zoledronic acid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

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 8061.24 11.50 2848 112762 32275 63341137
Exposed bone in jaw 1437.97 11.50 424 115186 2501 63370911
Bone pain 1053.82 11.50 840 114770 53801 63319611
Osteonecrosis 1017.64 11.50 605 115005 23925 63349487
Metastases to bone 801.03 11.50 491 115119 20528 63352884
Influenza like illness 575.49 11.50 658 114952 66166 63307246
Drug ineffective 568.91 11.50 643 114967 1044122 62329290
Malignant neoplasm progression 551.57 11.50 713 114897 81408 63292004
Pain in jaw 490.22 11.50 494 115116 43002 63330410
Myalgia 483.72 11.50 917 114693 145612 63227800
Atypical femur fracture 459.33 11.50 215 115395 5157 63368255
Neutropenia 448.28 11.50 986 114624 174019 63199393
Neuropathy peripheral 390.71 11.50 724 114886 112943 63260469
Metastases to liver 363.31 11.50 319 115291 23320 63350092
Femur fracture 357.35 11.50 410 115200 41346 63332066
Bone disorder 346.35 11.50 297 115313 21029 63352383
Bone sequestrum 342.57 11.50 121 115489 1353 63372059
Maternal exposure during pregnancy 312.61 11.50 23 115587 220039 63153373
Hypocalcaemia 303.26 11.50 330 115280 31383 63342029
Bone lesion 288.88 11.50 162 115448 5719 63367693
Systemic lupus erythematosus 279.91 11.50 28 115582 208890 63164522
Contraindicated product administered 276.95 11.50 35 115575 217613 63155799
Tooth extraction 269.43 11.50 190 115420 10074 63363338
Exposure during pregnancy 250.67 11.50 7 115603 155540 63217872
Glossodynia 250.32 11.50 20 115590 178856 63194556
Completed suicide 236.82 11.50 6 115604 145667 63227745
Sequestrectomy 235.47 11.50 79 115531 747 63372665
Metastases to lung 234.85 11.50 191 115419 12559 63360853
Iridocyclitis 231.37 11.50 106 115504 2416 63370996
Synovitis 230.77 11.50 33 115577 186885 63186527
Pyrexia 226.62 11.50 1548 114062 468930 62904482
Plasma cell myeloma 224.21 11.50 301 115309 35604 63337808
Back pain 222.98 11.50 1012 114598 263133 63110279
Chills 218.96 11.50 573 115037 112805 63260607
Hand deformity 204.36 11.50 25 115585 159432 63213980
Metastases to spine 200.09 11.50 104 115506 3145 63370267
Condition aggravated 194.91 11.50 269 115341 401948 62971464
Oral cavity fistula 190.68 11.50 64 115546 606 63372806
Neoplasm progression 178.34 11.50 272 115338 36156 63337256
Jaw disorder 176.22 11.50 114 115496 5235 63368177
Pericarditis 175.22 11.50 18 115592 131561 63241851
Toxicity to various agents 174.70 11.50 118 115492 247132 63126280
Purulent discharge 169.23 11.50 106 115504 4600 63368812
Tooth loss 168.64 11.50 122 115488 6734 63366678
Product use issue 167.16 11.50 97 115513 220423 63152989
Gingival swelling 162.62 11.50 101 115509 4317 63369095
Drug interaction 161.00 11.50 110 115500 229021 63144391
Breast cancer metastatic 160.69 11.50 150 115460 11868 63361544
Osteolysis 160 11.50 86 115524 2788 63370624
Spinal pain 154.89 11.50 153 115457 12986 63360426
Osteomyelitis 153.15 11.50 212 115398 25808 63347604
Death 152.98 11.50 1185 114425 373196 63000216
Acute phase reaction 152.20 11.50 44 115566 239 63373173
Overdose 147.53 11.50 18 115592 115060 63258352
Arthralgia 145.47 11.50 1630 113980 568080 62805332
Toothache 145.13 11.50 177 115433 19022 63354390
Arthropathy 144.36 11.50 129 115481 234663 63138749
Gingivitis 144.23 11.50 121 115489 8308 63365104
Osteitis 144.21 11.50 84 115526 3190 63370222
Therapeutic product effect decreased 142.15 11.50 88 115522 193099 63180313
Wound 141.51 11.50 60 115550 163203 63210209
Infusion related reaction 140.34 11.50 144 115466 245377 63128035
Abdominal discomfort 137.63 11.50 233 115377 320652 63052760
Rheumatoid factor positive 135.20 11.50 4 115606 84402 63289010
Blood creatinine increased 135.20 11.50 409 115201 87435 63285977
Helicobacter infection 133.68 11.50 9 115601 92776 63280636
Loose tooth 133.62 11.50 81 115529 3313 63370099
Carbohydrate antigen 15-3 increased 133.27 11.50 61 115549 1387 63372025
Osteopenia 132.98 11.50 172 115438 19613 63353799
Jaw operation 128.69 11.50 51 115559 801 63372611
Osteosclerosis 128.42 11.50 83 115527 3805 63369607
Drug hypersensitivity 125.64 11.50 234 115376 310453 63062959
Pathological fracture 125.37 11.50 114 115496 8720 63364692
Parophthalmia 125.17 11.50 39 115571 284 63373128
Atypical fracture 124.53 11.50 46 115564 590 63372822
Presbyacusis 122.22 11.50 72 115538 2793 63370619
Debridement 120.62 11.50 54 115556 1164 63372248
Rheumatoid arthritis 119.55 11.50 173 115437 253646 63119766
Fistula 118.77 11.50 119 115491 10274 63363138
Psoriatic arthropathy 118.08 11.50 14 115596 91506 63281906
Pain in extremity 116.85 11.50 1015 114595 330471 63042941
Therapeutic product effect incomplete 116.58 11.50 41 115569 125015 63248397
Palmar-plantar erythrodysaesthesia syndrome 115.68 11.50 174 115436 22841 63350571
Discomfort 114.03 11.50 83 115527 167291 63206121
Blister 113.62 11.50 47 115563 129767 63243645
Treatment failure 113.42 11.50 117 115493 198926 63174486
Disease progression 112.95 11.50 483 115127 122275 63251137
Drug intolerance 112.40 11.50 247 115363 308414 63064998
Pleural fibrosis 111.93 11.50 73 115537 3399 63370013
Pleural thickening 111.44 11.50 68 115542 2815 63370597
Musculoskeletal chest pain 111.14 11.50 163 115447 20920 63352492
Tumour marker increased 110.83 11.50 83 115527 4832 63368580
Blood magnesium increased 110.68 11.50 69 115541 2969 63370443
White blood cell count decreased 109.79 11.50 523 115087 138581 63234831
Pain 109.71 11.50 1924 113686 738704 62634708
Hepatic enzyme increased 107.49 11.50 126 115484 202202 63171210
Eye pain 105.48 11.50 207 115403 33647 63339765
Folliculitis 103.74 11.50 6 115604 70311 63303101
Dental fistula 102.60 11.50 40 115570 600 63372812
Spinal fracture 98.84 11.50 143 115467 18128 63355284
Tooth disorder 97.39 11.50 180 115430 27977 63345435
Deafness neurosensory 96.36 11.50 76 115534 4779 63368633
Metastases to central nervous system 96.11 11.50 119 115491 12986 63360426
Suicide attempt 93.69 11.50 4 115606 60914 63312498
Intentional product use issue 93.01 11.50 59 115551 127833 63245579
Metastases to lymph nodes 92.47 11.50 93 115517 8065 63365347
Diarrhoea 91.82 11.50 1818 113792 713548 62659864
Bone fistula 90.83 11.50 22 115588 50 63373362
Gingival erythema 90.05 11.50 38 115572 706 63372706
Muscle injury 89.45 11.50 8 115602 65337 63308075
Type 2 diabetes mellitus 86.94 11.50 8 115602 63860 63309552
Periodontitis 86.35 11.50 61 115549 3242 63370170
Wound closure 85.09 11.50 23 115587 93 63373319
Psoriasis 83.66 11.50 27 115583 86930 63286482
Hypophosphataemia 82.58 11.50 103 115507 11323 63362089
Neutrophil count decreased 82.44 11.50 258 115352 56148 63317264
Asthenia 82.02 11.50 1062 114548 382542 62990870
Breast cancer 81.79 11.50 233 115377 48150 63325262
Oral pain 80.56 11.50 167 115443 28227 63345185
Bone debridement 80.15 11.50 26 115584 219 63373193
Injection site pain 80.09 11.50 71 115539 129729 63243683
Irritable bowel syndrome 78.56 11.50 26 115584 82386 63291026
Fanconi syndrome 78.46 11.50 42 115568 1350 63372062
Sleep disorder due to general medical condition, insomnia type 78.45 11.50 4 115606 52213 63321199
Injection site reaction 77.90 11.50 8 115602 58516 63314896
Decreased appetite 77.33 11.50 747 114863 250305 63123107
Osteotomy 76.81 11.50 25 115585 213 63373199
Idiopathic orbital inflammation 76.65 11.50 24 115586 178 63373234
PIK3CA-activated mutation 74.24 11.50 37 115573 1022 63372390
Movement disorder 73.07 11.50 137 115473 21524 63351888
Hepatic lesion 71.89 11.50 64 115546 4761 63368651
Actinomycosis 71.59 11.50 36 115574 1014 63372398
Infusion site coldness 70.97 11.50 23 115587 193 63373219
C-reactive protein abnormal 70.97 11.50 3 115607 46093 63327319
Iritis 70.22 11.50 53 115557 3122 63370290
Off label use 69.73 11.50 840 114770 673622 62699790
Body height decreased 68.32 11.50 88 115522 9990 63363422
Asthma 68.18 11.50 79 115531 127482 63245930
Epigastric discomfort 67.32 11.50 72 115538 6708 63366704
Wheezing 66.93 11.50 46 115564 95549 63277863
Hypersensitivity 66.13 11.50 291 115319 292394 63081018
Intentional product misuse 65.95 11.50 15 115595 60902 63312510
Skin toxicity 65.26 11.50 60 115550 4654 63368758
Anaemia 64.60 11.50 817 114793 292613 63080799
Abortion spontaneous 64.00 11.50 6 115604 47189 63326223
Blood calcium decreased 63.01 11.50 145 115465 26306 63347106
Bone loss 62.56 11.50 49 115561 3050 63370362
Gamma-glutamyltransferase decreased 62.12 11.50 23 115587 297 63373115
Coma 61.88 11.50 20 115590 64344 63309068
Suicidal ideation 60.72 11.50 19 115591 62402 63311010
Breast cancer recurrent 59.61 11.50 55 115555 4286 63369126
Lower respiratory tract infection 59.49 11.50 93 115517 132214 63241198
Renal impairment 58.98 11.50 317 115293 88038 63285374
Wrong technique in product usage process 58.83 11.50 20 115590 62320 63311092
Jaw fracture 58.32 11.50 44 115566 2590 63370822
Loss of personal independence in daily activities 57.89 11.50 55 115555 97235 63276177
Multiple sclerosis relapse 56.52 11.50 10 115600 48468 63324944
Sinusitis 55.74 11.50 218 115392 226435 63146977
Renal tubular necrosis 55.74 11.50 87 115523 11791 63361621
Purulence 55.45 11.50 35 115575 1539 63371873
Metastases to pleura 55.23 11.50 35 115575 1550 63371862
Alveolar bone resorption 55.01 11.50 14 115596 42 63373370
Blood potassium increased 54.68 11.50 110 115500 18199 63355213
Ocular hyperaemia 54.65 11.50 133 115477 25011 63348401
Rheumatic fever 54.60 11.50 7 115603 43104 63330308
Bradycardia 54.30 11.50 33 115577 73194 63300218
Mucosal inflammation 53.89 11.50 198 115412 46730 63326682
Hypotension 53.45 11.50 285 115325 272319 63101093
Bone cyst 52.92 11.50 39 115571 2215 63371197
Weight increased 52.61 11.50 270 115340 260522 63112890
Medication error 52.51 11.50 15 115595 52269 63321143
Hyperpyrexia 51.79 11.50 47 115563 3585 63369827
Rib fracture 51.77 11.50 122 115488 22475 63350937
Ill-defined disorder 51.29 11.50 44 115566 81711 63291701
Bone density decreased 51.26 11.50 94 115516 14518 63358894
Corneal endotheliitis 50.32 11.50 11 115599 12 63373400
Swelling 50.13 11.50 295 115315 275083 63098329
Product dose omission issue 49.31 11.50 239 115371 234074 63139338
Oroantral fistula 48.79 11.50 17 115593 182 63373230
Nasal disorder 48.76 11.50 41 115569 2823 63370589
Hyperbaric oxygen therapy 48.75 11.50 12 115598 30 63373382
Adverse event 47.97 11.50 32 115578 67527 63305885
Eye inflammation 47.90 11.50 55 115555 5544 63367868
Angioedema 47.73 11.50 14 115596 47951 63325461
Hypoglycaemia 47.51 11.50 25 115585 60040 63313372
Anaphylactic reaction 47.35 11.50 31 115579 66069 63307343
