 | 16533 | 259691 | 56015573 |
| Pneumonia | 117.49 | 14.84 | 325 | 16478 | 406773 | 55868491 |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 110.92 | 14.84 | 38 | 16765 | 2545 | 56272719 |
| Renal tubular necrosis | 101.37 | 14.84 | 54 | 16749 | 10774 | 56264490 |
| Bronchiectasis | 98.60 | 14.84 | 54 | 16749 | 11380 | 56263884 |
| Death | 86.17 | 14.84 | 260 | 16543 | 341166 | 55934098 |
| Forced expiratory volume decreased | 82.55 | 14.84 | 36 | 16767 | 4624 | 56270640 |
| Cystic fibrosis respiratory infection suppression | 78.54 | 14.84 | 18 | 16785 | 266 | 56274998 |
| Sputum increased | 74.95 | 14.84 | 27 | 16776 | 2097 | 56273167 |
| Cystic fibrosis lung | 74.87 | 14.84 | 15 | 16788 | 111 | 56275153 |
| Ototoxicity | 73.75 | 14.84 | 23 | 16780 | 1143 | 56274121 |
| Hypopyon | 66.67 | 14.84 | 19 | 16784 | 690 | 56274574 |
| Aplastic anaemia | 65.68 | 14.84 | 38 | 16765 | 8890 | 56266374 |
| Proteinuria | 63.57 | 14.84 | 48 | 16755 | 17522 | 56257742 |
| Corneal perforation | 62.68 | 14.84 | 17 | 16786 | 513 | 56274751 |
| Staphylococcal infection | 58.70 | 14.84 | 64 | 16739 | 37554 | 56237710 |
| Corneal oedema | 57.49 | 14.84 | 20 | 16783 | 1402 | 56273862 |
| Bronchospasm | 57.12 | 14.84 | 43 | 16760 | 15626 | 56259638 |
| Disease complication | 56.66 | 14.84 | 24 | 16779 | 2871 | 56272393 |
| Conjunctival hyperaemia | 55.77 | 14.84 | 22 | 16781 | 2194 | 56273070 |
| Tinnitus | 53.79 | 14.84 | 55 | 16748 | 29987 | 56245277 |
| Infection | 53.72 | 14.84 | 156 | 16647 | 200050 | 56075214 |
| Lung disorder | 53.45 | 14.84 | 72 | 16731 | 52525 | 56222739 |
| Vasculitis | 52.29 | 14.84 | 40 | 16763 | 14883 | 56260381 |
| Endophthalmitis | 51.54 | 14.84 | 23 | 16780 | 3120 | 56272144 |
| Dysphonia | 49.78 | 14.84 | 62 | 16741 | 41885 | 56233379 |
| Pneumonia pseudomonal | 45.40 | 14.84 | 19 | 16784 | 2205 | 56273059 |
| Pseudomonas test positive | 45.36 | 14.84 | 14 | 16789 | 672 | 56274592 |
| Drug level increased | 44.67 | 14.84 | 42 | 16761 | 20683 | 56254581 |
| Corneal infiltrates | 44.20 | 14.84 | 10 | 16793 | 139 | 56275125 |
| Off label use | 43.47 | 14.84 | 299 | 16504 | 555881 | 55719383 |
| Lung transplant | 43.37 | 14.84 | 20 | 16783 | 2927 | 56272337 |
| Systemic lupus erythematosus | 42.17 | 14.84 | 3 | 16800 | 180075 | 56095189 |
| Pneumothorax | 39.70 | 14.84 | 34 | 16769 | 14833 | 56260431 |
| Eye irritation | 38.05 | 14.84 | 37 | 16766 | 18991 | 56256273 |
| Drug resistance | 37.48 | 14.84 | 38 | 16765 | 20504 | 56254760 |
| Ulcerative keratitis | 37.19 | 14.84 | 17 | 16786 | 2438 | 56272826 |
| Synovitis | 36.88 | 14.84 | 3 | 16800 | 161302 | 56113962 |
| Dyspnoea | 36.37 | 14.84 | 301 | 16502 | 592276 | 55682988 |
| Acute generalised exanthematous pustulosis | 35.78 | 14.84 | 27 | 16776 | 9842 | 56265422 |
| Chest discomfort | 35.60 | 14.84 | 86 | 16717 | 98771 | 56176493 |
| Deafness | 34.73 | 14.84 | 33 | 16770 | 16461 | 56258803 |
| Glossodynia | 34.40 | 14.84 | 3 | 16800 | 152455 | 56122809 |
| SLE arthritis | 33.95 | 14.84 | 11 | 16792 | 619 | 56274645 |
| Burkholderia cepacia complex infection | 33.53 | 14.84 | 8 | 16795 | 142 | 56275122 |
| Antibiotic level above therapeutic | 33.52 | 14.84 | 9 | 16794 | 261 | 56275003 |
| Aphonia | 33.40 | 14.84 | 25 | 16778 | 9004 | 56266260 |
| Productive cough | 33.27 | 14.84 | 60 | 16743 | 56172 | 56219092 |
| Overlap syndrome | 33.11 | 14.84 | 11 | 16792 | 670 | 56274594 |
| Abdominal discomfort | 33.08 | 14.84 | 21 | 16782 | 277253 | 55998011 |
| Condition aggravated | 32.12 | 14.84 | 194 | 16609 | 344704 | 55930560 |
| Drug reaction with eosinophilia and systemic symptoms | 31.56 | 14.84 | 42 | 16761 | 30262 | 56245002 |
| Infective exacerbation of bronchiectasis | 31.39 | 14.84 | 9 | 16794 | 334 | 56274930 |
| Pain | 31.36 | 14.84 | 98 | 16705 | 663086 | 55612178 |
