Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, produced by Streptomyces strains	2684	32986-56-4

Description:

Molecule	Description
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

Molecule

Description

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:

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)	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 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2B,BRAF,CAMK2D,CDK4,CDK5,DYRK1B,EIF2AK3,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK1,NTRK2,PDK2,PDK4,PRKDC,TEK,TGFBR1	20
kinase-selectivity-class	CHUK,IRAK4,MAP2K6,PDK1	4
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
July 20, 2011	EMA	MYLAN IRELAND LIMITED
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	1951.85	14.83	454	19869	9825	90598299
Hospitalisation	612.37	14.83	372	19951	127728	90480396
Cystic fibrosis	407.38	14.83	107	20216	3834	90604290
Pseudomonas infection	285.25	14.83	112	20211	14753	90593371
Pulmonary function test decreased	271.11	14.83	80	20243	4414	90603710
Acute kidney injury	238.96	14.83	325	19998	320062	90288062
Haemoptysis	229.33	14.83	123	20200	33197	90574927
Cough	184.83	14.83	311	20012	368651	90239473
Pneumonia	148.72	14.83	393	19930	637666	89970458
Conjunctival hyperaemia	138.29	14.83	44	20279	3125	90604999
Death	131.34	14.83	305	20018	456246	90151878
Renal tubular necrosis	118.03	14.83	60	20263	14495	90593629
Anti-neutrophil cytoplasmic antibody positive vasculitis	116.72	14.83	41	20282	3952	90604172
Drug resistance	106.90	14.83	73	20250	30376	90577748
Cystic fibrosis respiratory infection suppression	96.17	14.83	21	20302	334	90607790
Antibiotic level above therapeutic	94.35	14.83	22	20301	476	90607648
Ventilation perfusion mismatch	90.57	14.83	22	20301	570	90607554
Sputum increased	85.05	14.83	30	20293	2927	90605197
Forced expiratory volume decreased	84.83	14.83	36	20287	5772	90602352
Corneal perforation	84.76	14.83	21	20302	592	90607532
Ototoxicity	84.59	14.83	27	20296	1937	90606187
Bronchiectasis	84.28	14.83	56	20267	22274	90585850
Hypopyon	81.09	14.83	22	20301	892	90607232
Cystic fibrosis lung	77.79	14.83	15	20308	123	90608001
Corneal oedema	73.18	14.83	24	20299	1877	90606247
Staphylococcal infection	69.51	14.83	69	20254	48370	90559754
Systemic lupus erythematosus	68.41	14.83	3	20320	361893	90246231
Proteinuria	68.22	14.83	50	20273	23241	90584883
Aplastic anaemia	66.95	14.83	40	20283	13229	90594895
Disease complication	63.93	14.83	26	20297	3746	90604378
Tinnitus	62.97	14.83	62	20261	43040	90565084
Corneal infiltrates	62.78	14.83	13	20310	158	90607966
Dyspnoea	61.75	14.83	372	19951	880583	89727541
Synovitis	61.46	14.83	3	20320	329749	90278375
Pneumonia pseudomonal	60.95	14.83	24	20299	3179	90604945
Off label use	60.09	14.83	437	19886	1101815	89506309
Glossodynia	59.74	14.83	3	20320	321776	90286348
Bronchospasm	59.62	14.83	44	20279	20665	90587459
Corneal epithelium defect	58.83	14.83	15	20308	476	90607648
Infection	57.36	14.83	195	20128	361899	90246225
Infusion related reaction	56.99	14.83	12	20311	416768	90191356
Dysphonia	56.16	14.83	70	20253	63014	90545110
Endophthalmitis	55.30	14.83	25	20298	4660	90603464
Vasculitis	51.77	14.83	42	20281	22651	90585473
Productive cough	50.99	14.83	74	20249	76989	90531135
Visual acuity reduced	50.62	14.83	42	20281	23368	90584756
Wound	49.99	14.83	5	20318	302975	90305149
Abdominal discomfort	48.85	14.83	23	20300	477305	90130819
Nephropathy toxic	48.31	14.83	32	20291	12656	90595468
Drug level increased	48.30	14.83	44	20279	27718	90580406
Ocular hyperaemia	48.22	14.83	48	20275	33750	90574374
Lung transplant	47.74	14.83	21	20302	3671	90604453
Eye pain	47.54	14.83	54	20269	44114	90564010
Pneumothorax	46.98	14.83	37	20286	19130	90588994
Deafness	45.81	14.83	39	20284	22475	90585649
Drug reaction with eosinophilia and systemic symptoms	45.55	14.83	52	20271	42706	90565418
Corneal opacity	45.39	14.83	14	20309	897	90607227
Pseudomonas test positive	45.32	14.83	14	20309	902	90607222
Infective exacerbation of bronchiectasis	44.83	14.83	12	20311	462	90607662
Keratitis fungal	43.68	14.83	10	20313	199	90607925
Chest discomfort	42.43	14.83	95	20228	138270	90469854
Arthropathy	41.74	14.83	15	20308	366227	90241897
Mobility decreased	41.72	14.83	4	20319	250730	90357394
Eye irritation	40.81	14.83	44	20279	33934	90574190
SLE arthritis	39.92	14.83	12	20311	705	90607419
Psoriatic arthropathy	39.75	14.83	3	20320	228332	90379792
Ulcerative keratitis	39.41	14.83	18	20305	3435	90604689
Pelvic kidney	38.07	14.83	8	20315	105	90608019
Swelling	37.33	14.83	24	20299	419034	90189090
Aphonia	37.33	14.83	27	20296	12292	90595832
Pathogen resistance	37.18	14.83	23	20300	8092	90600032
Conjunctival oedema	36.36	14.83	12	20311	957	90607167
Condition aggravated	35.70	14.83	242	20081	595303	90012821
Acute generalised exanthematous pustulosis	34.76	14.83	27	20296	13676	90594448
Eyelid oedema	34.31	14.83	25	20298	11509	90596615
Increased bronchial secretion	33.63	14.83	14	20309	2139	90605985
Retinopathy of prematurity	33.17	14.83	9	20314	365	90607759
Burkholderia cepacia complex infection	32.76	14.83	8	20315	212	90607912
Stenotrophomonas infection	31.46	14.83	14	20309	2515	90605609
