Stem definition | Drug id | CAS RN |
---|---|---|
antibiotics, kanamycin and bekanamycin derivatives (obtained from Streptomyces kanamyceticus) | 157 | 37517-28-5 |
Dose | Unit | Route |
---|---|---|
0.59 | g | Inhal.solution |
1 | g | P |
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 98 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 25.61 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 0 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Vd (Volume of distribution) | 0.16 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 1.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.88 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 2.40 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
Jan. 22, 1981 | FDA | APOTHECON | |
March 23, 2021 | PMDA | Insmed GK |
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 |
---|---|---|---|---|---|---|
Drug resistance | 357.50 | 18.62 | 152 | 15201 | 22781 | 63450888 |
Dysphonia | 201.97 | 18.62 | 132 | 15221 | 47482 | 63426187 |
Pathogen resistance | 190.94 | 18.62 | 68 | 15285 | 6330 | 63467339 |
Septic shock | 153.80 | 18.62 | 128 | 15225 | 66501 | 63407168 |
Drug reaction with eosinophilia and systemic symptoms | 151.30 | 18.62 | 97 | 15256 | 33739 | 63439930 |
Deafness | 146.05 | 18.62 | 76 | 15277 | 17881 | 63455788 |
Multiple organ dysfunction syndrome | 145.66 | 18.62 | 116 | 15237 | 56636 | 63417033 |
Therapy interrupted | 127.94 | 18.62 | 86 | 15267 | 32369 | 63441300 |
Aphonia | 115.90 | 18.62 | 54 | 15299 | 10009 | 63463660 |
Ototoxicity | 114.81 | 18.62 | 32 | 15321 | 1330 | 63472339 |
Off label use | 105.21 | 18.62 | 379 | 14974 | 674083 | 62799586 |
Cough | 103.27 | 18.62 | 222 | 15131 | 292521 | 63181148 |
Tinnitus | 100.42 | 18.62 | 77 | 15276 | 35551 | 63438118 |
Thrombocytopenia | 98.76 | 18.62 | 150 | 15203 | 151007 | 63322662 |
Systemic candida | 91.20 | 18.62 | 33 | 15320 | 3212 | 63470457 |
Haemoptysis | 89.65 | 18.62 | 66 | 15287 | 28660 | 63445009 |
Eosinophilia | 86.56 | 18.62 | 59 | 15294 | 22697 | 63450972 |
Rash maculo-papular | 83.51 | 18.62 | 66 | 15287 | 31830 | 63441839 |
Hospitalisation | 80.48 | 18.62 | 101 | 15252 | 84980 | 63388689 |
Sputum increased | 80.48 | 18.62 | 28 | 15325 | 2431 | 63471238 |
Geotrichum infection | 78.23 | 18.62 | 19 | 15334 | 455 | 63473214 |
Pain | 75.36 | 18.62 | 43 | 15310 | 740585 | 62733084 |
Mycobacterium abscessus infection | 71.87 | 18.62 | 19 | 15334 | 645 | 63473024 |
Toxic skin eruption | 70.41 | 18.62 | 42 | 15311 | 12843 | 63460826 |
Klebsiella infection | 68.90 | 18.62 | 36 | 15317 | 8530 | 63465139 |
Candida infection | 68.55 | 18.62 | 56 | 15297 | 28295 | 63445374 |
Pseudomonas infection | 65.08 | 18.62 | 38 | 15315 | 11175 | 63462494 |
Sepsis | 63.14 | 18.62 | 124 | 15229 | 152999 | 63320670 |
Paradoxical drug reaction | 62.91 | 18.62 | 27 | 15326 | 4125 | 63469544 |
Bronchopulmonary aspergillosis | 60.21 | 18.62 | 33 | 15320 | 8602 | 63465067 |
Hepatotoxicity | 59.38 | 18.62 | 58 | 15295 | 36983 | 63436686 |
Immune reconstitution inflammatory syndrome | 58.95 | 18.62 | 29 | 15324 | 6055 | 63467614 |
Pyrexia | 57.27 | 18.62 | 245 | 15108 | 470233 | 63003436 |
Acute kidney injury | 56.08 | 18.62 | 165 | 15188 | 263250 | 63210419 |
Nephropathy toxic | 52.06 | 18.62 | 31 | 15322 | 9448 | 63464221 |
Enterococcal infection | 51.99 | 18.62 | 29 | 15324 | 7819 | 63465850 |
Hepatocellular injury | 51.79 | 18.62 | 47 | 15306 | 27334 | 63446335 |
Febrile neutropenia | 50.12 | 18.62 | 97 | 15256 | 118352 | 63355317 |
Mycobacterium avium complex infection | 49.83 | 18.62 | 21 | 15332 | 3067 | 63470602 |
Drug ineffective for unapproved indication | 48.46 | 18.62 | 50 | 15303 | 34013 | 63439656 |
Hyperlactacidaemia | 48.07 | 18.62 | 20 | 15333 | 2829 | 63470840 |
Infusion related reaction | 47.52 | 18.62 | 3 | 15350 | 245518 | 63228151 |
Fatigue | 46.99 | 18.62 | 90 | 15263 | 887938 | 62585731 |
Productive cough | 45.91 | 18.62 | 66 | 15287 | 63142 | 63410527 |
Acute respiratory distress syndrome | 45.69 | 18.62 | 41 | 15312 | 23493 | 63450176 |
Acute generalised exanthematous pustulosis | 45.13 | 18.62 | 30 | 15323 | 11069 | 63462600 |
Joint swelling | 44.73 | 18.62 | 12 | 15341 | 327654 | 63146015 |
Mucormycosis | 44.58 | 18.62 | 19 | 15334 | 2852 | 63470817 |
Product packaging difficult to open | 44.04 | 18.62 | 9 | 15344 | 94 | 63473575 |
Arthralgia | 43.84 | 18.62 | 44 | 15309 | 569666 | 62904003 |
Intentional dose omission | 43.28 | 18.62 | 26 | 15327 | 8049 | 63465620 |
Toxic epidermal necrolysis | 43.11 | 18.62 | 41 | 15312 | 25293 | 63448376 |
Clostridium difficile colitis | 42.26 | 18.62 | 37 | 15316 | 20532 | 63453137 |
Encephalopathy | 41.61 | 18.62 | 49 | 15304 | 38571 | 63435098 |
Deafness neurosensory | 40.75 | 18.62 | 21 | 15332 | 4834 | 63468835 |
Product use in unapproved indication | 38.84 | 18.62 | 113 | 15240 | 178967 | 63294702 |
Fall | 38.05 | 18.62 | 24 | 15329 | 392310 | 63081359 |
Osteomyelitis bacterial | 37.69 | 18.62 | 9 | 15344 | 200 | 63473469 |
Aplasia | 37.43 | 18.62 | 19 | 15334 | 4240 | 63469429 |
Acinetobacter infection | 36.78 | 18.62 | 14 | 15339 | 1569 | 63472100 |
Product administered to patient of inappropriate age | 35.97 | 18.62 | 17 | 15336 | 3251 | 63470418 |
Nosocomial infection | 35.64 | 18.62 | 14 | 15339 | 1707 | 63471962 |
Alopecia | 35.06 | 18.62 | 19 | 15334 | 337517 | 63136152 |
Swelling | 34.13 | 18.62 | 12 | 15341 | 275366 | 63198303 |
Synovitis | 34.12 | 18.62 | 3 | 15350 | 186915 | 63286754 |
Neutropenic colitis | 33.75 | 18.62 | 16 | 15337 | 3079 | 63470590 |
Headache | 33.56 | 18.62 | 64 | 15289 | 633177 | 62840492 |
Leukopenia | 33.53 | 18.62 | 64 | 15289 | 77226 | 63396443 |
Abdominal discomfort | 33.41 | 18.62 | 18 | 15335 | 320867 | 63152802 |
Nasopharyngitis | 33.41 | 18.62 | 10 | 15343 | 254247 | 63219422 |
Weight increased | 32.95 | 18.62 | 11 | 15342 | 260781 | 63212888 |
Dysbiosis | 32.30 | 18.62 | 11 | 15342 | 895 | 63472774 |
Pancreatitis acute | 31.84 | 18.62 | 36 | 15317 | 27130 | 63446539 |
Multiple-drug resistance | 31.27 | 18.62 | 18 | 15335 | 5152 | 63468517 |
Cholestasis | 31.14 | 18.62 | 37 | 15316 | 29397 | 63444272 |