| Wound | 30.60 | 14.84 | 3 | 16800 | 138801 | 56136463 |
| Retinopathy of prematurity | 30.39 | 14.84 | 9 | 16794 | 375 | 56274889 |
| Swelling | 30.22 | 14.84 | 17 | 16786 | 239754 | 56035510 |
| Nephropathy toxic | 30.19 | 14.84 | 23 | 16780 | 8504 | 56266760 |
| Stenotrophomonas infection | 29.09 | 14.84 | 13 | 16790 | 1768 | 56273496 |
| Arthropathy | 28.58 | 14.84 | 12 | 16791 | 200263 | 56075001 |
| Ocular hyperaemia | 28.52 | 14.84 | 34 | 16769 | 21945 | 56253319 |
| Visual acuity reduced | 28.45 | 14.84 | 33 | 16770 | 20693 | 56254571 |
| Drug ineffective | 27.91 | 14.84 | 161 | 16642 | 918828 | 55356436 |
| Sweat test abnormal | 27.75 | 14.84 | 5 | 16798 | 19 | 56275245 |
| Pathogen resistance | 27.67 | 14.84 | 19 | 16784 | 5981 | 56269283 |
| Rheumatoid arthritis | 27.44 | 14.84 | 45 | 16758 | 382559 | 55892705 |
| Corneal epithelium defect | 27.09 | 14.84 | 8 | 16795 | 330 | 56274934 |
| Keratitis fungal | 26.95 | 14.84 | 7 | 16796 | 178 | 56275086 |
| Peripheral swelling | 26.35 | 14.84 | 19 | 16784 | 234707 | 56040557 |
| Infusion related reaction | 26.06 | 14.84 | 15 | 16788 | 208916 | 56066348 |
| Alopecia | 25.55 | 14.84 | 30 | 16773 | 293428 | 55981836 |
| Corneal neovascularisation | 25.07 | 14.84 | 6 | 16797 | 108 | 56275156 |
| Elbow deformity | 24.96 | 14.84 | 11 | 16792 | 1448 | 56273816 |
| Rhinovirus infection | 24.43 | 14.84 | 15 | 16788 | 3907 | 56271357 |
| Lipogranuloma | 24.42 | 14.84 | 4 | 16799 | 7 | 56275257 |
| Pneumonia staphylococcal | 24.03 | 14.84 | 13 | 16790 | 2672 | 56272592 |
| Ocular hypertension | 22.87 | 14.84 | 9 | 16794 | 892 | 56274372 |
| Keratitis | 22.81 | 14.84 | 13 | 16790 | 2954 | 56272310 |
| Vitritis | 22.51 | 14.84 | 9 | 16794 | 930 | 56274334 |
| Injection site pain | 22.32 | 14.84 | 4 | 16799 | 117114 | 56158150 |
| Bronchopulmonary aspergillosis allergic | 21.86 | 14.84 | 10 | 16793 | 1436 | 56273828 |
| Distal intestinal obstruction syndrome | 21.76 | 14.84 | 7 | 16796 | 385 | 56274879 |
| Sputum discoloured | 21.73 | 14.84 | 24 | 16779 | 14268 | 56260996 |
| Therapeutic product effect incomplete | 21.61 | 14.84 | 3 | 16800 | 106028 | 56169236 |
| Respirovirus test positive | 21.48 | 14.84 | 4 | 16799 | 19 | 56275245 |
| Eyelid oedema | 21.44 | 14.84 | 20 | 16783 | 9748 | 56265516 |
| Increased bronchial secretion | 20.86 | 14.84 | 10 | 16793 | 1597 | 56273667 |
| Product administered to patient of inappropriate age | 20.62 | 14.84 | 12 | 16791 | 2836 | 56272428 |
| Respiratory tract infection bacterial | 20.21 | 14.84 | 6 | 16797 | 252 | 56275012 |
| Corneal thinning | 20.16 | 14.84 | 5 | 16798 | 105 | 56275159 |
| Therapy cessation | 19.97 | 14.84 | 32 | 16771 | 27232 | 56248032 |
| Mobility decreased | 19.71 | 14.84 | 3 | 16800 | 98988 | 56176276 |
| Overdose | 19.35 | 14.84 | 4 | 16799 | 105826 | 56169438 |
| Jaw fracture | 19.35 | 14.84 | 11 | 16792 | 2489 | 56272775 |
| Clubbing | 19.11 | 14.84 | 6 | 16797 | 305 | 56274959 |
| Keratitis bacterial | 18.98 | 14.84 | 4 | 16799 | 39 | 56275225 |
| Fall | 18.91 | 14.84 | 50 | 16753 | 357460 | 55917804 |
| Bronchial wall thickening | 18.02 | 14.84 | 8 | 16795 | 1072 | 56274192 |
| Corneal opacity | 17.83 | 14.84 | 7 | 16796 | 689 | 56274575 |
| Contusion | 17.83 | 14.84 | 8 | 16795 | 128422 | 56146842 |
| Anterior chamber fibrin | 17.79 | 14.84 | 4 | 16799 | 54 | 56275210 |
| Aspergilloma | 17.75 | 14.84 | 5 | 16798 | 174 | 56275090 |
| Respiration abnormal | 17.34 | 14.84 | 14 | 16789 | 5627 | 56269637 |
| Corneal disorder | 17.09 | 14.84 | 9 | 16794 | 1753 | 56273511 |
| Pupillary block | 16.53 | 14.84 | 3 | 16800 | 12 | 56275252 |
| Spirometry abnormal | 16.45 | 14.84 | 5 | 16798 | 228 | 56275036 |
| Mycobacterium chelonae infection | 16.37 | 14.84 | 6 | 16797 | 489 | 56274775 |
| Forced expiratory volume increased | 16.33 | 14.84 | 3 | 16800 | 13 | 56275251 |
