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

Stem definitionDrug idCAS RN
immunosuppressants, rapamycin derivatives 1118 159351-69-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • votubia
  • everolimus
  • afinitor
  • certican
  • RAD001
A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.
  • Molecular weight: 958.24
  • Formula: C53H83NO14
  • CLOGP: 7.10
  • LIPINSKI: 3
  • HAC: 15
  • HDO: 3
  • TPSA: 204.66
  • ALOGS: -5.77
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O
1.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Aug. 22, 2019 PMDA Novartis Pharma K.K.
Sept. 2, 2011 EMA
March 30, 2009 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
Malignant neoplasm progression 3527.45 13.32 1703 63192 80418 63343709
Stomatitis 1389.93 13.32 1142 63753 137583 63286544
Metastases to liver 1142.12 13.32 533 64362 23106 63401021
Metastases to bone 1103.21 13.32 502 64393 20517 63403610
Pneumonitis 965.72 13.32 542 64353 34680 63389447
Neoplasm progression 595.09 13.32 403 64492 36025 63388102
Metastases to lung 458.07 13.32 235 64660 12515 63411612
Death 411.38 13.32 1065 63830 373316 63050811
Disease progression 395.61 13.32 554 64341 122204 63301923
Pleural effusion 371.67 13.32 467 64428 92743 63331384
Mucosal inflammation 368.62 13.32 337 64558 46591 63377536
Tumour marker increased 285.12 13.32 126 64769 4789 63419338
Metastases to lymph nodes 283.31 13.32 147 64748 8011 63416116
Hyperglycaemia 270.54 13.32 270 64625 41597 63382530
Osteonecrosis of jaw 252.19 13.32 240 64655 34883 63389244
Interstitial lung disease 243.17 13.32 308 64587 61600 63362527
Rheumatoid arthritis 239.26 13.32 4 64891 253815 63170312
Ascites 211.92 13.32 234 64661 40494 63383633
Infusion related reaction 199.91 13.32 13 64882 245508 63178619
Arthropathy 195.49 13.32 11 64884 234781 63189346
Aphthous ulcer 194.29 13.32 140 64755 13798 63410329
Decreased appetite 191.73 13.32 628 64267 250424 63173703
Systemic lupus erythematosus 190.11 13.32 5 64890 208913 63215214
Synovitis 175.87 13.32 3 64892 186915 63237212
Condition aggravated 173.36 13.32 98 64797 402119 63022008
Cough 171.99 13.32 672 64223 292071 63132056
Breast cancer metastatic 168.16 13.32 121 64774 11897 63412230
Musculoskeletal stiffness 162.27 13.32 6 64889 184612 63239515
Metastases to pleura 161.98 13.32 61 64834 1524 63422603
Hepatic lesion 161.97 13.32 85 64810 4740 63419387
Drug ineffective 161.86 13.32 540 64355 1044225 62379902
Therapeutic product effect decreased 154.97 13.32 11 64884 193176 63230951
PIK3CA-activated mutation 150.45 13.32 52 64843 1007 63423120
Oral pain 142.29 13.32 160 64735 28234 63395893
Metastases to skin 137.95 13.32 55 64840 1608 63422519
Lung infiltration 135.78 13.32 115 64780 14348 63409779
Maternal exposure during pregnancy 134.79 13.32 30 64865 220032 63204095
Completed suicide 134.35 13.32 3 64892 145670 63278457
Exposure during pregnancy 121.50 13.32 10 64885 155537 63268590
Drug hypersensitivity 119.64 13.32 86 64809 310601 63113526
Lung disorder 119.21 13.32 222 64673 62039 63362088
Mouth ulceration 118.35 13.32 157 64738 32827 63391300
Joint swelling 116.92 13.32 98 64797 327568 63096559
Metastases to peritoneum 116.57 13.32 61 64834 3381 63420746
Neoplasm malignant 114.71 13.32 147 64748 29714 63394413
Epistaxis 114.67 13.32 239 64656 72486 63351641
Second primary malignancy 113.39 13.32 81 64814 7872 63416255
Metastasis 113.27 13.32 69 64826 5128 63418999
Transplant rejection 110.09 13.32 90 64805 10690 63413437
Blood creatinine increased 107.52 13.32 261 64634 87583 63336544
Pericarditis 106.93 13.32 7 64888 131572 63292555
Hypersensitivity 106.31 13.32 86 64809 292599 63131528
Metastases to spine 105.55 13.32 56 64839 3193 63420934
Wound 104.61 13.32 20 64875 163243 63260884
Accidental exposure to product packaging 104.50 13.32 19 64876 9 63424118
General physical health deterioration 104.34 13.32 445 64450 200957 63223170
Discomfort 102.10 13.32 23 64872 167351 63256776
Fall 99.15 13.32 155 64740 392179 63031948
Oedema peripheral 97.59 13.32 418 64477 189093 63235034
Anaemia 97.13 13.32 571 64324 292859 63131268
Polyomavirus viraemia 96.43 13.32 34 64861 700 63423427
Diarrhoea 96.08 13.32 1134 63761 714232 62709895
Blood triglycerides increased 94.71 13.32 88 64807 12400 63411727
BK virus infection 93.94 13.32 52 64843 3227 63420900
Lymphangiosis carcinomatosa 93.44 13.32 40 64855 1405 63422722
Pyrexia 93.01 13.32 808 64087 469670 62954457
Metastases to central nervous system 92.98 13.32 89 64806 13016 63411111
Immunosuppressant drug level increased 91.56 13.32 53 64842 3585 63420542
Thrombotic microangiopathy 91.07 13.32 80 64815 10481 63413646
Blood glucose increased 90.11 13.32 237 64658 83519 63340608
Pancreatic neuroendocrine tumour 88.70 13.32 28 64867 403 63423724
Acne 88.41 13.32 114 64781 23179 63400948
Sinusitis 86.85 13.32 63 64832 226590 63197537
Carbohydrate antigen 15-3 increased 86.82 13.32 38 64857 1410 63422717
Dysgeusia 86.23 13.32 164 64731 46546 63377581
Weight increased 85.82 13.32 84 64811 260708 63163419
Infusion site coldness 84.08 13.32 23 64872 193 63423934
Treatment failure 83.46 13.32 50 64845 198993 63225134
Arthralgia 82.64 13.32 302 64593 569408 62854719
Gamma-glutamyltransferase increased 81.58 13.32 134 64761 33897 63390230
Helicobacter infection 81.54 13.32 3 64892 92782 63331345
Off label use 80.83 13.32 385 64510 674077 62750050
Blood lactate dehydrogenase increased 79.81 13.32 108 64787 23008 63401119
Diabetes mellitus 79.44 13.32 176 64719 55634 63368493
Gamma-glutamyltransferase decreased 79.43 13.32 24 64871 296 63423831
Glossodynia 79.21 13.32 42 64853 178834 63245293
Pain 76.88 13.32 444 64451 740184 62683943
Lymphoedema 76.58 13.32 76 64819 11616 63412511
Hypertriglyceridaemia 76.28 13.32 58 64837 6201 63417926
Therapeutic product effect incomplete 74.63 13.32 18 64877 125038 63299089
Intentional product use issue 71.42 13.32 21 64874 127871 63296256
Drug intolerance 71.40 13.32 129 64766 308532 63115595
Bone lesion 70.58 13.32 54 64841 5827 63418300
Pericardial effusion 70.23 13.32 117 64778 29941 63394186
Concomitant disease progression 69.94 13.32 37 64858 2097 63422030
Renal impairment 69.93 13.32 224 64671 88131 63335996
Product dose omission issue 69.80 13.32 82 64813 234231 63189896
Mobility decreased 69.31 13.32 19 64876 121140 63302987
Blood chromogranin A increased 68.42 13.32 21 64874 274 63423853
Irritable bowel syndrome 68.10 13.32 4 64891 82408 63341719
Weight decreased 68.00 13.32 500 64395 276298 63147829
Therapy cessation 66.46 13.32 115 64780 30342 63393785
Polyomavirus-associated nephropathy 66.17 13.32 34 64861 1814 63422313
Dyspnoea 66.04 13.32 994 63901 660319 62763808
Nephritic syndrome 65.73 13.32 21 64874 315 63423812
Thrombocytopenia 65.53 13.32 317 64578 150840 63273287
Nail disorder 64.61 13.32 73 64822 12942 63411185
Device related thrombosis 64.37 13.32 33 64862 1752 63422375
Bone pain 64.33 13.32 160 64735 54481 63369646
Loss of personal independence in daily activities 64.29 13.32 11 64884 97279 63326848
Lower respiratory tract infection 63.23 13.32 28 64867 132279 63291848
Product use issue 62.70 13.32 80 64815 220440 63203687
Kidney transplant rejection 62.04 13.32 44 64851 4227 63419900
Hypophosphataemia 61.75 13.32 67 64828 11359 63412768
Drug abuse 61.54 13.32 3 64892 72515 63351612
Product use in unapproved indication 61.44 13.32 352 64543 178728 63245399
Post transplant lymphoproliferative disorder 59.95 13.32 46 64849 4985 63419142
Arthritis 59.52 13.32 22 64873 115899 63308228
Needle issue 58.10 13.32 62 64833 10314 63413813
Cell marker increased 57.03 13.32 18 64877 259 63423868
Feeding disorder 56.45 13.32 69 64826 13293 63410834
Alopecia 56.36 13.32 168 64727 337368 63086759
Abdominal lymphadenopathy 56.15 13.32 23 64872 722 63423405
Liver transplant rejection 56.05 13.32 28 64867 1407 63422720
Abdominal discomfort 54.81 13.32 158 64737 320727 63103400
Metastases to the mediastinum 54.33 13.32 20 64875 468 63423659
Palmar-plantar erythrodysaesthesia syndrome 52.98 13.32 89 64806 22926 63401201
Body temperature decreased 52.79 13.32 83 64812 20236 63403891
Breast cancer recurrent 52.40 13.32 40 64855 4301 63419826
Swelling 52.01 13.32 129 64766 275249 63148878
Polyneuropathy 51.64 13.32 69 64826 14520 63409607
Hepatic enzyme increased 50.95 13.32 80 64815 202248 63221879
Hormone receptor positive breast cancer 48.65 13.32 19 64876 525 63423602
Eating disorder 48.46 13.32 77 64818 18939 63405188
Lymphadenopathy mediastinal 48.04 13.32 32 64863 2776 63421351
Suicide attempt 47.31 13.32 4 64891 60914 63363213
Metastases to chest wall 47.07 13.32 19 64876 574 63423553
Concomitant disease aggravated 46.76 13.32 52 64843 9060 63415067
West Nile viral infection 46.74 13.32 17 64878 384 63423743
Viraemia 46.51 13.32 24 64871 1292 63422835
Folliculitis 46.34 13.32 8 64887 70309 63353818
Overdose 45.35 13.32 31 64864 115047 63309080
Bradycardia 44.75 13.32 10 64885 73217 63350910
Parvovirus B19 infection 44.71 13.32 18 64877 540 63423587
Somnolence 44.65 13.32 71 64824 178614 63245513
