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

Stem definitionDrug idCAS RN
antibiotics, kanamycin and bekanamycin derivatives (obtained from Streptomyces kanamyceticus) 157 37517-28-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amikacin
  • amicacin
  • amikacillin
  • arikace
  • lukadin
  • amikacin sulfate
  • amikacin hydrate
A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.
  • Molecular weight: 585.61
  • Formula: C22H43N5O13
  • CLOGP: -4.12
  • LIPINSKI: 3
  • HAC: 18
  • HDO: 13
  • TPSA: 331.94
  • ALOGS: -1.07
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.59 g Inhal.solution
1 g P

ADMET properties:

PropertyValueReference
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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK4,CDK5,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK1,NTRK2,PDK2,PDK4,PRKDC,TEK,TGFBR1 22
kinase-selectivity-class CHUK,MAP2K6,PDK1 3
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
March 23, 2021 PMDA Insmed GK
Jan. 22, 1981 FDA APOTHECON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 741.68 19.84 276 20965 30173 90577033
Pathogen resistance 371.30 19.84 118 21123 7997 90599209
Ototoxicity 322.94 19.84 78 21163 1886 90605320
Dysphonia 308.10 19.84 189 21052 62895 90544311
Mycobacterium avium complex infection 235.59 19.84 71 21170 4027 90603179
Mycobacterium abscessus infection 230.80 19.84 53 21188 1022 90606184
Deafness 223.56 19.84 108 21133 22406 90584800
Therapy interrupted 219.09 19.84 140 21101 49968 90557238
Drug reaction with eosinophilia and systemic symptoms 205.86 19.84 127 21114 42631 90564575
Tinnitus 204.92 19.84 127 21114 42975 90564231
Cough 195.79 19.84 327 20914 368635 90238571
Aphonia 178.85 19.84 77 21164 12242 90594964
Septic shock 172.41 19.84 149 21092 84011 90523195
Multiple organ dysfunction syndrome 164.87 19.84 133 21108 68203 90539003
Haemoptysis 157.91 19.84 98 21143 33222 90573984
Off label use 146.61 19.84 576 20665 1101676 89505530
Drug ineffective 137.29 19.84 662 20579 1383636 89223570
Nephropathy toxic 129.37 19.84 62 21179 12626 90594580
Hospitalisation 121.66 19.84 150 21091 127950 90479256
Pseudomonas infection 114.33 19.84 60 21181 14805 90592401
Thrombocytopenia 113.12 19.84 187 21054 208538 90398668
Sputum increased 106.93 19.84 36 21205 2921 90604285
Pain 102.69 19.84 53 21188 996288 89610918
Rash maculo-papular 101.52 19.84 81 21160 40852 90566354
Immune reconstitution inflammatory syndrome 99.01 19.84 43 21198 6976 90600230
Productive cough 98.06 19.84 105 21136 76958 90530248
Eosinophilia 96.49 19.84 68 21173 28465 90578741
Acute kidney injury 90.99 19.84 219 21022 320168 90287038
Deafness neurosensory 90.31 19.84 40 21201 6801 90600405
Candida infection 85.74 19.84 68 21173 33989 90573217
Systemic candida 85.36 19.84 35 21206 4924 90602282
Hyperlactacidaemia 84.41 19.84 33 21208 4103 90603103
Geotrichum infection 83.73 19.84 21 21220 595 90606611
Arthralgia 79.24 19.84 42 21199 778480 89828726
Sepsis 76.56 19.84 145 21096 179669 90427537
Joint swelling 76.55 19.84 13 21228 503287 90103919
Paradoxical drug reaction 70.64 19.84 32 21209 5734 90601472
Klebsiella infection 66.45 19.84 37 21204 10260 90596946
Bronchopulmonary aspergillosis 65.59 19.84 38 21203 11360 90595846
Drug ineffective for unapproved indication 64.77 19.84 79 21162 66565 90540641
Toxic skin eruption 63.80 19.84 42 21199 15732 90591474
Contraindicated product administered 62.50 19.84 3 21238 320136 90287070
Acute respiratory distress syndrome 61.15 19.84 52 21189 28634 90578572
Hepatotoxicity 61.02 19.84 64 21177 45778 90561428
Product use in unapproved indication 59.89 19.84 194 21047 336042 90271164
Alopecia 59.35 19.84 21 21220 495050 90112156
Enterococcal infection 59.33 19.84 34 21207 9957 90597249
Swelling 59.10 19.84 13 21228 419045 90188161
Glossodynia 56.97 19.84 5 21236 321774 90285432
Nasopharyngitis 56.66 19.84 13 21228 407091 90200115
Clostridium difficile colitis 56.08 19.84 48 21193 26658 90580548
Atypical mycobacterial infection 55.66 19.84 19 21222 1607 90605599
Wound 55.61 19.84 4 21237 302976 90304230
Electrocardiogram QT prolonged 54.96 19.84 76 21165 72380 90534826
Febrile neutropenia 54.60 19.84 117 21124 158232 90448974
Bronchospasm 53.52 19.84 42 21199 20667 90586539
Mucormycosis 52.56 19.84 23 21218 3798 90603408
Disseminated mycobacterium avium complex infection 50.92 19.84 12 21229 260 90606946
Musculoskeletal stiffness 48.90 19.84 6 21235 296526 90310680
Respiratory failure 48.53 19.84 94 21147 118324 90488882
Neuropathy peripheral 48.13 19.84 102 21139 136868 90470338
Intentional dose omission 47.98 19.84 37 21204 17746 90589460
Product packaging difficult to open 47.37 19.84 10 21231 128 90607078
Therapeutic product effect decreased 47.31 19.84 5 21236 277566 90329640
Pulmonary cavitation 46.89 19.84 15 21226 1036 90606170
Antimicrobial susceptibility test intermediate 46.85 19.84 8 21233 28 90607178
Headache 46.54 19.84 82 21159 862664 89744542
Mycobacterial infection 46.39 19.84 18 21223 2192 90605014
Encephalopathy 45.03 19.84 55 21186 46389 90560817
Pain in extremity 44.73 19.84 25 21216 450504 90156702
Fall 44.67 19.84 29 21212 481781 90125425
Pericarditis 43.26 19.84 6 21235 270145 90337061
Impaired healing 43.23 19.84 3 21238 234196 90373010
Weight increased 43.23 19.84 22 21219 417905 90189301
Neutropenia 42.96 19.84 133 21108 224771 90382435
Acute generalised exanthematous pustulosis 42.51 19.84 31 21210 13672 90593534
Multiple-drug resistance 42.30 19.84 25 21216 7751 90599455
Contusion 41.62 19.84 5 21236 251211 90355995
Hepatocellular injury 41.37 19.84 42 21199 28916 90578290
Hypoacusis 40.90 19.84 41 21200 27809 90579397
Overgrowth fungal 40.65 19.84 9 21232 146 90607060
Hypertension 40.46 19.84 29 21212 457503 90149703
Sinusitis 40.33 19.84 15 21226 343073 90264133
Cholestasis 40.17 19.84 46 21195 36253 90570953
Post-tussive vomiting 39.52 19.84 6 21235 7 90607199
Peripheral swelling 39.47 19.84 24 21217 413082 90194124
Aplasia 39.16 19.84 19 21222 3972 90603234
Toxic epidermal necrolysis 39.04 19.84 43 21198 32485 90574721
Leukopenia 38.91 19.84 78 21163 100632 90506574