| Foreign body sensation in eyes | 16.33 | 14.84 | 9 | 16794 | 1918 | 56273346 |
| Respiratory disorder | 16.11 | 14.84 | 33 | 16770 | 33924 | 56241340 |
| Pancreatic failure | 15.91 | 14.84 | 7 | 16796 | 918 | 56274346 |
| Eye pain | 15.85 | 14.84 | 31 | 16772 | 30816 | 56244448 |
| Corneal erosion | 15.72 | 14.84 | 5 | 16798 | 265 | 56274999 |
| Blastomycosis | 15.51 | 14.84 | 5 | 16798 | 277 | 56274987 |
| Acinetobacter infection | 15.46 | 14.84 | 8 | 16795 | 1502 | 56273762 |
| Central nervous system fungal infection | 15.39 | 14.84 | 4 | 16799 | 102 | 56275162 |
| Discomfort | 15.22 | 14.84 | 12 | 16791 | 141749 | 56133515 |
| Bartter's syndrome | 15.00 | 14.84 | 3 | 16800 | 22 | 56275242 |
| Renal failure | 14.95 | 14.84 | 69 | 16734 | 110431 | 56164833 |
| Intraocular pressure increased | 14.87 | 14.84 | 13 | 16790 | 5828 | 56269436 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 1616.65 | 16.99 | 409 | 14020 | 6075 | 31676840 |
| Cystic fibrosis | 960.55 | 16.99 | 214 | 14215 | 1752 | 31681163 |
| Hospitalisation | 433.68 | 16.99 | 274 | 14155 | 49533 | 31633382 |
| Pseudomonas infection | 213.29 | 16.99 | 104 | 14325 | 11297 | 31671618 |
| Pulmonary function test decreased | 195.53 | 16.99 | 74 | 14355 | 4311 | 31678604 |
| Choroiditis | 165.71 | 16.99 | 47 | 14382 | 1085 | 31681830 |
| Endophthalmitis | 139.74 | 16.99 | 55 | 14374 | 3561 | 31679354 |
| Eye pain | 138.52 | 16.99 | 80 | 14349 | 12224 | 31670691 |
| Intraocular pressure increased | 130.14 | 16.99 | 58 | 14371 | 5129 | 31677786 |
| Ototoxicity | 121.25 | 16.99 | 41 | 14388 | 1717 | 31681198 |
| Haemoptysis | 116.72 | 16.99 | 105 | 14324 | 32084 | 31650831 |
| Cough | 112.97 | 16.99 | 212 | 14217 | 134602 | 31548313 |
| Visual acuity reduced | 103.11 | 16.99 | 72 | 14357 | 15271 | 31667644 |
| Pneumonia | 98.72 | 16.99 | 355 | 14074 | 334957 | 31347958 |
| Condition aggravated | 98.66 | 16.99 | 225 | 14204 | 163784 | 31519131 |
| Cystic fibrosis respiratory infection suppression | 89.73 | 16.99 | 21 | 14408 | 217 | 31682698 |
| Infection | 78.89 | 16.99 | 137 | 14292 | 81794 | 31601121 |
| Uveitis | 78.51 | 16.99 | 45 | 14384 | 6771 | 31676144 |
| Sputum discoloured | 76.09 | 16.99 | 44 | 14385 | 6732 | 31676183 |
| Productive cough | 74.66 | 16.99 | 84 | 14345 | 33456 | 31649459 |
| Forced expiratory volume decreased | 70.57 | 16.99 | 32 | 14397 | 2945 | 31679970 |
| Sputum increased | 70.35 | 16.99 | 29 | 14400 | 2116 | 31680799 |
| Disease complication | 65.37 | 16.99 | 29 | 14400 | 2534 | 31680381 |
| Renal tubular necrosis | 65.34 | 16.99 | 54 | 14375 | 14705 | 31668210 |
| Painful respiration | 63.74 | 16.99 | 23 | 14406 | 1169 | 31681746 |
| Aplastic anaemia | 61.37 | 16.99 | 43 | 14386 | 9160 | 31673755 |
| Lung disorder | 52.46 | 16.99 | 69 | 14360 | 32243 | 31650672 |
| Pathogen resistance | 51.92 | 16.99 | 38 | 14391 | 8663 | 31674252 |
| Chest injury | 51.89 | 16.99 | 21 | 14408 | 1461 | 31681454 |
| Bronchospasm | 51.63 | 16.99 | 40 | 14389 | 9932 | 31672983 |
| Lung transplant | 50.41 | 16.99 | 22 | 14407 | 1848 | 31681067 |
| Walking aid user | 49.88 | 16.99 | 21 | 14408 | 1615 | 31681300 |
| Bronchiectasis | 47.27 | 16.99 | 34 | 14395 | 7546 | 31675369 |
| Dyspnoea | 46.76 | 16.99 | 291 | 14138 | 343188 | 31339727 |
| Drug resistance | 45.91 | 16.99 | 55 | 14374 | 23398 | 31659517 |
| Retinopathy of prematurity | 44.55 | 16.99 | 11 | 14418 | 145 | 31682770 |
| Pancreatic failure | 42.15 | 16.99 | 15 | 14414 | 732 | 31682183 |
| Product administered to patient of inappropriate age | 41.54 | 16.99 | 22 | 14407 | 2835 | 31680080 |
| Linear IgA disease | 40.89 | 16.99 | 18 | 14411 | 1544 | 31681371 |
| Hypoacusis | 39.36 | 16.99 | 41 | 14388 | 14958 | 31667957 |
| Nephropathy toxic | 39.08 | 16.99 | 36 | 14393 | 11317 | 31671598 |