Respiratory failure | 31.02 | 18.62 | 73 | 15280 | 101785 | 63371884 |
Hepatosplenic candidiasis | 30.51 | 18.62 | 8 | 15345 | 263 | 63473406 |
Hypertransaminasaemia | 29.64 | 18.62 | 19 | 15334 | 6590 | 63467079 |
Hepatitis | 29.55 | 18.62 | 42 | 15311 | 39746 | 63433923 |
Bronchospasm | 29.46 | 18.62 | 28 | 15325 | 17252 | 63456417 |
Antithrombin III | 29.13 | 18.62 | 7 | 15346 | 160 | 63473509 |
Musculoskeletal stiffness | 28.75 | 18.62 | 5 | 15348 | 184613 | 63289056 |
Butterfly rash | 28.42 | 18.62 | 12 | 15341 | 1761 | 63471908 |
Retinal ischaemia | 28.34 | 18.62 | 8 | 15345 | 348 | 63473321 |
Angular cheilitis | 27.57 | 18.62 | 9 | 15344 | 642 | 63473027 |
Glossodynia | 27.52 | 18.62 | 5 | 15348 | 178871 | 63294798 |
Bacteraemia | 27.48 | 18.62 | 27 | 15326 | 17321 | 63456348 |
Guillain-Barre syndrome | 27.47 | 18.62 | 15 | 15338 | 3878 | 63469791 |
Overgrowth fungal | 27.29 | 18.62 | 6 | 15347 | 91 | 63473578 |
Haemorrhage intracranial | 27.28 | 18.62 | 24 | 15329 | 13395 | 63460274 |
Hepatic function abnormal | 27.28 | 18.62 | 39 | 15314 | 37103 | 63436566 |
Coagulopathy | 27.15 | 18.62 | 29 | 15324 | 20515 | 63453154 |
Myelosuppression | 27.08 | 18.62 | 31 | 15322 | 23672 | 63449997 |
Herpes simplex hepatitis | 27.07 | 18.62 | 8 | 15345 | 410 | 63473259 |
Drug ineffective | 26.65 | 18.62 | 376 | 14977 | 1044389 | 62429280 |
Wound | 26.36 | 18.62 | 4 | 15349 | 163259 | 63310410 |
Granulomatous liver disease | 26.00 | 18.62 | 9 | 15344 | 769 | 63472900 |
Klebsiella bacteraemia | 25.71 | 18.62 | 11 | 15342 | 1667 | 63472002 |
Chemotherapeutic drug level increased | 25.06 | 18.62 | 6 | 15347 | 135 | 63473534 |
Pain in extremity | 24.98 | 18.62 | 26 | 15327 | 331460 | 63142209 |
Neuropathy peripheral | 24.88 | 18.62 | 72 | 15281 | 113595 | 63360074 |
Peripheral swelling | 24.77 | 18.62 | 17 | 15336 | 265925 | 63207744 |
Infective pulmonary exacerbation of cystic fibrosis | 24.70 | 18.62 | 19 | 15334 | 8798 | 63464871 |
Status epilepticus | 24.68 | 18.62 | 24 | 15329 | 15209 | 63458460 |
Deafness permanent | 24.60 | 18.62 | 4 | 15349 | 9 | 63473660 |
Dysgeusia | 24.48 | 18.62 | 42 | 15311 | 46668 | 63427001 |
Hypersensitivity | 24.34 | 18.62 | 21 | 15332 | 292664 | 63181005 |
Vulvovaginitis | 24.26 | 18.62 | 7 | 15346 | 330 | 63473339 |
Electrocardiogram QT prolonged | 24.24 | 18.62 | 48 | 15305 | 59482 | 63414187 |
Neutropenia | 24.23 | 18.62 | 95 | 15258 | 174910 | 63298759 |
Cholestatic liver injury | 23.98 | 18.62 | 12 | 15341 | 2598 | 63471071 |
Deafness bilateral | 23.91 | 18.62 | 10 | 15343 | 1432 | 63472237 |
Aspergillus infection | 23.91 | 18.62 | 18 | 15335 | 8075 | 63465594 |
Pancytopenia | 23.78 | 18.62 | 64 | 15289 | 96869 | 63376800 |
Bone marrow failure | 23.36 | 18.62 | 32 | 15321 | 29258 | 63444411 |
Atypical mycobacterial infection | 22.96 | 18.62 | 9 | 15344 | 1091 | 63472578 |
Capillary leak syndrome | 22.86 | 18.62 | 11 | 15342 | 2189 | 63471480 |
Acute hepatic failure | 22.70 | 18.62 | 25 | 15328 | 18302 | 63455367 |
Throat irritation | 22.62 | 18.62 | 36 | 15317 | 37611 | 63436058 |
Corneal opacity | 22.55 | 18.62 | 8 | 15345 | 735 | 63472934 |
Granulomatosis with polyangiitis | 22.55 | 18.62 | 11 | 15342 | 2254 | 63471415 |
Respiratory distress | 22.55 | 18.62 | 34 | 15319 | 33917 | 63439752 |
Hypofibrinogenaemia | 22.42 | 18.62 | 9 | 15344 | 1161 | 63472508 |
Agranulocytosis | 22.41 | 18.62 | 29 | 15324 | 25105 | 63448564 |
Rhinocerebral mucormycosis | 22.03 | 18.62 | 7 | 15346 | 458 | 63473211 |
Post-tussive vomiting | 21.98 | 18.62 | 3 | 15350 | 0 | 63473669 |
Lower respiratory tract infection bacterial | 21.87 | 18.62 | 7 | 15346 | 469 | 63473200 |
Polyneuropathy | 21.81 | 18.62 | 22 | 15331 | 14567 | 63459102 |
Kussmaul respiration | 21.55 | 18.62 | 6 | 15347 | 248 | 63473421 |
Anxiety | 21.49 | 18.62 | 13 | 15340 | 217528 | 63256141 |
Mycobacterium chelonae infection | 21.37 | 18.62 | 7 | 15346 | 505 | 63473164 |
Generalised bullous fixed drug eruption | 21.16 | 18.62 | 5 | 15348 | 106 | 63473563 |
Hypertension | 20.93 | 18.62 | 22 | 15331 | 279281 | 63194388 |
Muscle spasms | 20.76 | 18.62 | 6 | 15347 | 156144 | 63317525 |
Back pain | 20.72 | 18.62 | 20 | 15333 | 264125 | 63209544 |
Sinusitis | 20.42 | 18.62 | 15 | 15338 | 226638 | 63247031 |
Cytomegalovirus infection | 19.99 | 18.62 | 25 | 15328 | 20927 | 63452742 |
Purulence | 19.85 | 18.62 | 9 | 15344 | 1565 | 63472104 |
Renal failure | 19.75 | 18.62 | 68 | 15285 | 117584 | 63356085 |
Insomnia | 19.72 | 18.62 | 14 | 15339 | 215238 | 63258431 |
Endocarditis candida | 19.64 | 18.62 | 4 | 15349 | 41 | 63473628 |
Haemophagocytic lymphohistiocytosis | 19.62 | 18.62 | 18 | 15335 | 10609 | 63463060 |
Drug dose omission by device | 19.57 | 18.62 | 13 | 15340 | 4788 | 63468881 |
Retinal artery occlusion | 19.43 | 18.62 | 9 | 15344 | 1644 | 63472025 |
Cardiac failure acute | 19.29 | 18.62 | 17 | 15336 | 9506 | 63464163 |
Tinea versicolour | 19.14 | 18.62 | 4 | 15349 | 47 | 63473622 |
Cryptococcosis | 19.11 | 18.62 | 8 | 15345 | 1149 | 63472520 |
Pseudomonal sepsis | 19.05 | 18.62 | 10 | 15343 | 2391 | 63471278 |
Fungaemia | 19.04 | 18.62 | 10 | 15343 | 2393 | 63471276 |
Respiratory gas exchange disorder | 18.89 | 18.62 | 6 | 15347 | 392 | 63473277 |
Vascular device infection | 18.85 | 18.62 | 15 | 15338 | 7297 | 63466372 |
Febrile bone marrow aplasia | 18.82 | 18.62 | 15 | 15338 | 7310 | 63466359 |
Mycobacterial infection | 18.78 | 18.62 | 9 | 15344 | 1774 | 63471895 |
Weaning failure | 18.70 | 18.62 | 6 | 15347 | 405 | 63473264 |
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 |
---|---|---|---|---|---|---|
Drug resistance | 313.15 | 16.61 | 180 | 16702 | 25747 | 34914302 |
Ototoxicity | 251.29 | 16.61 | 74 | 16808 | 1843 | 34938206 |
Drug reaction with eosinophilia and systemic symptoms | 171.91 | 16.61 | 136 | 16746 | 32876 | 34907173 |
Septic shock | 160.03 | 16.61 | 185 | 16697 | 71649 | 34868400 |
Pathogen resistance | 153.59 | 16.61 | 80 | 16802 | 9402 | 34930647 |
Rash maculo-papular | 137.02 | 16.61 | 112 | 16770 | 28339 | 34911710 |
Deafness | 132.64 | 16.61 | 77 | 16805 | 11188 | 34928861 |