Elbow deformity	31.15	14.83	12	20311	1499	90606625
Hypoxia	30.86	14.83	57	20266	72342	90535782
Pain	30.37	14.83	118	20205	996223	89611901
Alopecia	30.31	14.83	40	20283	495031	90113093
Rhinovirus infection	30.14	14.83	18	20305	5945	90602179
Therapeutic product effect incomplete	29.98	14.83	4	20319	193892	90414232
Discomfort	29.97	14.83	12	20311	274323	90333801
Impaired healing	29.51	14.83	8	20315	234191	90373933
Sputum discoloured	29.16	14.83	29	20294	20362	90587762
Lower respiratory tract infection	29.00	14.83	10	20313	250649	90357475
Peripheral swelling	28.91	14.83	30	20293	413076	90195048
Therapy cessation	28.66	14.83	38	20285	36323	90571801
Lung disorder	28.48	14.83	86	20237	149797	90458327
Sweat test abnormal	28.23	14.83	5	20318	24	90608100
Mycobacterium chelonae infection	28.16	14.83	9	20314	648	90607476
Intentional product use issue	28.11	14.83	7	20316	216885	90391239
Blister	28.10	14.83	11	20312	254987	90353137
Corneal disorder	27.65	14.83	12	20311	2030	90606094
Renal failure	27.60	14.83	78	20245	130929	90477195
Confusional state	27.07	14.83	28	20295	386177	90221947
Eye swelling	26.77	14.83	33	20290	29353	90578771
Hypoaesthesia	26.62	14.83	19	20304	314191	90293933
Fibromyalgia	26.08	14.83	7	20316	206262	90401862
Distal intestinal obstruction syndrome	25.90	14.83	8	20315	515	90607609
Lipogranuloma	25.57	14.83	4	20319	7	90608117
Corneal neovascularisation	25.10	14.83	6	20317	145	90607979
Blood cholesterol increased	24.58	14.83	8	20315	208004	90400120
Jaw fracture	24.54	14.83	12	20311	2666	90605458
Ocular discomfort	24.09	14.83	16	20307	6354	90601770
Hypertension	24.09	14.83	41	20282	457491	90150633
Pneumonia staphylococcal	23.80	14.83	13	20310	3628	90604496
Hepatic enzyme increased	23.26	14.83	28	20295	360708	90247416
Retinal detachment	23.09	14.83	16	20307	6806	90601318
Stomatitis	22.76	14.83	17	20306	274681	90333443
Renal impairment	22.43	14.83	63	20260	105358	90502766
Respiratory tract infection bacterial	22.29	14.83	7	20316	476	90607648
Foreign body sensation in eyes	22.18	14.83	12	20311	3288	90604836
Respirovirus test positive	21.69	14.83	4	20319	25	90608099
C-reactive protein increased	21.39	14.83	7	20316	181382	90426742
Liver injury	21.16	14.83	6	20317	170561	90437563
Product administered to patient of inappropriate age	20.84	14.83	13	20310	4640	90603484
Antimicrobial susceptibility test intermediate	20.83	14.83	4	20319	32	90608092
Bacterial infection	20.83	14.83	26	20297	23418	90584706
Gait inability	20.44	14.83	4	20319	146452	90461672
Vitritis	20.29	14.83	9	20314	1605	90606519
Intraocular pressure increased	20.25	14.83	15	20308	7078	90601046
Contusion	20.24	14.83	16	20307	251200	90356924
Ocular hypertension	19.94	14.83	9	20314	1671	90606453
Corneal thinning	19.72	14.83	5	20318	155	90607969
Rash maculo-papular	19.72	14.83	34	20289	40899	90567225
Sinonasal papilloma	19.60	14.83	4	20319	45	90608079
Keratitis bacterial	19.21	14.83	4	20319	50	90608074
Manufacturing laboratory analytical testing issue	18.92	14.83	3	20320	6	90608118
Oxygen saturation decreased	18.86	14.83	60	20263	107423	90500701
Respiration abnormal	18.71	14.83	15	20308	7948	90600176
Cystic fibrosis related diabetes	18.47	14.83	4	20319	61	90608063
Vitreous opacities	18.36	14.83	6	20317	464	90607660
Tracheostomy infection	18.24	14.83	4	20319	65	90608059
Eye discharge	18.23	14.83	15	20308	8243	90599881
Blood creatinine increased	18.16	14.83	57	20266	101329	90506795
Respiratory failure	18.02	14.83	63	20260	118355	90489769
Clubbing	17.99	14.83	6	20317	494	90607630
Lacrimation increased	17.91	14.83	26	20297	27036	90581088
Macular oedema	17.77	14.83	12	20311	4897	90603227
Pancreatic failure	17.73	14.83	8	20315	1484	90606640
Tubulointerstitial nephritis	17.73	14.83	25	20298	25318	90582806
Paraesthesia	17.70	14.83	18	20305	250308	90357816
Osteoarthritis	17.70	14.83	11	20312	195719	90412405
General physical health deterioration	17.62	14.83	33	20290	355082	90253042
Bronchial disorder	17.44	14.83	8	20315	1542	90606582
Pupillary block	17.38	14.83	3	20320	12	90608112
Spirometry abnormal	17.04	14.83	5	20318	270	90607854
Respiratory symptom	16.86	14.83	11	20312	4241	90603883
Aspergilloma	16.79	14.83	5	20318	284	90607840
Multiple organ dysfunction syndrome	16.71	14.83	43	20280	68293	90539831
Weight increased	16.51	14.83	44	20279	417883	90190241
Bartter's syndrome	16.24	14.83	3	20320	19	90608105
Vitreous haemorrhage	16.13	14.83	9	20314	2617	90605507
Retinal haemorrhage	16.04	14.83	12	20311	5752	90602372
Pulmonary function test abnormal	15.78	14.83	9	20314	2730	90605394
Contraindicated product administered	15.66	14.83	30	20293	320109	90288015
Bronchopulmonary aspergillosis allergic	15.56	14.83	10	20313	3756	90604368
Anterior chamber fibrin	15.54	14.83	4	20319	132	90607992
Acinetobacter infection	15.47	14.83	8	20315	2000	90606124
Injection site pain	15.38	14.83	10	20313	173689	90434435
Perineal necrosis	15.37	14.83	4	20319	138	90607986
Pain in extremity	15.23	14.83	51	20272	450478	90157646
Underweight	15.09	14.83	7	20316	1383	90606741
Central nervous system fungal infection	15.07	14.83	4	20319	149	90607975
Bronchial wall thickening	15.02	14.83	8	20315	2123	90606001
Therapy interrupted	14.89	14.83	34	20289	50074	90558050