| Cystic fibrosis related diabetes | 38.18 | 16.99 | 10 | 14419 | 169 | 31682746 |
| Infective exacerbation of bronchiectasis | 37.54 | 16.99 | 12 | 14417 | 420 | 31682495 |
| Pneumonia pseudomonal | 37.20 | 16.99 | 22 | 14407 | 3507 | 31679408 |
| Tinnitus | 36.60 | 16.99 | 41 | 14388 | 16234 | 31666681 |
| Increased viscosity of bronchial secretion | 36.28 | 16.99 | 10 | 14419 | 207 | 31682708 |
| Mycobacterium chelonae infection | 34.78 | 16.99 | 13 | 14416 | 730 | 31682185 |
| Oxygen saturation decreased | 34.65 | 16.99 | 72 | 14357 | 49043 | 31633872 |
| Respiratory tract irritation | 34.43 | 16.99 | 9 | 14420 | 151 | 31682764 |
| Deafness | 33.74 | 16.99 | 32 | 14397 | 10433 | 31672482 |
| Cystic fibrosis lung | 31.63 | 16.99 | 7 | 14422 | 55 | 31682860 |
| Deafness neurosensory | 31.45 | 16.99 | 18 | 14411 | 2698 | 31680217 |
| Fall | 30.57 | 16.99 | 24 | 14405 | 186065 | 31496850 |
| Pseudomonas test positive | 30.47 | 16.99 | 13 | 14416 | 1033 | 31681882 |
| Vestibular disorder | 30.25 | 16.99 | 13 | 14416 | 1052 | 31681863 |
| Respiratory disorder | 30.25 | 16.99 | 39 | 14390 | 17861 | 31665054 |
| Distal intestinal obstruction syndrome | 29.51 | 16.99 | 9 | 14420 | 269 | 31682646 |
| Somnolence | 29.31 | 16.99 | 5 | 14424 | 99440 | 31583475 |
| Staphylococcal infection | 27.84 | 16.99 | 50 | 14379 | 30582 | 31652333 |
| Aortic aneurysm | 27.25 | 16.99 | 23 | 14406 | 6442 | 31676473 |
| Aphonia | 27.11 | 16.99 | 17 | 14412 | 3008 | 31679907 |
| Oral candidiasis | 26.80 | 16.99 | 29 | 14400 | 11048 | 31671867 |
| Increased bronchial secretion | 26.61 | 16.99 | 14 | 14415 | 1780 | 31681135 |
| Toxic epidermal necrolysis | 26.13 | 16.99 | 38 | 14391 | 19486 | 31663429 |
| Acute kidney injury | 25.76 | 16.99 | 216 | 14213 | 279498 | 31403417 |
| Influenza | 25.62 | 16.99 | 60 | 14369 | 44265 | 31638650 |
| Arthralgia | 25.53 | 16.99 | 19 | 14410 | 151405 | 31531510 |
| Ulcerative keratitis | 25.23 | 16.99 | 13 | 14416 | 1583 | 31681332 |
| Keratitis bacterial | 24.89 | 16.99 | 6 | 14423 | 71 | 31682844 |
| Wheezing | 24.49 | 16.99 | 52 | 14377 | 35934 | 31646981 |
| Ill-defined disorder | 23.79 | 16.99 | 29 | 14400 | 12548 | 31670367 |
| Death | 23.59 | 16.99 | 259 | 14170 | 360310 | 31322605 |
| Chronic sinusitis | 23.56 | 16.99 | 13 | 14416 | 1816 | 31681099 |
| Toxic anterior segment syndrome | 23.25 | 16.99 | 11 | 14418 | 1114 | 31681801 |
| Corneal epithelium defect | 23.10 | 16.99 | 8 | 14421 | 360 | 31682555 |
| Chest discomfort | 21.44 | 16.99 | 60 | 14369 | 49309 | 31633606 |
| Rhonchi | 21.38 | 16.99 | 12 | 14417 | 1733 | 31681182 |
| Product use issue | 20.86 | 16.99 | 65 | 14364 | 56694 | 31626221 |
| Chondritis | 20.73 | 16.99 | 6 | 14423 | 149 | 31682766 |
| Feeling cold | 19.67 | 16.99 | 23 | 14406 | 9531 | 31673384 |
| Flavobacterium infection | 19.29 | 16.99 | 5 | 14424 | 81 | 31682834 |
| Aspergillus infection | 19.29 | 16.99 | 25 | 14404 | 11503 | 31671412 |
| Anaemia | 19.23 | 16.99 | 43 | 14386 | 213479 | 31469436 |
| Febrile convulsion | 19.17 | 16.99 | 8 | 14421 | 602 | 31682313 |
| Bronchopulmonary aspergillosis allergic | 18.99 | 16.99 | 8 | 14421 | 616 | 31682299 |
| Ocular hyperaemia | 18.81 | 16.99 | 23 | 14406 | 9986 | 31672929 |
| Keratitis | 18.79 | 16.99 | 10 | 14419 | 1301 | 31681614 |
| Malaise | 18.71 | 16.99 | 136 | 14293 | 168375 | 31514540 |
| Neuralgic amyotrophy | 18.47 | 16.99 | 6 | 14423 | 221 | 31682694 |
| Carbon dioxide increased | 18.16 | 16.99 | 9 | 14420 | 1010 | 31681905 |
| Trichosporon infection | 18.14 | 16.99 | 8 | 14421 | 689 | 31682226 |
| Cholangitis infective | 18.12 | 16.99 | 6 | 14423 | 235 | 31682680 |
| Hypotony of eye | 18.12 | 16.99 | 5 | 14424 | 104 | 31682811 |
| Hypertension | 18.06 | 16.99 | 19 | 14410 | 128081 | 31554834 |
| Lipogranuloma | 18.01 | 16.99 | 3 | 14426 | 3 | 31682912 |
| Tracheostomy | 17.68 | 16.99 | 8 | 14421 | 732 | 31682183 |