Trismus 47.20 11.50 46 115564 3839 63369573
Iris adhesions 47.17 11.50 19 115591 312 63373100
Metastases to pelvis 47.02 11.50 21 115589 450 63372962
Liver injury 46.68 11.50 26 115584 60494 63312918
Tonsillar disorder 46.64 11.50 28 115582 1125 63372287
Bone density abnormal 46.56 11.50 43 115567 3355 63370057
Vein disorder 46.53 11.50 52 115558 5089 63368323
Constipation 46.39 11.50 619 114991 224324 63149088
Mastication disorder 46.23 11.50 35 115575 2071 63371341
Rash 45.88 11.50 732 114878 560139 62813273
Gingival pain 45.78 11.50 65 115545 8097 63365315
Scleritis 45.70 11.50 48 115562 4380 63369032
Feeling cold 45.30 11.50 120 115490 23768 63349644
Injection site erythema 44.99 11.50 51 115559 83123 63290289
Vein rupture 44.70 11.50 28 115582 1215 63372197
Thoracic vertebral fracture 44.25 11.50 48 115562 4544 63368868
Abscess jaw 44.03 11.50 29 115581 1373 63372039
Therapy non-responder 43.89 11.50 44 115566 75857 63297555
Cyst 43.65 11.50 86 115524 14013 63359399
Abdominal lymphadenopathy 43.46 11.50 23 115587 722 63372690
Chondrocalcinosis pyrophosphate 43.11 11.50 27 115583 1171 63372241
Electrocardiogram PR shortened 42.95 11.50 17 115593 266 63373146
Confusional state 42.60 11.50 254 115356 236126 63137286
Carcinoembryonic antigen increased 42.48 11.50 31 115579 1734 63371678
Bone marrow infiltration 42.42 11.50 22 115588 662 63372750
Gait disturbance 42.39 11.50 515 115095 182663 63190749
Knee arthroplasty 42.23 11.50 23 115587 54183 63319229
Tooth fracture 40.92 11.50 73 115537 11037 63362375
Treatment noncompliance 40.79 11.50 9 115601 37316 63336096
Premature delivery 40.66 11.50 4 115606 30277 63343135
Polyneuropathy 40.44 11.50 85 115525 14504 63358908
Glomerular filtration rate decreased 40.43 11.50 81 115529 13360 63360052
Oral disorder 40.37 11.50 64 115546 8790 63364622
Blood phosphorus decreased 40.23 11.50 45 115565 4408 63369004
Metastases to retroperitoneum 40.17 11.50 14 115596 150 63373262
Onycholysis 39.98 11.50 29 115581 1607 63371805
Prescribed overdose 39.91 11.50 7 115603 34146 63339266
Neck pain 39.86 11.50 239 115371 69079 63304333
Jaw fistula 39.48 11.50 11 115599 51 63373361
Aminoaciduria 39.31 11.50 13 115597 117 63373295
Spinal disorder 38.99 11.50 67 115543 9835 63363577
Musculoskeletal pain 38.57 11.50 294 115316 91983 63281429
Poor venous access 38.52 11.50 84 115526 14701 63358711
Lacrimation increased 38.47 11.50 103 115507 20528 63352884
Tumour marker abnormal 37.82 11.50 17 115593 370 63373042
Tooth abscess 37.81 11.50 84 115526 14885 63358527
Metastasis 37.80 11.50 47 115563 5150 63368262
Urticaria 37.30 11.50 165 115445 165637 63207775
Stress fracture 36.91 11.50 58 115552 7905 63365507
Urinary tract inflammation 36.89 11.50 10 115600 41 63373371
Product quality issue 36.56 11.50 10 115600 35855 63337557
Fanconi syndrome acquired 36.41 11.50 23 115587 1013 63372399
Isosthenuria 36.29 11.50 12 115598 108 63373304
Hospitalisation 36.18 11.50 62 115548 85019 63288393
Accidental exposure to product 35.82 11.50 4 115606 27401 63346011
Fracture 35.74 11.50 97 115513 19487 63353925
Drug ineffective for unapproved indication 35.67 11.50 9 115601 34054 63339358
Drug withdrawal syndrome 35.46 11.50 4 115606 27190 63346222
Tibia fracture 35.17 11.50 45 115565 5075 63368337
Rectal prolapse 35.03 11.50 29 115581 1954 63371458
Bladder hypertrophy 34.97 11.50 14 115596 226 63373186
Metastases to bone marrow 34.95 11.50 17 115593 445 63372967
Skin lesion 34.75 11.50 129 115481 30592 63342820
Exostosis of jaw 34.15 11.50 24 115586 1265 63372147
Gingival disorder 34.09 11.50 37 115573 3505 63369907
Therapeutic response decreased 34.07 11.50 37 115573 61488 63311924
Oxygen saturation decreased 33.75 11.50 69 115541 88516 63284896
Breath odour 33.63 11.50 24 115586 1296 63372116
Respiratory arrest 33.47 11.50 9 115601 32636 63340776
Haematochezia 33.36 11.50 29 115581 53515 63319897
Cardio-respiratory arrest 33.26 11.50 36 115574 59923 63313489
Soft tissue infection 33.14 11.50 29 115581 2108 63371304
Chronic inflammatory demyelinating polyradiculoneuropathy 32.71 11.50 17 115593 514 63372898
Osteopetrosis 32.43 11.50 9 115601 41 63373371
Thrombocytopenia 32.40 11.50 419 115191 150738 63222674
Peri-implantitis 32.31 11.50 10 115600 71 63373341
Upper limb fracture 31.71 11.50 91 115519 18877 63354535
Tooth erosion 31.61 11.50 16 115594 457 63372955
Injury 31.49 11.50 53 115557 73194 63300218
Hypercalcaemia 31.26 11.50 118 115492 28204 63345208
Cardiac arrest 31.25 11.50 77 115533 92468 63280944
Concomitant disease aggravated 31.19 11.50 58 115552 9054 63364358
Injection site pruritus 31.18 11.50 22 115588 45094 63328318
Periodontal disease 31.00 11.50 25 115585 1623 63371789
Numb chin syndrome 30.98 11.50 7 115603 10 63373402
Chikungunya virus infection 30.72 11.50 12 115598 181 63373231
Infusion site induration 30.63 11.50 22 115588 1200 63372212
Hydronephrosis 30.58 11.50 63 115547 10599 63362813
Drug level increased 30.53 11.50 3 115607 22733 63350679
Depressed level of consciousness 30.48 11.50 41 115569 62037 63311375
Vasodilatation 30.31 11.50 29 115581 2366 63371046
Wound treatment 30.31 11.50 12 115598 188 63373224
Uveitis 30.10 11.50 69 115541 12484 63360928
Full blood count decreased 30.04 11.50 110 115500 25914 63347498
Metaphyseal corner fracture 29.67 11.50 8 115602 32 63373380
Nasal congestion 29.65 11.50 46 115564 65614 63307798
Nausea 29.63 11.50 1867 113743 852604 62520808
Hypouricaemia 29.57 11.50 11 115599 144 63373268
Hip arthroplasty 29.45 11.50 26 115584 47620 63325792
Gastrointestinal haemorrhage 29.44 11.50 65 115545 81111 63292301
Dengue fever 29.36 11.50 17 115593 638 63372774
Malaise 29.34 11.50 977 114633 414977 62958435
Metastases to kidney 29.25 11.50 12 115598 207 63373205
Pyelitis 29.09 11.50 12 115598 210 63373202
Muscle spasticity 28.94 11.50 3 115607 21791 63351621
Prescribed underdose 28.94 11.50 9 115601 29680 63343732
Vitamin D decreased 28.77 11.50 60 115550 10182 63363230
Lactic acidosis 28.74 11.50 17 115593 38270 63335142
Polymyalgia rheumatica 28.72 11.50 35 115575 3756 63369656
Fatigue 28.39 11.50 1927 113683 886101 62487311
Tooth avulsion 28.39 11.50 8 115602 39 63373373
Dry eye 28.39 11.50 148 115462 40613 63332799
Bone swelling 28.28 11.50 24 115586 1674 63371738
Excessive granulation tissue 28.05 11.50 18 115592 815 63372597
Eastern Cooperative Oncology Group performance status worsened 27.88 11.50 21 115589 1233 63372179
No adverse event 27.57 11.50 21 115589 41384 63332028
Conjunctivitis 27.55 11.50 92 115518 20704 63352708
Metastases to soft tissue 27.46 11.50 11 115599 178 63373234
Hypokinesia 27.43 11.50 71 115539 13865 63359547
Spinal compression fracture 27.33 11.50 72 115538 14211 63359201
Lithiasis 27.29 11.50 8 115602 46 63373366
Bladder prolapse 27.08 11.50 26 115584 2130 63371282
Renal tubular dysfunction 27.00 11.50 14 115596 421 63372991
Drug reaction with eosinophilia and systemic symptoms 26.88 11.50 14 115596 33822 63339590
Nail toxicity 26.87 11.50 13 115597 336 63373076
Metastases to skin 26.66 11.50 23 115587 1640 63371772
Joint swelling 26.59 11.50 428 115182 327238 63046174
BRAF gene mutation 26.46 11.50 8 115602 52 63373360
Muscle spasms 26.33 11.50 415 115195 155735 63217677
Post-traumatic neck syndrome 26.03 11.50 25 115585 2049 63371363
Pneumonitis 26.00 11.50 130 115480 35092 63338320
Oral surgery 25.97 11.50 20 115590 1214 63372198
Humerus fracture 25.95 11.50 53 115557 8863 63364549
Compression fracture 25.87 11.50 44 115566 6404 63367008
Hypophosphataemic osteomalacia 25.84 11.50 11 115599 209 63373203
Apparent death 25.57 11.50 20 115590 1242 63372170
Osteitis condensans 25.57 11.50 7 115603 30 63373382
Dental caries 25.57 11.50 59 115551 10720 63362692
Mouth swelling 25.49 11.50 37 115573 4703 63368709
Device issue 25.45 11.50 6 115604 23775 63349637
Sedation 25.44 11.50 20 115590 38789 63334623
Concomitant disease progression 25.43 11.50 25 115585 2109 63371303
Hyperkalaemia 25.41 11.50 37 115573 54166 63319246
Biopsy bone abnormal 25.39 11.50 7 115603 31 63373381
Bone cancer 25.29 11.50 21 115589 1421 63371991
Gingival abscess 25.22 11.50 17 115593 837 63372575
Encephalopathy 25.19 11.50 20 115590 38600 63334812
Abdominal pain 24.92 11.50 380 115230 293076 63080336
Tenderness 24.86 11.50 94 115516 22484 63350928
Rhabdomyolysis 24.81 11.50 26 115584 43925 63329487
Obstructive airways disorder 24.72 11.50 4 115606 20695 63352717
Drug dependence 24.63 11.50 7 115603 24476 63348936
Dysarthria 24.41 11.50 25 115585 42686 63330726
Incorrect dose administered 24.32 11.50 45 115565 59923 63313489
Periodontal destruction 24.21 11.50 5 115605 3 63373409
Biliary dilatation 24.14 11.50 25 115585 2244 63371168
Feeling abnormal 24.12 11.50 392 115218 148000 63225412
Platelet count decreased 24.09 11.50 320 115290 115802 63257610
Fibromyalgia 24.07 11.50 71 115539 80349 63293063
Pulpitis dental 23.94 11.50 17 115593 911 63372501
Lumbar vertebral fracture 23.78 11.50 40 115570 5770 63367642
Pneumonia aspiration 23.66 11.50 17 115593 34523 63338889
Fistula discharge 23.63 11.50 18 115592 1075 63372337
Therapy interrupted 23.54 11.50 15 115595 32440 63340972
Nail discolouration 23.50 11.50 27 115583 2723 63370689
Oral mucosal erythema 23.45 11.50 21 115589 1574 63371838
Hip fracture 23.35 11.50 111 115499 29363 63344049
Depression 23.24 11.50 237 115373 196255 63177157
Conjunctival oedema 23.22 11.50 15 115595 687 63372725
Dysstasia 23.20 11.50 88 115522 21078 63352334
Seizure 23.09 11.50 144 115466 132490 63240922
Onychoclasis 23.07 11.50 41 115569 6181 63367231
Device dislocation 22.97 11.50 9 115601 25696 63347716
Face and mouth X-ray abnormal 22.88 11.50 6 115604 21 63373391
Pruritus 22.84 11.50 493 115117 360960 63012452
Accidental overdose 22.83 11.50 7 115603 23302 63350110
Oral pustule 22.71 11.50 7 115603 49 63373363
Foot fracture 22.66 11.50 95 115515 23819 63349593
Ulna fracture 22.44 11.50 18 115592 1160 63372252
Agitation 22.38 11.50 47 115563 59710 63313702
Exophthalmos 22.37 11.50 20 115590 1496 63371916
Nasopharyngitis 22.36 11.50 327 115283 253930 63119482
Emotional distress 22.33 11.50 16 115594 32533 63340879
Procollagen type I C-terminal propeptide increased 22.25 11.50 6 115604 24 63373388
Heavy menstrual bleeding 22.23 11.50 3 115607 17770 63355642
Invasive ductal breast carcinoma 22.22 11.50 43 115567 6915 63366497
Injection site inflammation 22.14 11.50 31 115579 3812 63369600
Fracture nonunion 22.13 11.50 24 115586 2271 63371141
Orbital swelling 22.12 11.50 7 115603 54 63373358
Metastases to adrenals 22.04 11.50 15 115595 750 63372662
Eosinophilia 22.00 11.50 7 115603 22749 63350663
