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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 16
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 5.023 Moderate 0.67
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.67
rat-kpuu-brain Rat brain Kpuu 0.035 % Moderate 0.67

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
Dermatitis atopic 580.96 13.57 389 135634 23083 90469341
Macular degeneration 432.97 13.57 398 135625 37572 90454852
Toxicity to various agents 370.66 13.57 14 136009 287832 90204592
Joint range of motion decreased 368.99 13.57 700 135323 134943 90357481
Obesity 353.00 13.57 596 135427 104911 90387513
Facet joint syndrome 333.42 13.57 559 135464 97830 90394594
Fibromyalgia 315.12 13.57 846 135177 205423 90287001
Lip dry 315.05 13.57 553 135470 100402 90392022
Type 2 diabetes mellitus 313.93 13.57 837 135186 202407 90290017
Acute kidney injury 298.74 13.57 59 135964 320328 90172096
Wound infection 297.88 13.57 556 135467 105846 90386578
Breast cancer stage III 294.42 13.57 486 135537 83961 90408463
Folliculitis 276.50 13.57 802 135221 203551 90288873
Psoriatic arthropathy 263.04 13.57 847 135176 227488 90264936
Adrenal insufficiency 245.18 13.57 262 135761 29659 90462765
Wheezing 235.31 13.57 839 135184 237241 90255183
Inflammation 233.97 13.57 693 135330 177899 90314525
Taste disorder 233.32 13.57 368 135655 61178 90431246
Irritable bowel syndrome 223.19 13.57 752 135271 206696 90285728
Synovitis 219.41 13.57 1028 134995 328724 90163700
Impaired healing 214.30 13.57 805 135218 233394 90259030
Blepharospasm 205.31 13.57 328 135695 55117 90437307
Peripheral venous disease 204.89 13.57 414 135609 83507 90408917
Rheumatic fever 204.19 13.57 598 135425 152523 90339901
Joint destruction 203.68 13.57 165 135858 13122 90479302
Urticaria 192.88 13.57 954 135069 311780 90180644
Neutropenia 192.38 13.57 50 135973 224854 90267570
Hypercholesterolaemia 191.87 13.57 450 135573 100442 90391982
Nail disorder 188.67 13.57 327 135696 58740 90433684
Mobility decreased 179.56 13.57 799 135224 249935 90242489
Bursitis 175.35 13.57 514 135509 131140 90361284
Polyarthritis 174.37 13.57 174 135849 18176 90474248
Prescribed underdose 173.59 13.57 362 135661 74657 90417767
Ill-defined disorder 171.13 13.57 638 135385 184253 90308171
Injury 169.52 13.57 665 135358 196684 90295740
Sleep disorder 168.25 13.57 665 135358 197365 90295059
Duodenal ulcer perforation 168.22 13.57 718 135305 220570 90271854
Road traffic accident 166.76 13.57 444 135579 107182 90385242
Helicobacter infection 165.52 13.57 727 135296 226123 90266301
Wound 163.07 13.57 890 135133 302090 90190334
Hypoaesthesia 162.46 13.57 913 135110 313297 90179127
Dry skin 159.00 13.57 385 135638 87688 90404736
Injection site atrophy 153.68 13.57 55 135968 789 90491635
Product quality issue 153.20 13.57 356 135667 78969 90413455
Dehydration 152.09 13.57 51 135972 194396 90298028
Chronic sinusitis 150.13 13.57 182 135841 23620 90468804
Somnolence 148.29 13.57 64 135959 209020 90283404
Dry mouth 148.29 13.57 608 135415 183451 90308973
C-reactive protein abnormal 147.75 13.57 474 135549 126955 90365469
Night sweats 146.61 13.57 476 135547 128290 90364134
Hand deformity 140.06 13.57 841 135182 295521 90196903
Muscle injury 139.52 13.57 580 135443 176074 90316350
Liver injury 138.63 13.57 565 135458 170002 90322422
Gait inability 138.51 13.57 509 135514 145947 90346477
Sepsis 137.46 13.57 49 135974 179765 90312659
Osteoarthritis 135.02 13.57 617 135406 195113 90297311
Pulmonary fibrosis 133.94 13.57 410 135613 107093 90385331
Febrile neutropenia 133.87 13.57 36 135987 158313 90334111
Therapeutic product effect incomplete 129.88 13.57 606 135417 193290 90299134
Death 128.28 13.57 312 135711 456239 90036185
Eczema 128.04 13.57 260 135763 52610 90439814
Swollen joint count increased 125.60 13.57 410 135613 110796 90381628
Skin exfoliation 124.85 13.57 299 135724 67614 90424810
Seizure 124.76 13.57 37 135986 152592 90339832
Pruritus 124.70 13.57 1301 134722 540224 89952200
C-reactive protein increased 124.51 13.57 571 135452 180818 90311606
Psoriasis 124.50 13.57 495 135528 147259 90345165
Stomatitis 124.38 13.57 771 135252 273927 90218497
Urinary tract infection 124.30 13.57 166 135857 305466 90186958
Live birth 122.16 13.57 326 135697 78781 90413643
Hyponatraemia 121.44 13.57 26 135997 133512 90358912
Rheumatoid factor positive 121.29 13.57 545 135478 171105 90321319
Dyspnoea 120.76 13.57 801 135222 880154 89612270
Fall 120.40 13.57 349 135674 481461 90010963
Intentional overdose 119.21 13.57 5 136018 93829 90398595
Epilepsy 118.20 13.57 330 135693 81876 90410548
Glossodynia 117.97 13.57 857 135166 320922 90171502
Blood cholesterol increased 117.91 13.57 620 135403 207392 90285032
Sciatica 117.40 13.57 377 135646 101005 90391419
Drug interaction 115.65 13.57 147 135876 276306 90216118
Atrial fibrillation 113.65 13.57 30 135993 133581 90358843
Onychomadesis 113.52 13.57 228 135795 45770 90446654
Vaginal flatulence 113.06 13.57 116 135907 12522 90479902
Back pain 111.83 13.57 190 135833 316985 90175439
Product use in unapproved indication 109.52 13.57 871 135152 335365 90157059
Drug abuse 109.49 13.57 3 136020 82344 90410080
Therapy non-responder 108.82 13.57 450 135573 136254 90356170
Cough 107.70 13.57 247 135776 368715 90123709
Anti-cyclic citrullinated peptide antibody 107.64 13.57 166 135857 27055 90465369
Systemic lupus erythematosus 107.44 13.57 918 135105 360978 90131446
Haemoglobin decreased 106.48 13.57 55 135968 161901 90330523
Renal impairment 105.64 13.57 16 136007 105405 90387019
Cardiac arrest 104.98 13.57 16 136007 104919 90387505
Lung disorder 104.46 13.57 474 135549 149409 90343015
Pancytopenia 104.21 13.57 26 135997 120237 90372187
Retinitis 103.86 13.57 198 135825 38260 90454164
White blood cell count decreased 103.70 13.57 61 135962 167048 90325376
Soft tissue disorder 101.11 13.57 69 135954 4221 90488203
Intentional product use issue 100.81 13.57 613 135410 216279 90276145
Recalled product administered 100.72 13.57 40 135983 775 90491649
C-reactive protein 100.60 13.57 174 135849 31193 90461231
Onychomycosis 99.18 13.57 191 135832 37185 90455239
Vaginal discharge 96.33 13.57 132 135891 19332 90473092
Cardiac failure 96.19 13.57 23 136000 109473 90382951
Infusion related reaction 96.14 13.57 1002 135021 415778 90076646
Human antichimeric antibody positive 96.07 13.57 49 135974 1737 90490687
Non-infectious endophthalmitis 95.84 13.57 30 135993 276 90492148
Platelet count decreased 95.39 13.57 43 135980 136926 90355498
Proctitis 95.13 13.57 116 135907 15143 90477281
Malignant neoplasm progression 94.76 13.57 22 136001 106848 90385576
Deep vein thrombosis postoperative 94.74 13.57 277 135746 70532 90421892
Underdose 94.13 13.57 233 135790 53784 90438640
Wheelchair user 93.40 13.57 84 135939 7701 90484723
Foot deformity 93.28 13.57 247 135776 59404 90433020
Bradycardia 93.16 13.57 9 136014 83838 90408586
Lower limb fracture 92.91 13.57 310 135713 84703 90407721
Pulmonary embolism 92.80 13.57 40 135983 130780 90361644
Female genital tract fistula 92.72 13.57 124 135899 17744 90474680
Body height below normal 92.61 13.57 51 135972 2117 90490307
Alanine aminotransferase increased 90.85 13.57 32 135991 118306 90374118
Disease progression 90.54 13.57 62 135961 156553 90335871
Gastrointestinal haemorrhage 89.73 13.57 14 136009 90234 90402190
Radiculopathy 89.34 13.57 124 135899 18381 90474043
Grip strength decreased 87.70 13.57 322 135701 92254 90400170
Respiratory failure 87.58 13.57 34 135989 118384 90374040
Ocular hypertension 87.21 13.57 45 135978 1635 90490789
Memory impairment 86.96 13.57 550 135473 196694 90295730
Pericarditis 86.38 13.57 697 135326 269454 90222970
Anti-cyclic citrullinated peptide antibody positive 85.61 13.57 628 135395 235805 90256619
Lupus-like syndrome 85.44 13.57 211 135812 48635 90443789
Musculoskeletal pain 85.34 13.57 493 135530 170758 90321666
Nausea 84.27 13.57 1168 134855 1109148 89383276
Myocardial infarction 84.23 13.57 27 135996 105945 90386479
Hypotension 83.93 13.57 232 135791 325165 90167259
Blood creatinine increased 83.90 13.57 24 135999 101362 90391062
Renal failure 83.89 13.57 46 135977 130961 90361463
Drug tolerance 83.44 13.57 118 135905 17798 90474626
Joint dislocation 82.70 13.57 197 135826 44385 90448039
Laryngitis 82.26 13.57 213 135810 50540 90441884
Paraesthesia oral 81.82 13.57 160 135863 31499 90460925
Electrocardiogram QT prolonged 79.91 13.57 8 136015 72448 90419976
Tremor 79.16 13.57 68 135955 153105 90339319
Weight increased 77.51 13.57 963 135060 416964 90075460
Syncope 77.38 13.57 52 135971 132611 90359813
Aspartate aminotransferase increased 77.04 13.57 29 135994 102908 90389516
Back injury 76.94 13.57 197 135826 46425 90445999
Anaemia 76.57 13.57 272 135751 352530 90139894
Dyspepsia 75.57 13.57 533 135490 197627 90294797
Cerebrovascular accident 75.36 13.57 46 135977 123487 90368937
Skin atrophy 75.05 13.57 64 135959 5465 90486959
Procedural pain 74.84 13.57 159 135864 33201 90459223
Multiple organ dysfunction syndrome 74.19 13.57 8 136015 68328 90424096
Skin fissures 74.14 13.57 121 135902 20688 90471736
Finger deformity 74.04 13.57 157 135866 32740 90459684
Pemphigus 73.51 13.57 782 135241 326082 90166342
Gastroenteritis viral 73.15 13.57 149 135874 30206 90462218
Cardio-respiratory arrest 72.24 13.57 6 136017 63134 90429290
Lupus vulgaris 71.90 13.57 188 135835 44871 90447553
Cardiac failure congestive 71.89 13.57 29 135994 98665 90393759
Oxygen saturation decreased 71.38 13.57 36 135987 107447 90384977
Product label confusion 70.99 13.57 125 135898 22725 90469699
Depressed level of consciousness 70.77 13.57 12 136011 72772 90419652
Seronegative arthritis 70.42 13.57 110 135913 18124 90474300
Retinal artery occlusion 69.42 13.57 43 135980 2228 90490196
Hypoglycaemia 69.07 13.57 11 136012 69837 90422587
Fatigue 68.78 13.57 1270 134753 1152753 89339671
Sleep disorder due to a general medical condition 67.67 13.57 183 135840 44555 90447869
Hyperkalaemia 67.09 13.57 9 136014 64955 90427469