| Malignant neoplasm progression | 17.53 | 16.99 | 7 | 14422 | 78991 | 31603924 |
| Nausea | 17.19 | 16.99 | 77 | 14352 | 307870 | 31375045 |
| Ocular hypertension | 17.16 | 16.99 | 8 | 14421 | 784 | 31682131 |
| Erythema of eyelid | 17.13 | 16.99 | 8 | 14421 | 787 | 31682128 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | 2615.06 | 13.87 | 647 | 24225 | 11511 | 70892061 |
| Cystic fibrosis | 1469.55 | 13.87 | 333 | 24539 | 3948 | 70899624 |
| Hospitalisation | 729.99 | 13.87 | 418 | 24454 | 82150 | 70821422 |
| Pulmonary function test decreased | 333.36 | 13.87 | 115 | 24757 | 6686 | 70896886 |
| Pseudomonas infection | 299.50 | 13.87 | 142 | 24730 | 18852 | 70884720 |
| Haemoptysis | 250.31 | 13.87 | 179 | 24693 | 51273 | 70852299 |
| Renal tubular necrosis | 179.74 | 13.87 | 108 | 24764 | 23063 | 70880509 |
| Ototoxicity | 176.82 | 13.87 | 58 | 24814 | 2883 | 70900689 |
| Acute kidney injury | 171.74 | 13.87 | 456 | 24416 | 474168 | 70429404 |
| Endophthalmitis | 157.55 | 13.87 | 65 | 24807 | 6190 | 70897382 |
| Choroiditis | 157.53 | 13.87 | 44 | 24828 | 1257 | 70902315 |
| Intraocular pressure increased | 135.55 | 13.87 | 65 | 24807 | 8836 | 70894736 |
| Pneumonia | 131.18 | 13.87 | 482 | 24390 | 595750 | 70307822 |
| Cough | 127.05 | 13.87 | 322 | 24550 | 325055 | 70578517 |
| Aplastic anaemia | 124.70 | 13.87 | 76 | 24796 | 16640 | 70886932 |
| Cystic fibrosis respiratory infection suppression | 123.35 | 13.87 | 29 | 24843 | 406 | 70903166 |
| Disease complication | 120.79 | 13.87 | 49 | 24823 | 4468 | 70899104 |
| Visual acuity reduced | 117.33 | 13.87 | 89 | 24783 | 27841 | 70875731 |
| Forced expiratory volume decreased | 116.22 | 13.87 | 55 | 24817 | 7259 | 70896313 |
| Sputum increased | 115.20 | 13.87 | 46 | 24826 | 4026 | 70899546 |
| Eye pain | 109.85 | 13.87 | 93 | 24779 | 34009 | 70869563 |
| Bronchiectasis | 102.01 | 13.87 | 66 | 24806 | 16031 | 70887541 |
| Cystic fibrosis lung | 98.61 | 13.87 | 20 | 24852 | 132 | 70903440 |
| Death | 82.26 | 13.87 | 375 | 24497 | 509686 | 70393886 |
| Drug resistance | 81.90 | 13.87 | 83 | 24789 | 38107 | 70865465 |
| Condition aggravated | 81.70 | 13.87 | 331 | 24541 | 427304 | 70476268 |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 78.77 | 13.87 | 33 | 24839 | 3264 | 70900308 |
| Ulcerative keratitis | 78.49 | 13.87 | 33 | 24839 | 3294 | 70900278 |
| Tinnitus | 78.26 | 13.87 | 79 | 24793 | 36097 | 70867475 |
| Pathogen resistance | 78.18 | 13.87 | 52 | 24820 | 13227 | 70890345 |
| Corneal perforation | 76.25 | 13.87 | 22 | 24850 | 708 | 70902864 |
| Pneumonia pseudomonal | 75.92 | 13.87 | 37 | 24835 | 5209 | 70898363 |
| Sputum discoloured | 74.63 | 13.87 | 58 | 24814 | 18793 | 70884779 |
| Nephropathy toxic | 71.21 | 13.87 | 56 | 24816 | 18458 | 70885114 |
| Lung transplant | 70.43 | 13.87 | 33 | 24839 | 4257 | 70899315 |
| Bronchospasm | 69.00 | 13.87 | 60 | 24812 | 22732 | 70880840 |
| Uveitis | 68.36 | 13.87 | 50 | 24822 | 14795 | 70888777 |
| Productive cough | 67.46 | 13.87 | 108 | 24764 | 78229 | 70825343 |
| Hypopyon | 67.45 | 13.87 | 22 | 24850 | 1073 | 70902499 |
| Corneal oedema | 63.43 | 13.87 | 26 | 24846 | 2434 | 70901138 |
| Staphylococcal infection | 62.39 | 13.87 | 85 | 24787 | 53319 | 70850253 |
| Infective exacerbation of bronchiectasis | 62.39 | 13.87 | 19 | 24853 | 739 | 70902833 |
| Drug level increased | 60.16 | 13.87 | 69 | 24803 | 36400 | 70867172 |
| Corneal infiltrates | 53.91 | 13.87 | 14 | 24858 | 301 | 70903271 |
| Conjunctival hyperaemia | 53.68 | 13.87 | 27 | 24845 | 4066 | 70899506 |
| Lung disorder | 50.75 | 13.87 | 89 | 24783 | 69395 | 70834177 |
| Fall | 49.15 | 13.87 | 50 | 24822 | 444046 | 70459526 |
| Painful respiration | 47.54 | 13.87 | 23 | 24849 | 3185 | 70900387 |
| Chest injury | 45.87 | 13.87 | 21 | 24851 | 2570 | 70901002 |