Pyrexia 38.75 19.84 276 20965 660209 89946997
Pancreatitis acute 37.76 19.84 42 21199 32073 90575133
Renal failure 37.57 19.84 90 21151 130917 90476289
Coagulopathy 37.39 19.84 36 21205 23253 90583953
Muscle spasms 37.17 19.84 7 21234 251876 90355330
Aspergillus infection 37.06 19.84 26 21215 10797 90596409
Cystic fibrosis 36.39 19.84 18 21223 3923 90603283
Osteomyelitis bacterial 36.33 19.84 9 21232 242 90606964
Dysbiosis 36.22 19.84 14 21227 1688 90605518
Mycobacterium chelonae infection 36.11 19.84 11 21230 646 90606560
Bone marrow failure 35.94 19.84 41 21200 32180 90575026
Retinal ischaemia 35.41 19.84 10 21231 450 90606756
Dysgeusia 35.24 19.84 52 21189 52508 90554698
Abdominal discomfort 35.19 19.84 36 21205 477292 90129914
Lower respiratory tract infection 34.86 19.84 8 21233 250651 90356555
Blood cholesterol increased 34.80 19.84 4 21237 208008 90399198
Osteoarthritis 34.74 19.84 3 21238 195727 90411479
Nosocomial infection 34.63 19.84 14 21227 1899 90605307
Ocular toxicity 34.59 19.84 12 21229 1065 90606141
Hypersensitivity 33.85 19.84 34 21207 454643 90152563
Product administered to patient of inappropriate age 33.56 19.84 18 21223 4635 90602571
Bacteraemia 33.06 19.84 33 21208 22267 90584939
Bronchiectasis 33.02 19.84 33 21208 22297 90584909
Mobility decreased 32.94 19.84 9 21232 250725 90356481
Pancytopenia 32.76 19.84 81 21160 120182 90487024
Lymphadenitis 32.67 19.84 17 21224 4120 90603086
Corneal opacity 32.58 19.84 11 21230 900 90606306
Skin maceration 32.48 19.84 8 21233 210 90606996
Pseudomonal sepsis 32.04 19.84 17 21224 4285 90602921
Systemic lupus erythematosus 31.89 19.84 23 21218 361873 90245333
Fatigue 31.80 19.84 151 21090 1153872 89453334
Myocardial calcification 31.72 19.84 8 21233 232 90606974
Cytomegalovirus infection 31.64 19.84 35 21206 26567 90580639
Acinetobacter infection 30.62 19.84 13 21228 1995 90605211
Hypersensitivity pneumonitis 30.53 19.84 16 21225 3932 90603274
Sleep disorder 30.31 19.84 5 21236 198025 90409181
Hepatic function abnormal 29.89 19.84 45 21196 46243 90560963
Rhinocerebral mucormycosis 29.81 19.84 10 21231 802 90606404
Neutropenic colitis 29.81 19.84 16 21225 4127 90603079
Antithrombin III 29.35 19.84 7 21234 160 90607046
Deafness bilateral 29.18 19.84 12 21229 1701 90605505
Hepatosplenic candidiasis 29.14 19.84 8 21233 324 90606882
Infective pulmonary exacerbation of cystic fibrosis 29.08 19.84 22 21219 10257 90596949
Migraine 28.72 19.84 5 21236 190387 90416819
Atypical mycobacterium test positive 28.37 19.84 5 21236 22 90607184
Insomnia 28.34 19.84 22 21219 333452 90273754
Granulomatous liver disease 28.28 19.84 10 21231 939 90606267
Guillain-Barre syndrome 28.20 19.84 16 21225 4596 90602610
Status epilepticus 28.10 19.84 28 21213 18846 90588360
Vulvovaginitis 27.63 19.84 8 21233 394 90606812
Hepatitis 27.57 19.84 55 21186 70684 90536522
Fungaemia 27.12 19.84 14 21227 3336 90603870
Drug dose omission by device 26.98 19.84 21 21220 10210 90596996
Abscess limb 26.88 19.84 17 21224 5945 90601261
Pulmonary toxicity 26.84 19.84 22 21219 11509 90595697
Throat irritation 26.81 19.84 44 21197 48651 90558555
Respiratory distress 26.79 19.84 39 21202 38907 90568299
Trichoglossia 26.51 19.84 8 21233 455 90606751
Hyperacusis 26.43 19.84 13 21228 2798 90604408
Hypoaesthesia 26.36 19.84 21 21220 314189 90293017
Secretion discharge 26.33 19.84 25 21216 15871 90591335
Sputum discoloured 26.29 19.84 28 21213 20363 90586843
Memory impairment 26.05 19.84 7 21234 197237 90409969
Hepatitis cholestatic 25.73 19.84 19 21222 8542 90598664
Polyneuropathy 25.73 19.84 27 21214 19314 90587892
Maternal exposure during pregnancy 25.57 19.84 28 21213 360035 90247171
Haemorrhage intracranial 25.41 19.84 24 21217 15138 90592068
Myocarditis 25.35 19.84 23 21218 13783 90593423
Depression 25.33 19.84 20 21221 300581 90306625
Renal impairment 24.59 19.84 67 21174 105354 90501852
Herpes simplex hepatitis 24.50 19.84 8 21233 590 90606616
Back pain 24.42 19.84 23 21218 317152 90290054
Rehabilitation therapy 24.32 19.84 11 21230 1963 90605243
Hydrocephalus 24.09 19.84 16 21225 6078 90601128
Angular cheilitis 24.06 19.84 9 21232 992 90606214
Transaminases increased 23.79 19.84 36 21205 37156 90570050
Skin lesion 23.67 19.84 36 21205 37329 90569877
Accidental underdose 23.31 19.84 9 21232 1082 90606124
Pulmonary function test decreased 23.28 19.84 14 21227 4480 90602726
Butterfly rash 23.25 19.84 11 21230 2174 90605032
Anxiety 23.22 19.84 23 21218 309749 90297457
Asthma 23.20 19.84 14 21227 242146 90365060
Staphylococcal infection 23.02 19.84 41 21200 48398 90558808
Chemotherapeutic drug level increased 22.70 19.84 6 21235 210 90606996
Hypertransaminasaemia 22.69 19.84 23 21218 15802 90591404
Agranulocytosis 22.56 19.84 34 21207 34968 90572238
Hepatic enzyme increased 22.51 19.84 31 21210 360705 90246501
Drug intolerance 22.22 19.84 180 21061 447411 90159795
Infective exacerbation of bronchiectasis 22.12 19.84 7 21234 467 90606739
Gait inability 21.75 19.84 4 21237 146452 90460754
Lower respiratory tract infection bacterial 21.65 19.84 7 21234 500 90606706
Shock 21.53 19.84 30 21211 28748 90578458
Granulomatosis with polyangiitis 21.50 19.84 11 21230 2574 90604632
Klebsiella bacteraemia 21.47 19.84 11 21230 2581 90604625
Blister 21.44 19.84 17 21224 254981 90352225
Hypofibrinogenaemia 21.32 19.84 9 21232 1361 90605845
Gait disturbance 21.11 19.84 18 21223 260478 90346728
Thrombocytopenia neonatal 21.00 19.84 4 21237 29 90607177
Kussmaul respiration 20.97 19.84 6 21235 283 90606923
Blood pressure increased 20.95 19.84 10 21231 197207 90409999
Oropharyngeal pain 20.94 19.84 67 21174 115120 90492086
Bursitis 20.88 19.84 3 21238 131651 90475555
Capillary leak syndrome 20.79 19.84 11 21230 2756 90604450
Cryptococcosis 20.71 19.84 9 21232 1462 90605744
Confusional state 20.48 19.84 37 21204 386168 90221038
Acetonaemia 20.15 19.84 6 21235 326 90606880
Cholestatic liver injury 20.11 19.84 12 21229 3785 90603421
Escherichia sepsis 19.98 19.84 14 21227 5802 90601404
Graft versus host disease 19.93 19.84 16 21225 8128 90599078
Retinal artery occlusion 19.87 19.84 10 21231 2261 90604945
Serratia infection 19.85 19.84 8 21233 1077 90606129

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 412.28 16.69 243 21796 34005 42565291
Ototoxicity 308.45 16.69 92 21947 2233 42597063
Pathogen resistance 223.46 16.69 112 21927 11338 42587958
Deafness 197.76 16.69 108 21931 13032 42586264
Drug ineffective 193.41 16.69 736 21303 629461 41969835
Drug reaction with eosinophilia and systemic symptoms 187.47 16.69 163 21876 41912 42557384
Septic shock 181.43 16.69 230 21809 91442 42507854
Electrocardiogram QT prolonged 159.83 16.69 158 21881 47787 42551509
Thrombocytopenia 128.19 16.69 295 21744 189984 42409312
Rash maculo-papular 127.58 16.69 125 21914 37378 42561918
Product use in unapproved indication 119.87 16.69 282 21757 184174 42415122
Deafness neurosensory 104.87 16.69 47 21992 3699 42595597
Multiple organ dysfunction syndrome 92.90 16.69 174 21865 96861 42502435
Immune reconstitution inflammatory syndrome 89.11 16.69 59 21980 10084 42589212
Candida infection 86.79 16.69 79 21960 21531 42577765
Therapy interrupted 84.81 16.69 79 21960 22171 42577125
Off label use 82.54 16.69 587 21452 637748 41961548
Treatment failure 79.14 16.69 127 21912 62497 42536799
Acute kidney injury 77.82 16.69 385 21654 366952 42232344
Eosinophilia 77.07 16.69 90 21949 32809 42566487
Drug ineffective for unapproved indication 76.05 16.69 106 21933 46057 42553239
Toxic skin eruption 75.22 16.69 60 21979 13670 42585626
Fall 73.11 16.69 16 22023 234504 42364792
Pseudomonas infection 69.46 16.69 61 21978 15862 42583434
Fatigue 68.30 16.69 75 21964 435566 42163730
Hepatotoxicity 67.72 16.69 74 21965 25093 42574203
Mycobacterium fortuitum infection 66.32 16.69 19 22020 398 42598898
Mycobacterium chelonae infection 64.79 16.69 24 22015 1154 42598142
Klebsiella infection 63.10 16.69 50 21989 11282 42588014
Brain abscess 61.09 16.69 34 22005 4250 42595046
Aspergillus infection 59.90 16.69 56 21983 15781 42583515
Pain 59.68 16.69 26 22013 244822 42354474
Mycobacterium abscessus infection 59.00 16.69 20 22019 740 42598556
Enterococcal infection 56.31 16.69 48 21991 11991 42587305
Bronchopulmonary aspergillosis 55.55 16.69 59 21980 19370 42579926
Nephropathy toxic 51.48 16.69 53 21986 16785 42582511
Mycobacterium avium complex infection 51.47 16.69 27 22012 3000 42596296
Vascular pseudoaneurysm thrombosis 49.54 16.69 11 22028 76 42599220
Pancytopenia 44.52 16.69 148 21891 117595 42481701
Condition aggravated 42.66 16.69 255 21784 260499 42338797
Bronchospasm 42.02 16.69 42 21997 12843 42586453
Scedosporium infection 41.86 16.69 19 22020 1539 42597757
Tuberculosis 40.69 16.69 37 22002 10062 42589234
Nocardiosis 40.36 16.69 28 22011 5162 42594134
Sputum increased 39.45 16.69 23 22016 3140 42596156
Hydrocephalus 38.60 16.69 29 22010 6049 42593247
Necrotising colitis 38.46 16.69 17 22022 1294 42598002
Product administered to patient of inappropriate age 37.76 16.69 26 22013 4735 42594561
Systemic candida 37.43 16.69 27 22012 5292 42594004
Mycobacterial peritonitis 37.26 16.69 10 22029 163 42599133
Cardiac valve vegetation 37.19 16.69 13 22026 528 42598768
Fungaemia 37.00 16.69 22 22017 3114 42596182
Acute respiratory distress syndrome 36.56 16.69 60 21979 30048 42569248
Multiple-drug resistance 35.90 16.69 30 22009 7292 42592004
Myocardial infarction 35.61 16.69 10 22029 123999 42475297
Inappropriate schedule of product administration 35.57 16.69 4 22035 95898 42503398
Clostridium difficile colitis 35.27 16.69 49 21990 21203 42578093
Atypical mycobacterial infection 34.64 16.69 16 22023 1350 42597946
Deafness bilateral 34.29 16.69 16 22023 1381 42597915
Paradoxical drug reaction 33.23 16.69 24 22015 4714 42594582
Respiratory distress 32.73 16.69 69 21970 41751 42557545
Acute febrile neutrophilic dermatosis 32.59 16.69 17 22022 1867 42597429
Drug-induced liver injury 32.13 16.69 65 21974 38208 42561088
Acute generalised exanthematous pustulosis 31.75 16.69 30 22009 8565 42590731
Cough 30.90 16.69 177 21862 177926 42421370
Hypoacusis 30.86 16.69 43 21996 18659 42580637
Tuberculosis of central nervous system 30.22 16.69 9 22030 217 42599079
Headache 29.50 16.69 49 21990 239320 42359976
Cerebrovascular accident 29.49 16.69 7 22032 97153 42502143
Hepatic cytolysis 29.28 16.69 51 21988 26793 42572503
Febrile bone marrow aplasia 29.24 16.69 31 22008 10150 42589146
Arthralgia 29.20 16.69 38 22001 205200 42394096
Leukopenia 29.16 16.69 95 21944 74651 42524645
Hypofibrinogenaemia 29.11 16.69 16 22023 1951 42597345
Acoustic neuroma 29.06 16.69 8 22031 144 42599152
Back pain 28.72 16.69 19 22020 141757 42457539
Atypical mycobacterium test positive 28.54 16.69 7 22032 78 42599218
Hypertransaminasaemia 28.12 16.69 29 22010 9198 42590098
Sepsis neonatal 27.88 16.69 9 22030 285 42599011
Dizziness 27.17 16.69 55 21984 249199 42350097
Hepatocellular injury 27.16 16.69 46 21993 23632 42575664
Blood pressure measurement 26.89 16.69 8 22031 192 42599104
Posterior reversible encephalopathy syndrome 26.61 16.69 33 22006 12788 42586508
Mucormycosis 26.51 16.69 25 22014 7118 42592178
Herpes zoster meningoencephalitis 26.49 16.69 10 22029 507 42598789
General physical condition abnormal 26.21 16.69 20 22019 4269 42595027
Pulmonary cavitation 26.15 16.69 13 22026 1291 42598005
Papilloma 25.71 16.69 9 22030 367 42598929
Linear IgA disease 25.46 16.69 15 22024 2088 42597208
Respiratory failure 25.34 16.69 132 21907 128000 42471296
Tinnitus 25.31 16.69 50 21989 28888 42570408
Hospitalisation 25.07 16.69 90 21949 74240 42525056
Myasthenia gravis crisis 24.91 16.69 11 22028 835 42598461
Dehydration 24.89 16.69 22 22017 141745 42457551
Candida sepsis 24.88 16.69 13 22026 1432 42597864
Hypertension 24.78 16.69 30 22009 167174 42432122
Pseudomembranous colitis 24.59 16.69 17 22022 3116 42596180
Pain in extremity 24.53 16.69 25 22014 150579 42448717
Vestibular disorder 24.39 16.69 12 22027 1165 42598131
Embolic cerebral infarction 24.39 16.69 11 22028 878 42598418
Disseminated intravascular coagulation 24.35 16.69 45 21994 24749 42574547
Incision site pain 24.16 16.69 14 22025 1889 42597407
Red blood cells urine positive 24.11 16.69 14 22025 1896 42597400
Hepatic haemorrhage 24.05 16.69 10 22029 655 42598641
Quadriparesis 23.92 16.69 15 22024 2335 42596961
Anxiety 23.86 16.69 16 22023 118544 42480752
Inflammatory marker increased 23.85 16.69 23 22016 6733 42592563
Trichosporon infection 23.67 16.69 11 22028 941 42598355
Hepatitis fulminant 23.65 16.69 20 22019 4939 42594357
Aspergillus test positive 23.54 16.69 10 22029 691 42598605
Fusarium infection 23.52 16.69 13 22026 1603 42597693
Wound drainage 23.36 16.69 10 22029 704 42598592
Cholestasis 23.16 16.69 52 21987 32827 42566469
Escherichia infection 23.12 16.69 29 22010 11367 42587929
Sepsis 23.00 16.69 179 21860 199155 42400141
Blood pressure increased 22.99 16.69 12 22027 101916 42497380
Cardiac failure congestive 22.61 16.69 8 22031 85594 42513702
Altered state of consciousness 22.57 16.69 48 21991 29211 42570085
Immunosuppressant drug level decreased 22.05 16.69 13 22026 1811 42597485
Stenotrophomonas infection 22.04 16.69 17 22022 3687 42595609
Thalamic infarction 21.93 16.69 10 22029 819 42598477
Urinary tract infection fungal 21.90 16.69 9 22030 572 42598724
Abscess bacterial 21.89 16.69 7 22032 215 42599081
Nervous system disorder 21.87 16.69 35 22004 17160 42582136
Pneumonia pseudomonal 21.79 16.69 19 22020 4890 42594406
Pulmonary resection 21.64 16.69 6 22033 111 42599185
Gait disturbance 21.42 16.69 12 22027 97988 42501308
Benign soft tissue neoplasm 21.20 16.69 6 22033 120 42599176
Constipation 21.13 16.69 32 22007 162259 42437037
Diabetes mellitus 21.08 16.69 3 22036 60084 42539212
Leukocytosis 20.94 16.69 47 21992 29661 42569635
Pyrexia 20.82 16.69 302 21737 393740 42205556
Optic neuropathy 20.59 16.69 14 22025 2498 42596798
Pneumatosis intestinalis 20.31 16.69 18 22021 4734 42594562
Deafness unilateral 20.26 16.69 13 22026 2106 42597190
Sputum purulent 20.14 16.69 9 22030 703 42598593
Haemoptysis 20.13 16.69 61 21978 46106 42553190
Calculus urinary 19.88 16.69 12 22027 1745 42597551
Premature baby death 19.70 16.69 3 22036 0 42599296
Drug intolerance 19.60 16.69 88 21951 80336 42518960
Feeling abnormal 19.34 16.69 6 22033 69780 42529516
Candida pneumonia 19.29 16.69 9 22030 777 42598519
Myelosuppression 19.11 16.69 55 21984 40406 42558890
Protein urine present 19.08 16.69 19 22020 5782 42593514
Immune effector cell-associated neurotoxicity syndrome 19.07 16.69 24 22015 9437 42589859
Purpura non-thrombocytopenic 19.02 16.69 5 22034 75 42599221
Enterobacter pneumonia 18.83 16.69 8 22031 553 42598743
Pseudomonal bacteraemia 18.80 16.69 13 22026 2383 42596913
Joint swelling 18.58 16.69 6 22033 68016 42531280
Gallstone ileus 18.50 16.69 4 22035 24 42599272
Hyperhidrosis 18.50 16.69 12 22027 90500 42508796
Hyperbilirubinaemia 18.46 16.69 36 22003 20599 42578697
Toxic neuropathy 18.37 16.69 8 22031 587 42598709
Skin hyperpigmentation 18.19 16.69 16 22023 4165 42595131
Haemoperitoneum 18.10 16.69 12 22027 2054 42597242
Rash pustular 17.98 16.69 19 22020 6196 42593100
Renal tubular disorder 17.87 16.69 17 22022 4892 42594404
Agranulocytosis 17.87 16.69 45 21994 30567 42568729
Flavobacterium infection 17.72 16.69 5 22034 99 42599197
Hypersensitivity vasculitis 17.39 16.69 14 22025 3230 42596066
Hepatosplenic candidiasis 17.37 16.69 6 22033 235 42599061
Shock 17.20 16.69 43 21996 29078 42570218
Fungal infection 17.15 16.69 34 22005 19688 42579608
Blood urea increased 16.88 16.69 46 21993 32747 42566549
Muscle spasms 16.79 16.69 12 22027 86032 42513264
Atrial fibrillation 16.78 16.69 29 22010 139564 42459732

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 842.32 16.88 397 35745 55977 110497180
Pathogen resistance 497.55 16.88 195 35947 17477 110535680
Ototoxicity 483.68 16.88 134 36008 3997 110549160
Drug reaction with eosinophilia and systemic symptoms 440.08 16.88 295 35847 81800 110471357
Septic shock 358.26 16.88 342 35800 157186 110395971
Drug ineffective 330.84 16.88 1165 34977 1519375 109033782
Deafness 299.93 16.88 155 35987 26554 110526603
Thrombocytopenia 253.53 16.88 428 35714 348457 110204700
Rash maculo-papular 252.98 16.88 203 35939 74019 110479138
Multiple organ dysfunction syndrome 251.58 16.88 278 35864 151432 110401725
Electrocardiogram QT prolonged 225.89 16.88 225 35917 108735 110444422
Acute kidney injury 185.25 16.88 540 35602 634890 109918267
Eosinophilia 183.78 16.88 152 35990 57784 110495373
Immune reconstitution inflammatory syndrome 181.67 16.88 94 36048 16132 110537025
Deafness neurosensory 178.93 16.88 79 36063 9540 110543617
Mycobacterium abscessus infection 170.92 16.88 49 36093 1657 110551500
Pseudomonas infection 161.00 16.88 105 36037 27748 110525409
Nephropathy toxic 152.53 16.88 101 36041 27377 110525780
Toxic skin eruption 152.40 16.88 101 36041 27414 110525743
Pain 147.55 16.88 64 36078 954891 109598266
Product use in unapproved indication 146.65 16.88 397 35745 446980 110106177
Off label use 141.18 16.88 903 35239 1499282 109053875
Mycobacterium avium complex infection 134.83 16.88 56 36086 5821 110547336
Candida infection 133.90 16.88 117 36025 47892 110505265
Hepatotoxicity 127.79 16.88 129 36013 63271 110489886
Tinnitus 127.21 16.88 126 36016 60414 110492743
Klebsiella infection 126.95 16.88 80 36062 19929 110533228
Bronchopulmonary aspergillosis 126.51 16.88 93 36049 29770 110523387
Fatigue 123.13 16.88 130 36012 1215828 109337329
Enterococcal infection 113.37 16.88 75 36067 20291 110532866
Fall 107.41 16.88 32 36110 603450 109949707
Drug ineffective for unapproved indication 106.68 16.88 149 35993 102689 110450468
Sepsis 104.65 16.88 288 35854 327058 110226099
Arthralgia 104.27 16.88 63 36079 779569 109773588
Acute respiratory distress syndrome 101.31 16.88 105 36037 53093 110500064
Joint swelling 95.96 16.88 15 36127 442830 110110327
Sputum increased 90.38 16.88 42 36100 5709 110547448
Headache 89.53 16.88 94 36048 882283 109670874
Geotrichum infection 83.19 16.88 26 36116 1186 110551971
Aspergillus infection 82.86 16.88 68 36074 25548 110527609
Clostridium difficile colitis 82.63 16.88 86 36056 43692 110509465
Pancytopenia 81.96 16.88 199 35943 209414 110343743
Respiratory failure 81.61 16.88 202 35940 215130 110338027
Mucormycosis 81.55 16.88 48 36094 10580 110542577
Dysphonia 80.21 16.88 111 36031 75818 110477339
Paradoxical drug reaction 79.73 16.88 46 36096 9771 110543386
Infusion related reaction 77.98 16.88 15 36127 381147 110172010
Synovitis 76.49 16.88 3 36139 274089 110279068
Mycobacterium chelonae infection 76.47 16.88 31 36111 3029 110550128
Mycobacterium fortuitum infection 76.31 16.88 20 36122 480 110552677
Acute generalised exanthematous pustulosis 75.34 16.88 60 36082 21604 110531553
Multiple-drug resistance 74.29 16.88 49 36093 13186 110539971
Nasopharyngitis 71.78 16.88 20 36122 394341 110158816
Pyrexia 71.58 16.88 520 35622 897745 109655412
Alopecia 71.22 16.88 16 36126 364737 110188420
Therapy interrupted 70.17 16.88 84 36058 49738 110503419
Contraindicated product administered 68.33 16.88 3 36139 248264 110304893
Neuropathy peripheral 66.67 16.88 167 35975 179110 110374047
Neutropenia 66.27 16.88 270 35872 374350 110178807
Atypical mycobacterial infection 66.08 16.88 27 36115 2691 110550466
Nocardiosis 65.96 16.88 37 36105 7449 110545708
Pain in extremity 65.54 16.88 39 36103 487079 110066078
Swelling 65.40 16.88 17 36125 351024 110202133
Hydrocephalus 64.60 16.88 41 36101 10334 110542823
Hypertension 64.30 16.88 44 36098 510040 110043117
Musculoskeletal stiffness 64.06 16.88 8 36134 279814 110273343
Deafness bilateral 62.82 16.88 26 36116 2678 110550479
Haemoptysis 61.83 16.88 95 36047 71259 110481898
Aphonia 61.22 16.88 43 36099 12817 110540340
Leukopenia 61.09 16.88 144 35998 148647 110404510
Therapeutic product effect decreased 61.07 16.88 5 36137 244311 110308846
Wound 60.88 16.88 4 36138 234433 110318724
Hepatocellular injury 59.53 16.88 78 36064 50564 110502593
Fungaemia 58.90 16.88 32 36110 6054 110547103
Peripheral swelling 57.73 16.88 30 36112 404004 110149153
Hypoacusis 57.39 16.88 64 36078 35127 110518030
Weight increased 57.29 16.88 33 36109 419611 110133546
Cough 56.70 16.88 299 35843 461342 110091815
Brain abscess 55.70 16.88 32 36110 6742 110546415
Contusion 55.08 16.88 6 36136 233355 110319802
Discomfort 54.77 16.88 4 36138 214703 110338454
Glossodynia 54.24 16.88 5 36137 221999 110331158
Vascular pseudoaneurysm thrombosis 54.08 16.88 11 36131 80 110553077
Sinusitis 54.06 16.88 15 36127 296673 110256484
Febrile bone marrow aplasia 53.65 16.88 45 36097 17420 110535737
Respiratory distress 51.84 16.88 86 36056 68788 110484369
Hyperlactacidaemia 49.75 16.88 32 36110 8254 110544903
Malaise 49.53 16.88 90 36052 671729 109881428
Impaired healing 49.23 16.88 4 36138 196713 110356444
Cholestasis 49.15 16.88 81 36061 64437 110488720
Anxiety 48.73 16.88 26 36116 345052 110208105
Scedosporium infection 48.34 16.88 21 36121 2437 110550720
Abdominal discomfort 48.26 16.88 35 36107 393823 110159334
Coagulopathy 48.06 16.88 63 36079 40848 110512309
Osteoarthritis 47.76 16.88 3 36139 182620 110370537
Mycobacterial infection 47.75 16.88 25 36117 4392 110548765
Helicobacter infection 47.53 16.88 3 36139 181874 110371283
Bone marrow failure 47.30 16.88 75 36067 57773 110495384
Muscle spasms 47.19 16.88 16 36126 278141 110275016
Tuberculosis 46.92 16.88 42 36100 17732 110535425
Acinetobacter infection 46.73 16.88 23 36119 3550 110549607
Systemic candida 46.66 16.88 33 36109 9941 110543216
Renal failure 46.30 16.88 171 35971 226403 110326754
Injury 46.09 16.88 3 36139 177262 110375895
Pancreatitis acute 45.01 16.88 75 36067 60199 110492958
Hypofibrinogenaemia 44.73 16.88 20 36122 2487 110550670
Hypertransaminasaemia 44.60 16.88 47 36095 24208 110528949
Hepatosplenic candidiasis 44.52 16.88 14 36128 652 110552505
Bronchospasm 44.25 16.88 52 36090 30187 110522970
Antimicrobial susceptibility test intermediate 44.19 16.88 8 36134 28 110553129
Inflammatory marker increased 43.86 16.88 37 36105 14432 110538725
Dizziness 43.47 16.88 103 36039 698090 109855067
Type 2 diabetes mellitus 43.27 16.88 4 36138 177228 110375929
Nosocomial infection 43.05 16.88 21 36121 3178 110549979
Lower respiratory tract infection 42.98 16.88 13 36129 243093 110310064
Atypical mycobacterium test positive 42.85 16.88 9 36133 78 110553079
Memory impairment 41.88 16.88 7 36135 196937 110356220
Staphylococcal infection 41.87 16.88 79 36063 69865 110483292
Polyneuropathy 41.87 16.88 52 36090 31960 110521197
Escherichia infection 41.76 16.88 45 36097 23771 110529386
Myelosuppression 41.67 16.88 94 36048 94246 110458911
Mobility decreased 41.43 16.88 13 36129 237409 110315748
Asthma 41.42 16.88 15 36127 250276 110302881
Hepatic cytolysis 40.44 16.88 68 36074 54985 110498172
Back pain 40.43 16.88 37 36105 370959 110182198
Leukocytosis 40.22 16.88 67 36075 53761 110499396
Guillain-Barre syndrome 40.04 16.88 31 36111 10713 110542444
Agranulocytosis 39.79 16.88 72 36070 61688 110491469
Disseminated mycobacterium avium complex infection 39.30 16.88 12 36130 506 110552651
Hepatitis fulminant 39.30 16.88 28 36114 8532 110544625
Haemophagocytic lymphohistiocytosis 39.26 16.88 50 36092 31509 110521648
Infective pulmonary exacerbation of cystic fibrosis 39.18 16.88 35 36107 14736 110538421
Depression 39.13 16.88 28 36114 317307 110235850
Aplasia 39.05 16.88 27 36115 7846 110545311
Migraine 39.05 16.88 5 36137 171647 110381510
Toxic epidermal necrolysis 38.95 16.88 68 36074 56659 110496498
Blood pressure increased 38.68 16.88 18 36124 258355 110294802
Hyperacusis 38.60 16.88 19 36123 2933 110550224
Mycobacterial peritonitis 38.44 16.88 10 36132 233 110552924
Osteomyelitis bacterial 38.11 16.88 12 36130 561 110552596
Pulmonary cavitation 37.54 16.88 17 36125 2177 110550980
Overgrowth fungal 37.33 16.88 9 36133 152 110553005
Acute febrile neutrophilic dermatosis 37.10 16.88 22 36120 4914 110548243
Product packaging difficult to open 36.62 16.88 8 36134 85 110553072
Blood cholesterol increased 36.26 16.88 8 36134 184777 110368380
Encephalopathy 36.06 16.88 81 36061 80974 110472183
Corneal opacity 35.88 16.88 14 36128 1237 110551920
Inappropriate schedule of product administration 35.79 16.88 11 36131 203626 110349531
Condition aggravated 35.74 16.88 382 35760 734454 109818703
Hypersensitivity 35.56 16.88 48 36094 403950 110149207
Pulmonary resection 35.39 16.88 9 36133 191 110552966
Rash pustular 35.22 16.88 31 36111 12798 110540359
Posterior reversible encephalopathy syndrome 34.99 16.88 49 36093 33812 110519345
Pneumonia bacterial 34.89 16.88 43 36099 26218 110526939
Transaminases increased 34.77 16.88 69 36073 63321 110489836
Cardiac valve vegetation 34.72 16.88 13 36129 1027 110552130
Bacteraemia 34.71 16.88 55 36087 42335 110510822
Febrile neutropenia 34.70 16.88 199 35943 316568 110236589
Aspergillus test positive 34.59 16.88 13 36129 1037 110552120
Pseudomembranous colitis 34.27 16.88 23 36119 6368 110546789
Herpes zoster meningoencephalitis 34.26 16.88 13 36129 1065 110552092
Neutropenic colitis 33.89 16.88 25 36117 8040 110545117
Gait disturbance 33.70 16.88 25 36117 278183 110274974
Pneumothorax 33.44 16.88 49 36093 35236 110517921
Immune effector cell-associated neurotoxicity syndrome 33.34 16.88 32 36110 14750 110538407
Dry mouth 33.05 16.88 12 36130 199936 110353221
Gastrooesophageal reflux disease 32.96 16.88 9 36133 179967 110373190
Loss of personal independence in daily activities 32.64 16.88 5 36137 150015 110403142
Trichosporon infection 31.90 16.88 13 36129 1287 110551870
Incision site pain 31.78 16.88 17 36125 3118 110550039
Bursitis 31.53 16.88 3 36139 129915 110423242
Stenotrophomonas infection 31.22 16.88 21 36121 5837 110547320
Blister 30.83 16.88 18 36124 227358 110325799
Maternal exposure during pregnancy 30.75 16.88 23 36119 254860 110298297
Drug hypersensitivity 30.67 16.88 64 36078 454026 110099131
Ill-defined disorder 30.35 16.88 7 36135 156846 110396311
Disseminated intravascular coagulation 30.33 16.88 51 36091 41235 110511922
Cystic fibrosis 30.22 16.88 19 36123 4712 110548445
Fungal infection 29.93 16.88 57 36085 50749 110502408
Trichoglossia 29.37 16.88 11 36131 869 110552288
Alanine aminotransferase increased 28.98 16.88 128 36014 183645 110369512
Insomnia 28.64 16.88 46 36096 360544 110192613
Red blood cells urine positive 28.62 16.88 19 36123 5166 110547991
Musculoskeletal pain 28.57 16.88 12 36130 183011 110370146
General physical condition abnormal 28.50 16.88 22 36120 7568 110545589
Hypersensitivity pneumonitis 28.36 16.88 19 36123 5246 110547911
Pneumatosis intestinalis 28.33 16.88 23 36119 8506 110544651
Myocardial calcification 28.26 16.88 8 36134 258 110552899
Hepatic haemorrhage 28.22 16.88 12 36130 1322 110551835
Dehydration 28.00 16.88 30 36112 279481 110273676
Blood urea increased 27.97 16.88 58 36084 54899 110498258
Haemoperitoneum 27.96 16.88 19 36123 5369 110547788
Skin hyperpigmentation 27.94 16.88 23 36119 8673 110544484
Serratia infection 27.94 16.88 14 36128 2245 110550912
Retinal ischaemia 27.93 16.88 11 36131 996 110552161
Anaemia 27.78 16.88 287 35855 546799 110006358
Pericarditis 27.44 16.88 19 36123 219095 110334062
Product administered to patient of inappropriate age 27.39 16.88 22 36120 8014 110545143
Haemolytic anaemia 27.38 16.88 34 36108 20886 110532271
Constipation 27.16 16.88 47 36095 357739 110195418
Systemic lupus erythematosus 26.95 16.88 26 36116 254312 110298845
Otitis media fungal 26.90 16.88 5 36137 21 110553136
Acoustic neuroma 26.85 16.88 8 36134 310 110552847
Pulmonary toxicity 26.77 16.88 31 36111 17715 110535442
Renal tubular disorder 26.74 16.88 21 36121 7408 110545749
Joint range of motion decreased 26.64 16.88 4 36138 121828 110431329
Tuberculosis of central nervous system 26.61 16.88 9 36133 528 110552629
Cerebrovascular accident 26.56 16.88 13 36129 181271 110371886
Papilloma 26.55 16.88 9 36133 532 110552625
Haemodynamic instability 26.50 16.88 35 36107 22853 110530304
Dermatitis exfoliative 26.42 16.88 25 36117 11322 110541835
Deafness unilateral 26.02 16.88 17 36125 4502 110548655
Hypoaesthesia 25.99 16.88 39 36103 314184 110238973
Status epilepticus 25.90 16.88 41 36101 31530 110521627
Vulvovaginitis 25.60 16.88 8 36134 365 110552792
Shock 25.47 16.88 55 36087 53533 110499624
Immunosuppressant drug level decreased 25.24 16.88 14 36128 2757 110550400
Skin maceration 25.15 16.88 7 36135 212 110552945
Altered state of consciousness 24.98 16.88 57 36085 57569 110495588
Myocardial infarction 24.93 16.88 16 36126 192067 110361090
Feeling abnormal 24.93 16.88 14 36128 180697 110372460
Anuria 24.82 16.88 35 36107 24306 110528851
Thalamic infarction 24.81 16.88 11 36131 1341 110551816
Lung abscess 24.42 16.88 17 36125 4995 110548162
Nervous system disorder 24.39 16.88 40 36102 31681 110521476
Pneumonia pseudomonal 24.33 16.88 20 36122 7526 110545631
Protein urine present 24.29 16.88 24 36118 11460 110541697
Immune reconstitution inflammatory syndrome associated tuberculosis 24.03 16.88 10 36132 1044 110552113
Linear IgA disease 24.03 16.88 16 36126 4373 110548784
Drug-induced liver injury 23.99 16.88 90 36052 119977 110433180
Productive cough 23.94 16.88 87 36055 114218 110438939
Sleep disorder 23.86 16.88 18 36124 198626 110354531
Wheezing 23.82 16.88 29 36113 255201 110297956
Hepatitis 23.69 16.88 74 36068 89980 110463177
Embolic cerebral infarction 23.67 16.88 11 36131 1495 110551662
Rhinocerebral mucormycosis 23.59 16.88 11 36131 1506 110551651
Calculus urinary 23.56 16.88 14 36128 3138 110550019
Benign soft tissue neoplasm 23.43 16.88 6 36136 131 110553026
Muscular weakness 23.43 16.88 28 36114 248440 110304717
Optic neuropathy 23.16 16.88 16 36126 4642 110548515
Granulomatous liver disease 23.14 16.88 11 36131 1573 110551584
Pseudomonal sepsis 23.13 16.88 21 36121 9025 110544132
Pulmonary tuberculosis 22.95 16.88 21 36121 9118 110544039
Drug interaction 22.87 16.88 257 35885 499926 110053231
Gait inability 22.85 16.88 8 36134 136368 110416789
Blood pressure measurement 22.84 16.88 8 36134 522 110552635
Treatment failure 22.81 16.88 162 35980 277072 110276085
Fusarium infection 22.54 16.88 13 36129 2758 110550399
Lymphopenia 22.36 16.88 44 36098 40126 110513031
Renal injury 22.26 16.88 29 36113 18684 110534473
Granulomatosis with polyangiitis 22.25 16.88 14 36128 3476 110549681
Chest pain 22.22 16.88 57 36085 376318 110176839
Hepatitis cholestatic 22.12 16.88 28 36114 17538 110535619
Nasal congestion 22.02 16.88 3 36139 98279 110454878
Wound drainage 21.98 16.88 10 36132 1294 110551863
Bronchitis 21.90 16.88 12 36130 157020 110396137
Liver abscess 21.85 16.88 19 36123 7720 110545437
Candida sepsis 21.74 16.88 13 36129 2948 110550209
Ocular toxicity 21.74 16.88 10 36132 1328 110551829
Myasthenia gravis crisis 21.72 16.88 11 36131 1803 110551354
Hypoalbuminaemia 21.56 16.88 36 36106 28938 110524219
Face oedema 21.53 16.88 39 36103 33430 110519727
Hospitalisation 21.52 16.88 98 36044 142395 110410762
Urticaria 21.47 16.88 45 36097 318812 110234345
Lung transplant rejection 21.07 16.88 11 36131 1920 110551237
Stomatitis 20.96 16.88 35 36107 270207 110282950
Dyspepsia 20.84 16.88 19 36123 190946 110362211
Gallstone ileus 20.63 16.88 4 36138 22 110553135
Vestibular disorder 20.49 16.88 12 36130 2620 110550537
Purpura 20.46 16.88 32 36110 24356 110528801
Device related infection 20.46 16.88 42 36100 39477 110513680
Toxic neuropathy 20.16 16.88 9 36133 1114 110552043
Capillary leak syndrome 20.14 16.88 15 36127 4893 110548264
Cachexia 20.09 16.88 23 36119 12982 110540175
Butterfly rash 20.05 16.88 11 36131 2120 110551037
Hyperhidrosis 20.01 16.88 19 36123 187279 110365878
Syncope 19.99 16.88 22 36120 202514 110350643
Moraxella infection 19.93 16.88 8 36134 762 110552395
Stress 19.79 16.88 5 36137 105343 110447814
Abdominal pain upper 19.75 16.88 54 36088 349057 110204100
Herpes simplex hepatitis 19.74 16.88 8 36134 781 110552376
Dermatitis exfoliative generalised 19.71 16.88 21 36121 10951 110542206
Disseminated tuberculosis 19.51 16.88 15 36127 5131 110548026
Urogenital infection bacterial 19.20 16.88 5 36137 117 110553040
Malnutrition 19.11 16.88 33 36109 27246 110525911
Dermatitis bullous 19.06 16.88 26 36116 17503 110535654
Dyschromatopsia 18.95 16.88 9 36133 1285 110551872
Urinary tract infection fungal 18.94 16.88 9 36133 1286 110551871
Clostridial infection 18.86 16.88 16 36126 6286 110546871
Flavobacterium infection 18.66 16.88 5 36137 131 110553026
Paraesthesia 18.63 16.88 39 36103 276482 110276675
Quadriparesis 18.46 16.88 14 36128 4693 110548464
Abscess bacterial 18.41 16.88 8 36134 929 110552228
Drug diversion 18.39 16.88 9 36133 1371 110551786
Acute pulmonary oedema 18.17 16.88 25 36117 16971 110536186
Enterobacter pneumonia 18.17 16.88 7 36135 598 110552559
Pneumonia klebsiella 18.16 16.88 16 36126 6616 110546541
Disease recurrence 17.92 16.88 52 36090 60732 110492425
Pneumonia fungal 17.76 16.88 23 36119 14731 110538426
Cardiac failure congestive 17.73 16.88 14 36128 150986 110402171
Graft versus host disease 17.65 16.88 26 36116 18780 110534377
Gamma-glutamyltransferase increased 17.64 16.88 52 36090 61257 110491900
Night sweats 17.61 16.88 11 36131 133972 110419185
Hyperbilirubinaemia 17.56 16.88 34 36108 30637 110522520
Allodynia 17.55 16.88 10 36132 2073 110551084
Blood albumin decreased 17.51 16.88 32 36110 27620 110525537
AIDS related complication 17.50 16.88 4 36138 53 110553104
Product dose omission issue 17.30 16.88 51 36091 321731 110231426
Pseudomonal bacteraemia 17.14 16.88 13 36129 4358 110548799
Choroiditis 17.06 16.88 9 36133 1606 110551551

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Systemic candida 45.63 28.68 11 161 33 113748

Pharmacologic Action:

SourceCodeDescription
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:33231 antitubercular agent
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:36047 antibacterial drug
CHEBI has role CHEBI:50909 nephrotoxic agent
CHEBI has role CHEBI:66981 ophthalmology drug
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents

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

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
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




🐶 Veterinary Drug Use

SpeciesUseRelation
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

🐶 Veterinary products

ProductApplicantIngredients
Amiglyde-V Zoetis Inc. 1
Amikacin Sulfate Injection Cronus Pharma Specialities India Private Limited 1
AmiMax E Solution Elanco US Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
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 12016873 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 12168021 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 12168022 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 12377114 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 12616708 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B) Enzyme Km 4.20 WOMBAT-PK

External reference:

IDSource
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
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
4018137 VANDF
4019602 VANDF
002781 NDDF
004899 NDDF
1269009 SNOMEDCT_US
387266001 SNOMEDCT_US
48836000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 23155-290 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 19 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-785 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 19 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 23155-786 INJECTION, SOLUTION 1 g INTRAMUSCULAR ANDA 19 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 67184-0569 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 19 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 67184-0570 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 19 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 33 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 83301-0022 INJECTION 250 mg INTRAVENOUS ANDA 23 sections
Amikacin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 83301-0023 INJECTION 250 mg INTRAMUSCULAR ANDA 23 sections