Creatinine renal clearance increased 21.99 11.50 14 115596 625 63372787
Cancer pain 21.75 11.50 28 115582 3177 63370235
Otitis externa 21.53 11.50 21 115589 1754 63371658
Obesity 21.51 11.50 14 115596 29938 63343474
Serum procollagen type I N-terminal propeptide increased 21.51 11.50 6 115604 28 63373384
Blood cholesterol increased 21.49 11.50 93 115517 93939 63279473
Dry skin 21.44 11.50 177 115433 56710 63316702
Aggression 21.38 11.50 8 115602 23490 63349922
Feeding disorder 21.27 11.50 63 115547 13299 63360113
Medical device site joint inflammation 21.24 11.50 4 115606 0 63373412
Neuroendocrine breast tumour 21.17 11.50 6 115604 30 63373382
Periorbital inflammation 21.07 11.50 7 115603 64 63373348
Pulmonary hypertension 20.91 11.50 22 115588 37101 63336311
Blood calcium increased 20.90 11.50 50 115560 9300 63364112
Acute hepatic failure 20.89 11.50 4 115606 18323 63355089
Alopecia 20.85 11.50 462 115148 337074 63036338
Hypoxia 20.77 11.50 49 115561 59743 63313669
Delirium 20.43 11.50 38 115572 50503 63322909
Sleep apnoea syndrome 20.41 11.50 14 115596 29119 63344293
Bone lesion excision 20.39 11.50 6 115604 35 63373377
Pleural neoplasm 20.37 11.50 11 115599 360 63373052
Inappropriate schedule of product administration 20.17 11.50 109 115501 103856 63269556
Plasma cell myeloma recurrent 20.14 11.50 27 115583 3186 63370226
Somnolence 20.12 11.50 218 115392 178467 63194945
Skin sensitisation 20.02 11.50 15 115595 874 63372538
Abnormal behaviour 19.99 11.50 7 115603 21419 63351993
Deafness 19.97 11.50 75 115535 17882 63355530
Facial pain 19.97 11.50 53 115557 10508 63362904
Product use in unapproved indication 19.96 11.50 219 115391 178861 63194551
Allergy to plants 19.85 11.50 14 115596 742 63372670
Spinal stenosis 19.74 11.50 66 115544 14859 63358553
Avulsion fracture 19.71 11.50 10 115600 287 63373125
Hyphaema 19.65 11.50 10 115600 289 63373123
Hypophosphatasia 19.65 11.50 5 115605 15 63373397
Red blood cell count decreased 19.57 11.50 134 115476 40511 63332901
Gait inability 19.54 11.50 164 115446 52795 63320617
Oral dysaesthesia 19.37 11.50 7 115603 84 63373328
Renal glycosuria 19.17 11.50 5 115605 17 63373395
Hyperparathyroidism secondary 19.01 11.50 18 115592 1449 63371963
Radius fracture 19.00 11.50 28 115582 3607 63369805
Ear infection 19.00 11.50 25 115585 38188 63335224
Cellulitis orbital 18.98 11.50 12 115598 529 63372883
Laboratory test abnormal 18.93 11.50 98 115512 26814 63346598
Caesarean section 18.83 11.50 4 115606 17028 63356384
Monoclonal gammopathy 18.82 11.50 13 115597 666 63372746
Acetabulum fracture 18.81 11.50 10 115600 317 63373095
Cytopenia 18.76 11.50 55 115555 11546 63361866
Hyponatraemia 18.70 11.50 123 115487 111777 63261635
Hormone receptor positive HER2 negative breast cancer 18.70 11.50 8 115602 154 63373258
Orthostatic hypotension 18.66 11.50 23 115587 36137 63337275
Serotonin syndrome 18.52 11.50 15 115595 28667 63344745
Parathyroid hormone-related protein increased 18.48 11.50 4 115606 4 63373408
Dental operation 18.45 11.50 17 115593 1322 63372090
Adnexa uteri mass 18.35 11.50 12 115598 561 63372851
Wound infection 18.32 11.50 8 115602 21402 63352010
Hand fracture 18.31 11.50 35 115575 5578 63367834
Blood parathyroid hormone increased 18.24 11.50 25 115585 3013 63370399
Migraine 18.09 11.50 112 115498 103234 63270178
Product prescribing error 17.93 11.50 13 115597 26276 63347136
Carcinoid tumour pulmonary 17.77 11.50 11 115599 467 63372945
Exostosis 17.75 11.50 72 115538 17790 63355622
Thermal burn 17.66 11.50 36 115574 6010 63367402
Pelvic fracture 17.63 11.50 59 115551 13289 63360123
Tooth infection 17.62 11.50 72 115538 17848 63355564
Fall 17.56 11.50 878 114732 391456 62981956
Breast pain 17.50 11.50 45 115565 8753 63364659
Selenium deficiency 17.48 11.50 5 115605 26 63373386
Eye swelling 17.46 11.50 88 115522 23830 63349582
Vertebral column mass 17.35 11.50 8 115602 185 63373227
Cardiac failure congestive 17.33 11.50 98 115512 92335 63281077
Hypertension 17.32 11.50 382 115228 278921 63094491
Paronychia 17.29 11.50 34 115576 5531 63367881
Leukopenia 17.29 11.50 216 115394 77074 63296338
Metastases to peritoneum 17.26 11.50 26 115584 3416 63369996
Right ventricular failure 17.13 11.50 5 115605 17183 63356229
Pachymeningitis 17.10 11.50 7 115603 120 63373292
Groin pain 17.10 11.50 49 115561 10154 63363258
Osteonecrosis of external auditory canal 17.10 11.50 7 115603 120 63373292
Osteoarthritis 17.06 11.50 256 115354 95087 63278325
Trichorrhexis 17.06 11.50 16 115594 1273 63372139
Wrist fracture 17.02 11.50 59 115551 13528 63359884
Lymphadenopathy 16.89 11.50 124 115486 38334 63335078
Tumour marker decreased 16.83 11.50 6 115604 69 63373343
Mucosal hypertrophy 16.74 11.50 5 115605 31 63373381
Musculoskeletal discomfort 16.73 11.50 71 115539 17896 63355516
Hallucination 16.69 11.50 48 115562 54769 63318643
Plasmacytoma 16.67 11.50 22 115588 2557 63370855
Disorder of orbit 16.60 11.50 5 115605 32 63373380
Cranial nerve paralysis 16.59 11.50 7 115603 130 63373282
Metastases to meninges 16.52 11.50 22 115588 2580 63370832
Vomiting 16.34 11.50 1206 114404 558411 62815001
Peripheral coldness 16.27 11.50 54 115556 12111 63361301
Cranial nerve disorder 16.27 11.50 11 115599 544 63372868
Frequent bowel movements 16.21 11.50 11 115599 23011 63350401
Injection site urticaria 16.19 11.50 3 115607 14070 63359342
Eczema 16.18 11.50 21 115589 32270 63341142
Neutrophil count abnormal 16.17 11.50 23 115587 2869 63370543
Mobility decreased 16.08 11.50 142 115468 121017 63252395
Tetany 16.02 11.50 19 115591 1982 63371430
Taste disorder 15.98 11.50 58 115552 13604 63359808
Venous perforation 15.93 11.50 3 115607 0 63373412
Drug tolerance decreased 15.81 11.50 6 115604 17467 63355945
Pleural effusion 15.80 11.50 248 115362 92962 63280450
Dystonia 15.79 11.50 3 115607 13816 63359596
Rebound effect 15.73 11.50 29 115581 4497 63368915
Injection site swelling 15.73 11.50 40 115570 47532 63325880
Abdominal pain upper 15.63 11.50 273 115337 206171 63167241
Pulmonary arterial hypertension 15.61 11.50 11 115599 22566 63350846
Lower limb fracture 15.54 11.50 86 115524 24135 63349277
Bone marrow oedema 15.54 11.50 15 115595 1237 63372175
Heart rate increased 15.54 11.50 104 115506 94134 63279278
Disability 15.47 11.50 7 115603 18340 63355072
Grip strength decreased 15.23 11.50 11 115599 22276 63351136
Nightmare 15.16 11.50 8 115602 19186 63354226
Joint warmth 15.13 11.50 16 115594 1471 63371941
Myoclonus 15.13 11.50 5 115605 15863 63357549
Calcium deficiency 15.07 11.50 14 115596 1100 63372312
Blood creatinine decreased 15.01 11.50 32 115578 5513 63367899
Mediastinal disorder 14.98 11.50 9 115601 362 63373050
Spinal cord compression 14.95 11.50 27 115583 4121 63369291
Cardiogenic shock 14.88 11.50 7 115603 17925 63355487
HER2 positive breast cancer 14.87 11.50 9 115601 367 63373045
Glucose urine 14.83 11.50 4 115606 16 63373396
Callus formation delayed 14.83 11.50 4 115606 16 63373396
Lymphatic disorder 14.76 11.50 9 115601 372 63373040
Light chain analysis increased 14.75 11.50 15 115595 1318 63372094
Blood urea increased 14.55 11.50 90 115520 26289 63347123
Recurrent cancer 14.50 11.50 18 115592 1969 63371443
Weight decreased 14.42 11.50 629 114981 276169 63097243
Adjusted calcium decreased 14.40 11.50 7 115603 183 63373229
Lupus-like syndrome 14.27 11.50 5 115605 15290 63358122
Activated PI3 kinase delta syndrome 14.11 11.50 4 115606 20 63373392
Decreased immune responsiveness 14.10 11.50 29 115581 4872 63368540
Unresponsive to stimuli 14.05 11.50 25 115585 33791 63339621
Lymphoedema 13.98 11.50 50 115560 11642 63361770
Oesophagogastroduodenoscopy abnormal 13.86 11.50 3 115607 3 63373409
Carbohydrate antigen 27.29 increased 13.84 11.50 5 115605 60 63373352
Lymphadenopathy mediastinal 13.78 11.50 21 115589 2787 63370625
Anal erythema 13.67 11.50 7 115603 205 63373207
Fluid retention 13.65 11.50 59 115551 59627 63313785
Naevus haemorrhage 13.59 11.50 6 115604 125 63373287
Ovarian disorder 13.58 11.50 11 115599 719 63372693
Dysaesthesia 13.48 11.50 27 115583 4451 63368961
Pancreatitis 13.48 11.50 45 115565 49010 63324402
Cytomegalovirus infection 13.48 11.50 11 115599 20941 63352471
Extraocular muscle disorder 13.46 11.50 6 115604 128 63373284
Osteomalacia 13.38 11.50 11 115599 734 63372678
Hypoaesthesia oral 13.32 11.50 53 115557 12980 63360432
Poor personal hygiene 13.27 11.50 8 115602 324 63373088
Pseudarthrosis 13.23 11.50 9 115601 450 63372962
Acute respiratory distress syndrome 13.20 11.50 14 115596 23520 63349892
Therapy cessation 13.12 11.50 22 115588 30435 63342977
Multiple sclerosis 13.11 11.50 15 115595 24357 63349055
Deep vein thrombosis 13.10 11.50 220 115390 83580 63289832
Palpable purpura 13.01 11.50 5 115605 72 63373340
Dyskinesia 12.99 11.50 24 115586 31978 63341434
Restlessness 12.95 11.50 21 115589 29432 63343980
Product administration error 12.92 11.50 13 115597 22384 63351028
Mydriasis 12.83 11.50 3 115607 11953 63361459
Flushing 12.82 11.50 82 115528 75005 63298407
Dental discomfort 12.78 11.50 9 115601 476 63372936
Ulcerative gastritis 12.74 11.50 4 115606 30 63373382
Dental necrosis 12.74 11.50 6 115604 146 63373266
Hypervolaemia 12.73 11.50 20 115590 28393 63345019
Metastases to the mediastinum 12.73 11.50 9 115601 479 63372933
Hepatic mass 12.65 11.50 16 115594 1784 63371628
Dental restoration failure 12.58 11.50 12 115598 975 63372437
Parathyroid tumour malignant 12.51 11.50 4 115606 32 63373380
Dyspnoea 12.46 11.50 1036 114574 660277 62713135
Drug-induced liver injury 12.40 11.50 35 115575 40187 63333225
Cholesteatoma 12.30 11.50 6 115604 158 63373254
Nuchal rigidity 12.27 11.50 10 115600 659 63372753
Cognitive disorder 12.27 11.50 56 115554 55759 63317653
Urine output decreased 12.24 11.50 47 115563 11323 63362089
Fungal infection 12.19 11.50 31 115579 36843 63336569
Toxic epidermal necrolysis 12.17 11.50 17 115593 25317 63348095
Drug eruption 12.11 11.50 21 115589 28673 63344739
Tumour pain 12.10 11.50 14 115596 1423 63371989
Dermal sinus 12.10 11.50 4 115606 36 63373376
Altered state of consciousness 12.05 11.50 17 115593 25213 63348199
Teeth brittle 11.99 11.50 9 115601 526 63372886
Skeletal injury 11.93 11.50 13 115597 1237 63372175
Vulvovaginal dryness 11.91 11.50 20 115590 2881 63370531
Eating disorder 11.86 11.50 67 115543 18949 63354463
Multiple organ dysfunction syndrome 11.85 11.50 58 115552 56694 63316718
Tachycardia 11.80 11.50 148 115462 118008 63255404
Maxillofacial operation 11.79 11.50 3 115607 9 63373403
Bone formation increased 11.71 11.50 6 115604 176 63373236
Acute kidney injury 11.66 11.50 589 115021 262826 63110586