| Aphonia | 44.51 | 13.87 | 32 | 24840 | 9219 | 70894353 |
| Product administered to patient of inappropriate age | 43.94 | 13.87 | 25 | 24847 | 4818 | 70898754 |
| Ocular hypertension | 43.90 | 13.87 | 17 | 24855 | 1371 | 70902201 |
| Pseudomonas test positive | 43.78 | 13.87 | 18 | 24854 | 1698 | 70901874 |
| Cystic fibrosis related diabetes | 43.64 | 13.87 | 11 | 24861 | 209 | 70903363 |
| Corneal epithelium defect | 42.94 | 13.87 | 14 | 24858 | 682 | 70902890 |
| Dyspnoea | 42.52 | 13.87 | 434 | 24438 | 769626 | 70133946 |
| Lipogranuloma | 42.49 | 13.87 | 7 | 24865 | 10 | 70903562 |
| Pancreatic failure | 42.36 | 13.87 | 17 | 24855 | 1507 | 70902065 |
| Acute generalised exanthematous pustulosis | 41.57 | 13.87 | 38 | 24834 | 15359 | 70888213 |
| Mycobacterium chelonae infection | 41.34 | 13.87 | 19 | 24853 | 2345 | 70901227 |
| Linear IgA disease | 40.45 | 13.87 | 20 | 24852 | 2904 | 70900668 |
| Distal intestinal obstruction syndrome | 39.26 | 13.87 | 13 | 24859 | 665 | 70902907 |
| Keratitis fungal | 39.15 | 13.87 | 11 | 24861 | 321 | 70903251 |
| Hypoacusis | 39.03 | 13.87 | 48 | 24824 | 27221 | 70876351 |
| Deafness | 37.85 | 13.87 | 40 | 24832 | 19263 | 70884309 |
| Corneal neovascularisation | 36.87 | 13.87 | 9 | 24863 | 149 | 70903423 |
| Deafness neurosensory | 36.71 | 13.87 | 25 | 24847 | 6607 | 70896965 |
| Pneumothorax | 36.20 | 13.87 | 45 | 24827 | 25801 | 70877771 |
| Therapeutic product effect decreased | 36.08 | 13.87 | 4 | 24868 | 143014 | 70760558 |
| Antibiotic level above therapeutic | 35.92 | 13.87 | 12 | 24860 | 631 | 70902941 |
| Corneal opacity | 34.50 | 13.87 | 13 | 24859 | 973 | 70902599 |
| Increased viscosity of bronchial secretion | 34.49 | 13.87 | 11 | 24861 | 499 | 70903073 |
| Off label use | 33.28 | 13.87 | 402 | 24470 | 742658 | 70160914 |
| Ocular hyperaemia | 33.08 | 13.87 | 42 | 24830 | 24597 | 70878975 |
| Keratitis | 33.03 | 13.87 | 19 | 24853 | 3738 | 70899834 |
| Infection | 32.35 | 13.87 | 153 | 24719 | 210632 | 70692940 |
| Pain | 32.19 | 13.87 | 113 | 24759 | 628703 | 70274869 |
| Bronchopulmonary aspergillosis allergic | 31.87 | 13.87 | 15 | 24857 | 1954 | 70901618 |
| Keratitis bacterial | 31.79 | 13.87 | 8 | 24864 | 151 | 70903421 |
| Increased bronchial secretion | 30.87 | 13.87 | 17 | 24855 | 3076 | 70900496 |
| Aortic aneurysm | 30.67 | 13.87 | 24 | 24848 | 7849 | 70895723 |
| Vasculitis | 30.57 | 13.87 | 36 | 24836 | 19522 | 70884050 |
| Injection site pain | 30.41 | 13.87 | 3 | 24869 | 117616 | 70785956 |
| Forced expiratory volume increased | 29.93 | 13.87 | 6 | 24866 | 37 | 70903535 |
| Respiratory disorder | 29.71 | 13.87 | 51 | 24821 | 39072 | 70864500 |
| Stenotrophomonas infection | 29.61 | 13.87 | 17 | 24855 | 3332 | 70900240 |
| Rhinovirus infection | 29.47 | 13.87 | 22 | 24850 | 6711 | 70896861 |
| Swelling | 28.92 | 13.87 | 15 | 24857 | 188524 | 70715048 |
| Syncope | 28.84 | 13.87 | 11 | 24861 | 165698 | 70737874 |
| Proteinuria | 28.77 | 13.87 | 43 | 24829 | 29331 | 70874241 |
| Trichosporon infection | 27.68 | 13.87 | 11 | 24861 | 950 | 70902622 |
| Vestibular disorder | 26.65 | 13.87 | 14 | 24858 | 2306 | 70901266 |
| Somnolence | 26.50 | 13.87 | 22 | 24850 | 215584 | 70687988 |
| Burkholderia cepacia complex infection | 26.50 | 13.87 | 8 | 24864 | 302 | 70903270 |
| SLE arthritis | 25.91 | 13.87 | 9 | 24863 | 533 | 70903039 |
| Chest discomfort | 25.83 | 13.87 | 99 | 24773 | 124282 | 70779290 |
| Mobility decreased | 25.68 | 13.87 | 3 | 24869 | 102996 | 70800576 |
| Wheezing | 25.65 | 13.87 | 82 | 24790 | 94088 | 70809484 |
| Toxic epidermal necrolysis | 25.48 | 13.87 | 48 | 24824 | 39509 | 70864063 |
| Systemic lupus erythematosus | 25.32 | 13.87 | 3 | 24869 | 101899 | 70801673 |
| Anaemia | 25.26 | 13.87 | 66 | 24806 | 403357 | 70500215 |
| Toxic anterior segment syndrome | 25.01 | 13.87 | 14 | 24858 | 2616 | 70900956 |