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	1629.58	16.22	417	16712	7401	42596805
Hospitalisation	500.08	16.22	332	16797	73998	42530208
Cystic fibrosis	305.29	16.22	84	17045	1971	42602235
Pulmonary function test decreased	220.59	16.22	84	17045	5648	42598558
Pseudomonas infection	203.90	16.22	108	17021	15815	42588391
Choroiditis	180.40	16.22	51	17078	1324	42602882
Endophthalmitis	152.89	16.22	60	17069	4373	42599833
Ototoxicity	150.00	16.22	50	17079	2275	42601931
Eye pain	146.35	16.22	89	17040	16941	42587265
Intraocular pressure increased	137.68	16.22	62	17067	6371	42597835
Pneumonia	132.23	16.22	420	16709	421729	42182477
Cough	130.17	16.22	246	16883	177857	42426349
Visual acuity reduced	128.85	16.22	83	17046	17467	42586739
Infection	123.41	16.22	186	16943	111882	42492324
Haemoptysis	106.37	16.22	111	17018	46056	42558150
Ill-defined disorder	95.46	16.22	67	17062	16229	42587977
Cystic fibrosis respiratory infection suppression	94.58	16.22	22	17107	253	42603953
Sputum increased	92.42	16.22	38	17091	3125	42601081
Condition aggravated	88.28	16.22	267	16862	260487	42343719
Sputum discoloured	87.15	16.22	53	17076	10079	42594127
Uveitis	83.69	16.22	50	17079	9208	42594998
Productive cough	79.88	16.22	101	17028	51466	42552740
Vitamin K deficiency	70.44	16.22	19	17110	412	42603794
Lung transplant	64.10	16.22	27	17102	2359	42601847
Disease complication	63.82	16.22	29	17100	3041	42601165
Painful respiration	63.42	16.22	23	17106	1346	42602860
Drug resistance	61.00	16.22	72	17057	34176	42570030
Renal tubular necrosis	60.94	16.22	54	17075	18300	42585906
Aplastic anaemia	59.11	16.22	45	17084	12339	42591867
Pathogen resistance	55.52	16.22	42	17087	11408	42592798
Forced expiratory volume decreased	53.32	16.22	35	17094	7595	42596611
Dyspnoea	51.87	16.22	329	16800	442292	42161914
Bronchospasm	51.13	16.22	42	17087	12843	42591363
Chest injury	50.22	16.22	21	17108	1801	42602405
Lung disorder	46.31	16.22	75	17054	47848	42556358
Walking aid user	45.83	16.22	22	17107	2611	42601595
Increased viscosity of bronchial secretion	45.22	16.22	12	17117	244	42603962
Toxic epidermal necrolysis	43.96	16.22	54	17075	26696	42577510
Retinopathy of prematurity	43.58	16.22	11	17118	182	42604024
Pneumonia pseudomonal	43.03	16.22	26	17103	4883	42599323
Influenza	42.94	16.22	84	17045	62091	42542115
Pancreatic failure	42.06	16.22	16	17113	1071	42603135
Hypoacusis	41.31	16.22	44	17085	18658	42585548
Linear IgA disease	41.00	16.22	19	17110	2084	42602122
Keratitis	40.67	16.22	18	17111	1773	42602433
Cystic fibrosis related diabetes	38.42	16.22	10	17119	188	42604018
Infective keratitis	38.33	16.22	8	17121	53	42604153
Oxygen saturation decreased	38.29	16.22	82	17047	64605	42539601
Off label use	37.12	16.22	405	16724	637930	41966276
Nephropathy toxic	36.11	16.22	39	17090	16799	42587407
Product administered to patient of inappropriate age	33.65	16.22	22	17107	4739	42599467
Infective exacerbation of bronchiectasis	33.26	16.22	11	17118	488	42603718
Arthralgia	32.86	16.22	21	17108	205217	42398989
Death	32.59	16.22	310	16819	470875	42133331
Fall	32.39	16.22	28	17101	234492	42369714
Keratitis bacterial	32.30	16.22	8	17121	122	42604084
Pseudomonas test positive	30.98	16.22	14	17115	1449	42602757
Deafness	30.96	16.22	32	17097	13108	42591098
Deafness neurosensory	30.69	16.22	19	17110	3727	42600479