Myalgia 66.30 13.57 100 135923 175025 90317399
Frequent bowel movements 65.23 13.57 211 135812 56724 90435700
Blister 64.96 13.57 626 135397 254372 90238052
Dislocation of vertebra 64.65 13.57 208 135815 55760 90436664
Exostosis 64.61 13.57 201 135822 52933 90439491
Mucosal inflammation 64.50 13.57 6 136017 57619 90434805
Red blood cell sedimentation rate increased 64.22 13.57 270 135753 82325 90410099
Cognitive disorder 64.15 13.57 13 136010 69394 90423030
Drug-induced liver injury 63.92 13.57 287 135736 90031 90402393
Autoimmune disorder 63.71 13.57 256 135767 76488 90415936
Infection 63.55 13.57 826 135197 361268 90131156
Liver function test increased 62.59 13.57 273 135750 84582 90407842
Metabolic acidosis 61.78 13.57 6 136017 55670 90436754
Dysphagia 61.56 13.57 47 135976 112231 90380193
Hypocholesterolaemia 60.98 13.57 61 135962 6388 90486036
Antibody test positive 60.95 13.57 44 135979 2945 90489479
Neutrophil count decreased 60.93 13.57 16 136007 71516 90420908
Diarrhoea 60.85 13.57 1018 135005 938172 89554252
Chills 60.72 13.57 65 135958 131916 90360508
Adjustment disorder with depressed mood 60.27 13.57 205 135818 56548 90435876
Immunodeficiency 59.63 13.57 171 135852 43063 90449361
Thrombocytopenia 59.02 13.57 142 135881 208583 90283841
Swelling 58.77 13.57 919 135104 418139 90074285
Suicide attempt 58.54 13.57 20 136003 75379 90417045
Gastrooesophageal reflux disease 58.00 13.57 438 135585 165899 90326525
Hyperhidrosis 57.46 13.57 72 135951 136233 90356191
Prescribed overdose 57.34 13.57 294 135729 97331 90395093
Sleep disorder due to general medical condition, insomnia type 56.78 13.57 359 135664 128335 90364089
Interstitial lung disease 56.38 13.57 22 136001 76383 90416041
Red blood cell sedimentation rate abnormal 56.20 13.57 117 135906 24087 90468337
Hepatic enzyme 55.11 13.57 53 135970 5291 90487133
Bone density increased 54.97 13.57 27 135996 882 90491542
Liver disorder 54.56 13.57 340 135683 120929 90371495
Joint stiffness 52.99 13.57 245 135778 77797 90414627
Feeling abnormal 52.85 13.57 107 135916 167128 90325296
Hallucination 52.07 13.57 17 136006 65942 90426482
Bone erosion 51.54 13.57 186 135837 52835 90439589
Rhabdomyolysis 50.84 13.57 8 136015 51248 90441176
Short stature 50.81 13.57 27 135996 1043 90491381
Hypothalamic pituitary adrenal axis suppression 50.35 13.57 19 136004 319 90492105
Lethargy 50.33 13.57 16 136007 63123 90429301
Blood pressure decreased 49.86 13.57 25 135998 74870 90417554
Lactic acidosis 49.77 13.57 8 136015 50455 90441969
Walking aid user 49.51 13.57 141 135882 35365 90457059
Ankle arthroplasty 49.51 13.57 38 135985 2793 90489631
Deep vein thrombosis 49.40 13.57 39 135984 91581 90400843
Intraocular pressure increased 49.29 13.57 57 135966 7036 90485388
Drug reaction with eosinophilia and systemic symptoms 49.09 13.57 4 136019 42754 90449670
Palpitations 48.97 13.57 81 135942 136647 90355777
Sedation 48.97 13.57 7 136016 48164 90444260
Pneumonia 47.92 13.57 672 135351 637387 89855037
Chest discomfort 46.80 13.57 85 135938 138280 90354144
Eye infection toxoplasmal 46.26 13.57 19 136004 403 90492021
Abortion spontaneous 46.22 13.57 12 136011 54044 90438380
Oral candidiasis 45.80 13.57 137 135886 35318 90457106
Endophthalmitis 45.57 13.57 45 135978 4640 90487784
Serotonin syndrome 45.05 13.57 3 136020 37884 90454540
Hepatic failure 44.83 13.57 4 136019 39724 90452700
Adverse reaction 44.40 13.57 121 135902 29591 90462833
Angioedema 44.18 13.57 21 136002 64855 90427569
Pneumonia aspiration 43.91 13.57 5 136018 40935 90451489
Hepatotoxicity 43.60 13.57 8 136015 45834 90446590
Disorientation 43.50 13.57 7 136016 44107 90448317
Dysarthria 43.08 13.57 14 136009 54468 90437956
Urticarial vasculitis 43.04 13.57 24 135999 1021 90491403
Hypoxia 42.72 13.57 28 135995 72371 90420053
Arthritis 42.70 13.57 411 135612 166904 90325520
Pulmonary oedema 42.42 13.57 20 136003 62060 90430364
Pneumonia viral 42.40 13.57 59 135964 8764 90483660
Hypocalcaemia 42.35 13.57 150 135873 42218 90450206
Colitis ulcerative 42.25 13.57 191 135832 60075 90432349
Ascites 41.97 13.57 10 136013 47730 90444694
Foetal exposure during pregnancy 41.97 13.57 7 136016 42968 90449456
X-ray abnormal 41.34 13.57 156 135867 45268 90447156
Neuropathy peripheral 41.29 13.57 90 135933 136880 90355544
Migraine 41.12 13.57 452 135571 189940 90302484
Rhegmatogenous retinal detachment 41.02 13.57 13 136010 125 90492299
Blood pressure fluctuation 40.52 13.57 14 136009 52399 90440025
Orthostatic hypotension 40.43 13.57 7 136016 41820 90450604
Nodule 40.20 13.57 109 135914 26577 90465847
Balance disorder 40.16 13.57 52 135971 97028 90395396
Paraesthesia 40.15 13.57 562 135461 249764 90242660
Gamma-glutamyltransferase increased 39.81 13.57 5 136018 37947 90454477
Hepatic cirrhosis 39.62 13.57 194 135829 63059 90429365
Heart rate increased 39.40 13.57 68 135955 112834 90379590
Haemorrhage 39.36 13.57 28 135995 69341 90423083
Cardiac disorder 39.36 13.57 18 136005 56854 90435570
General physical health deterioration 39.34 13.57 750 135273 354365 90138059
Pneumonitis 39.33 13.57 9 136014 44161 90448263
Osteonecrosis of jaw 39.02 13.57 6 136017 39097 90453327
Osteoporosis 38.74 13.57 263 135760 96268 90396156
Overdose 38.74 13.57 115 135908 157594 90334830
Respiratory arrest 38.56 13.57 3 136020 33308 90459116
Lower respiratory tract infection 38.30 13.57 558 135465 250101 90242323
Acute myocardial infarction 38.09 13.57 4 136019 34886 90457538
Melaena 37.96 13.57 4 136019 34793 90457631
Femur fracture 37.95 13.57 11 136012 46071 90446353
Cerebral haemorrhage 37.58 13.57 4 136019 34518 90457906
Swollen joint count 37.38 13.57 55 135968 8598 90483826
Dysgeusia 37.37 13.57 16 136007 52544 90439880
Maternal exposure timing unspecified 37.09 13.57 95 135928 22388 90470036
Angina pectoris 36.89 13.57 7 136016 39153 90453271
Peripheral swelling 36.80 13.57 845 135178 412261 90080163
Injection site reaction 36.43 13.57 250 135773 91830 90400594
Hepatic function abnormal 36.41 13.57 12 136011 46276 90446148
Joint swelling 36.13 13.57 1000 135023 502300 89990124
Drug specific antibody 36.00 13.57 30 135993 2482 90489942
Mouth ulceration 35.89 13.57 8 136015 39966 90452458
Visual impairment 35.69 13.57 329 135694 132036 90360388
Unresponsive to stimuli 35.52 13.57 7 136016 38114 90454310
Skin hypopigmentation 35.22 13.57 22 136001 1157 90491267
Toxic epidermal necrolysis 34.82 13.57 4 136019 32524 90459900
Blood bilirubin increased 34.67 13.57 11 136012 43459 90448965
Mental status changes 34.42 13.57 12 136011 44667 90447757
Chronic obstructive pulmonary disease 34.36 13.57 36 135987 73793 90418631
Transient ischaemic attack 34.31 13.57 11 136012 43165 90449259
Adverse event 34.30 13.57 297 135726 117121 90375303
International normalised ratio increased 34.29 13.57 14 136009 47302 90445122
Neoplasm progression 34.18 13.57 12 136011 44474 90447950
Hepatic enzyme increased 34.05 13.57 744 135279 359992 90132432
Heart rate decreased 33.93 13.57 19 136004 53486 90438938
Lipoatrophy 33.49 13.57 14 136009 311 90492113
Oedema 33.46 13.57 453 135570 199842 90292582
Generalised tonic-clonic seizure 33.39 13.57 6 136017 34897 90457527
Arrhythmia 33.26 13.57 11 136012 42321 90450103
Device expulsion 33.23 13.57 10 136013 40876 90451548
Wrong technique in product usage process 33.19 13.57 35 135988 71536 90420888
Periarthritis calcarea 33.02 13.57 6 136017 0 90492424
Asthenia 33.00 13.57 583 135440 533168 89959256
Urinary retention 33.00 13.57 8 136015 37736 90454688
Necrotising scleritis 32.98 13.57 12 136011 181 90492243
Cushing's syndrome 32.91 13.57 17 136006 619 90491805
Cystitis 32.81 13.57 31 135992 66687 90425737
Epistaxis 32.80 13.57 48 135975 85077 90407347
Blood alkaline phosphatase increased 32.07 13.57 16 136007 48063 90444361
Acute respiratory distress syndrome 32.07 13.57 3 136020 28683 90463741
Bone marrow failure 32.02 13.57 5 136018 32216 90460208
Hypertension 31.97 13.57 906 135117 456626 90035798
Thrombosis 31.59 13.57 38 135985 73213 90419211
Constipation 31.54 13.57 269 135754 280126 90212298
Hemiparesis 31.48 13.57 5 136018 31814 90460610
Multiple sclerosis relapse 31.17 13.57 20 136003 52285 90440139
Tractional retinal detachment 31.16 13.57 9 136014 61 90492363
Disturbance in attention 30.94 13.57 16 136007 47093 90445331
Injection site joint infection 30.59 13.57 6 136017 3 90492421
Aphasia 30.49 13.57 13 136010 42799 90449625
Restlessness 30.40 13.57 8 136015 35712 90456712
Disability 29.97 13.57 131 135892 40614 90451810
Agitation 29.80 13.57 34 135989 67064 90425360
Pancreatitis acute 29.71 13.57 6 136017 32109 90460315
Conjunctival ulcer 29.43 13.57 8 136015 42 90492382
Ocular lymphoma 29.41 13.57 10 136013 122 90492302
Therapy cessation 29.36 13.57 9 136014 36352 90456072
Haematocrit decreased 29.32 13.57 13 136010 41819 90450605
Blood calcium decreased 29.29 13.57 5 136018 30177 90462247
Vertigo 29.28 13.57 37 135986 69774 90422650
Haematoma 29.21 13.57 11 136012 39037 90453387
Cytomegalovirus infection 29.17 13.57 3 136020 26599 90465825
Retinal pigment epithelial tear 29.02 13.57 12 136011 259 90492165
Headache 28.96 13.57 1032 134991 861714 89630710
Chronic kidney disease 28.82 13.57 20 136003 50171 90442253
Coeliac disease 28.78 13.57 138 135885 44472 90447952
Ejection fraction decreased 28.68 13.57 3 136020 26250 90466174
Influenza like illness 28.63 13.57 48 135975 80563 90411861
Pulmonary hypertension 28.59 13.57 14 136009 42509 90449915
Blood creatine phosphokinase increased 28.24 13.57 8 136015 34015 90458409
Blood lactate dehydrogenase increased 28.24 13.57 3 136020 25929 90466495
Rash 28.12 13.57 1462 134561 794638 89697786
Sleep disorder due to general medical condition, hypersomnia type 28.09 13.57 24 135999 2055 90490369
Influenza 27.80 13.57 111 135912 139153 90353271
Secondary adrenocortical insufficiency 27.78 13.57 25 135998 2293 90490131
Blood pressure increased 27.02 13.57 179 135844 197038 90295386
Transaminases increased 26.96 13.57 11 136012 37181 90455243
Postmenopausal haemorrhage 26.77 13.57 25 135998 2405 90490019