Gastroenteritis 11.65 11.50 19 115591 26571 63346841
Psychotic disorder 11.62 11.50 18 115592 25694 63347718
Bone callus excessive 11.55 11.50 4 115606 42 63373370
Atrophy 11.55 11.50 15 115595 1717 63371695
Haemangioma 11.54 11.50 19 115591 2693 63370719
Dysgeusia 11.52 11.50 133 115477 46577 63326835
Elbow deformity 11.50 11.50 14 115596 1501 63371911

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 6773.45 13.34 1953 43291 15936 34895751
Exposed bone in jaw 1173.51 13.34 295 44949 1291 34910396
Osteonecrosis 806.74 13.34 391 44853 14499 34897188
Bone disorder 425.55 13.34 192 45052 6023 34905664
Pain in jaw 357.08 13.34 218 45026 12822 34898865
Oral cavity fistula 274.72 13.34 59 45185 101 34911586
Bone sequestrum 266.28 13.34 74 45170 508 34911179
Plasma cell myeloma 251.98 13.34 291 44953 41746 34869941
Osteomyelitis 233.20 13.34 182 45062 15954 34895733
Hypocalcaemia 216.81 13.34 208 45036 24081 34887606
Prostatic specific antigen increased 206.57 13.34 163 45081 14517 34897170
Malignant neoplasm progression 205.87 13.34 391 44853 87655 34824032
Metastases to bone 188.27 13.34 142 45102 11828 34899859
Bone pain 184.33 13.34 177 45067 20509 34891178
Neuropathy peripheral 175.46 13.34 354 44890 82909 34828778
Fatigue 164.28 13.34 925 44319 369728 34541959
Tooth extraction 158.15 13.34 90 45154 4638 34907049
Sequestrectomy 150.62 13.34 39 45205 196 34911491
Oroantral fistula 150.02 13.34 38 45206 172 34911515
Purulent discharge 142.41 13.34 71 45173 2792 34908895
Drug interaction 138.00 13.34 60 45184 225886 34685801
Gingivitis 127.56 13.34 71 45173 3504 34908183
Jaw fracture 124.12 13.34 48 45196 1010 34910677
Hypophosphataemia 122.93 13.34 107 45137 10919 34900768
Drug ineffective 110.72 13.34 270 44974 456481 34455206
Completed suicide 109.39 13.34 4 45240 98164 34813523
Toxicity to various agents 109.04 13.34 62 45182 200300 34711387
Pathological fracture 106.50 13.34 68 45176 4323 34907364
Jaw fistula 106.30 13.34 22 45222 28 34911659
Fistula 105.01 13.34 80 45164 6760 34904927
Tooth disorder 104.34 13.34 97 45147 10785 34900902
Acute phase reaction 102.21 13.34 24 45220 73 34911614
Impaired healing 98.31 13.34 110 45134 15224 34896463
Gingival swelling 96.09 13.34 42 45202 1218 34910469
Osteotomy 96.00 13.34 22 45222 58 34911629
Atypical femur fracture 93.41 13.34 29 45215 305 34911382
Periodontitis 92.95 13.34 47 45197 1905 34909782
Bone fistula 91.96 13.34 18 45226 13 34911674
Pain 90.97 13.34 512 44732 204163 34707524
Bone lesion 87.43 13.34 52 45192 2911 34908776
Wound closure 86.40 13.34 20 45224 56 34911631
Myoglobinuria 82.77 13.34 33 45211 755 34910932
Purulence 78.95 13.34 33 45211 855 34910832
Toothache 75.28 13.34 64 45180 6324 34905363
Back pain 74.77 13.34 334 44910 121455 34790232
Dental fistula 74.30 13.34 19 45225 90 34911597
Decreased appetite 72.37 13.34 414 44830 165978 34745709
Periodontal disease 71.61 13.34 30 45214 782 34910905
Prostate cancer 71.13 13.34 158 45086 39491 34872196
Bone debridement 70.97 13.34 21 45223 185 34911502
Abscess jaw 70.12 13.34 29 45215 731 34910956
Metastases to lymph nodes 69.73 13.34 54 45190 4674 34907013
Metastases to lung 68.73 13.34 72 45172 9248 34902439
Actinomycosis 67.95 13.34 25 45219 456 34911231
Overdose 66.14 13.34 18 45226 91041 34820646
Parophthalmia 65.61 13.34 15 45229 39 34911648
Plasma cell myeloma recurrent 59.41 13.34 48 45196 4417 34907270
Gingival erythema 58.58 13.34 16 45228 102 34911585
Osteitis 57.62 13.34 32 45212 1572 34910115
Neutropenia 57.32 13.34 373 44871 156405 34755282
Tooth loss 56.76 13.34 44 45200 3814 34907873
Osteopetrosis 56.51 13.34 10 45234 0 34911687
Jaw disorder 56.04 13.34 35 45209 2140 34909547
Debridement 55.83 13.34 26 45218 877 34910810
Constipation 55.74 13.34 335 44909 136647 34775040
Condition aggravated 53.42 13.34 105 45139 192091 34719596
Osteolysis 50.94 13.34 38 45206 3110 34908577
Bone fissure 50.79 13.34 11 45233 20 34911667
Influenza like illness 50.54 13.34 111 45133 27523 34884164
Prostate cancer metastatic 48.56 13.34 48 45196 5755 34905932
Body height decreased 48.37 13.34 40 45204 3803 34907884
Thrombosis 47.88 13.34 159 45085 50299 34861388
Osteonecrosis of external auditory canal 46.24 13.34 11 45233 36 34911651
Jaw operation 45.72 13.34 15 45229 191 34911496
Intentional product misuse 44.30 13.34 4 45240 45607 34866080
Hypercalcaemia 44.11 13.34 75 45169 15393 34896294
Loose tooth 43.82 13.34 24 45220 1147 34910540
Pyrexia 43.72 13.34 638 44606 332375 34579312
Gingival pain 43.15 13.34 34 45210 3018 34908669
Fanconi syndrome 42.61 13.34 27 45217 1693 34909994
Colon cancer stage III 42.20 13.34 14 45230 185 34911502
Swelling 41.54 13.34 135 45109 42231 34869456
Femur fracture 40.06 13.34 51 45193 8073 34903614
Hospitalisation 39.92 13.34 12 45232 56890 34854797
Pneumonia 39.73 13.34 674 44570 361953 34549734
Squamous cell carcinoma of skin 39.63 13.34 59 45185 10822 34900865
Laboratory test abnormal 38.53 13.34 83 45161 20308 34891379
White blood cell count decreased 38.51 13.34 233 45011 95212 34816475
Deep vein thrombosis 37.79 13.34 176 45068 65072 34846615
Spinal compression fracture 37.21 13.34 46 45198 7070 34904617
Full blood count decreased 36.93 13.34 76 45168 18012 34893675
Metastases to liver 36.03 13.34 64 45180 13599 34898088
Oral pain 35.61 13.34 56 45188 10771 34900916
Suicidal ideation 35.56 13.34 5 45239 40383 34871304
Thoracic vertebral fracture 35.17 13.34 24 45220 1706 34909981
Thrombocytopenia 35.00 13.34 332 44912 155915 34755772
Rib fracture 34.86 13.34 65 45179 14335 34897352
Drug hypersensitivity 34.50 13.34 32 45212 80497 34831190
Systemic inflammatory response syndrome 34.49 13.34 43 45201 6666 34905021
Neoplasm progression 34.31 13.34 86 45158 23214 34888473
Metastasis 34.16 13.34 34 45210 4110 34907577
Hyperbaric oxygen therapy 33.91 13.34 8 45236 25 34911662
Respiratory tract infection viral 33.36 13.34 27 45217 2490 34909197
Osteosclerosis 33.34 13.34 21 45223 1303 34910384
Hypotension 33.05 13.34 161 45083 221488 34690199
Spinal fracture 32.23 13.34 44 45200 7454 34904233
Respiratory tract infection bacterial 32.21 13.34 23 45221 1759 34909928
Myocardial infarction 32.03 13.34 68 45176 121017 34790670
Idiopathic orbital inflammation 31.80 13.34 8 45236 35 34911652
Asthenia 31.37 13.34 468 44776 244783 34666904
Oral infection 31.17 13.34 24 45220 2059 34909628
Atypical fracture 31.09 13.34 10 45234 119 34911568
Bone loss 30.77 13.34 15 45229 561 34911126
Metastases to spine 30.67 13.34 26 45218 2558 34909129
Monoclonal immunoglobulin present 30.25 13.34 18 45226 1008 34910679
Seizure 30.21 13.34 56 45188 104801 34806886
Depressed level of consciousness 30.11 13.34 9 45235 42832 34868855
Injection site pain 29.67 13.34 7 45237 38998 34872689
Coma 29.65 13.34 11 45233 45667 34866020
Aggression 29.63 13.34 7 45237 38957 34872730
Diarrhoea 29.63 13.34 686 44558 389226 34522461
Psoriasis 29.46 13.34 7 45237 38805 34872882
Tooth abscess 29.27 13.34 37 45207 5816 34905871
Tooth deposit 29.13 13.34 9 45235 93 34911594
Dental operation 28.96 13.34 13 45231 402 34911285
Blood calcium decreased 28.89 13.34 49 45195 10035 34901652
Wound treatment 28.74 13.34 7 45237 26 34911661
Hypoglycaemia 28.12 13.34 18 45226 54622 34857065
Bradycardia 27.80 13.34 34 45210 75384 34836303
Bone swelling 27.74 13.34 11 45233 248 34911439
Pulmonary embolism 27.70 13.34 205 45039 89541 34822146
Oral surgery 27.51 13.34 14 45230 575 34911112
Hormone-refractory prostate cancer 27.23 13.34 15 45229 725 34910962
Mouth swelling 26.94 13.34 21 45223 1835 34909852
Bone abscess 26.90 13.34 10 45234 188 34911499
International normalised ratio increased 26.62 13.34 14 45230 47313 34864374
Gastrointestinal haemorrhage 26.61 13.34 46 45198 88431 34823256
Spinal cord compression 26.30 13.34 29 45215 3946 34907741
Spinal pain 25.98 13.34 35 45209 5854 34905833
Agitation 25.55 13.34 22 45222 57377 34854310
Soft tissue infection 25.49 13.34 22 45222 2218 34909469
Death 25.08 13.34 683 44561 397366 34514321
Exophthalmos 24.76 13.34 13 45231 570 34911117
Lumbar vertebral fracture 24.75 13.34 22 45222 2307 34909380
Pityriasis rubra pilaris 24.30 13.34 8 45236 103 34911584
Peripheral swelling 24.28 13.34 176 45068 76365 34835322
Hypouricaemia 24.18 13.34 10 45234 252 34911435
Periorbital inflammation 23.93 13.34 7 45237 59 34911628
Stress fracture 23.85 13.34 15 45229 928 34910759
Encephalopathy 23.79 13.34 8 45236 35311 34876376
Metastases to central nervous system 23.68 13.34 40 45204 8165 34903522
Protein total decreased 23.42 13.34 31 45213 5099 34906588
Hyperuricosuria 23.12 13.34 5 45239 9 34911678
SARS-CoV-2 sepsis 22.94 13.34 8 45236 124 34911563
Face and mouth X-ray abnormal 22.61 13.34 4 45240 0 34911687
Hyperphosphaturia 22.60 13.34 7 45237 73 34911614
Cancer pain 22.17 13.34 22 45222 2650 34909037
Excessive granulation tissue 21.95 13.34 11 45233 437 34911250
Osteomalacia 21.74 13.34 14 45230 903 34910784
Myalgia 21.50 13.34 184 45060 83926 34827761
Platelet count decreased 21.38 13.34 243 45001 119474 34792213
Plasma cell leukaemia 21.37 13.34 14 45230 930 34910757
Mastication disorder 21.36 13.34 16 45228 1317 34910370
Haemophilus bacteraemia 21.34 13.34 5 45239 15 34911672
Incorrect dose administered 21.32 13.34 13 45231 40502 34871185
Plasmacytoma 21.16 13.34 25 45219 3666 34908021
Off label use 20.97 13.34 400 44844 419124 34492563
Tooth infection 20.87 13.34 34 45210 6737 34904950
Light chain analysis increased 20.66 13.34 16 45228 1385 34910302
Chronic papillomatous dermatitis 20.47 13.34 6 45238 51 34911636
Respiratory tract infection 20.39 13.34 64 45180 19648 34892039
Dermal sinus 20.37 13.34 4 45240 3 34911684
Gingival abscess 20.31 13.34 8 45236 177 34911510
Blood calcium increased 20.04 13.34 24 45220 3570 34908117
Compression fracture 19.73 13.34 22 45222 3030 34908657
Microangiopathic haemolytic anaemia 19.37 13.34 13 45231 899 34910788
Muscle spasms 19.13 13.34 164 45080 74837 34836850
Melaena 19.12 13.34 11 45233 35369 34876318
Blood creatine phosphokinase increased 19.00 13.34 18 45226 44839 34866848
Hepatocellular injury 18.98 13.34 3 45241 22208 34889479
Vasodilatation 18.85 13.34 14 45230 1138 34910549
Anaemia 18.73 13.34 414 44830 232921 34678766
Cerebral haemorrhage 18.68 13.34 11 45233 34926 34876761
Oral disorder 18.36 13.34 25 45219 4224 34907463
Angioedema 18.30 13.34 13 45231 37361 34874326
Eye pain 18.08 13.34 48 45196 13414 34898273
Oxygen saturation decreased 18.05 13.34 26 45218 53792 34857895
Cardiogenic shock 17.97 13.34 6 45238 26612 34885075
Abdominal pain 17.92 13.34 131 45113 163487 34748200
Abscess oral 17.72 13.34 9 45235 368 34911319