| Vitritis | 24.99 | 13.87 | 12 | 24860 | 1634 | 70901938 |
| Eye irritation | 24.96 | 13.87 | 31 | 24841 | 17757 | 70885815 |
| Clubbing | 24.94 | 13.87 | 9 | 24863 | 596 | 70902976 |
| Eyelid oedema | 24.29 | 13.87 | 26 | 24846 | 12701 | 70890871 |
| Dysphonia | 24.23 | 13.87 | 54 | 24818 | 50046 | 70853526 |
| Intentional overdose | 24.21 | 13.87 | 3 | 24869 | 98432 | 70805140 |
| Walking aid user | 24.13 | 13.87 | 21 | 24851 | 7960 | 70895612 |
| Overdose | 23.89 | 13.87 | 15 | 24857 | 169730 | 70733842 |
| Hypotony of eye | 23.72 | 13.87 | 7 | 24865 | 244 | 70903328 |
| Aspergillus infection | 23.26 | 13.87 | 30 | 24842 | 17838 | 70885734 |
| Infusion related reaction | 23.25 | 13.87 | 21 | 24851 | 197513 | 70706059 |
| Oxygen saturation decreased | 22.82 | 13.87 | 91 | 24781 | 116338 | 70787234 |
| Overlap syndrome | 22.81 | 13.87 | 9 | 24863 | 763 | 70902809 |
| Pneumonia staphylococcal | 22.34 | 13.87 | 16 | 24856 | 4582 | 70898990 |
| Arthralgia | 22.18 | 13.87 | 96 | 24776 | 503294 | 70400278 |
| Rheumatoid arthritis | 22.12 | 13.87 | 43 | 24829 | 291762 | 70611810 |
| Wound | 22.01 | 13.87 | 4 | 24868 | 98728 | 70804844 |
| Bronchial wall thickening | 21.81 | 13.87 | 12 | 24860 | 2167 | 70901405 |
| Respiratory tract irritation | 21.51 | 13.87 | 8 | 24864 | 577 | 70902995 |
| Arthropathy | 21.48 | 13.87 | 13 | 24859 | 150044 | 70753528 |
| Malignant neoplasm progression | 21.32 | 13.87 | 8 | 24864 | 121731 | 70781841 |
| Corneal thinning | 21.26 | 13.87 | 6 | 24866 | 178 | 70903394 |
| Pain in extremity | 21.05 | 13.87 | 53 | 24819 | 328029 | 70575543 |
| Gastrointestinal haemorrhage | 20.96 | 13.87 | 11 | 24861 | 137397 | 70766175 |
| Therapeutic product effect incomplete | 20.79 | 13.87 | 8 | 24864 | 119874 | 70783698 |
| Macular oedema | 20.68 | 13.87 | 16 | 24856 | 5146 | 70898426 |
| Abdominal discomfort | 20.64 | 13.87 | 27 | 24845 | 214631 | 70688941 |
| Respiration abnormal | 20.63 | 13.87 | 18 | 24854 | 6846 | 70896726 |
| Hypertension | 20.44 | 13.87 | 46 | 24826 | 295987 | 70607585 |
| Glossodynia | 20.40 | 13.87 | 3 | 24869 | 86484 | 70817088 |
| Respiratory distress | 20.10 | 13.87 | 53 | 24819 | 54597 | 70848975 |
| Drug reaction with eosinophilia and systemic symptoms | 20.07 | 13.87 | 55 | 24817 | 57958 | 70845614 |
| Flavobacterium infection | 19.69 | 13.87 | 5 | 24867 | 98 | 70903474 |
| Oral candidiasis | 19.57 | 13.87 | 33 | 24839 | 24919 | 70878653 |
| Gait disturbance | 19.14 | 13.87 | 22 | 24850 | 185084 | 70718488 |
| Neuralgic amyotrophy | 19.01 | 13.87 | 6 | 24866 | 263 | 70903309 |
| Erythema of eyelid | 18.89 | 13.87 | 11 | 24861 | 2214 | 70901358 |
| Respiratory tract infection bacterial | 18.59 | 13.87 | 10 | 24862 | 1727 | 70901845 |
| Rhonchi | 18.40 | 13.87 | 13 | 24859 | 3642 | 70899930 |
| Post procedural complication | 18.39 | 13.87 | 30 | 24842 | 22051 | 70881521 |
| Sweat test abnormal | 18.34 | 13.87 | 4 | 24868 | 39 | 70903533 |
| Multiple organ dysfunction syndrome | 18.28 | 13.87 | 81 | 24791 | 108434 | 70795138 |
| Underweight | 18.13 | 13.87 | 8 | 24864 | 898 | 70902674 |
| Febrile convulsion | 18.07 | 13.87 | 8 | 24864 | 905 | 70902667 |
| Fatigue | 17.88 | 13.87 | 194 | 24678 | 824125 | 70079447 |
| Haemodialysis | 17.84 | 13.87 | 26 | 24846 | 17340 | 70886232 |
| Influenza | 17.76 | 13.87 | 83 | 24789 | 113617 | 70789955 |
| Corneal erosion | 17.75 | 13.87 | 6 | 24866 | 327 | 70903245 |
| Pericarditis | 17.70 | 13.87 | 4 | 24868 | 84701 | 70818871 |
| Chondritis | 17.60 | 13.87 | 5 | 24867 | 152 | 70903420 |
| Restrictive cardiomyopathy | 17.39 | 13.87 | 8 | 24864 | 990 | 70902582 |
| Elbow deformity | 17.33 | 13.87 | 9 | 24863 | 1449 | 70902123 |
| Contusion | 17.09 | 13.87 | 12 | 24860 | 128024 | 70775548 |
| Therapy cessation | 17.08 | 13.87 | 37 | 24835 | 33639 | 70869933 |