Psychotic disorder 26.57 13.57 7 136016 31223 90461201
Palmar-plantar erythrodysaesthesia syndrome 26.42 13.57 5 136018 28018 90464406
Therapeutic response shortened 26.39 13.57 85 135938 22794 90469630
Therapeutic product effect decreased 26.34 13.57 573 135450 276998 90215426
Full blood count abnormal 26.25 13.57 11 136012 36586 90455838
Sinus polyp degeneration 26.22 13.57 8 136015 67 90492357
Dyskinesia 26.17 13.57 11 136012 36523 90455901
Arthropathy 26.06 13.57 727 135296 365515 90126909
Coronary artery disease 25.95 13.57 9 136014 33614 90458810
Respiratory distress 25.92 13.57 13 136010 38933 90453491
Hyperglycaemia 25.87 13.57 23 136000 50947 90441477
Rhinorrhoea 25.82 13.57 59 135964 88257 90404167
Hypothyroidism 25.75 13.57 25 135998 53102 90439322
Adrenal suppression 25.63 13.57 17 136006 992 90491432
Productive cough 25.47 13.57 48 135975 77015 90415409
Blood pressure systolic increased 25.44 13.57 30 135993 58315 90434109
Muscle spasms 25.20 13.57 524 135499 251359 90241065
Skin haemorrhage 25.18 13.57 80 135943 21300 90471124
Speech disorder 25.08 13.57 19 136004 45566 90446858
Tubulointerstitial nephritis 25.03 13.57 4 136019 25339 90467085
Hypercalcaemia 25.03 13.57 10 136013 34230 90458194
Pseudomeningocele 24.73 13.57 6 136017 18 90492406
Pyloric abscess 24.58 13.57 5 136018 4 90492420
Cytokine release syndrome 24.32 13.57 6 136017 27967 90464457
Stevens-Johnson syndrome 24.21 13.57 7 136016 29369 90463055
Drug level increased 24.04 13.57 6 136017 27756 90464668
Rash maculo-papular 23.92 13.57 16 136007 40917 90451507
Human anti-human antibody test 23.77 13.57 12 136011 416 90492008
Hip fracture 23.63 13.57 10 136013 33067 90459357
Normal newborn 23.59 13.57 83 135940 23279 90469145
Obstructive airways disorder 23.58 13.57 5 136018 25864 90466560
Spinal fusion surgery 23.56 13.57 55 135968 12228 90480196
Suicidal ideation 23.54 13.57 47 135976 73808 90418616
Metastases to liver 23.50 13.57 7 136016 28800 90463624
Pericardial effusion 23.47 13.57 13 136010 36820 90455604
Ulcer 23.39 13.57 10 136013 32872 90459552
Posterior reversible encephalopathy syndrome 23.29 13.57 3 136020 22336 90470088
Breast cancer 23.06 13.57 28 135995 53733 90438691
Ischaemic stroke 23.05 13.57 3 136020 22163 90470261
Skin swelling 22.94 13.57 38 135985 6576 90485848
Ear infection 22.78 13.57 181 135842 69594 90422830
Rebound atopic dermatitis 22.66 13.57 19 136004 1585 90490839
Cerebral infarction 22.55 13.57 6 136017 26590 90465834
Spondylitis 22.45 13.57 59 135964 14119 90478305
Intestinal obstruction 22.40 13.57 14 136009 37117 90455307
Proteinuria 22.29 13.57 4 136019 23287 90469137
Drug resistance 22.08 13.57 9 136014 30440 90461984
Unevaluable event 22.05 13.57 30 135993 54818 90437606
Rectal haemorrhage 21.96 13.57 205 135818 82539 90409885
Faeces discoloured 21.90 13.57 3 136020 21317 90471107
Upper gastrointestinal haemorrhage 21.87 13.57 4 136019 22972 90469452
Renal disorder 21.85 13.57 15 136008 37844 90454580
Skin plaque 21.74 13.57 47 135976 9928 90482496
Shock 21.71 13.57 8 136015 28770 90463654
Bursitis infective 21.57 13.57 18 136005 1492 90490932
Hot flush 21.52 13.57 35 135988 59453 90432971
Dyspnoea exertional 21.37 13.57 48 135975 72240 90420184
Haematemesis 21.35 13.57 12 136011 33714 90458710
Encephalopathy 21.21 13.57 23 136000 46421 90446003
Subcutaneous drug absorption impaired 21.08 13.57 56 135967 13489 90478935
Acute respiratory failure 21.03 13.57 20 136003 42898 90449526
Dementia 20.97 13.57 5 136018 23856 90468568
Scratch 20.95 13.57 46 135977 9820 90482604
Chorioretinal folds 20.86 13.57 5 136018 14 90492410
Cholelithiasis 20.82 13.57 29 135994 52477 90439947
COVID-19 20.80 13.57 158 135865 168685 90323739
Drug dependence 20.74 13.57 9 136014 29318 90463106
Insomnia 20.73 13.57 651 135372 332823 90159601
Incorrect product administration duration 20.69 13.57 70 135953 19252 90473172
Depressed mood 20.67 13.57 27 135996 50195 90442229
Retinal deposits 20.62 13.57 7 136016 85 90492339
Bone density decreased 20.52 13.57 65 135958 17280 90475144
Blood urea increased 20.47 13.57 10 136013 30403 90462021
Tender joint count 20.42 13.57 17 136006 1404 90491020
Blood potassium decreased 20.32 13.57 25 135998 47702 90444722
Rheumatoid arthritis 20.23 13.57 403 135620 362211 90130213
Lymphocyte count decreased 20.08 13.57 14 136009 35036 90457388
Pneumocystis jirovecii pneumonia 20.07 13.57 4 136019 21612 90470812
Diabetes mellitus 20.07 13.57 42 135981 64833 90427591
Porphyria acute 20.03 13.57 66 135957 17909 90474515
Atrophy 20.01 13.57 20 136003 2092 90490332
Scleral thinning 19.80 13.57 6 136017 49 90492375
Dysphonia 19.38 13.57 41 135982 63043 90429381
Hypomagnesaemia 19.37 13.57 15 136008 35573 90456851
Limb discomfort 19.21 13.57 110 135913 37950 90454474
Orbital infection 18.97 13.57 7 136016 110 90492314
Movement disorder 18.84 13.57 10 136013 29009 90463415
Neuralgia 18.83 13.57 12 136011 31488 90460936
Swelling face 18.78 13.57 61 135962 81291 90411133
Infective uveitis 18.78 13.57 4 136019 5 90492419
Rapidly progressive osteoarthritis 18.76 13.57 5 136018 24 90492400
Abdominal pain lower 18.73 13.57 11 136012 30166 90462258
Haematuria 18.67 13.57 15 136008 34922 90457502
Cardiomegaly 18.66 13.57 3 136020 18922 90473502
Skin weeping 18.62 13.57 22 136001 2778 90489646
Kounis syndrome 18.56 13.57 21 136002 2532 90489892
Hypophagia 18.50 13.57 16 136007 35921 90456503
Bone pain 18.45 13.57 41 135982 61942 90430482
Face oedema 18.42 13.57 6 136017 23312 90469112
Mental disorder 18.39 13.57 13 136010 32305 90460119
Hip arthroplasty 18.35 13.57 185 135838 76023 90416401
Diabetic ketoacidosis 18.05 13.57 7 136016 24400 90468024
Drug eruption 17.94 13.57 16 136007 35391 90457033
Injection site pain 17.90 13.57 363 135660 173336 90319088
No adverse event 17.83 13.57 168 135855 67814 90424610
Coordination abnormal 17.77 13.57 5 136018 21351 90471073
Gastroenteritis 17.66 13.57 11 136012 29218 90463206
Clostridium difficile infection 17.63 13.57 17 136006 36228 90456196
Anaphylactic shock 17.63 13.57 13 136010 31604 90460820
Aggression 17.60 13.57 9 136014 26659 90465765
Eye pruritus 17.44 13.57 88 135935 28939 90463485
Product prescribing error 17.32 13.57 12 136011 30133 90462291
Periorbital abscess 17.31 13.57 4 136019 9 90492415
Electrolyte imbalance 17.25 13.57 7 136016 23738 90468686
Neck pain 17.11 13.57 253 135770 113710 90378714
Red blood cell count decreased 17.02 13.57 27 135996 46324 90446100
Motor dysfunction 16.96 13.57 4 136019 19226 90473198
Haemoptysis 16.95 13.57 15 136008 33305 90459119
Foot operation 16.93 13.57 40 135983 8961 90483463
Full blood count decreased 16.82 13.57 12 136011 29677 90462747
Plasma cell myeloma 16.75 13.57 22 136001 40806 90451618
Coagulopathy 16.70 13.57 7 136016 23282 90469142
Muscular weakness 16.63 13.57 417 135606 206249 90286175
Soft tissue atrophy 16.59 13.57 5 136018 40 90492384
Device related infection 16.58 13.57 9 136014 25777 90466647
Tendon dislocation 16.51 13.57 3 136020 0 90492424
Status epilepticus 16.50 13.57 4 136019 18870 90473554
Nervous system disorder 16.29 13.57 6 136017 21587 90470837
Food allergy 16.22 13.57 9 136014 25469 90466955
Caesarean section 16.12 13.57 4 136019 18573 90473851
Malnutrition 16.09 13.57 4 136019 18554 90473870
Depression 15.92 13.57 576 135447 300025 90192399
Head injury 15.92 13.57 14 136009 31174 90461250
Small intestinal obstruction 15.85 13.57 6 136017 21228 90471196
Pulmonary mass 15.82 13.57 12 136011 28760 90463664
Gallbladder disorder 15.81 13.57 5 136018 19798 90472626
Hyperthyroidism 15.77 13.57 4 136019 18306 90474118
Peritonitis 15.69 13.57 5 136018 19700 90472724
Gastric ulcer 15.68 13.57 11 136012 27437 90464987
Liver function test abnormal 15.57 13.57 130 135893 50715 90441709
Product substitution issue 15.39 13.57 4 136019 18004 90474420
Complication associated with device 15.37 13.57 5 136018 19444 90472980
Pulmonary congestion 15.35 13.57 5 136018 19428 90472996
Poor quality sleep 15.33 13.57 9 136014 24684 90467740
Hypertensive crisis 15.10 13.57 4 136019 17780 90474644
Eating disorder 15.07 13.57 12 136011 28061 90464363
Hepatic steatosis 15.06 13.57 20 136003 36925 90455499
Keratitis fungal 15.05 13.57 7 136016 202 90492222
Injection site fibrosis 15.05 13.57 4 136019 19 90492405
Hemiplegia 14.99 13.57 3 136020 16157 90476267
Lung neoplasm malignant 14.85 13.57 9 136014 24264 90468160
Heart rate irregular 14.84 13.57 9 136014 24259 90468165
Soft tissue swelling 14.84 13.57 14 136009 1364 90491060
Blood glucose increased 14.84 13.57 83 135940 95163 90397261
Confusional state 14.77 13.57 715 135308 385490 90106934
Lymphopenia 14.69 13.57 8 136015 22873 90469551
Escherichia infection 14.64 13.57 3 136020 15892 90476532
Vitreous opacities 14.62 13.57 9 136014 461 90491963
Breast cancer stage II 14.61 13.57 97 135926 35237 90457187
Nasopharyngitis 14.59 13.57 749 135274 406355 90086069
Cellulitis 14.56 13.57 79 135944 91258 90401166
Hepatitis 14.38 13.57 166 135857 70573 90421851
Stress 14.34 13.57 68 135955 81327 90411097
Factitious disorder 14.32 13.57 6 136017 134 90492290
Acute hepatic failure 14.32 13.57 8 136015 22553 90469871
Mitral valve incompetence 14.28 13.57 8 136015 22516 90469908
Hypothermia 14.22 13.57 3 136020 15572 90476852
Device issue 14.20 13.57 14 136009 29523 90462901
Diverticulitis 14.19 13.57 29 135994 45158 90447266
Sinus bradycardia 14.04 13.57 4 136019 16948 90475476
Spinal cord infarction 14.02 13.57 8 136015 356 90492068
Myelodysplastic syndrome 13.88 13.57 7 136016 20896 90471528
Lymphadenopathy 13.85 13.57 30 135993 45745 90446679
Flushing 13.85 13.57 77 135946 88414 90404010
Fracture 13.77 13.57 8 136015 22068 90470356
Tricuspid valve incompetence 13.77 13.57 4 136019 16727 90475697
Poisoning 13.75 13.57 3 136020 15214 90477210
Mental impairment 13.75 13.57 4 136019 16716 90475708
Cyanosis 13.71 13.57 6 136017 19449 90472975
Pharyngitis 13.62 13.57 8 136015 21939 90470485

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 784.35 14.32 277 20951 12127 42587980
Pruritus 499.18 14.32 538 20690 188233 42411874
