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

Stem definitionDrug idCAS RN
calcium metabolism regulator, pharmaceutical aid 2868 118072-93-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zoledronic acid
  • zoledronate
  • zoledronic acid monohydrate
  • zometa
  • zoledronic acid hydrate
An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.
  • Molecular weight: 272.09
  • Formula: C5H10N2O7P2
  • CLOGP: -1.22
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 5
  • TPSA: 153.11
  • ALOGS: -1.92
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 39 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.78 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT1,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K2,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,MAPK9,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 58
kinase-selectivity-class AURKA,AXL,BMX,BRAF,CDK2,CDK4,CDK9,CHUK,DDR1,DYRK1B,EPHB4,ERBB2,GRK2,JAK2,MAP2K6,MAP3K14,MAP3K2,MAP3K21,MAPK7,MAPK8,PIK3CB,PIK3CD,PIK3CG,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 29
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
March 20, 2001 EMA
Aug. 20, 2001 FDA NOVARTIS

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
Osteonecrosis of jaw 9653.24 10.63 3187 132212 35916 90457132
Exposed bone in jaw 1539.00 10.63 428 134971 2498 90490550
Bone pain 1315.21 10.63 932 134467 61051 90431997
Metastases to bone 1210.63 10.63 642 134757 24863 90468185
Osteonecrosis 1146.08 10.63 625 134774 25616 90467432
Neutropenia 943.89 10.63 1404 133995 223500 90269548
Malignant neoplasm progression 826.77 10.63 905 134494 105965 90387083
Atypical femur fracture 708.45 10.63 290 135109 6131 90486917
Influenza like illness 691.03 10.63 721 134678 79890 90413158
Myalgia 648.05 10.63 1032 134367 174093 90318955
Pain in jaw 608.77 10.63 533 134866 47452 90445596
Metastases to liver 544.21 10.63 404 134995 28403 90464645
Neuropathy peripheral 513.16 10.63 812 134587 136158 90356890
Femur fracture 467.96 10.63 452 134947 45630 90447418
Drug ineffective 455.44 10.63 864 134535 1383434 89109614
Bone disorder 451.91 10.63 331 135068 22789 90470259
Systemic lupus erythematosus 422.01 10.63 31 135368 361865 90131183
Hypocalcaemia 417.88 10.63 409 134990 41959 90451089
Glossodynia 388.60 10.63 23 135376 321756 90171292
Bone sequestrum 387.94 10.63 126 135273 1327 90491721
Maternal exposure during pregnancy 387.20 10.63 43 135356 360020 90133028
Bone lesion 386.60 10.63 190 135209 6247 90486801
Iridocyclitis 365.57 10.63 154 135245 3507 90489541
Chills 356.15 10.63 677 134722 131304 90361744
Back pain 346.94 10.63 1152 134247 316023 90177025
Synovitis 345.54 10.63 43 135356 329709 90163339
Contraindicated product administered 344.77 10.63 38 135361 320101 90172947
Hand deformity 338.10 10.63 28 135371 296334 90196714
Anti-cyclic citrullinated peptide antibody positive 336.38 10.63 3 135396 236430 90256618
Pericarditis 327.09 10.63 19 135380 270132 90222916
Tooth extraction 300.66 10.63 197 135202 11316 90481732
Metastases to lung 299.15 10.63 223 135176 15768 90477280
Helicobacter infection 297.66 10.63 9 135390 226841 90266207
Exposure during pregnancy 297.31 10.63 14 135385 238396 90254652
Neoplasm progression 294.89 10.63 348 135051 44138 90448910
Plasma cell myeloma 286.70 10.63 329 135070 40499 90452549
Psoriatic arthropathy 279.66 10.63 15 135384 228320 90264728
Folliculitis 272.21 10.63 7 135392 204346 90288702
Pyrexia 265.79 10.63 1791 133608 658694 89834354
Wound 256.30 10.63 68 135331 302912 90190136
Sequestrectomy 254.39 10.63 79 135320 710 90492338
Oral cavity fistula 252.69 10.63 75 135324 569 90492479
Type 2 diabetes mellitus 246.88 10.63 14 135385 203230 90289818
Blood creatinine increased 244.26 10.63 496 134903 100890 90392158
Metastases to spine 241.38 10.63 116 135283 3627 90489421
Disease progression 237.57 10.63 639 134760 155976 90337072
Rheumatoid factor positive 236.04 10.63 4 135395 171646 90321402
Death 232.45 10.63 1316 134083 455235 90037813
Carbohydrate antigen 15-3 increased 229.44 10.63 93 135306 1914 90491134
Breast cancer metastatic 228.70 10.63 186 135213 14946 90478102
Acute phase reaction 228.24 10.63 60 135339 272 90492776
Muscle injury 228.19 10.63 8 135391 176646 90316402
Blister 223.83 10.63 53 135346 254945 90238103
Irritable bowel syndrome 217.33 10.63 27 135372 207421 90285627
Osteolysis 216.82 10.63 106 135293 3444 90489604
Infusion related reaction 211.43 10.63 187 135212 416593 90076455
White blood cell count decreased 210.81 10.63 638 134761 166471 90326577
Arthropathy 208.88 10.63 146 135253 366096 90126952
Osteomyelitis 208.45 10.63 232 135167 27614 90465434
Wheezing 202.13 10.63 53 135346 238027 90255021
Hepatic enzyme increased 201.53 10.63 147 135252 360589 90132459
Tooth loss 201.51 10.63 131 135268 7423 90485625
Jaw disorder 200.85 10.63 117 135282 5442 90487606
Product use issue 199.67 10.63 123 135276 329796 90163252
Renal tubular necrosis 199.36 10.63 169 135230 14386 90478662
Purulent discharge 198.58 10.63 115 135284 5290 90487758
Rheumatic fever 197.54 10.63 7 135392 153114 90339934
Condition aggravated 196.10 10.63 370 135029 595175 89897873
Spinal pain 195.59 10.63 173 135226 15594 90477454
Completed suicide 189.36 10.63 6 135393 145052 90347996
Therapeutic product effect decreased 183.05 10.63 93 135306 277478 90215570
Osteosclerosis 177.80 10.63 99 135300 4221 90488827
Abdominal discomfort 175.84 10.63 276 135123 477052 90015996
Arthralgia 175.79 10.63 1855 133544 776667 89716381
Anaemia 174.80 10.63 1010 134389 351792 90141256
Pathological fracture 174.65 10.63 132 135267 9528 90483520
Gingival swelling 171.89 10.63 102 135297 4911 90488137
Drug hypersensitivity 171.79 10.63 267 135132 463342 90029706
Toothache 171.21 10.63 188 135211 22042 90471006
C-reactive protein abnormal 171.06 10.63 4 135395 127425 90365623
Gingivitis 169.33 10.63 128 135271 9241 90483807
Sleep disorder due to general medical condition, insomnia type 169.15 10.63 5 135394 128689 90364359
Palmar-plantar erythrodysaesthesia syndrome 169.01 10.63 209 135190 27814 90465234
Discomfort 162.21 10.63 105 135294 274230 90218818
Drug intolerance 159.95 10.63 264 135135 447327 90045721
Osteitis 159.49 10.63 88 135311 3685 90489363
Atypical fracture 156.05 10.63 57 135342 874 90492174
Osteopenia 155.83 10.63 182 135217 22820 90470228
Treatment failure 155.69 10.63 135 135264 303793 90189255
Overdose 154.70 10.63 25 135374 157684 90335364
Idiopathic orbital inflammation 153.22 10.63 42 135357 230 90492818
Liver injury 152.52 10.63 34 135365 170533 90322515
Metastases to central nervous system 150.33 10.63 157 135242 17385 90475663
Rheumatoid arthritis 146.92 10.63 196 135203 362418 90130630
Ill-defined disorder 146.18 10.63 47 135352 184844 90308204
Diarrhoea 146.05 10.63 2086 133313 937104 89555944
Injury 146.03 10.63 56 135343 197293 90295755
Loose tooth 143.81 10.63 82 135317 3661 90489387
Fanconi syndrome 143.10 10.63 66 135333 1877 90491171
Lower respiratory tract infection 140.10 10.63 102 135297 250557 90242491
Musculoskeletal chest pain 139.81 10.63 175 135224 23575 90469473
Parophthalmia 139.10 10.63 43 135356 380 90492668
Jaw operation 137.40 10.63 51 135348 820 90492228
Eye pain 137.28 10.63 241 135158 43927 90449121
Tumour marker increased 136.31 10.63 93 135306 5714 90487334
Spinal fracture 135.67 10.63 166 135233 21850 90471198
Presbyacusis 134.25 10.63 73 135326 2969 90490079
Neutrophil count decreased 133.62 10.63 316 135083 71216 90421832
Facet joint syndrome 132.40 10.63 3 135396 98386 90394662
Fibromyalgia 130.24 10.63 73 135326 206196 90286852
Debridement 129.60 10.63 54 135345 1195 90491853
Wound infection 127.14 10.63 8 135391 106394 90386654
Toxicity to various agents 126.62 10.63 146 135253 287700 90205348
Hypophosphataemia 125.60 10.63 132 135267 14722 90478326
Pleural fibrosis 125.48 10.63 74 135325 3522 90489526
Psoriasis 125.16 10.63 33 135366 147721 90345327
Asthma 124.68 10.63 107 135292 242053 90250995
Renal impairment 124.06 10.63 393 135006 105028 90388020
Fistula 123.46 10.63 119 135280 11970 90481078
Hyperpyrexia 123.17 10.63 81 135318 4680 90488368
Tooth disorder 122.77 10.63 189 135210 30901 90462147
Hypersensitivity 122.71 10.63 315 135084 454362 90038686
Intentional product use issue 121.53 10.63 88 135311 216804 90276244
Breast cancer 121.18 10.63 256 135143 53505 90439543
Pain 121.15 10.63 2124 133275 994217 89498831
Lip dry 119.41 10.63 8 135391 100947 90392101
Pleural thickening 119.04 10.63 69 135330 3179 90489869
Blood magnesium increased 118.57 10.63 70 135329 3338 90489710
Prescribed overdose 117.67 10.63 7 135392 97618 90395430
Therapeutic product effect incomplete 114.86 10.63 74 135325 193822 90299226
Pain in extremity 113.09 10.63 1098 134301 449431 90043617
Urticaria 110.20 10.63 186 135213 312548 90180500
Metastases to lymph nodes 109.94 10.63 110 135289 11579 90481469
Obesity 109.81 10.63 14 135385 105493 90387555
Dental fistula 108.12 10.63 40 135359 637 90492411
Drug interaction 107.34 10.63 154 135245 276299 90216749
Weight increased 107.10 10.63 297 135102 417630 90075418
Actinomycosis 104.20 10.63 45 135354 1091 90491957
Periodontitis 103.21 10.63 67 135332 3786 90489262
Oral pain 102.43 10.63 179 135220 32504 90460544
Asthenia 101.62 10.63 1231 134168 532520 89960528
Swelling 101.39 10.63 306 135093 418752 90074296
Injection site reaction 98.84 10.63 11 135388 92069 90400979
Grip strength decreased 97.03 10.63 12 135387 92564 90400484
Breast cancer recurrent 96.84 10.63 74 135325 5429 90487619
Bone fistula 95.16 10.63 22 135377 50 90492998
Oroantral fistula 94.90 10.63 27 135372 173 90492875
Blood cholesterol increased 94.18 10.63 103 135296 207909 90285139
Deafness neurosensory 92.80 10.63 79 135320 6762 90486286
Confusional state 92.00 10.63 284 135115 385921 90107127
Bursitis 91.49 10.63 41 135358 131613 90361435
Sinusitis 90.74 10.63 240 135159 342848 90150200
PIK3CA-activated mutation 88.99 10.63 41 135358 1163 90491885
Hepatic lesion 88.40 10.63 71 135328 5602 90487446
Acute kidney injury 87.89 10.63 796 134603 319591 90173457
Peripheral venous disease 87.66 10.63 11 135388 83910 90409138
Bone debridement 86.72 10.63 26 135373 205 90492843
Osteopetrosis 85.75 10.63 20 135379 48 90493000
Gingival erythema 85.55 10.63 39 135360 1079 90491969
Blood calcium decreased 85.25 10.63 158 135241 30024 90463024
Mucosal inflammation 85.15 10.63 233 135166 57392 90435656
Joint range of motion decreased 84.18 10.63 49 135350 135594 90357454
Suicide attempt 83.53 10.63 8 135391 75391 90417657
Prescribed underdose 83 10.63 8 135391 75011 90418037
Wound closure 82.56 10.63 23 135376 135 90492913
Fatigue 82.45 10.63 2280 133119 1151743 89341305
Product quality issue 81.41 10.63 11 135388 79314 90413734
Injection site pain 80.87 10.63 84 135315 173615 90319433
Jaw fracture 80.28 10.63 50 135349 2628 90490420
Mobility decreased 79.51 10.63 159 135240 250575 90242473
Pregnancy 79.44 10.63 3 135396 62044 90431004
Body height decreased 78.37 10.63 93 135306 11856 90481192
Movement disorder 78.34 10.63 149 135250 28870 90464178
Intentional product misuse 77.82 10.63 19 135380 89585 90403463
Fracture 77.24 10.63 127 135272 21949 90471099
Therapy non-responder 77.16 10.63 55 135344 136649 90356399
Osteotomy 76.32 10.63 25 135374 271 90492777
Metastases to skin 74.57 10.63 44 135355 2096 90490952
Constipation 74.52 10.63 692 134707 279703 90213345
Epigastric discomfort 74.47 10.63 73 135326 7495 90485553
Metastases to pelvis 73.87 10.63 29 135370 547 90492501
Infusion site coldness 73.54 10.63 23 135376 212 90492836
Decreased appetite 72.67 10.63 871 134528 375669 90117379
Iritis 72.52 10.63 53 135346 3633 90489415
Fanconi syndrome acquired 71.74 10.63 36 135363 1238 90491810
Rib fracture 71.69 10.63 136 135263 26299 90466749
Haematotoxicity 71.61 10.63 91 135308 12444 90480604
Metastases to pleura 71.15 10.63 42 135357 2002 90491046
Hypercholesterolaemia 70.76 10.63 31 135368 100861 90392187
Dislocation of vertebra 70.66 10.63 3 135396 55965 90437083
Leukopenia 70.54 10.63 318 135081 100392 90392656
Bone loss 70.50 10.63 51 135348 3441 90489607
Thrombocytopenia 69.64 10.63 542 134857 208183 90284865
Full blood count decreased 68.79 10.63 143 135256 29546 90463502
Adjustment disorder with depressed mood 68.60 10.63 4 135395 56749 90436299
Blood potassium increased 68.10 10.63 116 135283 20633 90472415
Nausea 67.88 10.63 2152 133247 1108164 89384884
Autoimmune disorder 67.18 10.63 16 135383 76728 90416320
Adrenocortical insufficiency acute 66.67 10.63 44 135355 2557 90490491
Scleritis 66.30 10.63 58 135341 5150 90487898
Uveitis 66.07 10.63 99 135300 15804 90477244
Skin toxicity 65.98 10.63 65 135334 6714 90486334
Thoracic vertebral fracture 65.78 10.63 59 135340 5415 90487633
Bone density decreased 65.07 10.63 103 135296 17242 90475806
Platelet count decreased 64.36 10.63 387 135012 136582 90356466
Delirium 64.32 10.63 38 135361 104321 90388727
Gamma-glutamyltransferase decreased 63.86 10.63 23 135376 338 90492710
Aminoaciduria 63.05 10.63 18 135381 117 90492931
Adverse event 62.72 10.63 50 135349 117368 90375680
Feeling cold 62.13 10.63 131 135268 27334 90465714
Carcinoembryonic antigen increased 60.84 10.63 40 135359 2310 90490738
Purulence 60.75 10.63 35 135364 1594 90491454
Joint swelling 60.43 10.63 472 134927 502828 89990220
Bone cyst 60.40 10.63 40 135359 2338 90490710
Iris adhesions 60.10 10.63 23 135376 404 90492644
Glomerular filtration rate decreased 60.04 10.63 98 135301 16834 90476214
Abortion spontaneous 59.18 10.63 6 135393 54050 90438998
Rash 58.40 10.63 838 134561 795262 89697786
Abscess jaw 58.39 10.63 33 135366 1448 90491600
Jaw fistula 58.37 10.63 15 135384 61 90492987
Metastases to bone marrow 58.35 10.63 25 135374 594 90492454
Epilepsy 58.06 10.63 25 135374 82181 90410867
Suicidal ideation 57.95 10.63 19 135380 73836 90419212
Alveolar bone resorption 57.76 10.63 14 135385 42 90493006
Ocular hyperaemia 57.43 10.63 144 135255 33654 90459394
Hypercalcaemia 57.26 10.63 145 135254 34095 90458953