Electrocardiogram QT prolonged | 112.83 | 16.61 | 118 | 16764 | 40834 | 34899215 |
Drug ineffective | 108.77 | 16.61 | 471 | 16411 | 456280 | 34483769 |
Product use in unapproved indication | 101.79 | 16.61 | 194 | 16688 | 117305 | 34822744 |
Thrombocytopenia | 98.05 | 16.61 | 226 | 16656 | 156021 | 34784028 |
Multiple organ dysfunction syndrome | 86.37 | 16.61 | 142 | 16740 | 76424 | 34863625 |
Eosinophilia | 83.98 | 16.61 | 82 | 16800 | 26140 | 34913909 |
Immune reconstitution inflammatory syndrome | 82.77 | 16.61 | 52 | 16830 | 8707 | 34931342 |
Acute kidney injury | 70.29 | 16.61 | 312 | 16570 | 304676 | 34635373 |
Deafness neurosensory | 66.74 | 16.61 | 31 | 16851 | 2840 | 34937209 |
Toxic skin eruption | 63.74 | 16.61 | 49 | 16833 | 11336 | 34928713 |
Drug ineffective for unapproved indication | 62.90 | 16.61 | 67 | 16815 | 23648 | 34916401 |
Fall | 61.00 | 16.61 | 12 | 16870 | 202873 | 34737176 |
Candida infection | 59.73 | 16.61 | 57 | 16825 | 17658 | 34922391 |
Klebsiella infection | 59.68 | 16.61 | 42 | 16840 | 8489 | 34931560 |
Fatigue | 59.56 | 16.61 | 55 | 16827 | 370598 | 34569451 |
Mycobacterium chelonae infection | 58.97 | 16.61 | 20 | 16862 | 795 | 34939254 |
Off label use | 58.75 | 16.61 | 374 | 16508 | 419150 | 34520899 |
Hepatotoxicity | 57.51 | 16.61 | 61 | 16821 | 21424 | 34918625 |
Treatment failure | 53.13 | 16.61 | 87 | 16795 | 46610 | 34893439 |
Enterococcal infection | 47.65 | 16.61 | 38 | 16844 | 9268 | 34930781 |
Brain abscess | 46.71 | 16.61 | 25 | 16857 | 3100 | 34936949 |
Pain | 45.50 | 16.61 | 21 | 16861 | 204654 | 34735395 |
Blood pressure measurement | 42.34 | 16.61 | 11 | 16871 | 169 | 34939880 |
Therapy interrupted | 42.28 | 16.61 | 42 | 16840 | 13655 | 34926394 |
Pseudomonas infection | 42.03 | 16.61 | 40 | 16842 | 12342 | 34927707 |
Bronchospasm | 40.94 | 16.61 | 37 | 16845 | 10694 | 34929355 |
Pancytopenia | 38.44 | 16.61 | 117 | 16765 | 95040 | 34845009 |
Nephropathy toxic | 37.75 | 16.61 | 38 | 16844 | 12550 | 34927499 |
Hepatic cytolysis | 36.75 | 16.61 | 40 | 16842 | 14456 | 34925593 |
Tuberculosis of central nervous system | 36.16 | 16.61 | 10 | 16872 | 197 | 34939852 |
Deafness bilateral | 35.46 | 16.61 | 15 | 16867 | 1099 | 34938950 |
Myelosuppression | 35.27 | 16.61 | 45 | 16837 | 19220 | 34920829 |
Bronchopulmonary aspergillosis | 34.66 | 16.61 | 39 | 16843 | 14620 | 34925429 |
Hypoacusis | 34.56 | 16.61 | 41 | 16841 | 16260 | 34923789 |
Acute respiratory distress syndrome | 33.13 | 16.61 | 51 | 16831 | 25918 | 34914131 |
Febrile bone marrow aplasia | 32.69 | 16.61 | 29 | 16853 | 8180 | 34931869 |
Hydrocephalus | 32.57 | 16.61 | 24 | 16858 | 5208 | 34934841 |
Systemic candida | 32.41 | 16.61 | 21 | 16861 | 3705 | 34936344 |
Vascular pseudoaneurysm thrombosis | 32.05 | 16.61 | 7 | 16875 | 48 | 34940001 |
Aspergillus infection | 31.39 | 16.61 | 34 | 16848 | 12220 | 34927829 |
Nocardiosis | 31.29 | 16.61 | 21 | 16861 | 3930 | 34936119 |
Hypertransaminasaemia | 31.09 | 16.61 | 24 | 16858 | 5582 | 34934467 |
Myocardial infarction | 30.89 | 16.61 | 10 | 16872 | 121075 | 34818974 |
Multiple-drug resistance | 30.31 | 16.61 | 23 | 16859 | 5216 | 34934833 |
Linear IgA disease | 30.04 | 16.61 | 15 | 16867 | 1611 | 34938438 |
Mucormycosis | 29.86 | 16.61 | 24 | 16858 | 5918 | 34934131 |
Posterior reversible encephalopathy syndrome | 29.76 | 16.61 | 30 | 16852 | 9924 | 34930125 |
Acute generalised exanthematous pustulosis | 29.12 | 16.61 | 25 | 16857 | 6751 | 34933298 |
Stenotrophomonas infection | 29.09 | 16.61 | 16 | 16866 | 2094 | 34937955 |
Sepsis neonatal | 29.05 | 16.61 | 9 | 16873 | 267 | 34939782 |
Hepatocellular injury | 28.86 | 16.61 | 44 | 16838 | 22167 | 34917882 |
Acoustic neuroma | 28.81 | 16.61 | 8 | 16874 | 160 | 34939889 |
Headache | 28.47 | 16.61 | 33 | 16849 | 200602 | 34739447 |
Fusarium infection | 28.44 | 16.61 | 13 | 16869 | 1147 | 34938902 |
Cholestasis | 27.70 | 16.61 | 48 | 16834 | 26900 | 34913149 |
Trichosporon infection | 27.14 | 16.61 | 11 | 16871 | 723 | 34939326 |
Inflammatory marker increased | 26.74 | 16.61 | 21 | 16861 | 5007 | 34935042 |
Hypofibrinogenaemia | 26.64 | 16.61 | 14 | 16868 | 1672 | 34938377 |
Thalamic infarction | 26.48 | 16.61 | 11 | 16871 | 770 | 34939279 |
Respiratory distress | 26.12 | 16.61 | 55 | 16827 | 35610 | 34904439 |
Necrotising colitis | 26.07 | 16.61 | 12 | 16870 | 1076 | 34938973 |
Incision site pain | 25.51 | 16.61 | 14 | 16868 | 1824 | 34938225 |
Sepsis | 25.32 | 16.61 | 152 | 16730 | 166409 | 34773640 |
Myasthenia gravis crisis | 25.28 | 16.61 | 10 | 16872 | 617 | 34939432 |
Agranulocytosis | 25.23 | 16.61 | 43 | 16839 | 23778 | 34916271 |
Scedosporium infection | 25.19 | 16.61 | 11 | 16871 | 871 | 34939178 |
Hyperbilirubinaemia | 24.23 | 16.61 | 35 | 16847 | 16808 | 34923241 |
Candida sepsis | 24.22 | 16.61 | 12 | 16870 | 1267 | 34938782 |
Leukopenia | 24.17 | 16.61 | 76 | 16806 | 62780 | 34877269 |
Cardiac valve vegetation | 23.97 | 16.61 | 9 | 16873 | 482 | 34939567 |
Disseminated intravascular coagulation | 23.93 | 16.61 | 40 | 16842 | 21776 | 34918273 |
Red blood cells urine positive | 22.98 | 16.61 | 13 | 16869 | 1796 | 34938253 |
Weight bearing difficulty | 22.92 | 16.61 | 11 | 16871 | 1084 | 34938965 |
Condition aggravated | 22.90 | 16.61 | 165 | 16717 | 192031 | 34748018 |
Cardiac failure congestive | 22.83 | 16.61 | 6 | 16876 | 83264 | 34856785 |
Vestibular disorder | 22.80 | 16.61 | 11 | 16871 | 1096 | 34938953 |
Dehydration | 22.34 | 16.61 | 18 | 16864 | 129951 | 34810098 |
Tuberculosis | 22.32 | 16.61 | 24 | 16858 | 8553 | 34931496 |
Sputum increased | 22.21 | 16.61 | 14 | 16868 | 2356 | 34937693 |
Nervous system disorder | 22.07 | 16.61 | 31 | 16851 | 14512 | 34925537 |
Protein urine present | 21.88 | 16.61 | 19 | 16863 | 5209 | 34934840 |
Respiratory failure | 21.84 | 16.61 | 107 | 16775 | 108465 | 34831584 |
Benign soft tissue neoplasm | 21.80 | 16.61 | 6 | 16876 | 116 | 34939933 |
Cerebrovascular accident | 21.63 | 16.61 | 7 | 16875 | 84804 | 34855245 |
Death | 21.60 | 16.61 | 109 | 16773 | 397940 | 34542109 |
Urinary tract infection fungal | 20.88 | 16.61 | 8 | 16874 | 453 | 34939596 |
Candida pneumonia | 20.81 | 16.61 | 8 | 16874 | 457 | 34939592 |