Dry skin 452.48 14.32 288 20940 48050 42552057
Skin exfoliation 298.15 14.32 210 21018 41343 42558764
Product use in unapproved indication 285.54 14.32 402 20826 184054 42416053
Skin fissures 251.75 14.32 114 21114 9562 42590545
Endophthalmitis 216.76 14.32 82 21146 4351 42595756
Eczema 198.60 14.32 152 21076 33934 42566173
Non-infectious endophthalmitis 165.80 14.32 36 21192 231 42599876
Intraocular pressure increased 155.40 14.32 72 21156 6361 42593746
Drug ineffective 154.97 14.32 670 20558 629527 41970580
Rash 147.50 14.32 383 20845 276571 42323536
Ocular hypertension 139.33 14.32 42 21186 1099 42599008
Injection site pain 113.71 14.32 142 21086 57656 42542451
Skin haemorrhage 113.08 14.32 62 21166 7823 42592284
Visual acuity reduced 112.69 14.32 83 21145 17467 42582640
Pseudomeningocele 107.46 14.32 18 21210 16 42600091
Infective scleritis 103.06 14.32 19 21209 43 42600064
Recalled product administered 98.57 14.32 29 21199 696 42599411
Chorioretinopathy 95.90 14.32 34 21194 1497 42598610
Toxicity to various agents 90.73 14.32 6 21222 229130 42370977
Pseudoendophthalmitis 89.77 14.32 18 21210 73 42600034
Ocular hyperaemia 88.14 14.32 69 21159 15894 42584213
Nightmare 85.09 14.32 82 21146 24930 42575177
Hypothalamic pituitary adrenal axis suppression 82.81 14.32 21 21207 282 42599825
Dry eye 81.26 14.32 65 21163 15441 42584666
Psoriasis 80.90 14.32 110 21118 48494 42551613
Sleep disorder due to a general medical condition 80.65 14.32 68 21160 17385 42582722
Eye pruritus 77.86 14.32 56 21172 11356 42588751
Nephrolithiasis 76.44 14.32 93 21135 36737 42563370
Scratch 71.68 14.32 40 21188 5221 42594886
Macular oedema 71.11 14.32 35 21193 3534 42596573
Sedation 69.92 14.32 81 21147 30394 42569713
Therapeutic response shortened 65.09 14.32 54 21174 13500 42586607
Retinal artery occlusion 63.67 14.32 28 21200 2187 42597920
Skin hypopigmentation 63.05 14.32 18 21210 387 42599720
Adrenal suppression 62.61 14.32 22 21206 943 42599164
Eye infection toxoplasmal 62.14 14.32 17 21211 311 42599796
Product dose omission issue 61.84 14.32 193 21035 154172 42445935
Injection site atrophy 61.20 14.32 13 21215 74 42600033
Eye pain 56.35 14.32 55 21173 16975 42583132
Treatment failure 55.00 14.32 106 21122 62518 42537589
Necrotising retinitis 53.79 14.32 20 21208 1010 42599097
Maculopathy 52.95 14.32 20 21208 1055 42599052
Conjunctivitis 52.87 14.32 47 21181 12892 42587215
Vitreous opacities 51.63 14.32 16 21212 460 42599647
Erythema 51.12 14.32 144 21084 108649 42491458
Cerebrospinal fistula 50.26 14.32 9 21219 16 42600091
Dermatitis 48.25 14.32 43 21185 11832 42588275
Eye inflammation 48.06 14.32 26 21202 3192 42596915
Retinal artery embolism 48.04 14.32 9 21219 23 42600084
Therapeutic response decreased 47.36 14.32 74 21154 36938 42563169
Exposure via skin contact 46.96 14.32 30 21198 5008 42595099
Glaucoma 46.27 14.32 36 21192 8212 42591895
Injection site swelling 45.60 14.32 49 21179 16924 42583183
Rash pruritic 42.73 14.32 67 21161 33536 42566571
Eye abscess 41.82 14.32 11 21217 172 42599935
Retinal haemorrhage 40.93 14.32 29 21199 5741 42594366
Rash macular 40.60 14.32 46 21182 16845 42583262
Eye irritation 40.17 14.32 38 21190 11280 42588827
Acute kidney injury 39.58 14.32 77 21151 367260 42232847
Necrotising scleritis 39.28 14.32 9 21219 76 42600031
Blindness 38.27 14.32 46 21182 17932 42582175
Drug abuse 37.96 14.32 4 21224 104767 42495340
Visual impairment 37.86 14.32 73 21155 43040 42557067
Hypopyon 37.81 14.32 13 21215 522 42599585
Macular fibrosis 37.80 14.32 12 21216 374 42599733
Cardiac arrest 37.57 14.32 5 21223 109315 42490792
Skin burning sensation 36.30 14.32 30 21198 7457 42592650
Thrombocytopenia 35.26 14.32 26 21202 190253 42409854
Dermatitis contact 35.14 14.32 24 21204 4479 42595628
Neutropenia 34.74 14.32 29 21199 199402 42400705
Vision blurred 34.47 14.32 80 21148 53619 42546488
Skin swelling 34.39 14.32 20 21208 2822 42597285
Hyperhidrosis 34.20 14.32 111 21117 90401 42509706
Open globe injury 34.17 14.32 8 21220 75 42600032
Product use issue 33.52 14.32 99 21129 76652 42523455
Cauda equina syndrome 33.48 14.32 14 21214 966 42599141
Eye discharge 33.42 14.32 20 21208 2975 42597132
Accidental exposure to product 32.17 14.32 45 21183 20348 42579759
Seborrhoeic keratosis 32.14 14.32 16 21212 1655 42598452
Skin irritation 31.91 14.32 28 21200 7546 42592561
Lacrimation increased 31.68 14.32 34 21194 11724 42588383
Death 31.23 14.32 125 21103 471060 42129047
Disseminated paracoccidioidomycosis 30.85 14.32 6 21222 20 42600087
Periorbital abscess 30.68 14.32 5 21223 3 42600104
Skin weeping 30.02 14.32 15 21213 1564 42598543
Anaemia 29.94 14.32 59 21169 280219 42319888
Expired product administered 29.70 14.32 21 21207 4142 42595965
Injection site calcification 29.56 14.32 5 21223 5 42600102
Cystoid macular oedema 29.50 14.32 13 21215 1020 42599087
Retinal detachment 29.27 14.32 25 21203 6500 42593607
Uveitis-glaucoma-hyphaema syndrome 29.09 14.32 5 21223 6 42600101
Symmetrical drug-related intertriginous and flexural exanthema 28.32 14.32 12 21216 856 42599251
Choroidal infarction 28.03 14.32 7 21221 88 42600019
Eye swelling 27.86 14.32 32 21196 11888 42588219
Spinal cord infarction 27.85 14.32 11 21217 655 42599452
Adrenal insufficiency 27.27 14.32 40 21188 18884 42581223
Rhegmatogenous retinal detachment 27.20 14.32 7 21221 100 42600007
Rebound atopic dermatitis 27.11 14.32 12 21216 952 42599155
Product contamination 26.74 14.32 12 21216 983 42599124
Illness 26.69 14.32 46 21182 24884 42575223
Drug effect less than expected 26.47 14.32 19 21209 3838 42596269
Diabetic retinal oedema 26.02 14.32 8 21220 224 42599883
Neurodermatitis 25.93 14.32 11 21217 787 42599320
Type I hypersensitivity 25.57 14.32 15 21213 2151 42597956
Intentional product use issue 25.26 14.32 86 21142 71747 42528360
Confusional state 24.96 14.32 28 21200 167569 42432538
Sleep disorder 24.89 14.32 66 21162 48029 42552078
Product used for unknown indication 24.59 14.32 12 21216 1189 42598918
Oesophageal perforation 24.29 14.32 12 21216 1221 42598886
General physical health deterioration 23.94 14.32 24 21204 151222 42448885
Rhabdomyolysis 23.63 14.32 5 21223 78014 42522093
Madarosis 23.43 14.32 9 21219 497 42599610
Retinal pigment epithelial tear 23.15 14.32 8 21220 326 42599781
Off label use 22.95 14.32 445 20783 637890 41962217
Overdose 22.77 14.32 12 21216 105252 42494855
Human T-cell lymphotropic virus type I infection 22.17 14.32 5 21223 39 42600068
Pain 22.04 14.32 202 21026 244646 42355461
Orbital compartment syndrome 22.03 14.32 4 21224 8 42600099
Injection site discolouration 21.85 14.32 13 21215 1913 42598194
Infective uveitis 21.71 14.32 4 21224 9 42600098
Febrile neutropenia 21.67 14.32 37 21191 185666 42414441
Optic nerve compression 21.14 14.32 4 21224 11 42600096
Arthritis infective 21.05 14.32 17 21211 4089 42596018
Skin atrophy 21.00 14.32 14 21214 2511 42597596
Cross sensitivity reaction 20.83 14.32 12 21216 1663 42598444
Retinal degeneration 20.45 14.32 9 21219 704 42599403
Cerebrospinal fluid leakage 20.39 14.32 9 21219 709 42599398
Choroiditis 20.23 14.32 11 21217 1364 42598743
Central vision loss 20.20 14.32 4 21224 15 42600092
Conjunctival ulcer 20.16 14.32 5 21223 61 42600046
Subretinal fluid 20.09 14.32 9 21219 734 42599373
Cataract 20.07 14.32 46 21182 30558 42569549
Hypotension 19.90 14.32 64 21164 257567 42342540
No adverse event 19.63 14.32 53 21175 38968 42561139
Skin plaque 19.51 14.32 19 21209 5844 42594263
Cardio-respiratory arrest 19.39 14.32 3 21225 58633 42541474
Arthralgia 19.32 14.32 171 21057 205067 42395040
Renal failure 19.30 14.32 26 21202 143700 42456407
Atrophy 19.13 14.32 10 21218 1145 42598962
Cataract subcapsular 18.95 14.32 8 21220 565 42599542
Seborrhoeic dermatitis 18.69 14.32 12 21216 2020 42598087
Somnolence 18.47 14.32 26 21202 141079 42459028
Ophthalmic herpes simplex 18.43 14.32 7 21221 375 42599732
Vitritis 18.40 14.32 10 21218 1239 42598868
Pancytopenia 18.27 14.32 19 21209 117724 42482383
Haemangioma of skin 18.26 14.32 6 21222 209 42599898
Eye infection 18.13 14.32 16 21212 4345 42595762
Anterior chamber inflammation 18.05 14.32 7 21221 397 42599710
Psoriatic arthropathy 18.03 14.32 39 21189 24928 42575179
Renal impairment 18.01 14.32 17 21211 110211 42489896
Therapy non-responder 17.98 14.32 63 21165 53296 42546811
Retinal vascular occlusion 17.89 14.32 6 21222 223 42599884
Retinal oedema 17.83 14.32 9 21219 959 42599148
Pneumonia lipoid 17.81 14.32 5 21223 101 42600006
Condition aggravated 17.67 14.32 203 21025 260551 42339556
Arthritis bacterial 17.65 14.32 18 21210 5850 42594257
Periarthritis 17.47 14.32 10 21218 1370 42598737
Product dose omission in error 17.16 14.32 21 21207 8333 42591774
Dermatitis allergic 16.91 14.32 21 21207 8462 42591645
Eczema infantile 16.88 14.32 3 21225 5 42600102
Therapeutic product effect incomplete 16.82 14.32 75 21153 70864 42529243
Melanocytic naevus 16.65 14.32 13 21215 2979 42597128
Rash erythematous 16.56 14.32 44 21184 32047 42568060
Chorioretinal folds 16.52 14.32 3 21225 6 42600101
Distal intestinal obstruction syndrome 16.51 14.32 7 21221 500 42599607
Alanine aminotransferase increased 16.46 14.32 12 21216 88394 42511713
Anterior spinal artery syndrome 16.21 14.32 3 21225 7 42600100
Conjunctival scar 16.19 14.32 6 21222 300 42599807
Inappropriate schedule of product administration 16.12 14.32 92 21136 95810 42504297
Amblyopia 16.00 14.32 5 21223 148 42599959
Papule 15.96 14.32 17 21211 5809 42594298
Staphylococcal infection 15.89 14.32 48 21180 37595 42562512
Scrotal cyst 15.87 14.32 5 21223 152 42599955
Guttate psoriasis 15.77 14.32 7 21221 559 42599548
Discomfort 15.55 14.32 37 21191 25182 42574925
Skin discolouration 15.51 14.32 33 21195 20857 42579250
Vomiting 15.49 14.32 83 21145 289640 42310467
Interstitial lung disease 15.47 14.32 10 21218 78452 42521655
Bradycardia 15.40 14.32 12 21216 85472 42514635
Xerosis 15.37 14.32 8 21220 908 42599199
Embolia cutis medicamentosa 15.34 14.32 6 21222 348 42599759
Urticaria 15.16 14.32 75 21153 73961 42526146