Renal tubular necrosis 43.31 13.32 57 64838 11821 63412306
Spinal pain 43.26 13.32 60 64835 13079 63411048
Malignant pleural effusion 42.91 13.32 29 64866 2577 63421550
Ill-defined disorder 42.84 13.32 15 64880 81740 63342387
Pneumocystis jirovecii pneumonia 42.43 13.32 68 64827 16846 63407281
Infusion site induration 42.36 13.32 22 64873 1200 63422927
Dehydration 41.85 13.32 312 64583 173042 63251085
Oncologic complication 40.87 13.32 13 64882 192 63423935
Pancreatic neuroendocrine tumour metastatic 40.79 13.32 9 64886 26 63424101
Karnofsky scale worsened 40.62 13.32 8 64887 10 63424117
Hepatic neoplasm 40.39 13.32 25 64870 1911 63422216
Adverse event 39.76 13.32 10 64885 67549 63356578
Complications of transplanted kidney 39.35 13.32 27 64868 2459 63421668
Injury 39.14 13.32 13 64882 73234 63350893
Drug level decreased 38.60 13.32 44 64851 7875 63416252
Cholangitis 38.00 13.32 37 64858 5524 63418603
Neoplasm 37.83 13.32 42 64853 7303 63416824
Psoriasis 37.62 13.32 21 64874 86936 63337191
Proteinuria 37.54 13.32 69 64826 19076 63405051
Suicidal ideation 37.20 13.32 9 64886 62412 63361715
Osteoarthritis 37.14 13.32 26 64869 95317 63328810
Depression 37.11 13.32 92 64803 196400 63227727
Haemoglobin decreased 36.92 13.32 265 64630 145220 63278907
Onychoclasis 36.30 13.32 38 64857 6184 63417943
Injection site hypersensitivity 36.12 13.32 24 64871 2073 63422054
Hypotension 35.88 13.32 150 64745 272454 63151673
Blood alkaline phosphatase increased 35.87 13.32 111 64784 42856 63381271
Headache 35.85 13.32 445 64450 632796 62791331
Injection site reaction 35.75 13.32 8 64887 58516 63365611
Liver injury 35.53 13.32 9 64886 60511 63363616
Skin toxicity 35.32 13.32 33 64862 4681 63419446
Cachexia 35.26 13.32 36 64859 5690 63418437
Gastrointestinal disorder 34.86 13.32 50 64845 131189 63292938
Carcinoembryonic antigen increased 34.83 13.32 22 64873 1743 63422384
Metastases to thorax 34.64 13.32 12 64883 234 63423893
Mean cell haemoglobin decreased 34.54 13.32 34 64861 5145 63418982
Post-traumatic neck syndrome 33.96 13.32 23 64872 2051 63422076
Platelet count decreased 33.92 13.32 219 64676 115903 63308224
Fatigue 33.71 13.32 1164 63731 886864 62537263
Metastases to pelvis 33.66 13.32 14 64881 457 63423670
Dry skin 33.59 13.32 131 64764 56756 63367371
Adverse drug reaction 33.42 13.32 20 64875 79694 63344433
Muscle contractions involuntary 33.27 13.32 24 64871 2368 63421759
Heart transplant rejection 33.21 13.32 15 64880 600 63423527
Anaphylactic reaction 33.16 13.32 13 64882 66087 63358040
Hypophagia 33.13 13.32 88 64807 31171 63392956
Glomerular filtration rate decreased 32.31 13.32 53 64842 13388 63410739
Asthenia 32.27 13.32 561 64334 383043 63041084
Congenital coronary artery malformation 32.06 13.32 10 64885 138 63423989
Metastases to muscle 32.06 13.32 10 64885 138 63423989
Hyperhidrosis 31.80 13.32 38 64857 107798 63316329
Confusional state 31.76 13.32 129 64766 236251 63187876
Breast cancer 31.53 13.32 115 64780 48268 63375859
Injection site mass 31.37 13.32 63 64832 18593 63405534
Pseudocirrhosis 31.22 13.32 15 64880 692 63423435
Abdominal distension 30.82 13.32 172 64723 86443 63337684
Nephrotic syndrome 30.66 13.32 33 64862 5543 63418584
Neutropenia 30.56 13.32 293 64602 174712 63249415
Cardiac failure 30.38 13.32 175 64720 88967 63335160
Chronic obstructive pulmonary disease 30.36 13.32 13 64882 62673 63361454
Metastases to adrenals 30.09 13.32 15 64880 750 63423377
Injection site pruritus 30.02 13.32 5 64890 45111 63379016
Cytomegalovirus infection 29.72 13.32 66 64829 20886 63403241
Unevaluable event 29.49 13.32 8 64887 51378 63372749
Joint stiffness 29.33 13.32 4 64891 41865 63382262
Reflux gastritis 28.99 13.32 17 64878 1178 63422949
Vasodilatation 28.76 13.32 22 64873 2373 63421754
Bone cancer 28.52 13.32 18 64877 1424 63422703
Flatulence 28.37 13.32 89 64806 34613 63389514
Ingrowing nail 28.32 13.32 22 64873 2427 63421700
Metastases to kidney 28.22 13.32 10 64885 209 63423918
Hepatic angiosarcoma 27.82 13.32 6 64889 15 63424112
Soft tissue sarcoma 27.46 13.32 9 64886 147 63423980
Neuroendocrine tumour 27.30 13.32 14 64881 744 63423383
Intestinal metastasis 27.18 13.32 9 64886 152 63423975
Injection site erythema 27.07 13.32 27 64868 83147 63340980
Ovarian cyst 27.00 13.32 54 64841 15891 63408236
Nasopharyngitis 26.99 13.32 151 64744 254106 63170021
Lymphocyte count decreased 26.98 13.32 80 64815 30177 63393950
Blood pressure fluctuation 26.98 13.32 7 64888 46310 63377817
Red blood cell sedimentation rate increased 26.88 13.32 6 64889 43976 63380151
Immunosuppressant drug level decreased 26.84 13.32 15 64880 948 63423179
Blister 26.73 13.32 58 64837 129756 63294371
Pleural neoplasm 26.42 13.32 11 64884 360 63423767
Lymphocele 26.31 13.32 14 64881 803 63423324
Drug level increased 26.14 13.32 66 64829 22670 63401457
Gait disturbance 25.85 13.32 98 64797 183080 63241047
Renal failure 25.73 13.32 207 64688 117445 63306682
Memory impairment 25.49 13.32 42 64853 104216 63319911
Epstein-Barr virus infection 25.37 13.32 36 64859 8014 63416113
Multiple organ dysfunction syndrome 25.27 13.32 120 64775 56632 63367495
Treatment noncompliance 25.14 13.32 4 64891 37321 63386806
Injection site pain 25.10 13.32 60 64835 129740 63294387
Agitation 25.04 13.32 15 64880 59742 63364385
Exposed bone in jaw 24.90 13.32 22 64873 2903 63421224
Cognitive disorder 24.84 13.32 13 64882 55802 63368325
Eyelid oedema 24.75 13.32 41 64854 10438 63413689
Blood pressure systolic increased 24.69 13.32 105 64790 47292 63376835
Balance disorder 24.62 13.32 30 64865 84392 63339735
Metastases to bladder 24.35 13.32 9 64886 213 63423914
Dizziness 24.32 13.32 302 64593 429623 62994504
Jejunal ulcer perforation 23.97 13.32 6 64889 34 63424093
Lymphadenopathy 23.88 13.32 90 64805 38368 63385759
Urticaria 23.85 13.32 88 64807 165714 63258413
Carcinoid tumour pulmonary 23.75 13.32 11 64884 467 63423660
Insulinoma 23.65 13.32 7 64888 80 63424047
Therapy change 23.44 13.32 30 64865 6051 63418076
Leukopenia 23.32 13.32 147 64748 77143 63346984
Recurrent cancer 23.31 13.32 18 64877 1969 63422158
Nasal discharge discolouration 23.27 13.32 19 64876 2252 63421875
Cancer pain 23.18 13.32 22 64873 3183 63420944
Asthma 23.09 13.32 61 64834 127500 63296627
Angiosarcoma 23.07 13.32 9 64886 248 63423879
Joint range of motion decreased 22.95 13.32 3 64892 32425 63391702
Hepatic mass 22.64 13.32 17 64878 1783 63422344
Hallucination 22.63 13.32 14 64881 54803 63369324
Cardio-respiratory arrest 22.50 13.32 17 64878 59942 63364185
Blood creatinine decreased 22.40 13.32 28 64867 5517 63418610
Pulmonary mass 22.33 13.32 62 64833 22534 63401593
Urine output decreased 22.32 13.32 41 64854 11329 63412798
Hepatic function abnormal 22.30 13.32 86 64809 37056 63387071
Nephropathy toxic 22.27 13.32 37 64858 9442 63414685
Lymphangitis 22.26 13.32 13 64882 894 63423233
Aspartate aminotransferase increased 22.06 13.32 163 64732 90114 63334013
Kidney fibrosis 21.98 13.32 17 64878 1864 63422263
Drug reaction with eosinophilia and systemic symptoms 21.96 13.32 4 64891 33832 63390295
Lactic acidosis 21.89 13.32 6 64889 38281 63385846
Plasma cell myeloma 21.74 13.32 5 64890 35900 63388227
Visual impairment 21.61 13.32 33 64862 84413 63339714
Pulmonary tumour thrombotic microangiopathy 21.46 13.32 6 64889 55 63424072
Aortitis salmonella 21.41 13.32 5 64890 20 63424107
Hepatitis E 21.26 13.32 15 64880 1429 63422698
Myocardial infarction 21.09 13.32 44 64851 99849 63324278
Cardiac arrest 21.06 13.32 39 64856 92506 63331621
Tumour necrosis 20.79 13.32 12 64883 807 63423320
Toxicity to various agents 20.58 13.32 158 64737 247092 63177035
Hypercholesterolaemia 20.55 13.32 58 64837 21276 63402851
Amnesia 20.55 13.32 16 64879 55569 63368558
Sedation 20.53 13.32 7 64888 38802 63385325
Metastases to stomach 20.39 13.32 8 64887 224 63423903
Peripheral coldness 20.36 13.32 41 64854 12124 63412003
Japanese spotted fever 20.34 13.32 5 64890 26 63424101
Kidney congestion 20.34 13.32 5 64890 26 63424101
Ageusia 20.32 13.32 44 64851 13684 63410443
Cheilitis 20.29 13.32 23 64872 4090 63420037
Loss of consciousness 20.24 13.32 58 64837 118063 63306064
Cerebrovascular accident 20.05 13.32 51 64844 107973 63316154
Skin sensitisation 19.88 13.32 12 64883 877 63423250
Vision blurred 19.82 13.32 40 64855 91884 63332243
Abortion spontaneous 19.56 13.32 12 64883 47183 63376944
Pneumothorax 19.53 13.32 48 64847 16213 63407914
Tongue ulceration 19.42 13.32 21 64874 3545 63420582
Generalised oedema 19.33 13.32 47 64848 15771 63408356
Cerebral ventricle collapse 19.33 13.32 5 64890 33 63424094
C-reactive protein increased 19.30 13.32 164 64731 94543 63329584
Metastases to spleen 19.21 13.32 7 64888 159 63423968
Metastases to meninges 19.08 13.32 18 64877 2584 63421543
Tumour pain 19.03 13.32 14 64881 1423 63422704
Sleep disorder 18.90 13.32 34 64861 81532 63342595
Hepatic atrophy 18.85 13.32 8 64887 275 63423852
Emotional distress 18.80 13.32 5 64890 32544 63391583
Neutrophil count decreased 18.74 13.32 110 64785 56296 63367831
Oral herpes 18.73 13.32 64 64831 26010 63398117
Odynophagia 18.64 13.32 30 64865 7456 63416671