Back pain | 20.77 | 16.61 | 17 | 16865 | 121772 | 34818277 |
Dizziness | 20.62 | 16.61 | 47 | 16835 | 218474 | 34721575 |
Drug-induced liver injury | 20.58 | 16.61 | 44 | 16838 | 28788 | 34911261 |
Pyrexia | 20.47 | 16.61 | 248 | 16634 | 332765 | 34607284 |
Sputum purulent | 20.31 | 16.61 | 8 | 16874 | 488 | 34939561 |
Product administered to patient of inappropriate age | 20.27 | 16.61 | 15 | 16867 | 3276 | 34936773 |
Premature baby death | 19.91 | 16.61 | 3 | 16879 | 0 | 34940049 |
Herpes zoster meningoencephalitis | 19.79 | 16.61 | 7 | 16875 | 316 | 34939733 |
Mycobacterium abscessus infection | 19.59 | 16.61 | 8 | 16874 | 536 | 34939513 |
Allodynia | 19.40 | 16.61 | 9 | 16873 | 822 | 34939227 |
Toxic neuropathy | 19.38 | 16.61 | 8 | 16874 | 551 | 34939498 |
Purpura non-thrombocytopenic | 19.36 | 16.61 | 5 | 16877 | 75 | 34939974 |
Pericarditis tuberculous | 19.23 | 16.61 | 5 | 16877 | 77 | 34939972 |
Malaise | 19.17 | 16.61 | 38 | 16844 | 185787 | 34754262 |
Hepatitis fulminant | 19.11 | 16.61 | 16 | 16866 | 4174 | 34935875 |
Arthralgia | 19.11 | 16.61 | 33 | 16849 | 170008 | 34770041 |
Lymphocyte count decreased | 19.08 | 16.61 | 37 | 16845 | 22585 | 34917464 |
Acinetobacter infection | 19.01 | 16.61 | 10 | 16872 | 1197 | 34938852 |
Flavobacterium infection | 19.00 | 16.61 | 5 | 16877 | 81 | 34939968 |
Clostridium difficile colitis | 18.82 | 16.61 | 30 | 16852 | 15700 | 34924349 |
Fungaemia | 18.79 | 16.61 | 13 | 16869 | 2555 | 34937494 |
Atypical mycobacterial infection | 18.78 | 16.61 | 9 | 16873 | 884 | 34939165 |
Gallstone ileus | 18.77 | 16.61 | 4 | 16878 | 24 | 34940025 |
Immune effector cell-associated neurotoxicity syndrome | 18.66 | 16.61 | 15 | 16867 | 3698 | 34936351 |
Atypical mycobacterium test positive | 18.50 | 16.61 | 4 | 16878 | 26 | 34940023 |
Pulmonary cavitation | 18.43 | 16.61 | 9 | 16873 | 921 | 34939128 |
General physical condition abnormal | 18.36 | 16.61 | 15 | 16867 | 3784 | 34936265 |
Inappropriate schedule of product administration | 18.03 | 16.61 | 4 | 16878 | 62292 | 34877757 |
Hypersensitivity vasculitis | 17.89 | 16.61 | 14 | 16868 | 3321 | 34936728 |
Pain in extremity | 17.72 | 16.61 | 21 | 16861 | 126492 | 34813557 |
Hypertension | 17.71 | 16.61 | 24 | 16858 | 136419 | 34803630 |
Renal tubular disorder | 17.69 | 16.61 | 16 | 16866 | 4627 | 34935422 |
Hepatosplenic candidiasis | 17.65 | 16.61 | 6 | 16876 | 240 | 34939809 |
Infective pulmonary exacerbation of cystic fibrosis | 17.64 | 16.61 | 19 | 16863 | 6782 | 34933267 |
Shock | 17.37 | 16.61 | 37 | 16845 | 24142 | 34915907 |
Vasculitis | 17.02 | 16.61 | 24 | 16858 | 11272 | 34928777 |
Peripheral swelling | 16.75 | 16.61 | 8 | 16874 | 76533 | 34863516 |
Haemorrhagic pneumonia | 16.73 | 16.61 | 5 | 16877 | 131 | 34939918 |
Blood pressure increased | 16.70 | 16.61 | 11 | 16871 | 88091 | 34851958 |
Antibiotic associated colitis | 16.62 | 16.61 | 3 | 16879 | 6 | 34940043 |
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 |
---|---|---|---|---|---|---|
Drug resistance | 570.04 | 16.65 | 284 | 27788 | 41929 | 79674387 |
Drug reaction with eosinophilia and systemic symptoms | 340.90 | 16.65 | 236 | 27836 | 64008 | 79652308 |
Ototoxicity | 338.74 | 16.65 | 98 | 27974 | 3176 | 79713140 |
Pathogen resistance | 313.98 | 16.65 | 135 | 27937 | 14207 | 79702109 |
Septic shock | 289.23 | 16.65 | 281 | 27791 | 122520 | 79593796 |
Rash maculo-papular | 227.04 | 16.65 | 175 | 27897 | 55903 | 79660413 |
Deafness | 216.30 | 16.65 | 118 | 27954 | 20919 | 79695397 |
Multiple organ dysfunction syndrome | 210.81 | 16.65 | 235 | 27837 | 120011 | 79596305 |
Thrombocytopenia | 186.09 | 16.65 | 334 | 27738 | 264925 | 79451391 |
Eosinophilia | 169.44 | 16.65 | 135 | 27937 | 45210 | 79671106 |
Drug ineffective | 146.79 | 16.65 | 757 | 27315 | 1080156 | 78636160 |
Toxic skin eruption | 137.53 | 16.65 | 90 | 27982 | 22203 | 79694113 |
Electrocardiogram QT prolonged | 137.06 | 16.65 | 164 | 27908 | 90222 | 79626094 |
Acute kidney injury | 131.31 | 16.65 | 441 | 27631 | 518963 | 79197353 |
Immune reconstitution inflammatory syndrome | 129.56 | 16.65 | 73 | 27999 | 13768 | 79702548 |
Klebsiella infection | 128.73 | 16.65 | 76 | 27996 | 15644 | 79700672 |
Fatigue | 120.81 | 16.65 | 91 | 27981 | 929636 | 78786680 |
Hepatotoxicity | 116.03 | 16.65 | 115 | 27957 | 51237 | 79665079 |
Pain | 112.16 | 16.65 | 54 | 28018 | 703748 | 79012568 |
Product use in unapproved indication | 112.12 | 16.65 | 262 | 27810 | 250097 | 79466219 |
Off label use | 108.95 | 16.65 | 615 | 27457 | 906600 | 78809716 |
Deafness neurosensory | 103.71 | 16.65 | 50 | 28022 | 6848 | 79709468 |
Enterococcal infection | 100.95 | 16.65 | 65 | 28007 | 15595 | 79700721 |
Pseudomonas infection | 99.65 | 16.65 | 72 | 28000 | 20831 | 79695485 |
Candida infection | 92.72 | 16.65 | 89 | 27983 | 38125 | 79678191 |
Fall | 91.45 | 16.65 | 29 | 28043 | 487600 | 79228716 |
Bronchopulmonary aspergillosis | 91.09 | 16.65 | 70 | 28002 | 22224 | 79694092 |
Drug ineffective for unapproved indication | 84.33 | 16.65 | 97 | 27975 | 51141 | 79665175 |
Sepsis | 80.86 | 16.65 | 243 | 27829 | 269185 | 79447131 |
Geotrichum infection | 78.15 | 16.65 | 24 | 28048 | 957 | 79715359 |
Acute respiratory distress syndrome | 76.89 | 16.65 | 86 | 27986 | 43981 | 79672335 |
Headache | 74.93 | 16.65 | 72 | 28000 | 653700 | 79062616 |
Mucormycosis | 74.77 | 16.65 | 43 | 28029 | 8426 | 79707890 |
Nephropathy toxic | 74.55 | 16.65 | 60 | 28012 | 20359 | 79695957 |
Pyrexia | 72.71 | 16.65 | 447 | 27625 | 678262 | 79038054 |
Acute generalised exanthematous pustulosis | 70.10 | 16.65 | 54 | 28018 | 17200 | 79699116 |
Tinnitus | 69.73 | 16.65 | 82 | 27990 | 44251 | 79672065 |
Mycobacterium abscessus infection | 68.96 | 16.65 | 23 | 28049 | 1199 | 79715117 |
Arthralgia | 66.63 | 16.65 | 62 | 28010 | 571741 | 79144575 |
Myelosuppression | 65.82 | 16.65 | 76 | 27996 | 40220 | 79676096 |
Sputum increased | 65.03 | 16.65 | 32 | 28040 | 4581 | 79711735 |
Paradoxical drug reaction | 64.82 | 16.65 | 37 | 28035 | 7148 | 79709168 |
Hepatocellular injury | 61.90 | 16.65 | 80 | 27992 | 47513 | 79668803 |
Joint swelling | 60.00 | 16.65 | 14 | 28058 | 288632 | 79427684 |