Off label use 56.46 10.63 1237 134162 1101015 89392033
Coma 56.44 10.63 19 135380 72613 90420435
Blepharospasm 56.16 10.63 8 135391 55437 90437611
Migraine 55.94 10.63 126 135273 190266 90302782
Cyst 54.90 10.63 93 135306 16468 90476580
Medication error 54.80 10.63 29 135370 84623 90408425
Eye inflammation 54.64 10.63 63 135336 7788 90485260
Vein disorder 53.73 10.63 53 135346 5483 90487565
Night sweats 53.72 10.63 68 135331 128698 90364350
Loss of personal independence in daily activities 53.60 10.63 75 135324 136030 90357018
Hypertension 53.55 10.63 432 134967 457100 90035948
Tonsillar disorder 53.47 10.63 29 135370 1173 90491875
Sciatica 53.12 10.63 44 135355 101338 90391710
Knee arthroplasty 53.11 10.63 29 135370 83153 90409895
Nasal disorder 53.00 10.63 42 135357 3250 90489798
Oral disorder 52.72 10.63 71 135328 10274 90482774
X-ray abnormal 52.55 10.63 4 135395 45420 90447628
Bone density abnormal 52.49 10.63 46 135353 4094 90488954
Hormone receptor positive HER2 negative breast cancer 52.40 10.63 19 135380 285 90492763
Urinary tract inflammation 52.13 10.63 14 135385 70 90492978
Nasopharyngitis 52.07 10.63 375 135024 406729 90086319
Lupus-like syndrome 52.00 10.63 6 135393 48840 90444208
Chondrocalcinosis pyrophosphate 51.21 10.63 27 135372 1031 90492017
Hyperbaric oxygen therapy 51.11 10.63 12 135387 30 90493018
Anaphylactic reaction 51.00 10.63 34 135365 87490 90405558
Blood phosphorus decreased 50.36 10.63 49 135350 4985 90488063
Angioedema 50.36 10.63 17 135382 64859 90428189
Gingival pain 50.35 10.63 67 135332 9585 90483463
Dental caries 50.30 10.63 73 135326 11324 90481724
Trismus 50.25 10.63 48 135351 4773 90488275
Hip fracture 50.12 10.63 135 135264 32942 90460106
Pulmonary fibrosis 50.01 10.63 52 135347 107451 90385597
Stress fracture 49.96 10.63 63 135336 8548 90484500
Polyneuropathy 49.38 10.63 97 135302 19244 90473804
Corneal endotheliitis 49.22 10.63 11 135388 20 90493028
Pulpitis dental 48.90 10.63 26 135373 1010 90492038
Sleep disorder due to a general medical condition 48.89 10.63 5 135394 44733 90448315
Feeling abnormal 48.63 10.63 421 134978 166814 90326234
Periorbital inflammation 47.91 10.63 16 135383 185 90492863
Tooth abscess 47.71 10.63 87 135312 16326 90476722
Mastication disorder 47.61 10.63 35 135364 2421 90490627
Multiple sclerosis relapse 47.60 10.63 10 135389 52295 90440753
Hyperparathyroidism secondary 47.46 10.63 31 135368 1770 90491278
Giant cell arteritis 47.39 10.63 38 135361 2991 90490057
Spinal compression fracture 47.39 10.63 83 135316 15095 90477953
Fall 46.57 10.63 993 134406 480817 90012231
Frequent bowel movements 45.82 10.63 14 135385 56921 90436127
Metastases to retroperitoneum 45.43 10.63 15 135384 167 90492881
Nail discolouration 45.13 10.63 38 135361 3204 90489844
Bone marrow infiltration 45.10 10.63 23 135376 819 90492229
Tooth fracture 44.77 10.63 73 135326 12527 90480521
Wrong technique in product usage process 44.19 10.63 26 135373 71545 90421503
Gingival disorder 44.02 10.63 41 135358 3950 90489098
Hypouricaemia 43.64 10.63 16 135383 248 90492800
Pruritus 43.24 10.63 560 134839 540965 89952083
Depression 42.86 10.63 268 135131 300333 90192715
Nail ridging 42.70 10.63 19 135380 496 90492552
Tibia fracture 42.63 10.63 49 135350 6038 90487010
Vein rupture 42.34 10.63 28 135371 1633 90491415
Upper limb fracture 42.11 10.63 97 135302 21481 90471567
Spinal disorder 41.96 10.63 68 135331 11611 90481437
Isosthenuria 41.94 10.63 13 135386 116 90492932
Compression fracture 41.30 10.63 58 135341 8731 90484317
Muscle spasticity 41.18 10.63 3 135396 35319 90457729
Injection site erythema 41.10 10.63 52 135347 98450 90394598
Abdominal lymphadenopathy 41.06 10.63 23 135376 992 90492056
Bone erosion 40.97 10.63 14 135385 53007 90440041
Pelvic fracture 40.90 10.63 78 135321 15141 90477907
Breath odour 40.76 10.63 26 135373 1425 90491623
Skin lesion 40.06 10.63 135 135264 37230 90455818
Tubulointerstitial nephritis 39.98 10.63 105 135294 25238 90467810
Hospitalisation 39.93 10.63 82 135317 128018 90365030
Coeliac disease 39.64 10.63 9 135390 44601 90448447
Lacrimation increased 39.55 10.63 109 135290 26953 90466095
Hypoglycaemia 39.54 10.63 28 135371 69820 90423228
Ear infection 39.46 10.63 28 135371 69747 90423301
Onycholysis 39.27 10.63 30 135369 2200 90490848
Oedema 39.14 10.63 160 135239 200135 90292913
Metastasis 38.99 10.63 47 135352 6090 90486958
Exostosis of jaw 38.85 10.63 24 135375 1243 90491805
Hip arthroplasty 38.79 10.63 34 135365 76174 90416874
Onychomycosis 38.78 10.63 5 135394 37371 90455677
Gait disturbance 38.75 10.63 575 134824 259921 90233127
Disability 38.74 10.63 7 135392 40738 90452310
Deep vein thrombosis 38.73 10.63 252 135147 91368 90401680
Electrocardiogram PR shortened 38.67 10.63 18 135381 523 90492525
Bradycardia 38.50 10.63 41 135358 83806 90409242
Breast cancer stage II 38.48 10.63 4 135395 35330 90457718
Poor venous access 38.35 10.63 88 135311 19439 90473609
Excessive granulation tissue 38.33 10.63 21 135378 867 90492181
Vitamin D decreased 38.04 10.63 66 135333 11913 90481135
Humerus fracture 37.95 10.63 59 135340 9726 90483322
Tumour marker abnormal 37.83 10.63 16 135383 368 90492680
Hepatic cirrhosis 37.63 10.63 24 135375 63229 90429819
Peripheral coldness 37.09 10.63 71 135328 13821 90479227
Contusion 36.83 10.63 222 135177 250994 90242054
Eye swelling 36.81 10.63 112 135287 29274 90463774
Therapeutic response decreased 36.78 10.63 48 135351 89681 90403367
Red blood cell count decreased 36.77 10.63 152 135247 46199 90446849
Accidental exposure to product 36.75 10.63 9 135390 42357 90450691
Rectal prolapse 36.66 10.63 29 135370 2238 90490810
Renal tubular dysfunction 36.45 10.63 17 135382 496 90492552
Metastases to adrenals 36.43 10.63 21 135378 957 90492091
Hydronephrosis 36.38 10.63 66 135333 12336 90480712
Lumbar vertebral fracture 36.21 10.63 50 135349 7408 90485640
Eastern Cooperative Oncology Group performance status worsened 36.17 10.63 27 135372 1912 90491136
Pneumonitis 35.95 10.63 146 135253 44024 90449024
Hypokinesia 35.65 10.63 75 135324 15622 90477426
Bone cancer 35.22 10.63 25 135374 1637 90491411
Back injury 34.84 10.63 13 135386 46609 90446439
Periodontal disease 34.55 10.63 25 135374 1687 90491361
Alopecia 34.52 10.63 526 134873 494545 89998503
Metastases to soft tissue 34.50 10.63 14 135385 289 90492759
Abdominal pain upper 34.49 10.63 324 135075 332350 90160698
Gastrointestinal disorder 34.48 10.63 233 135166 256454 90236594
Invasive ductal breast carcinoma 34.39 10.63 50 135349 7768 90485280
Lung disorder 34.38 10.63 112 135287 149771 90343277
Product dose omission issue 34.28 10.63 275 135124 291412 90201636
Premature delivery 34.08 10.63 8 135391 38754 90454294
Atrial fibrillation 34.07 10.63 327 135072 133284 90359764
Skin wrinkling 33.91 10.63 23 135376 1399 90491649
Foot fracture 33.89 10.63 102 135297 26504 90466544
No adverse event 33.80 10.63 31 135368 67951 90425097
Peri-implantitis 33.67 10.63 10 135389 76 90492972
Tooth erosion 33.56 10.63 16 135383 491 90492557
Multiple fractures 33.44 10.63 55 135344 9507 90483541
Metastases to kidney 33.37 10.63 13 135386 240 90492808
Acetabulum fracture 33.07 10.63 15 135384 410 90492638
Chikungunya virus infection 33.03 10.63 12 135387 181 90492867
Pyelitis 32.88 10.63 13 135386 250 90492798
Road traffic accident 32.61 10.63 70 135329 107556 90385492
Dental cyst 32.57 10.63 9 135390 51 90492997
Wound treatment 32.33 10.63 12 135387 193 90492855
Oral pustule 32.28 10.63 9 135390 53 90492995
Tooth infection 32.26 10.63 84 135315 20086 90472962
Haematochezia 32.20 10.63 35 135364 70878 90422170
Progressive bulbar palsy 32.14 10.63 9 135390 54 90492994
Musculoskeletal stiffness 31.95 10.63 286 135113 296246 90196802
Bone swelling 31.81 10.63 24 135375 1727 90491321
Lymphadenopathy 31.63 10.63 144 135255 45631 90447417
HER2 positive breast cancer 31.63 10.63 15 135384 455 90492593
Malaise 31.58 10.63 1120 134279 584866 89908182
Blood alkaline phosphatase increased 31.57 10.63 149 135250 47930 90445118
Bladder prolapse 31.53 10.63 26 135373 2129 90490919
Drug ineffective for unapproved indication 31.26 10.63 32 135367 66612 90426436
Metaphyseal corner fracture 31.24 10.63 8 135391 32 90493016
Liver disorder 31.13 10.63 86 135313 121183 90371865
Foot deformity 31.11 10.63 26 135373 59625 90433423
Concomitant disease aggravated 30.91 10.63 59 135340 11459 90481589
Groin pain 30.88 10.63 61 135338 12152 90480896
Orbital swelling 30.83 10.63 9 135390 64 90492984
Onychoclasis 30.65 10.63 46 135353 7353 90485695
Vasodilatation 30.60 10.63 29 135370 2855 90490193
Soft tissue infection 30.49 10.63 29 135370 2868 90490180
Nephropathy toxic 30.43 10.63 62 135337 12626 90480422
Musculoskeletal discomfort 30.13 10.63 84 135315 20907 90472141
Dysstasia 30.00 10.63 94 135305 24958 90468090
Hypophosphataemic osteomalacia 29.97 10.63 12 135387 239 90492809
Osteonecrosis of external auditory canal 29.86 10.63 11 135388 173 90492875
Apparent death 29.85 10.63 20 135379 1192 90491856
Polymyalgia rheumatica 29.81 10.63 37 135362 4940 90488108
Cellulitis orbital 29.80 10.63 16 135383 634 90492414
Bladder hypertrophy 29.78 10.63 15 135384 520 90492528
Pleural neoplasm 29.75 10.63 14 135385 417 90492631
Infusion site induration 29.73 10.63 22 135377 1537 90491511
Biopsy bone abnormal 29.67 10.63 7 135392 18 90493030
Drug withdrawal syndrome 29.43 10.63 4 135395 28719 90464329
Aspartate aminotransferase increased 29.31 10.63 258 135141 102679 90390369
Oral surgery 29.27 10.63 22 135377 1574 90491474
Cancer pain 29.20 10.63 33 135366 3992 90489056
Exophthalmos 29.03 10.63 23 135376 1779 90491269
Pleural effusion 29.00 10.63 275 135124 111716 90381332
Conjunctival oedema 28.82 10.63 18 135381 951 90492097
Aspiration bone marrow 28.81 10.63 11 135388 192 90492856
Tenderness 28.74 10.63 97 135302 26771 90466277
Concomitant disease progression 28.70 10.63 25 135374 2207 90490841
Injection site pruritus 28.65 10.63 23 135376 53811 90439237
Ulcer haemorrhage 28.61 10.63 3 135396 26318 90466730
Calcification of muscle 28.49 10.63 11 135388 198 90492850
Colitis ulcerative 28.20 10.63 29 135370 60237 90432811
Fracture nonunion 28.13 10.63 25 135374 2267 90490781
Drug level increased 28.13 10.63 4 135395 27758 90465290
Stevens-Johnson syndrome 28.03 10.63 5 135394 29371 90463677
Hot flush 27.87 10.63 168 135231 59320 90433728
BRAF gene mutation 27.76 10.63 8 135391 54 90492994
Plasmacytoma 27.59 10.63 27 135372 2766 90490282
Chronic inflammatory demyelinating polyradiculoneuropathy 27.54 10.63 18 135381 1029 90492019
Tooth avulsion 27.51 10.63 8 135391 56 90492992
Gingival abscess 27.45 10.63 18 135381 1035 90492013
Dengue fever 27.44 10.63 17 135382 885 90492163
Conjunctivitis 27.33 10.63 95 135304 26611 90466437
Fistula discharge 27.11 10.63 18 135381 1057 90491991
Nail toxicity 27.09 10.63 13 135386 405 90492643
Sleep disorder 26.96 10.63 179 135220 197851 90295197
Osteitis condensans 26.94 10.63 7 135392 30 90493018
Dry eye 26.76 10.63 163 135236 57768 90435280
Chloropsia 26.69 10.63 8 135391 63 90492985
Metastases to peritoneum 26.69 10.63 32 135367 4123 90488925
Dental operation 26.61 10.63 21 135378 1615 90491433
Treatment noncompliance 26.42 10.63 23 135376 51704 90441344
Vulvovaginal dryness 26.39 10.63 29 135370 3402 90489646
Nasal congestion 26.33 10.63 53 135346 83361 90409687
Post-traumatic neck syndrome 26.15 10.63 25 135374 2489 90490559
Mouth swelling 26.06 10.63 37 135362 5625 90487423
Hypophosphatasia 25.95 10.63 8 135391 70 90492978
Therapy interrupted 25.93 10.63 22 135377 50086 90442962
Drug reaction with eosinophilia and systemic symptoms 25.74 10.63 16 135383 42742 90450306
Drug tolerance decreased 25.67 10.63 8 135391 32122 90460926
Amnesia 25.63 10.63 80 135319 108425 90384623
Obstructive airways disorder 25.58 10.63 4 135395 25865 90467183
Blood calcium increased 25.53 10.63 56 135343 12002 90481046
Dry mouth 25.24 10.63 166 135233 183893 90309155
Dry skin 25.21 10.63 221 135178 87852 90405196
Periodontal destruction 25.19 10.63 5 135394 3 90493045
Dysuria 25.07 10.63 121 135278 39280 90453768
Glucose urine 25.01 10.63 6 135393 17 90493031
Depressed level of consciousness 24.95 10.63 44 135355 72740 90420308
Numb chin syndrome 24.86 10.63 7 135392 43 90493005
Lymphadenopathy mediastinal 24.76 10.63 27 135372 3140 90489908
Face and mouth X-ray abnormal 24.76 10.63 6 135393 18 90493030
Deafness 24.72 10.63 82 135317 22432 90470616
Hypotension 24.65 10.63 340 135059 325057 90167991
Motor neurone disease 24.44 10.63 10 135389 211 90492837
Injection site inflammation 24.42 10.63 32 135367 4509 90488539
Metastases to meninges 24.38 10.63 29 135370 3706 90489342
Spinal stenosis 24.30 10.63 69 135330 17355 90475693
Cytopenia 24.24 10.63 69 135330 17380 90475668
Ulna fracture 24.06 10.63 18 135381 1279 90491769
Sedation 23.90 10.63 22 135377 48149 90444899
Product use in unapproved indication 23.83 10.63 356 135043 335880 90157168
Respiratory arrest 23.73 10.63 10 135389 33301 90459747
Pneumonia aspiration 23.72 10.63 16 135383 40924 90452124
Dysarthria 23.53 10.63 28 135371 54454 90438594
Withdrawal syndrome 23.40 10.63 3 135396 22521 90470527
Oral mucosal erythema 23.39 10.63 20 135379 1722 90491326
Otitis externa 23.39 10.63 21 135378 1930 90491118
Encephalopathy 23.30 10.63 21 135378 46423 90446625
Selenium deficiency 23.15 10.63 7 135392 57 90492991
Parathyroid tumour malignant 23.15 10.63 7 135392 57 90492991
Abdominal pain 23.14 10.63 434 134965 395287 90097761
Dysgeusia 23.09 10.63 146 135253 52414 90440634
Pubic pain 23.06 10.63 9 135390 167 90492881
Fluid retention 22.96 10.63 62 135337 88029 90405019
Blood parathyroid hormone increased 22.95 10.63 27 135372 3410 90489638
Monoclonal gammopathy 22.91 10.63 15 135384 860 90492188
Procollagen type I C-terminal propeptide increased 22.86 10.63 6 135393 27 90493021
Biliary dilatation 22.75 10.63 24 135375 2687 90490361
Lymphoedema 22.74 10.63 58 135341 13695 90479353
Serum procollagen type I N-terminal propeptide increased 22.68 10.63 6 135393 28 90493020