Hepatic failure 18.58 13.32 79 64816 35577 63388550
Organising pneumonia 18.45 13.32 26 64869 5750 63418377
Therapeutic product effective for unapproved indication 18.42 13.32 6 64889 96 63424031
Eastern Cooperative Oncology Group performance status worsened 18.40 13.32 13 64882 1241 63422886
Toothache 18.31 13.32 52 64843 19147 63404980
Lymphangioleiomyomatosis 18.22 13.32 7 64888 185 63423942
Hormone refractory breast cancer 18.02 13.32 4 64891 12 63424115
Subileus 17.81 13.32 19 64876 3160 63420967
Vein disorder 17.71 13.32 24 64871 5117 63419010
Neutrophilic panniculitis 17.41 13.32 5 64890 51 63424076
Invasive lobular breast carcinoma 17.27 13.32 11 64884 884 63423243
Bowel movement irregularity 17.27 13.32 24 64871 5240 63418887
Biliary dilatation 17.22 13.32 16 64879 2253 63421874
Oral mucosal blistering 17.13 13.32 25 64870 5708 63418419
Rhabdomyolysis 17.09 13.32 12 64883 43939 63380188
Crepitations 17.07 13.32 30 64865 8010 63416117
COVID-19 16.95 13.32 59 64836 113044 63311083
Alveolar proteinosis 16.90 13.32 8 64887 357 63423770
Mediastinal disorder 16.77 13.32 8 64887 363 63423764
Device dislocation 16.77 13.32 3 64892 25702 63398425
Incorrect dose administered 16.77 13.32 22 64873 59946 63364181
Varicella zoster virus infection 16.73 13.32 17 64878 2672 63421455
Orthostatic hypotension 16.72 13.32 8 64887 36152 63387975
Foot deformity 16.62 13.32 4 64891 27849 63396278
Presyncope 16.56 13.32 4 64891 27781 63396346
Transient ischaemic attack 16.49 13.32 9 64886 37744 63386383
Tumour marker abnormal 16.45 13.32 8 64887 379 63423748
Carcinoid tumour 16.37 13.32 8 64887 383 63423744
Post transplant distal limb syndrome 16.35 13.32 7 64888 246 63423881
Renal lymphocele 16.31 13.32 5 64890 65 63424062
Renal transplant failure 16.30 13.32 10 64885 752 63423375
Tinnitus 16.30 13.32 8 64887 35620 63388507
Bronchitis 16.25 13.32 69 64826 124866 63299261
Abdominal pain 16.05 13.32 403 64492 293053 63131074
Cornea verticillata 16.00 13.32 6 64889 148 63423979
Pancreatic steatosis 16.00 13.32 11 64884 1005 63423122
Mouth injury 15.99 13.32 11 64884 1006 63423121
Anorexia nervosa 15.91 13.32 7 64888 263 63423864
Febrile infection 15.90 13.32 13 64882 1544 63422583
Sleep apnoea syndrome 15.86 13.32 5 64890 29128 63394999
Anal ulcer 15.78 13.32 9 64886 592 63423535
Tonic convulsion 15.76 13.32 12 64883 1285 63422842
Hormone receptor positive HER2 negative breast cancer 15.71 13.32 6 64889 156 63423971
Impaired healing 15.69 13.32 53 64842 102489 63321638
Splenic lesion 15.69 13.32 7 64888 272 63423855
Mucinous breast carcinoma 15.65 13.32 4 64891 25 63424102
Wheezing 15.61 13.32 48 64847 95547 63328580
Vomiting 15.60 13.32 710 64185 558907 62865220
Hydronephrosis 15.59 13.32 34 64861 10628 63413499
Vasoactive intestinal polypeptide increased 15.58 13.32 3 64892 3 63424124
Primary pulmonary melanoma 15.58 13.32 3 64892 3 63424124
Macular degeneration 15.57 13.32 3 64892 24373 63399754
Wrong technique in product usage process 15.34 13.32 25 64870 62315 63361812
Delayed graft function 15.28 13.32 11 64884 1082 63423045
Impaired insulin secretion 15.26 13.32 4 64891 28 63424099
Product prescribing error 15.26 13.32 4 64891 26285 63397842
International normalised ratio increased 15.19 13.32 15 64880 46410 63377717
Metastases to ovary 15.18 13.32 8 64887 450 63423677
Syncope 15.16 13.32 65 64830 117320 63306807
Premature delivery 15.11 13.32 6 64889 30275 63393852
Pneumonia 15.09 13.32 590 64305 456177 62967950
Colitis ulcerative 15.08 13.32 4 64891 26087 63398040
Uterine mass 15.05 13.32 7 64888 300 63423827
Metastases to breast 15.03 13.32 7 64888 301 63423826
Carcinoid heart disease 15.02 13.32 4 64891 30 63424097
Retinal detachment 14.97 13.32 24 64871 5945 63418182
Infusion site haemorrhage 14.94 13.32 22 64873 5064 63419063
Basal cell carcinoma 14.89 13.32 5 64890 27986 63396141
Muscle spasms 14.84 13.32 96 64799 156054 63268073
Aortic intramural haematoma 14.65 13.32 5 64890 93 63424034
Noninfective gingivitis 14.65 13.32 12 64883 1429 63422698
Bursitis 14.55 13.32 10 64885 37031 63387096
Steatorrhoea 14.53 13.32 8 64887 491 63423636
Peritoneal disorder 14.49 13.32 8 64887 494 63423633
Dysplasia 14.48 13.32 10 64885 920 63423207
Focal segmental glomerulosclerosis 14.45 13.32 12 64883 1456 63422671
Skin lesion 14.44 13.32 66 64829 30655 63393472
Ascariasis 14.37 13.32 3 64892 6 63424121
Pleural mass 14.37 13.32 3 64892 6 63424121
Ovarian cyst torsion 14.37 13.32 3 64892 6 63424121
Dermatitis 14.33 13.32 44 64851 16914 63407213
Blood cholesterol increased 14.27 13.32 153 64742 93879 63330248
Depressed level of consciousness 14.27 13.32 26 64869 62052 63362075
Gastrooesophageal reflux disease 14.25 13.32 50 64845 95589 63328538
Intestinal obstruction 14.24 13.32 66 64829 30833 63393294
Atypical pneumonia 14.20 13.32 20 64875 4420 63419707
Osteoporosis 14.10 13.32 23 64872 57315 63366812
Stevens-Johnson syndrome 14.10 13.32 4 64891 24946 63399181
Haemolytic uraemic syndrome 14.09 13.32 15 64880 2488 63421639
Sciatica 13.85 13.32 9 64886 34315 63389812
Oral disorder 13.82 13.32 29 64866 8825 63415302
Burning sensation mucosal 13.82 13.32 4 64891 42 63424085
Hypoaesthesia 13.82 13.32 108 64787 168285 63255842
Central nervous system viral infection 13.79 13.32 5 64890 112 63424015
Oral administration complication 13.79 13.32 5 64890 112 63424015
Therapeutic product ineffective for unapproved indication 13.77 13.32 6 64889 220 63423907
Dyslipidaemia 13.69 13.32 26 64869 7367 63416760
Radiation pneumonitis 13.66 13.32 12 64883 1571 63422556
Choroid melanoma 13.65 13.32 4 64891 44 63424083
Eosinophil cationic protein increased 13.65 13.32 4 64891 44 63424083
Atrial fibrillation 13.63 13.32 67 64828 116569 63307558
Perineal ulceration 13.57 13.32 4 64891 45 63424082
Pneumonitis chemical 13.52 13.32 6 64889 230 63423897
Pancreatitis viral 13.51 13.32 3 64892 9 63424118
Mass 13.43 13.32 38 64857 13962 63410165
Portal hypertension 13.42 13.32 18 64877 3801 63420326
Oxygen saturation decreased 13.41 13.32 46 64849 88539 63335588
Muscular weakness 13.33 13.32 72 64823 122281 63301846

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
Malignant neoplasm progression 983.25 12.84 847 43712 87199 34825173
Stomatitis 634.22 12.84 485 44074 42029 34870343
Neoplasm malignant 325.16 12.84 240 44319 19665 34892707
Neoplasm progression 277.12 12.84 233 44326 23067 34889305
Metastases to liver 210.27 12.84 159 44400 13504 34898868
Metastases to lung 181.21 12.84 125 44434 9195 34903177
Pneumonitis 175.24 12.84 216 44343 33662 34878710
Polyomavirus-associated nephropathy 159.67 12.84 84 44475 3760 34908612
Diarrhoea 149.95 12.84 927 43632 388985 34523387
Interstitial lung disease 149.53 12.84 285 44274 64997 34847375
Polyomavirus viraemia 145.02 12.84 52 44507 893 34911479
Kidney transplant rejection 142.10 12.84 99 44460 7398 34904974
Post transplant lymphoproliferative disorder 137.48 12.84 92 44467 6436 34905936
BK virus infection 125.99 12.84 83 44476 5655 34906717
Oral pain 113.92 12.84 101 44458 10726 34901646
Mouth ulceration 113.33 12.84 105 44454 11805 34900567
Death 109.65 12.84 873 43686 397176 34515196
Proteinuria 108.07 12.84 126 44433 18516 34893856
Drug abuse 105.34 12.84 5 44554 99091 34813281
Cough 102.88 12.84 421 44138 149719 34762653
Transplant rejection 98.29 12.84 91 44468 10220 34902152
Decreased appetite 97.47 12.84 445 44114 165947 34746425
Liver transplant rejection 95.74 12.84 49 44510 2070 34910302
Metastases to bone 94.06 12.84 95 44464 11875 34900497
Viraemia 90.90 12.84 40 44519 1198 34911174
Hepatitis E 90.68 12.84 47 44512 2039 34910333
Immunosuppressant drug level decreased 90.41 12.84 40 44519 1214 34911158
Heart transplant rejection 87.89 12.84 39 44520 1192 34911180
Renal impairment 87.32 12.84 292 44267 94221 34818151
Thrombotic microangiopathy 86.53 12.84 86 44473 10544 34901828
Acne 81.83 12.84 85 44474 10981 34901391
Hyperglycaemia 76.69 12.84 161 44398 39319 34873053
Mucosal inflammation 70.98 12.84 154 44405 38468 34873904
Fatigue 68.99 12.84 748 43811 369905 34542467
C-reactive protein increased 67.67 12.84 186 44373 53912 34858460
Cytomegalovirus infection 65.90 12.84 119 44440 26016 34886356
Concomitant disease progression 64.13 12.84 40 44519 2478 34909894
Lymphocele 63.11 12.84 32 44527 1325 34911047
Fall 62.93 12.84 101 44458 202784 34709588
Blood creatinine increased 62.34 12.84 263 44296 94713 34817659
Lung disorder 62.22 12.84 137 44422 34559 34877813
Product use in unapproved indication 61.24 12.84 304 44255 117195 34795177
Complications of transplanted kidney 60.83 12.84 49 44510 4560 34907812
Blood chromogranin A increased 60.81 12.84 20 44539 261 34912111
Immunosuppressant drug level increased 60.75 12.84 55 44504 6000 34906372
Gamma-glutamyltransferase increased 60.04 12.84 122 44437 29109 34883263
Pleural effusion 60.02 12.84 234 44325 81312 34831060
Bradycardia 49.75 12.84 17 44542 75401 34836971
Hypotension 49.58 12.84 133 44426 221516 34690856
Aphthous ulcer 49.38 12.84 45 44514 4950 34907422
Cholangitis 49.13 12.84 58 44501 8631 34903741
Epstein-Barr virus infection 48.33 12.84 54 44505 7574 34904798
Renal transplant failure 48.30 12.84 25 44534 1081 34911291
Atrial fibrillation 48.11 12.84 51 44508 122342 34790030
Hepatic lesion 48.01 12.84 39 44520 3673 34908699
Blood pressure increased 46.63 12.84 229 44330 87873 34824499
Lung infiltration 46.41 12.84 69 44490 12836 34899536
Drug ineffective 46.38 12.84 367 44192 456384 34455988
Second primary malignancy 45.19 12.84 53 44506 7833 34904539
Oedema peripheral 44.48 12.84 283 44276 119529 34792843
Renal tubular atrophy 44.14 12.84 24 44535 1148 34911224
Acanthoma 43.62 12.84 10 44549 27 34912345
Human herpesvirus 8 infection 42.47 12.84 22 44537 953 34911419
Condition aggravated 42.45 12.84 116 44443 192080 34720292
Osteonecrosis of jaw 42.00 12.84 79 44480 17810 34894562
Metastases to lymph nodes 41.75 12.84 40 44519 4688 34907684
Myocardial infarction 41.68 12.84 56 44503 121029 34791343
Needle issue 41.40 12.84 45 44514 6120 34906252
Bile duct stenosis 40.68 12.84 23 44536 1188 34911184
Drug hypersensitivity 39.66 12.84 27 44532 80502 34831870
Pyrexia 38.66 12.84 617 43942 332396 34579976
Metastasis 38.38 12.84 36 44523 4108 34908264
Palmar-plantar erythrodysaesthesia syndrome 37.99 12.84 73 44486 16722 34895650
Electrocardiogram QT prolonged 37.95 12.84 4 44555 40948 34871424
Epistaxis 37.94 12.84 161 44398 58090 34854282
Metastases to peritoneum 36.46 12.84 25 44534 1819 34910553
Carcinoid crisis 35.28 12.84 13 44546 242 34912130
Lymphangiosis carcinomatosa 34.86 12.84 19 44540 913 34911459
Suicidal ideation 34.85 12.84 5 44554 40383 34871989
Chronic allograft nephropathy 34.64 12.84 21 44538 1236 34911136
Vascular hyalinosis 34.58 12.84 10 44549 82 34912290
Intentional product misuse 34.30 12.84 8 44551 45603 34866769
Metastases to central nervous system 34.10 12.84 47 44512 8158 34904214
Pancreatic neuroendocrine tumour metastatic 33.56 12.84 10 44549 92 34912280
Squamous cell carcinoma of skin 33.29 12.84 54 44505 10827 34901545
Anaemia 33.20 12.84 448 44111 232887 34679485
Product dose omission issue 33.07 12.84 64 44495 119647 34792725
Weight decreased 32.70 12.84 356 44203 175945 34736427
Dizziness 32.28 12.84 156 44403 218365 34694007
Kidney fibrosis 32.22 12.84 25 44534 2203 34910169
Foetal exposure during pregnancy 32.22 12.84 5 44554 38096 34874276
Metastases to gastrointestinal tract 31.54 12.84 9 44550 70 34912302
Febrile neutropenia 31.40 12.84 81 44478 136768 34775604
Depression 31.33 12.84 47 44512 97051 34815321
Somnolence 31.05 12.84 59 44500 111057 34801315
Paraesthesia 30.95 12.84 22 44537 64150 34848222
Psoriasis 30.84 12.84 6 44553 38806 34873566
Musculoskeletal stiffness 29.96 12.84 11 44548 46669 34865703
Blood pressure systolic increased 29.76 12.84 80 44479 22872 34889500
Loss of consciousness 29.70 12.84 37 44522 82630 34829742
Tachycardia 29.37 12.84 39 44520 84733 34827639
Haemoglobin decreased 29.29 12.84 258 44301 120514 34791858
Asthma 29.21 12.84 9 44550 42647 34869725
International normalised ratio increased 28.98 12.84 12 44547 47315 34865057
Disease progression 28.91 12.84 236 44323 107841 34804531
Cardiac arrest 28.71 12.84 49 44510 96110 34816262
Angiomyolipoma 28.33 12.84 5 44554 0 34912372
Pancreatic neuroendocrine tumour 27.74 12.84 11 44548 252 34912120
Metastases to pleura 27.71 12.84 13 44546 453 34911919
Isosporiasis 27.68 12.84 9 44550 113 34912259
Blood alkaline phosphatase increased 26.70 12.84 94 44465 31081 34881291
Off label use 26.61 12.84 376 44183 419148 34493224
Cardio-respiratory arrest 26.59 12.84 19 44540 55254 34857118
Metastases to pancreas 26.51 12.84 11 44548 284 34912088
Gastric ulcer haemorrhage, obstructive 26.22 12.84 6 44553 16 34912356
Therapeutic product effect incomplete 26.16 12.84 16 44543 50525 34861847
Hypercholesterolaemia 26.15 12.84 43 44516 8719 34903653
Hypertriglyceridaemia 25.94 12.84 42 44517 8406 34903966
Coma 25.76 12.84 13 44546 45665 34866707
Metastases to adrenals 25.58 12.84 16 44543 996 34911376
Granulomatous rosacea 25.51 12.84 9 44550 147 34912225
Drug level decreased 25.46 12.84 40 44519 7806 34904566
Insulinoma 25.23 12.84 6 44553 20 34912352
General physical health deterioration 25.15 12.84 262 44297 128007 34784365
Pseudohypoaldosteronism 24.87 12.84 5 44554 5 34912367
Hypoaesthesia 24.81 12.84 25 44534 61419 34850953
Agitation 24.76 12.84 22 44537 57377 34854995
Human polyomavirus infection 24.64 12.84 14 44545 730 34911642
Chronic obstructive pulmonary disease 24.62 12.84 16 44543 48902 34863470
Hallucination 24.38 12.84 18 44541 51480 34860892
Prostate cancer 24.36 12.84 10 44549 39639 34872733
Anxiety 24.25 12.84 57 44502 99371 34813001
Neuroendocrine tumour 24.11 12.84 14 44545 761 34911611
Hyperhidrosis 24.06 12.84 37 44522 75655 34836717
Overdose 24.01 12.84 50 44509 91009 34821363
Neoplasm 23.75 12.84 32 44527 5435 34906937
Intentional product use issue 23.40 12.84 25 44534 59791 34852581
Parvovirus B19 infection 22.83 12.84 14 44545 841 34911531
Blood gastrin increased 22.81 12.84 6 44553 33 34912339
Loss of personal independence in daily activities 22.72 12.84 7 44552 33172 34879200
Accidental exposure to product packaging 22.67 12.84 4 44555 0 34912372
Neuropathy peripheral 22.56 12.84 45 44514 83218 34829154
Neutropenia 22.50 12.84 113 44446 156665 34755707
Ascites 22.47 12.84 118 44441 46453 34865919
Cell marker increased 22.40 12.84 11 44548 425 34911947
Abdominal pain 22.35 12.84 312 44247 163306 34749066
Superinfection viral 22.23 12.84 5 44554 12 34912360
Dysgeusia 21.93 12.84 79 44480 26418 34885954
Bone pain 21.87 12.84 67 44492 20619 34891753
Hepatic artery stenosis 21.86 12.84 8 44551 146 34912226
Syncope 21.84 12.84 53 44506 91398 34820974
Actinic keratosis 21.81 12.84 28 44531 4539 34907833
Cardiac failure congestive 21.72 12.84 46 44513 83224 34829148
Anorectal varices 21.45 12.84 6 44553 43 34912329
Haemolytic uraemic syndrome 21.44 12.84 20 44539 2266 34910106
Transitional cell carcinoma metastatic 21.33 12.84 6 44553 44 34912328
Metastases to spine 21.20 12.84 21 44538 2563 34909809
Blood lactate dehydrogenase increased 21.15 12.84 71 44488 22919 34889453
Lactic acidosis 20.99 12.84 9 44550 34763 34877609
Treatment noncompliance 20.98 12.84 5 44554 28095 34884277
Biliary anastomosis complication 20.64 12.84 7 44552 101 34912271
Cerebrovascular accident 20.37 12.84 49 44510 84762 34827610
Renal cancer metastatic 20.31 12.84 11 44548 522 34911850
Gastrointestinal ulcer perforation 20.15 12.84 6 44553 55 34912317
Anaphylactic reaction 20.08 12.84 8 44551 32293 34880079
Metastases to the mediastinum 20.07 12.84 9 44550 282 34912090
Muscle spasms 19.92 12.84 41 44518 74960 34837412
Donor specific antibody present 19.92 12.84 7 44552 113 34912259
Concomitant disease aggravated 19.81 12.84 30 44529 5671 34906701
Polyomavirus test positive 19.81 12.84 7 44552 115 34912257
Arthropathy 19.68 12.84 5 44554 26902 34885470
Cardiogenic shock 19.37 12.84 5 44554 26613 34885759
Complications of transplanted heart 19.36 12.84 9 44550 307 34912065
Cytokine release syndrome 19.35 12.84 3 44556 22874 34889498
Crepitations 19.18 12.84 22 44537 3174 34909198
Tumour compression 19.11 12.84 7 44552 128 34912244
Dehydration 19.03 12.84 251 44308 129718 34782654
Necrosis of artery 19.01 12.84 4 44555 6 34912366
Diabetes mellitus 18.79 12.84 113 44446 46760 34865612
Dyslipidaemia 18.74 12.84 34 44525 7454 34904918
Carcinoid tumour pulmonary 18.63 12.84 4 44555 7 34912365
Ileal ulcer 18.59 12.84 11 44548 619 34911753
Drug level increased 18.38 12.84 66 44493 22030 34890342
Obstructive nephropathy 18.11 12.84 5 44554 34 34912338
Erythrophagocytosis 17.98 12.84 5 44554 35 34912337
Toxic epidermal necrolysis 17.94 12.84 3 44556 21643 34890729
Feeding disorder 17.76 12.84 32 44527 6978 34905394
Contraindicated product administered 17.75 12.84 3 44556 21478 34890894
Transitional cell cancer of renal pelvis and ureter metastatic 17.67 12.84 4 44555 10 34912362
Eating disorder 17.64 12.84 35 44524 8205 34904167
Muscular weakness 17.60 12.84 42 44517 72855 34839517
Body temperature decreased 17.47 12.84 46 44513 12988 34899384
Hepatic vein stenosis 17.39 12.84 4 44555 11 34912361
Incisional hernia 17.25 12.84 14 44545 1316 34911056
Coronary artery aneurysm 17.24 12.84 6 44553 94 34912278
Cell death 17.23 12.84 18 44541 2339 34910033
Rash 17.21 12.84 388 44171 222364 34690008
Rhabdomyoma 17.00 12.84 3 44556 0 34912372
Lymphatic fistula 17.00 12.84 3 44556 0 34912372
Complex regional pain syndrome 17.00 12.84 10 44549 557 34911815
Metastatic carcinoid tumour 16.89 12.84 4 44555 13 34912359
Pulmonary toxicity 16.79 12.84 29 44530 6118 34906254
Astrocytoma, low grade 16.68 12.84 5 44554 47 34912325
Onychoclasis 16.63 12.84 16 44543 1884 34910488
Carcinoid syndrome 16.57 12.84 6 44553 106 34912266
Haematochezia 16.53 12.84 21 44538 46513 34865859
Oropharyngeal pain 16.49 12.84 89 44470 35396 34876976
Gonococcal infection 16.41 12.84 5 44554 50 34912322
Oedema 16.30 12.84 107 44452 45634 34866738
Dysphonia 16.29 12.84 66 44493 23317 34889055
Asthenia 16.17 12.84 418 44141 244833 34667539
Hepatic neoplasm 16.10 12.84 16 44543 1961 34910411
Blood triglycerides increased 16.04 12.84 47 44512 14112 34898260
Bacteriuria 15.96 12.84 8 44551 323 34912049
Coronary artery disease 15.94 12.84 23 44536 48282 34864090
Blood glucose increased 15.88 12.84 142 44417 66576 34845796
Brain neoplasm 15.84 12.84 20 44539 3189 34909183
Metastases to kidney 15.78 12.84 8 44551 331 34912041
Respiratory arrest 15.78 12.84 8 44551 28035 34884337
Adverse drug reaction 15.59 12.84 9 44550 29333 34883039
Acute respiratory distress syndrome 15.54 12.84 70 44489 25899 34886473
Oxygen saturation decreased 15.53 12.84 28 44531 53790 34858582
Alveolitis necrotising 15.52 12.84 4 44555 20 34912352
Procedural hypertension 15.51 12.84 5 44554 61 34912311
Oral discomfort 15.46 12.84 18 44541 2639 34909733
Dyspnoea 15.36 12.84 606 43953 376176 34536196
Oesophageal obstruction 15.34 12.84 9 44550 499 34911873
Tumour pain 15.20 12.84 12 44547 1085 34911287
Chimerism 15.14 12.84 7 44552 236 34912136
Epstein Barr virus positive mucocutaneous ulcer 14.98 12.84 8 44551 369 34912003
Renal hamartoma 14.92 12.84 3 44556 3 34912369
Infected seroma 14.92 12.84 3 44556 3 34912369
Tuberous sclerosis complex 14.91 12.84 4 44555 24 34912348
Insomnia 14.83 12.84 75 44484 103832 34808540
Restlessness 14.75 12.84 7 44552 25475 34886897
Hernial eventration 14.57 12.84 5 44554 75 34912297
Subdural haematoma 14.54 12.84 4 44555 20417 34891955
Metastases to eye 14.44 12.84 5 44554 77 34912295
Therapy cessation 14.38 12.84 51 44508 16922 34895450
Amnesia 14.33 12.84 8 44551 26555 34885817
Bile output abnormal 14.14 12.84 4 44555 30 34912342
Bone neoplasm 14.12 12.84 7 44552 276 34912096
Renal cell carcinoma 14.03 12.84 24 44535 5024 34907348
Acquired phimosis 13.99 12.84 5 44554 85 34912287
Focal segmental glomerulosclerosis 13.98 12.84 15 44544 2010 34910362
Drug withdrawal syndrome 13.91 12.84 4 44555 19830 34892542
Unresponsive to stimuli 13.89 12.84 9 44550 27560 34884812
Gastroduodenal haemorrhage 13.78 12.84 6 44553 175 34912197
Balance disorder 13.77 12.84 19 44540 40635 34871737
Ventricular fibrillation 13.76 12.84 6 44553 22948 34889424
Disturbance in attention 13.73 12.84 8 44551 25937 34886435
Psychotic disorder 13.72 12.84 7 44552 24445 34887927
Orthostatic hypotension 13.70 12.84 8 44551 25911 34886461
Malignant ascites 13.66 12.84 8 44551 442 34911930
Renal failure 13.62 12.84 238 44321 130319 34782053
Cachexia 13.59 12.84 29 44530 7157 34905215
Lymphocyte count decreased 13.55 12.84 61 44498 22561 34889811
Depressed level of consciousness 13.55 12.84 21 44538 42820 34869552
Blood cholesterol increased 13.53 12.84 57 44502 20486 34891886
Gastrointestinal injury 13.48 12.84 8 44551 453 34911919
Unevaluable event 13.45 12.84 13 44546 32577 34879795
Metastases to pelvis 13.37 12.84 7 44552 310 34912062
Mesenteric vein thrombosis 13.32 12.84 10 44549 839 34911533
Thoracic cavity drainage 13.18 12.84 6 44553 195 34912177
Dermatosis 13.14 12.84 7 44552 321 34912051
Plasma cell myeloma 12.93 12.84 21 44538 42016 34870356
JC virus infection 12.92 12.84 15 44544 2193 34910179
Glomerulonephritis proliferative 12.90 12.84 6 44553 205 34912167
Computerised tomogram thorax abnormal 12.85 12.84 9 44550 678 34911694

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
Malignant neoplasm progression 2730.48 12.68 1700 78796 134290 79529602
Stomatitis 1245.10 12.68 1093 79403 145664 79518228
Metastases to liver 943.73 12.68 494 80002 27820 79636072
Metastases to bone 876.85 12.68 448 80048 23979 79639913
Pneumonitis 532.57 12.68 462 80034 60398 79603494
Metastases to lung 466.87 12.68 267 80229 17896 79645996
Neoplasm progression 455.51 12.68 394 80102 51288 79612604
Mucosal inflammation 311.83 12.68 383 80113 75197 79588695
Polyomavirus-associated nephropathy 308.05 12.68 138 80358 5489 79658403
Interstitial lung disease 307.36 12.68 467 80029 112133 79551759
Disease progression 306.18 12.68 614 79882 183748 79480144
Post transplant lymphoproliferative disorder 282.53 12.68 164 80332 11300 79652592
BK virus infection 280.09 12.68 149 80347 8655 79655237
Metastases to lymph nodes 262.24 12.68 151 80345 10246 79653646
Polyomavirus viraemia 248.14 12.68 85 80411 1622 79662270
Hyperglycaemia 233.20 12.68 320 80176 70015 79593877
Transplant rejection 232.10 12.68 177 80319 19260 79644632
Pleural effusion 223.58 12.68 469 80027 144793 79519099
Thrombotic microangiopathy 211.28 12.68 170 80326 19999 79643893
Kidney transplant rejection 209.50 12.68 130 80366 10116 79653776
Osteonecrosis of jaw 201.18 12.68 233 80263 42993 79620899
Death 194.53 12.68 1102 79394 565412 79098480
Cough 182.36 12.68 793 79703 365996 79297896
Infusion related reaction 179.37 12.68 14 80482 230223 79433669
Tumour marker increased 178.74 12.68 87 80409 4185 79659707
Aphthous ulcer 176.15 12.68 142 80354 16747 79647145
Mouth ulceration 175.40 12.68 205 80291 38189 79625703
Renal impairment 163.83 12.68 437 80059 157346 79506546
Hepatic lesion 156.90 12.68 94 80402 6865 79657027
Immunosuppressant drug level increased 148.72 12.68 100 80396 8927 79654965
Decreased appetite 144.68 12.68 706 79790 341712 79322180
Arthropathy 140.12 12.68 10 80486 177101 79486791
Drug abuse 138.52 12.68 6 80490 162685 79501207
Musculoskeletal stiffness 135.29 12.68 11 80485 174997 79488895
Viraemia 133.95 12.68 63 80433 2806 79661086
Condition aggravated 133.39 12.68 187 80309 500937 79162955
Synovitis 130.21 12.68 5 80491 150729 79513163
Therapeutic product effect decreased 127.50 12.68 10 80486 163853 79500039
Needle issue 123.99 12.68 104 80392 12964 79650928
Immunosuppressant drug level decreased 122.13 12.68 53 80443 1951 79661941
Fall 121.93 12.68 190 80306 487439 79176453
Proteinuria 120.13 12.68 156 80340 32346 79631546
Metastases to skin 119.24 12.68 50 80446 1689 79662203
Lung disorder 114.53 12.68 252 80244 80305 79583587
Oral pain 111.92 12.68 149 80347 31649 79632243
Pancreatic neuroendocrine tumour 111.49 12.68 37 80459 638 79663254
Product use in unapproved indication 109.83 12.68 522 79974 249837 79414055
Neoplasm malignant 108.82 12.68 147 80349 31663 79632229
Ascites 106.99 12.68 236 80260 75326 79588566
Diarrhoea 106.99 12.68 1356 79140 879133 78784759
Liver transplant rejection 106.22 12.68 56 80440 3192 79660700
Acne 105.99 12.68 134 80362 27056 79636836
Cytomegalovirus infection 105.27 12.68 169 80327 42475 79621417
Oedema peripheral 102.76 12.68 515 79981 251773 79412119
Lung infiltration 102.41 12.68 121 80375 22791 79641101
Drug ineffective 102.02 12.68 657 79839 1080256 78583636
Complications of transplanted kidney 101.24 12.68 69 80427 6297 79657595
Heart transplant rejection 98.81 12.68 42 80454 1468 79662424
Systemic lupus erythematosus 98.29 12.68 6 80490 121143 79542749
Breast cancer metastatic 97.58 12.68 76 80420 8526 79655366
Accidental exposure to product packaging 97.01 12.68 18 80478 12 79663880
Lymphocele 94.48 12.68 42 80454 1639 79662253
Metastases to pleura 94.38 12.68 41 80455 1513 79662379
Metastasis 94.11 12.68 68 80428 6812 79657080
Lymphangiosis carcinomatosa 93.53 12.68 45 80451 2109 79661783
Second primary malignancy 92.60 12.68 92 80404 14258 79649634
Drug hypersensitivity 88.27 12.68 103 80393 298813 79365079
Metastases to peritoneum 88.18 12.68 55 80441 4317 79659575
Pyrexia 86.87 12.68 1056 79440 677653 78986239
Blood creatinine increased 83.63 12.68 344 80152 154713 79509179
Hypersensitivity 83.35 12.68 85 80411 262154 79401738
Infusion site coldness 82.07 12.68 23 80473 216 79663676
Hypotension 81.96 12.68 204 80292 440113 79223779
Blood chromogranin A increased 80.85 12.68 27 80469 475 79663417
Joint swelling 80.45 12.68 104 80392 288542 79375350
Renal transplant failure 80.27 12.68 39 80457 1868 79662024
Epstein-Barr virus infection 79.60 12.68 85 80411 14331 79649561
Diabetes mellitus 79.15 12.68 215 80281 78175 79585717
Exposure during pregnancy 79.14 12.68 6 80490 101126 79562766
Body temperature decreased 78.80 12.68 127 80369 32018 79631874
Bone pain 78.79 12.68 174 80322 55568 79608324
Bradycardia 78.46 12.68 20 80476 135537 79528355
PIK3CA-activated mutation 76.01 12.68 27 80469 576 79663316
Gamma-glutamyltransferase decreased 75.41 12.68 24 80472 360 79663532
Blood triglycerides increased 74.67 12.68 99 80397 20941 79642951
Cell marker increased 73.99 12.68 27 80469 624 79663268
Epistaxis 72.89 12.68 263 80233 111252 79552640
Gamma-glutamyltransferase increased 72.06 12.68 166 80330 54514 79609378
Maternal exposure during pregnancy 71.96 12.68 24 80472 136514 79527378
Pericarditis 71.74 12.68 10 80486 104226 79559666
Somnolence 70.91 12.68 82 80414 238899 79424993
Therapy cessation 69.39 12.68 131 80365 37431 79626461
Metastases to spine 69.08 12.68 47 80449 4277 79659615
Hypertriglyceridaemia 68.38 12.68 74 80422 12666 79651226
Suicide attempt 67.59 12.68 4 80492 82928 79580964
Metastases to central nervous system 67.49 12.68 83 80413 16292 79647600
Therapeutic product effect incomplete 66.21 12.68 30 80466 141615 79522277
Intentional product misuse 65.80 12.68 9 80487 95156 79568736
Loss of personal independence in daily activities 65.74 12.68 12 80484 102568 79561324
Product dose omission issue 65.11 12.68 93 80403 247444 79416448
Blood glucose increased 65.09 12.68 259 80237 114716 79549176
Carbohydrate antigen 15-3 increased 64.80 12.68 29 80467 1150 79662742
Arthralgia 64.78 12.68 327 80169 571476 79092416
Anaemia 64.66 12.68 710 79786 444305 79219587
Parvovirus B19 infection 64.51 12.68 31 80465 1449 79662443
Drug level decreased 64.26 12.68 76 80420 14326 79649566
Hepatitis E 63.87 12.68 39 80457 2947 79660945
Kidney fibrosis 62.68 12.68 41 80455 3494 79660398
Dysgeusia 60.92 12.68 160 80336 57017 79606875
Pancreatic neuroendocrine tumour metastatic 60.87 12.68 16 80480 115 79663777
Blood lactate dehydrogenase increased 60.78 12.68 127 80369 39043 79624849
Weight decreased 60.26 12.68 585 79911 354613 79309279
Bone lesion 60.10 12.68 49 80447 5870 79658022
Intentional product use issue 59.82 12.68 40 80456 152072 79511820
Drug level increased 58.57 12.68 126 80370 39525 79624367
Metastases to the mediastinum 57.29 12.68 22 80474 588 79663304
Nephritic syndrome 57.09 12.68 20 80476 409 79663483
Nail disorder 56.99 12.68 65 80431 11787 79652105
Arthritis 55.81 12.68 23 80473 114857 79549035
Wound 55.25 12.68 24 80472 116155 79547737
Weight increased 53.54 12.68 126 80370 277260 79386632
Blood pressure systolic increased 53.49 12.68 169 80327 66817 79597075
Eating disorder 52.41 12.68 83 80413 20614 79643278
Mobility decreased 52.40 12.68 29 80467 122146 79541746
Atrial fibrillation 52.37 12.68 74 80422 197812 79466080
Device related thrombosis 52.22 12.68 33 80463 2650 79661242
Concomitant disease progression 51.36 12.68 36 80460 3437 79660455
Pneumocystis jirovecii pneumonia 51.14 12.68 106 80390 32402 79631490
Dizziness 50.92 12.68 317 80179 526124 79137768
Irritable bowel syndrome 50.73 12.68 3 80493 62238 79601654
Hepatic neoplasm 49.48 12.68 35 80461 3391 79660501
Neuroendocrine tumour 49.21 12.68 25 80471 1319 79662573
Sinusitis 48.92 12.68 76 80420 195425 79468467
Suicidal ideation 48.76 12.68 9 80487 76331 79587561
Palmar-plantar erythrodysaesthesia syndrome 48.60 12.68 105 80391 33029 79630863
Concomitant disease aggravated 48.34 12.68 63 80433 13104 79650788
Hypophosphataemia 47.89 12.68 78 80418 19835 79644057
Renal tubular atrophy 46.91 12.68 27 80469 1829 79662063
Feeding disorder 46.54 12.68 69 80427 16185 79647707
Lymphoedema 46.52 12.68 60 80436 12353 79651539
Cardio-respiratory arrest 46.19 12.68 26 80470 108484 79555408
Human herpesvirus 8 infection 45.56 12.68 23 80473 1197 79662695
Discomfort 45.53 12.68 36 80460 125581 79538311
Metastases to pelvis 45.27 12.68 19 80477 643 79663249
Cardiac arrest 44.89 12.68 65 80431 172031 79491861
Dyslipidaemia 44.81 12.68 57 80439 11576 79652316
Depression 44.66 12.68 95 80401 216695 79447197
Drug reaction with eosinophilia and systemic symptoms 44.59 12.68 6 80490 64238 79599654
Thrombocytopenia 44.51 12.68 436 80060 264823 79399069
Vascular hyalinosis 44.20 12.68 12 80484 99 79663793
Infusion site induration 44.16 12.68 22 80474 1113 79662779
Myocardial infarction 43.79 12.68 74 80422 184055 79479837
Confusional state 43.08 12.68 170 80326 317827 79346065
International normalised ratio increased 42.73 12.68 16 80480 84705 79579187
Insulinoma 42.14 12.68 12 80484 120 79663772
Acanthoma 41.99 12.68 10 80486 45 79663847
Anaphylactic reaction 41.93 12.68 16 80480 83727 79580165
Chronic obstructive pulmonary disease 41.65 12.68 17 80479 85402 79578490
General physical health deterioration 41.22 12.68 442 80054 274796 79389096
Overdose 41.13 12.68 77 80419 184129 79479763
Helicobacter infection 40.87 12.68 10 80486 69694 79594198
Dry skin 40.77 12.68 156 80340 67839 79596053
Hypercholesterolaemia 40.75 12.68 79 80417 23016 79640876
Granulomatous rosacea 40.36 12.68 13 80483 203 79663689
Treatment failure 40.10 12.68 69 80427 170417 79493475
Hyperhidrosis 39.73 12.68 57 80439 151435 79512457
Haemolytic uraemic syndrome 39.32 12.68 34 80462 4415 79659477
Cholangitis 39.14 12.68 56 80440 12720 79651172
Blood alkaline phosphatase increased 38.94 12.68 147 80349 63517 79600375
Chronic allograft nephropathy 38.28 12.68 23 80473 1688 79662204
Renal tubular necrosis 37.47 12.68 80 80416 24959 79638933
Neoplasm 37.24 12.68 46 80450 9070 79654822
Hepatic enzyme increased 36.79 12.68 81 80415 182529 79481363
Injection site mass 36.79 12.68 70 80426 20114 79643778
Metastases to breast 36.65 12.68 13 80483 276 79663616
Pericardial effusion 36.31 12.68 116 80380 46121 79617771
Human polyomavirus infection 35.97 12.68 19 80477 1087 79662805
Loss of consciousness 35.93 12.68 72 80424 167871 79496021
Injection site hypersensitivity 35.78 12.68 23 80473 1902 79661990
Cerebrovascular accident 35.48 12.68 64 80432 155228 79508664
Drug intolerance 35.25 12.68 142 80354 263977 79399915
Syncope 35.01 12.68 81 80415 179368 79484524
Congenital coronary artery malformation 34.59 12.68 10 80486 106 79663786
Lower respiratory tract infection 34.50 12.68 48 80448 129172 79534720
Oxygen saturation decreased 34.38 12.68 48 80448 128999 79534893
Agitation 34.37 12.68 30 80466 99685 79564207
Serotonin syndrome 34.31 12.68 3 80493 45024 79618868
Post-traumatic neck syndrome 34.02 12.68 23 80473 2071 79661821
Toxic epidermal necrolysis 33.89 12.68 3 80493 44578 79619314
Hormone receptor positive breast cancer 33.63 12.68 13 80483 354 79663538
Headache 33.44 12.68 462 80034 653310 79010582
Psoriasis 33.32 12.68 25 80471 89562 79574330
Osteoarthritis 32.94 12.68 24 80472 87285 79576607
Sleep disorder due to general medical condition, insomnia type 32.92 12.68 3 80493 43553 79620339
Metastases to thorax 32.81 12.68 11 80485 196 79663696
Lactic acidosis 32.72 12.68 15 80481 70344 79593548
Fatigue 32.65 12.68 1195 79301 928532 78735360
Abdominal lymphadenopathy 32.64 12.68 19 80477 1315 79662577
Bile duct stenosis 32.41 12.68 22 80474 1994 79661898
Actinic keratosis 32.26 12.68 35 80461 6007 79657885
Polyomavirus test positive 32.05 12.68 11 80485 211 79663681
West Nile viral infection 31.98 12.68 17 80479 985 79662907
Metastases to chest wall 31.86 12.68 14 80482 531 79663361
Injection site reaction 31.85 12.68 8 80488 54777 79609115
Asthenia 31.69 12.68 707 79789 510982 79152910
Cachexia 31.66 12.68 47 80449 11036 79652856
Treatment noncompliance 31.64 12.68 7 80489 52261 79611631
Haemoglobin decreased 31.53 12.68 353 80143 221766 79442126
Vasodilatation 31.52 12.68 26 80470 3165 79660727
Alopecia 31.11 12.68 124 80372 231231 79432661
Depressed level of consciousness 31.05 12.68 31 80465 96621 79567271
Injury 30.97 12.68 20 80476 77476 79586416
Crepitations 30.82 12.68 44 80452 9973 79653919
Blood cholesterol increased 30.62 12.68 166 80330 83554 79580338
Hallucination 30.53 12.68 25 80471 85720 79578172
Metastases to muscle 30.33 12.68 12 80484 348 79663544
Balance disorder 30.30 12.68 33 80463 98824 79565068
Biliary anastomosis complication 30.10 12.68 10 80486 173 79663719
Complications of transplanted heart 30.01 12.68 12 80484 358 79663534
Squamous cell carcinoma of skin 29.80 12.68 52 80444 13981 79649911
Mean cell haemoglobin decreased 29.70 12.68 34 80462 6190 79657702
Renal lymphocele 29.68 12.68 9 80487 114 79663778
Tachycardia 29.51 12.68 87 80409 177681 79486211
Memory impairment 29.33 12.68 42 80454 111692 79552200
Abdominal distension 29.25 12.68 214 80282 119436 79544456
Carcinoid crisis 29.18 12.68 13 80483 510 79663382
Pseudocirrhosis 28.90 12.68 14 80482 666 79663226
Epstein-Barr virus infection reactivation 28.89 12.68 20 80476 1872 79662020
Platelet count decreased 28.83 12.68 312 80184 194352 79469540
Respiratory arrest 28.80 12.68 11 80485 57539 79606353
Focal segmental glomerulosclerosis 28.59 12.68 25 80471 3296 79660596
Reflux gastritis 28.49 12.68 17 80479 1232 79662660
Epstein-Barr viraemia 28.36 12.68 21 80475 2184 79661708
Ovarian cyst 28.32 12.68 48 80448 12607 79651285
Off label use 28.25 12.68 699 79797 906516 78757376
Cell death 28.25 12.68 29 80467 4670 79659222
Red blood cell sedimentation rate increased 28.12 12.68 6 80490 45936 79617956
Therapy change 28.09 12.68 36 80460 7363 79656529
Impaired insulin secretion 28.01 12.68 7 80489 40 79663852
Adverse event 27.75 12.68 13 80483 60201 79603691
Ill-defined disorder 27.72 12.68 16 80480 65859 79598033
Ingrowing nail 27.71 12.68 23 80473 2824 79661068
Gastric ulcer haemorrhage, obstructive 27.62 12.68 6 80490 16 79663876
Tumour pain 27.58 12.68 21 80475 2278 79661614
Sedation 27.54 12.68 9 80487 51886 79612006
Hypoaesthesia 27.50 12.68 91 80405 179261 79484631
Oncologic complication 27.45 12.68 11 80485 330 79663562
Febrile neutropenia 27.29 12.68 130 80366 230869 79433023
Muscular weakness 27.16 12.68 78 80418 160651 79503241
Injection site pruritus 26.97 12.68 5 80491 42278 79621614
Cheilitis 26.89 12.68 30 80466 5311 79658581
Hepatic mass 26.39 12.68 21 80475 2430 79661462
Spinal pain 26.36 12.68 52 80444 15340 79648552
Urticaria 26.35 12.68 97 80399 185104 79478788
Asthma 26.33 12.68 61 80435 135034 79528858
Sleep apnoea syndrome 26.31 12.68 3 80493 36475 79627417
Lymphadenopathy mediastinal 26.20 12.68 27 80469 4369 79659523
Hydrothorax 25.96 12.68 17 80479 1451 79662441
Isosporiasis 25.92 12.68 9 80487 179 79663713
Gastrointestinal ulcer perforation 25.86 12.68 7 80489 57 79663835
Anaphylactic shock 25.86 12.68 3 80493 35993 79627899
Nephropathy toxic 25.81 12.68 61 80435 20358 79643534
Unresponsive to stimuli 25.77 12.68 12 80484 55776 79608116
Joint stiffness 25.68 12.68 5 80491 40825 79623067
Cardiac failure congestive 25.64 12.68 67 80429 142335 79521557
Toxicity to various agents 25.61 12.68 287 80209 421253 79242639
Amnesia 25.57 12.68 16 80480 63041 79600851
Metastases to kidney 25.56 12.68 12 80484 532 79663360
Carcinoid heart disease 25.44 12.68 7 80489 61 79663831
Oral herpes 25.43 12.68 73 80423 27381 79636511
Lung transplant rejection 25.31 12.68 17 80479 1514 79662378
Glossodynia 25.05 12.68 41 80455 103296 79560596
Soft tissue sarcoma 24.99 12.68 9 80487 200 79663692
Metastases to pancreas 24.83 12.68 12 80484 568 79663324
Breast cancer recurrent 24.80 12.68 22 80474 2955 79660937
Lymphocyte count decreased 24.74 12.68 104 80392 47185 79616707
Metastases to gastrointestinal tract 24.72 12.68 8 80488 127 79663765
Acute respiratory distress syndrome 24.70 12.68 99 80397 43968 79619924
Glomerular filtration rate decreased 24.66 12.68 64 80432 22638 79641254
Blood pressure fluctuation 24.63 12.68 19 80477 67126 79596766
Orthostatic hypotension 24.56 12.68 13 80483 56151 79607741
Renal failure 24.39 12.68 310 80186 200658 79463234
Hepatic angiosarcoma 24.35 12.68 6 80490 32 79663860
Cognitive disorder 24.14 12.68 21 80475 69905 79593987
Adverse drug reaction 24.08 12.68 19 80477 66373 79597519
Tumour necrosis 24.04 12.68 18 80478 1904 79661988
Muscle contractions involuntary 24.03 12.68 24 80472 3741 79660151
Insomnia 23.97 12.68 147 80349 245023 79418869
Skin sensitisation 23.89 12.68 14 80482 981 79662911
Pulmonary mass 23.86 12.68 74 80422 28960 79634932
Pain 23.61 12.68 536 79960 703266 78960626
C-reactive protein increased 23.56 12.68 216 80280 128811 79535081
Liver injury 23.47 12.68 14 80482 56600 79607292
Hypophagia 23.14 12.68 99 80397 45268 79618624
Tumour compression 22.91 12.68 8 80488 162 79663730
Hallucination, visual 22.85 12.68 3 80493 32726 79631166
Electrocardiogram QT prolonged 22.72 12.68 35 80461 90351 79573541
Drug-induced liver injury 22.65 12.68 20 80476 66097 79597795
Anorectal varices 22.60 12.68 6 80490 45 79663847
Transitional cell carcinoma metastatic 22.60 12.68 6 80490 45 79663847
Exposed bone in jaw 22.44 12.68 23 80473 3697 79660195
Donor specific antibody present 22.43 12.68 9 80487 271 79663621
Gastrointestinal disorder 22.38 12.68 57 80439 122148 79541744
Drug withdrawal syndrome 22.37 12.68 4 80492 34714 79629178
Cancer pain 22.29 12.68 27 80469 5218 79658674
Liver abscess 22.27 12.68 29 80467 6025 79657867
Steatorrhoea 22.22 12.68 13 80483 908 79662984
Nephrotic syndrome 21.92 12.68 40 80456 11134 79652758
Nasal discharge discolouration 21.74 12.68 19 80477 2502 79661390
Post transplant distal limb syndrome 21.50 12.68 11 80485 589 79663303
Cytokine release syndrome 21.43 12.68 5 80491 35993 79627899
Toothache 21.38 12.68 56 80440 19914 79643978
Unevaluable event 21.33 12.68 15 80481 55570 79608322
Abdominal discomfort 21.18 12.68 157 80339 250570 79413322
Emotional distress 21.09 12.68 7 80489 39962 79623930
Gait disturbance 21.03 12.68 123 80373 207383 79456509
Injection site erythema 20.91 12.68 29 80467 78168 79585724
Aortitis salmonella 20.91 12.68 5 80491 23 79663869
Rash 20.86 12.68 746 79750 577612 79086280
Vasoactive intestinal polypeptide increased 20.83 12.68 4 80492 4 79663888
Eyelid oedema 20.79 12.68 44 80452 13643 79650249
Recurrent cancer 20.66 12.68 19 80477 2674 79661218
Infusion site haemorrhage 20.65 12.68 22 80474 3698 79660194
Metastatic carcinoid tumour 20.56 12.68 5 80491 25 79663867
Hyponatraemia 20.47 12.68 101 80395 177747 79486145
Japanese spotted fever 20.40 12.68 5 80491 26 79663866
Pulmonary toxicity 20.18 12.68 42 80454 12872 79651020
Blister 20.17 12.68 58 80438 119418 79544474
Cytomegalovirus gastrointestinal infection 20.14 12.68 10 80486 502 79663390
Biliary dilatation 20.11 12.68 19 80477 2767 79661125
Pleural neoplasm 20.06 12.68 9 80487 359 79663533
Coma 19.97 12.68 45 80451 100604 79563288
Urine output decreased 19.77 12.68 51 80445 17971 79645921
Carcinoembryonic antigen increased 19.76 12.68 17 80479 2192 79661700
Carcinoid tumour pulmonary 19.69 12.68 9 80487 375 79663517
Dehydration 19.33 12.68 355 80141 247832 79416060
Visual impairment 19.27 12.68 40 80456 92091 79571801
Transient ischaemic attack 19.21 12.68 15 80481 52680 79611212
Necrosis of artery 19.21 12.68 4 80492 8 79663884
Wrong technique in product usage process 19.16 12.68 28 80468 73847 79590045
Swelling 19.12 12.68 134 80362 216577 79447315
Muscle spasms 19.10 12.68 101 80395 174629 79489263
Prostate cancer 19.06 12.68 5 80491 33263 79630629
Bone cancer 19.06 12.68 16 80480 1996 79661896
Renal mass 18.98 12.68 20 80476 3320 79660572
Erythrophagocytosis 18.89 12.68 5 80491 37 79663855
Alveolar proteinosis 18.68 12.68 11 80485 778 79663114
Pseudohypoaldosteronism 18.66 12.68 5 80491 39 79663853
Tumour marker abnormal 18.65 12.68 8 80488 286 79663606
Flatulence 18.62 12.68 89 80407 42635 79621257
Pulmonary tumour thrombotic microangiopathy 18.49 12.68 6 80490 96 79663796
Throat tightness 18.46 12.68 3 80493 27904 79635988
Superinfection viral 18.44 12.68 5 80491 41 79663851
Lymphadenopathy 18.41 12.68 104 80392 53143 79610749
Transitional cell cancer of renal pelvis and ureter metastatic 18.32 12.68 4 80492 11 79663881
COVID-19 pneumonia 17.96 12.68 67 80429 28782 79635110
Angiomyolipoma 17.96 12.68 7 80489 195 79663697
Blood creatinine decreased 17.94 12.68 30 80466 7795 79656097
Ventricular fibrillation 17.92 12.68 5 80491 31921 79631971
Onychoclasis 17.90 12.68 25 80471 5553 79658339
Cardiogenic shock 17.89 12.68 10 80486 41904 79621988
Metastases to adrenals 17.86 12.68 13 80483 1317 79662575
Vein disorder 17.80 12.68 24 80472 5158 79658734
Angiosarcoma 17.78 12.68 9 80487 471 79663421
Therapeutic product effective for unapproved indication 17.74 12.68 6 80490 110 79663782
Neutropenic sepsis 17.70 12.68 3 80493 27061 79636831
Palpitations 17.56 12.68 67 80429 126543 79537349
Varicella zoster virus infection 17.48 12.68 22 80474 4419 79659473
Dysplasia 17.38 12.68 13 80483 1373 79662519
Tongue oedema 17.28 12.68 28 80468 7089 79656803
Joint range of motion decreased 17.27 12.68 6 80490 33276 79630616
Blood glucose abnormal 17.26 12.68 35 80461 10531 79653361
Restlessness 17.25 12.68 13 80483 46479 79617413
Stevens-Johnson syndrome 17.22 12.68 9 80487 39157 79624735
Dyspnoea 17.16 12.68 1042 79454 855983 78807909
Obesity 17.10 12.68 7 80489 35118 79628774
Jejunal ulcer perforation 17.02 12.68 6 80490 125 79663767
5-hydroxyindolacetic acid increased 16.98 12.68 4 80492 17 79663875
Febrile convulsion 16.84 12.68 11 80485 935 79662957
Renal cancer metastatic 16.80 12.68 10 80486 721 79663171
Malignant ascites 16.80 12.68 12 80484 1180 79662712
Complex regional pain syndrome 16.80 12.68 15 80481 2033 79661859
Obstructive nephropathy 16.73 12.68 5 80491 60 79663832
Odynophagia 16.73 12.68 36 80460 11291 79652601
Gastric antral vascular ectasia 16.71 12.68 11 80485 947 79662945
Delirium 16.66 12.68 38 80458 84589 79579303
Intentional self-injury 16.55 12.68 6 80490 32413 79631479
Ventricular tachycardia 16.51 12.68 11 80485 41924 79621968
Burning sensation mucosal 16.51 12.68 5 80491 63 79663829
Alveolitis necrotising 16.45 12.68 4 80492 20 79663872
Oral administration complication 16.43 12.68 6 80490 139 79663753
Folliculitis 16.41 12.68 19 80477 55361 79608531
Anxiety 16.36 12.68 166 80330 248346 79415546
Anorexia nervosa 16.35 12.68 7 80489 249 79663643
Dysarthria 16.23 12.68 27 80469 67595 79596297
Incisional hernia 16.15 12.68 16 80480 2470 79661422
Coronary artery aneurysm 16.08 12.68 6 80490 148 79663744
Metastases to eye 16.07 12.68 7 80489 260 79663632
Gonococcal infection 16.03 12.68 5 80491 70 79663822
Hernial eventration 15.90 12.68 5 80491 72 79663820
Mucosal toxicity 15.89 12.68 9 80487 591 79663301
Prescribed underdose 15.87 12.68 5 80491 29509 79634383
Graft loss 15.86 12.68 11 80485 1032 79662860
Presyncope 15.86 12.68 11 80485 41043 79622849
Mental disorder 15.63 12.68 6 80490 31296 79632596
Primary pulmonary melanoma 15.62 12.68 3 80493 3 79663889
Cholestasis 15.59 12.68 98 80398 52011 79611881
Metastases to bladder 15.58 12.68 7 80489 280 79663612
Hepatic atrophy 15.56 12.68 8 80488 433 79663459
Leukopenia 15.54 12.68 183 80313 116330 79547562
Metastases to stomach 15.47 12.68 7 80489 285 79663607
Cornea verticillata 15.46 12.68 6 80490 165 79663727
Bone neoplasm 15.46 12.68 10 80486 836 79663056
Withdrawal syndrome 15.46 12.68 4 80492 26850 79637042
Epstein-Barr virus associated lymphoma 15.44 12.68 11 80485 1078 79662814
Gastroduodenal haemorrhage 15.42 12.68 7 80489 287 79663605
Urinary fistula 15.41 12.68 5 80491 80 79663812
Chimerism 15.38 12.68 7 80489 289 79663603
Skin toxicity 15.35 12.68 29 80467 8285 79655607
Mucinous breast carcinoma 15.31 12.68 4 80492 28 79663864
Tongue ulceration 15.29 12.68 20 80476 4173 79659719
Panic attack 15.15 12.68 3 80493 24213 79639679
Neutrophilic panniculitis 15.13 12.68 5 80491 85 79663807
Biliary obstruction 15.08 12.68 21 80475 4653 79659239
Ileal ulcer 15.07 12.68 11 80485 1119 79662773
Foot deformity 15.03 12.68 3 80493 24071 79639821
Delayed graft function 14.81 12.68 18 80478 3489 79660403
Renal cell carcinoma 14.79 12.68 25 80471 6553 79657339
Bile output abnormal 14.73 12.68 4 80492 33 79663859
Contusion 14.64 12.68 89 80407 148687 79515205
Abdominal pain 14.64 12.68 505 79991 389064 79274828
Gait inability 14.63 12.68 23 80473 58894 79604998
Nightmare 14.60 12.68 4 80492 25857 79638035
Pneumothorax 14.59 12.68 62 80434 28261 79635631
Therapeutic product ineffective for unapproved indication 14.52 12.68 6 80490 195 79663697
Haematochezia 14.46 12.68 43 80453 87602 79576290
Ascariasis 14.41 12.68 3 80493 6 79663886
Intestinal obstruction 14.20 12.68 83 80413 42937 79620955
Bowel movement irregularity 14.14 12.68 24 80472 6310 79657582
Poisoning 14.10 12.68 4 80492 25268 79638624
Pyelonephritis 14.09 12.68 49 80447 20339 79643553
Vision blurred 14.07 12.68 57 80439 105841 79558051
Neck pain 13.94 12.68 35 80461 75382 79588510
Hydronephrosis 13.89 12.68 44 80452 17410 79646482
Product use issue 13.87 12.68 140 80356 209682 79454210
Breast cancer 13.74 12.68 69 80427 33712 79630180
Skin laceration 13.74 12.68 6 80490 28956 79634936
Malignant pleural effusion 13.71 12.68 17 80479 3363 79660529
Eosinophil cationic protein increased 13.70 12.68 4 80492 44 79663848
Hepatocellular carcinoma 13.70 12.68 29 80467 8992 79654900
Intestinal metastasis 13.61 12.68 7 80489 379 79663513
Disseminated varicella zoster vaccine virus infection 13.56 12.68 5 80491 119 79663773
Blood urea increased 13.52 12.68 90 80406 48700 79615192
Central nervous system viral infection 13.49 12.68 5 80491 121 79663771
Oedema 13.47 12.68 182 80314 119398 79544494
Respiratory failure 13.47 12.68 257 80239 180654 79483238
Cerebral ventricle collapse 13.45 12.68 5 80491 122 79663770
Disturbance in attention 13.42 12.68 19 80477 50782 79613110
Renal hamartoma 13.41 12.68 5 80491 123 79663769
Eye pain 13.32 12.68 11 80485 37567 79626325
Chronic kidney disease 13.23 12.68 113 80383 66041 79597851
Blood pressure diastolic decreased 13.21 12.68 63 80433 30153 79633739
Dermatosis 13.20 12.68 8 80488 596 79663296
Anal ulcer 13.14 12.68 11 80485 1367 79662525
Angiofibroma 13.11 12.68 5 80491 131 79663761
Renal disorder 13.11 12.68 80 80416 42025 79621867
Angina pectoris 13.03 12.68 20 80476 51712 79612180
Plasma cell myeloma 13.03 12.68 21 80475 53238 79610654
Blood gastrin increased 12.96 12.68 4 80492 54 79663838
Depressed mood 12.94 12.68 18 80478 48462 79615430
Bronchitis 12.93 12.68 78 80418 130566 79533326
Shock 12.84 12.68 15 80481 43533 79620359
Rhabdomyolysis 12.78 12.68 57 80439 103074 79560818
Pancreatic steatosis 12.73 12.68 10 80486 1135 79662757
Multiple organ dysfunction syndrome 12.73 12.68 181 80315 120065 79543827
Subdural haematoma 12.71 12.68 8 80488 31426 79632466
Illness 12.69 12.68 17 80479 46494 79617398

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EG02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Mammalian target of rapamycin (mTOR) kinase inhibitors
ATC L04AA18 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
FDA MoA N0000175076 Protein Kinase Inhibitors
FDA PE N0000175550 Decreased Immunologic Activity
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D000091203 MTOR Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
FDA MoA N0000175624 mTOR Inhibitors
FDA EPC N0000175625 mTOR Inhibitor Immunosuppressant
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:68481 mTOR inhibitors
CHEBI has role CHEBI:149553 anticoronaviral drug
CHEBI has role CHEBI:176497 geroprotectors

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

DiseaseRelationSNOMED_IDDOID
Tuberous sclerosis syndrome indication 7199000 DOID:13515
Carcinoma of breast indication 254838004 DOID:3459
Angiomyolipoma of kidney indication 254921004 DOID:8411
Hormone receptor positive malignant neoplasm of breast indication 417181009
Renal cell carcinoma indication 702391001 DOID:4450
Pancreatic Neuroendocrine Tumor indication 717919005
Prevention of Kidney Transplant Rejection indication
Subependymal Giant Cell Astrocytoma associated with Tuberous Sclerosis indication
Hypercholesterolemia contraindication 13644009
Proteinuria contraindication 29738008 DOID:576
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Stomatitis contraindication 61170000 DOID:9637
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Diabetes mellitus contraindication 73211009 DOID:9351
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Thrombosis of renal artery contraindication 95579008
Hemolytic uremic syndrome contraindication 111407006 DOID:12554
Malignant lymphoma contraindication 118600007 DOID:0060058
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Impaired wound healing contraindication 271618001
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Primary malignant neoplasm contraindication 372087000
Pericardial effusion contraindication 373945007 DOID:118
Ascites contraindication 389026000
Breastfeeding (mother) contraindication 413712001
BK Polyomavirus Reactivation Nephropathy contraindication
Pleural Effusions contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.5 acidic
pKa2 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 8410131 Nov. 1, 2025 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 9006224 July 1, 2028 TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL Feb. 26, 2023 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL Feb. 26, 2023 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL Feb. 26, 2023 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL Feb. 26, 2023 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
2MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL April 10, 2025 FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
3MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL April 10, 2025 FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
5MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL April 10, 2025 FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Peptidyl-prolyl cis-trans isomerase FKBP1A Enzyme INHIBITOR IC50 8.26 WOMBAT-PK CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
Serine/threonine-protein kinase mTOR Kinase INHIBITOR IC50 8.70 IUPHAR

External reference:

IDSource
4028636 VUID
N0000178379 NUI
D02714 KEGG_DRUG
4028636 VANDF
C0541315 UMLSCUI
CHEBI:68478 CHEBI
E53 PDB_CHEM_ID
CHEMBL1908360 ChEMBL_ID
D000068338 MESH_DESCRIPTOR_UI
DB01590 DRUGBANK_ID
5889 IUPHAR_LIGAND_ID
7863 INN_ID
9HW64Q8G6G UNII
6442177 PUBCHEM_CID
141704 RXNORM
162489 MMSL
20447 MMSL
269938 MMSL
d05626 MMSL
010829 NDDF
428127005 SNOMEDCT_US
428698007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0470 TABLET 0.25 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0471 TABLET 0.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0472 TABLET 0.75 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0480 TABLET 2.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0480 TABLET 2.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0481 TABLET 5 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0481 TABLET 5 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0482 TABLET 10 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0482 TABLET 10 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0497 TABLET 7.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0497 TABLET 7.50 mg ORAL ANDA 27 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0054-0604 TABLET 1 mg ORAL ANDA 27 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0414 TABLET 0.50 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0414 TABLET 0.50 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0414 TABLET 0.50 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0415 TABLET 0.75 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0415 TABLET 0.75 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0415 TABLET 0.75 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0417 TABLET 0.25 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0417 TABLET 0.25 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0417 TABLET 0.25 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0422 TABLET 1 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0422 TABLET 1 mg ORAL NDA 31 sections
Zortress HUMAN PRESCRIPTION DRUG LABEL 1 0078-0422 TABLET 1 mg ORAL NDA 31 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0566 TABLET 5 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0566 TABLET 5 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0567 TABLET 10 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0567 TABLET 10 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0594 TABLET 2.50 mg ORAL NDA 33 sections
Afinitor HUMAN PRESCRIPTION DRUG LABEL 1 0078-0594 TABLET 2.50 mg ORAL NDA 33 sections