Respiratory disorder	30.65	16.22	41	17088	22044	42582162
Vestibular disorder	30.55	16.22	13	17116	1164	42603042
Increased bronchial secretion	30.25	16.22	16	17113	2330	42601876
Somnolence	29.42	16.22	10	17119	141095	42463111
Respiratory tract irritation	29.23	16.22	9	17120	316	42603890
Distal intestinal obstruction syndrome	29.14	16.22	10	17119	497	42603709
Rhonchi	28.86	16.22	15	17114	2108	42602098
Aphonia	28.74	16.22	19	17110	4170	42600036
Staphylococcal infection	27.37	16.22	52	17077	37591	42566615
Acute kidney injury	27.02	16.22	245	16884	367092	42237114
Corneal epithelium defect	26.92	16.22	9	17120	413	42603793
Aortic aneurysm	26.18	16.22	23	17106	7700	42596506
Cystic fibrosis lung	25.71	16.22	6	17123	70	42604136
Tracheostomy	25.43	16.22	11	17118	1026	42603180
Infective corneal ulcer	25.15	16.22	5	17124	25	42604181
Chest discomfort	24.14	16.22	68	17061	63548	42540658
Rash morbilliform	24.13	16.22	17	17112	4136	42600070
Malignant neoplasm progression	23.81	16.22	7	17122	108393	42495813
Tinnitus	23.59	16.22	42	17087	28896	42575310
Oral candidiasis	23.53	16.22	29	17100	14376	42589830
Ulcerative keratitis	23.47	16.22	13	17116	2075	42602131
Factor V inhibition	23.38	16.22	7	17122	223	42603983
Rubber sensitivity	23.27	16.22	8	17121	400	42603806
Wheezing	23.23	16.22	61	17068	54720	42549486
Bronchiectasis	22.81	16.22	32	17097	17987	42586219
Product use issue	22.54	16.22	75	17054	76676	42527530
Nausea	22.44	16.22	83	17046	396716	42207490
Toxic anterior segment syndrome	22.15	16.22	11	17118	1405	42602801
Anaemia	22.15	16.22	50	17079	280228	42323978
Ocular hypertension	21.28	16.22	10	17119	1131	42603075
Hypopyon	21.15	16.22	8	17121	527	42603679
Corneal thinning	21.03	16.22	6	17123	161	42604045
Mycobacterium chelonae infection	20.98	16.22	10	17119	1168	42603038
Corneal infiltrates	20.68	16.22	6	17123	171	42604035
Cronobacter infection	20.12	16.22	4	17125	20	42604186
Chondritis	20.02	16.22	6	17123	192	42604014
Necrotising scleritis	19.97	16.22	5	17124	80	42604126
Eyelid oedema	19.38	16.22	17	17112	5678	42598528
Tracheitis	19.06	16.22	9	17120	1030	42603176
Malaise	19.00	16.22	148	16981	212008	42392198
Febrile convulsion	18.97	16.22	8	17121	701	42603505
Flavobacterium infection	18.96	16.22	5	17124	99	42604107
Erythema of eyelid	18.67	16.22	10	17119	1493	42602713
Post procedural complication	18.43	16.22	24	17105	12566	42591640
Pain in extremity	18.43	16.22	20	17109	150584	42453622
Lipogranuloma	18.38	16.22	3	17126	3	42604203
Antibiotic therapy	18.34	16.22	5	17124	113	42604093
Ocular hyperaemia	18.23	16.22	27	17102	15936	42588270
Joint swelling	17.73	16.22	3	17126	68019	42536187
Chronic sinusitis	17.68	16.22	13	17116	3379	42600827
Neuralgic amyotrophy	17.53	16.22	6	17123	296	42603910
Scleromalacia	17.36	16.22	4	17125	44	42604162
Rhinovirus infection	17.35	16.22	17	17112	6531	42597675
Carbon dioxide increased	17.33	16.22	9	17120	1263	42602943
Haemodialysis	17.32	16.22	21	17108	10239	42593967
Staphylococcal sepsis	17.09	16.22	22	17107	11392	42592814
Moaning	16.98	16.22	8	17121	911	42603295
Eyelids pruritus	16.66	16.22	6	17123	344	42603862
Hypertension	16.56	16.22	26	17103	167178	42437028
Overdose	16.52	16.22	11	17118	105253	42498953
Muscle spasms	16.42	16.22	7	17122	86037	42518169
Feeling cold	16.36	16.22	23	17106	12950	42591256
Device related thrombosis	16.25	16.22	9	17120	1436	42602770