Orbital infection 15.12 14.32 4 21224 64 42600043
Dysmenorrhoea 14.99 14.32 3 21225 12 42600095
Mediastinal abscess 14.79 14.32 4 21224 70 42600037
Visual field defect 14.59 14.32 15 21213 4923 42595184

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 750.57 12.90 433 130421 25108 110433337
Toxicity to various agents 489.62 12.90 18 130836 480537 109977908
Facet joint syndrome 448.69 12.90 563 130291 96265 110362180
Lip dry 423.02 12.90 556 130298 99527 110358918
Acute kidney injury 420.62 12.90 116 130738 635314 109823131
Folliculitis 414.05 12.90 725 130129 166928 110291517
Fibromyalgia 402.66 12.90 724 130130 170185 110288260
Obesity 396.85 12.90 575 130279 112776 110345669
Type 2 diabetes mellitus 383.81 12.90 724 130130 176508 110281937
Joint range of motion decreased 370.92 12.90 579 130275 121253 110337192
Synovitis 359.70 12.90 915 129939 273177 110185268
Psoriatic arthropathy 350.70 12.90 741 130113 196020 110262425
Breast cancer stage III 324.22 12.90 433 130421 78684 110379761
Glossodynia 323.92 12.90 772 130082 221232 110237213
Systemic lupus erythematosus 316.09 12.90 832 130022 253506 110204939
Hand deformity 314.66 12.90 756 130098 217750 110240695
Impaired healing 309.88 12.90 705 130149 196012 110262433
Irritable bowel syndrome 307.27 12.90 631 130223 163584 110294861
Ill-defined disorder 298.55 12.90 607 130247 156246 110302199
Inflammation 297.16 12.90 686 130168 192552 110265893
Taste disorder 294.59 12.90 375 130479 65012 110393433
Wound 292.41 12.90 768 130086 233669 110224776
Rheumatic fever 290.80 12.90 521 130333 122058 110336387
Duodenal ulcer perforation 286.72 12.90 643 130211 177057 110281388
Helicobacter infection 277.80 12.90 644 130210 181233 110277212
Peripheral venous disease 277.45 12.90 415 130439 83702 110374743
Dry skin 274.06 12.90 472 130382 107181 110351264
Blepharospasm 268.57 12.90 328 130526 54523 110403922
Completed suicide 266.01 12.90 4 130850 242377 110216068
Wound infection 260.19 12.90 434 130420 96031 110362414
Neutropenia 257.91 12.90 63 130791 374557 110083888
Nail disorder 251.14 12.90 326 130528 57609 110400836
Bursitis 248.65 12.90 504 130350 129414 110329031
Pemphigus 240.58 12.90 676 130178 213894 110244551
Sleep disorder 235.75 12.90 639 130215 198005 110260440
Pruritus 228.22 12.90 1318 129536 580242 109878203
Urticaria 225.93 12.90 859 129995 317998 110140447
Non-infectious endophthalmitis 223.48 12.90 61 130793 430 110458015
Muscle injury 217.62 12.90 501 130353 140306 110318139
Mobility decreased 217.04 12.90 696 130158 236726 110221719
Product quality issue 216.82 12.90 354 130500 76945 110381500
Injury 215.13 12.90 575 130279 176690 110281755
C-reactive protein abnormal 213.29 12.90 473 130381 129222 110329223
Wheezing 210.85 12.90 723 130131 254507 110203938
Hypoaesthesia 209.96 12.90 831 130023 313392 110145053
Stomatitis 208.14 12.90 748 130106 269494 110188951
Night sweats 207.36 12.90 477 130377 133506 110324939
Dry mouth 205.83 12.90 611 130243 199337 110259108
Product use in unapproved indication 197.46 12.90 1047 129807 446330 110012115
Adrenal insufficiency 197.08 12.90 247 130607 42143 110416302
Live birth 194.59 12.90 318 130536 69166 110389279
Macular degeneration 192.70 12.90 178 130676 21481 110436964
Recalled product administered 192.13 12.90 68 130786 1214 110457231
Febrile neutropenia 187.71 12.90 70 130784 316697 110141748
Swelling 186.42 12.90 866 129988 350175 110108270
Ocular hypertension 186.34 12.90 79 130775 2329 110456116
Drug abuse 182.75 12.90 6 130848 177405 110281040
Liver injury 178.55 12.90 484 130370 149929 110308516
Infusion related reaction 174.99 12.90 902 129952 380260 110078185
Injection site atrophy 172.55 12.90 50 130804 449 110457996
Skin exfoliation 172.40 12.90 344 130510 87307 110371138
Endophthalmitis 171.87 12.90 112 130742 8075 110450370
Death 170.91 12.90 357 130497 698512 109759933
Joint destruction 169.15 12.90 124 130730 10819 110447626
Cardiac arrest 168.91 12.90 18 130836 196735 110261710
Chronic sinusitis 168.83 12.90 177 130677 24907 110433538
Skin fissures 167.15 12.90 174 130680 24284 110434161
Somnolence 166.00 12.90 72 130782 297377 110161068
Hypercholesterolaemia 165.04 12.90 345 130509 90492 110367953
Intentional product use issue 163.40 12.90 653 130201 247253 110211192
Pericarditis 163.16 12.90 600 130254 218514 110239931
Swollen joint count increased 162.93 12.90 327 130527 83334 110375111
Gait inability 161.02 12.90 438 130416 135938 110322507
Intraocular pressure increased 158.60 12.90 119 130735 10757 110447688
Onychomadesis 157.31 12.90 230 130624 45433 110413012
Osteoarthritis 153.96 12.90 521 130333 182102 110276343
Rheumatoid factor positive 151.65 12.90 419 130435 131221 110327224
Anti-cyclic citrullinated peptide antibody positive 151.50 12.90 517 130337 181467 110276978
Sepsis 150.88 12.90 101 130753 327245 110131200
Therapeutic product effect incomplete 150.28 12.90 593 130261 223212 110235233
Blood cholesterol increased 147.78 12.90 518 130336 184267 110274178
Road traffic accident 146.35 12.90 364 130490 107034 110351411
Hypotension 145.20 12.90 248 130606 523601 109934844
Drug interaction 144.01 12.90 231 130623 499952 109958493
Musculoskeletal pain 140.31 12.90 506 130348 182517 110275928
Eczema 140.09 12.90 282 130572 72011 110386434
C-reactive protein 139.81 12.90 176 130678 30155 110428290
Dehydration 138.86 12.90 79 130775 279432 110179013
Vaginal flatulence 138.59 12.90 115 130739 12029 110446416
Pancytopenia 137.04 12.90 39 130815 209574 110248871
Renal impairment 134.97 12.90 29 130825 188416 110270029
Anaemia 134.04 12.90 279 130575 546807 109911638
Platelet count decreased 131.41 12.90 54 130800 230389 110228056
Onychomycosis 129.73 12.90 192 130662 38339 110420106
Renal failure 129.35 12.90 53 130801 226521 110231924
Hyponatraemia 127.40 12.90 49 130805 217604 110240841
Lung disorder 127.32 12.90 485 130369 179562 110278883
Vaginal discharge 127.06 12.90 130 130724 17778 110440667
Sleep disorder due to general medical condition, insomnia type 125.39 12.90 340 130514 105303 110353142
Intentional overdose 125.06 12.90 8 130846 132493 110325952
Epilepsy 124.48 12.90 328 130526 99881 110358564
Polyarthritis 124.40 12.90 132 130722 18831 110439614
Female genital tract fistula 122.84 12.90 123 130731 16396 110442049
Seizure 122.65 12.90 54 130800 221131 110237314
Prescribed underdose 122.45 12.90 251 130603 64923 110393522
Bradycardia 121.98 12.90 19 130835 155498 110302947
Coma 121.33 12.90 4 130850 117865 110340580
Blister 120.62 12.90 561 130293 226815 110231630
Pseudomeningocele 120.19 12.90 24 130830 26 110458419
Haemoglobin decreased 116.95 12.90 75 130779 248652 110209793
Retinal artery occlusion 116.77 12.90 69 130785 4180 110454265
Therapy non-responder 115.57 12.90 429 130425 156878 110301567
Underdose 114.99 12.90 241 130613 63313 110395132
Myocardial infarction 114.49 12.90 42 130812 192041 110266404
Dyspnoea 113.88 12.90 805 130049 1106067 109352378
Alanine aminotransferase increased 113.29 12.90 38 130816 183735 110274710
Atrial fibrillation 112.49 12.90 66 130788 229576 110228869
Cardio-respiratory arrest 112.36 12.90 6 130848 115830 110342615
Cardiac failure 111.88 12.90 41 130813 187585 110270860
Sciatica 109.27 12.90 297 130557 92102 110366343
Back injury 109.19 12.90 199 130655 47200 110411245
Joint swelling 108.66 12.90 895 129959 441950 110016495
Gastrointestinal haemorrhage 107.81 12.90 31 130823 165487 110292958
Multiple organ dysfunction syndrome 107.31 12.90 24 130830 151686 110306759
Paraesthesia oral 106.54 12.90 163 130691 33508 110424937
Proctitis 106.06 12.90 115 130739 16812 110441633
Respiratory failure 105.31 12.90 62 130792 215270 110243175
Human antichimeric antibody positive 105.17 12.90 48 130806 1694 110456751
Radiculopathy 105.12 12.90 122 130732 19214 110439231
Blood creatinine increased 104.03 12.90 43 130811 182846 110275599
Finger deformity 103.03 12.90 159 130695 32933 110425512
Migraine 101.92 12.90 438 130416 171214 110287231
Wheelchair user 101.64 12.90 80 130774 7762 110450683
Arthropathy 101.20 12.90 634 130220 286888 110171557
Malignant neoplasm progression 100.99 12.90 40 130814 174527 110283918
Rhabdomyolysis 100.84 12.90 12 130842 120389 110338056
Thrombocytopenia 100.46 12.90 161 130693 348724 110109721
White blood cell count decreased 100.11 12.90 75 130779 229315 110229130
Lower respiratory tract infection 99.67 12.90 558 130296 242548 110215897
Hyperkalaemia 99.08 12.90 20 130834 135776 110322669
Lower limb fracture 98.06 12.90 251 130603 75097 110383348
Eye infection toxoplasmal 97.73 12.90 36 130818 724 110457721
Electrocardiogram QT prolonged 96.02 12.90 9 130845 108951 110349494
Aspartate aminotransferase increased 95.27 12.90 35 130819 159901 110298544
Procedural pain 94.49 12.90 159 130695 35406 110423039
Body height below normal 94.01 12.90 47 130807 2037 110456408
C-reactive protein increased 93.89 12.90 507 130347 217412 110241033
Pulmonary embolism 93.75 12.90 70 130784 214404 110244041
Infective scleritis 93.59 12.90 23 130831 100 110458345
Product label confusion 92.67 12.90 124 130730 22553 110435892
Dyspepsia 92.46 12.90 459 130395 190506 110267939
Pseudoendophthalmitis 90.08 12.90 21 130833 69 110458376
Fall 88.59 12.90 390 130464 603092 109855353
Gastrooesophageal reflux disease 87.42 12.90 433 130421 179543 110278902
Weight increased 87.28 12.90 818 130036 418826 110039619
Disease progression 87.18 12.90 96 130758 243938 110214507
Hypothalamic pituitary adrenal axis suppression 86.58 12.90 32 130822 650 110457795
Maternal exposure during pregnancy 86.56 12.90 557 130297 254326 110204119
Deep vein thrombosis postoperative 86.12 12.90 206 130648 59085 110399360
Memory impairment 86.05 12.90 460 130394 196484 110261961
Metabolic acidosis 85.90 12.90 9 130845 99735 110358710
X-ray abnormal 85.23 12.90 158 130696 37959 110420486
Depressed level of consciousness 85.19 12.90 15 130839 112263 110346182
Hypoglycaemia 84.91 12.90 17 130837 116087 110342358
Therapeutic product effect decreased 84.25 12.90 536 130318 243780 110214665
Interstitial lung disease 83.82 12.90 30 130824 139304 110319141
Rash 83.79 12.90 1400 129454 819564 109638881
Cardiac failure congestive 83.49 12.90 37 130817 150963 110307482
Pulmonary fibrosis 83.21 12.90 288 130566 101754 110356691
Skin atrophy 80.87 12.90 65 130789 6499 110451946
Cough 80.07 12.90 279 130575 461362 109997083
Paraesthesia 80.05 12.90 581 130273 275940 110182505
Pneumonia 79.46 12.90 660 130194 876054 109582391
Hepatic enzyme increased 79.42 12.90 650 130204 320242 110138203
Grip strength decreased 78.64 12.90 241 130613 79933 110378512
Urinary tract infection 78.47 12.90 168 130686 326114 110132331
Lactic acidosis 78.34 12.90 9 130845 92802 110365643
Treatment failure 78.25 12.90 579 130275 276655 110181790
Syncope 77.63 12.90 75 130779 202461 110255984
Mucosal inflammation 77.10 12.90 11 130843 96130 110362315
Sleep disorder due to a general medical condition 76.71 12.90 182 130672 51930 110406515
Psoriasis 76.11 12.90 348 130506 139645 110318800
Back pain 75.83 12.90 208 130646 370788 110087657
Chorioretinopathy 75.75 12.90 42 130812 2253 110456192
Oxygen saturation decreased 75.62 12.90 46 130808 156936 110301509
Skin hypopigmentation 75.27 12.90 36 130818 1415 110457030
Tremor 75.08 12.90 77 130777 202155 110256290
Neutrophil count decreased 74.54 12.90 25 130829 120916 110337529
Gastroenteritis viral 74.34 12.90 133 130721 31093 110427352
Hypocholesterolaemia 73.67 12.90 61 130793 6360 110452085
Cerebrovascular accident 71.98 12.90 65 130789 181219 110277226
Alopecia 71.36 12.90 702 130152 364051 110094394
Adverse event 70.31 12.90 285 130569 108524 110349921
Suicide attempt 69.89 12.90 18 130836 103376 110355069
Injection site reaction 69.70 12.90 248 130606 88822 110369623
Hepatic enzyme 67.63 12.90 53 130801 5110 110453335
Blood pressure decreased 65.54 12.90 27 130827 115064 110343381
Liver disorder 65.39 12.90 337 130517 141906 110316539
Adverse reaction 64.08 12.90 121 130733 29473 110428972
Frequent bowel movements 63.96 12.90 208 130646 71182 110387263
Soft tissue disorder 63.86 12.90 44 130810 3480 110454965
Chills 63.72 12.90 79 130775 190501 110267944
Rhegmatogenous retinal detachment 62.77 12.90 20 130834 254 110458191
Melaena 62.43 12.90 5 130849 68752 110389693
Immunodeficiency 61.95 12.90 140 130714 38698 110419747
Bone density increased 61.91 12.90 28 130826 967 110457478
Necrotising scleritis 61.58 12.90 20 130834 271 110458174
Adrenal suppression 61.41 12.90 33 130821 1663 110456782
Antibody test positive 61.40 12.90 41 130813 3079 110455366
Ascites 61.13 12.90 17 130837 92791 110365654
Anti-cyclic citrullinated peptide antibody 60.85 12.90 95 130759 19869 110438576
Diarrhoea 60.77 12.90 966 129888 1138539 109319906
Drug reaction with eosinophilia and systemic symptoms 60.07 12.90 12 130842 82083 110376362
Lethargy 60.06 12.90 18 130836 93558 110364887
Overdose 59.92 12.90 116 130738 233678 110224767
Short stature 59.54 12.90 28 130826 1059 110457386
Hepatic function abnormal 59.49 12.90 16 130838 89279 110369166
Ankle arthroplasty 58.75 12.90 37 130817 2514 110455931
Drug intolerance 58.74 12.90 737 130117 405775 110052670
Peripheral swelling 58.60 12.90 733 130121 403301 110055144
Pulmonary oedema 58.32 12.90 23 130831 100636 110357809
Skin haemorrhage 58.14 12.90 105 130749 24722 110433723
Serotonin syndrome 57.56 12.90 3 130851 59150 110399295
Cerebrospinal fistula 56.77 12.90 12 130842 21 110458424
Altered state of consciousness 55.83 12.90 3 130851 57623 110400822
Hypoxia 55.65 12.90 43 130811 129472 110328973
Cerebral haemorrhage 55.59 12.90 6 130848 64962 110393483
Vitreous opacities 55.26 12.90 25 130829 864 110457581
Infection 55.06 12.90 663 130191 361537 110096908
Hepatic failure 54.80 12.90 8 130846 68731 110389714
Retinitis 54.34 12.90 119 130735 32208 110426237
Dysphagia 54.21 12.90 61 130793 153539 110304906
Cognitive disorder 54.08 12.90 18 130836 87493 110370952
Respiratory arrest 53.61 12.90 4 130850 58295 110400150
Visual acuity reduced 53.59 12.90 118 130736 32055 110426390
Product use issue 53.41 12.90 584 130270 311111 110147334
Tachycardia 53.39 12.90 118 130736 226527 110231918
No adverse event 53.05 12.90 200 130654 73639 110384806
Cardiogenic shock 52.54 12.90 4 130850 57334 110401111
Dysarthria 52.52 12.90 17 130837 84104 110374341
Orthostatic hypotension 52.15 12.90 8 130846 66241 110392204
Tubulointerstitial nephritis 52.05 12.90 3 130851 54281 110404164
Maternal exposure timing unspecified 51.95 12.90 91 130763 20922 110437523
Toxic epidermal necrolysis 51.86 12.90 4 130850 56723 110401722
Autoimmune disorder 51.80 12.90 183 130671 65300 110393145
International normalised ratio increased 51.64 12.90 19 130835 86753 110371692
Angioedema 51.58 12.90 26 130828 98474 110359971
Retinal pigment epithelial tear 51.01 12.90 20 130834 480 110457965
Eosinophilia 50.48 12.90 5 130849 57931 110400514
Acute myocardial infarction 50.45 12.90 18 130836 83759 110374686
Contraindicated product administered 50.08 12.90 481 130373 247786 110210659
Hallucination 49.86 12.90 29 130825 101403 110357042
Unresponsive to stimuli 49.54 12.90 8 130846 63782 110394663
Oral candidiasis 49.08 12.90 140 130714 44620 110413825
Blood creatine phosphokinase increased 48.86 12.90 13 130841 73064 110385381
Coeliac disease 48.25 12.90 136 130718 43051 110415394
Cholestasis 48.12 12.90 9 130845 64509 110393936
Blood bilirubin increased 48.06 12.90 15 130839 75957 110382488
Muscle spasms 48.03 12.90 522 130332 277635 110180810
Pneumonia aspiration 47.99 12.90 18 130836 81215 110377230
Drug tolerance 47.90 12.90 77 130777 16508 110441937
Arrhythmia 47.23 12.90 12 130842 69563 110388882
Foot deformity 46.86 12.90 145 130709 48335 110410110
Laryngitis 46.84 12.90 133 130721 42278 110416167
Agitation 46.73 12.90 39 130815 113012 110345433
Necrotising retinitis 46.71 12.90 27 130827 1569 110456876
Subcutaneous drug absorption impaired 46.18 12.90 51 130803 7608 110450837
Heart rate decreased 46.18 12.90 20 130834 82736 110375709
Cytokine release syndrome 46.08 12.90 13 130841 70293 110388152
Swollen joint count 45.93 12.90 54 130800 8620 110449825
Pancreatitis acute 45.83 12.90 8 130846 60266 110398179
Red blood cell sedimentation rate abnormal 45.56 12.90 94 130760 24415 110434030
Eye abscess 45.38 12.90 17 130837 359 110458086
Gamma-glutamyltransferase increased 44.78 12.90 9 130845 61300 110397145
Mental status changes 44.75 12.90 17 130837 76105 110382340
Insomnia 44.72 12.90 636 130218 359954 110098491
Palpitations 44.36 12.90 75 130779 159137 110299308
Dislocation of vertebra 44.35 12.90 133 130721 43588 110414857
Neuropathy peripheral 44.17 12.90 91 130763 179186 110279259
Maculopathy 43.87 12.90 33 130821 2994 110455451
Blood pressure fluctuation 43.50 12.90 17 130837 74807 110383638
Prescribed overdose 43.42 12.90 212 130642 87369 110371076
Discomfort 43.30 12.90 416 130438 214291 110244154
Bone marrow failure 43.29 12.90 8 130846 57840 110400605
Lupus-like syndrome 43.19 12.90 126 130728 40666 110417779
Gastrointestinal disorder 43.13 12.90 457 130397 241495 110216950
Disorientation 42.87 12.90 15 130839 70656 110387789
Epistaxis 42.58 12.90 55 130799 130317 110328128
Myalgia 42.24 12.90 129 130725 222252 110236193
Chest discomfort 42.19 12.90 89 130765 173759 110284686
Cytomegalovirus infection 41.90 12.90 7 130847 54437 110404008
Exposure during pregnancy 41.83 12.90 340 130514 167084 110291361
Angina pectoris 41.80 12.90 11 130843 62284 110396161
Heart rate increased 41.71 12.90 66 130788 143768 110314677
Periorbital abscess 41.47 12.90 9 130845 19 110458426
Nausea 41.38 12.90 1130 129724 1234560 109223885
Ocular hyperaemia 41.26 12.90 121 130733 39165 110419280
Jaundice 40.63 12.90 10 130844 59226 110399219
Red blood cell sedimentation rate increased 40.59 12.90 192 130662 78110 110380335
Dysgeusia 40.52 12.90 16 130838 69969 110388476
Haemorrhage 40.30 12.90 40 130814 106652 110351793
Nasopharyngitis 40.25 12.90 673 130181 393688 110064757
Haematocrit decreased 40.16 12.90 14 130840 66103 110392342
Chronic obstructive pulmonary disease 40.01 12.90 42 130812 109116 110349329
Generalised tonic-clonic seizure 39.99 12.90 8 130846 54672 110403773
Drug resistance 39.69 12.90 9 130845 56365 110402080
Exostosis 39.47 12.90 132 130722 45824 110412621
Ventricular tachycardia 39.45 12.90 6 130848 50003 110408442
Adjustment disorder with depressed mood 39.43 12.90 128 130726 43755 110414690
Circulatory collapse 39.39 12.90 3 130851 42990 110415455
Eye pruritus 39.38 12.90 106 130748 32669 110425776
Hepatotoxicity 39.25 12.90 13 130841 63387 110395058
Drug specific antibody 39.15 12.90 30 130824 2798 110455647
Cushing's syndrome 39.10 12.90 20 130834 910 110457535
Blood pressure increased 39.04 12.90 165 130689 258208 110200237
Skin swelling 39.02 12.90 48 130806 8032 110450413
Coronary artery disease 38.94 12.90 18 130836 71672 110386773
Pneumonitis 38.88 12.90 21 130833 76510 110381935
Aggression 38.71 12.90 11 130843 59199 110399246
Pericardial effusion 38.59 12.90 10 130844 57207 110401238
Neurotoxicity 38.51 12.90 3 130851 42204 110416241
Acute respiratory distress syndrome 38.46 12.90 8 130846 53190 110405255
Sinus tachycardia 38.35 12.90 4 130850 44489 110413956
Retinal artery embolism 37.55 12.90 12 130842 154 110458291
Sinusitis 37.46 12.90 525 130329 296163 110162282
Upper gastrointestinal haemorrhage 37.33 12.90 7 130847 50089 110408356
Normal newborn 37.25 12.90 81 130773 21815 110436630
Chorioretinal folds 37.22 12.90 9 130845 36 110458409
Rash maculo-papular 36.79 12.90 21 130833 74201 110384244
Colitis ulcerative 36.74 12.90 185 130669 77178 110381267
Exposure via skin contact 36.56 12.90 60 130794 13087 110445358
Transient ischaemic attack 36.44 12.90 15 130839 63967 110394478
Deep vein thrombosis 36.18 12.90 69 130785 139818 110318627
Hypopyon 35.99 12.90 22 130832 1418 110457027
Conjunctival ulcer 35.98 12.90 10 130844 76 110458369
Transaminases increased 35.88 12.90 15 130839 63375 110395070
Breast cancer stage II 35.41 12.90 91 130763 27284 110431161
Obstructive airways disorder 35.36 12.90 6 130848 46143 110412302
Pneumonia viral 35.28 12.90 54 130800 11103 110447342
Hemiparesis 35.25 12.90 5 130849 43898 110414547
Dermatitis contact 35.24 12.90 61 130793 13892 110444553
Neck pain 35.18 12.90 258 130596 122872 110335573
Haematuria 35.10 12.90 28 130826 82977 110375468
Drug level increased 34.86 12.90 7 130847 47712 110410733
Ischaemic stroke 34.82 12.90 4 130850 41259 110417186
Vertigo 34.65 12.90 31 130823 86839 110371606
Infective uveitis 34.62 12.90 8 130846 25 110458420
Injection site pain 34.53 12.90 342 130512 177580 110280865
Scratch 34.44 12.90 58 130796 12921 110445524
Injection site calcification 34.38 12.90 8 130846 26 110458419
Thrombosis 34.30 12.90 47 130807 108615 110349830
Lupus vulgaris 34.29 12.90 103 130751 33780 110424665
Hypothyroidism 34.22 12.90 22 130832 72877 110385568
Blood pressure systolic increased 33.85 12.90 29 130825 82962 110375483
Sleep disorder due to general medical condition, hypersomnia type 33.76 12.90 24 130830 1995 110456450
Liver function test increased 33.47 12.90 199 130655 88349 110370096
Spinal cord infarction 33.27 12.90 19 130835 1079 110457366
Shock 33.15 12.90 11 130843 53577 110404868
Haemoptysis 32.86 12.90 22 130832 71332 110387113
Haematoma 32.83 12.90 14 130840 58462 110399983
Incorrect product administration duration 32.81 12.90 74 130780 20424 110438021
Urinary retention 32.75 12.90 21 130833 69662 110388783
Retinal detachment 32.69 12.90 52 130802 11048 110447397
Blood alkaline phosphatase increased 32.49 12.90 22 130832 70913 110387532
Disseminated intravascular coagulation 32.46 12.90 5 130849 41281 110417164
Neoplasm progression 32.42 12.90 18 130836 64577 110393868
Restlessness 32.35 12.90 13 130841 56246 110402199
Psychotic disorder 32.32 12.90 10 130844 50927 110407518
Full blood count abnormal 32.15 12.90 13 130841 56039 110402406
Orbital infection 32.08 12.90 11 130843 178 110458267
Ejection fraction decreased 32.03 12.90 5 130849 40875 110417570
Aphasia 31.75 12.90 15 130839 58982 110399463
Bone density decreased 31.57 12.90 63 130791 15979 110442466
Femur fracture 31.51 12.90 7 130847 44462 110413983
Blood lactate dehydrogenase increased 31.37 12.90 7 130847 44327 110414118
Osteonecrosis of jaw 31.24 12.90 9 130845 48008 110410437
Speech disorder 31.13 12.90 17 130837 61552 110396893
Proteinuria 31.12 12.90 5 130849 40013 110418432
Haematemesis 30.35 12.90 16 130838 59092 110399353
Constipation 30.23 12.90 274 130580 357512 110100933
Abdominal discomfort 30.13 12.90 643 130211 393215 110065230
Product contamination 30.11 12.90 22 130832 1909 110456536
Retinal haemorrhage 30.06 12.90 46 130808 9455 110448990
Therapy cessation 29.95 12.90 8 130846 44849 110413596
Hyperglycaemia 29.79 12.90 34 130820 85056 110373389
Balance disorder 29.70 12.90 58 130796 116502 110341943
Drug dependence 29.68 12.90 11 130843 50009 110408436
Chronic kidney disease 29.51 12.90 28 130826 76263 110382182
Posterior reversible encephalopathy syndrome 29.30 12.90 3 130851 33858 110424587
Blood pressure diastolic decreased 29.02 12.90 4 130850 35881 110422564
Abdominal pain upper 29.02 12.90 577 130277 348534 110109911
Blood calcium decreased 28.97 12.90 4 130850 35841 110422604
Encephalopathy 28.80 12.90 32 130822 81023 110377422
Foot operation 28.38 12.90 39 130815 7274 110451171
Stevens-Johnson syndrome 28.37 12.90 10 130844 46891 110411554
Suicidal ideation 28.29 12.90 42 130812 93895 110364550
Hypertension 28.28 12.90 797 130057 509287 109949158
Productive cough 28.17 12.90 58 130796 114247 110344198
Feeling abnormal 28.16 12.90 114 130740 180597 110277848
Skin weeping 28.12 12.90 28 130826 3707 110454738
Sinus polyp degeneration 28.00 12.90 8 130846 68 110458377
Lipoatrophy 27.72 12.90 14 130840 620 110457825
Tractional retinal detachment 27.71 12.90 9 130845 122 110458323
Hypersensitivity 27.58 12.90 649 130205 403349 110055096
Pustular psoriasis 27.46 12.90 54 130800 13551 110444894
Disturbance in attention 27.37 12.90 20 130834 61975 110396470
Hypomagnesaemia 27.28 12.90 19 130835 60351 110398094
Respiratory depression 27.26 12.90 3 130851 31998 110426447
Rash vesicular 27.00 12.90 56 130798 14596 110443849
Respiratory distress 26.97 12.90 25 130829 68849 110389596
Human anti-human antibody test 26.96 12.90 12 130842 399 110458046
General symptom 26.83 12.90 42 130812 8804 110449641
Scleral thinning 26.75 12.90 8 130846 81 110458364
Blood urea increased 26.60 12.90 16 130838 54941 110403504
General physical health deterioration 26.57 12.90 675 130179 424620 110033825
Blood glucose increased 26.50 12.90 75 130779 132421 110326024
Dyskinesia 26.31 12.90 14 130840 51432 110407013
Open globe injury 26.27 12.90 10 130844 221 110458224
Cardiac disorder 26.14 12.90 31 130823 76249 110382196
COVID-19 pneumonia 26.01 12.90 6 130848 37137 110421308
Tumour lysis syndrome 25.96 12.90 3 130851 30798 110427647
Porphyria acute 25.93 12.90 64 130790 18716 110439729
Cataract subcapsular 25.86 12.90 17 130837 1244 110457201
Pyloric abscess 25.77 12.90 5 130849 4 110458441
Diabetes mellitus 25.72 12.90 49 130805 99332 110359113
Eye inflammation 25.70 12.90 42 130812 9129 110449316
Leukopenia 25.70 12.90 90 130764 148701 110309744
Wrong technique in product usage process 25.40 12.90 40 130814 87308 110371137
Macular oedema 25.32 12.90 36 130818 6930 110451515
Subdural haematoma 25.30 12.90 6 130848 36448 110421997
Lymphopenia 25.28 12.90 8 130846 40162 110418283
Glaucoma 25.24 12.90 71 130783 22446 110435999
Cerebral infarction 25.22 12.90 15 130839 51823 110406622
Multiple sclerosis relapse 25.21 12.90 14 130840 50226 110408219
Myocarditis 25.15 12.90 3 130851 30052 110428393
Bone erosion 24.98 12.90 115 130739 46256 110412189
Hypercalcaemia 24.90 12.90 12 130842 46645 110411800
Troponin increased 24.84 12.90 3 130851 29763 110428682
Product prescribing error 24.77 12.90 15 130839 51316 110407129
Mouth ulceration 24.76 12.90 13 130841 48125 110410320
Lymphocyte count decreased 24.59 12.90 19 130835 57224 110401221
Red blood cell count decreased 24.57 12.90 25 130829 65898 110392547
Renal disorder 24.52 12.90 14 130840 49465 110408980
Palmar-plantar erythrodysaesthesia syndrome 24.38 12.90 9 130845 41016 110417429
Pneumocystis jirovecii pneumonia 24.37 12.90 10 130844 42725 110415720
Metastases to liver 24.22 12.90 6 130848 35380 110423065
Tender joint count 24.17 12.90 17 130837 1390 110457055
Secondary adrenocortical insufficiency 24.14 12.90 28 130826 4406 110454039
Poisoning 24.12 12.90 3 130851 29102 110429343
Disseminated paracoccidioidomycosis 24.07 12.90 6 130848 28 110458417
Neutropenic sepsis 23.55 12.90 4 130850 30742 110427703
Asthenia 23.51 12.90 628 130226 688371 109770074
Atrophy 23.38 12.90 21 130833 2443 110456002
Injection site joint infection 23.31 12.90 7 130847 72 110458373
Renal tubular necrosis 23.27 12.90 4 130850 30471 110427974
Ocular lymphoma 23.27 12.90 9 130845 208 110458237
Hepatic encephalopathy 23.20 12.90 3 130851 28253 110430192
Choroidal infarction 23.19 12.90 9 130845 210 110458235
Prostate cancer 22.81 12.90 8 130846 37633 110420812
Dry eye 22.78 12.90 128 130726 55665 110402780
Polyneuropathy 22.76 12.90 5 130849 32007 110426438
Bronchopulmonary aspergillosis 22.63 12.90 4 130850 29859 110428586
Rebound atopic dermatitis 22.61 12.90 19 130835 2022 110456423
Retinal deposits 22.59 12.90 8 130846 143 110458302
Toxic skin eruption 22.41 12.90 3 130851 27512 110430933
Incorrect route of product administration 22.33 12.90 141 130713 63920 110394525
Haemophagocytic lymphohistiocytosis 22.29 12.90 5 130849 31554 110426891
Pneumothorax 22.26 12.90 7 130847 35278 110423167
Sinus bradycardia 22.23 12.90 4 130850 29479 110428966
Eye irritation 21.90 12.90 88 130766 33364 110425081
Haemorrhage intracranial 21.69 12.90 4 130850 28965 110429480
Myocardial ischaemia 21.52 12.90 3 130851 26681 110431764
Ileus 21.44 12.90 5 130849 30724 110427721
Cystitis 21.41 12.90 28 130826 66008 110392437
Urosepsis 21.39 12.90 5 130849 30670 110427775
Tachypnoea 21.23 12.90 10 130844 39385 110419060
Hallucination, auditory 21.21 12.90 3 130851 26394 110432051
Infusion site reaction 21.06 12.90 57 130797 17625 110440820
Faeces discoloured 20.94 12.90 7 130847 33941 110424504
Oedema 20.90 12.90 357 130497 209619 110248826
Dyspnoea exertional 20.74 12.90 59 130795 104001 110354444
Diabetic ketoacidosis 20.70 12.90 12 130842 42046 110416399
Electrolyte imbalance 20.57 12.90 9 130845 37019 110421426
Macular fibrosis 20.53 12.90 12 130842 712 110457733
Dementia 20.49 12.90 6 130848 31667 110426778
Cyanosis 20.44 12.90 5 130849 29736 110428709
Ophthalmic herpes simplex 20.41 12.90 13 130841 901 110457544
Subarachnoid haemorrhage 20.40 12.90 5 130849 29697 110428748
Pallor 20.38 12.90 22 130832 56445 110402000
Mitral valve incompetence 20.34 12.90 7 130847 33322 110425123
Therapeutic response shortened 20.32 12.90 79 130775 29504 110428941
Clostridium difficile infection 20.32 12.90 19 130835 52110 110406335
Blood potassium increased 20.26 12.90 7 130847 33242 110425203
Hypophosphataemia 20.20 12.90 7 130847 33175 110425270
Metastases to bone 20.19 12.90 6 130848 31366 110427079
Plasma cell myeloma 20.09 12.90 27 130827 62909 110395536
Acute hepatic failure 20.05 12.90 9 130845 36459 110421986
Diabetic retinal oedema 19.99 12.90 10 130844 434 110458011
Device related infection 19.85 12.90 11 130843 39508 110418937
Respiratory rate increased 19.81 12.90 3 130851 25080 110433365
Pulmonary congestion 19.79 12.90 6 130848 30960 110427485
Drug-induced liver injury 19.64 12.90 223 130631 119844 110338601
Blood potassium decreased 19.63 12.90 21 130833 54093 110404352
Abortion spontaneous 19.58 12.90 8 130846 34274 110424171
Oesophageal perforation 19.53 12.90 16 130838 1643 110456802
Hyperbilirubinaemia 19.50 12.90 6 130848 30665 110427780
Myelodysplastic syndrome 19.46 12.90 10 130844 37474 110420971
Cholelithiasis 19.45 12.90 28 130826 63394 110395051
Eye infection fungal 19.44 12.90 11 130843 614 110457831
Pain 19.28 12.90 1344 129510 953611 109504834
Transplant rejection 19.26 12.90 3 130851 24564 110433881
Eye discharge 19.21 12.90 36 130818 8718 110449727
Eye pain 19.19 12.90 113 130741 49986 110408459
Diverticulitis 19.16 12.90 21 130833 53501 110404944
Exposure via breast milk 19.02 12.90 13 130841 1015 110457430
Accidental overdose 18.93 12.90 20 130834 51814 110406631
Intestinal obstruction 18.92 12.90 21 130833 53206 110405239
Hypothermia 18.92 12.90 4 130850 26298 110432147
Back disorder 18.77 12.90 61 130793 20861 110437584
Muscle rigidity 18.69 12.90 3 130851 24028 110434417
Dystonia 18.41 12.90 4 130850 25801 110432644
Arthritis bacterial 18.37 12.90 40 130814 10780 110447665
Myoclonus 18.37 12.90 8 130846 32990 110425455
Rapidly progressive osteoarthritis 18.35 12.90 5 130849 35 110458410
Pulmonary hypertension 18.33 12.90 23 130831 55197 110403248
Blood albumin decreased 18.33 12.90 5 130849 27647 110430798
Coagulopathy 18.32 12.90 13 130841 40898 110417547
Influenza 18.25 12.90 121 130733 168980 110289465
Intentional product misuse 18.19 12.90 88 130766 132816 110325629
Drug eruption 18.18 12.90 22 130832 53637 110404808
Transfusion 18.06 12.90 4 130850 25468 110432977
Peritonitis 18.00 12.90 8 130846 32599 110425846
Cardiomegaly 17.98 12.90 6 130848 29124 110429321
Malnutrition 17.96 12.90 5 130849 27274 110431171
Acute respiratory failure 17.86 12.90 39 130815 75221 110383224
Joint dislocation 17.84 12.90 84 130770 34106 110424339
Hypoalbuminaemia 17.83 12.90 6 130848 28968 110429477
Coordination abnormal 17.81 12.90 4 130850 25224 110433221
Arteriosclerosis coronary artery 17.70 12.90 4 130850 25114 110433331
Bronchitis 17.64 12.90 111 130743 156921 110301524
Anaphylactic shock 17.61 12.90 21 130833 51525 110406920
Fatigue 17.57 12.90 1221 129633 1214737 109243708
Periarthritis calcarea 17.56 12.90 6 130848 96 110458349
Progressive multifocal leukoencephalopathy 17.54 12.90 4 130850 24952 110433493
Hepatitis 17.41 12.90 173 130681 89881 110368564
Retinal degeneration 17.41 12.90 15 130839 1651 110456794
Embolia cutis medicamentosa 17.39 12.90 12 130842 951 110457494
Hemiplegia 17.37 12.90 3 130851 22779 110435666
Unevaluable event 17.33 12.90 27 130827 59200 110399245
Appendicitis 17.33 12.90 6 130848 28458 110429987
Soft tissue atrophy 17.24 12.90 5 130849 45 110458400
Tendon dislocation 17.22 12.90 3 130851 0 110458445
Keratitis fungal 17.19 12.90 9 130845 430 110458015
Eye injury 17.15 12.90 32 130822 7723 110450722
Hyperadrenocorticism 17.12 12.90 10 130844 593 110457852
Acidosis 17.11 12.90 3 130851 22528 110435917
Immune thrombocytopenia 17.07 12.90 3 130851 22491 110435954
Injection site discolouration 17.02 12.90 35 130819 9068 110449377
Clostridium difficile colitis 17.01 12.90 16 130838 43762 110414683
Anuria 16.91 12.90 4 130850 24337 110434108
COVID-19 16.85 12.90 197 130657 244863 110213582
Abnormal behaviour 16.72 12.90 13 130841 39026 110419419
Heart rate irregular 16.56 12.90 10 130844 34264 110424181
Gastroenteritis 16.51 12.90 13 130841 38787 110419658
Ulcer 16.47 12.90 16 130838 43100 110415345
Hyperthyroidism 16.44 12.90 7 130847 29254 110429191
Neuralgia 16.29 12.90 20 130834 48458 110409987
Cauda equina syndrome 16.14 12.90 16 130838 2106 110456339
Gastric ulcer 16.14 12.90 14 130840 39813 110418632
Blood uric acid increased 16.06 12.90 3 130851 21526 110436919
Left ventricular dysfunction 16.05 12.90 4 130850 23489 110434956
Oesophagitis 15.92 12.90 7 130847 28708 110429737
Chest pain 15.88 12.90 332 130522 376043 110082402
Bacteraemia 15.88 12.90 16 130838 42374 110416071
Hyperthermia 15.79 12.90 3 130851 21269 110437176
Cystoid macular oedema 15.78 12.90 18 130836 2782 110455663
Influenza like illness 15.58 12.90 53 130801 88359 110370086
Eosinophil count increased 15.57 12.90 3 130851 21055 110437390
Arteriosclerosis 15.47 12.90 5 130849 24762 110433683
Nodule 15.47 12.90 78 130776 32553 110425892
Joint stiffness 15.43 12.90 134 130720 67109 110391336
Swollen tongue 15.41 12.90 30 130824 60332 110398113
Cardiac murmur 15.33 12.90 5 130849 24623 110433822
Cardiovascular disorder 15.31 12.90 4 130850 22756 110435689
Mental disorder 15.28 12.90 14 130840 38777 110419668
Cytomegalovirus chorioretinitis 15.25 12.90 29 130825 7099 110451346
Pneumonia bacterial 15.21 12.90 6 130848 26255 110432190
Pregnancy 15.15 12.90 108 130746 50959 110407486
Neurodermatitis 15.11 12.90 18 130836 2914 110455531
Pulmonary arterial hypertension 15.05 12.90 10 130844 32558 110425887
Body temperature decreased 14.95 12.90 13 130841 36922 110421523
Device expulsion 14.94 12.90 9 130845 30882 110427563
Stress 14.86 12.90 69 130785 105279 110353166
Pyrexia 14.83 12.90 891 129963 897374 109561071
Hallucination, visual 14.78 12.90 15 130839 39590 110418855
Rectal haemorrhage 14.68 12.90 211 130643 119622 110338823
Staphyloma 14.68 12.90 4 130850 28 110458417
Tricuspid valve incompetence 14.59 12.90 5 130849 23868 110434577
Presyncope 14.58 12.90 22 130832 48865 110409580
Optic nerve compression 14.56 12.90 4 130850 29 110458416
Hepatic steatosis 14.54 12.90 22 130832 48809 110409636
Escherichia infection 14.54 12.90 5 130849 23811 110434634
Joint effusion 14.50 12.90 56 130798 20849 110437596
Blood magnesium decreased 14.47 12.90 3 130851 19993 110438452
Nightmare 14.46 12.90 87 130767 38776 110419669
Bronchospasm 14.36 12.90 9 130845 30230 110428215
Hypocalcaemia 14.34 12.90 129 130725 65237 110393208
Musculoskeletal stiffness 14.32 12.90 433 130421 279389 110179056
Nervous system disorder 14.31 12.90 10 130844 31711 110426734
Blood test abnormal 14.26 12.90 8 130846 28546 110429899
Postmenopausal haemorrhage 14.19 12.90 14 130840 1832 110456613
Drug hypersensitivity 14.16 12.90 665 130189 453425 110005020
Abdominal pain lower 14.05 12.90 14 130840 37269 110421176
Myopathy 13.97 12.90 6 130848 24954 110433491
Skin burning sensation 13.96 12.90 57 130797 21768 110436677
Flushing 13.96 12.90 70 130784 104666 110353779
Arthritis 13.91 12.90 277 130577 167309 110291136
Visual impairment 13.90 12.90 230 130624 134198 110324247
Plethoric face 13.90 12.90 4 130850 35 110458410
Symmetrical drug-related intertriginous and flexural exanthema 13.87 12.90 14 130840 1883 110456562
Subretinal fluid 13.84 12.90 12 130842 1332 110457113
Choroiditis 13.84 12.90 13 130841 1602 110456843
Foreign body reaction 13.72 12.90 6 130848 191 110458254
Type I hypersensitivity 13.67 12.90 26 130828 6367 110452078
Lung neoplasm malignant 13.59 12.90 12 130842 33830 110424615
Factitious disorder 13.49 12.90 6 130848 199 110458246
Disability 13.46 12.90 71 130783 30152 110428293
Decreased appetite 13.40 12.90 445 130409 475401 109983044
Treatment noncompliance 13.39 12.90 43 130811 72947 110385498
Atrial flutter 13.32 12.90 6 130848 24256 110434189
Face oedema 13.28 12.90 12 130842 33457 110424988
Depressed mood 13.23 12.90 33 130821 60776 110397669
Vitritis 13.20 12.90 16 130838 2637 110455808
Eyelid skin dryness 13.20 12.90 9 130845 700 110457745
Cellulitis 13.18 12.90 91 130763 125925 110332520
Head injury 13.18 12.90 19 130835 42998 110415447
Paranoia 13.14 12.90 5 130849 22369 110436076
Shock haemorrhagic 13.09 12.90 8 130846 27239 110431206
Retinal vasculitis 12.97 12.90 14 130840 2035 110456410
Soft tissue swelling 12.96 12.90 13 130841 1736 110456709
Cytopenia 12.93 12.90 10 130844 30106 110428339
Ataxia 12.92 12.90 10 130844 30098 110428347
Depression 12.91 12.90 478 130376 316857 110141588
Status epilepticus 12.91 12.90 11 130843 31560 110426885

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D005938 Glucocorticoids
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D006728 Hormones
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:77715 nasal decongestant

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 HARROW EYE N022048 Nov. 29, 2007 RX INJECTABLE INTRAVITREAL 8211880 March 10, 2029 TREATMENT OF OPHTHALMIC DISORDERS
40MG/ML (40MG/ML) TRIESENCE HARROW EYE 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
40MG/ML XIPERE BAUSCH AND LOMB INC N211950 Oct. 22, 2021 RX SUSPENSION INJECTION 12419833 April 16, 2040 TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS

Orange Book exclusivity data (new drug applications)

None

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
1TA PDB_CHEM_ID
CHEMBL1504 ChEMBL_ID
D014222 MESH_DESCRIPTOR_UI
2867 IUPHAR_LIGAND_ID
F446C597KA UNII
6436 PUBCHEM_CID
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
DB00620 DRUGBANK_ID
31307 PUBCHEM_CID
755 INN_ID
D014221 MESH_DESCRIPTOR_UI
CHEBI:9667 CHEBI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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-10 HUMAN PRESCRIPTION DRUG LABEL 1 0003-0494 INJECTION, SUSPENSION 10 mg INTRA-ARTICULAR NDA 22 sections
TRIESENCE HUMAN PRESCRIPTION DRUG LABEL 1 0078-0897 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
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0143-9387 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 18 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
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
Triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0440-0251 CREAM 1 mg TOPICAL ANDA 18 sections
Triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0440-0317 CREAM 0.25 mg TOPICAL ANDA 17 sections
Triamcinolone acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0440-0318 CREAM 5 mg TOPICAL ANDA 17 sections
Nasal Allergy HUMAN OTC DRUG LABEL 1 0536-1457 SPRAY, METERED 55 ug NASAL ANDA 13 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0703-0241 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 20 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0703-0243 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 20 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0703-0245 INJECTION, SUSPENSION 40 mg INTRA-ARTICULAR ANDA 20 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0225 CREAM 1 mg TOPICAL ANDA 18 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0226 CREAM 0.25 mg TOPICAL ANDA 18 sections
Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 1 0713-0228 OINTMENT 1 mg TOPICAL ANDA 11 sections