Mycobacterium chelonae infection | 59.99 | 16.65 | 25 | 28047 | 2431 | 79713885 |
Dysphonia | 59.45 | 16.65 | 86 | 27986 | 56786 | 79659530 |
Deafness bilateral | 59.35 | 16.65 | 24 | 28048 | 2161 | 79714155 |
Multiple-drug resistance | 57.86 | 16.65 | 37 | 28035 | 8771 | 79707545 |
Pancytopenia | 54.95 | 16.65 | 155 | 27917 | 165590 | 79550726 |
Acinetobacter infection | 53.81 | 16.65 | 24 | 28048 | 2753 | 79713563 |
Febrile bone marrow aplasia | 53.44 | 16.65 | 41 | 28031 | 12979 | 79703337 |
Hypertransaminasaemia | 52.15 | 16.65 | 39 | 28033 | 11885 | 79704431 |
Mycobacterium avium complex infection | 50.60 | 16.65 | 27 | 28045 | 4573 | 79711743 |
Nocardiosis | 50.58 | 16.65 | 29 | 28043 | 5650 | 79710666 |
Respiratory failure | 50.33 | 16.65 | 159 | 27913 | 180752 | 79535564 |
Therapy interrupted | 49.33 | 16.65 | 58 | 28014 | 31283 | 79685033 |
Weight increased | 49.32 | 16.65 | 18 | 28054 | 277368 | 79438948 |
Aphonia | 47.96 | 16.65 | 35 | 28037 | 10277 | 79706039 |
Nasopharyngitis | 47.70 | 16.65 | 15 | 28057 | 253866 | 79462450 |
Aspergillus infection | 47.17 | 16.65 | 45 | 28027 | 19116 | 79697200 |
Pain in extremity | 46.72 | 16.65 | 36 | 28036 | 364502 | 79351814 |
Therapeutic product effect decreased | 45.87 | 16.65 | 3 | 28069 | 163860 | 79552456 |
Leukopenia | 45.71 | 16.65 | 116 | 27956 | 116397 | 79599919 |
Hydrocephalus | 45.51 | 16.65 | 32 | 28040 | 8868 | 79707448 |
Agranulocytosis | 45.47 | 16.65 | 67 | 28005 | 44963 | 79671353 |
Hepatosplenic candidiasis | 45.21 | 16.65 | 14 | 28058 | 574 | 79715742 |
Clostridium difficile colitis | 44.71 | 16.65 | 56 | 28016 | 32227 | 79684089 |
Respiratory distress | 44.04 | 16.65 | 76 | 27996 | 58263 | 79658053 |
Nosocomial infection | 44.00 | 16.65 | 21 | 28051 | 2811 | 79713505 |
Neuropathy peripheral | 43.79 | 16.65 | 129 | 27943 | 141176 | 79575140 |
Hyperlactacidaemia | 43.07 | 16.65 | 26 | 28046 | 5569 | 79710747 |
Infusion related reaction | 42.55 | 16.65 | 14 | 28058 | 230223 | 79486093 |
Peripheral swelling | 42.33 | 16.65 | 21 | 28051 | 269596 | 79446720 |
Malaise | 42.30 | 16.65 | 67 | 28005 | 489802 | 79226514 |
Aplasia | 42.05 | 16.65 | 29 | 28043 | 7791 | 79708525 |
Hypoacusis | 41.28 | 16.65 | 52 | 28020 | 30098 | 79686218 |
Anxiety | 41.11 | 16.65 | 18 | 28054 | 248494 | 79467822 |
Hypofibrinogenaemia | 41.04 | 16.65 | 18 | 28054 | 1984 | 79714332 |
Cholestasis | 40.80 | 16.65 | 69 | 28003 | 52040 | 79664276 |
Neutropenic colitis | 40.05 | 16.65 | 25 | 28047 | 5682 | 79710634 |
Hypertension | 39.54 | 16.65 | 35 | 28037 | 330957 | 79385359 |
Alopecia | 39.48 | 16.65 | 16 | 28056 | 231339 | 79484977 |
Osteomyelitis bacterial | 39.28 | 16.65 | 12 | 28060 | 470 | 79715846 |
Pancreatitis acute | 39.26 | 16.65 | 66 | 28006 | 49538 | 79666778 |
Infective pulmonary exacerbation of cystic fibrosis | 39.12 | 16.65 | 34 | 28038 | 12817 | 79703499 |
Toxic epidermal necrolysis | 38.91 | 16.65 | 62 | 28010 | 44519 | 79671797 |
Synovitis | 38.76 | 16.65 | 4 | 28068 | 150730 | 79565586 |
Systemic candida | 38.75 | 16.65 | 26 | 28046 | 6680 | 79709636 |
Polyneuropathy | 38.51 | 16.65 | 45 | 28027 | 24106 | 79692210 |
Guillain-Barre syndrome | 38.49 | 16.65 | 29 | 28043 | 8936 | 79707380 |
Contusion | 38.13 | 16.65 | 4 | 28068 | 148772 | 79567544 |
Inflammatory marker increased | 38.02 | 16.65 | 31 | 28041 | 10709 | 79705607 |
Bronchospasm | 37.46 | 16.65 | 45 | 28027 | 24814 | 79691502 |
Musculoskeletal stiffness | 37.33 | 16.65 | 8 | 28064 | 175000 | 79541316 |
Haemoptysis | 37.20 | 16.65 | 69 | 28003 | 55930 | 79660386 |
Haemophagocytic lymphohistiocytosis | 37.03 | 16.65 | 42 | 28030 | 21795 | 79694521 |
Swelling | 36.96 | 16.65 | 15 | 28057 | 216696 | 79499620 |
Atypical mycobacterial infection | 36.79 | 16.65 | 16 | 28056 | 1727 | 79714589 |
Neutropenia | 36.18 | 16.65 | 198 | 27874 | 287512 | 79428804 |
Hepatic cytolysis | 35.86 | 16.65 | 46 | 28026 | 27105 | 79689211 |
Abdominal discomfort | 35.78 | 16.65 | 22 | 28050 | 250705 | 79465611 |
Blood pressure measurement | 35.73 | 16.65 | 11 | 28061 | 442 | 79715874 |
Stenotrophomonas infection | 35.57 | 16.65 | 20 | 28052 | 3753 | 79712563 |
Dizziness | 35.04 | 16.65 | 84 | 27988 | 526357 | 79189959 |
Product packaging difficult to open | 34.92 | 16.65 | 7 | 28065 | 43 | 79716273 |
Back pain | 34.17 | 16.65 | 34 | 28038 | 304146 | 79412170 |
Posterior reversible encephalopathy syndrome | 33.89 | 16.65 | 44 | 28028 | 26237 | 79690079 |
Treatment failure | 33.75 | 16.65 | 134 | 27938 | 170352 | 79545964 |
Vascular pseudoaneurysm thrombosis | 33.53 | 16.65 | 7 | 28065 | 54 | 79716262 |
Discomfort | 33.18 | 16.65 | 3 | 28069 | 125614 | 79590702 |
Brain abscess | 33.08 | 16.65 | 21 | 28051 | 4915 | 79711401 |
Coagulopathy | 32.70 | 16.65 | 51 | 28021 | 35955 | 79680361 |
Dehydration | 32.43 | 16.65 | 24 | 28048 | 248163 | 79468153 |
Blood pressure increased | 32.37 | 16.65 | 17 | 28055 | 211343 | 79504973 |
Hepatitis fulminant | 32.31 | 16.65 | 24 | 28048 | 7238 | 79709078 |
Incision site pain | 32.23 | 16.65 | 17 | 28055 | 2813 | 79713503 |
Immune effector cell-associated neurotoxicity syndrome | 32.18 | 16.65 | 22 | 28050 | 5826 | 79710490 |
Fungaemia | 31.94 | 16.65 | 20 | 28052 | 4571 | 79711745 |
Febrile neutropenia | 31.79 | 16.65 | 163 | 27909 | 230836 | 79485480 |
Sinusitis | 31.02 | 16.65 | 15 | 28057 | 195486 | 79520830 |
Myocardial infarction | 30.98 | 16.65 | 13 | 28059 | 184116 | 79532200 |
Tuberculosis of central nervous system | 30.71 | 16.65 | 10 | 28062 | 483 | 79715833 |
Gait disturbance | 29.89 | 16.65 | 18 | 28054 | 207488 | 79508828 |
Leukocytosis | 28.18 | 16.65 | 53 | 28019 | 43402 | 79672914 |
Linear IgA disease | 27.91 | 16.65 | 16 | 28056 | 3116 | 79713200 |
Wound | 27.62 | 16.65 | 4 | 28068 | 116175 | 79600141 |
Thalamic infarction | 27.60 | 16.65 | 12 | 28060 | 1295 | 79715021 |
Serratia infection | 27.08 | 16.65 | 13 | 28059 | 1763 | 79714553 |
Renal failure | 27.08 | 16.65 | 141 | 27931 | 200827 | 79515489 |
Corneal opacity | 27.01 | 16.65 | 11 | 28061 | 1009 | 79715307 |
Muscle spasms | 26.83 | 16.65 | 14 | 28058 | 174716 | 79541600 |
Otitis media fungal | 26.53 | 16.65 | 5 | 28067 | 21 | 79716295 |
Herpes zoster meningoencephalitis | 26.47 | 16.65 | 10 | 28062 | 751 | 79715565 |
Acoustic neuroma | 26.44 | 16.65 | 8 | 28064 | 303 | 79716013 |
Encephalopathy | 26.32 | 16.65 | 67 | 28005 | 67330 | 79648986 |
Gastrooesophageal reflux disease | 26.21 | 16.65 | 3 | 28069 | 104243 | 79612073 |
Scedosporium infection | 26.18 | 16.65 | 12 | 28060 | 1466 | 79714850 |
Myasthenia gravis crisis | 26.10 | 16.65 | 11 | 28061 | 1100 | 79715216 |
Depression | 25.78 | 16.65 | 23 | 28049 | 216767 | 79499549 |
Red blood cells urine positive | 25.74 | 16.65 | 18 | 28054 | 4945 | 79711371 |
Renal tubular disorder | 25.69 | 16.65 | 20 | 28052 | 6466 | 79709850 |
Immune reconstitution inflammatory syndrome associated tuberculosis | 25.55 | 16.65 | 10 | 28062 | 826 | 79715490 |
Tuberculosis | 25.38 | 16.65 | 29 | 28043 | 15169 | 79701147 |
Protein urine present | 25.37 | 16.65 | 24 | 28048 | 10088 | 79706228 |
Bacteraemia | 25.08 | 16.65 | 43 | 28029 | 32781 | 79683535 |
Staphylococcal infection | 24.92 | 16.65 | 60 | 28012 | 58235 | 79658081 |
Pulmonary cavitation | 24.88 | 16.65 | 12 | 28060 | 1644 | 79714672 |
Overgrowth fungal | 24.75 | 16.65 | 6 | 28066 | 96 | 79716220 |
Escherichia infection | 24.54 | 16.65 | 31 | 28041 | 17986 | 79698330 |
Feeling abnormal | 24.08 | 16.65 | 13 | 28059 | 159186 | 79557130 |
Dermatitis exfoliative | 23.98 | 16.65 | 24 | 28048 | 10805 | 79705511 |
Granulomatosis with polyangiitis | 23.82 | 16.65 | 14 | 28058 | 2856 | 79713460 |
Trichosporon infection | 23.74 | 16.65 | 10 | 28062 | 998 | 79715318 |
Lower respiratory tract infection | 23.61 | 16.65 | 8 | 28064 | 129212 | 79587104 |
Disseminated intravascular coagulation | 23.60 | 16.65 | 44 | 28028 | 35798 | 79680518 |
Status epilepticus | 23.48 | 16.65 | 36 | 28036 | 25005 | 79691311 |
Lung disorder | 23.48 | 16.65 | 72 | 28000 | 80485 | 79635831 |
Hypersensitivity | 23.43 | 16.65 | 35 | 28037 | 262204 | 79454112 |
Bone marrow failure | 23.37 | 16.65 | 54 | 28018 | 51053 | 79665263 |
Benign soft tissue neoplasm | 23.21 | 16.65 | 6 | 28066 | 126 | 79716190 |
Constipation | 23.20 | 16.65 | 40 | 28032 | 283010 | 79433306 |
Inappropriate schedule of product administration | 23.18 | 16.65 | 9 | 28063 | 133619 | 79582697 |
Rash pustular | 23.10 | 16.65 | 24 | 28048 | 11287 | 79705029 |
Deafness permanent | 23.10 | 16.65 | 4 | 28068 | 9 | 79716307 |
Cerebrovascular accident | 23.03 | 16.65 | 13 | 28059 | 155279 | 79561037 |
Candida sepsis | 22.83 | 16.65 | 13 | 28059 | 2500 | 79713816 |
Pneumonia bacterial | 22.82 | 16.65 | 31 | 28041 | 19300 | 79697016 |
Blood urea increased | 22.80 | 16.65 | 52 | 28020 | 48738 | 79667578 |
Retinal ischaemia | 22.60 | 16.65 | 9 | 28063 | 779 | 79715537 |
Hepatitis | 22.38 | 16.65 | 56 | 28016 | 55671 | 79660645 |
Vulvovaginitis | 22.35 | 16.65 | 7 | 28065 | 298 | 79716018 |
Anuria | 22.34 | 16.65 | 32 | 28040 | 20931 | 79695385 |
Pulmonary tuberculosis | 22.32 | 16.65 | 20 | 28052 | 7845 | 79708471 |
Capillary leak syndrome | 22.16 | 16.65 | 15 | 28057 | 3910 | 79712406 |
Memory impairment | 22.07 | 16.65 | 6 | 28066 | 111728 | 79604588 |
Drug-induced liver injury | 22.05 | 16.65 | 62 | 28010 | 66055 | 79650261 |
Herpes simplex hepatitis | 22.04 | 16.65 | 8 | 28064 | 537 | 79715779 |
Dermatitis bullous | 21.81 | 16.65 | 26 | 28046 | 14219 | 79702097 |
Haemolytic anaemia | 21.68 | 16.65 | 29 | 28043 | 17791 | 79698525 |
Face oedema | 21.68 | 16.65 | 37 | 28035 | 28099 | 79688217 |
Butterfly rash | 21.65 | 16.65 | 11 | 28061 | 1685 | 79714631 |
Pneumothorax | 21.50 | 16.65 | 37 | 28035 | 28286 | 79688030 |
Glossodynia | 21.47 | 16.65 | 5 | 28067 | 103332 | 79612984 |
Cardiac valve vegetation | 21.26 | 16.65 | 9 | 28063 | 910 | 79715406 |
Granulomatous liver disease | 21.06 | 16.65 | 10 | 28062 | 1323 | 79714993 |
Shock | 21.00 | 16.65 | 47 | 28025 | 43501 | 79672815 |
Cardiac failure congestive | 21.00 | 16.65 | 12 | 28060 | 142390 | 79573926 |
Impaired healing | 20.88 | 16.65 | 3 | 28069 | 87652 | 79628664 |
Haemoperitoneum | 20.79 | 16.65 | 15 | 28057 | 4328 | 79711988 |
Toxic neuropathy | 20.70 | 16.65 | 9 | 28063 | 971 | 79715345 |
Mycobacterial infection | 20.66 | 16.65 | 14 | 28058 | 3654 | 79712662 |
Klebsiella bacteraemia | 20.65 | 16.65 | 13 | 28059 | 2997 | 79713319 |
Hypoalbuminaemia | 20.51 | 16.65 | 31 | 28041 | 21266 | 79695050 |
Gallstone ileus | 20.33 | 16.65 | 4 | 28068 | 22 | 79716294 |
Mycobacterium fortuitum infection | 20.18 | 16.65 | 6 | 28066 | 214 | 79716102 |
Hyperbilirubinaemia | 19.90 | 16.65 | 33 | 28039 | 24485 | 79691831 |
Transaminases increased | 19.74 | 16.65 | 51 | 28021 | 51692 | 79664624 |
Flavobacterium infection | 19.67 | 16.65 | 5 | 28067 | 98 | 79716218 |
Drug hypersensitivity | 19.61 | 16.65 | 48 | 28024 | 298868 | 79417448 |
Angular cheilitis | 19.43 | 16.65 | 8 | 28064 | 754 | 79715562 |
Urogenital infection bacterial | 19.39 | 16.65 | 5 | 28067 | 104 | 79716212 |
Hospitalisation | 19.39 | 16.65 | 75 | 27997 | 94161 | 79622155 |
Pericarditis tuberculous | 19.30 | 16.65 | 5 | 28067 | 106 | 79716210 |
Clostridial infection | 19.20 | 16.65 | 16 | 28056 | 5698 | 79710618 |
Deafness unilateral | 19.14 | 16.65 | 14 | 28058 | 4124 | 79712192 |
Syncope | 19.08 | 16.65 | 21 | 28051 | 179428 | 79536888 |
Allodynia | 19.05 | 16.65 | 10 | 28062 | 1638 | 79714678 |
Nervous system disorder | 18.98 | 16.65 | 34 | 28038 | 26822 | 79689494 |
Insomnia | 18.87 | 16.65 | 36 | 28036 | 245134 | 79471182 |
Migraine | 18.65 | 16.65 | 4 | 28068 | 87489 | 79628827 |
Haemorrhagic pneumonia | 18.18 | 16.65 | 5 | 28067 | 134 | 79716182 |
Fusarium infection | 18.06 | 16.65 | 10 | 28062 | 1822 | 79714494 |
Choroiditis | 17.75 | 16.65 | 9 | 28063 | 1372 | 79714944 |
Haemodynamic instability | 17.74 | 16.65 | 26 | 28046 | 17356 | 79698960 |
Asthma | 17.72 | 16.65 | 13 | 28059 | 135082 | 79581234 |
Injury | 17.67 | 16.65 | 3 | 28069 | 77493 | 79638823 |
Cough | 17.62 | 16.65 | 202 | 27870 | 366587 | 79349729 |
Product administered to patient of inappropriate age | 17.52 | 16.65 | 15 | 28057 | 5538 | 79710778 |
Chemotherapeutic drug level increased | 17.32 | 16.65 | 6 | 28066 | 351 | 79715965 |
Alanine aminotransferase increased | 17.23 | 16.65 | 107 | 27965 | 162463 | 79553853 |
Mobility decreased | 17.03 | 16.65 | 11 | 28061 | 122164 | 79594152 |
Acid fast bacilli infection | 17.02 | 16.65 | 5 | 28067 | 171 | 79716145 |
Urinary tract infection fungal | 16.95 | 16.65 | 8 | 28064 | 1045 | 79715271 |
Cholestatic liver injury | 16.94 | 16.65 | 14 | 28058 | 4927 | 79711389 |
Rhinocerebral mucormycosis | 16.91 | 16.65 | 8 | 28064 | 1050 | 79715266 |
AIDS related complication | 16.87 | 16.65 | 4 | 28068 | 58 | 79716258 |
Fungal infection | 16.81 | 16.65 | 42 | 28030 | 41706 | 79674610 |
Pneumonia pseudomonal | 16.71 | 16.65 | 15 | 28057 | 5896 | 79710420 |
None
Source | Code | Description |
---|---|---|
ATC | D06AX12 | DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Other antibiotics for topical use |
ATC | J01GB06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE AMINOGLYCOSIDE ANTIBACTERIALS Other aminoglycosides |
ATC | J01RA06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials |
ATC | S01AA21 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics |
FDA CS | M0000946 | Aminoglycosides |
FDA EPC | N0000175477 | Aminoglycoside Antibacterial |
CHEBI has role | CHEBI:33281 | antibiotics |
CHEBI has role | CHEBI:36047 | antibacterial drugs |
CHEBI has role | CHEBI:61015 | nephrotoxins |
MeSH PA | D000900 | Anti-Bacterial Agents |
MeSH PA | D000890 | Anti-Infective Agents |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Septicemia due to Escherichia coli | indication | 9323009 | |
Bacterial septicemia | indication | 10001005 | DOID:0040085 |
Infection due to Pseudomonas aeruginosa | indication | 11218009 | |
Staphylococcal meningitis | indication | 12166008 | |
Infection of skin AND/OR subcutaneous tissue | indication | 19824006 | |
Staphylococcal pneumonia | indication | 22754005 | |
Pneumonia due to Pseudomonas | indication | 41381004 | |
Pneumonia due to Escherichia coli | indication | 51530003 | |
Bacterial pneumonia | indication | 53084003 | DOID:874 |
Osteomyelitis | indication | 60168000 | |
Infection due to Escherichia coli | indication | 71057007 | |
Bacterial infection due to Serratia | indication | 71120004 | |
Rhinoscleroma | indication | 72409005 | DOID:11336 |
Septicemia due to Serratia | indication | 82091000 | |
Cholangitis | indication | 82403002 | DOID:9446 |
Bacterial meningitis | indication | 95883001 | DOID:9470 |
Infection of bone | indication | 111253001 | |
Staphylococcal septicemia | indication | 111821004 | |
Infectious disease of abdomen | indication | 128070006 | |
Infection due to Enterobacteriaceae | indication | 128945009 | |
Bacterial infection due to Klebsiella pneumoniae | indication | 186435004 | |
Escherichia coli meningitis | indication | 192655005 | |
Proteus pneumonia | indication | 195888009 | |
Sepsis of the newborn | indication | 206376005 | |
Neonatal pneumonia | indication | 233619008 | |
Diverticulitis of gastrointestinal tract | indication | 271366000 | |
Neonatal meningitis | indication | 276674008 | |
Nontuberculous mycobacterial pulmonary disease caused by amikacin-sensitive Mycobacteriumavium complex | indication | 277869007 | |
Proteus septicemia | indication | 300986008 | |
Escherichia coli urinary tract infection | indication | 301011002 | |
Proteus meningitis | indication | 302877009 | |
Bacterial urinary infection | indication | 312124009 | |
Infectious disorder of joint | indication | 363162000 | |
Meningitis due to Klebsiella mobilis | indication | 420585007 | |
Nosocomial pneumonia | indication | 425464007 | |
Bacterial meningitis due to Gram-negative bacteria | indication | 425887005 | |
Pneumonia due to Gram negative bacteria | indication | 430395005 | |
Sepsis due to Pseudomonas | indication | 448813005 | |
Sepsis due to Gram negative bacteria | indication | 449082003 | |
Urinary tract infection caused by Klebsiella | indication | 369001000119100 | |
Skin and Skin Structure Pseudomonas Aeruginosa Infection | indication | ||
Pseudomonas Aeruginosa Osteomyelitis | indication | ||
Skin and Skin Structure Proteus Infection | indication | ||
Pseudomonas Aeruginosa Meningitis | indication | ||
Serratia Meningitis | indication | ||
Complicated UTI with Pseudomonas Aeruginosa | indication | ||
Complicated Urinary Tract Infections | indication | ||
Klebsiella Septicemia | indication | ||
Skin and Skin Structure Staphylococcus Infection | indication | ||
Enterobacter Meningitis | indication | ||
Burn Wound Infections | indication | ||
Pseudomonas Aeruginosa Biliary Tract Infection | indication | ||
Gram-Negative Aerobic Bacillary Pneumonia | indication | ||
Complicated Bacterial Peritonitis | indication | ||
Complicated Proteus UTI | indication | ||
Complicated Urinary Tract Infection due to Acinetobacter | indication | ||
Pseudomonas Aeruginosa Joint Infection | indication | ||
Serratia Osteomyelitis | indication | ||
Serratia Complicated UTI | indication | ||
Enterobacter Pneumonia | indication | ||
Skin and Skin Structure Serratia Infection | indication | ||
Necrotizing enterocolitis in fetus OR newborn | off-label use | 2707005 | |
Pyrexia of unknown origin | off-label use | 7520000 | |
Enteric campylobacteriosis | off-label use | 18081009 | |
Acute tuberculosis | off-label use | 25629007 | |
Pseudotuberculosis | off-label use | 36753006 | |
Infection by Yersinia enterocolitica | off-label use | 80960004 | |
Pulmonary tuberculosis | off-label use | 154283005 | DOID:2957 |
Synergy for Group B Streptococcal Septicemia | off-label use | ||
Citrobacter Osteomyelitis | off-label use | ||
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa | off-label use | ||
Citrobacter Septicemia | off-label use | ||
Citrobacter Complicated UTI | off-label use | ||
Listeria Monocytogenes Septicemia | off-label use | ||
Skin and Skin Structure Citrobacter Infection | off-label use | ||
Synergy for P. Aeruginosa Infection in Cystic Fibrosis | off-label use | ||
Synergy for Neonatal Meningitis | off-label use | ||
Citrobacter Meningitis | off-label use | ||
Synergy for Bacterial Meningitis | off-label use | ||
Citrobacter Pneumonia | off-label use | ||
Synergy for Staphylococcal Infections | off-label use | ||
Synergy for Staphylococcal Endocarditis | off-label use | ||
Skin and Skin Structure Acinetobacter Infection | off-label use | ||
Hypocalcemia | contraindication | 5291005 | |
Parkinsonism | contraindication | 32798002 | |
Dehydration | contraindication | 34095006 | |
Tinnitus | contraindication | 60862001 | |
Kidney disease | contraindication | 90708001 | DOID:557 |
Myasthenia gravis | contraindication | 91637004 | DOID:437 |
Pregnancy, function | contraindication | 289908002 | |
Vertigo | contraindication | 399153001 | |
Disorder of the 8th Cranial Nerve | contraindication | ||
Infant Botulism | contraindication | ||
Amikacin Toxicity | contraindication |
Species | Use | Relation |
---|---|---|
Dogs | Genitourinary tract infections caused by Escherichia coli | Indication |
Dogs | Genitourinary tract infections caused by Proteus species | Indication |
Dogs | Skin and soft tissue infections caused by Pseudomonas species | Indication |
Dogs | Skin and soft tissue infections caused by Escherichia coli | Indication |
Horses | Genital tract infections caused by Escherichia coli | Indication |
Horses | Genital tract infections caused by Pseudomonas species | Indication |
Horses | Genital tract infections caused by Klebsiella species | Indication |
Product | Applicant | Ingredients |
---|---|---|
Amiglyde-V | Zoetis Inc. | 1 |
Amikacin Sulfate Injection | Cronus Pharma Specialities India Private Limited | 1 |
AmiMax E Solution | Elanco US Inc. | 1 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 12.04 | acidic |
pKa2 | 12.95 | acidic |
pKa3 | 13.39 | acidic |
pKa4 | 13.72 | acidic |
pKa5 | 9.4 | Basic |
pKa6 | 7.84 | Basic |
pKa7 | 7.41 | Basic |
pKa8 | 6.86 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 8802137 | April 8, 2024 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 9827317 | April 8, 2024 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 7718189 | June 6, 2025 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 8632804 | Dec. 5, 2026 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 8679532 | Dec. 5, 2026 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 9566234 | Jan. 18, 2034 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 10251900 | May 15, 2035 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 10751355 | May 15, 2035 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 11446318 | May 15, 2035 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | 9895385 | May 15, 2035 | TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | Sept. 28, 2025 | TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY |
EQ 590MG BASE/8.4ML | ARIKAYCE KIT | INSMED INC | N207356 | Sept. 28, 2018 | RX | SUSPENSION, LIPOSOMAL | INHALATION | Sept. 28, 2030 | GENERATING ANTIBIOTIC INCENTIVES NOW |
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 | 4.20 | WOMBAT-PK |
ID | Source |
---|---|
4019602 | VUID |
N0000147698 | NUI |
D00865 | KEGG_DRUG |
39831-55-5 | SECONDARY_CAS_RN |
641 | RXNORM |
C0002499 | UMLSCUI |
CHEBI:2637 | CHEBI |
AKN | PDB_CHEM_ID |
CHEMBL177 | ChEMBL_ID |
CHEMBL1164318 | ChEMBL_ID |
CHEMBL4208954 | ChEMBL_ID |
D000583 | MESH_DESCRIPTOR_UI |
DB00479 | DRUGBANK_ID |
10894 | IUPHAR_LIGAND_ID |
3492 | INN_ID |
84319SGC3C | UNII |
37768 | PUBCHEM_CID |
2863 | MMSL |
35287 | MMSL |
4165 | MMSL |
d00087 | MMSL |
1269009 | SNOMEDCT_US |
387266001 | SNOMEDCT_US |
48836000 | SNOMEDCT_US |
4018137 | VANDF |
4019602 | VANDF |
002781 | NDDF |
004899 | NDDF |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6166 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 22 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6166 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 22 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6167 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 22 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0641-6167 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 22 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0703-9032 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0703-9040 | INJECTION, SOLUTION | 1 g | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-290 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-290 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-290 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-785 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-785 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-785 | INJECTION, SOLUTION | 500 mg | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-786 | INJECTION, SOLUTION | 1 g | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-786 | INJECTION, SOLUTION | 1 g | INTRAMUSCULAR | ANDA | 20 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-786 | INJECTION, SOLUTION | 1 g | INTRAMUSCULAR | ANDA | 20 sections |
amikacin sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-173 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | ANDA | 23 sections |
amikacin sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-173 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | ANDA | 23 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-815 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | ANDA | 21 sections |
Amikacin Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-815 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | ANDA | 21 sections |
Amikacin Sulfate Injection, 500 mg/2ml | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70297-996 | INJECTION | 500 mg | INTRAMUSCULAR | Export only | |
Amikacin Sulfate Injection, 500 mg/2ml | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71309-996 | INJECTION | 500 mg | INTRAMUSCULAR | Export only | |
ARIKAYCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71558-590 | SUSPENSION | 590 mg | RESPIRATORY (INHALATION) | NDA | 34 sections |
ARIKAYCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71558-590 | SUSPENSION | 590 mg | RESPIRATORY (INHALATION) | NDA | 34 sections |
ARIKAYCE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71558-590 | SUSPENSION | 590 mg | RESPIRATORY (INHALATION) | NDA | 34 sections |