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	2678.85	13.97	650	28893	14121	110545635
Hospitalisation	694.98	13.97	447	29096	142046	110417710
Cystic fibrosis	530.08	13.97	142	29401	4589	110555167
Pulmonary function test decreased	375.70	13.97	125	29418	8575	110551181
Pseudomonas infection	317.39	13.97	153	29390	27700	110532056
Haemoptysis	264.13	13.97	189	29354	71165	110488591
Acute kidney injury	258.18	13.97	541	29002	634889	109924867
Ototoxicity	201.10	13.97	65	29478	4066	110555690
Renal tubular necrosis	197.86	13.97	115	29428	30360	110529396
Endophthalmitis	181.84	13.97	72	29471	8115	110551641
Choroiditis	178.64	13.97	48	29495	1567	110558189
Visual acuity reduced	174.11	13.97	108	29435	32065	110527691
Pneumonia	169.53	13.97	566	28977	876148	109683608
Eye pain	165.65	13.97	124	29419	49975	110509781
Cough	164.21	13.97	373	29170	461268	110098488
Intraocular pressure increased	158.91	13.97	71	29472	10805	110548951
Sputum increased	150.57	13.97	57	29486	5694	110554062
Conjunctival hyperaemia	135.54	13.97	53	29490	5778	110553978
Cystic fibrosis respiratory infection suppression	133.24	13.97	30	29513	459	110559297
Drug resistance	131.98	13.97	114	29429	56260	110503496
Disease complication	128.55	13.97	51	29492	5776	110553980
Death	127.61	13.97	443	29100	698426	109861330
Aplastic anaemia	127.48	13.97	80	29463	24228	110535528
Forced expiratory volume decreased	105.29	13.97	57	29486	13119	110546637
Cystic fibrosis lung	94.98	13.97	19	29524	158	110559598
Pathogen resistance	94.78	13.97	59	29484	17613	110542143
Corneal perforation	94.47	13.97	26	29517	930	110558826
Antibiotic level above therapeutic	92.47	13.97	26	29517	1007	110558749
Nephropathy toxic	90.78	13.97	68	29475	27410	110532346
Pneumonia pseudomonal	90.63	13.97	43	29500	7503	110552253
Hypopyon	88.18	13.97	27	29516	1413	110558343
Sputum discoloured	87.55	13.97	67	29476	27878	110531878
Corneal oedema	85.06	13.97	32	29511	3141	110556615
Condition aggravated	82.45	13.97	401	29142	734435	109825321
Productive cough	81.86	13.97	125	29418	114180	110445576
Anti-neutrophil cytoplasmic antibody positive vasculitis	81.17	13.97	36	29507	5381	110554375
Ventilation perfusion mismatch	80.26	13.97	22	29521	775	110558981
Ulcerative keratitis	78.98	13.97	34	29509	4732	110555024
Lung transplant	78.79	13.97	35	29508	5251	110554505
Corneal epithelium defect	77.32	13.97	22	29521	890	110558866
Corneal infiltrates	75.98	13.97	18	29525	348	110559408
Uveitis	74.57	13.97	55	29488	21655	110538101
Tinnitus	72.30	13.97	85	29458	60455	110499301
Staphylococcal infection	68.69	13.97	89	29454	69855	110489901
Bronchospasm	68.44	13.97	60	29483	30179	110529577
Corneal opacity	66.29	13.97	21	29522	1230	110558526
Drug level increased	65.46	13.97	72	29471	47647	110512109
Bronchiectasis	64.35	13.97	63	29480	36430	110523326
Dyspnoea	62.28	13.97	506	29037	1106366	109453390
Infective exacerbation of bronchiectasis	60.41	13.97	18	29525	858	110558898
Off label use	58.50	13.97	634	28909	1499551	109060205
Keratitis fungal	57.89	13.97	15	29528	424	110559332
Systemic lupus erythematosus	55.66	13.97	3	29540	254335	110305421
Toxic epidermal necrolysis	55.41	13.97	72	29471	56655	110503101
Ocular hyperaemia	53.41	13.97	59	29484	39227	110520529
Completed suicide	52.60	13.97	3	29540	242378	110317378
Hypoacusis	51.60	13.97	55	29488	35136	110524620
Vitamin K deficiency	51.05	13.97	16	29527	905	110558851
Conjunctival oedema	50.25	13.97	18	29525	1538	110558218
Painful respiration	50.10	13.97	23	29520	3724	110556032
Keratitis	48.91	13.97	25	29518	5119	110554637
Mobility decreased	48.43	13.97	4	29539	237418	110322338
Therapeutic product effect decreased	47.48	13.97	5	29538	244311	110315445
Glossodynia	47.41	13.97	3	29540	222001	110337755
Aphonia	47.39	13.97	34	29509	12826	110546930
Cystic fibrosis related diabetes	46.27	13.97	11	29532	216	110559540
Chest injury	45.82	13.97	21	29522	3388	110556368
Infusion related reaction	44.71	13.97	23	29520	381139	110178617
Pneumothorax	44.56	13.97	51	29492	35234	110524522
Lipogranuloma	44.39	13.97	7	29536	10	110559746
Eyelid oedema	44.34	13.97	35	29508	15227	110544529
Deafness neurosensory	43.86	13.97	29	29514	9590	110550166
Pericarditis	43.85	13.97	4	29539	219110	110340646
Deafness	43.20	13.97	44	29499	26665	110533091
Rhinovirus infection	43.05	13.97	31	29512	11758	110547998
Pseudomonas test positive	43.01	13.97	18	29525	2336	110557420
Pancreatic failure	43.01	13.97	18	29525	2336	110557420
Ocular hypertension	42.62	13.97	18	29525	2390	110557366
Infective keratitis	41.77	13.97	9	29534	111	110559645
Corneal neovascularisation	41.66	13.97	10	29533	205	110559551
Infection	41.43	13.97	199	29344	362001	110197755