Adverse drug reaction 17.60 13.34 80 45164 29262 34882425
Albumin urine present 17.57 13.34 9 45235 375 34911312
Therapeutic product effect incomplete 17.37 13.34 24 45220 50517 34861170
Unresponsive to stimuli 17.29 13.34 7 45237 27562 34884125
Exostosis of jaw 17.21 13.34 6 45238 93 34911594
Wrong technique in product usage process 17.00 13.34 13 45231 35973 34875714
Cavernous sinus syndrome 16.95 13.34 3 45241 0 34911687
Mesenteric phlebosclerosis 16.95 13.34 3 45241 0 34911687
Peripheral sensorimotor neuropathy 16.92 13.34 15 45229 1567 34910120
Cataract 16.92 13.34 73 45171 26113 34885574
Leukopenia 16.85 13.34 139 45105 62717 34848970
Cerebrovascular accident 16.80 13.34 55 45189 84756 34826931
Respiratory distress 16.70 13.34 13 45231 35652 34876035
Cardiac arrest 16.63 13.34 66 45178 96093 34815594
Accidental overdose 16.59 13.34 3 45241 20137 34891550
Tenderness 16.41 13.34 31 45213 6903 34904784
Treatment noncompliance 16.26 13.34 8 45236 28092 34883595
Abnormal behaviour 16.22 13.34 6 45238 24963 34886724
Metastases to pelvis 16.17 13.34 8 45236 309 34911378
Trismus 16.16 13.34 18 45226 2477 34909210
Eye inflammation 16.11 13.34 17 45227 2201 34909486
Epilepsy 16.07 13.34 4 45240 21491 34890196
Oral mucosal erythema 16.00 13.34 9 45235 453 34911234
Hypercalcaemia of malignancy 15.92 13.34 7 45237 206 34911481
Laryngeal leukoplakia 15.90 13.34 5 45239 55 34911632
Fanconi syndrome acquired 15.80 13.34 16 45228 1975 34909712
Jaundice 15.73 13.34 11 45233 31871 34879816
Cellulitis orbital 15.69 13.34 8 45236 330 34911357
Coronary artery disease 15.56 13.34 24 45220 48281 34863406
Anxiety 15.50 13.34 71 45173 99357 34812330
Blood parathyroid hormone increased 15.49 13.34 14 45230 1500 34910187
Cardio-respiratory arrest 15.49 13.34 30 45214 55243 34856444
Hypoaesthesia 15.47 13.34 134 45110 61310 34850377
Treatment failure 15.23 13.34 23 45221 46674 34865013
Restlessness 15.14 13.34 7 45237 25475 34886212
Wound dehiscence 15.10 13.34 20 45224 3291 34908396
Maxillofacial operation 14.88 13.34 3 45241 3 34911684
Pancreatitis acute 14.85 13.34 9 45235 28132 34883555
Aspartate aminotransferase increased 14.82 13.34 42 45202 67741 34843946
Ventricular tachycardia 14.74 13.34 8 45236 26571 34885116
Dysarthria 14.68 13.34 14 45230 34768 34876919
Portal venous gas 14.63 13.34 8 45236 381 34911306
Pulmonary fibrosis 14.60 13.34 3 45241 18393 34893294
Pelvic pain 14.55 13.34 17 45227 2463 34909224
Hypoproteinaemia 14.44 13.34 16 45228 2188 34909499
Bone density decreased 14.40 13.34 15 45229 1914 34909773
Respiratory failure 14.39 13.34 82 45162 108490 34803197
Alanine aminotransferase increased 14.27 13.34 55 45189 80760 34830927
Mental status changes 14.21 13.34 17 45227 38066 34873621
Chest wall mass 14.08 13.34 5 45239 82 34911605
Bone lesion excision 14.02 13.34 3 45241 5 34911682
Pruritus 13.99 13.34 117 45127 141864 34769823
Vertebral column mass 13.91 13.34 5 45239 85 34911602
Swelling face 13.86 13.34 63 45181 23042 34888645
Transitional cell cancer of the renal pelvis and ureter 13.86 13.34 4 45240 32 34911655
Dental care 13.79 13.34 7 45237 286 34911401
Hyperkalaemia 13.74 13.34 45 45199 69344 34842343
Sedation 13.73 13.34 5 45239 21001 34890686
Biopsy bone abnormal 13.67 13.34 3 45241 6 34911681
Pallor 13.65 13.34 8 45236 25472 34886215
Pulmonary hypertension 13.64 13.34 5 45239 20919 34890768
Gingival recession 13.63 13.34 8 45236 437 34911250
Hallucination 13.54 13.34 29 45215 51469 34860218
Electrocardiogram QT prolonged 13.52 13.34 20 45224 40932 34870755
Bronchial fistula 13.44 13.34 6 45238 183 34911504
Dental discomfort 13.40 13.34 5 45239 95 34911592
Drug ineffective for unapproved indication 13.35 13.34 7 45237 23708 34887979

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 13602.55 11.32 4239 115851 38987 79585311
Exposed bone in jaw 2456.85 11.32 652 119438 3068 79621230
Osteonecrosis 1678.02 11.32 855 119235 30240 79594058
Metastases to bone 808.63 11.32 487 119603 23940 79600358
Bone pain 729.04 11.32 632 119458 55110 79569188
Pain in jaw 629.35 11.32 536 119554 45615 79578683
Bone sequestrum 600.40 11.32 170 119920 1059 79623239
Malignant neoplasm progression 584.96 11.32 863 119227 135127 79489171
Bone disorder 578.72 11.32 360 119730 18753 79605545
Atypical femur fracture 525.63 11.32 221 119869 4968 79619330
Hypocalcaemia 439.96 11.32 455 119635 49469 79574829
Neutropenia 427.81 11.32 1170 118920 286540 79337758
Neuropathy peripheral 421.51 11.32 760 119330 140545 79483753
Plasma cell myeloma 384.60 11.32 437 119653 52822 79571476
Tooth extraction 373.61 11.32 223 119867 10772 79613526
Sequestrectomy 370.84 11.32 108 119982 754 79623544
Bone lesion 364.00 11.32 178 119912 5741 79618557
Oral cavity fistula 355.35 11.32 100 119990 607 79623691
Osteomyelitis 349.73 11.32 332 119758 32533 79591765
Femur fracture 349.08 11.32 357 119733 38295 79586003
Completed suicide 344.14 11.32 5 120085 245762 79378536
Drug ineffective 328.07 11.32 715 119375 1080198 78544100
Purulent discharge 319.52 11.32 164 119926 5875 79618423
Influenza like illness 309.36 11.32 456 119634 71251 79553047
Metastases to liver 291.73 11.32 281 119809 28033 79596265
Metastases to lung 291.53 11.32 232 119858 17931 79606367
Toxicity to various agents 275.23 11.32 146 119944 421394 79202904
Drug interaction 256.39 11.32 154 119936 415029 79209269
Fistula 250.97 11.32 185 119905 12755 79611543
Gingivitis 248.27 11.32 160 119930 8861 79615437
Myalgia 237.72 11.32 716 119374 184925 79439373
Acute phase reaction 234.43 11.32 63 120027 313 79623985
Drug abuse 229.04 11.32 3 120087 162688 79461610
Neoplasm progression 220.48 11.32 327 119763 51355 79572943
Iridocyclitis 211.75 11.32 106 119984 3598 79620700
Pathological fracture 207.40 11.32 152 119938 10385 79613913
Gingival swelling 198.16 11.32 109 119981 4500 79619798
Osteitis 196.87 11.32 103 119987 3840 79620458
Hypophosphataemia 189.03 11.32 189 119901 19724 79604574
Metastases to spine 182.44 11.32 101 119989 4223 79620075
Debridement 182.36 11.32 76 120014 1669 79622629
Overdose 180.93 11.32 30 120060 184176 79440122
Back pain 180.52 11.32 920 119170 303260 79321038
Prostatic specific antigen increased 180.36 11.32 139 119951 10247 79614051
Osteosclerosis 179.28 11.32 97 119993 3874 79620424
Periodontitis 178.76 11.32 101 119989 4395 79619903
Jaw operation 177.49 11.32 61 120029 768 79623530
Parophthalmia 176.37 11.32 51 120039 346 79623952
Pyrexia 173.78 11.32 1670 118420 677039 78947259
Osteolysis 173.33 11.32 99 119991 4399 79619899
Wound closure 172.47 11.32 42 120048 128 79624170
Loose tooth 171.73 11.32 87 120003 3030 79621268
Oroantral fistula 171.43 11.32 50 120040 351 79623947
Osteotomy 171.09 11.32 46 120044 229 79624069
Tooth loss 169.28 11.32 115 119975 6960 79617338
Condition aggravated 167.90 11.32 312 119778 500812 79123486
Bone fistula 163.92 11.32 36 120054 57 79624241
Pain 154.44 11.32 1678 118412 702124 78922174
Dental fistula 153.37 11.32 49 120041 483 79623815
Bone debridement 152.42 11.32 47 120043 408 79623890
Actinomycosis 148.94 11.32 58 120032 1061 79623237
Jaw fracture 148.32 11.32 78 120012 2939 79621359
Intentional overdose 144.75 11.32 3 120087 105957 79518341
Maternal exposure during pregnancy 141.51 11.32 19 120071 136519 79487779
Jaw fistula 139.86 11.32 33 120057 84 79624214
Atypical fracture 139.77 11.32 49 120041 657 79623641
Purulence 138.81 11.32 67 120023 2098 79622200
White blood cell count decreased 138.24 11.32 606 119484 187682 79436616
Carbohydrate antigen 15-3 increased 135.62 11.32 55 120035 1124 79623174
Synovitis 134.44 11.32 31 120059 150703 79473595
Contraindicated product administered 133.53 11.32 36 120054 157502 79466796
Toothache 132.60 11.32 157 119933 19813 79604485
Exposure during pregnancy 126.98 11.32 6 120084 101126 79523172
Presbyacusis 122.95 11.32 66 120024 2594 79621704
Spinal pain 120.85 11.32 132 119958 15260 79609038
Breast cancer metastatic 119.41 11.32 101 119989 8501 79615797
Fanconi syndrome 118.55 11.32 66 120024 2790 79621508
Decreased appetite 116.97 11.32 899 119191 341519 79282779
Osteopenia 114.77 11.32 140 119950 18224 79606074
Systemic lupus erythematosus 114.01 11.32 22 120068 121127 79503171
Metastases to lymph nodes 112.42 11.32 106 119984 10291 79614007
Jaw disorder 111.82 11.32 78 120012 4928 79619370
Pleural thickening 110.55 11.32 64 120026 2918 79621380
Gingival erythema 109.58 11.32 40 120050 607 79623691
Glossodynia 107.99 11.32 14 120076 103323 79520975
Suicide attempt 107.19 11.32 4 120086 82928 79541370
Pleural fibrosis 105.12 11.32 70 120020 4097 79620201
Blood magnesium increased 103.48 11.32 65 120025 3441 79620857
Oral pain 102.35 11.32 177 119913 31621 79592677
Idiopathic orbital inflammation 100.45 11.32 30 120060 231 79624067
Intentional product misuse 96.82 11.32 14 120076 95151 79529147
Osteopetrosis 95.67 11.32 20 120070 21 79624277
Metastases to central nervous system 94.58 11.32 120 119970 16255 79608043
Fatigue 94.05 11.32 1940 118150 927787 78696511
Chills 93.73 11.32 483 119607 159751 79464547
Tooth disorder 92.37 11.32 152 119938 26081 79598217
Palmar-plantar erythrodysaesthesia syndrome 92.06 11.32 173 119917 32961 79591337
Hypotension 90.50 11.32 349 119741 439968 79184330
Hand deformity 87.57 11.32 24 120066 103895 79520403
Hyperbaric oxygen therapy 87.43 11.32 20 120070 42 79624256
Eye pain 87.26 11.32 182 119908 37396 79586902
Drug hypersensitivity 84.94 11.32 204 119886 298712 79325586
Tumour marker increased 84.92 11.32 62 120028 4210 79620088
Blister 82.92 11.32 38 120052 119438 79504860
Periodontal disease 82.53 11.32 45 120045 1825 79622473
Coma 79.80 11.32 26 120064 100623 79523675
Helicobacter infection 79.06 11.32 7 120083 69697 79554601
Suicidal ideation 78.19 11.32 11 120079 76329 79547969
Bradycardia 77.10 11.32 55 120035 135502 79488796
Anaemia 77.01 11.32 1015 119075 444000 79180298
Abscess jaw 76.99 11.32 42 120048 1705 79622593
Disease progression 76.78 11.32 508 119582 183854 79440444
Breast cancer 76.57 11.32 162 119928 33619 79590679
Arthralgia 76.10 11.32 1246 118844 570557 79053741
Deafness neurosensory 75.87 11.32 71 120019 6827 79617471
Rheumatoid factor positive 73.69 11.32 4 120086 59835 79564463
Psoriasis 73.07 11.32 22 120068 89565 79534733
Infusion site coldness 72.98 11.32 23 120067 216 79624082
Hypoglycaemia 72.57 11.32 31 120059 101563 79522735
Therapeutic product effect incomplete 72.36 11.32 64 120026 141581 79482717
Psoriatic arthropathy 71.63 11.32 15 120075 77984 79546314
Diarrhoea 71.00 11.32 1780 118310 878709 78745589
Musculoskeletal chest pain 69.66 11.32 130 119960 24634 79599664
Blood creatinine increased 68.68 11.32 434 119656 154623 79469675
Neutrophil count decreased 68.57 11.32 302 119788 93657 79530641
Therapeutic product effect decreased 68.14 11.32 88 120002 163775 79460523
Impaired healing 68.00 11.32 287 119803 87368 79536930
Myoglobinuria 67.39 11.32 33 120057 1067 79623231
Metastasis 66.58 11.32 66 120024 6814 79617484
Pericarditis 66.56 11.32 37 120053 104199 79520099
Iritis 65.64 11.32 51 120039 3804 79620494
Wheezing 65.48 11.32 48 120042 116616 79507682
Injection site pain 64.72 11.32 60 120030 129778 79494520
Respiratory arrest 64.67 11.32 6 120084 57544 79566754
Oral surgery 63.84 11.32 32 120058 1089 79623209
Off label use 62.93 11.32 975 119115 906240 78718058
Gamma-glutamyltransferase decreased 62.29 11.32 23 120067 361 79623937
Asthma 62.11 11.32 67 120023 135028 79489270
Hyperpyrexia 61.86 11.32 60 120030 6032 79618266
Gingival pain 61.82 11.32 72 120018 8926 79615372
Hypercalcaemia 61.65 11.32 161 119929 38269 79586029
Breast cancer recurrent 60.98 11.32 44 120046 2933 79621365
Infusion related reaction 60.84 11.32 163 119927 230074 79394224
Injection site reaction 60.80 11.32 6 120084 54779 79569519
Wound treatment 60.71 11.32 19 120071 174 79624124
Constipation 60.42 11.32 672 119418 282378 79341920
Plasma cell myeloma recurrent 59.92 11.32 54 120036 4947 79619351
Metastases to pelvis 59.79 11.32 26 120064 636 79623662
Lactic acidosis 59.74 11.32 16 120074 70343 79553955
Thoracic vertebral fracture 59.57 11.32 55 120035 5198 79619100
Arthropathy 58.51 11.32 111 119979 177000 79447298
Hepatic enzyme increased 58.12 11.32 117 119973 182493 79441805
Thrombocytopenia 57.63 11.32 632 119458 264627 79359671
Spinal fracture 57.45 11.32 100 119990 17954 79606344
Osteonecrosis of external auditory canal 57.41 11.32 18 120072 166 79624132
Bone loss 57.34 11.32 40 120050 2527 79621771
Epigastric discomfort 57.31 11.32 65 120025 7831 79616467
C-reactive protein abnormal 57.25 11.32 4 120086 48363 79575935
Folliculitis 56.67 11.32 8 120082 55372 79568926
Product use issue 56.61 11.32 147 119943 209675 79414623
Abdominal discomfort 56.56 11.32 191 119899 250536 79373762
Deep vein thrombosis 55.76 11.32 342 119748 120577 79503721
Spinal compression fracture 55.36 11.32 95 119995 16863 79607435
Irritable bowel syndrome 55.08 11.32 13 120077 62228 79562070
Muscle injury 54.74 11.32 5 120085 48556 79575742
Angioedema 54.62 11.32 23 120067 76012 79548286
Asthenia 54.21 11.32 1076 119014 510613 79113685
Eye inflammation 53.86 11.32 57 120033 6356 79617942
Hepatic lesion 53.45 11.32 59 120031 6900 79617398
Intentional product use issue 53.22 11.32 92 119998 152020 79472278
Mastication disorder 53.08 11.32 39 120051 2674 79621624
Weight increased 53.05 11.32 226 119864 277160 79347138
Alveolar bone resorption 53.05 11.32 14 120076 64 79624234
Blood calcium decreased 52.78 11.32 135 119955 31684 79592614
Type 2 diabetes mellitus 52.42 11.32 11 120079 57111 79567187
Rib fracture 52.10 11.32 124 119966 27823 79596475
Trismus 52.08 11.32 52 120038 5415 79618883
Rheumatoid arthritis 51.80 11.32 152 119938 208318 79415980
Stress fracture 51.61 11.32 56 120034 6424 79617874
Depressed level of consciousness 51.40 11.32 42 120048 96610 79527688
Bone fissure 50.70 11.32 16 120074 151 79624147
Aggression 50.67 11.32 8 120082 50950 79573348
Bone marrow infiltration 50.61 11.32 24 120066 722 79623576
Soft tissue infection 50.37 11.32 44 120046 3868 79620430
Gastrointestinal haemorrhage 50.19 11.32 91 119999 147628 79476670
Scleritis 50.16 11.32 46 120044 4310 79619988
Cardiac arrest 50.00 11.32 116 119974 171980 79452318
Pain in extremity 49.73 11.32 798 119292 363740 79260558
Multiple sclerosis relapse 49.35 11.32 6 120084 46527 79577771
Abdominal pain 49.14 11.32 364 119726 389205 79235093
Nail toxicity 48.97 11.32 19 120071 344 79623954
Wound 48.69 11.32 62 120028 116117 79508181
Dental operation 48.63 11.32 27 120063 1135 79623163
Exophthalmos 48.38 11.32 31 120059 1699 79622599
Tooth abscess 47.99 11.32 87 120003 16123 79608175
Iris adhesions 47.87 11.32 21 120069 525 79623773
Sleep disorder due to general medical condition, insomnia type 47.74 11.32 5 120085 43551 79580747
Mouth swelling 47.68 11.32 52 120038 5999 79618299
Cyst 47.12 11.32 79 120011 13761 79610537
Fanconi syndrome acquired 46.65 11.32 36 120054 2658 79621640
Body height decreased 46.60 11.32 61 120029 8519 79615779
Skin toxicity 46.55 11.32 60 120030 8254 79616044
Drug dependence 46.49 11.32 4 120086 40765 79583533
Tonsillar disorder 46.47 11.32 27 120063 1239 79623059
Prostate cancer 46.01 11.32 132 119958 33136 79591162
Loss of personal independence in daily activities 45.90 11.32 52 120038 102528 79521770
PIK3CA-activated mutation 45.87 11.32 21 120069 582 79623716
Poor venous access 45.81 11.32 91 119999 18058 79606240
Hypouricaemia 45.77 11.32 19 120071 413 79623885
Cardio-respiratory arrest 45.38 11.32 58 120032 108452 79515846
Vein disorder 45.20 11.32 47 120043 5135 79619163
Periorbital inflammation 45.11 11.32 13 120077 87 79624211
Ocular hyperaemia 45.07 11.32 118 119972 28088 79596210
Drug level increased 44.91 11.32 4 120086 39647 79584651
Treatment failure 44.79 11.32 121 119969 170365 79453933
Drug intolerance 44.69 11.32 225 119865 263894 79360404
Confusional state 44.59 11.32 288 119802 317709 79306589
Treatment noncompliance 44.16 11.32 12 120078 52256 79572042
Breath odour 44.02 11.32 29 120061 1667 79622631
Anaphylactic reaction 43.77 11.32 37 120053 83706 79540592
Vasodilatation 43.33 11.32 37 120053 3154 79621144
Wrong technique in product usage process 43.29 11.32 29 120061 73846 79550452
Platelet count decreased 43.27 11.32 466 119624 194198 79430100
Discomfort 43.01 11.32 77 120013 125540 79498758
Bone cyst 42.97 11.32 38 120052 3395 79620903
Encephalopathy 42.91 11.32 24 120066 67373 79556925
Excessive granulation tissue 42.27 11.32 23 120067 929 79623369
Gingival abscess 41.80 11.32 22 120068 830 79623468
Oxygen saturation decreased 41.63 11.32 82 120008 128965 79495333
Metastases to pleura 41.37 11.32 27 120063 1527 79622771
Bone swelling 41.34 11.32 28 120062 1686 79622612
Agitation 40.98 11.32 54 120036 99661 79524637
Haematochezia 40.80 11.32 43 120047 87602 79536696
Aminoaciduria 40.63 11.32 17 120073 377 79623921
Full blood count decreased 40.62 11.32 110 119980 26709 79597589
Dysarthria 40.36 11.32 26 120064 67596 79556702
Myocardial infarction 40.33 11.32 142 119948 183987 79440311
Blood potassium increased 40.33 11.32 116 119974 29159 79595139
Renal tubular necrosis 40.26 11.32 105 119985 24934 79599364
International normalised ratio increased 40.07 11.32 41 120049 84680 79539618
Lumbar vertebral fracture 39.82 11.32 51 120039 6971 79617327
Drug ineffective for unapproved indication 39.28 11.32 14 120076 51224 79573074
Bone density abnormal 38.56 11.32 34 120056 3026 79621272
Seizure 38.50 11.32 150 119940 188684 79435614
Isosthenuria 38.24 11.32 12 120078 111 79624187
Bladder prolapse 38.18 11.32 25 120065 1422 79622876
Oral mucosal erythema 38.08 11.32 28 120062 1922 79622376
Face and mouth X-ray abnormal 37.84 11.32 9 120081 24 79624274
Electrocardiogram PR shortened 37.28 11.32 15 120075 300 79623998
Stevens-Johnson syndrome 37.07 11.32 7 120083 39159 79585139
Corneal endotheliitis 36.80 11.32 11 120079 85 79624213
Hyperkalaemia 36.64 11.32 73 120017 114325 79509973
Onycholysis 36.43 11.32 28 120062 2055 79622243
Nasal disorder 36.18 11.32 36 120054 3733 79620565
Obstructive airways disorder 36.11 11.32 3 120087 31456 79592842
Biopsy bone abnormal 35.93 11.32 8 120082 14 79624284
Infusion site induration 35.92 11.32 22 120068 1113 79623185
Tenderness 35.84 11.32 97 119993 23545 79600753
Unresponsive to stimuli 35.33 11.32 20 120070 55768 79568530
Product dose omission issue 35.29 11.32 223 119867 247314 79376984
Compression fracture 35.20 11.32 46 120044 6414 79617884
Uveitis 35.04 11.32 78 120012 16752 79607546
Bone density decreased 34.99 11.32 68 120022 13279 79611019
Carcinoembryonic antigen increased 34.98 11.32 28 120062 2181 79622117
Bone lesion excision 34.87 11.32 9 120081 37 79624261
Oral disorder 34.87 11.32 58 120032 10037 79614261
Cellulitis orbital 34.63 11.32 19 120071 780 79623518
Fistula discharge 34.56 11.32 23 120067 1345 79622953
Chronic papillomatous dermatitis 34.31 11.32 10 120080 70 79624228
Nasal congestion 34.04 11.32 39 120051 76513 79547785
Medication error 33.87 11.32 32 120058 68610 79555688
Sedation 33.74 11.32 18 120072 51877 79572421
Dermal sinus 33.73 11.32 8 120082 21 79624277
Accidental overdose 33.60 11.32 9 120081 39572 79584726
Accidental exposure to product 33.31 11.32 4 120086 31318 79592980
Skin lesion 33.22 11.32 138 119952 41706 79582592
Rectal prolapse 33.20 11.32 27 120063 2151 79622147
Conjunctival oedema 33.00 11.32 21 120069 1137 79623161
Pulpitis dental 32.98 11.32 22 120068 1291 79623007
Cardiogenic shock 32.91 11.32 11 120079 41903 79582395
Cancer pain 32.79 11.32 40 120050 5205 79619093
Inappropriate schedule of product administration 32.77 11.32 98 119992 133530 79490768
Blood phosphorus decreased 32.54 11.32 45 120045 6623 79617675
Renal tubular dysfunction 32.37 11.32 18 120072 759 79623539
Urticaria 32.33 11.32 156 119934 185045 79439253
Emotional distress 32.25 11.32 10 120080 39959 79584339
Therapy non-responder 32.12 11.32 56 120034 92249 79532049
Hospitalisation 32.05 11.32 58 120032 94178 79530120
Leukopenia 31.74 11.32 291 119799 116222 79508076
Serotonin syndrome 31.73 11.32 14 120076 45013 79579285
Exostosis of jaw 31.47 11.32 21 120069 1233 79623065
Metaphyseal corner fracture 31.17 11.32 8 120082 32 79624266
Numb chin syndrome 31.17 11.32 7 120083 13 79624285
Periodontal destruction 31.17 11.32 7 120083 13 79624285
Hypersensitivity 31.16 11.32 249 119841 261990 79362308
Incorrect dose administered 30.97 11.32 42 120048 76588 79547710
Prostate cancer metastatic 30.82 11.32 34 120056 3973 79620325
Abortion spontaneous 30.81 11.32 4 120086 29503 79594795
Injury 30.79 11.32 43 120047 77453 79546845
Hallucination 30.78 11.32 51 120039 85694 79538604
Somnolence 30.72 11.32 222 119868 238759 79385539
Osteomalacia 30.60 11.32 22 120068 1458 79622840
Metastases to retroperitoneum 30.51 11.32 14 120076 390 79623908
Product quality issue 30.20 11.32 7 120083 33933 79590365
Epilepsy 29.93 11.32 12 120078 40848 79583450
Post-traumatic neck syndrome 29.92 11.32 25 120065 2069 79622229
Abnormal behaviour 29.59 11.32 9 120081 36412 79587886
Injection site erythema 29.49 11.32 45 120045 78152 79546146
Maxillofacial operation 29.37 11.32 6 120084 5 79624293
Renal impairment 29.36 11.32 365 119725 157418 79466880
Squamous cell carcinoma of skin 29.17 11.32 65 120025 13968 79610330
Plasma cell leukaemia 29.05 11.32 23 120067 1763 79622535
Chondrocalcinosis pyrophosphate 28.94 11.32 23 120067 1773 79622525
Tooth avulsion 28.90 11.32 9 120081 81 79624217
Hyperuricosuria 28.85 11.32 6 120084 6 79624292
Hypophosphataemic osteomalacia 28.85 11.32 13 120077 347 79623951
Hormone-refractory prostate cancer 28.78 11.32 14 120076 446 79623852
Oral infection 28.58 11.32 39 120051 5668 79618630
Ulna fracture 28.32 11.32 19 120071 1126 79623172
Pruritus 28.29 11.32 421 119669 394227 79230071
Spinal cord compression 28.12 11.32 41 120049 6336 79617962
Tumour marker abnormal 28.04 11.32 12 120078 282 79624016
Pulmonary hypertension 28.00 11.32 19 120071 48061 79576237
Abdominal lymphadenopathy 27.97 11.32 20 120070 1314 79622984
Dry eye 27.92 11.32 120 119970 36811 79587487
Bone abscess 27.78 11.32 14 120076 482 79623816
Orbital swelling 27.57 11.32 8 120082 55 79624243
Acetabulum fracture 27.49 11.32 15 120075 609 79623689
Drug withdrawal syndrome 27.46 11.32 9 120081 34709 79589589
Poisoning 27.44 11.32 3 120087 25269 79599029
Tibia fracture 27.40 11.32 37 120053 5324 79618974
Tooth erosion 27.29 11.32 13 120077 395 79623903
Acute hepatic failure 27.22 11.32 6 120084 30107 79594191
Heart rate increased 27.17 11.32 92 119998 120632 79503666
Creatinine renal clearance increased 27.13 11.32 17 120073 896 79623402
Wound dehiscence 27.07 11.32 41 120049 6554 79617744
Osteitis condensans 26.89 11.32 7 120083 30 79624268
Hydronephrosis 26.85 11.32 72 120018 17382 79606916
Movement disorder 26.62 11.32 96 119994 27163 79597135
Metastases to kidney 26.56 11.32 14 120076 530 79623768
Pyelitis 26.26 11.32 12 120078 331 79623967
Restlessness 26.24 11.32 19 120071 46473 79577825
Trichorrhexis 26.17 11.32 16 120074 807 79623491
Blood calcium increased 26.07 11.32 52 120038 10348 79613950
Myoclonus 26.06 11.32 5 120085 27655 79596643
Mucosal inflammation 26.03 11.32 199 119891 75381 79548917
Respiratory tract infection bacterial 26.02 11.32 23 120067 2054 79622244
Pulmonary embolism 25.74 11.32 382 119708 171272 79453026
Cardiac failure congestive 25.40 11.32 119 119971 142283 79482015
Chronic inflammatory demyelinating polyradiculoneuropathy 25.39 11.32 18 120072 1167 79623131
Exostosis 25.39 11.32 69 120021 16789 79607509
Device issue 25.33 11.32 5 120085 27103 79597195
Metastases to soft tissue 25.08 11.32 14 120076 595 79623703
Withdrawal syndrome 24.99 11.32 5 120085 26849 79597449
Eosinophilia 24.99 11.32 19 120071 45326 79578972
Premature delivery 24.95 11.32 3 120087 23464 79600834
Prescribed overdose 24.83 11.32 13 120077 37870 79586428
Ill-defined disorder 24.76 11.32 38 120052 65837 79558461
Adnexa uteri mass 24.68 11.32 12 120078 382 79623916
Cytomegalovirus infection 24.63 11.32 17 120073 42627 79581671
Peri-implantitis 24.54 11.32 10 120080 207 79624091
Monoclonal immunoglobulin present 24.45 11.32 17 120073 1068 79623230
Product prescribing error 24.41 11.32 19 120071 44794 79579504
Blood parathyroid hormone increased 24.39 11.32 28 120062 3417 79620881
Drug reaction with eosinophilia and systemic symptoms 24.20 11.32 37 120053 64207 79560091
Spinal stenosis 24.15 11.32 65 120025 15726 79608572
Vertebral column mass 24.10 11.32 10 120080 217 79624081
Bladder hypertrophy 24.05 11.32 14 120076 645 79623653
Chikungunya virus infection 23.98 11.32 10 120080 220 79624078
Bone fragmentation 23.83 11.32 14 120076 656 79623642
Biliary dilatation 23.82 11.32 25 120065 2761 79621537
Vitamin D decreased 23.63 11.32 48 120042 9677 79614621
Multiple organ dysfunction syndrome 23.56 11.32 97 119993 120149 79504149
Polyneuropathy 23.54 11.32 85 120005 24066 79600232
Light chain analysis increased 23.49 11.32 20 120070 1698 79622600
Coronary artery disease 23.44 11.32 39 120051 65435 79558863
Procollagen type I C-terminal propeptide increased 23.38 11.32 6 120084 24 79624274
Therapy interrupted 23.29 11.32 9 120081 31332 79592966
Rheumatic fever 23.26 11.32 7 120083 28518 79595780
Otitis externa 23.26 11.32 23 120067 2367 79621931
Blood creatine phosphokinase increased 23.08 11.32 40 120050 66050 79558248
Gingival disorder 23.08 11.32 28 120062 3623 79620675
Spinal disorder 23.01 11.32 49 120041 10211 79614087
Injection site pruritus 22.94 11.32 18 120072 42265 79582033
Hyperhidrosis 22.87 11.32 134 119956 151358 79472940
Pneumonia 22.87 11.32 1214 118876 659032 78965266
Hyperphosphaturia 22.84 11.32 8 120082 107 79624191
Urinary tract inflammation 22.79 11.32 10 120080 250 79624048
Right ventricular failure 22.67 11.32 4 120086 23493 79600805
Concomitant disease progression 22.55 11.32 27 120063 3446 79620852
Pityriasis rubra pilaris 22.50 11.32 8 120082 112 79624186
Tetany 22.47 11.32 24 120066 2704 79621594
Serum procollagen type I N-terminal propeptide increased 22.46 11.32 6 120084 29 79624269
Adverse event 22.37 11.32 35 120055 60179 79564119
Metastases to the mediastinum 22.37 11.32 13 120077 597 79623701
Neuroendocrine breast tumour 22.29 11.32 6 120084 30 79624268
Allergy to plants 22.22 11.32 14 120076 745 79623553
Agranulocytosis 22.21 11.32 21 120069 45009 79579289
Facial pain 22.16 11.32 54 120036 12296 79612002
Depression 22.14 11.32 214 119876 216576 79407722
Medical device site joint inflammation 22.00 11.32 4 120086 0 79624298
Plasmacytoma 21.92 11.32 30 120060 4373 79619925
Abscess oral 21.76 11.32 18 120072 1469 79622829
Hypoxia 21.68 11.32 81 120009 103162 79521136
SARS-CoV-2 sepsis 21.53 11.32 8 120082 128 79624170
Delirium 21.52 11.32 61 120029 84566 79539732
Metastases to skin 21.27 11.32 19 120071 1720 79622578
Pneumonia aspiration 21.21 11.32 43 120047 66924 79557374
Respiratory tract infection viral 21.17 11.32 29 120061 4230 79620068
Rhabdomyolysis 20.96 11.32 82 120008 103049 79521249
Psychotic disorder 20.78 11.32 19 120071 41383 79582915
Acute myocardial infarction 20.73 11.32 54 120036 76982 79547316
Metastases to peritoneum 20.58 11.32 29 120061 4343 79619955
Vein rupture 20.57 11.32 20 120070 2016 79622282
Rebound effect 20.40 11.32 38 120052 7188 79617110
Pelvic pain 20.38 11.32 55 120035 13326 79610972
Abdominal pain upper 20.37 11.32 227 119863 223592 79400706
Knee arthroplasty 20.37 11.32 21 120069 43227 79581071
Humerus fracture 20.34 11.32 44 120046 9269 79615029
Eastern Cooperative Oncology Group performance status worsened 20.34 11.32 20 120070 2045 79622253
Fluid retention 20.31 11.32 47 120043 69762 79554536
Noninfective gingivitis 20.26 11.32 18 120072 1618 79622680
Melaena 20.23 11.32 38 120052 60852 79563446
Muscle spasticity 19.98 11.32 4 120086 21471 79602827
Dental necrosis 19.61 11.32 8 120082 166 79624132
Orthostatic hypotension 19.61 11.32 34 120056 56130 79568168
Dysaesthesia 19.40 11.32 33 120057 5815 79618483
Internal fixation of fracture 19.31 11.32 10 120080 365 79623933
Dyspnoea 19.30 11.32 1075 119015 855950 78768348
Cytopenia 19.24 11.32 71 120019 20312 79603986
Dehiscence 19.22 11.32 8 120082 175 79624123
Cerebral haemorrhage 19.16 11.32 36 120054 57637 79566661
Liver injury 19.11 11.32 35 120055 56579 79567719
Dyschezia 19.03 11.32 23 120067 2965 79621333
Gingival ulceration 19.01 11.32 14 120076 963 79623335
Obesity 19.00 11.32 15 120075 35110 79589188
Anxiety 18.88 11.32 262 119828 248250 79376048
Skin sensitisation 18.78 11.32 14 120076 981 79623317
No adverse event 18.75 11.32 17 120073 37175 79587123
Oral mucosal roughening 18.75 11.32 5 120085 24 79624274
Anaphylactic shock 18.69 11.32 16 120074 35980 79588318
Tooth deposit 18.55 11.32 9 120081 285 79624013
Avulsion fracture 18.52 11.32 9 120081 286 79624012
Oral dysaesthesia 18.50 11.32 8 120082 193 79624105
Upper gastrointestinal haemorrhage 18.48 11.32 21 120069 41359 79582939
Pseudarthrosis 18.44 11.32 9 120081 289 79624009
Hypercalcaemia of malignancy 18.42 11.32 10 120080 402 79623896
Polymyalgia rheumatica 18.33 11.32 28 120062 4509 79619789
Peripheral sensory neuropathy 18.30 11.32 52 120038 12981 79611317
Conjunctivitis 18.25 11.32 82 120008 25633 79598665
Cerebrovascular accident 18.18 11.32 148 119942 155144 79469154
Fracture 18.17 11.32 73 120017 21728 79602570
Pneumonitis 18.11 11.32 155 119935 60705 79563593
Sinusitis 17.90 11.32 198 119892 195303 79428995
Dengue fever 17.87 11.32 13 120077 878 79623420
Mucosal hypertrophy 17.79 11.32 6 120084 71 79624227
Lithiasis 17.77 11.32 8 120082 213 79624085
Bone marrow oedema 17.65 11.32 17 120073 1694 79622604
Renal glycosuria 17.54 11.32 5 120085 32 79624266
Respiratory failure 17.46 11.32 181 119909 180730 79443568
Toxic epidermal necrolysis 17.45 11.32 25 120065 44556 79579742
HER2 positive breast cancer 17.36 11.32 9 120081 329 79623969
Systemic inflammatory response syndrome 17.34 11.32 47 120043 11418 79612880
Paranoia 17.31 11.32 4 120086 19428 79604870
Mood altered 17.30 11.32 3 120087 17844 79606454
Selenium deficiency 17.28 11.32 5 120085 34 79624264
Bronchopulmonary aspergillosis 17.25 11.32 6 120084 22288 79602010
Deformity 17.24 11.32 42 120048 9563 79614735
Nail discolouration 17.17 11.32 22 120068 3009 79621289
Haemorrhage intracranial 17.15 11.32 9 120081 26184 79598114
Mydriasis 17.03 11.32 3 120087 17640 79606658
Pancreatitis 17.02 11.32 50 120040 68525 79555773
Monoclonal immunoglobulin increased 17.00 11.32 7 120083 149 79624149
Ventricular tachycardia 16.93 11.32 23 120067 41912 79582386
Sleep apnoea syndrome 16.86 11.32 18 120072 36460 79587838
Pulmonary arterial hypertension 16.80 11.32 11 120079 28355 79595943
Frequent bowel movements 16.77 11.32 12 120078 29527 79594771
Injection site inflammation 16.72 11.32 25 120065 3951 79620347
Haemodynamic instability 16.68 11.32 3 120087 17379 79606919
Dyskinesia 16.66 11.32 26 120064 44747 79579551
Invasive ductal breast carcinoma 16.66 11.32 31 120059 5861 79618437
Infusion site haemorrhage 16.52 11.32 24 120066 3696 79620602
Mesenteric phlebosclerosis 16.50 11.32 3 120087 0 79624298
Venous perforation 16.50 11.32 3 120087 0 79624298
Enterocolitis bacterial 16.45 11.32 11 120079 648 79623650
Respiratory distress 16.39 11.32 40 120050 58299 79565999
Disability 16.33 11.32 3 120087 17117 79607181
Haemophilus bacteraemia 16.26 11.32 5 120085 43 79624255
Lacrimation increased 16.20 11.32 72 120018 22405 79601893
Transfusion 16.06 11.32 6 120084 21324 79602974
Eczema 15.87 11.32 23 120067 40795 79583503
Poor personal hygiene 15.84 11.32 10 120080 534 79623764
Radius fracture 15.84 11.32 23 120067 3541 79620757
Pachymeningitis 15.81 11.32 8 120082 278 79624020
Oral mucosal hypertrophy 15.79 11.32 4 120086 15 79624283
Stress 15.73 11.32 64 120026 79548 79544750
Urine phosphorus decreased 15.68 11.32 5 120085 49 79624249
Hyponatraemia 15.55 11.32 182 119908 177666 79446632
Fracture nonunion 15.47 11.32 15 120075 1507 79622791
Acute sinusitis 15.44 11.32 26 120064 4544 79619754
Muscle spasms 15.39 11.32 358 119732 174372 79449926
Multiple fractures 15.38 11.32 36 120054 7990 79616308
Tooth fracture 15.22 11.32 45 120045 11485 79612813
Paraganglion neoplasm malignant 15.21 11.32 4 120086 18 79624280
Irritability 15.20 11.32 24 120066 41120 79583178
Dry skin 15.19 11.32 163 119927 67832 79556466
Soft tissue inflammation 15.18 11.32 9 120081 429 79623869
Carbohydrate antigen 27.29 increased 15.16 11.32 5 120085 55 79624243
Pleural effusion 15.16 11.32 305 119785 144957 79479341
Drug-induced liver injury 15.14 11.32 50 120040 66067 79558231
Peritonitis 15.13 11.32 12 120078 28024 79596274
Laryngeal leukoplakia 15.08 11.32 5 120085 56 79624242
Tumour marker decreased 15.08 11.32 5 120085 56 79624242
Therapeutic response decreased 15.00 11.32 51 120039 66802 79557496
Dental discomfort 14.96 11.32 9 120081 441 79623857
Tooth infection 14.86 11.32 62 120028 18770 79605528
Staphylococcal infection 14.83 11.32 42 120048 58253 79566045
Hypervolaemia 14.76 11.32 26 120064 42664 79581634
Cholesteatoma 14.69 11.32 6 120084 125 79624173
Naevus haemorrhage 14.69 11.32 6 120084 125 79624173
Bronchial fistula 14.69 11.32 7 120083 213 79624085
Dysgeusia 14.66 11.32 141 119949 57036 79567262
Adjusted calcium decreased 14.54 11.32 7 120083 218 79624080
Lymphatic disorder 14.50 11.32 8 120082 332 79623966
Posterior reversible encephalopathy syndrome 14.50 11.32 11 120079 26270 79598028
Eyelid ptosis 14.48 11.32 43 120047 11001 79613297
Status epilepticus 14.44 11.32 10 120080 25031 79599267
Parathyroid hormone-related protein increased 14.43 11.32 3 120087 3 79624295
Oesophagogastroduodenoscopy abnormal 14.43 11.32 3 120087 3 79624295
Eosinophil count increased 14.31 11.32 4 120086 17101 79607197
Hepatic cirrhosis 14.24 11.32 19 120071 34887 79589411
Ovarian disorder 14.23 11.32 9 120081 482 79623816
Peripheral sensorimotor neuropathy 14.22 11.32 20 120070 2990 79621308
Hepatic mass 14.21 11.32 18 120072 2433 79621865
Lymphoedema 14.12 11.32 46 120044 12367 79611931
Dental prosthesis placement 14.11 11.32 4 120086 25 79624273
Colorectal cancer metastatic 14.11 11.32 13 120077 1225 79623073
Foot fracture 14.06 11.32 68 120022 21913 79602385
Nausea 14.04 11.32 1646 118444 955550 78668748
Altered state of consciousness 13.99 11.32 28 120062 43794 79580504
Nasopharyngitis 13.93 11.32 284 119806 253597 79370701
Gingival recession 13.85 11.32 13 120077 1254 79623044
Thrombosis 13.73 11.32 190 119900 83910 79540388
Gingival injury 13.72 11.32 4 120086 28 79624270
Albumin urine present 13.67 11.32 10 120080 681 79623617
Carcinoid tumour pulmonary 13.60 11.32 8 120082 376 79623922
Microangiopathic haemolytic anaemia 13.59 11.32 14 120076 1513 79622785
Oedema mucosal 13.56 11.32 15 120075 1758 79622540
Amnesia 13.55 11.32 49 120041 63008 79561290
Protein total decreased 13.48 11.32 37 120053 9055 79615243
Elbow deformity 13.44 11.32 14 120076 1533 79622765
Anhedonia 13.40 11.32 3 120087 14895 79609403
Angina pectoris 13.36 11.32 37 120053 51695 79572603
Osteoarthritis 13.35 11.32 195 119895 87114 79537184
Gait disturbance 13.34 11.32 408 119682 207098 79417200
Monoclonal gammopathy 13.26 11.32 11 120079 901 79623397
Bone callus excessive 13.26 11.32 4 120086 32 79624266
Colitis 13.22 11.32 61 120029 73246 79551052
Blood glucose decreased 13.21 11.32 12 120078 26222 79598076
Dental care 13.20 11.32 11 120079 907 79623391
Pancreatitis acute 13.17 11.32 35 120055 49569 79574729
Fibromyalgia 13.17 11.32 51 120039 64289 79560009
Device malfunction 13.14 11.32 8 120082 21440 79602858
Loss of consciousness 13.13 11.32 176 119914 167767 79456531
Portal venous gas 13.08 11.32 8 120082 404 79623894
Feeling cold 13.07 11.32 81 120009 28648 79595650
Oral pustule 13.07 11.32 7 120083 274 79624024
Wrist deformity 13 11.32 16 120074 2101 79622197
Respiratory tract infection 12.94 11.32 121 119969 48568 79575730
Device dislocation 12.94 11.32 12 120078 25958 79598340
Onychoclasis 12.93 11.32 27 120063 5551 79618747
Bone hypertrophy 12.91 11.32 9 120081 568 79623730
Recurrent cancer 12.88 11.32 18 120072 2675 79621623
Pallor 12.79 11.32 36 120054 50026 79574272
Injection site swelling 12.71 11.32 33 120057 47099 79577199
Disorientation 12.70 11.32 50 120040 62726 79561572
Decubitus ulcer 12.66 11.32 52 120038 15635 79608663
Blood alkaline phosphatase increased 12.58 11.32 149 119941 63515 79560783
Chest wall mass 12.58 11.32 6 120084 183 79624115
Wound complication 12.56 11.32 25 120065 4968 79619330
Diabetic ketoacidosis 12.52 11.32 20 120070 34102 79590196
Mental status changes 12.51 11.32 55 120035 66904 79557394
Radiation skin injury 12.50 11.32 13 120077 1421 79622877
Optic neuritis 12.42 11.32 37 120053 9483 79614815
Taste disorder 12.41 11.32 52 120038 15771 79608527
Death 12.39 11.32 1002 119088 565512 79058786
Lymphadenopathy mediastinal 12.27 11.32 23 120067 4373 79619925
Grip strength decreased 12.26 11.32 9 120081 21860 79602438
Psychomotor hyperactivity 12.25 11.32 5 120085 16844 79607454
Heavy menstrual bleeding 12.25 11.32 3 120087 14008 79610290
Dizziness 12.25 11.32 658 119432 525783 79098515
Hydrothorax 12.24 11.32 13 120077 1455 79622843
Rectal adenocarcinoma 12.21 11.32 13 120077 1460 79622838
Lower limb fracture 12.21 11.32 68 120022 23147 79601151
Conjunctival hyperaemia 12.20 11.32 23 120067 4390 79619908
Sinus bradycardia 12.19 11.32 12 120078 25235 79599063
Hallucination, visual 12.18 11.32 19 120071 32710 79591588
Hip arthroplasty 12.16 11.32 22 120068 35734 79588564
Petechiae 12.14 11.32 8 120082 20557 79603741
Metastases to bone marrow 12.13 11.32 10 120080 812 79623486
Laboratory test abnormal 12.09 11.32 78 120012 27970 79596328
Wound infection 12.05 11.32 11 120079 23980 79600318
Hand fracture 12.01 11.32 28 120062 6197 79618101
Hip deformity 12.00 11.32 6 120084 203 79624095
Therapy cessation 11.99 11.32 24 120066 37538 79586760
Tremor 11.97 11.32 182 119908 169901 79454397
Tumour pain 11.95 11.32 16 120074 2283 79622015
Hypothermia 11.94 11.32 10 120080 22736 79601562
Tachycardia 11.91 11.32 192 119898 177576 79446722
Oral discomfort 11.86 11.32 37 120053 9723 79614575
Light chain analysis abnormal 11.84 11.32 6 120084 209 79624089
Upper limb fracture 11.80 11.32 56 120034 17911 79606387
Acute respiratory distress syndrome 11.77 11.32 31 120059 44036 79580262
Blood creatinine decreased 11.75 11.32 32 120058 7793 79616505
Aspiration 11.69 11.32 8 120082 20150 79604148
Cavernous sinus syndrome 11.69 11.32 3 120087 12 79624286
Lymph node pain 11.66 11.32 13 120077 1537 79622761
Wrist fracture 11.65 11.32 42 120048 11879 79612419
Underdose 11.63 11.32 20 120070 33131 79591167
Breast pain 11.63 11.32 33 120057 8232 79616066
Haematoma 11.59 11.32 40 120050 52155 79572143
Hypoaesthesia oral 11.54 11.32 47 120043 14077 79610221
Metastases to meninges 11.53 11.32 20 120070 3581 79620717
Metastases to spinal cord 11.52 11.32 4 120086 52 79624246
Parathyroid tumour malignant 11.45 11.32 4 120086 53 79624245
Ventricular fibrillation 11.44 11.32 19 120071 31907 79592391
Unevaluable event 11.42 11.32 44 120046 55541 79568757
Pleurodesis 11.38 11.32 4 120086 54 79624244
Musculoskeletal pain 11.38 11.32 217 119873 102137 79522161
Flushing 11.33 11.32 82 120008 88186 79536112

FDA Adverse Event Reporting System (Pediatric)

None

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:50646 antiosteoporotic

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 5MG BASE/100ML RECLAST SANDOZ N021817 April 16, 2007 RX INJECTABLE INTRAVENOUS 8052987 Oct. 27, 2023 TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
EQ 4MG BASE/100ML ZOMETA NOVARTIS N021223 June 17, 2011 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 BONE METASTASES
EQ 4MG BASE/100ML ZOMETA NOVARTIS N021223 June 17, 2011 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 HYPERCALCEMIA OF MALIGNANCY
EQ 4MG BASE/100ML ZOMETA NOVARTIS N021223 June 17, 2011 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 MULTIPLE MYELOMA
EQ 4MG BASE/5ML ZOMETA NOVARTIS N021223 March 7, 2003 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 BONE METASTASES
EQ 4MG BASE/5ML ZOMETA NOVARTIS N021223 March 7, 2003 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 HYPERCALCEMIA OF MALIGNANCY
EQ 4MG BASE/5ML ZOMETA NOVARTIS N021223 March 7, 2003 RX INJECTABLE INTRAVENOUS 8324189 May 29, 2025 MULTIPLE MYELOMA

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 Unclassified Ki 8 CHEMBL

External reference:

IDSource
4021276 VUID
N0000179387 NUI
D01968 KEGG_DRUG
4021276 VANDF
C0257685 UMLSCUI
CHEBI:46557 CHEBI
ZOL PDB_CHEM_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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Reclast HUMAN PRESCRIPTION DRUG LABEL 1 0078-0435 INJECTION, SOLUTION 5 mg INTRAVENOUS NDA 32 sections
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 0143-9642 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 26 sections
ZOLEDRONIC ACID HUMAN PRESCRIPTION DRUG LABEL 1 0409-4215 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 28 sections
ZOLEDRONIC ACID HUMAN PRESCRIPTION DRUG LABEL 1 0409-4215 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 28 sections
ZOLEDRONIC ACID HUMAN PRESCRIPTION DRUG LABEL 1 0409-4215 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 28 sections
Zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 16714-815 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 17478-324 SOLUTION 5 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 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 25 sections
zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 25021-801 INJECTION, SOLUTION, CONCENTRATE 0.80 mg INTRAVENOUS ANDA 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 25021-826 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 27 sections
zoledronic acid HUMAN PRESCRIPTION DRUG LABEL 1 25021-830 INJECTION, SOLUTION 0.05 mg INTRAVENOUS ANDA 27 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 43598-233 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 27 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 43598-330 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 50742-416 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 23 sections
Zoledronic Acid HUMAN PRESCRIPTION DRUG LABEL 1 51991-065 INJECTION, SOLUTION, CONCENTRATE 4 mg INTRAVENOUS ANDA 30 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 54288-100 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