| Anterior chamber fibrin | 17.04 | 13.87 | 5 | 24867 | 171 | 70903401 |
| Discomfort | 16.74 | 13.87 | 8 | 24864 | 105428 | 70798144 |
| Surgical procedure repeated | 16.73 | 13.87 | 7 | 24865 | 690 | 70902882 |
| Corneal disorder | 16.48 | 13.87 | 10 | 24862 | 2169 | 70901403 |
| Psoriasis | 16.36 | 13.87 | 7 | 24865 | 98426 | 70805146 |
| Pulmonary haemorrhage | 16.32 | 13.87 | 22 | 24850 | 13651 | 70889921 |
| Muscle spasms | 16.26 | 13.87 | 18 | 24854 | 154028 | 70749544 |
| Hypoaesthesia | 16.19 | 13.87 | 18 | 24854 | 153721 | 70749851 |
| Alopecia | 16.14 | 13.87 | 28 | 24844 | 198462 | 70705110 |
| Suicide attempt | 16.13 | 13.87 | 4 | 24868 | 79506 | 70824066 |
| Herpes zoster | 15.96 | 13.87 | 5 | 24867 | 85230 | 70818342 |
| Loss of consciousness | 15.57 | 13.87 | 19 | 24853 | 155697 | 70747875 |
| Cronobacter infection | 15.50 | 13.87 | 3 | 24869 | 15 | 70903557 |
| Vitamin A deficiency | 15.45 | 13.87 | 4 | 24868 | 85 | 70903487 |
| Mycobacterium abscessus infection | 15.42 | 13.87 | 8 | 24864 | 1284 | 70902288 |
| Cholangitis infective | 15.20 | 13.87 | 6 | 24866 | 509 | 70903063 |
| Interstitial lung disease | 15.07 | 13.87 | 9 | 24863 | 104676 | 70798896 |
| Vitamin E deficiency | 15.04 | 13.87 | 3 | 24869 | 18 | 70903554 |
| Pyrexia | 14.94 | 13.87 | 297 | 24575 | 606655 | 70296917 |
| Infectious crystalline keratopathy | 14.90 | 13.87 | 3 | 24869 | 19 | 70903553 |
| Acinetobacter infection | 14.85 | 13.87 | 10 | 24862 | 2594 | 70900978 |
| Scedosporium infection | 14.80 | 13.87 | 8 | 24864 | 1396 | 70902176 |
| Muscular weakness | 14.78 | 13.87 | 16 | 24856 | 138320 | 70765252 |
| Staphylococcus test positive | 14.73 | 13.87 | 14 | 24858 | 5940 | 70897632 |
| Carbon dioxide increased | 14.49 | 13.87 | 9 | 24863 | 2036 | 70901536 |
| Bacterial infection | 14.47 | 13.87 | 30 | 24842 | 26462 | 70877110 |
| Bartter's syndrome | 14.40 | 13.87 | 3 | 24869 | 23 | 70903549 |
| Renal impairment | 14.35 | 13.87 | 93 | 24779 | 143844 | 70759728 |
| Angle closure glaucoma | 14.26 | 13.87 | 10 | 24862 | 2769 | 70900803 |
| Plasma cell myeloma | 14.24 | 13.87 | 4 | 24868 | 73197 | 70830375 |
| Dermatitis exfoliative | 14.18 | 13.87 | 18 | 24854 | 10533 | 70893039 |
| Injection site erythema | 14.16 | 13.87 | 4 | 24868 | 72920 | 70830652 |
| Chronic sinusitis | 13.95 | 13.87 | 16 | 24856 | 8435 | 70895137 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 300MG/4ML | BETHKIS | CHIESI | N201820 | Oct. 12, 2012 | RX | SOLUTION | INHALATION | 7939502 | June 14, 2022 | MANAGEMENT OF CYSTIC FIBROSIS PATIENTS |
| 28MG | TOBI PODHALER | MYLAN SPECIALITY LP | N201688 | March 22, 2013 | RX | POWDER | INHALATION | 7368102 | Dec. 19, 2022 | TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA |
| 28MG | TOBI PODHALER | MYLAN SPECIALITY LP | N201688 | March 22, 2013 | RX | POWDER | INHALATION | 8715623 | Dec. 19, 2022 | TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA |
| 28MG | TOBI PODHALER | MYLAN SPECIALITY LP | N201688 | March 22, 2013 | RX | POWDER | INHALATION | 9421166 | Dec. 19, 2022 | 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B) | Enzyme | Km | 5.82 | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 | 30 sections |
| Tobramycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-883 | SOLUTION/ DROPS | 3 mg | OPHTHALMIC | ANDA | 18 sections |
| Tobramycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13985-604 | SOLUTION/ DROPS | 3 mg | OPHTHALMIC | ANDA | 18 sections |
| TOBRADEX | HUMAN PRESCRIPTION DRUG LABEL | 2 | 16590-223 | SUSPENSION | 3 mg | OPHTHALMIC | NDA | 19 sections |
| TOBRAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-224 | SOLUTION/ DROPS | 3 mg | OPHTHALMIC | ANDA | 18 sections |
| TOBREX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-225 | OINTMENT | 3 mg | OPHTHALMIC | NDA | 17 sections |