Distal intestinal obstruction syndrome	41.36	13.97	14	29529	1011	110558745
Psoriatic arthropathy	41.01	13.97	3	29540	196758	110362998
Linear IgA disease	40.77	13.97	21	29522	4368	110555388
Keratitis bacterial	40.52	13.97	10	29533	231	110559525
Wound	40.34	13.97	7	29536	234430	110325326
Swelling	39.97	13.97	22	29521	351019	110208737
Increased bronchial secretion	39.91	13.97	20	29523	3928	110555828
Increased viscosity of bronchial secretion	39.45	13.97	12	29531	614	110559142
Acute generalised exanthematous pustulosis	39.32	13.97	38	29505	21626	110538130
Drug reaction with eosinophilia and systemic symptoms	39.20	13.97	75	29468	82020	110477736
Oxygen saturation decreased	39.06	13.97	111	29432	156871	110402885
Corneal thinning	39.00	13.97	10	29533	271	110559485
Product administered to patient of inappropriate age	38.53	13.97	25	29518	8011	110551745
Mycobacterium chelonae infection	38.48	13.97	18	29525	3042	110556714
Abdominal discomfort	37.67	13.97	30	29513	393828	110165928
Arthropathy	37.38	13.97	15	29528	287507	110272249
Fall	36.43	13.97	66	29477	603416	109956340
Fibromyalgia	34.52	13.97	3	29540	170906	110388850
Influenza	34.04	13.97	111	29432	168990	110390766
Chest discomfort	34.00	13.97	113	29430	173735	110386021
Necrotising scleritis	33.84	13.97	9	29534	282	110559474
Drug abuse	33.54	13.97	4	29539	177407	110382349
Vestibular disorder	31.61	13.97	15	29528	2617	110557139
Aortic aneurysm	31.58	13.97	24	29519	9880	110549876
Rash morbilliform	31.56	13.97	22	29521	7929	110551827
SLE arthritis	30.91	13.97	10	29533	627	110559129
Eye irritation	30.42	13.97	41	29502	33411	110526345
Proteinuria	30.39	13.97	45	29498	39973	110519783
Osteoarthritis	30.24	13.97	6	29537	182617	110377139
Pain	29.55	13.97	143	29400	954812	109604944
Hypertension	28.83	13.97	58	29485	510026	110049730
Corneal disorder	28.76	13.97	14	29529	2583	110557173
Hypoaesthesia	28.72	13.97	25	29518	314198	110245558
Dry mouth	28.42	13.97	9	29534	199939	110359817
Discomfort	28.23	13.97	11	29532	214696	110345060
Stenotrophomonas infection	27.54	13.97	18	29525	5840	110553916
Aspergillus infection	27.36	13.97	34	29509	25582	110534174
Infective corneal ulcer	27.19	13.97	5	29538	25	110559731
Macular oedema	27.01	13.97	19	29524	6947	110552809
Scleromalacia	26.88	13.97	6	29537	88	110559668
Alopecia	26.67	13.97	35	29508	364718	110195038
Rhonchi	26.56	13.97	16	29527	4502	110555254
Stevens-Johnson syndrome	26.38	13.97	46	29497	46855	110512901
Pain in extremity	26.17	13.97	57	29486	487061	110072695
Erythema of eyelid	26.00	13.97	15	29528	3900	110555856
Multiple organ dysfunction syndrome	25.66	13.97	94	29449	151616	110408140
Dysphonia	25.38	13.97	60	29483	75869	110483887
Vasculitis	25.34	13.97	39	29504	35834	110523922
Blood cholesterol increased	25.07	13.97	9	29534	184776	110374980
Burkholderia cepacia complex infection	25.05	13.97	8	29535	481	110559275
Intentional overdose	25.01	13.97	3	29540	132498	110427258
Toxic anterior segment syndrome	25.00	13.97	14	29529	3440	110556316
Renal impairment	24.83	13.97	108	29435	188337	110371419
Clubbing	24.82	13.97	9	29534	796	110558960
Forced expiratory volume increased	24.59	13.97	6	29537	132	110559624
Somnolence	24.46	13.97	26	29517	297423	110262333
Tracheitis	24.39	13.97	11	29532	1710	110558046
Muscle spasms	24.38	13.97	23	29520	278134	110281622
Stomatitis	24.09	13.97	22	29521	270220	110289536
Therapy cessation	23.94	13.97	43	29500	44814	110514942
Sputum abnormal	23.33	13.97	10	29533	1376	110558380
Haemodialysis	23.03	13.97	26	29517	17693	110542063
Respiratory failure	22.94	13.97	116	29427	215216	110344540
Malignant neoplasm progression	22.85	13.97	9	29534	174558	110385198
Therapeutic product effect incomplete	22.73	13.97	16	29527	223789	110335967
Vitritis	22.66	13.97	12	29531	2641	110557115
Confusional state	22.65	13.97	58	29485	468622	110091134
Elbow deformity	22.51	13.97	10	29533	1500	110558256
Joint range of motion decreased	22.41	13.97	3	29540	121829	110437927
Pyrexia	22.28	13.97	350	29193	897915	109661841
Pneumonia staphylococcal	22.20	13.97	16	29527	6075	110553681
Lung disorder	22.08	13.97	101	29442	179946	110379810
Injection site pain	21.97	13.97	10	29533	177912	110381844
Candida infection	21.86	13.97	43	29500	47966	110511790
Cronobacter infection	21.75	13.97	4	29539	20	110559736
Post procedural complication	21.73	13.97	31	29512	26627	110533129
Respiratory tract irritation	21.72	13.97	8	29535	740	110559016
Gait inability	21.52	13.97	5	29538	136371	110423385
Respiratory distress	21.49	13.97	53	29490	68821	110490935
Mycobacterium abscessus infection	21.34	13.97	10	29533	1696	110558060
Respiratory disorder	21.30	13.97	54	29489	71328	110488428
Hypotony of eye	21.20	13.97	7	29536	468	110559288
Arthralgia	21.15	13.97	122	29421	779510	109780246
