triamcinolone acetonide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
steroids not used as glucocorticosteroids 2726 76-25-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nasacort
  • triamcinolone acetonide
  • aristicort
  • allernaze
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
  • Molecular weight: 434.50
  • Formula: C24H31FO6
  • CLOGP: 2.21
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 93.06
  • ALOGS: -4.01
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.26 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 4, 1960 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
Macular degeneration 557.91 11.87 285 40584 24091 63424062
Adrenal insufficiency 283.19 11.87 164 40705 17751 63430402
Dermatitis atopic 264.74 11.87 128 40741 9596 63438557
Injection site atrophy 264.14 11.87 65 40804 578 63447575
Joint destruction 187.59 11.87 88 40781 6164 63441989
Wheelchair user 168.44 11.87 82 40787 6237 63441916
Soft tissue disorder 160.28 11.87 71 40798 4351 63443802
Polyarthritis 157.98 11.87 92 40777 10054 63438099
Obesity 128.07 11.87 125 40744 29827 63418326
Body height below normal 126.46 11.87 49 40820 2134 63446019
Non-infectious endophthalmitis 125.31 11.87 28 40841 155 63447998
Human antichimeric antibody positive 123.00 11.87 45 40824 1669 63446484
Skin atrophy 122.82 11.87 61 40808 4845 63443308
Dry skin 120.21 11.87 165 40704 56722 63391431
Chronic sinusitis 116.78 11.87 83 40786 12760 63435393
Toxicity to various agents 116.41 11.87 12 40857 247238 63200915
Psoriasis 108.37 11.87 198 40671 86759 63361394
Gastroenteritis viral 105.25 11.87 101 40768 23599 63424554
Skin exfoliation 104.90 11.87 134 40735 42968 63405185
Endophthalmitis 102.97 11.87 49 40820 3543 63444610
Pruritus 102.48 11.87 482 40387 360971 63087182
Pneumonia viral 93.05 11.87 60 40809 7862 63440291
Arthritis 92.75 11.87 220 40649 115701 63332452
Immunodeficiency 87.46 11.87 85 40784 20169 63427984
Hypocalcaemia 80.98 11.87 101 40768 31612 63416541
Antibody test positive 80.88 11.87 38 40831 2669 63445484
Therapeutic product effect incomplete 79.91 11.87 218 40651 124838 63323315
Liver function test abnormal 78.96 11.87 124 40745 48057 63400096
Ankle arthroplasty 78.47 11.87 33 40836 1780 63446373
Intraocular pressure increased 76.27 11.87 48 40821 6030 63442123
Acute kidney injury 74.94 11.87 38 40831 263377 63184776
Paraesthesia oral 74.26 11.87 76 40793 19180 63428973
Procedural pain 74.04 11.87 80 40789 21489 63426664
Eczema 71.74 11.87 96 40773 32195 63415958
Therapy non-responder 69.50 11.87 152 40717 75749 63372404
Hypothalamic pituitary adrenal axis suppression 67.92 11.87 17 40852 163 63447990
Bone density increased 66.12 11.87 23 40846 735 63447418
Eye infection toxoplasmal 64.12 11.87 18 40851 277 63447876
Drug ineffective 63.45 11.87 982 39887 1043783 62404370
Fibromyalgia 62.54 11.87 151 40718 80269 63367884
Ocular hypertension 62.36 11.87 24 40845 1026 63447127
Product use in unapproved indication 61.38 11.87 253 40616 178827 63269326
Death 59.71 11.87 93 40776 374288 63073865
Skin fissures 59.20 11.87 53 40816 11335 63436818
Drug specific antibody 58.11 11.87 29 40840 2326 63445827
Cushing's syndrome 56.68 11.87 20 40849 667 63447486
Short stature 56.60 11.87 20 40849 670 63447483
Vaginal flatulence 51.63 11.87 30 40839 3263 63444890
Bone density decreased 49.80 11.87 54 40815 14558 63433595
Septic shock 49.55 11.87 123 40746 66506 63381647
Lipoatrophy 49.39 11.87 15 40854 308 63447845
Rhegmatogenous retinal detachment 49.03 11.87 12 40857 104 63448049
Synovitis 49.02 11.87 244 40625 186674 63261479
Red blood cell sedimentation rate abnormal 47.33 11.87 61 40808 19721 63428432
Vaginal discharge 46.22 11.87 42 40827 9156 63438997
Necrotising scleritis 45.43 11.87 12 40857 145 63448008
Visual acuity reduced 44.12 11.87 62 40807 21764 63426389
Adrenal suppression 43.98 11.87 18 40851 906 63447247
Retinal pigment epithelial tear 43.80 11.87 13 40856 246 63447907
Bursitis infective 43.70 11.87 20 40849 1323 63446830
Postmenopausal haemorrhage 43.11 11.87 23 40846 2119 63446034
Nodule 42.91 11.87 60 40809 20966 63427187
Retinal artery occlusion 42.70 11.87 21 40848 1632 63446521
Secondary adrenocortical insufficiency 42.52 11.87 20 40849 1408 63446745
Urticarial vasculitis 42.04 11.87 16 40853 663 63447490
Injection site discolouration 39.76 11.87 36 40833 7812 63440341
Proctitis 37.94 11.87 30 40839 5411 63442742
Intentional product use issue 37.90 11.87 173 40696 127719 63320434
Human anti-human antibody test 37.03 11.87 13 40856 427 63447726
Conjunctival ulcer 36.65 11.87 8 40861 39 63448114
Foot operation 36.30 11.87 33 40836 7198 63440955
Skin discolouration 36.03 11.87 77 40792 37751 63410402
Kounis syndrome 36.02 11.87 19 40850 1711 63446442
Tractional retinal detachment 35.69 11.87 8 40861 45 63448108
Drug abuse 35.47 11.87 3 40866 72515 63375638
Radiculopathy 35.05 11.87 35 40834 8576 63439577
Female genital tract fistula 35.05 11.87 33 40836 7526 63440627
Blood cholesterol increased 34.69 11.87 136 40733 93896 63354257
Neutropenia 33.43 11.87 38 40831 174967 63273186
Skin hypopigmentation 32.91 11.87 14 40855 777 63447376
Retinal detachment 31.46 11.87 28 40841 5941 63442212
Maculopathy 31.27 11.87 19 40850 2243 63445910
Injection site pain 30.91 11.87 165 40704 129635 63318518
Overdose 30.65 11.87 18 40851 115060 63333093
Scleral thinning 30.59 11.87 6 40863 15 63448138
Thrombocytopenia 29.77 11.87 32 40837 151125 63297028
Intentional overdose 29.31 11.87 6 40863 74146 63374007
Limb discomfort 28.89 11.87 61 40808 29655 63418498
Atrophy 27.74 11.87 16 40853 1716 63446437
Herpes zoster 27.04 11.87 115 40754 82347 63365806
Soft tissue swelling 26.86 11.87 14 40855 1230 63446923
General physical health deterioration 26.70 11.87 56 40813 201346 63246807
Joint effusion 26.69 11.87 43 40826 17017 63431136
Quality of life decreased 25.67 11.87 30 40839 8773 63439380
Chorioretinal folds 25.63 11.87 5 40864 12 63448141
Periarthritis calcarea 25.40 11.87 4 40865 0 63448153
Eye inflammation 25.11 11.87 24 40845 5575 63442578
Sinus polyp degeneration 24.72 11.87 6 40863 50 63448103
Impaired quality of life 24.72 11.87 37 40832 13746 63434407
Hyperadrenocorticism 24.34 11.87 9 40860 344 63447809
Drug tolerance 24.24 11.87 26 40843 6923 63441230
Hypopyon 24.13 11.87 11 40858 721 63447432
Cardiac arrest 23.91 11.87 15 40854 92530 63355623
Dyspepsia 23.71 11.87 129 40740 102067 63346086
Skin plaque 23.68 11.87 28 40841 8292 63439861
Retinal haemorrhage 23.63 11.87 22 40847 4947 63443206
Foot deformity 23.48 11.87 54 40815 27799 63420354
Pancytopenia 23.32 11.87 17 40852 96916 63351237
Renal impairment 23.27 11.87 14 40855 88341 63359812
Bradycardia 23.25 11.87 9 40860 73218 63374935
Polypoidal choroidal vasculopathy 23.06 11.87 6 40863 68 63448085
Spinal cord infarction 22.99 11.87 8 40861 256 63447897
Loss of personal independence in daily activities 22.70 11.87 123 40746 97167 63350986
Chorioretinopathy 22.70 11.87 11 40858 828 63447325
Pyloric abscess 22.63 11.87 4 40865 4 63448149
Infective uveitis 22.63 11.87 4 40865 4 63448149
Infection 22.50 11.87 236 40633 228937 63219216
Keratitis fungal 22.34 11.87 7 40862 160 63447993
Retinal deposits 22.24 11.87 6 40863 79 63448074
Disease recurrence 22.17 11.87 53 40816 27977 63420176
Ophthalmic herpes simplex 22.03 11.87 9 40860 451 63447702
Dyspnoea 21.98 11.87 297 40572 661016 62787137
Hyponatraemia 21.68 11.87 24 40845 111876 63336277
Pneumonia 21.64 11.87 189 40680 456578 62991575
Tenderness 21.55 11.87 46 40823 22532 63425621
Cardio-respiratory arrest 21.44 11.87 6 40863 59953 63388200
Decreased appetite 21.43 11.87 86 40783 250966 63197187
Vitreous opacities 21.31 11.87 8 40861 319 63447834
Febrile neutropenia 21.25 11.87 27 40842 118422 63329731
Mobility decreased 21.13 11.87 142 40727 121017 63327136
Seizure 21.04 11.87 33 40836 132601 63315552
Skin haemorrhage 20.88 11.87 29 40840 10065 63438088
Dehydration 20.70 11.87 51 40818 173303 63274850
Product contamination 20.67 11.87 10 40859 750 63447403
Exposure via breast milk 20.34 11.87 14 40855 2043 63446110
Somnolence 20.24 11.87 54 40815 178631 63269522
Orbital infection 20.07 11.87 5 40864 47 63448106
Electrocardiogram QT prolonged 19.43 11.87 7 40862 59523 63388630
Asthenia 19.39 11.87 156 40713 383448 63064705
Malignant neoplasm progression 18.99 11.87 15 40854 82106 63366047
Dermatitis contact 18.96 11.87 29 40840 10979 63437174
Hypokalaemia 18.91 11.87 123 40746 103681 63344472
Retinal scar 18.87 11.87 6 40863 144 63448009
Arthritis bacterial 18.80 11.87 22 40847 6441 63441712
Injection site fibrosis 18.41 11.87 4 40865 19 63448134
Pseudoendophthalmitis 18.24 11.87 4 40865 20 63448133
Erythema 18.20 11.87 183 40686 175568 63272585
Acute febrile neutrophilic dermatosis 17.80 11.87 15 40854 2959 63445194
Infective scleritis 17.63 11.87 4 40865 24 63448129
Papule 17.61 11.87 20 40849 5671 63442482
Atrial fibrillation 17.59 11.87 30 40839 116606 63331547
Dermatophytosis 17.42 11.87 6 40863 186 63447967
Cardiac failure 17.40 11.87 19 40850 89123 63359030
Cytomegalovirus chorioretinitis 17.25 11.87 12 40857 1781 63446372
Purpura senile 17.12 11.87 8 40861 555 63447598
Metabolic acidosis 17.09 11.87 4 40865 45065 63403088
Periarthritis 16.92 11.87 13 40856 2248 63445905
Endometrial thickening 16.87 11.87 7 40862 365 63447788
Allergic reaction to excipient 16.85 11.87 7 40862 366 63447787
Foreign body reaction 16.78 11.87 5 40864 96 63448057
Vitreous disorder 16.68 11.87 5 40864 98 63448055
Oral pain 16.63 11.87 48 40821 28346 63419807
Rhabdomyolysis 16.47 11.87 4 40865 43947 63404206
Detachment of retinal pigment epithelium 16.45 11.87 7 40862 389 63447764
Leukopenia 16.23 11.87 95 40774 77195 63370958
Pleural effusion 16.10 11.87 109 40760 93101 63355052
Conjunctivitis allergic 15.88 11.87 9 40860 933 63447220
Skin swelling 15.84 11.87 15 40854 3444 63444709
Rebound atopic dermatitis 15.77 11.87 5 40864 119 63448034
Periorbital abscess 15.76 11.87 3 40866 6 63448147
Fall 15.75 11.87 169 40700 392165 63055988
Xerosis 15.54 11.87 9 40860 973 63447180
Cushingoid 15.53 11.87 23 40846 8462 63439691
Conjunctival haemorrhage 15.38 11.87 15 40854 3572 63444581
Prescribed underdose 15.33 11.87 48 40821 29641 63418512
Respiratory tract infection 15.29 11.87 60 40809 41423 63406730
Injection site scar 15.24 11.87 9 40860 1009 63447144
Gastrointestinal haemorrhage 15.09 11.87 18 40851 81158 63366995
Epicondylitis 15.06 11.87 12 40857 2188 63445965
Peripheral vascular disorder 15.05 11.87 19 40850 6016 63442137
Eye infection fungal 15.03 11.87 5 40864 139 63448014
Blindness 15.02 11.87 39 40830 21660 63426493
Skin weeping 14.91 11.87 8 40861 745 63447408
Parakeratosis 14.91 11.87 6 40863 289 63447864
Oral candidiasis 14.79 11.87 40 40829 22758 63425395
Blood creatinine increased 14.76 11.87 21 40848 87823 63360330
Sinusitis 14.71 11.87 216 40653 226437 63221716
Skin burning sensation 14.60 11.87 28 40841 12706 63435447
Mucosal inflammation 14.52 11.87 6 40863 46922 63401231
Sleep disorder 14.46 11.87 96 40773 81470 63366683
Ocular lymphoma 14.34 11.87 4 40865 60 63448093
Pulmonary fibrosis 14.21 11.87 57 40812 39752 63408401
Rapidly progressive osteoarthritis 14.03 11.87 3 40866 13 63448140
Sepsis 13.99 11.87 51 40818 153072 63295081
Tarsal tunnel syndrome 13.96 11.87 7 40862 567 63447586
Product dose omission issue 13.93 11.87 220 40649 234093 63214060
Myocardial infarction 13.89 11.87 27 40842 99866 63348287
Injection site abscess 13.89 11.87 9 40860 1189 63446964
Hyperkalaemia 13.70 11.87 9 40860 54194 63393959
Cataract subcapsular 13.69 11.87 7 40862 591 63447562
Iridoschisis 13.68 11.87 3 40866 15 63448138
Retinal artery embolism 13.66 11.87 4 40865 72 63448081
Urticaria 13.65 11.87 165 40704 165637 63282516
Aspirin-exacerbated respiratory disease 13.62 11.87 8 40861 887 63447266
Haemoglobin decreased 13.60 11.87 48 40821 145437 63302716
Red blood cell sedimentation rate increased 13.39 11.87 60 40809 43922 63404231
Resorption bone increased 13.38 11.87 9 40860 1265 63446888
Choroidal infarction 13.22 11.87 4 40865 81 63448072
Tendon rupture 13.21 11.87 21 40848 8218 63439935
Cognitive disorder 13.15 11.87 10 40859 55805 63392348
Diabetic ulcer 13.07 11.87 5 40864 210 63447943
Necrotising retinitis 12.98 11.87 6 40863 406 63447747
Injection site necrosis 12.95 11.87 9 40860 1335 63446818
Muscle atrophy 12.78 11.87 19 40850 7014 63441139
Loss of consciousness 12.71 11.87 124 40745 117997 63330156
Retinal exudates 12.51 11.87 7 40862 709 63447444
Vertigo positional 12.38 11.87 12 40857 2837 63445316
Staphylococcal infection 12.35 11.87 56 40813 41200 63406953
Maternal exposure during pregnancy 12.28 11.87 87 40782 219975 63228178
Dermatitis 12.28 11.87 31 40838 16927 63431226
Oxygen saturation decreased 12.27 11.87 24 40845 88561 63359592
Therapeutic response shortened 12.25 11.87 25 40844 11863 63436290
Orthostatic hypotension 12.24 11.87 4 40865 36156 63411997
Poor dental condition 12.23 11.87 6 40863 464 63447689
Respiratory arrest 12.18 11.87 3 40866 32642 63415511
Malaise 12.14 11.87 352 40517 415602 63032551
Periorbital swelling 12.13 11.87 12 40857 2906 63445247
Respiratory failure 12.13 11.87 30 40839 101828 63346325
Corneal oedema 12.09 11.87 9 40860 1484 63446669
Fatigue 12.07 11.87 459 40410 887569 62560584
Aspartate aminotransferase increased 12.04 11.87 25 40844 90252 63357901
Perioral dermatitis 12.02 11.87 5 40864 262 63447891
Alanine aminotransferase increased 12.02 11.87 31 40838 103739 63344414
Hepatic failure 11.97 11.87 4 40865 35652 63412501
Open angle glaucoma 11.90 11.87 5 40864 269 63447884

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
Dermatitis atopic 309.29 13.50 106 14008 5241 34937576
Endophthalmitis 236.30 13.50 78 14036 3430 34939387
Non-infectious endophthalmitis 172.89 13.50 33 14081 127 34942690
Dry skin 160.94 13.50 119 13995 31168 34911649
Pruritus 146.54 13.50 229 13885 141752 34801065
Visual acuity reduced 132.33 13.50 82 14032 16067 34926750
Ocular hypertension 118.29 13.50 33 14081 811 34942006
Chorioretinopathy 103.75 13.50 34 14080 1459 34941358
Skin exfoliation 99.49 13.50 85 14029 27347 34915470
Intraocular pressure increased 93.61 13.50 45 14069 5338 34937479
Product use in unapproved indication 92.39 13.50 168 13946 117331 34825486
Infective scleritis 92.35 13.50 15 14099 14 34942803
Skin fissures 88.54 13.50 43 14071 5216 34937601
Hypothalamic pituitary adrenal axis suppression 84.93 13.50 18 14096 129 34942688
Eczema 79.11 13.50 63 14051 18373 34924444
Maculopathy 75.77 13.50 24 14090 922 34941895
Drug ineffective 72.59 13.50 369 13745 456382 34486435
Eye infection toxoplasmal 70.81 13.50 17 14097 225 34942592
Retinal artery occlusion 70.15 13.50 27 14087 1858 34940959
Macular oedema 65.14 13.50 29 14085 2885 34939932
Injection site atrophy 62.90 13.50 12 14102 46 34942771
Adrenal suppression 62.72 13.50 19 14095 628 34942189
Rash 61.12 13.50 213 13901 222539 34720278
Toxicity to various agents 56.96 13.50 7 14107 200355 34742462
Necrotising retinitis 53.80 13.50 18 14096 824 34941993
Hypopyon 53.29 13.50 15 14099 381 34942436
Eye inflammation 49.34 13.50 22 14092 2196 34940621
Psoriasis 49.05 13.50 69 14045 38743 34904074
Intentional product use issue 47.51 13.50 86 14028 59730 34883087
Glaucoma 46.46 13.50 31 14083 6881 34935936
Pseudoendophthalmitis 44.59 13.50 9 14105 49 34942768
Eye pruritus 44.20 13.50 31 14083 7458 34935359
Ocular hyperaemia 42.54 13.50 36 14078 11416 34931401
Retinal haemorrhage 42.06 13.50 26 14088 5063 34937754
Necrotising scleritis 41.48 13.50 9 14105 73 34942744
Skin haemorrhage 41.48 13.50 25 14089 4653 34938164
Symmetrical drug-related intertriginous and flexural exanthema 41.21 13.50 12 14102 345 34942472
Macular fibrosis 40.60 13.50 12 14102 364 34942453
Injection site pain 38.79 13.50 62 14052 38943 34903874
Product contamination 36.67 13.50 13 14101 709 34942108
Retinal artery embolism 36.45 13.50 7 14107 28 34942789
Dermatitis contact 34.18 13.50 20 14094 3526 34939291
Retinal detachment 33.42 13.50 23 14091 5368 34937449
Scratch 32.58 13.50 19 14095 3329 34939488
Rhegmatogenous retinal detachment 32.58 13.50 7 14107 54 34942763
Uveitis-glaucoma-hyphaema syndrome 31.73 13.50 5 14109 3 34942814
Open globe injury 31.73 13.50 5 14109 3 34942814
Injection site calcification 30.61 13.50 5 14109 5 34942812
Eye abscess 30.23 13.50 8 14106 160 34942657
Skin hypopigmentation 29.72 13.50 9 14105 297 34942520
Choroidal infarction 29.49 13.50 7 14107 88 34942729
Cystoid macular oedema 29.34 13.50 11 14103 704 34942113
Conjunctivitis 29.05 13.50 27 14087 9678 34933139
Diabetic retinal oedema 29.05 13.50 8 14106 187 34942630
Eye pain 28.43 13.50 31 14083 13431 34929386
Product use issue 28.27 13.50 72 14042 63144 34879673
Vitreous opacities 28.11 13.50 9 14105 358 34942459
Dermatitis 27.69 13.50 26 14088 9442 34933375
Blindness 27.37 13.50 32 14082 14954 34927863
Sleep disorder 26.99 13.50 47 14067 31641 34911176
Drug abuse 26.85 13.50 4 14110 99092 34843725
Vision blurred 26.71 13.50 58 14056 45905 34896912
Retinal pigment epithelial tear 26.11 13.50 8 14106 275 34942542
Product used for unknown indication 25.94 13.50 11 14103 972 34941845
Cardiac arrest 25.78 13.50 4 14110 96155 34846662
Cross sensitivity reaction 25.26 13.50 12 14102 1385 34941432
Retinal degeneration 25.10 13.50 9 14105 507 34942310
Expired product administered 24.93 13.50 16 14098 3325 34939492
Lacrimation increased 24.24 13.50 23 14091 8459 34934358
Cauda equina syndrome 23.99 13.50 9 14105 577 34942240
Oesophageal perforation 23.85 13.50 11 14103 1188 34941629
Dry eye 23.70 13.50 24 14090 9551 34933266
Vitritis 23.61 13.50 10 14104 881 34941936
Subretinal fluid 23.19 13.50 8 14106 402 34942415
Rash pruritic 23.00 13.50 40 14074 26901 34915916
Visual impairment 22.91 13.50 47 14067 35755 34907062
Optic nerve compression 22.87 13.50 4 14110 8 34942809
Infective uveitis 22.55 13.50 4 14110 9 34942808
Skin weeping 21.73 13.50 8 14106 486 34942331
Periarthritis 21.73 13.50 10 14104 1074 34941743
Anterior chamber inflammation 21.71 13.50 7 14107 285 34942532
Spinal cord infarction 21.45 13.50 7 14107 296 34942521
Conjunctival ulcer 21.43 13.50 5 14109 58 34942759
Eye infection 21.20 13.50 15 14099 3658 34939159
Central vision loss 21.03 13.50 4 14110 15 34942802
Arthritis bacterial 20.94 13.50 17 14097 5089 34937728
Adrenal insufficiency 20.82 13.50 27 14087 14020 34928797
Uveitis 20.72 13.50 20 14094 7515 34935302
Treatment failure 20.67 13.50 53 14061 46644 34896173
Pain 20.45 13.50 147 13967 204528 34738289
Distal intestinal obstruction syndrome 20.35 13.50 7 14107 349 34942468
Pneumonia lipoid 20.24 13.50 5 14109 75 34942742
Anaphylactic reaction 20.19 13.50 42 14072 32259 34910558
Arthritis infective 19.82 13.50 14 14100 3405 34939412
Retinal oedema 19.63 13.50 8 14106 640 34942177
Death 18.71 13.50 90 14024 397959 34544858
Cataract 18.70 13.50 36 14078 26150 34916667
Skin burning sensation 18.08 13.50 15 14099 4628 34938189
Product dose omission issue 17.61 13.50 95 14019 119616 34823201
Chorioretinal folds 17.15 13.50 3 14111 6 34942811
Eye irritation 17.00 13.50 18 14096 7543 34935274
Ophthalmic herpes simplex 16.98 13.50 6 14108 324 34942493
Cytomegalovirus chorioretinitis 16.98 13.50 13 14101 3576 34939241
Cellulitis orbital 16.84 13.50 6 14108 332 34942485
Anterior spinal artery syndrome 16.84 13.50 3 14111 7 34942810
Incorrect route of product administration 16.71 13.50 25 14089 14820 34927997
Visual field defect 16.46 13.50 14 14100 4469 34938348
Erythema 16.27 13.50 75 14039 88705 34854112
Eye infection fungal 16.15 13.50 6 14108 374 34942443
Confusional state 15.85 13.50 21 14093 144139 34798678
Rhabdomyolysis 15.83 13.50 4 14110 68159 34874658
Cataract subcapsular 15.77 13.50 6 14108 400 34942417
Acute kidney injury 15.47 13.50 67 14047 304921 34637896
Rash erythematous 15.05 13.50 32 14082 24945 34917872
Choroiditis 14.83 13.50 8 14106 1207 34941610
Inadequate aseptic technique in use of product 14.76 13.50 3 14111 17 34942800
Injection site reaction 14.74 13.50 22 14092 13011 34929806
Intracranial hypotension 14.73 13.50 5 14109 239 34942578
Seborrhoeic keratosis 14.49 13.50 8 14106 1263 34941554
Eye swelling 14.48 13.50 19 14095 9976 34932841
Hyperlipasaemia 14.47 13.50 6 14108 501 34942316
Lenticular opacities 14.40 13.50 5 14109 256 34942561
Renal failure 14.37 13.50 19 14095 130538 34812279
Subretinal fibrosis 14.23 13.50 4 14110 101 34942716
Anal ulcer 14.18 13.50 7 14107 879 34941938
Scleral disorder 14.09 13.50 3 14111 22 34942795
Thrombocytopenia 14.09 13.50 26 14088 156221 34786596
Amblyopia 13.98 13.50 4 14110 108 34942709
Therapeutic response shortened 13.84 13.50 16 14098 7388 34935429
Overdose 13.77 13.50 10 14104 91049 34851768
Application site pruritus 13.57 13.50 8 14106 1429 34941388

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
Dermatitis atopic 338.13 11.32 146 43566 9910 79690766
Injection site atrophy 279.48 11.32 61 43651 360 79700316
Non-infectious endophthalmitis 270.96 11.32 57 43655 274 79700402
Endophthalmitis 268.73 11.32 109 43603 6319 79694357
Adrenal insufficiency 268.65 11.32 177 43535 28310 79672366
Joint destruction 199.09 11.32 86 43626 5839 79694837
Toxicity to various agents 172.88 11.32 16 43696 421524 79279152
Dry skin 170.24 11.32 198 43514 67797 79632879
Wheelchair user 164.42 11.32 76 43636 6056 79694620
Ocular hypertension 155.59 11.32 50 43662 1470 79699206
Intraocular pressure increased 154.54 11.32 83 43629 9122 79691554
Polyarthritis 150.72 11.32 90 43622 12112 79688564
Visual acuity reduced 136.92 11.32 120 43592 29349 79671327
Pruritus 135.32 11.32 499 43213 394149 79306527
Macular degeneration 133.52 11.32 81 43631 11215 79689461
Eye infection toxoplasmal 131.59 11.32 35 43677 517 79700159
Human antichimeric antibody positive 124.21 11.32 43 43669 1598 79699078
Body height below normal 122.13 11.32 45 43667 2008 79698668
Gastroenteritis viral 121.19 11.32 104 43608 24727 79675949
Obesity 120.78 11.32 121 43591 35004 79665672
Skin exfoliation 117.57 11.32 148 43564 54952 79645724
Completed suicide 116.85 11.32 4 43708 245763 79454913
Psoriasis 113.71 11.32 188 43524 89399 79611277
Chronic sinusitis 113.31 11.32 77 43635 12949 79687727
Chorioretinopathy 111.32 11.32 43 43669 2188 79698488
Skin atrophy 108.61 11.32 56 43656 5662 79695014
Hypothalamic pituitary adrenal axis suppression 107.94 11.32 27 43685 308 79700368
Soft tissue disorder 105.08 11.32 47 43665 3468 79697208
Retinal artery occlusion 104.76 11.32 46 43666 3248 79697428
Infective scleritis 102.50 11.32 19 43693 39 79700637
Skin fissures 101.34 11.32 72 43640 13001 79687675
Maculopathy 98.18 11.32 42 43670 2783 79697893
Immunodeficiency 95.85 11.32 86 43626 21682 79678994
Adrenal suppression 95.70 11.32 34 43678 1365 79699311
Acute kidney injury 93.83 11.32 88 43624 519316 79181360
Paraesthesia oral 86.45 11.32 79 43633 20392 79680284
Ankle arthroplasty 85.49 11.32 32 43680 1493 79699183
Necrotising scleritis 80.13 11.32 20 43692 226 79700450
Eczema 79.79 11.32 105 43607 40713 79659963
Rhegmatogenous retinal detachment 79.44 11.32 19 43693 177 79700499
Product use in unapproved indication 79.37 11.32 309 43403 250050 79450626
Procedural pain 78.39 11.32 79 43633 23005 79677671
Intentional product use issue 78.02 11.32 221 43491 151891 79548785
Arthritis 75.36 11.32 183 43529 114697 79585979
Pneumonia viral 74.61 11.32 52 43660 9106 79691570
Antibody test positive 72.97 11.32 34 43678 2758 79697918
Therapy non-responder 72.64 11.32 158 43554 92147 79608529
Bone density increased 71.66 11.32 24 43688 805 79699871
Retinal pigment epithelial tear 71.42 11.32 21 43691 455 79700221
Therapeutic product effect incomplete 68.96 11.32 202 43510 141443 79559233
Cushing's syndrome 67.37 11.32 24 43688 971 79699705
Retinal detachment 67.26 11.32 49 43663 9198 79691478
Drug abuse 67.07 11.32 6 43706 162685 79537991
Death 65.12 11.32 133 43579 566381 79134295
Necrotising retinitis 62.13 11.32 24 43688 1221 79699455
Synovitis 61.37 11.32 202 43510 150532 79550144
Retinal haemorrhage 60.81 11.32 44 43668 8173 79692503
Hypopyon 60.52 11.32 23 43689 1119 79699557
Vaginal flatulence 60.08 11.32 29 43683 2546 79698130
Pseudoendophthalmitis 59.87 11.32 12 43700 43 79700633
Drug specific antibody 59.52 11.32 29 43683 2599 79698077
Short stature 58.99 11.32 20 43692 697 79699979
Bone density decreased 57.32 11.32 52 43660 13295 79687381
Vaginal discharge 55.31 11.32 40 43672 7423 79693253
Hypocalcaemia 54.44 11.32 98 43614 49826 79650850
Fibromyalgia 53.92 11.32 113 43599 64227 79636449
Overdose 52.01 11.32 18 43694 184188 79516488
Product contamination 51.40 11.32 21 43691 1239 79699437
Red blood cell sedimentation rate abnormal 50.69 11.32 60 43652 20903 79679773
Cardiac arrest 50.02 11.32 16 43696 172080 79528596
Skin hypopigmentation 49.01 11.32 19 43693 976 79699700
Vitreous opacities 48.44 11.32 17 43695 658 79700018
Neutropenia 48.14 11.32 52 43660 287658 79413018
Eye inflammation 46.68 11.32 34 43678 6379 79694297
Injection site pain 45.86 11.32 166 43546 129672 79571004
Thrombocytopenia 45.43 11.32 47 43665 265212 79435464
Foot operation 45.42 11.32 32 43680 5701 79694975
Chorioretinal folds 44.96 11.32 9 43703 32 79700644
Conjunctival ulcer 43.62 11.32 10 43702 76 79700600
Injection site discolouration 43.61 11.32 35 43677 7579 79693097
Drug ineffective 43.61 11.32 832 42880 1080081 78620595
Dermatitis contact 43.53 11.32 41 43671 10992 79689684
Blindness 42.10 11.32 64 43648 28319 79672357
Spinal cord infarction 42.08 11.32 15 43697 608 79700068
Glaucoma 42.01 11.32 53 43659 19708 79680968
Female genital tract fistula 41.96 11.32 31 43681 5944 79694732
Infective uveitis 40.75 11.32 8 43704 25 79700651
Choroidal infarction 40.71 11.32 11 43701 173 79700503
Coma 40.70 11.32 4 43708 100645 79600031
Skin haemorrhage 40.67 11.32 41 43671 11940 79688736
Injection site calcification 40.52 11.32 8 43704 26 79700650
Product use issue 40.47 11.32 224 43488 209598 79491078
Nodule 40.14 11.32 56 43656 22938 79677738
Arthritis bacterial 39.93 11.32 36 43676 9130 79691546
Macular oedema 39.80 11.32 29 43683 5445 79695231
Human anti-human antibody test 39.58 11.32 13 43699 410 79700266
Liver function test abnormal 39.40 11.32 100 43612 64375 79636301
Retinal artery embolism 38.16 11.32 10 43702 139 79700537
Eye abscess 38.10 11.32 12 43700 330 79700346
Scleral thinning 37.77 11.32 8 43704 40 79700636
Cytomegalovirus chorioretinitis 37.47 11.32 28 43684 5462 79695214
Rhabdomyolysis 37.10 11.32 6 43706 103125 79597551
Bradycardia 36.98 11.32 14 43698 135543 79565133
Lipoatrophy 36.96 11.32 14 43698 675 79700001
Ocular hyperaemia 36.85 11.32 60 43652 28146 79672530
Intentional overdose 36.30 11.32 7 43705 105953 79594723
General physical health deterioration 35.64 11.32 60 43652 275178 79425498
Proctitis 35.64 11.32 29 43683 6403 79694273
Secondary adrenocortical insufficiency 34.05 11.32 21 43691 2993 79697683
Hyperadrenocorticism 33.52 11.32 11 43701 346 79700330
Cardio-respiratory arrest 33.51 11.32 9 43703 108501 79592175
Diabetic retinal oedema 33.46 11.32 11 43701 348 79700328
Radiculopathy 33.31 11.32 32 43680 8792 79691884
Limb discomfort 32.69 11.32 62 43650 32788 79667888
Cataract subcapsular 32.45 11.32 14 43698 947 79699729
Cross sensitivity reaction 32.41 11.32 22 43690 3690 79696986
Tractional retinal detachment 32.25 11.32 8 43704 88 79700588
Joint effusion 31.63 11.32 44 43668 17970 79682706
Eye pain 31.48 11.32 66 43646 37512 79663164
Blood cholesterol increased 31.23 11.32 109 43603 83611 79617065
Foot deformity 31.16 11.32 51 43661 24023 79676653
Pancytopenia 31.14 11.32 27 43685 165718 79534958
Dyspepsia 31.07 11.32 130 43582 108557 79592119
Mobility decreased 31.01 11.32 141 43571 122034 79578642
Electrocardiogram QT prolonged 30.90 11.32 6 43706 90380 79610296
Renal impairment 30.50 11.32 25 43687 157758 79542918
Vitritis 29.62 11.32 16 43696 1778 79698898
Macular fibrosis 29.32 11.32 12 43700 711 79699965
Ophthalmic herpes simplex 29.21 11.32 12 43700 718 79699958
Loss of personal independence in daily activities 28.78 11.32 122 43590 102458 79598218
Exposure via breast milk 28.76 11.32 13 43699 983 79699693
Retinal degeneration 28.76 11.32 14 43698 1252 79699424
Oesophageal perforation 28.73 11.32 15 43697 1556 79699120
Cystoid macular oedema 28.14 11.32 16 43696 1964 79698712
Open globe injury 27.89 11.32 7 43705 81 79700595
Eye pruritus 27.20 11.32 44 43668 20526 79680150
Metabolic acidosis 27.14 11.32 6 43706 82523 79618153
Symmetrical drug-related intertriginous and flexural exanthema 26.97 11.32 12 43700 874 79699802
Somnolence 26.63 11.32 57 43655 238924 79461752
Keratitis fungal 26.51 11.32 9 43703 315 79700361
Periorbital abscess 26.44 11.32 5 43707 12 79700664
Eye infection fungal 25.70 11.32 10 43702 519 79700157
Sinus polyp degeneration 25.68 11.32 6 43706 50 79700626
Quality of life decreased 25.48 11.32 30 43682 10390 79690286
Polypoidal choroidal vasculopathy 25.09 11.32 8 43704 229 79700447
Impaired quality of life 25.05 11.32 35 43677 14351 79686325
Septic shock 24.93 11.32 133 43579 122668 79578008
Sleep disorder 24.89 11.32 103 43609 85574 79615102
Pain 24.67 11.32 531 43181 703271 78997405
Subretinal fluid 24.47 11.32 11 43701 821 79699855
Cataract 24.14 11.32 82 43630 62038 79638638
Renal failure 24.04 11.32 46 43666 200922 79499754
Retinal deposits 23.88 11.32 7 43705 150 79700526
Soft tissue swelling 23.71 11.32 13 43699 1488 79699188
Skin discolouration 23.38 11.32 62 43650 40972 79659704
Pyloric abscess 23.27 11.32 4 43708 4 79700672
Kounis syndrome 23.08 11.32 19 43693 4263 79696413
Orbital infection 23.06 11.32 6 43706 81 79700595
Drug tolerance 22.93 11.32 26 43686 8649 79692027
Seizure 22.78 11.32 43 43669 188791 79511885
Febrile neutropenia 22.62 11.32 59 43653 230940 79469736
Alanine aminotransferase increased 22.39 11.32 34 43678 162536 79538140
Therapeutic product effect decreased 22.25 11.32 160 43552 163703 79536973
Retinal vasculitis 22.15 11.32 12 43700 1341 79699335
Corneal oedema 21.63 11.32 15 43697 2605 79698071
Disease recurrence 21.53 11.32 63 43649 44046 79656630
Prescribed underdose 21.49 11.32 49 43663 29465 79671211
Urticaria 21.33 11.32 174 43538 185027 79515649
Platelet count decreased 21.21 11.32 47 43665 194617 79506059
Hyponatraemia 21.01 11.32 41 43671 177807 79522869
Pneumonia 20.71 11.32 247 43465 659999 79040677
Product used for unknown indication 20.67 11.32 12 43700 1532 79699144
Postmenopausal haemorrhage 20.61 11.32 12 43700 1540 79699136
Ill-defined disorder 20.57 11.32 81 43631 65794 79634882
Eye irritation 20.53 11.32 39 43673 20642 79680034
Retinal scar 20.47 11.32 8 43704 420 79700256
Tendon rupture 20.37 11.32 29 43683 12097 79688579
Dehydration 20.25 11.32 69 43643 248118 79452558
Malignant neoplasm progression 20.15 11.32 27 43685 135963 79564713
Periarthritis 20.04 11.32 15 43697 2933 79697743
Skin swelling 19.96 11.32 17 43695 3997 79696679
Optic nerve compression 19.81 11.32 4 43708 15 79700661
Cardiac failure 19.80 11.32 34 43678 154808 79545868
Respiratory arrest 19.29 11.32 4 43708 57546 79643130
Anal ulcer 19.22 11.32 11 43701 1367 79699309
Foreign body reaction 19.19 11.32 6 43706 161 79700515
Skin weeping 19.15 11.32 10 43702 1037 79699639
Cauda equina syndrome 19.04 11.32 11 43701 1392 79699284
Decreased appetite 18.99 11.32 110 43602 342308 79358368
Myocardial infarction 18.82 11.32 46 43666 184083 79516593
Hyperkalaemia 18.75 11.32 21 43691 114377 79586299
Pulmonary fibrosis 18.72 11.32 60 43652 44052 79656624
Haemoglobin decreased 18.64 11.32 61 43651 222058 79478618
Drug reaction with eosinophilia and systemic symptoms 18.61 11.32 6 43706 64238 79636438
Detachment of retinal pigment epithelium 18.46 11.32 9 43703 807 79699869
Macular hole 18.41 11.32 9 43703 812 79699864
Gastrointestinal haemorrhage 18.38 11.32 33 43679 147686 79552990
Allergic reaction to excipient 18.33 11.32 7 43705 345 79700331
Atrial fibrillation 18.28 11.32 52 43660 197834 79502842
Aspartate aminotransferase increased 18.14 11.32 30 43682 138611 79562065
Incorrect route of product administration 18.12 11.32 51 43661 34878 79665798
Arthropathy 18.08 11.32 162 43550 176949 79523727
Oral pain 18.07 11.32 48 43664 31750 79668926
Lactic acidosis 17.99 11.32 8 43704 70351 79630325
Depressed level of consciousness 17.84 11.32 16 43696 96636 79604040
Eyelid skin dryness 17.75 11.32 6 43706 207 79700469
Staphyloma 17.74 11.32 4 43708 28 79700648
Cutaneous nocardiosis 17.73 11.32 6 43706 208 79700468
Multiple organ dysfunction syndrome 17.69 11.32 24 43688 120222 79580454
Rash 17.63 11.32 428 43284 577930 79122746
Cerebral haemorrhage 17.40 11.32 5 43707 57668 79643008
Hypoglycaemia 17.38 11.32 18 43694 101576 79599100
Blood creatinine increased 17.25 11.32 37 43675 155020 79545656
Vitrectomy 17.23 11.32 6 43706 227 79700449
Atrophy 17.21 11.32 12 43700 2102 79698574
Melaena 17.09 11.32 6 43706 60884 79639792
Retinal oedema 17.04 11.32 9 43703 956 79699720
Infection 17.03 11.32 205 43507 241507 79459169
Skin burning sensation 17.02 11.32 28 43684 13244 79687432
Asthenia 16.97 11.32 189 43523 511500 79189176
Tenderness 16.94 11.32 39 43673 23603 79677073
Erythema 16.90 11.32 192 43520 223098 79477578
Epicondylitis 16.89 11.32 12 43700 2166 79698510
Orthostatic hypotension 16.71 11.32 5 43707 56159 79644517
Vitreous disorder 16.56 11.32 6 43706 255 79700421
Red blood cell sedimentation rate increased 16.43 11.32 59 43653 45883 79654793
Hepatotoxicity 16.35 11.32 4 43708 51348 79649328
Vertigo positional 16.35 11.32 14 43698 3316 79697360
Sepsis 16.33 11.32 84 43628 269344 79431332
Cushingoid 16.28 11.32 23 43689 9529 79691147
Dermatitis 16.20 11.32 36 43676 21285 79679391
Sinusitis 16.12 11.32 171 43541 195330 79505346
Gamma-glutamyltransferase increased 16.03 11.32 5 43707 54675 79646001
Vision blurred 15.90 11.32 106 43606 105792 79594884
Mucosal inflammation 15.85 11.32 11 43701 75569 79625107
Endometrial thickening 15.81 11.32 6 43706 291 79700385
Upper respiratory tract infection bacterial 15.79 11.32 5 43707 140 79700536
Product dose omission issue 15.75 11.32 206 43506 247331 79453345
Confusional state 15.64 11.32 106 43606 317891 79382785
Delirium 15.63 11.32 14 43698 84613 79616063
Hepatic failure 15.59 11.32 7 43705 61205 79639471
Purpura senile 15.57 11.32 7 43705 523 79700153
Lethargy 15.56 11.32 13 43699 81279 79619397
Conjunctival oedema 15.50 11.32 9 43703 1149 79699527
Tarsal tunnel syndrome 15.49 11.32 7 43705 529 79700147
Serotonin syndrome 15.37 11.32 3 43709 45024 79655652
Subretinal fibrosis 15.24 11.32 5 43707 157 79700519
Aspirin-exacerbated respiratory disease 15.16 11.32 9 43703 1198 79699478
Expired product administered 15.13 11.32 19 43693 7032 79693644
Interstitial lung disease 15.07 11.32 24 43688 112576 79588100
Fall 15.04 11.32 183 43529 487446 79213230
Pneumonia lipoid 15.01 11.32 5 43707 165 79700511
Retinal exudates 14.96 11.32 9 43703 1226 79699450
Injection site fibrosis 14.91 11.32 3 43709 11 79700665
Anaemia 14.90 11.32 164 43548 444851 79255825
Hypokalaemia 14.83 11.32 132 43580 143908 79556768
Unresponsive to stimuli 14.82 11.32 6 43706 55782 79644894
Altered state of consciousness 14.79 11.32 3 43709 43819 79656857
Bursitis infective 14.51 11.32 9 43703 1295 79699381
Anterior chamber cell 14.39 11.32 8 43704 941 79699735
Retinal occlusive vasculitis 14.35 11.32 4 43708 71 79700605
Perioral dermatitis 14.34 11.32 6 43706 376 79700300
Iridoschisis 14.16 11.32 3 43709 15 79700661
Eye discharge 14.14 11.32 17 43695 6017 79694659
Choroiditis 14.04 11.32 9 43703 1372 79699304
Retinal fibrosis 14 11.32 3 43709 16 79700660
Scleral disorder 13.90 11.32 5 43707 208 79700468
Rapidly progressive osteoarthritis 13.85 11.32 3 43709 17 79700659
Joint injury 13.64 11.32 43 43669 31292 79669384
Respiratory failure 13.62 11.32 52 43660 180859 79519817
Anti-cyclic citrullinated peptide antibody positive 13.57 11.32 85 43627 83058 79617618
Eosinophilia 13.55 11.32 4 43708 45341 79655335
Condition aggravated 13.54 11.32 365 43347 500759 79199917
Resorption bone increased 13.50 11.32 9 43703 1466 79699210
Rheumatoid arthritis 13.48 11.32 174 43538 208296 79492380
Therapeutic response shortened 13.44 11.32 28 43684 15835 79684841
Periarthritis calcarea 13.42 11.32 4 43708 91 79700585
Oxygen saturation decreased 13.37 11.32 32 43680 129015 79571661
Anaphylactic reaction 13.29 11.32 85 43627 83658 79617018
Toxic epidermal necrolysis 13.20 11.32 4 43708 44577 79656099
Dermatophytosis 13.06 11.32 6 43706 471 79700205
Type I hypersensitivity 13.04 11.32 14 43698 4384 79696292
Diabetic ulcer 12.99 11.32 5 43707 252 79700424
Ocular lymphoma 12.99 11.32 4 43708 102 79700574
Dizziness 12.98 11.32 379 43333 526062 79174614
Periphlebitis 12.95 11.32 3 43709 24 79700652
Macular ischaemia 12.95 11.32 4 43708 103 79700573
Distal intestinal obstruction syndrome 12.94 11.32 7 43705 780 79699896
Conjunctival haemorrhage 12.89 11.32 16 43696 5849 79694827
Vitreous haze 12.88 11.32 4 43708 105 79700571
Application site pruritus 12.86 11.32 13 43699 3797 79696879
Retinal tear 12.82 11.32 9 43703 1593 79699083
Suicide attempt 12.76 11.32 16 43696 82916 79617760
Septic arthritis staphylococcal 12.74 11.32 7 43705 804 79699872
Cardiac failure congestive 12.72 11.32 38 43674 142364 79558312
Mental status changes 12.46 11.32 11 43701 66948 79633728
Pupillary reflex impaired 12.35 11.32 12 43700 3341 79697335
Uveitis 12.32 11.32 28 43684 16802 79683874
Oral candidiasis 12.30 11.32 40 43672 29588 79671088
Dyspnoea 12.29 11.32 367 43345 856658 78844018
Nasal oedema 12.23 11.32 9 43703 1715 79698961
Tachycardia 12.19 11.32 53 43659 177715 79522961
Plethoric face 12.18 11.32 3 43709 32 79700644
Application site pain 12.16 11.32 14 43698 4733 79695943
Eye infection viral 12.06 11.32 4 43708 130 79700546
Anterior chamber inflammation 12.00 11.32 6 43706 568 79700108
Cardiogenic shock 11.99 11.32 4 43708 41910 79658766
Stomatitis 11.92 11.32 128 43584 146629 79554047
Periorbital swelling 11.88 11.32 11 43701 2885 79697791
Lacrimation increased 11.84 11.32 33 43679 22444 79678232
White blood cell count decreased 11.81 11.32 58 43654 188230 79512446
Staphylococcal infection 11.73 11.32 63 43649 58232 79642444
Retinitis viral 11.70 11.32 4 43708 143 79700533
Ligament sprain 11.69 11.32 24 43688 13440 79687236
C-reactive protein 11.62 11.32 14 43698 4965 79695711
Skin plaque 11.59 11.32 21 43691 10724 79689952
Injection site reaction 11.57 11.32 60 43652 54725 79645951
Epilepsy 11.51 11.32 4 43708 40856 79659820
Sinus tachycardia 11.51 11.32 3 43709 36905 79663771
Retinoschisis 11.49 11.32 3 43709 41 79700635
Underdose 11.37 11.32 42 43670 33109 79667567
Arthritis infective 11.36 11.32 18 43694 8253 79692423
Mycobacterium kansasii infection 11.33 11.32 5 43707 357 79700319
Vitreous haemorrhage 11.33 11.32 12 43700 3701 79696975
Allergy to animal 11.32 11.32 8 43704 1431 79699245

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:50857 anti-allergic drugs
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents

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

DiseaseRelationSNOMED_IDDOID
Cerebral edema indication 2032001
Lichen planus indication 4776004 DOID:9201
Berylliosis indication 8247009 DOID:10322
Psoriasis indication 9014002 DOID:8893
Ankylosing spondylitis indication 9631008 DOID:7147
Rheumatic heart disease indication 23685000
Atopic dermatitis indication 24079001 DOID:3310
Inflammatory bowel disease indication 24526004 DOID:0050589
Multiple sclerosis indication 24700007 DOID:2377
Severe adrenal insufficiency indication 24867002
Sarcoidosis indication 31541009 DOID:11335
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001
Keloid scar indication 33659008
Crohn's disease indication 34000006
Tendinitis indication 34840004 DOID:971
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Angioedema indication 41291007 DOID:1558
Humoral hypercalcemia of malignancy indication 47709007
Articular gout indication 48440001 DOID:13189
Candidiasis of skin indication 49883006
Seborrheic dermatitis indication 50563003 DOID:8741
Edema of larynx indication 51599000
Nephrotic syndrome indication 52254009 DOID:1184
Lichen simplex chronicus indication 53891004
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Löffler's syndrome indication 64936001 DOID:9503
Pemphigus indication 65172003 DOID:9182
Granuloma annulare indication 65508009 DOID:3777
Tenosynovitis indication 67801009 DOID:970
Alopecia areata indication 68225006 DOID:986
Rheumatoid arthritis indication 69896004 DOID:7148
Transfusion reaction due to serum protein reaction indication 72284000
Epicondylitis indication 73583000 DOID:14087
Acquired thrombocytopenia indication 74576004 DOID:11126
Sympathetic uveitis indication 75315001 DOID:12029
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Autoimmune disease indication 85828009
Infection by larvae of Trichinella spiralis indication 88264003
Pruritus ani indication 90446007
Acute lymphoid leukemia indication 91857003 DOID:9952
Subacute bursitis indication 109298000
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009
Non-Hodgkin's lymphoma indication 118601006
Mycosis fungoides indication 118618005
Uveitis indication 128473001 DOID:13141
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Transplanted organ rejection indication 213148006
Scalp psoriasis indication 238608008
Adrenogenital disorder indication 267395000 DOID:0050811
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Seasonal allergic rhinitis indication 367498001
Disorder of eye indication 371405004 DOID:5614
Adrenal cortical hypofunction indication 386584007 DOID:10493
Erythroderma indication 399992009
Primary cutaneous T-cell lymphoma indication 400122007
Asthma management indication 406162001
Autoimmune hemolytic anemia indication 413603009 DOID:718
Giant cell arteritis indication 414341000 DOID:13375
Synovitis indication 416209007 DOID:2703
Aphthous ulcer of mouth indication 426965005 DOID:9663
Post traumatic osteoarthritis indication 699262001
Severe Ocular Inflammation indication
Chronic Non-Allergic Rhinitis indication
Cystic Aponeurosis Tumor indication
Systemic Dermatomyositis indication
Allergic Rhinitis Prevention indication
Gingival Disorders indication
Erythroblastic Anemia indication
Transfusion Reaction Urticaria indication
Vitrectomy Adjunct to Enhance Visualization indication
Synovitis due to Osteoarthritis indication
Respiratory distress syndrome in the newborn off-label use 46775006
Congenital hypoplastic anemia off-label use 88854002 DOID:1339
Severe chronic obstructive pulmonary disease off-label use 313299006
Neonatal Bronchopulmonary Dysplasia off-label use
Infection by Strongyloides contraindication 1214006 DOID:10955
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Inactive tuberculosis contraindication 11999007
Epistaxis contraindication 12441001
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Measles contraindication 14189004 DOID:8622
Disease caused by parasite contraindication 17322007
Cirrhosis of liver contraindication 19943007 DOID:5082
Arginase deficiency contraindication 23501004 DOID:9278
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Fungal infection of eye contraindication 31194008
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Herpes zoster keratoconjunctivitis contraindication 42448002
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Tuberculosis of eye contraindication 49107007
Cerebral malaria contraindication 53622003 DOID:14069
Tuberculosis contraindication 56717001
Congenital hyperammonemia, type I contraindication 62522004
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Candidiasis of mouth contraindication 79740000 DOID:14262
Perforation of nasal septum contraindication 80142000
Hyperglycemia contraindication 80394007 DOID:4195
Ornithine Carbamyltransferase Deficiency contraindication 80908008 DOID:9271
Open-angle glaucoma contraindication 84494001 DOID:1067
Bacterial infectious disease contraindication 87628006
Muscle atrophy contraindication 88092000 DOID:767
Herpes simplex contraindication 88594005 DOID:8566
Operation on nose contraindication 88733004
Bilateral cataracts contraindication 95722004
Seizure disorder contraindication 128613002
Disorder of muscle contraindication 129565002 DOID:423
Ophthalmic herpes simplex contraindication 186542001
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Telangiectasia disorder contraindication 247479008
Edema contraindication 267038008
Pathological fracture contraindication 268029009
Diverticulitis of gastrointestinal tract contraindication 271366000
Cerebral trauma contraindication 275382005
Oral infection contraindication 275393007
Varicella-zoster virus infection contraindication 309465005
Viral eye infection contraindication 312132001
Osteopenia contraindication 312894000
Skin irritation contraindication 367466007
Herpes zoster keratitis contraindication 397573005
Avascular necrosis of bone contraindication 397758007 DOID:10159
Citrullinemia contraindication 398680004 DOID:9273
Atrophoderma contraindication 399979006
Traumatic rupture of tendon contraindication 415749005
Exposure to varicella contraindication 444453009
Nasal Septal Ulcers contraindication
Periodontal Infections contraindication
Untreated Fungal Infection contraindication
Nasal Trauma contraindication
Nasal Candidiasis contraindication
Uncontrolled Bacterial Infections contraindication
Oropharyngeal Candidiasis contraindication
Arginosuccinate Lyase Deficiency contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Inflammation and related disorders Indication
Dogs Acute arthritis Indication
Dogs Allergic disorder Indication
Dogs Dermatologic disorders Indication
Cats Inflammation and related disorders Indication
Cats Acute arthritis Indication
Cats Allergic disorder Indication
Cats Dermatologic disorders Indication
Horses Inflammation and related disorders Indication

🐶 Veterinary products

ProductApplicantIngredients
Vetalog Parenteral Boehringer lngelheim Animal Health USA Inc. 1
Panolog Ointment Zoetis Inc. 4
Triamcinolone Acetonide Boehringer lngelheim Animal Health USA Inc. 1
Vetalog Cream Boehringer lngelheim Animal Health USA Inc. 1
Panolog Cream Zoetis Inc. 4
Vetalog Oral Powder Boehringer lngelheim Animal Health USA Inc. 1
Vetalog Boehringer lngelheim Animal Health USA Inc. 1
Triamcinolone Acetonide Suspension Cronus Pharma Specialities India Private Limited 1
DERMA-VET Ointment Med-Pharmex Inc. 4
Animax Ointment Fougera Pharmaceuticals Inc. 4
Derma 4 Ointment Zoetis Inc. 4
Derm-Otic Ointment Zoetis Inc. 4
Genesis Topical Spray Virbac AH Inc. 1
Derma-Vet Cream Med-Pharmex Inc. 4
Medalone Cream Med-Pharmex Inc. 1
Animax Cream Fougera Pharmaceuticals Inc. 4

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.08 acidic
pKa2 11.78 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
40MG/ML XIPERE BAUSCH AND LOMB INC N211950 Oct. 22, 2021 RX SUSPENSION INJECTION 8636713 May 2, 2027 TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS
40MG/ML (40MG/ML) TRIESENCE NOVARTIS N022048 Nov. 29, 2007 RX INJECTABLE INTRAVITREAL 8211880 March 10, 2029 TREATMENT OF OPHTHALMIC DISORDERS
40MG/ML (40MG/ML) TRIESENCE NOVARTIS N022048 Nov. 29, 2007 RX INJECTABLE INTRAVITREAL 8211880 March 10, 2029 VISUALIZATION DURING VITRECTOMY PROCEDURES
32MG/VIAL ZILRETTA PACIRA PHARMS INC N208845 Oct. 6, 2017 RX FOR SUSPENSION, EXTENDED RELEASE INTRA-ARTICULAR 9555048 Aug. 4, 2031 METHOD OF TREATING PAIN OR INFLAMMATION WITH AN INJECTABLE CONTROLLED OR SUSTAINED RELEASE FORMULATION OF TRIAMCINOLONE ACETONIDE
40MG/ML XIPERE BAUSCH AND LOMB INC N211950 Oct. 22, 2021 RX SUSPENSION INJECTION 9636332 Nov. 8, 2033 TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
40MG/ML XIPERE BAUSCH AND LOMB INC N211950 Oct. 22, 2021 RX SUSPENSION INJECTION Oct. 22, 2024 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 9.30 WOMBAT-PK CHEMBL
Annexin A1 Cytosolic other WOMBAT-PK
Progesterone receptor Transcription factor Ki 7.64 DRUG MATRIX

External reference:

IDSource
D00983 KEGG_DRUG
4017597 VANDF
4017599 VANDF
C0040866 UMLSCUI
CHEBI:71418 CHEBI
CHEBI:9667 CHEBI
1TA PDB_CHEM_ID
CHEMBL1504 ChEMBL_ID
D014222 MESH_DESCRIPTOR_UI
2867 IUPHAR_LIGAND_ID
F446C597KA UNII
6436 PUBCHEM_CID
DB00620 DRUGBANK_ID
10759 RXNORM
2967 MMSL
4582 MMSL
5613 MMSL
5614 MMSL
6440 MMSL
d00620 MMSL
002188 NDDF
002189 NDDF
116594009 SNOMEDCT_US
395913005 SNOMEDCT_US
6028009 SNOMEDCT_US
C0040864 UMLSCUI
755 INN_ID
31307 PUBCHEM_CID
D014221 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KENALOG-40 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0293 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
KENALOG-40 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0293 INJECTION, SUSPENSION 40 mg INTRAMUSCULAR NDA 21 sections
KENALOG-80 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0315 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 21 sections
KENALOG-80 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0315 INJECTION, SUSPENSION 80 mg INTRAMUSCULAR NDA 21 sections
KENALOG-10 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0494 INJECTION, SUSPENSION 10 mg INTRA-ARTICULAR NDA 22 sections
TRIESENCE HUMAN PRESCRIPTION DRUG LABEL 1 0065-0543 INJECTION, SUSPENSION 40 mg OPHTHALMIC NDA 23 sections
TRIESENCE HUMAN PRESCRIPTION DRUG LABEL 1 0065-0543 INJECTION, SUSPENSION 40 mg OPHTHALMIC NDA 23 sections
TRIESENCE HUMAN PRESCRIPTION DRUG LABEL 1 0065-0543 INJECTION, SUSPENSION 40 mg OPHTHALMIC NDA 23 sections
Good Sense Nasal Allergy HUMAN OTC DRUG LABEL 1 0113-0443 SPRAY, METERED 55 ug NASAL ANDA 16 sections
Good Sense Nasal Allergy HUMAN OTC DRUG LABEL 1 0113-0443 SPRAY, METERED 55 ug NASAL ANDA 16 sections
basic care nasal allergy HUMAN OTC DRUG LABEL 1 0113-7005 SPRAY, METERED 55 ug NASAL ANDA 16 sections
triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0002 CREAM 5 mg TOPICAL ANDA 17 sections
triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0003 CREAM 0.25 mg TOPICAL ANDA 17 sections
triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0004 CREAM 1 mg TOPICAL ANDA 17 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0005 OINTMENT 0.25 mg TOPICAL ANDA 19 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0006 OINTMENT 1 mg TOPICAL ANDA 19 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0168-0081 CREAM 1 mg TOPICAL ANDA 16 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0168-0089 OINTMENT 1 mg TOPICAL ANDA 19 sections
triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0336 LOTION 0.25 mg TOPICAL ANDA 17 sections
triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0168-0337 LOTION 1 mg TOPICAL ANDA 17 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0165 CREAM 0.25 mg TOPICAL ANDA 18 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0165 CREAM 0.25 mg TOPICAL ANDA 18 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0170 CREAM 1 mg TOPICAL ANDA 18 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0170 CREAM 1 mg TOPICAL ANDA 18 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0175 CREAM 5 mg TOPICAL ANDA 18 sections
TRIDERM HUMAN PRESCRIPTION DRUG LABEL 1 0316-0175 CREAM 5 mg TOPICAL ANDA 18 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0316-0223 CREAM 1 mg TOPICAL ANDA 18 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0316-0223 CREAM 1 mg TOPICAL ANDA 18 sections
Allergy Nasal HUMAN OTC DRUG LABEL 1 0363-0811 SPRAY, METERED 55 ug NASAL ANDA 16 sections
Allergy Nasal HUMAN OTC DRUG LABEL 1 0363-0811 SPRAY, METERED 55 ug NASAL ANDA 16 sections