Lithiasis 22.63 10.63 7 135392 62 90492986
Radius fracture 22.53 10.63 29 135370 4015 90489033
Thermal burn 22.45 10.63 38 135361 6724 90486324
Tumour marker decreased 22.43 10.63 7 135392 64 90492984
Drug dependence 22.22 10.63 8 135391 29319 90463729
Medical device site joint inflammation 22.03 10.63 4 135395 0 90493048
Hand fracture 22.03 10.63 38 135361 6827 90486221
Wrist fracture 21.91 10.63 62 135337 15562 90477486
Renal glycosuria 21.74 10.63 5 135394 11 90493037
Finger deformity 21.69 10.63 11 135388 32886 90460162
Onychomadesis 21.67 10.63 22 135377 45976 90447072
General physical health deterioration 21.53 10.63 387 135012 354728 90138320
Plasma cell myeloma recurrent 21.52 10.63 29 135370 4199 90488849
Hepatic mass 21.42 10.63 21 135378 2156 90490892
Post procedural inflammation 21.31 10.63 8 135391 133 90492915
Feeding disorder 21.24 10.63 66 135333 17446 90475602
Joint warmth 21.19 10.63 19 135380 1743 90491305
Allergy to plants 21.02 10.63 14 135385 826 90492222
Disorder of orbit 21.02 10.63 6 135393 39 90493009
Vomiting 21.02 10.63 1406 133993 786887 89706161
Eczema 20.94 10.63 29 135370 52841 90440207
Skin sensitisation 20.89 10.63 15 135384 1000 90492048
Avulsion fracture 20.88 10.63 10 135389 310 90492738
Chondrocalcinosis 20.88 10.63 18 135381 1567 90491481
Device issue 20.82 10.63 9 135390 29528 90463520
Heavy menstrual bleeding 20.70 10.63 3 135396 20527 90472521
Urine output decreased 20.68 10.63 53 135346 12550 90480498
Ultrasound foetal abnormal 20.67 10.63 8 135391 145 90492903
Respiratory disorder 20.61 10.63 41 135358 64775 90428273
Clinical death 20.50 10.63 7 135392 87 90492961
Hungry bone syndrome 20.47 10.63 8 135391 149 90492899
Liver function test increased 20.44 10.63 62 135337 84793 90408255
Rhabdomyolysis 20.42 10.63 28 135371 51228 90441820
Pulmonary embolism 20.31 10.63 291 135108 130529 90362519
Infection 20.28 10.63 400 134999 361694 90131354
Bone lesion excision 20.27 10.63 6 135393 45 90493003
Paronychia 20.25 10.63 40 135359 7966 90485082
Joint dislocation 20.24 10.63 22 135377 44560 90448488
Renal failure 20.17 10.63 291 135108 130716 90362332
Device dislocation 20.06 10.63 11 135388 31471 90461577
Cardio-respiratory arrest 20.03 10.63 40 135359 63100 90429948
Bone hypertrophy 19.82 10.63 11 135388 466 90492582
Inflammation 19.77 10.63 171 135228 178421 90314627
Oxygen saturation decreased 19.67 10.63 88 135311 107395 90385653
Hyphaema 19.61 10.63 10 135389 356 90492692
Spinal cord compression 19.59 10.63 30 135369 4881 90488167
Haematocrit decreased 19.51 10.63 118 135281 41714 90451334
Vaginal discharge 19.27 10.63 3 135396 19461 90473587
Adnexa uteri mass 19.21 10.63 12 135387 634 90492414
Memory impairment 19.20 10.63 195 135204 197049 90295999
Facial pain 19.17 10.63 53 135346 13129 90479919
Cardiac arrest 19.15 10.63 86 135313 104849 90388199
Stomatitis 19.06 10.63 292 135107 274406 90218642
Blood urea increased 19.06 10.63 93 135306 30320 90462728
Drug-induced liver injury 19.01 10.63 70 135329 90248 90402800
Aggression 19.00 10.63 8 135391 26660 90466388
Carcinoid tumour pulmonary 18.93 10.63 11 135388 509 90492539
Incorrect route of product administration 18.84 10.63 29 135370 50597 90442451
Blood potassium decreased 18.80 10.63 129 135270 47598 90445450
Bone fissure 18.78 10.63 11 135388 517 90492531
Osteochondrosis 18.55 10.63 18 135381 1825 90491223
Dyspepsia 18.44 10.63 198 135201 197962 90295086
Anal erythema 18.42 10.63 9 135390 292 90492756
Breast pain 18.34 10.63 45 135354 10373 90482675
Normal newborn 18.34 10.63 6 135393 23356 90469692
Gastrointestinal haemorrhage 18.31 10.63 71 135328 90177 90402871
Hepatitis 18.27 10.63 50 135349 70689 90422359
Oral dysaesthesia 18.24 10.63 7 135392 124 90492924
Pulmonary hypertension 18.21 10.63 22 135377 42501 90450547
Hypoaesthesia oral 18.19 10.63 58 135341 15542 90477506
Dehydration 18.17 10.63 399 135000 194048 90299000
Thrombosis 18.04 10.63 178 135221 73073 90419975
Neovascular age-related macular degeneration 18.03 10.63 10 135389 423 90492625
Optic perineuritis 18.00 10.63 4 135395 7 90493041
Serotonin syndrome 17.99 10.63 18 135381 37869 90455179
Neck pain 17.89 10.63 254 135145 113709 90379339
Pelvic pain 17.82 10.63 57 135342 15300 90477748
Decreased immune responsiveness 17.82 10.63 40 135359 8708 90484340
Recurrent cancer 17.57 10.63 20 135379 2439 90490609
Pancreatitis 17.56 10.63 50 135349 69776 90423272
Blood calcium abnormal 17.49 10.63 18 135381 1959 90491089
Haematological malignancy 17.38 10.63 10 135389 454 90492594
Parathyroid tumour benign 17.38 10.63 13 135386 923 90492125
Bone fragmentation 17.33 10.63 12 135387 755 90492293
Neuroendocrine breast tumour 17.19 10.63 5 135394 35 90493013
Cataract 17.18 10.63 174 135225 71918 90421130
Vertebral column mass 17.17 10.63 8 135391 233 90492815
Female genital tract fistula 17.14 10.63 3 135396 17865 90475183
Light chain analysis increased 17.14 10.63 16 135383 1546 90491502
Amyotrophic lateral sclerosis 17.13 10.63 15 135384 1333 90491715
Pancreatogenous diabetes 17.04 10.63 4 135395 10 90493038
Skin discolouration 16.99 10.63 119 135280 44196 90448852
Impaired healing 16.92 10.63 247 135152 233952 90259096
Renal tubular acidosis 16.83 10.63 19 135380 2296 90490752
Incorrect dose administered 16.73 10.63 61 135338 78869 90414179
Mucosal hypertrophy 16.72 10.63 5 135394 39 90493009
Device difficult to use 16.69 10.63 3 135396 17522 90475526
Episcleritis 16.67 10.63 14 135385 1176 90491872
Weight decreased 16.61 10.63 710 134689 379200 90113848
Venous perforation 16.52 10.63 3 135396 0 90493048
Porphyromonas infection 16.52 10.63 3 135396 0 90493048
Parathyroid hormone-related protein increased 16.50 10.63 4 135395 12 90493036
Injection site swelling 16.45 10.63 41 135358 59798 90433250
Cardiogenic shock 16.40 10.63 8 135391 24460 90468588
Hypercalcaemia of malignancy 16.36 10.63 8 135391 260 90492788
Laryngitis 16.23 10.63 32 135367 50721 90442327
Metastases to ovary 16.20 10.63 10 135389 517 90492531
Agitation 16.18 10.63 49 135350 67049 90425999
Throat lesion 16.14 10.63 8 135391 268 90492780
Bone marrow oedema 16.08 10.63 15 135384 1448 90491600
Blood pressure abnormal 16.04 10.63 65 135334 19580 90473468
Caesarean section 16.01 10.63 4 135395 18573 90474475
Hyperkalaemia 15.98 10.63 47 135352 64917 90428131
Hypoxia 15.98 10.63 55 135344 72344 90420704
Cytomegalovirus infection 15.95 10.63 10 135389 26592 90466456
Vitamin D deficiency 15.88 10.63 60 135339 17496 90475552
Cranial nerve disorder 15.83 10.63 11 135388 696 90492352
Laboratory test abnormal 15.82 10.63 112 135287 41742 90451306
Abnormal behaviour 15.79 10.63 7 135392 22621 90470427
Dystonia 15.75 10.63 3 135396 16816 90476232
Cholesteatoma 15.72 10.63 7 135392 183 90492865
Therapy partial responder 15.72 10.63 70 135329 21973 90471075
Osteomalacia 15.67 10.63 12 135387 883 90492165
Underdose 15.65 10.63 36 135363 53981 90439067
Epistaxis 15.54 10.63 195 135204 84930 90408118
Orthostatic hypotension 15.53 10.63 24 135375 41803 90451245
Dysaesthesia 15.46 10.63 28 135371 5227 90487821
Vision blurred 15.43 10.63 241 135158 110052 90382996
Deafness unilateral 15.37 10.63 22 135377 3369 90489679
Anxiety 15.35 10.63 349 135050 309423 90183625
Lethargy 15.34 10.63 153 135246 62986 90430062
Calcium deficiency 15.29 10.63 14 135385 1319 90491729
Injection site urticaria 15.29 10.63 4 135395 18007 90475041
Dermatitis atopic 15.25 10.63 8 135391 23464 90469584
Hypokalaemia 15.24 10.63 278 135121 130838 90362210
Peripheral sensorimotor neuropathy 15.23 10.63 17 135382 2028 90491020
Gastrooesophageal reflux disease 15.15 10.63 167 135232 166170 90326878
Tetany 15.14 10.63 19 135380 2565 90490483
Influenza 15.05 10.63 292 135107 138972 90354076
Naevus haemorrhage 15.01 10.63 6 135393 119 90492929
Tonsillar inflammation 14.91 10.63 6 135393 121 90492927
Infusion site haemorrhage 14.87 10.63 28 135371 5383 90487665
Toxic epidermal necrolysis 14.83 10.63 16 135383 32512 90460536
Retinal detachment 14.81 10.63 32 135367 6790 90486258
Infusion site reaction 14.75 10.63 5 135394 19034 90474014
Food allergy 14.70 10.63 10 135389 25468 90467580
Pseudarthrosis 14.66 10.63 9 135390 461 90492587
Blood creatinine abnormal 14.66 10.63 24 135375 4133 90488915
Blood creatinine decreased 14.65 10.63 31 135368 6484 90486564
Palpable purpura 14.65 10.63 6 135393 127 90492921
Quality of life decreased 14.60 10.63 45 135354 11844 90481204
Anastomotic complication 14.59 10.63 8 135391 331 90492717
Nerve injury 14.54 10.63 43 135356 11063 90481985
Adjusted calcium decreased 14.50 10.63 7 135392 221 90492827
Oesophagogastroduodenoscopy abnormal 14.45 10.63 3 135396 3 90493045
Lymphatic disorder 14.23 10.63 9 135390 486 90492562
Dental necrosis 14.23 10.63 6 135393 137 90492911
Central nervous system lesion 14.22 10.63 44 135355 11602 90481446
Acute hepatic failure 14.20 10.63 8 135391 22553 90470495
Mediastinal disorder 14.20 10.63 9 135390 488 90492560
Metastases to the mediastinum 14.19 10.63 10 135389 647 90492401
Hyperparathyroidism 14.18 10.63 21 135378 3316 90489732
Tachycardia 14.09 10.63 159 135240 157514 90335534
Sleep apnoea syndrome 14.05 10.63 16 135383 31731 90461317
Trichorrhexis 13.99 10.63 14 135385 1473 90491575
Deformity 13.97 10.63 45 135354 12125 90480923
Intracardiac mass 13.91 10.63 5 135394 73 90492975
Eyelid ptosis 13.89 10.63 37 135362 8969 90484079
Terminal state 13.84 10.63 19 135380 2799 90490249
Dental discomfort 13.84 10.63 9 135390 510 90492538
Elbow deformity 13.81 10.63 14 135385 1497 90491551
Ageusia 13.77 10.63 54 135345 16022 90477026
Callus formation delayed 13.76 10.63 4 135395 28 90493020
Electrolyte imbalance 13.74 10.63 71 135328 23674 90469374
Osteoradionecrosis 13.72 10.63 6 135393 150 90492898
Discharge 13.72 10.63 15 135384 1749 90491299
Weight bearing difficulty 13.65 10.63 19 135380 2837 90490211
Osteosarcoma recurrent 13.63 10.63 4 135395 29 90493019
Lymph node pain 13.60 10.63 15 135384 1766 90491282
Affect lability 13.56 10.63 5 135394 18058 90474990
Pachymeningitis 13.55 10.63 7 135392 256 90492792
Gingival bleeding 13.54 10.63 51 135348 14852 90478196
Alanine aminotransferase decreased 13.50 10.63 11 135388 886 90492162
Neutrophil count abnormal 13.44 10.63 23 135376 4105 90488943
Mydriasis 13.39 10.63 3 135396 15009 90478039
Ovarian disorder 13.39 10.63 11 135388 896 90492152
Computerised tomogram abnormal 13.38 10.63 18 135381 2601 90490447
Poor personal hygiene 13.33 10.63 8 135391 393 90492655
Adrenal insufficiency 13.33 10.63 15 135384 29906 90463142
Bone formation increased 13.19 10.63 6 135393 165 90492883
Dermal sinus 13.18 10.63 4 135395 33 90493015
Vitreous detachment 13.17 10.63 17 135382 2361 90490687
Extraocular muscle disorder 13.09 10.63 6 135393 168 90492880
Alanine aminotransferase increased 13.09 10.63 249 135150 118089 90374959
Low turnover osteopathy 13.08 10.63 23 135376 4195 90488853
Eosinophilia 13.04 10.63 14 135385 28519 90464529
Macular degeneration 12.97 10.63 23 135376 37947 90455101
Decubitus ulcer 12.94 10.63 43 135356 11770 90481278
Pulmonary arterial hypertension 12.94 10.63 12 135387 26175 90466873
Dental restoration failure 12.92 10.63 12 135387 1152 90491896
Acute sinusitis 12.91 10.63 23 135376 4238 90488810
Hypophagia 12.91 10.63 95 135304 35842 90457206
Oral infection 12.90 10.63 26 135373 5254 90487794
Tumour pain 12.89 10.63 15 135384 1872 90491176
Bone callus excessive 12.88 10.63 4 135395 36 90493012
Cranial nerve paralysis 12.87 10.63 7 135392 285 90492763
Urinary tract infection 12.87 10.63 569 134830 305063 90187985
Lactic acidosis 12.79 10.63 36 135363 50427 90442621
Water intoxication 12.78 10.63 9 135390 582 90492466
Nuchal rigidity 12.73 10.63 10 135389 764 90492284
Keratomileusis 12.71 10.63 6 135393 180 90492868
Emotional distress 12.71 10.63 22 135377 36640 90456408
Mean cell haemoglobin decreased 12.69 10.63 27 135372 5668 90487380
Panniculitis 12.68 10.63 3 135396 14455 90478593
Walking aid user 12.59 10.63 21 135378 35485 90457563
Biliary sepsis 12.59 10.63 11 135388 975 90492073
Hepatotoxicity 12.58 10.63 114 135285 45728 90447320
Product prescribing error 12.48 10.63 16 135383 30129 90462919
Maxillofacial operation 12.38 10.63 3 135396 9 90493039
Burning sensation 12.30 10.63 147 135252 63305 90429743
Peripheral sensory neuropathy 12.29 10.63 36 135363 9214 90483834
Tooth injury 12.23 10.63 13 135386 1468 90491580
Incontinence 12.22 10.63 46 135353 13389 90479659
Ejection fraction decreased 12.20 10.63 74 135325 26179 90466869
Internal fixation of fracture 12.18 10.63 10 135389 814 90492234
Gingival recession 12.15 10.63 14 135385 1729 90491319
Mucosal dryness 12.15 10.63 19 135380 3148 90489900
Teeth brittle 12.14 10.63 9 135390 631 90492417
C-telopeptide increased 12.08 10.63 4 135395 45 90493003
Gingival ulceration 12.05 10.63 11 135388 1033 90492015
Essential thrombocythaemia 12.02 10.63 6 135393 204 90492844
Cognitive disorder 12.00 10.63 58 135341 69349 90423699
Peripheral swelling 11.96 10.63 500 134899 412606 90080442
Phlebitis 11.94 10.63 31 135368 7399 90485649
Nightmare 11.92 10.63 9 135390 21716 90471332
Hepatic cancer 11.88 10.63 24 135375 4857 90488191
Rhinovirus infection 11.85 10.63 27 135372 5936 90487112
Mouth ulceration 11.80 10.63 101 135298 39873 90453175
Myoclonus 11.78 10.63 7 135392 19161 90473887
Bone neoplasm 11.74 10.63 10 135389 856 90492192
Oophorectomy bilateral 11.74 10.63 5 135394 117 90492931
Mean cell haemoglobin increased 11.73 10.63 21 135378 3884 90489164
Limb injury 11.72 10.63 84 135315 31424 90461624
CALR gene mutation 11.71 10.63 3 135396 12 90493036
Carbohydrate antigen 27.29 increased 11.70 10.63 5 135394 118 90492930
Corneal abrasion 11.67 10.63 12 135387 1304 90491744
Vulvovaginal inflammation 11.57 10.63 11 135388 1087 90491961
Atrophy 11.54 10.63 15 135384 2097 90490951
Breast neoplasm 11.54 10.63 13 135386 1567 90491481
Skin disorder 11.50 10.63 94 135305 36612 90456436
Body mass index decreased 11.30 10.63 8 135391 522 90492526
Metastases to bladder 11.26 10.63 6 135393 234 90492814
Chronic papillomatous dermatitis 11.22 10.63 4 135395 57 90492991
Intramedullary rod insertion 11.21 10.63 15 135384 2157 90490891
Rectal adenocarcinoma 11.18 10.63 9 135390 712 90492336
Squamous cell breast carcinoma 11.17 10.63 3 135396 15 90493033
Defaecation disorder 11.14 10.63 10 135389 919 90492129
Basophil count increased 11.13 10.63 11 135388 1140 90491908
Soft tissue mass 11.10 10.63 7 135392 376 90492672
Acute respiratory distress syndrome 11.10 10.63 16 135383 28670 90464378
Meralgia paraesthetica 11.07 10.63 8 135391 539 90492509
Toxic neuropathy 11.06 10.63 8 135391 540 90492508
Hypervolaemia 11.05 10.63 20 135379 32737 90460311
Dental alveolar anomaly 11.03 10.63 4 135395 60 90492988
Restlessness 11.01 10.63 23 135376 35697 90457351
Ankylosing spondylitis 10.99 10.63 3 135396 13130 90479918
Apical granuloma 10.97 10.63 4 135395 61 90492987
Trigger finger 10.93 10.63 24 135375 5146 90487902
Metastatic neoplasm 10.93 10.63 23 135376 4792 90488256
Breast mass 10.90 10.63 35 135364 9412 90483636
Myositis 10.85 10.63 12 135387 24116 90468932
Limb deformity 10.81 10.63 21 135378 4131 90488917
Ulcerative gastritis 10.79 10.63 4 135395 64 90492984
Abnormal sensation in eye 10.77 10.63 14 135385 1957 90491091
Nephrogenic diabetes insipidus 10.77 10.63 10 135389 960 90492088
Therapy cessation 10.72 10.63 24 135375 36337 90456711
Accidental overdose 10.71 10.63 16 135383 28257 90464791
Pelvic bone injury 10.68 10.63 4 135395 66 90492982
Skin necrosis 10.68 10.63 6 135393 16935 90476113
Hyperaesthesia teeth 10.66 10.63 15 135384 2262 90490786
Vertebral lesion 10.64 10.63 9 135390 763 90492285
Beta 2 microglobulin increased 10.64 10.63 6 135393 262 90492786
Oropharyngeal pain 10.64 10.63 236 135163 114951 90378097

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
Osteonecrosis of jaw 7619.21 13.26 2148 50400 16901 42551886
Exposed bone in jaw 1232.37 13.26 304 52244 1285 42567502
Osteonecrosis 804.01 13.26 392 52156 15473 42553314
Bone disorder 429.36 13.26 194 52354 6419 42562368
Pain in jaw 373.27 13.26 229 52319 14273 42554514
Plasma cell myeloma 301.12 13.26 331 52217 47247 42521540
Prostatic specific antigen increased 298.40 13.26 211 52337 16714 42552073
Malignant neoplasm progression 289.35 13.26 496 52052 107904 42460883
Bone sequestrum 286.61 13.26 76 52472 451 42568336
Oral cavity fistula 282.96 13.26 59 52489 87 42568700
Bone pain 281.66 13.26 234 52314 23558 42545229
Hypocalcaemia 281.26 13.26 259 52289 29914 42538873
Metastases to bone 236.76 13.26 174 52374 14635 42554152
Osteomyelitis 229.87 13.26 186 52362 18037 42550750
Fatigue 201.75 13.26 1062 51486 434579 42134208
Neuropathy peripheral 185.08 13.26 396 52152 101457 42467330
Tooth extraction 155.07 13.26 92 52456 5388 42563399
Sequestrectomy 154.53 13.26 39 52509 184 42568603
Jaw fistula 152.39 13.26 31 52517 37 42568750
Oroantral fistula 151.85 13.26 38 52510 172 42568615
Purulent discharge 140.47 13.26 72 52476 3157 42565630
Acute phase reaction 135.55 13.26 33 52515 130 42568657
Jaw fracture 132.46 13.26 50 52498 1034 42567753
Pathological fracture 132.12 13.26 82 52466 5211 42563576
Drug interaction 131.03 13.26 84 52464 266915 42301872
Osteopetrosis 128.28 13.26 23 52525 3 42568784
Gingivitis 126.46 13.26 72 52476 3901 42564886
Hypophosphataemia 122.60 13.26 140 52408 20805 42547982
Toxicity to various agents 118.10 13.26 68 52480 229068 42339719
Metastases to lymph nodes 115.57 13.26 79 52469 5919 42562868
Fistula 115.38 13.26 88 52460 7824 42560963
Parophthalmia 108.12 13.26 26 52522 96 42568691
Drug ineffective 106.83 13.26 409 52139 629788 41938999
Atypical femur fracture 105.53 13.26 32 52516 326 42568461
Tooth disorder 104.19 13.26 99 52449 11880 42556907
Actinomycosis 101.67 13.26 35 52513 549 42568238
Completed suicide 101.49 13.26 4 52544 96461 42472326
Osteotomy 97.90 13.26 22 52526 55 42568732
Bone lesion 97.57 13.26 58 52490 3408 42565379
Dental fistula 96.06 13.26 23 52525 83 42568704
Impaired healing 94.79 13.26 111 52437 16942 42551845
Gingival swelling 93.80 13.26 42 52506 1358 42567429
Bone fistula 93.42 13.26 18 52530 12 42568775
Periodontitis 92.43 13.26 48 52500 2163 42566624
Back pain 91.85 13.26 382 52166 141394 42427393
Decreased appetite 91.66 13.26 475 52073 192662 42376125
Pain 87.93 13.26 559 51989 244289 42324498
Wound closure 85.85 13.26 20 52528 62 42568725
Myoglobinuria 83.72 13.26 33 52515 770 42568017
Purulence 82.72 13.26 34 52514 887 42567900
Influenza like illness 82.52 13.26 144 52404 31696 42537091
Toothache 82.33 13.26 71 52477 7512 42561275
Prostate cancer 79.15 13.26 172 52376 44471 42524316
Osteolysis 78.24 13.26 51 52497 3529 42565258
Metastases to liver 75.73 13.26 97 52451 16229 42552558
Bone debridement 75.72 13.26 21 52527 151 42568636
Neutropenia 72.57 13.26 457 52091 198974 42369813
Abscess jaw 72.27 13.26 29 52519 710 42568077
Periodontal disease 71.48 13.26 30 52518 826 42567961
Metastases to lung 69.63 13.26 78 52470 11346 42557441
Body height decreased 67.38 13.26 49 52499 4051 42564736
Constipation 66.08 13.26 383 52165 161908 42406879
Osteonecrosis of external auditory canal 63.11 13.26 15 52533 52 42568735
Osteitis 62.77 13.26 34 52514 1670 42567117
Tooth loss 62.32 13.26 47 52501 4107 42564680
Asthenia 60.90 13.26 570 51978 280223 42288564
Jaw disorder 60.84 13.26 36 52512 2097 42566690
Plasma cell myeloma recurrent 60.68 13.26 53 52495 5704 42563083
Gingival erythema 60.61 13.26 16 52532 93 42568694
Prostate cancer metastatic 59.97 13.26 56 52492 6573 42562214
Overdose 57.42 13.26 29 52519 105235 42463552
Colon cancer stage III 55.64 13.26 17 52531 178 42568609
Debridement 55.16 13.26 26 52522 948 42567839
Condition aggravated 55.15 13.26 153 52395 260601 42308186
Intentional product misuse 55.11 13.26 6 52542 61894 42506893
Spinal fracture 54.73 13.26 62 52486 9128 42559659
Bone fissure 53.95 13.26 15 52533 109 42568678
Hypercalcaemia 53.88 13.26 87 52461 17971 42550816
C-telopeptide increased 53.64 13.26 10 52538 4 42568783
Femur fracture 53.08 13.26 63 52485 9749 42559038
Pneumonia 51.86 13.26 768 51780 421381 42147406
Intentional overdose 51.32 13.26 3 52545 51453 42517334
Metastasis 50.97 13.26 44 52504 4661 42564126
Pyrexia 48.81 13.26 718 51830 393324 42175463
Jaw operation 46.22 13.26 15 52533 194 42568593
Injection site pain 45.80 13.26 8 52540 57790 42510997
Idiopathic orbital inflammation 44.58 13.26 12 52536 76 42568711
Loose tooth 44.34 13.26 24 52524 1177 42567610
Cancer pain 44.09 13.26 36 52512 3531 42565256
Drug hypersensitivity 43.75 13.26 35 52513 99354 42469433
Anaemia 43.44 13.26 532 52016 279746 42289041
Respiratory tract infection viral 43.42 13.26 35 52513 3371 42565416
Fanconi syndrome 42.77 13.26 27 52521 1767 42567020
White blood cell count decreased 41.97 13.26 256 52292 110140 42458647
Squamous cell carcinoma of skin 41.69 13.26 64 52484 12662 42556125
Suicidal ideation 39.65 13.26 6 52542 48155 42520632
Blood calcium decreased 39.43 13.26 58 52490 11050 42557737
Osteosclerosis 39.31 13.26 24 52524 1480 42567307
Rib fracture 39.15 13.26 72 52476 16499 42552288
Hospitalisation 38.30 13.26 22 52526 74308 42494479
Psoriasis 37.92 13.26 7 52541 48597 42520190
Laboratory test abnormal 37.86 13.26 86 52462 22892 42545895
Full blood count decreased 37.32 13.26 80 52468 20480 42548307
Neonatal hypocalcaemia 37.06 13.26 12 52536 154 42568633
Hormone-refractory prostate cancer 36.89 13.26 20 52528 984 42567803
Hypotension 36.74 13.26 178 52370 257453 42311334
Neoplasm progression 36.60 13.26 98 52450 28902 42539885
Fibroblast growth factor 23 increased 36.50 13.26 8 52540 17 42568770
Lactic acidosis 36.45 13.26 6 52542 45255 42523532
Metastases to spine 35.84 13.26 30 52518 3047 42565740
Parathyroid tumour malignant 35.81 13.26 10 52538 74 42568713
SARS-CoV-2 sepsis 35.70 13.26 13 52535 242 42568545
Metastases to peritoneum 35.18 13.26 27 52521 2422 42566365
Salivary gland fistula 35.05 13.26 7 52541 7 42568780
Thrombosis 34.86 13.26 172 52376 68339 42500448
Hyperbaric oxygen therapy 34.79 13.26 8 52540 23 42568764
Foetal exposure during pregnancy 34.46 13.26 8 52540 47303 42521484
Systemic inflammatory response syndrome 34.41 13.26 44 52504 7346 42561441
Deep vein thrombosis 34.16 13.26 186 52362 76771 42492016
Respiratory tract infection bacterial 34.09 13.26 24 52524 1885 42566902
Spinal compression fracture 33.97 13.26 44 52504 7439 42561348
Oral pain 33.97 13.26 58 52490 12538 42556249
Tooth avulsion 33.60 13.26 8 52540 28 42568759
Thrombocytopenia 33.36 13.26 370 52178 189909 42378878
Spinal cord compression 33.15 13.26 33 52515 4191 42564596
Aggression 33.11 13.26 7 52541 44156 42524631
Bradycardia 32.98 13.26 34 52514 85450 42483337
Bone loss 32.90 13.26 16 52532 626 42568161
Spinal pain 32.56 13.26 41 52507 6741 42562046
Thoracic vertebral fracture 31.80 13.26 25 52523 2323 42566464
Diarrhoea 31.39 13.26 766 51782 460083 42108704
Depressed level of consciousness 31.39 13.26 10 52538 47960 42520827
Multiple fractures 31.27 13.26 21 52527 1527 42567260
Tooth abscess 31.05 13.26 40 52508 6728 42562059
Monoclonal immunoglobulin present 31.04 13.26 19 52529 1177 42567610
Tooth deposit 30.77 13.26 9 52539 80 42568707
Wound treatment 30.47 13.26 7 52541 20 42568767
Osteoporosis 29.39 13.26 60 52488 14846 42553941
Hypoglycaemia 29.04 13.26 19 52529 59835 42508952
Off label use 28.87 13.26 585 51963 637750 41931037
Coma 28.82 13.26 15 52533 53539 42515248
Oral infection 28.78 13.26 24 52524 2424 42566363
Swelling 28.78 13.26 139 52409 54746 42514041
Mouth swelling 28.46 13.26 23 52525 2223 42566564
Dental operation 28.45 13.26 13 52535 441 42568346
Agitation 27.86 13.26 23 52525 64291 42504496
Cellulitis orbital 27.84 13.26 13 52535 464 42568323
Oral surgery 27.60 13.26 14 52534 600 42568187
Agranulocytosis 27.16 13.26 3 52545 30609 42538178
Hypouricaemia 27.12 13.26 11 52537 277 42568510
Conjunctival oedema 27.03 13.26 14 52534 627 42568160
Hyperphosphaturia 26.60 13.26 8 52540 79 42568708
Encephalopathy 26.37 13.26 9 52539 41324 42527463
Myocardial infarction 25.99 13.26 73 52475 123936 42444851
Periorbital inflammation 25.83 13.26 8 52540 88 42568699
Metastases to central nervous system 25.74 13.26 46 52502 10309 42558478
Hyperuricosuria 25.66 13.26 6 52542 19 42568768
Bone abscess 25.42 13.26 11 52537 327 42568460
Myalgia 25.42 13.26 204 52344 95876 42472911
International normalised ratio increased 25.18 13.26 14 52534 48154 42520633
Atypical fracture 24.45 13.26 9 52539 173 42568614
Bone swelling 24.10 13.26 11 52537 372 42568415
Treatment failure 24.04 13.26 25 52523 62599 42506188
Spinal cord infarction 23.73 13.26 13 52535 653 42568134
Excessive granulation tissue 23.69 13.26 12 52536 513 42568274
Oxygen saturation decreased 23.54 13.26 27 52521 64660 42504127
Stress fracture 23.52 13.26 15 52533 999 42567788
Lumbar vertebral fracture 23.41 13.26 24 52524 3155 42565632
Fracture nonunion 23.32 13.26 9 52539 198 42568589
Platelet count decreased 23.14 13.26 267 52281 138314 42430473
Soft tissue infection 22.93 13.26 22 52526 2671 42566116
Stress 22.89 13.26 13 52535 44199 42524588
Osteomalacia 22.83 13.26 14 52534 870 42567917
Face and mouth X-ray abnormal 22.80 13.26 4 52544 0 42568787
Somnolence 22.79 13.26 93 52455 141012 42427775
Fracture 22.77 13.26 38 52510 8065 42560722
Pruritus 22.70 13.26 138 52410 188633 42380154
Treatment noncompliance 22.69 13.26 9 52539 37663 42531124
Seizure 22.39 13.26 75 52473 120486 42448301
Therapeutic product effect incomplete 22.33 13.26 33 52515 70906 42497881
Mastication disorder 22.11 13.26 18 52530 1758 42567029
Peripheral swelling 21.91 13.26 188 52360 90082 42478705
Compression fracture 21.87 13.26 25 52523 3717 42565070
Fanconi syndrome acquired 21.70 13.26 19 52529 2051 42566736
Incorrect dose administered 21.66 13.26 20 52528 52954 42515833
Hypophosphataemic osteomalacia 21.30 13.26 8 52540 163 42568624
Contraindicated product administered 21.14 13.26 3 52545 25269 42543518
Respiratory failure 20.97 13.26 84 52464 128048 42440739
Protein total decreased 20.92 13.26 31 52517 5945 42562842
Nightmare 20.85 13.26 3 52545 25009 42543778
Eczema 20.77 13.26 8 52540 34078 42534709
Exophthalmos 20.67 13.26 13 52535 845 42567942
Respiratory distress 20.66 13.26 13 52535 41807 42526980
Melaena 20.63 13.26 11 52537 38735 42530052
Gingival abscess 20.61 13.26 8 52540 179 42568608
Sedation 20.58 13.26 6 52542 30469 42538318
Dermal sinus 20.56 13.26 4 52544 3 42568784
Plasmacytoma 20.34 13.26 26 52522 4338 42564449
Chronic papillomatous dermatitis 19.98 13.26 6 52542 59 42568728
Epilepsy 19.92 13.26 4 52544 26167 42542620
Unresponsive to stimuli 19.75 13.26 7 52541 31396 42537391
Musculoskeletal chest pain 19.65 13.26 43 52505 11161 42557626
Cerebral haemorrhage 19.41 13.26 12 52536 38954 42529833
Hepatocellular injury 19.37 13.26 3 52545 23675 42545112
Hypercalcaemia of malignancy 19.15 13.26 9 52539 326 42568461
Tenderness 19.00 13.26 37 52511 8846 42559941
Pancreatitis acute 18.66 13.26 9 52539 33555 42535232
Angioedema 18.63 13.26 15 52533 42462 42526325
Peripheral sensorimotor neuropathy 18.60 13.26 17 52531 1941 42566846
Abdominal pain 18.58 13.26 148 52400 190323 42378464
Plasma cell leukaemia 18.53 13.26 14 52534 1226 42567561
Multiple organ dysfunction syndrome 18.26 13.26 60 52488 96975 42471812
Vasodilatation 18.17 13.26 14 52534 1263 42567524
Tooth infection 17.91 13.26 34 52514 7977 42560810
Leukopenia 17.79 13.26 155 52393 74591 42494196
Pelvic pain 17.78 13.26 21 52527 3233 42565554
Protein deficiency 17.71 13.26 8 52540 264 42568523
Gingival pain 17.71 13.26 35 52513 8459 42560328
Albumin urine present 17.55 13.26 9 52539 395 42568392
Hot flush 17.50 13.26 64 52484 22287 42546500
Cytomegalovirus infection 17.45 13.26 9 52539 32297 42536490
Microangiopathic haemolytic anaemia 17.26 13.26 13 52535 1134 42567653
Aspartate aminotransferase increased 17.23 13.26 44 52504 77119 42491668
Mesenteric phlebosclerosis 17.10 13.26 3 52545 0 42568787
Anaphylactic shock 17.08 13.26 4 52544 23513 42545274
Metastases to pelvis 17.06 13.26 9 52539 419 42568368
Ulna fracture 17.06 13.26 9 52539 419 42568368
Exostosis of jaw 17.04 13.26 6 52542 101 42568686
Pityriasis rubra pilaris 16.91 13.26 8 52540 294 42568493
Hypoaesthesia 16.90 13.26 148 52400 71315 42497472
Ventricular tachycardia 16.90 13.26 8 52540 30152 42538635
Inappropriate schedule of product administration 16.90 13.26 61 52487 95841 42472946
Oral disorder 16.90 13.26 25 52523 4787 42564000
Blood parathyroid hormone increased 16.89 13.26 16 52532 1911 42566876
Anxiety 16.81 13.26 82 52466 118478 42450309
Muscle spasms 16.77 13.26 171 52377 85873 42482914
Blood creatine phosphokinase increased 16.71 13.26 21 52527 48317 42520470
Pulmonary fibrosis 16.69 13.26 6 52542 26675 42542112
Death 16.53 13.26 724 51824 470461 42098326
Abnormal behaviour 16.46 13.26 6 52542 26445 42542342
Cardiac arrest 16.45 13.26 74 52474 109246 42459541
Electrocardiogram QT prolonged 16.39 13.26 21 52527 47924 42520863
Metastases to pleura 16.32 13.26 10 52538 621 42568166
Dysarthria 16.31 13.26 15 52533 39792 42528995
Laryngeal leukoplakia 16.14 13.26 5 52543 55 42568732
Chest wall mass 16.08 13.26 6 52542 120 42568667
Gastrointestinal haemorrhage 16.03 13.26 64 52484 97662 42471125
Restlessness 16.02 13.26 8 52540 29241 42539546
Oral mucosal erythema 15.99 13.26 10 52538 644 42568143
Coronary artery disease 15.94 13.26 26 52522 53694 42515093
Pulmonary embolism 15.92 13.26 221 52327 119391 42449396
PIK3CA-activated mutation 15.90 13.26 6 52542 124 42568663
Peripheral sensory neuropathy 15.79 13.26 34 52514 8728 42560059
Light chain analysis increased 15.79 13.26 15 52533 1799 42566988
Accidental exposure to product 15.77 13.26 3 52545 20390 42548397
Hyperkalaemia 15.66 13.26 49 52499 80409 42488378
Bone deformity 15.60 13.26 5 52543 62 42568725
Abscess oral 15.58 13.26 9 52539 501 42568286
Respiratory tract infection 15.51 13.26 69 52479 26253 42542534
Kyphosis 15.44 13.26 13 52535 1331 42567456
Eye pain 15.27 13.26 51 52497 16979 42551808
Pulmonary hypertension 15.26 13.26 5 52543 23564 42545223
Cardio-respiratory arrest 15.06 13.26 31 52517 58605 42510182
Maxillofacial operation 15.02 13.26 3 52545 3 42568784
PO2 increased 14.91 13.26 9 52539 544 42568243
Wheezing 14.90 13.26 28 52520 54753 42514034
Proteinuria 14.89 13.26 62 52486 22921 42545866
Premature baby 14.84 13.26 5 52543 23148 42545639
Aminoaciduria 14.80 13.26 7 52541 257 42568530
Therapy non-responder 14.76 13.26 27 52521 53332 42515455
Trismus 14.75 13.26 18 52530 2866 42565921
Eye inflammation 14.73 13.26 19 52529 3199 42565588
Cytokine release syndrome 14.71 13.26 20 52528 44507 42524280
Colitis ulcerative 14.58 13.26 7 52541 26168 42542619
Cardiomyopathy 14.49 13.26 3 52545 19207 42549580
Alanine aminotransferase increased 14.43 13.26 58 52490 88348 42480439
Transitional cell cancer of the renal pelvis and ureter 14.39 13.26 4 52544 29 42568758
Asthma 14.33 13.26 35 52513 62279 42506508
Bone lesion excision 14.16 13.26 3 52545 5 42568782
Cavernous sinus syndrome 14.16 13.26 4 52544 31 42568756
Rheumatoid arthritis 14.09 13.26 19 52529 42421 42526366
Loss of personal independence in daily activities 13.96 13.26 25 52523 49791 42518996
Cardiogenic shock 13.94 13.26 14 52534 35626 42533161
Biopsy bone abnormal 13.81 13.26 3 52545 6 42568781
Rectal haemorrhage 13.81 13.26 25 52523 49581 42519206
Wound dehiscence 13.71 13.26 20 52528 3780 42565007
Ascites 13.70 13.26 31 52517 56647 42512140
Cataract 13.59 13.26 74 52474 30530 42538257
Hallucination 13.46 13.26 32 52516 57475 42511312
Bronchitis 13.45 13.26 102 52446 47099 42521688
Vertebral column mass 13.40 13.26 5 52543 100 42568687
Bone density decreased 13.33 13.26 15 52533 2191 42566596
Gingival recession 13.32 13.26 8 52540 479 42568308
Hyperpyrexia 13.31 13.26 19 52529 3521 42565266
Haematochezia 13.29 13.26 33 52515 58403 42510384

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
Osteonecrosis of jaw 15705.53 11.09 4703 140785 43314 110400497
Exposed bone in jaw 2572.23 11.09 661 144827 3150 110440661
Osteonecrosis 1810.28 11.09 885 144603 32856 110410955
Metastases to bone 1173.43 11.09 646 144842 30726 110413085
Bone pain 990.42 11.09 762 144726 64371 110379440
Malignant neoplasm progression 898.19 11.09 1127 144361 173440 110270371
Neutropenia 821.86 11.09 1634 143854 372986 110070825
Atypical femur fracture 756.75 11.09 291 145197 5928 110437883
Pain in jaw 709.35 11.09 567 144921 50610 110393201
Bone disorder 683.14 11.09 396 145092 20796 110423015
Bone sequestrum 650.60 11.09 176 145312 1057 110442754
Hypocalcaemia 615.83 11.09 581 144907 64785 110379026
Neuropathy peripheral 501.53 11.09 869 144619 178408 110265403
Plasma cell myeloma 477.11 11.09 497 144991 62439 110381372
Metastases to liver 473.21 11.09 384 145104 35002 110408809
Bone lesion 453.52 11.09 210 145278 6877 110436934
Femur fracture 433.65 11.09 403 145085 44066 110399745
Oral cavity fistula 423.93 11.09 111 145377 576 110443235
Influenza like illness 409.07 11.09 542 144946 87870 110355941
Osteomyelitis 402.69 11.09 355 145133 36245 110407566
Sequestrectomy 388.53 11.09 108 145380 728 110443083
Tooth extraction 387.75 11.09 231 145257 12760 110431051
Acute phase reaction 367.15 11.09 92 145396 387 110443424
Myalgia 358.82 11.09 858 144630 221523 110222288
Purulent discharge 344.73 11.09 174 145314 6909 110436902
Metastases to lung 342.02 11.09 266 145222 22797 110421014
Iridocyclitis 335.97 11.09 157 145331 5251 110438560
Neoplasm progression 330.08 11.09 416 145072 64179 110379632
Completed suicide 293.43 11.09 5 145483 242376 110201435
Drug ineffective 281.33 11.09 1043 144445 1519497 108924314
Back pain 271.08 11.09 1085 144403 369911 110073900
Pathological fracture 268.67 11.09 178 145310 11854 110431957
Gingivitis 265.60 11.09 167 145321 10164 110433647
Prostatic specific antigen increased 264.74 11.09 179 145309 12332 110431479
Fistula 259.02 11.09 191 145297 15108 110428703
Osteolysis 252.28 11.09 130 145358 5393 110438418
Parophthalmia 234.29 11.09 66 145422 470 110443341
Osteosclerosis 231.76 11.09 115 145373 4400 110439411
Systemic lupus erythematosus 230.17 11.09 31 145457 254307 110189504
Glossodynia 229.85 11.09 16 145472 221988 110221823
Pyrexia 229.52 11.09 1987 143501 896278 109547533
Synovitis 228.63 11.09 42 145446 274050 110169761
Toxicity to various agents 228.05 11.09 179 145309 480376 109963435
Hypophosphataemia 226.61 11.09 248 145240 32934 110410877
Osteopetrosis 225.23 11.09 43 145445 21 110443790
Anti-cyclic citrullinated peptide antibody positive 223.47 11.09 3 145485 181981 110261830
Drug abuse 217.52 11.09 3 145485 177408 110266403
Actinomycosis 215.60 11.09 77 145411 1263 110442548
Maternal exposure during pregnancy 214.88 11.09 38 145450 254845 110188966
White blood cell count decreased 214.60 11.09 727 144761 228663 110215148
Oroantral fistula 214.57 11.09 58 145430 347 110443464
Carbohydrate antigen 15-3 increased 213.78 11.09 80 145408 1507 110442304
Osteitis 213.36 11.09 107 145381 4189 110439622
Helicobacter infection 207.74 11.09 7 145481 181870 110261941
Jaw fistula 205.59 11.09 46 145442 102 110443709
Anaemia 205.25 11.09 1326 144162 545760 109898051
Contraindicated product administered 202.90 11.09 40 145448 248227 110195584
Gingival swelling 199.86 11.09 110 145378 5220 110438591
Psoriatic arthropathy 198.52 11.09 16 145472 196745 110247066
Tooth loss 198.47 11.09 127 145361 7969 110435842
Hand deformity 196.83 11.09 27 145461 218479 110225332
Metastases to spine 194.13 11.09 108 145380 5235 110438576
Periodontitis 193.96 11.09 107 145381 5101 110438710
Debridement 186.69 11.09 76 145412 1807 110442004
Folliculitis 186.18 11.09 8 145480 167645 110276166
Idiopathic orbital inflammation 186.06 11.09 51 145437 324 110443487
Jaw operation 184.50 11.09 61 145427 783 110443028
Drug interaction 179.62 11.09 237 145251 499946 109943865
Loose tooth 179.35 11.09 87 145401 3166 110440645
Breast cancer metastatic 179.03 11.09 135 145353 11046 110432765
Jaw fracture 178.82 11.09 86 145402 3070 110440741
Fanconi syndrome 178.76 11.09 89 145399 3430 110440381
Wheezing 177.96 11.09 57 145431 255173 110188638
Overdose 174.41 11.09 46 145442 233748 110210063
Chills 173.82 11.09 599 144889 189981 110253830
Blister 172.95 11.09 43 145445 227333 110216478
Type 2 diabetes mellitus 171.81 11.09 17 145471 177215 110266596
Pericarditis 171.46 11.09 39 145449 219075 110224736
Exposure during pregnancy 170.62 11.09 13 145475 167411 110276400
Fatigue 170.60 11.09 2388 143100 1213570 109230241
Osteotomy 169.36 11.09 46 145442 281 110443530
Condition aggravated 168.98 11.09 456 145032 734380 109709431
Bone fistula 168.77 11.09 36 145452 57 110443754
Atypical fracture 167.56 11.09 60 145428 992 110442819
Wound closure 167.16 11.09 42 145446 179 110443632
Irritable bowel syndrome 163.87 11.09 14 145474 164201 110279610
Dental fistula 162.89 11.09 51 145437 543 110443268
Muscle injury 162.29 11.09 5 145483 140802 110303009
Bone debridement 162.18 11.09 47 145441 375 110443436
Metastases to lymph nodes 161.72 11.09 144 145344 14888 110428923
Intentional overdose 155.32 11.09 4 145484 132497 110311314
Renal tubular necrosis 155.22 11.09 196 145292 30279 110413532
Spinal pain 154.41 11.09 154 145334 18361 110425450
Rheumatoid factor positive 154.21 11.09 4 145484 131636 110312175
Toothache 153.73 11.09 172 145316 23403 110420408
C-reactive protein abnormal 148.07 11.09 5 145483 129690 110314121
Drug hypersensitivity 147.37 11.09 231 145257 453859 109989952
Purulence 145.92 11.09 68 145420 2259 110441552
Metastases to central nervous system 144.57 11.09 164 145324 22653 110421158
Decreased appetite 142.91 11.09 1093 144395 474753 109969058
Pain 138.34 11.09 1887 143601 953068 109490743
Wound 134.81 11.09 70 145418 234367 110209444
Disease progression 132.77 11.09 654 144834 243380 110200431
Rheumatic fever 132.38 11.09 7 145481 122572 110321239
Presbyacusis 130.62 11.09 67 145421 2752 110441059
Hepatic enzyme increased 130.13 11.09 138 145350 320754 110123057
Blood creatinine increased 128.66 11.09 529 144959 182360 110261451
Hyperpyrexia 128.25 11.09 97 145391 7972 110435839
Eye pain 125.97 11.09 232 145256 49867 110393944
Jaw disorder 125.88 11.09 81 145407 5131 110438680
Osteopenia 124.65 11.09 150 145338 22059 110421752
Palmar-plantar erythrodysaesthesia syndrome 123.97 11.09 206 145282 40819 110402992
Asthma 122.74 11.09 90 145398 250201 110193610
Suicide attempt 117.98 11.09 4 145484 103390 110340421
Oral pain 117.16 11.09 191 145297 37253 110406558
Arthropathy 115.07 11.09 125 145363 287397 110156414
Sleep disorder due to general medical condition, insomnia type 114.19 11.09 6 145482 105637 110338174
Pleural fibrosis 114.17 11.09 71 145417 4237 110439574
Intentional product misuse 113.76 11.09 19 145469 132885 110310926
Pleural thickening 113.47 11.09 65 145423 3334 110440477
Therapeutic product effect decreased 112.03 11.09 94 145394 244222 110199589
Injury 111.04 11.09 47 145441 177218 110266593
Blood magnesium increased 108.95 11.09 66 145422 3757 110440054
Psoriasis 107.36 11.09 26 145462 139967 110303844
Diarrhoea 106.85 11.09 2096 143392 1137409 109306402
Neutrophil count decreased 105.77 11.09 375 145113 120566 110323245
Tooth disorder 105.47 11.09 160 145328 29349 110414462
Lip dry 104.18 11.09 7 145481 100076 110343735
Tumour marker increased 103.73 11.09 71 145417 4989 110438822
Infusion related reaction 102.97 11.09 217 145271 380945 110062866
Breast cancer 101.36 11.09 182 145306 38360 110405451
Arthralgia 101.28 11.09 1512 143976 778120 109665691
Gingival erythema 100.70 11.09 41 145447 975 110442836
Obesity 99.73 11.09 15 145473 113336 110330475
Thrombocytopenia 98.89 11.09 791 144697 348094 110095717
Ill-defined disorder 97.58 11.09 42 145446 156811 110287000
Fibromyalgia 96.81 11.09 52 145436 170857 110272954
Abdominal discomfort 94.48 11.09 239 145249 393619 110050192
Spinal fracture 94.38 11.09 132 145356 22501 110421310
Drug intolerance 94.21 11.09 251 145237 406261 110037550
Hypercalcaemia 94.17 11.09 197 145291 46460 110397351
Treatment failure 93.76 11.09 137 145351 277097 110166714
Weight increased 93.60 11.09 264 145224 419380 110024431
Urticaria 93.46 11.09 173 145315 318684 110125127
Abscess jaw 92.50 11.09 46 145442 1768 110442043
Musculoskeletal chest pain 91.41 11.09 148 145340 28699 110415112
Breast cancer recurrent 90.99 11.09 59 145429 3787 110440024
Asthenia 90.90 11.09 1340 144148 687659 109756152
Hyperbaric oxygen therapy 89.81 11.09 20 145468 43 110443768
Epilepsy 88.77 11.09 13 145475 100196 110343615
Constipation 88.57 11.09 787 144701 356999 110086812
Osteonecrosis of external auditory canal 87.15 11.09 26 145462 232 110443579
Metastases to pelvis 86.57 11.09 35 145453 817 110442994
Injection site reaction 85.12 11.09 9 145479 89061 110354750
Periodontal disease 84.94 11.09 45 145443 1977 110441834
Deep vein thrombosis 83.35 11.09 385 145103 139502 110304309
Wound infection 82.09 11.09 14 145474 96451 110347360
Peripheral venous disease 81.68 11.09 8 145480 84109 110359702
Suicidal ideation 81.35 11.09 13 145475 93924 110349887
Therapeutic product effect incomplete 81.29 11.09 105 145383 223700 110220111
Leukopenia 81.04 11.09 399 145089 148392 110295419
Metastasis 80.71 11.09 75 145413 8192 110435619
Injection site pain 79.66 11.09 70 145418 177852 110265959
Rheumatoid arthritis 78.87 11.09 173 145315 299440 110144371
Full blood count decreased 78.63 11.09 147 145341 31952 110411859
Renal impairment 78.08 11.09 469 145019 187976 110255835
Discomfort 77.71 11.09 101 145387 214606 110229205
Liver injury 76.46 11.09 52 145436 150361 110293450
Confusional state 76.27 11.09 337 145151 468343 109975468
Hypersensitivity 76.18 11.09 274 145214 403724 110040087
Platelet count decreased 75.68 11.09 541 144947 229902 110213909
Fanconi syndrome acquired 75.38 11.09 48 145440 2986 110440825
Grip strength decreased 74.36 11.09 9 145479 80165 110363646
Thoracic vertebral fracture 74.08 11.09 65 145423 6590 110437221
Product quality issue 73.38 11.09 8 145480 77291 110366520
Bursitis 72.88 11.09 40 145448 129878 110313933
Infusion site coldness 72.54 11.09 23 145465 256 110443555
Periorbital inflammation 72.22 11.09 23 145465 260 110443551
Spinal compression fracture 70.42 11.09 103 145385 18289 110425522
Product use issue 70.27 11.09 195 145293 311500 110132311
Prescribed overdose 69.67 11.09 15 145473 87566 110356245
Deafness neurosensory 69.36 11.09 74 145414 9545 110434266
Blood calcium decreased 68.47 11.09 148 145340 35697 110408114
Myoglobinuria 68.18 11.09 33 145455 1195 110442616
Rib fracture 67.46 11.09 142 145346 33628 110410183
Bradycardia 67.46 11.09 63 145425 155454 110288357
Scleritis 66.55 11.09 56 145432 5364 110438447
Hypoglycaemia 66.22 11.09 35 145453 116069 110327742
Blood cholesterol increased 65.76 11.09 88 145400 184697 110259114
Body height decreased 65.35 11.09 75 145413 10488 110433323
Bone fissure 65.07 11.09 26 145462 588 110443223
Gamma-glutamyltransferase decreased 64.36 11.09 23 145465 378 110443433
Therapy non-responder 63.33 11.09 68 145420 157239 110286572
Iritis 63.26 11.09 51 145437 4601 110439210
Plasma cell myeloma recurrent 63.24 11.09 61 145427 6981 110436830
Wound treatment 62.96 11.09 19 145469 177 110443634
Intentional product use issue 62.91 11.09 146 145342 247760 110196051
PIK3CA-activated mutation 62.76 11.09 26 145462 647 110443164
Fracture 62.57 11.09 115 145373 24673 110419138
Oral surgery 62.43 11.09 33 145455 1443 110442368
Aminoaciduria 61.99 11.09 22 145466 354 110443457
Uveitis 61.59 11.09 106 145382 21604 110422207
Cancer pain 61.46 11.09 59 145429 6713 110437098
Hypotension 60.92 11.09 421 145067 523428 109920383
Joint range of motion decreased 60.75 11.09 43 145445 121789 110322022
Hepatic lesion 60.64 11.09 65 145423 8428 110435383
Bone loss 60.58 11.09 42 145446 3013 110440798
Stress fracture 60.09 11.09 60 145428 7161 110436650
Iris adhesions 59.91 11.09 25 145463 634 110443177
Hypouricaemia 59.61 11.09 24 145464 554 110443257
Prostate cancer 59.26 11.09 144 145344 37497 110406314
Epigastric discomfort 59.16 11.09 66 145422 8949 110434862
Angioedema 58.72 11.09 28 145460 98472 110345339
Haematotoxicity 58.59 11.09 102 145386 20980 110422831
Cellulitis orbital 58.15 11.09 28 145460 1002 110442809
Coma 56.95 11.09 43 145445 117826 110325985
Parathyroid tumour malignant 56.85 11.09 17 145471 153 110443658
Tooth abscess 56.30 11.09 94 145394 18695 110425116
Multiple fractures 56.19 11.09 64 145424 8876 110434935
Metastases to skin 56.19 11.09 36 145452 2263 110441548
Off label use 55.54 11.09 1527 143961 1498658 108945153
Alveolar bone resorption 54.93 11.09 14 145474 64 110443747
Pregnancy 54.87 11.09 3 145485 51064 110392747
Autoimmune disorder 54.63 11.09 10 145478 65473 110378338
Compression fracture 54.14 11.09 64 145424 9235 110434576
Cyst 54.13 11.09 86 145402 16410 110427401
Tooth avulsion 54.10 11.09 15 145473 100 110443711
Excessive granulation tissue 53.60 11.09 27 145461 1067 110442744
Bone marrow infiltration 53.30 11.09 25 145463 843 110442968
Frequent bowel movements 53.29 11.09 14 145474 71376 110372435
Sleep disorder due to a general medical condition 53.21 11.09 4 145484 52108 110391703
Eye inflammation 53.20 11.09 63 145425 9108 110434703
Respiratory arrest 52.96 11.09 7 145481 58292 110385519
Mastication disorder 52.86 11.09 41 145447 3497 110440314
Adrenocortical insufficiency acute 52.73 11.09 45 145443 4395 110439416
Pulpitis dental 52.72 11.09 30 145458 1519 110442292
Conjunctival oedema 52.59 11.09 30 145458 1526 110442285
Anaphylactic reaction 52.34 11.09 44 145444 114256 110329555
C-telopeptide increased 52.07 11.09 12 145476 32 110443779
Nail toxicity 51.88 11.09 20 145468 410 110443401
Lumbar vertebral fracture 51.78 11.09 62 145426 9069 110434742
Aggression 51.70 11.09 8 145480 59202 110384609
Exophthalmos 51.65 11.09 34 145454 2239 110441572
Hypophosphataemic osteomalacia 51.56 11.09 20 145468 417 110443394
Lower respiratory tract infection 51.21 11.09 157 145331 242949 110200862
Metastases to peritoneum 51.14 11.09 49 145439 5561 110438250
Loss of personal independence in daily activities 50.82 11.09 74 145414 149946 110293865
Trismus 49.79 11.09 52 145436 6544 110437267
Skin toxicity 49.54 11.09 69 145419 11714 110432097
Depressed level of consciousness 49.26 11.09 45 145443 112233 110331578
Obstructive airways disorder 48.70 11.09 3 145485 46146 110397665
Mouth swelling 48.53 11.09 54 145434 7300 110436511
Tonsillar disorder 48.44 11.09 28 145460 1461 110442350
Breath odour 48.21 11.09 31 145457 1961 110441850
Pruritus 48.06 11.09 511 144977 581049 109862762
Bone cyst 47.94 11.09 39 145449 3564 110440247
Drug dependence 47.93 11.09 5 145483 50015 110393796
Blood potassium increased 47.93 11.09 123 145365 33126 110410685
Delirium 47.33 11.09 65 145423 134960 110308851
Blepharospasm 46.58 11.09 8 145480 54843 110388968
Medication error 46.50 11.09 42 145446 105324 110338487
Night sweats 46.46 11.09 65 145423 133918 110309893
Dental operation 45.96 11.09 27 145461 1452 110442359
Multiple sclerosis relapse 45.71 11.09 6 145482 50234 110393577
Soft tissue infection 45.41 11.09 44 145444 5063 110438748
Ocular hyperaemia 45.37 11.09 134 145354 39152 110404659
Drug level increased 45.14 11.09 5 145483 47714 110396097
Carcinoembryonic antigen increased 44.99 11.09 34 145454 2790 110441021
Lung disorder 44.89 11.09 107 145381 179940 110263871
Vein disorder 44.79 11.09 48 145440 6222 110437589
Prostate cancer metastatic 44.73 11.09 43 145445 4900 110438911
Haematochezia 44.24 11.09 52 145436 115472 110328339
Hypercholesterolaemia 44.06 11.09 33 145455 90804 110353007
Encephalopathy 43.96 11.09 26 145462 81029 110362782
Blood phosphorus decreased 43.39 11.09 52 145436 7613 110436198
Isosthenuria 43.28 11.09 13 145475 119 110443692
Bone swelling 43.24 11.09 28 145460 1793 110442018
Sinusitis 43.14 11.09 222 145266 296466 110147345
Adjustment disorder with depressed mood 43.06 11.09 4 145484 43879 110399932
Pain in extremity 43.04 11.09 889 144599 486229 109957582
Dysarthria 42.85 11.09 29 145459 84092 110359719
Oral disorder 42.77 11.09 65 145423 11938 110431873
Adverse event 42.73 11.09 48 145440 108761 110335050
Vasodilatation 42.54 11.09 37 145451 3707 110440104
Metastases to pleura 42.41 11.09 29 145459 2034 110441777
Gingival abscess 42.32 11.09 23 145465 1064 110442747
Poor venous access 42.06 11.09 97 145391 24425 110419386
Depression 42.00 11.09 245 145243 317090 110126721
Sciatica 41.78 11.09 36 145452 92363 110351448
Nausea 41.68 11.09 2005 143483 1233685 109210126
Bladder prolapse 41.36 11.09 25 145463 1417 110442394
Bone density decreased 41.22 11.09 75 145413 15967 110427844
Bone density abnormal 41.21 11.09 37 145451 3866 110439945
Gingival pain 40.98 11.09 74 145414 15662 110428149
Accidental exposure to product 40.94 11.09 8 145480 50000 110393811
Giant cell arteritis 40.50 11.09 36 145452 3713 110440098
Pulmonary fibrosis 40.09 11.09 45 145443 101997 110341814
Fracture nonunion 39.94 11.09 25 145463 1509 110442302
Abdominal pain 39.88 11.09 457 145031 512532 109931279
Nail ridging 39.72 11.09 18 145470 560 110443251
Migraine 39.70 11.09 106 145382 171546 110272265
Prescribed underdose 39.66 11.09 18 145470 65156 110378655
Mucosal inflammation 39.62 11.09 239 145249 95902 110347909
Electrocardiogram PR shortened 39.55 11.09 16 145472 374 110443437
Tenderness 39.48 11.09 106 145382 29331 110414480
Blood alkaline phosphatase increased 39.15 11.09 191 145297 70744 110373067
Pulmonary embolism 39.09 11.09 443 145045 214031 110229780
Hormone receptor positive HER2 negative breast cancer 39.07 11.09 14 145474 232 110443579
Face and mouth X-ray abnormal 39.05 11.09 9 145479 24 110443787
Nasal disorder 38.63 11.09 37 145451 4197 110439614
Lactic acidosis 38.61 11.09 39 145449 92772 110351039
Respiratory tract infection viral 38.51 11.09 43 145445 5835 110437976
Sedation 38.29 11.09 22 145466 69661 110374150
Hot flush 38.03 11.09 180 145308 65856 110377955
Renal tubular dysfunction 37.93 11.09 20 145468 870 110442941
Spinal cord compression 37.55 11.09 48 145440 7504 110436307
Oral mucosal erythema 37.50 11.09 28 145460 2256 110441555
Cardiac arrest 37.34 11.09 133 145355 196620 110247191
Mobility decreased 37.20 11.09 173 145315 237249 110206562
Agitation 37.09 11.09 57 145431 112994 110330817
Hypercalcaemia of malignancy 37.04 11.09 17 145471 545 110443266
Biopsy bone abnormal 37.00 11.09 8 145480 14 110443797
Hospitalisation 36.88 11.09 83 145405 142410 110301401
Dry mouth 36.73 11.09 137 145351 199811 110244000
Ulna fracture 36.58 11.09 22 145466 1236 110442575
Nasopharyngitis 36.52 11.09 337 145151 394024 110049787
Hepatic cirrhosis 36.24 11.09 22 145466 67604 110376207
Skin lesion 35.99 11.09 149 145339 51482 110392329
Back injury 35.95 11.09 9 145479 47390 110396421
Fistula discharge 35.90 11.09 24 145464 1622 110442189
Acetabulum fracture 35.86 11.09 20 145468 974 110442837
Nasal congestion 35.78 11.09 46 145442 98236 110345575
Nail discolouration 35.53 11.09 33 145455 3602 110440209
Corneal endotheliitis 35.14 11.09 11 145477 117 110443694
Serotonin syndrome 34.97 11.09 17 145471 59136 110384675
Pneumonia 34.85 11.09 1447 144041 875267 109568544
Dermal sinus 34.80 11.09 8 145480 21 110443790
Metastases to retroperitoneum 34.80 11.09 15 145473 413 110443398
Treatment noncompliance 34.78 11.09 27 145461 72963 110370848
Infusion site induration 34.76 11.09 22 145466 1354 110442457
Hormone-refractory prostate cancer 34.72 11.09 19 145469 891 110442920
Amnesia 34.72 11.09 53 145435 105355 110338456
Salivary gland fistula 34.60 11.09 7 145481 7 110443804
Chronic papillomatous dermatitis 34.59 11.09 10 145478 79 110443732
Tibia fracture 34.56 11.09 43 145445 6542 110437269
Onycholysis 34.53 11.09 29 145459 2770 110441041
Lupus-like syndrome 34.53 11.09 6 145482 40786 110403025
SARS-CoV-2 sepsis 34.39 11.09 13 145475 252 110443559
Exostosis of jaw 34.37 11.09 21 145467 1214 110442597
Bone lesion excision 34.32 11.09 9 145479 47 110443764
Osteomalacia 34.28 11.09 23 145465 1564 110442247
Gastrointestinal haemorrhage 34.06 11.09 108 145380 165410 110278401
Gastrooesophageal reflux disease 33.92 11.09 122 145366 179854 110263957
Acute kidney injury 33.57 11.09 1083 144405 634347 109809464
Muscle spasticity 33.38 11.09 4 145484 35911 110407900
Product dose omission issue 33.35 11.09 267 145221 321515 110122296
Chondrocalcinosis pyrophosphate 33.32 11.09 23 145465 1638 110442173
Orbital swelling 33.25 11.09 10 145478 92 110443719
Coeliac disease 33.14 11.09 8 145480 43179 110400632
Joint swelling 33.06 11.09 398 145090 442447 110001364
Colitis ulcerative 32.77 11.09 32 145456 77331 110366480
Fibroblast growth factor 23 increased 32.65 11.09 8 145480 30 110443781
Rectal prolapse 32.54 11.09 27 145461 2536 110441275
Urinary tract inflammation 32.53 11.09 14 145474 384 110443427
Skin wrinkling 32.33 11.09 22 145466 1531 110442280
Nightmare 32.28 11.09 6 145482 38857 110404954
Periodontal destruction 32.11 11.09 7 145481 13 110443798
Chronic inflammatory demyelinating polyradiculoneuropathy 31.85 11.09 25 145463 2170 110441641
Squamous cell carcinoma of skin 31.68 11.09 70 145418 17133 110426678
Cytomegalovirus infection 31.65 11.09 16 145472 54428 110389383
Hepatic mass 31.64 11.09 28 145460 2870 110440941
Hyperuricosuria 31.45 11.09 7 145481 15 110443796
Abortion spontaneous 31.42 11.09 4 145484 34278 110409533
X-ray abnormal 31.41 11.09 6 145482 38111 110405700
Hydronephrosis 31.41 11.09 78 145410 20587 110423224
Injection site erythema 31.36 11.09 47 145441 94129 110349682
Aspiration bone marrow 31.34 11.09 11 145477 171 110443640
Metaphyseal corner fracture 31.31 11.09 8 145480 37 110443774
Emotional distress 31.26 11.09 10 145478 44837 110398974
Polyneuropathy 31.25 11.09 103 145385 31909 110411902
Oxygen saturation decreased 31.21 11.09 104 145384 156878 110286933
Chloropsia 30.96 11.09 8 145480 39 110443772
Oral infection 30.95 11.09 40 145448 6321 110437490
Plasma cell leukaemia 30.77 11.09 24 145464 2064 110441747
Pelvic pain 30.64 11.09 66 145422 15876 110427935
Hyperkalaemia 30.54 11.09 85 145403 135711 110308100
Eczema 30.51 11.09 30 145458 72263 110371548
Plasmacytoma 30.28 11.09 36 145452 5226 110438585
Cardiogenic shock 30.25 11.09 19 145469 57319 110386492
Metastases to soft tissue 30.20 11.09 16 145472 703 110443108
Maxillofacial operation 30.18 11.09 6 145482 5 110443806
International normalised ratio increased 30.18 11.09 42 145446 86730 110357081
Metastases to bone marrow 30.18 11.09 18 145470 996 110442815
Metastases to kidney 29.89 11.09 15 145473 588 110443223
Onychomycosis 29.84 11.09 7 145481 38524 110405287
Systemic inflammatory response syndrome 29.80 11.09 58 145430 12985 110430826
Wrong technique in product usage process 29.66 11.09 43 145445 87305 110356506
Wound dehiscence 29.63 11.09 44 145444 7918 110435893
Blood parathyroid hormone increased 29.43 11.09 32 145456 4216 110439595
Bone fragmentation 29.38 11.09 16 145472 743 110443068
Movement disorder 29.37 11.09 110 145378 36294 110407517
Progressive bulbar palsy 29.34 11.09 9 145479 89 110443722
Liver disorder 29.14 11.09 93 145395 142150 110301661
Eastern Cooperative Oncology Group performance status worsened 29.11 11.09 27 145461 2942 110440869
Road traffic accident 29.08 11.09 61 145427 107337 110336474
Drug ineffective for unapproved indication 29.04 11.09 57 145431 102781 110341030
Disability 29.01 11.09 3 145485 30220 110413591
Abdominal pain upper 28.70 11.09 307 145181 348804 110095007
Pyelitis 28.38 11.09 13 145475 415 110443396
Memory impairment 28.26 11.09 148 145340 196796 110247015
Post-traumatic neck syndrome 28.19 11.09 25 145463 2570 110441241
Pulmonary hypertension 28.17 11.09 19 145469 55201 110388610
Tooth erosion 28.14 11.09 13 145475 423 110443388
Osteitis condensans 27.83 11.09 7 145481 30 110443781
Fluid retention 27.75 11.09 51 145437 94256 110349555
Respiratory tract infection bacterial 27.70 11.09 24 145464 2392 110441419
Ear infection 27.68 11.09 25 145463 62707 110381104
Pelvic fracture 27.67 11.09 59 145429 14095 110429716
Bone abscess 27.66 11.09 15 145473 691 110443120
Peripheral sensory neuropathy 27.53 11.09 65 145423 16615 110427196
Vitamin D decreased 27.53 11.09 54 145434 12161 110431650
Humerus fracture 27.20 11.09 50 145438 10726 110433085
Stevens-Johnson syndrome 26.94 11.09 14 145474 46887 110396924
Hypertension 26.77 11.09 491 144997 509593 109934218
Abnormal behaviour 26.69 11.09 9 145479 39030 110404781
Hyperparathyroidism secondary 26.66 11.09 27 145461 3277 110440534
Gingival disorder 26.56 11.09 30 145458 4123 110439688
Death 26.27 11.09 1147 144341 697722 109746089
Knee arthroplasty 26.22 11.09 28 145460 64920 110378891
Anxiety 26.18 11.09 309 145179 344769 110099042
Hyperphosphaturia 26.12 11.09 9 145479 132 110443679
Tumour marker abnormal 25.96 11.09 11 145477 290 110443521
Peri-implantitis 25.94 11.09 10 145478 205 110443606
Therapy partial responder 25.87 11.09 107 145381 36954 110406857
Finger deformity 25.65 11.09 6 145482 33086 110410725
Nephropathy toxic 25.57 11.09 87 145401 27391 110416420
Seizure 25.54 11.09 178 145310 221007 110222804
Lymphoedema 25.54 11.09 59 145429 14870 110428941
Myoclonus 25.54 11.09 6 145482 32992 110410819
Incorrect dose administered 25.51 11.09 62 145426 103579 110340232
Inappropriate schedule of product administration 25.47 11.09 160 145328 203477 110240334
Numb chin syndrome 25.33 11.09 7 145481 46 110443765
Restlessness 25.33 11.09 22 145466 56237 110387574
Chikungunya virus infection 25.33 11.09 10 145478 219 110443592
Pneumonitis 25.28 11.09 180 145308 76351 110367460
Poisoning 25.26 11.09 4 145484 29101 110414710
Ultrasound foetal abnormal 25.23 11.09 8 145480 89 110443722
Unresponsive to stimuli 25.20 11.09 28 145460 63762 110380049
Abdominal lymphadenopathy 24.77 11.09 20 145468 1808 110442003
Oedema 24.73 11.09 168 145320 209808 110234003
Concomitant disease progression 24.67 11.09 27 145461 3583 110440228
No adverse event 24.44 11.09 37 145451 73802 110370009
Peripheral sensorimotor neuropathy 24.40 11.09 28 145460 3915 110439896
Cytopenia 24.30 11.09 91 145397 30025 110413786
Therapy interrupted 24.29 11.09 18 145470 49804 110394007
Eyelid ptosis 24.28 11.09 54 145434 13273 110430538
Onychomadesis 24.27 11.09 15 145473 45648 110398163
Pleural effusion 24.26 11.09 348 145140 177361 110266450
Multiple organ dysfunction syndrome 24.08 11.09 110 145378 151600 110292211
Tooth infection 23.98 11.09 74 145414 22142 110421669
Adnexa uteri mass 23.87 11.09 12 145476 472 110443339
Musculoskeletal stiffness 23.83 11.09 244 145244 279578 110164233
Withdrawal syndrome 23.72 11.09 6 145482 31374 110412437
Somnolence 23.47 11.09 264 145224 297185 110146626
Metastases to the mediastinum 23.40 11.09 14 145474 779 110443032
Serum procollagen type I N-terminal propeptide increased 23.27 11.09 6 145482 29 110443782
Breast cancer stage II 23.23 11.09 4 145484 27371 110416440
Calcification of muscle 23.19 11.09 9 145479 188 110443623
Vulvovaginal dryness 23.18 11.09 23 145465 2724 110441087
Hallucination 23.18 11.09 63 145425 101369 110342442
HER2 positive breast cancer 23.15 11.09 11 145477 382 110443429
Otitis externa 23.15 11.09 23 145465 2729 110441082
Injection site pruritus 23.13 11.09 20 145468 51238 110392573
Spinal disorder 23.06 11.09 49 145439 11679 110432132
Spinal stenosis 22.96 11.09 66 145422 18990 110424821
Pneumonia aspiration 22.96 11.09 45 145443 81188 110362623
Procollagen type I C-terminal propeptide increased 22.94 11.09 6 145482 31 110443780
Lymphadenopathy mediastinal 22.89 11.09 32 145456 5452 110438359
Feeling cold 22.85 11.09 97 145391 33890 110409921
Abscess oral 22.65 11.09 18 145470 1591 110442220
Selenium deficiency 22.57 11.09 7 145481 72 110443739
Medical device site joint inflammation 22.54 11.09 4 145484 0 110443811
Acute hepatic failure 22.30 11.09 10 145478 36458 110407353
Anaphylactic shock 22.20 11.09 21 145467 51525 110392286
Bronchopulmonary aspergillosis 22.02 11.09 6 145482 29857 110413954
Allergy to plants 22.01 11.09 14 145474 869 110442942
Parathyroid tumour benign 21.96 11.09 15 145473 1050 110442761
Renal tubular acidosis 21.93 11.09 29 145459 4686 110439125
Dry eye 21.91 11.09 137 145351 55656 110388155
Device issue 21.87 11.09 9 145479 34526 110409285
Hypoxia 21.71 11.09 92 145396 129423 110314388
Vertebral column mass 21.63 11.09 10 145478 326 110443485
Hungry bone syndrome 21.55 11.09 10 145478 329 110443482
Cardio-respiratory arrest 21.51 11.09 79 145409 115757 110328054
Sleep disorder 21.42 11.09 163 145325 198481 110245330
Chondrocalcinosis 21.32 11.09 19 145469 1966 110441845
Bladder hypertrophy 21.23 11.09 15 145473 1109 110442702
Eosinophilia 21.21 11.09 27 145461 57909 110385902
Eye swelling 21.20 11.09 93 145395 32955 110410856
Biliary dilatation 21.19 11.09 25 145463 3600 110440211
Peripheral coldness 21.18 11.09 63 145425 18477 110425334
Trichorrhexis 21.14 11.09 14 145474 931 110442880
Monoclonal immunoglobulin increased 21.06 11.09 12 145476 609 110443202
Premature delivery 21.05 11.09 7 145481 30625 110413186
Pubic pain 21.01 11.09 9 145479 244 110443567
Dental necrosis 20.98 11.09 8 145480 159 110443652
Drug withdrawal syndrome 20.93 11.09 12 145476 38042 110405769
Invasive ductal breast carcinoma 20.92 11.09 34 145454 6612 110437199
Product prescribing error 20.86 11.09 22 145466 51309 110392502
Hepatitis 20.52 11.09 56 145432 89998 110353813
Oral dysaesthesia 20.45 11.09 9 145479 261 110443550
Light chain analysis increased 20.40 11.09 20 145468 2335 110441476
Agranulocytosis 20.39 11.09 31 145457 61729 110382082
Hip fracture 20.37 11.09 96 145392 35055 110408756
Haemodynamic instability 20.19 11.09 3 145485 22885 110420926
Toxic epidermal necrolysis 20.19 11.09 27 145461 56700 110387111
Dysaesthesia 20.17 11.09 34 145454 6813 110436998
Proteinuria 20.14 11.09 105 145383 39913 110403898
Oral pustule 20.10 11.09 9 145479 272 110443539
Tumour marker decreased 20.06 11.09 6 145482 54 110443757
Clinical death 19.99 11.09 7 145481 108 110443703
Pancreatitis 19.97 11.09 60 145428 93473 110350338
Hypokalaemia 19.87 11.09 344 145144 182104 110261707
Bone erosion 19.85 11.09 19 145469 46352 110397459
Tetany 19.66 11.09 24 145464 3580 110440231
Pleural neoplasm 19.65 11.09 10 145478 404 110443407
Posterior reversible encephalopathy syndrome 19.61 11.09 10 145478 33851 110409960
Melaena 19.51 11.09 38 145450 68719 110375092
Deformity 19.46 11.09 42 145446 10118 110433693
Foot deformity 19.46 11.09 21 145467 48459 110395352
Drug tolerance decreased 19.45 11.09 6 145482 27534 110416277
Infusion site haemorrhage 19.44 11.09 27 145461 4571 110439240
Psychotic disorder 19.42 11.09 23 145465 50914 110392897
Dysgeusia 19.41 11.09 158 145330 69827 110373984
Blood calcium increased 19.39 11.09 60 145428 17980 110425831
Facial pain 19.34 11.09 54 145434 15285 110428526
Mydriasis 19.33 11.09 3 145485 22154 110421657
Accidental overdose 19.14 11.09 24 145464 51810 110392001
Blood calcium abnormal 19.13 11.09 17 145471 1752 110442059
Skin sensitisation 19.01 11.09 14 145474 1105 110442706
Cytokine release syndrome 18.97 11.09 40 145448 70266 110373545
Noninfective gingivitis 18.96 11.09 18 145470 2019 110441792
Hypophosphatasia 18.95 11.09 7 145481 127 110443684
Renal glycosuria 18.93 11.09 5 145483 27 110443784
Tooth deposit 18.90 11.09 9 145479 314 110443497
Pseudarthrosis 18.90 11.09 9 145479 314 110443497
Vein rupture 18.90 11.09 20 145468 2555 110441256
Bone hypertrophy 18.87 11.09 12 145476 745 110443066
Foot fracture 18.82 11.09 75 145413 25471 110418340
Lymphadenopathy 18.74 11.09 146 145342 63689 110380122
Injection site inflammation 18.67 11.09 27 145461 4744 110439067
Dyschezia 18.62 11.09 24 145464 3783 110440028
Blood creatine phosphokinase increased 18.55 11.09 43 145445 73034 110370777
Injection site swelling 18.55 11.09 33 145455 61757 110382054
Avulsion fracture 18.54 11.09 9 145479 328 110443483
Coronary artery disease 18.35 11.09 42 145446 71648 110372163
Atrial fibrillation 18.28 11.09 413 145075 229229 110214582
Myocardial infarction 18.26 11.09 163 145325 191920 110251891
Dyspnoea 18.22 11.09 1233 144255 1105639 109338172
Gastrointestinal disorder 18.21 11.09 217 145271 241735 110202076
Stress 18.17 11.09 74 145414 105274 110338537
Post procedural inflammation 18.14 11.09 8 145480 233 110443578
Respiratory disorder 18.12 11.09 42 145446 71340 110372471
Contusion 18.06 11.09 208 145280 233153 110210658
Heart rate increased 17.99 11.09 113 145375 143721 110300090
Neuroendocrine breast tumour 17.82 11.09 5 145483 35 110443776
Oral mucosal roughening 17.82 11.09 5 145483 35 110443776
Therapeutic response decreased 17.79 11.09 66 145422 96433 110347378
Rectal haemorrhage 17.78 11.09 89 145399 119744 110324067
Aspiration 17.71 11.09 9 145479 30524 110413287
Radius fracture 17.68 11.09 24 145464 3976 110439835
Polymyalgia rheumatica 17.68 11.09 31 145457 6411 110437400
Gingival ulceration 17.63 11.09 14 145474 1236 110442575
Orthostatic hypotension 17.62 11.09 38 145450 66211 110377600
Cerebral haemorrhage 17.50 11.09 37 145451 64931 110378880
Episcleritis 17.47 11.09 14 145474 1252 110442559
Glomerular filtration rate decreased 17.46 11.09 80 145408 28876 110414935
Paranoia 17.45 11.09 4 145484 22370 110421441
Limb deformity 17.36 11.09 23 145465 3723 110440088
Drug reaction with eosinophilia and systemic symptoms 17.28 11.09 53 145435 82042 110361769
Internal fixation of fracture 17.28 11.09 10 145478 523 110443288
Ageusia 17.23 11.09 61 145427 19584 110424227
Decubitus ulcer 17.20 11.09 58 145430 18178 110425633
Metastases to meninges 17.19 11.09 27 145461 5101 110438710
Transfusion 17.19 11.09 6 145482 25466 110418345
Dental care 17.10 11.09 13 145475 1076 110442735
Pityriasis rubra pilaris 17.08 11.09 8 145480 269 110443542
Blood creatinine abnormal 17.02 11.09 29 145459 5863 110437948
Spinal cord infarction 17.01 11.09 13 145475 1085 110442726
Venous perforation 16.90 11.09 3 145485 0 110443811
Lacrimation increased 16.84 11.09 83 145405 30867 110412944
Red blood cell count decreased 16.78 11.09 146 145342 65777 110378034
Upper limb fracture 16.75 11.09 63 145425 20825 110422986
Urine phosphorus decreased 16.72 11.09 5 145483 45 110443766
Rebound effect 16.62 11.09 50 145438 14756 110429055
Amaurosis fugax 16.55 11.09 18 145470 2372 110441439
Glucose urine 16.43 11.09 5 145483 48 110443763
Soft tissue inflammation 16.43 11.09 10 145478 574 110443237
Optic perineuritis 16.34 11.09 5 145483 49 110443762
Bone marrow oedema 16.28 11.09 17 145471 2139 110441672
Swelling 16.25 11.09 345 145143 350696 110093115
Drug-induced liver injury 16.24 11.09 92 145396 119975 110323836
Lithiasis 16.22 11.09 8 145480 302 110443509
Cholesteatoma 16.20 11.09 7 145481 194 110443617
Hand fracture 16.04 11.09 34 145454 8088 110435723
Incorrect route of product administration 16.02 11.09 38 145450 64023 110379788
Hypoaesthesia oral 15.97 11.09 54 145434 16948 110426863
Mucosal hypertrophy 15.94 11.09 6 145482 115 110443696
Poor personal hygiene 15.89 11.09 10 145478 609 110443202
Monoclonal gammopathy 15.87 11.09 13 145475 1199 110442612
Electrolyte imbalance 15.86 11.09 93 145395 36935 110406876
Vomiting 15.81 11.09 1397 144091 909278 109534533
Naevus haemorrhage 15.75 11.09 6 145482 119 110443692
Laryngeal leukoplakia 15.74 11.09 5 145483 56 110443755
Hip arthroplasty 15.70 11.09 31 145457 55782 110388029
Gait disturbance 15.66 11.09 478 145010 277730 110166081
Monoclonal immunoglobulin present 15.65 11.09 18 145470 2522 110441289
Underdose 15.65 11.09 38 145450 63516 110380295
Gait inability 15.62 11.09 110 145378 136266 110307545
Pulmonary arterial hypertension 15.58 11.09 12 145476 32556 110411255
Hyperparathyroidism 15.55 11.09 22 145466 3788 110440023
Acute sinusitis 15.52 11.09 26 145462 5185 110438626
Oral discomfort 15.44 11.09 41 145447 11270 110432541
Groin pain 15.38 11.09 50 145438 15378 110428433
Elbow deformity 15.32 11.09 14 145474 1496 110442315
Chest wall mass 15.32 11.09 7 145481 222 110443589
Cardiac failure congestive 15.31 11.09 126 145362 150874 110292937
Tooth fracture 15.29 11.09 45 145443 13122 110430689
Paraganglion neoplasm malignant 15.24 11.09 4 145484 21 110443790
Colitis 15.18 11.09 76 145412 102247 110341564
Vertebral lesion 15.17 11.09 10 145478 660 110443151
Dental caries 15.16 11.09 44 145444 12729 110431082
Rash 15.13 11.09 905 144583 820059 109623752
Onychoclasis 15.12 11.09 31 145457 7206 110436605
Impaired work ability 15.01 11.09 8 145480 26411 110417400
Paronychia 14.96 11.09 40 145448 11041 110432770
Disorder of orbit 14.92 11.09 6 145482 138 110443673
Blood potassium decreased 14.92 11.09 122 145366 53992 110389819
Osteoradionecrosis 14.88 11.09 6 145482 139 110443672
Breast mass 14.85 11.09 33 145455 8108 110435703
Respiratory distress 14.83 11.09 44 145444 68830 110374981
Follicular dendritic cell sarcoma 14.83 11.09 3 145485 3 110443808
Bone deformity 14.82 11.09 8 145480 365 110443446
Dengue fever 14.75 11.09 13 145475 1326 110442485
Haemorrhage intracranial 14.73 11.09 10 145478 28959 110414852
Dental discomfort 14.72 11.09 9 145479 521 110443290
Colorectal cancer metastatic 14.71 11.09 14 145474 1575 110442236
Conjunctivitis 14.56 11.09 85 145403 33707 110410104
Adjusted calcium decreased 14.55 11.09 7 145481 250 110443561
Wrong schedule 14.52 11.09 10 145478 710 110443101
Atypical pneumonia 14.49 11.09 32 145456 7830 110435981
Motor neurone disease 14.47 11.09 10 145478 714 110443097
Hyperhidrosis 14.47 11.09 167 145321 187131 110256680
Respiratory failure 14.39 11.09 198 145290 215134 110228677
Enterocolitis bacterial 14.38 11.09 10 145478 721 110443090
Lymph node pain 14.37 11.09 15 145473 1887 110441924
Hypervolaemia 14.32 11.09 27 145461 49433 110394378
Recurrent cancer 14.32 11.09 20 145468 3403 110440408
Blood pressure abnormal 14.30 11.09 63 145425 22361 110421450
Dental prosthesis placement 14.26 11.09 4 145484 28 110443783
Bronchial fistula 14.25 11.09 7 145481 262 110443549
Musculoskeletal discomfort 14.17 11.09 65 145423 23473 110420338
Thermal burn 14.14 11.09 32 145456 7956 110435855
Device malfunction 14.14 11.09 8 145480 25550 110418261
Weight decreased 14.13 11.09 752 144736 467305 109976506
Bone neoplasm 14.12 11.09 11 145477 944 110442867
Dermatitis atopic 14.12 11.09 8 145480 25533 110418278
Albumin urine present 14.11 11.09 10 145478 743 110443068
Osteochondrosis 14.10 11.09 17 145471 2504 110441307
Hip deformity 14.08 11.09 7 145481 269 110443542
Keratomileusis 14.06 11.09 6 145482 161 110443650
Rectal adenocarcinoma 13.99 11.09 14 145474 1675 110442136
Dry skin 13.97 11.09 209 145279 107444 110336367
Bone callus excessive 13.90 11.09 4 145484 31 110443780
Activated partial thromboplastin time prolonged 13.89 11.09 6 145482 22362 110421449
Neovascular age-related macular degeneration 13.87 11.09 9 145479 578 110443233
Carcinoid tumour pulmonary 13.86 11.09 8 145480 416 110443395
Ovarian disorder 13.83 11.09 9 145479 581 110443230
Foetal heart rate deceleration abnormality 13.83 11.09 6 145482 168 110443643
Ocular discomfort 13.81 11.09 33 145455 8500 110435311
Lymphatic disorder 13.74 11.09 8 145480 423 110443388
Thrombosis 13.73 11.09 210 145278 108452 110335359
Oophorectomy bilateral 13.73 11.09 5 145483 87 110443724
Arteriosclerosis coronary artery 13.70 11.09 8 145480 25110 110418701
Parkinsonism 13.70 11.09 6 145482 22181 110421630
Sleep apnoea syndrome 13.64 11.09 20 145468 40427 110403384
Hypophagia 13.63 11.09 117 145371 52509 110391302
Oesophagogastroduodenoscopy abnormal 13.62 11.09 3 145485 6 110443805
Porphyromonas infection 13.62 11.09 3 145485 6 110443805
Hallucination, auditory 13.58 11.09 9 145479 26388 110417423
Device dislocation 13.56 11.09 13 145475 31691 110412120
Oral mucosal hypertrophy 13.48 11.09 4 145484 35 110443776
Conjunctival hyperaemia 13.41 11.09 26 145462 5805 110438006
Swollen tongue 13.41 11.09 38 145450 60324 110383487
Enterococcal infection 13.40 11.09 5 145483 20361 110423450
Normal newborn 13.40 11.09 6 145482 21890 110421921
Ventricular fibrillation 13.39 11.09 21 145467 41292 110402519
Epstein-Barr virus infection 13.38 11.09 4 145484 18734 110425077
Rhabdomyolysis 13.36 11.09 98 145390 120303 110323508
Proctitis 13.26 11.09 3 145485 16924 110426887
Joint warmth 13.25 11.09 15 145473 2067 110441744
Drug level decreased 13.17 11.09 4 145484 18544 110425267
Gingival recession 13.15 11.09 13 145475 1533 110442278
Breast neoplasm 13.13 11.09 11 145477 1047 110442764
Tonsillar inflammation 13.11 11.09 6 145482 191 110443620
Upper gastrointestinal haemorrhage 13.10 11.09 29 145459 50067 110393744
Influenza 13.10 11.09 303 145185 168798 110275013
Cavernous sinus syndrome 13.09 11.09 4 145484 39 110443772
Gingival injury 13.09 11.09 4 145484 39 110443772
Defaecation disorder 13.08 11.09 10 145478 835 110442976
Dyspepsia 12.97 11.09 175 145313 190790 110253021
Wrist fracture 12.85 11.09 45 145443 14372 110429439
Blood alkaline phosphatase decreased 12.84 11.09 16 145472 2437 110441374
Therapeutic response shortened 12.80 11.09 12 145476 29571 110414240
Urine output decreased 12.80 11.09 56 145432 19820 110423991
Female genital tract fistula 12.79 11.09 3 145485 16516 110427295
Mesenteric phlebosclerosis 12.76 11.09 3 145485 9 110443802
Heavy menstrual bleeding 12.62 11.09 3 145485 16362 110427449
Pachymeningitis 12.60 11.09 8 145480 495 110443316
Carbohydrate antigen 27.29 increased 12.60 11.09 5 145483 111 110443700
Radiation skin injury 12.56 11.09 13 145475 1619 110442192
Photophobia 12.55 11.09 67 145421 25704 110418107
Eosinophil count increased 12.53 11.09 6 145482 21052 110422759
Dyskinesia 12.48 11.09 31 145457 51415 110392396
Discharge 12.45 11.09 15 145473 2207 110441604
Protein total decreased 12.43 11.09 37 145451 10853 110432958
Throat irritation 12.43 11.09 33 145455 53519 110390292
Needle issue 12.39 11.09 4 145484 17836 110425975
Hydrothorax 12.39 11.09 13 145475 1645 110442166
Incontinence 12.38 11.09 49 145439 16586 110427225
Microangiopathic haemolytic anaemia 12.36 11.09 14 145474 1929 110441882
Myeloproliferative neoplasm 12.30 11.09 12 145476 1393 110442418
Portal venous gas 12.19 11.09 8 145480 524 110443287
Oedema mucosal 12.17 11.09 15 145473 2261 110441550
Tongue geographic 12.16 11.09 5 145483 122 110443689
CALR gene mutation 12.09 11.09 3 145485 12 110443799
Parathyroid hormone-related protein increased 12.09 11.09 3 145485 12 110443799
Light chain analysis abnormal 12.08 11.09 6 145482 230 110443581
Impaired quality of life 12.05 11.09 13 145475 30004 110413807
Lichenoid keratosis 12.01 11.09 26 145462 6276 110437535
Retinal detachment 12.00 11.09 37 145451 11063 110432748
Acute myocardial infarction 11.99 11.09 63 145425 83714 110360097
Hepatic cytolysis 11.98 11.09 35 145453 55018 110388793
Haemophilus bacteraemia 11.96 11.09 6 145482 235 110443576
Middle insomnia 11.96 11.09 6 145482 20496 110423315
Petechiae 11.93 11.09 8 145480 23309 110420502
Tumour pain 11.92 11.09 17 145471 2950 110440861
Myositis 11.92 11.09 14 145474 31102 110412709
Optic neuritis 11.91 11.09 37 145451 11110 110432701
Vulvovaginal inflammation 11.89 11.09 9 145479 740 110443071
Angina pectoris 11.88 11.09 42 145446 62253 110381558
Right ventricular failure 11.87 11.09 10 145478 25944 110417867
Panniculitis 11.74 11.09 3 145485 15579 110428232
Hypocalcaemic seizure 11.73 11.09 5 145483 134 110443677
Injection site urticaria 11.71 11.09 4 145484 17211 110426600
Therapy cessation 11.71 11.09 26 145462 44831 110398980
Tubulointerstitial nephritis 11.69 11.09 116 145372 54168 110389643
Metastases to ovary 11.64 11.09 7 145481 393 110443418
Metastases to spinal cord 11.64 11.09 6 145482 249 110443562
Affect lability 11.57 11.09 5 145483 18632 110425179
Anhedonia 11.56 11.09 3 145485 15425 110428386
Aspergillus infection 11.55 11.09 10 145478 25606 110418205
Squamous cell breast carcinoma 11.55 11.09 3 145485 15 110443796
Haematological malignancy 11.54 11.09 10 145478 997 110442814
Acute pulmonary oedema 11.48 11.09 4 145484 16992 110426819
Pleurodesis 11.47 11.09 4 145484 61 110443750
Squamous cell carcinoma of lung 11.37 11.09 16 145472 2743 110441068
Cognitive disorder 11.33 11.09 68 145420 87443 110356368
Parainfluenzae virus infection 11.32 11.09 27 145461 6947 110436864
Osteoporotic fracture 11.31 11.09 23 145465 5314 110438497
Gastroenteritis radiation 11.29 11.09 9 145479 799 110443012
Adenocarcinoma of colon 11.25 11.09 25 145463 6143 110437668
Empty sella syndrome 11.23 11.09 5 145483 149 110443662
Wound complication 11.22 11.09 25 145463 6152 110437659
Bone cancer 11.19 11.09 15 145473 2455 110441356
Transitional cell cancer of the renal pelvis and ureter 11.12 11.09 4 145484 67 110443744
Meralgia paraesthetica 11.12 11.09 8 145480 609 110443202
Haemangioma 11.11 11.09 16 145472 2800 110441011

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Neonatal hypocalcaemia 27.48 7.82 3 3 0 113947

Pharmacologic Action:

SourceCodeDescription
ATC M05BA08 MUSCULO-SKELETAL SYSTEM
DRUGS FOR TREATMENT OF BONE DISEASES
DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
Bisphosphonates
ATC M05BB08 MUSCULO-SKELETAL SYSTEM
DRUGS FOR TREATMENT OF BONE DISEASES
DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
Bisphosphonates, combinations
MeSH PA D050071 Bone Density Conservation Agents
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50646 bone density conservation agent

Related Drugs by ATC class:

M05BA Bisphosphonates 7 drugs
alendronic acidclodronic acidetidronic acidibandronic acidpamidronic acidrisedronic acidtiludronic acid
M05BB Bisphosphonates, combinations 6 drugs
alendronic acidalfacalcidolcolecalciferoletidronic acidibandronic acidrisedronic acid

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

DiseaseRelationSNOMED_IDDOID
Osteitis deformans indication 2089002 DOID:5408
Humoral hypercalcemia of malignancy indication 47709007
Osteoporosis indication 64859006 DOID:11476
Postmenopausal osteoporosis indication 102447009
Bone Metastases of Solid Tumors indication
Prevention of Glucocorticoid-Induced Osteoporosis indication
Glucocorticoid Induced Osteoporosis indication
Osteolytic Lesions of Multiple Myeloma indication
Hypogonadal Osteoporosis in Males indication
Drug-induced osteoporosis off-label use 14651005
Intracranial hemorrhage contraindication 1386000
Anuria contraindication 2472002 DOID:2983
Hypophosphatemia contraindication 4996001
Hypocalcemia contraindication 5291005
Bone pain contraindication 12584003
Hyperkalemia contraindication 14140009
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hypoparathyroidism contraindication 36976004 DOID:11199
Hypernatremia contraindication 39355002
Severe renal impairment contraindication 42399005 DOID:1074
Chronic heart failure contraindication 48447003
Joint pain contraindication 57676002
Acute nephropathy contraindication 58574008
Pulmonary congestion contraindication 67599009
Muscle pain contraindication 68962001
Fracture of femur contraindication 71620000
Oliguria contraindication 83128009
Hyponatremia contraindication 89627008
Small intestine excision contraindication 107938000
Hypomagnesemia contraindication 190855004
Impaired renal function disorder contraindication 197663003
Tooth disorder contraindication 234947003 DOID:1091
Fragile capillaries contraindication 248726001
Pregnancy, function contraindication 289908002
Breastfeeding (mother) contraindication 413712001
Aseptic necrosis of bone of jaw contraindication 441809006
Severe dehydration contraindication 450316000
Thyroid Surgery contraindication
Invasive Dental Procedure contraindication
Malabsorption States contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.38 acidic
pKa2 5.45 acidic
pKa3 6.59 acidic
pKa4 10.35 acidic
pKa5 11.04 acidic
pKa6 5.92 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Farnesyl pyrophosphate synthase Enzyme INHIBITOR Ki 10.15 CHEMBL CHEMBL
Carbonic anhydrase 9 Enzyme IC50 5.27 CHEMBL
Carbonic anhydrase 12 Enzyme IC50 6.50 CHEMBL
72 kDa type IV collagenase Enzyme IC50 5.15 CHEMBL
Carbonic anhydrase 14 Enzyme IC50 7.04 CHEMBL
Matrix metalloproteinase-14 Enzyme IC50 4.90 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 4.28 CHEMBL
Neutrophil collagenase Enzyme IC50 4.75 CHEMBL
Geranylgeranyl pyrophosphate synthase Enzyme Ki 5.57 CHEMBL
Butyrophilin subfamily 3 member A1 Antibody EC50 6.31 CHEMBL
Carbonic anhydrase 2 Enzyme IC50 7.21 CHEMBL
Farnesyl diphosphate synthase Enzyme IC50 5.96 CHEMBL
Farnesyl pyrophosphate synthase Enzyme Ki 7.96 CHEMBL
Geranylgeranyl pyrophosphate synthase Enzyme Ki 6.59 CHEMBL
Farnesyl pyrophosphate synthase Enzyme INHIBITOR IC50 6.30 IUPHAR
Farnesyl pyrophosphate synthase, EC 2.5.1.1, EC 2.5.1.10 Enzyme Ki 8 CHEMBL

External reference:

IDSource
4021276 VUID
N0000179387 NUI
D01968 KEGG_DRUG
4021276 VANDF
C0257685 UMLSCUI
CHEBI:46557 CHEBI
ZOL PDB_CHEM_ID
CHEMBL4303669 ChEMBL_ID
CHEMBL924 ChEMBL_ID
DB00399 DRUGBANK_ID
D000077211 MESH_DESCRIPTOR_UI
68740 PUBCHEM_CID
3177 IUPHAR_LIGAND_ID
6XC1PAD3KF UNII
285143 RXNORM
15839 MMSL
199263 MMSL
40691 MMSL
d04708 MMSL
008997 NDDF
134600006 SNOMEDCT_US
395926009 SNOMEDCT_US
427076004 SNOMEDCT_US
768145002 SNOMEDCT_US
165800-06-6 SECONDARY_CAS_RN
6XC1PAD3KF INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Reclast HUMAN PRESCRIPTION DRUG LABEL 1 0078-0435 INJECTION, SOLUTION 5 mg INTRAVENOUS NDA 32 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 0143-9642 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 16729-242 INJECTION 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 16729-242 INJECTION 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 17478-327 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 23155-170 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 25021-826 INJECTION, SOLUTION 0.04 mg INTRAVENOUS NDA 27 sections
zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 25021-826 INJECTION, SOLUTION 0.04 mg INTRAVENOUS NDA 27 sections
zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 25021-830 INJECTION, SOLUTION 0.05 mg INTRAVENOUS ANDA 31 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 43598-233 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 43598-255 INJECTION, SOLUTION 4 mg INTRAVENOUS ANDA 25 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 43598-330 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 43598-331 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 25 sections
Zoledronic Acid Human Prescription Drug Label 1 54288-100 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid Human Prescription Drug Label 1 54288-183 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 55111-685 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 55111-688 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Zoledronic Acid Human Prescription Drug Label 1 55150-266 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
Zoledronic Acid Human Prescription Drug Label 1 55150-283 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 29 sections
Zoledronic Acid Human Prescription Drug Label 1 60505-6110 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 25 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 63323-961 INJECTION 4 mg INTRAVENOUS ANDA 29 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 63323-966 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Reclast HUMAN PRESCRIPTION DRUG LABEL 1 66758-155 INJECTION, SOLUTION 5 mg INTRAVENOUS NDA 31 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 67457-390 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 67457-619 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 30 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 67457-794 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 31 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 68001-437 INJECTION 4 mg INTRAVENOUS ANDA 27 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 68001-610 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 68001-611 INJECTION 5 mg INTRAVENOUS ANDA 29 sections
Zoledronic Acid Human Prescription Drug Label 1 68083-116 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 sections