Pulmonary haemorrhage	21.14	13.97	24	29519	16432	110543324
Gait disturbance	21.05	13.97	26	29517	278182	110281574
Respiratory tract infection bacterial	20.84	13.97	11	29532	2405	110557351
Bronchial wall thickening	20.53	13.97	12	29531	3195	110556561
Antimicrobial susceptibility test intermediate	20.13	13.97	4	29539	32	110559724
Blood creatinine increased	19.82	13.97	99	29444	182790	110376966
Septic shock	19.78	13.97	89	29454	157439	110402317
Flavobacterium infection	19.66	13.97	5	29538	131	110559625
Contusion	19.63	13.97	20	29523	233341	110326415
Bacterial infection	19.49	13.97	40	29503	45996	110513760
Respiration abnormal	19.31	13.97	18	29525	9791	110549965
Eye discharge	19.07	13.97	17	29526	8737	110551019
Restrictive cardiomyopathy	19.01	13.97	8	29535	1053	110558703
Sweat test abnormal	18.98	13.97	4	29539	44	110559712
Sinonasal papilloma	18.98	13.97	4	29539	44	110559712
Rash maculo-papular	18.96	13.97	53	29490	74169	110485587
Neuralgic amyotrophy	18.78	13.97	6	29537	361	110559395
Insomnia	18.70	13.97	43	29500	360547	110199209
Febrile convulsion	18.66	13.97	8	29535	1102	110558654
Syncope	18.64	13.97	16	29527	202520	110357236
Overdose	18.60	13.97	21	29522	233773	110325983
Manufacturing laboratory analytical testing issue	18.39	13.97	3	29540	6	110559750
Staphylococcal sepsis	18.37	13.97	23	29520	17431	110542325
Photophobia	18.17	13.97	28	29515	25743	110534013
Surgical procedure repeated	18.12	13.97	7	29536	738	110559018
Peripheral swelling	18.01	13.97	52	29491	403982	110155774
Stenotrophomonas test positive	17.97	13.97	6	29537	415	110559341
C-reactive protein increased	17.97	13.97	19	29524	217900	110341856
Liver injury	17.73	13.97	9	29534	150404	110409352
Foreign body sensation in eyes	17.54	13.97	11	29532	3323	110556433
Conjunctivitis	17.53	13.97	32	29511	33760	110525996
Ocular discomfort	17.46	13.97	16	29527	8517	110551239
Dermatitis exfoliative	17.10	13.97	18	29525	11329	110548427
Corneal exfoliation	17.07	13.97	3	29540	11	110559745
Muscular weakness	16.99	13.97	25	29518	248443	110311313
Eye pruritus	16.96	13.97	31	29512	32744	110527012
Anaemia	16.83	13.97	82	29461	547004	110012752
Road traffic accident	16.82	13.97	4	29539	107394	110452362
Anterior chamber fibrin	16.65	13.97	5	29538	245	110559511
Infectious crystalline keratopathy	16.62	13.97	4	29539	83	110559673
Bursitis	16.51	13.97	7	29536	129911	110429845
Chondritis	16.47	13.97	5	29538	254	110559502
Impaired healing	16.39	13.97	17	29526	196700	110363056
Wound infection	16.33	13.97	3	29540	96462	110463294
Depression	16.32	13.97	38	29505	317297	110242459
Tracheostomy	16.22	13.97	8	29535	1519	110558237
Underweight	16.20	13.97	8	29535	1522	110558234
Steatorrhoea	15.73	13.97	7	29536	1054	110558702
Retinal detachment	15.66	13.97	17	29526	11083	110548673
Persistent corneal epithelial defect	15.65	13.97	4	29539	107	110559649
Psoriasis	15.59	13.97	9	29534	139984	110419772
Bartter's syndrome	15.58	13.97	3	29540	20	110559736
Jaw fracture	15.58	13.97	10	29533	3146	110556610
Hypoxia	15.39	13.97	72	29471	129443	110430313
Rubber sensitivity	15.36	13.97	9	29534	2409	110557347
Gastrointestinal haemorrhage	15.32	13.97	13	29530	165505	110394251
Weight increased	15.28	13.97	59	29484	419585	110140171
Herpes zoster	15.18	13.97	5	29538	108374	110451382
Contraindicated product administered	15.08	13.97	27	29516	248240	110311516
Joint swelling	15.03	13.97	64	29479	442781	110116975
Hypercholesterolaemia	15.00	13.97	3	29540	90834	110468922
Eyelids pruritus	14.99	13.97	8	29535	1789	110557967
Respirovirus test positive	14.90	13.97	4	29539	130	110559626
Dialysis	14.81	13.97	22	29521	19597	110540159
Angle closure glaucoma	14.64	13.97	10	29533	3489	110556267
Dizziness	14.57	13.97	118	29425	698075	109861681
Fatigue	14.56	13.97	233	29310	1215725	109344031
Blister	14.48	13.97	24	29519	227352	110332404
Acinetobacter infection	14.45	13.97	10	29533	3563	110556193
Lacrimation increased	14.43	13.97	28	29515	30922	110528834
Trichosporon infection	14.37	13.97	7	29536	1293	110558463
Factor V inhibition	14.32	13.97	5	29538	396	110559360
Vitamin E decreased	14.24	13.97	3	29540	33	110559723
Cognitive disorder	14.23	13.97	3	29540	87508	110472248
Bronchial disorder	14.21	13.97	9	29534	2767	110556989
Intentional product misuse	14.16	13.97	9	29534	132895	110426861
Vitamin E deficiency	14.16	13.97	3	29540	34	110559722
Osteopenia	14.10	13.97	23	29520	22186	110537570
Tubulointerstitial nephritis	14.10	13.97	39	29504	54245	110505511
Suicide attempt	14.08	13.97	5	29538	103389	110456367
Sputum retention	14.08	13.97	7	29536	1352	110558404
Vitamin A deficiency	14.03	13.97	4	29539	163	110559593
Carbon dioxide increased	14.01	13.97	9	29534	2835	110556921

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	D000890	Anti-Infective Agents
MeSH PA	D000900	Anti-Bacterial Agents
CHEBI has role	CHEBI:27026	toxin
CHEBI has role	CHEBI:33281	antimicrobial agent
CHEBI has role	CHEBI:33282	antibacterial agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:66981	ophthalmology drug
CHEBI has role	CHEBI:67079	anti-inflammatory agent

Related Drugs by ATC class:

J01GB Other aminoglycosides 12 drugs

amikacin arbekacin bekanamycin dibekacin gentamicin isepamicin kanamycin neomycin netilmicin plazomicin ribostamycin sisomicin

S01AA Antibiotics 27 drugs

amikacin ampicillin azidamfenicol azithromycin bacitracin benzylpenicillin cefmenoxime cefuroxime chloramphenicol chlortetracycline dibekacin dihydrostreptomycin show all 27 →

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
0.05%;0.3%	TOBRADEX ST	HARROW EYE	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	HARROW EYE	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	VIATRIS	N201688	March 22, 2013	RX	POWDER	INHALATION	8869794	Sept. 12, 2028	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG	TOBI PODHALER	VIATRIS	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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.5%;0.3%	LOTEPREDNOL ETABONATE AND TOBRAMYCIN	ALEMBIC	A217597	Dec. 10, 2025	RX	SUSPENSION/DROPS	OPHTHALMIC	July 14, 2026	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source
Heparanase	Enzyme	Q9Y251	HPSE_HUMAN		IC50	6.05	CHEMBL
Taste receptor type 2 member 20	GPCR	P59543	T2R20_HUMAN	AGONIST	EC50	4.29	IUPHAR
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B)	Enzyme		O32553_ECOLX		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
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	0078-0813	OINTMENT	3 mg	OPHTHALMIC	NDA	16 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0876	OINTMENT	3 mg	OPHTHALMIC	NDA	18 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	0093-4085	SOLUTION	300 mg	RESPIRATORY (INHALATION)	ANDA	27 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	33 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
Tobramycin Inhalation Solution	HUMAN PRESCRIPTION DRUG LABEL	1	16714-119	INHALANT	300 mg	RESPIRATORY (INHALATION)	ANDA	28 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	17478-290	SOLUTION/ DROPS	3 mg	OPHTHALMIC	ANDA	19 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	17478-340	SOLUTION	300 mg	RESPIRATORY (INHALATION)	ANDA	29 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	21695-203	SUSPENSION	3 mg	OPHTHALMIC	NDA	20 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	21695-204	SOLUTION	3 mg	OPHTHALMIC	ANDA	17 sections
Tobramycin and Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	2	21695-416	SUSPENSION/ DROPS	3 mg	OPHTHALMIC	NDA	20 sections
Tobrex	HUMAN PRESCRIPTION DRUG LABEL	1	21695-458	OINTMENT	3 mg	OPHTHALMIC	NDA	17 sections
TobraDex	HUMAN PRESCRIPTION DRUG LABEL	2	21695-628	OINTMENT	3 mg	OPHTHALMIC	NDA	20 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	24208-290	SOLUTION	3 mg	OPHTHALMIC	ANDA	16 sections
Tobramycin and Dexamethasone	HUMAN PRESCRIPTION DRUG LABEL	2	24208-295	SUSPENSION/ DROPS	3 mg	OPHTHALMIC	ANDA	17 sections
Zylet	HUMAN PRESCRIPTION DRUG LABEL	2	24208-358	SUSPENSION/ DROPS	3 mg	OPHTHALMIC	NDA	21 sections
Kitabis Pak	HUMAN PRESCRIPTION DRUG LABEL	1	24492-850	SOLUTION	300 mg	RESPIRATORY (INHALATION)	NDA	30 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	33261-519	SOLUTION/ DROPS	3 mg	OPHTHALMIC	ANDA	18 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	36000-242	INJECTION	40 mg	INTRAVENOUS	ANDA	21 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	36000-242	INJECTION	40 mg	INTRAVENOUS	ANDA	21 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	36000-244	INJECTION	40 mg	INTRAVENOUS	ANDA	21 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	36000-244	INJECTION	40 mg	INTRAVENOUS	ANDA	21 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	39822-0412	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1.20 g	INTRAVENOUS	ANDA	22 sections
Tobramycin	HUMAN PRESCRIPTION DRUG LABEL	1	42254-187	SOLUTION	3 mg	OPHTHALMIC	ANDA	15 sections

Ask DrugCentral

tobramycin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: