everolimus ๐Ÿถ 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) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 ยตM/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 3310.08 12.72 1620 59478 66504 50477522
Stomatitis 1488.17 12.72 1119 59979 100225 50443801
Metastases to liver 1053.95 12.72 505 60593 19599 50524427
Metastases to bone 1029.18 12.72 480 60618 17515 50526511
Pneumonitis 933.08 12.72 528 60570 28982 50515044
Neoplasm progression 538.86 12.72 371 60727 28786 50515240
Metastases to lung 433.48 12.72 228 60870 10792 50533234
Disease progression 342.71 12.72 496 60602 95370 50448656
Mucosal inflammation 340.65 12.72 324 60774 39818 50504208
Death 323.65 12.72 993 60105 324386 50219640
Pleural effusion 323.08 12.72 443 60655 81011 50463015
Tumour marker increased 294.86 12.72 126 60972 3714 50540312
Metastases to lymph nodes 258.36 12.72 139 60959 6885 50537141
Hyperglycaemia 257.26 12.72 266 60832 36139 50507887
Rheumatoid arthritis 224.57 12.72 4 61094 202546 50341480
Interstitial lung disease 210.39 12.72 289 60809 52887 50491139
Osteonecrosis of jaw 198.63 12.72 220 60878 32306 50511720
Aphthous ulcer 198.38 12.72 136 60962 10461 50533565
Ascites 197.68 12.72 230 60868 35631 50508395
Decreased appetite 190.64 12.72 604 60494 200319 50343707
Drug ineffective 177.01 12.72 463 60635 818870 49725156
Cough 167.32 12.72 654 60444 240610 50303416
Infusion related reaction 158.98 12.72 12 61086 169545 50374481
Breast cancer metastatic 157.15 12.72 117 60981 10247 50533779
Arthropathy 148.53 12.72 11 61087 157895 50386131
PIK3CA-activated mutation 147.71 12.72 50 61048 760 50543266
Systemic lupus erythematosus 147.38 12.72 5 61093 140617 50403409
Metastases to pleura 145.52 12.72 56 61042 1250 50542776
Completed suicide 144.52 12.72 3 61095 131886 50412140
Condition aggravated 142.07 12.72 92 61006 296966 50247060
Hepatic lesion 138.19 12.72 76 61022 3932 50540094
General physical health deterioration 137.52 12.72 431 60667 142003 50402023
Metastases to skin 135.41 12.72 54 61044 1329 50542697
Oral pain 135.34 12.72 159 60939 24874 50519152
Synovitis 135.00 12.72 3 61095 123862 50420164
Exposure during pregnancy 131.62 12.72 3 61095 121012 50423014
Musculoskeletal stiffness 129.79 12.72 6 61092 128475 50415551
Therapeutic product effect decreased 126.47 12.72 10 61088 136040 50407986
Lung disorder 125.10 12.72 207 60891 44592 50499434
Drug hypersensitivity 119.61 12.72 78 61020 250932 50293094
Neoplasm malignant 117.34 12.72 144 60954 23571 50520455
Maternal exposure during pregnancy 117.06 12.72 25 61073 159753 50384273
Metastases to peritoneum 112.46 12.72 59 61039 2774 50541252
Second primary malignancy 111.46 12.72 81 61017 6833 50537193
Metastasis 111.07 12.72 68 61030 4307 50539719
Mouth ulceration 108.81 12.72 151 60947 27873 50516153
Epistaxis 106.21 12.72 237 60861 63717 50480309
Fall 106.15 12.72 150 60948 334782 50209244
Lung infiltration 102.10 12.72 102 60996 13291 50530735
Joint swelling 100.50 12.72 89 61009 245197 50298829
Blood creatinine increased 99.32 12.72 257 60841 75903 50468123
Polyomavirus viraemia 97.88 12.72 32 61066 434 50543592
Pyrexia 97.20 12.72 787 60311 379416 50164610
Metastases to spine 95.72 12.72 53 61045 2778 50541248
Oedema peripheral 95.69 12.72 411 60687 157550 50386476
Lymphangiosis carcinomatosa 91.01 12.72 39 61059 1157 50542869
Metastases to central nervous system 89.85 12.72 88 61010 11194 50532832
Dysgeusia 88.10 12.72 164 60934 38752 50505274
Hypersensitivity 84.64 12.72 81 61017 215080 50328946
Acne 84.31 12.72 111 60987 19484 50524542
Blood triglycerides increased 84.11 12.72 85 61013 11227 50532799
Blood glucose increased 82.24 12.72 230 60868 71094 50472932
Diarrhoea 80.93 12.72 1073 60025 587403 49956623
Infusion site coldness 80.51 12.72 23 61075 191 50543835
Lymphoedema 79.93 12.72 75 61023 9047 50534979
Carbohydrate antigen 15-3 increased 79.88 12.72 35 61063 1097 50542929
Gamma-glutamyltransferase increased 78.84 12.72 134 60964 29489 50514537
Blood lactate dehydrogenase increased 76.83 12.72 106 60992 19456 50524570
Transplant rejection 76.61 12.72 75 61023 9534 50534492
BK virus infection 76.27 12.72 46 61052 2835 50541191
Gamma-glutamyltransferase decreased 76.16 12.72 24 61074 287 50543739
Sinusitis 73.35 12.72 59 61039 170499 50373527
Weight decreased 72.99 12.72 487 60611 220758 50323268
Anaemia 72.94 12.72 538 60560 251918 50292108
Discomfort 71.53 12.72 21 61077 108359 50435667
Product use in unapproved indication 71.36 12.72 303 60795 115516 50428510
Treatment failure 70.78 12.72 39 61059 137598 50406428
Wound 70.74 12.72 20 61078 105774 50438252
Weight increased 70.47 12.72 84 61014 201807 50342219
Hypertriglyceridaemia 70.14 12.72 56 61042 5435 50538591
Off label use 69.99 12.72 315 60783 474111 50069915
Pericarditis 69.81 12.72 7 61091 78682 50465344
Bone lesion 68.78 12.72 54 61044 5116 50538910
Immunosuppressant drug level increased 68.42 12.72 44 61054 3038 50540988
Blood chromogranin A increased 68.15 12.72 21 61077 232 50543794
Arthralgia 67.29 12.72 287 60811 438415 50105611
Hypophosphataemia 63.98 12.72 64 61034 8350 50535676
Concomitant disease progression 62.95 12.72 36 61062 2009 50542017
Pericardial effusion 60.63 12.72 110 60988 25479 50518547
Product dose omission issue 60.49 12.72 80 61018 183758 50360268
Pain 60.16 12.72 431 60667 578472 49965554
Therapeutic product effect incomplete 59.90 12.72 18 61080 91497 50452529
Thrombotic microangiopathy 59.84 12.72 63 61035 8728 50535298
Drug abuse 59.75 12.72 3 61095 59843 50484183
Diabetes mellitus 59.36 12.72 161 60937 48872 50495154
Dyspnoea 58.42 12.72 956 60142 546652 49997374
Kidney transplant rejection 58.19 12.72 44 61054 3943 50540083
Bone pain 58.10 12.72 156 60942 47073 50496953
Nail disorder 56.38 12.72 64 61034 9644 50534382
Therapy cessation 55.62 12.72 107 60991 25904 50518122
Renal impairment 55.44 12.72 209 60889 75452 50468574
Thrombocytopenia 55.43 12.72 302 60796 127371 50416655
Cell marker increased 54.34 12.72 18 61080 255 50543771
Loss of personal independence in daily activities 53.27 12.72 10 61088 70040 50473986
Feeding disorder 51.77 12.72 64 61034 10549 50533477
Breast cancer recurrent 51.14 12.72 40 61058 3768 50540258
Abdominal lymphadenopathy 51.14 12.72 22 61076 659 50543367
Arthritis 50.02 12.72 21 61077 86700 50457326
Eating disorder 49.59 12.72 76 61022 15333 50528693
Pancreatic neuroendocrine tumour 49.47 12.72 17 61081 271 50543755
Somnolence 49.40 12.72 69 61029 154916 50389110
Overdose 48.78 12.72 30 61068 99697 50444329
Device related thrombosis 48.43 12.72 26 61072 1281 50542745
Palmar-plantar erythrodysaesthesia syndrome 48.38 12.72 87 61011 20011 50524015
Hypotension 48.19 12.72 136 60962 235333 50308693
Helicobacter infection 48.05 12.72 3 61095 49699 50494327
Metastases to chest wall 47.97 12.72 19 61079 459 50543567
Suicide attempt 47.49 12.72 4 61094 51728 50492298
Lower respiratory tract infection 47.46 12.72 28 61070 95173 50448853
Bradycardia 47.31 12.72 10 61088 64416 50479610
Glossodynia 47.18 12.72 42 61056 115527 50428499
Irritable bowel syndrome 47.17 12.72 4 61094 51437 50492589
Mobility decreased 46.69 12.72 19 61079 79929 50464097
Lymphadenopathy mediastinal 46.45 12.72 32 61066 2479 50541547
Infusion site induration 45.90 12.72 22 61076 851 50543175
Liver transplant rejection 45.60 12.72 25 61073 1285 50542741
Intentional product use issue 45.38 12.72 18 61080 76900 50467126
Drug intolerance 45.24 12.72 126 60972 218978 50325048
West Nile viral infection 44.92 12.72 17 61081 362 50543664
Spinal pain 44.63 12.72 60 61038 10743 50533283
Viraemia 44.42 12.72 23 61075 1052 50542974
Oncologic complication 44.38 12.72 13 61085 119 50543907
Polyomavirus-associated nephropathy 44.26 12.72 26 61072 1526 50542500
Hormone receptor positive breast cancer 44.21 12.72 18 61080 468 50543558
Parvovirus B19 infection 44.18 12.72 18 61080 469 50543557
Concomitant disease aggravated 43.07 12.72 51 61047 8040 50535986
Mean cell haemoglobin decreased 42.68 12.72 34 61064 3289 50540737
Product use issue 42.41 12.72 72 61026 149403 50394623
Needle issue 42.32 12.72 48 61050 7227 50536799
Alopecia 42.13 12.72 153 60945 244894 50299132
Malignant pleural effusion 41.48 12.72 29 61069 2301 50541725
Metastases to the mediastinum 41.37 12.72 17 61081 453 50543573
Suicidal ideation 39.85 12.72 9 61089 55376 50488650
Depression 39.70 12.72 88 61010 165335 50378691
Karnofsky scale worsened 39.29 12.72 8 61090 10 50544016
Pancreatic neuroendocrine tumour metastatic 39.29 12.72 8 61090 10 50544016
Polyneuropathy 39.27 12.72 60 61038 12071 50531955
Injection site pain 38.91 12.72 46 61052 110978 50433048
Cholangitis 38.87 12.72 37 61061 4542 50539484
Fatigue 38.45 12.72 1121 59977 706480 49837546
Blood cholesterol increased 38.37 12.72 150 60948 55065 50488961
Injection site reaction 38.34 12.72 7 61091 50025 50494001
Renal tubular necrosis 38.28 12.72 54 61044 10114 50533912
Body temperature decreased 38.23 12.72 70 61028 16325 50527701
Cachexia 37.29 12.72 36 61062 4497 50539529
Abdominal discomfort 36.99 12.72 149 60949 231492 50312534
Hypercholesterolaemia 36.65 12.72 57 61041 11646 50532380
Hepatic neoplasm 36.54 12.72 24 61074 1718 50542308
Pneumocystis jirovecii pneumonia 35.97 12.72 64 61034 14599 50529427
Carcinoembryonic antigen increased 35.11 12.72 22 61076 1452 50542574
Toxicity to various agents 35 12.72 135 60963 212364 50331662
Injection site pruritus 34.80 12.72 4 61094 40407 50503619
Hyperhidrosis 34.73 12.72 34 61064 89392 50454634
Drug level decreased 34.48 12.72 41 61057 6492 50537534
Accidental exposure to product packaging 34.32 12.72 6 61092 0 50544026
Neoplasm 34.29 12.72 39 61059 5889 50538137
Unevaluable event 34.13 12.72 7 61091 46059 50497967
Blood alkaline phosphatase increased 33.81 12.72 111 60987 37415 50506611
Metastases to thorax 33.78 12.72 12 61086 212 50543814
Ill-defined disorder 33.56 12.72 12 61086 54642 50489384
C-reactive protein increased 33.51 12.72 164 60934 66310 50477716
Swelling 33.48 12.72 127 60971 200745 50343281
Psoriasis 33.40 12.72 21 61077 68979 50475047
Anaphylactic reaction 32.96 12.72 12 61086 54043 50489983
Proteinuria 32.73 12.72 66 61032 16531 50527495
Post-traumatic neck syndrome 32.21 12.72 23 61075 1887 50542139
Injection site erythema 32.09 12.72 26 61072 74910 50469116
Skin toxicity 32.05 12.72 31 61067 3882 50540144
Complications of transplanted kidney 31.75 12.72 24 61074 2149 50541877
Headache 31.45 12.72 427 60671 506108 50037918
Balance disorder 30.84 12.72 24 61074 70566 50473460
Metastases to muscle 30.76 12.72 10 61088 133 50543893
Dehydration 30.73 12.72 300 60798 152149 50391877
Chronic obstructive pulmonary disease 30.71 12.72 13 61085 53422 50490604
Haemoglobin decreased 30.54 12.72 260 60838 126956 50417070
Pseudocirrhosis 30.49 12.72 15 61083 615 50543411
Osteoarthritis 30.39 12.72 23 61075 68583 50475443
Glomerular filtration rate decreased 30.06 12.72 52 61046 11600 50532426
Hepatic enzyme increased 29.84 12.72 77 61021 137303 50406723
Adverse event 29.75 12.72 8 61090 43755 50500271
Onychoclasis 29.74 12.72 34 61064 5162 50538864
Pleural neoplasm 29.25 12.72 11 61087 230 50543796
Asthenia 29.19 12.72 544 60554 318498 50225528
Neuroendocrine tumour 29.15 12.72 14 61084 544 50543482
Metastases to adrenals 29.11 12.72 15 61083 679 50543347
Agitation 29.10 12.72 14 61084 53370 50490656
Bone cancer 28.99 12.72 18 61080 1169 50542857
Cardiac arrest 28.94 12.72 35 61063 83616 50460410
Nephrotic syndrome 28.64 12.72 32 61066 4738 50539288
Drug interaction 27.86 12.72 135 60963 199486 50344540
Metastases to kidney 27.78 12.72 10 61088 184 50543842
Nephritic syndrome 27.68 12.72 10 61088 186 50543840
Platelet count decreased 27.50 12.72 212 60886 100514 50443512
Gait disturbance 26.86 12.72 92 61006 149913 50394113
Hypophagia 26.77 12.72 84 61014 27644 50516382
Nasopharyngitis 26.62 12.72 131 60967 192796 50351230
Vasodilatation 26.49 12.72 22 61076 2257 50541769
Flatulence 26.41 12.72 87 61011 29371 50514655
Injury 26.41 12.72 13 61085 48912 50495114
Gastrointestinal disorder 26.32 12.72 46 61052 94410 50449616
Abdominal distension 26.13 12.72 164 60934 72739 50471287
Cardiac failure 25.98 12.72 169 60929 75871 50468155
Treatment noncompliance 25.92 12.72 3 61095 30147 50513879
Immunosuppressant drug level decreased 25.86 12.72 15 61083 860 50543166
Dry skin 25.79 12.72 112 60986 43079 50500947
Heart transplant rejection 25.58 12.72 12 61086 442 50543584
Reflux gastritis 25.57 12.72 15 61083 878 50543148
Breast cancer 25.45 12.72 111 60987 42779 50501247
Cardio-respiratory arrest 25.27 12.72 17 61081 53875 50490151
Confusional state 25.22 12.72 127 60971 185801 50358225
Folliculitis 25.15 12.72 8 61090 39217 50504809
Myocardial infarction 25.13 12.72 43 61055 88984 50455042
Metastases to bladder 24.78 12.72 9 61089 170 50543856
Lymphocele 24.53 12.72 14 61084 778 50543248
Eastern Cooperative Oncology Group performance status worsened 24.51 12.72 13 61085 625 50543401
Dizziness 24.44 12.72 284 60814 346085 50197941
Visual impairment 24.22 12.72 28 61070 68247 50475779
Cancer pain 24.07 12.72 22 61076 2565 50541461
Vision blurred 24.07 12.72 36 61062 78611 50465415
Lymphocyte count decreased 23.86 12.72 78 61020 26229 50517797
Adverse drug reaction 23.84 12.72 19 61079 55203 50488823
Cerebrovascular accident 23.84 12.72 49 61049 94631 50449395
Loss of consciousness 23.82 12.72 57 61041 104296 50439730
Joint stiffness 23.75 12.72 4 61094 30304 50513722
Syncope 23.72 12.72 56 61042 102946 50441080
Blood pressure fluctuation 23.51 12.72 7 61091 35816 50508210
Carcinoid tumour pulmonary 23.28 12.72 11 61087 412 50543614
Insulinoma 23.17 12.72 7 61091 72 50543954
Jejunal ulcer perforation 22.98 12.72 6 61092 34 50543992
Lactic acidosis 22.86 12.72 6 61092 33349 50510677
Hallucination 22.86 12.72 14 61084 46643 50497383
Plasma cell myeloma 22.71 12.72 5 61093 31317 50512709
Exposed bone in jaw 22.59 12.72 22 61076 2778 50541248
Cognitive disorder 21.95 12.72 13 61085 44110 50499916
Metastases to pelvis 21.66 12.72 10 61088 355 50543671
Therapy change 21.55 12.72 29 61069 5196 50538830
Lymphangitis 21.47 12.72 13 61085 807 50543219
Pulmonary tumour thrombotic microangiopathy 21.31 12.72 6 61092 47 50543979
Infusion site haemorrhage 21.29 12.72 22 61076 2982 50541044
Pulmonary mass 21.22 12.72 60 61038 18645 50525381
Abortion spontaneous 21.22 12.72 12 61086 41760 50502266
Hepatitis E 21.19 12.72 15 61083 1214 50542812
Blood creatinine decreased 21.11 12.72 28 61070 4948 50539078
Memory impairment 20.90 12.72 40 61058 79320 50464706
Hepatic mass 20.75 12.72 16 61082 1476 50542550
Recurrent cancer 20.50 12.72 17 61081 1740 50542286
Ageusia 20.43 12.72 44 61054 11539 50532487
Intestinal metastasis 20.35 12.72 7 61091 112 50543914
Cornea verticillata 20.19 12.72 6 61092 58 50543968
Tumour necrosis 20.16 12.72 12 61086 722 50543304
Lymphadenopathy 20.10 12.72 87 61011 33412 50510614
Kidney congestion 20.02 12.72 5 61093 23 50544003
Emotional distress 19.94 12.72 5 61093 28658 50515368
Post transplant lymphoproliferative disorder 19.94 12.72 25 61073 4179 50539847
Metastases to spleen 19.85 12.72 7 61091 121 50543905
Skin sensitisation 19.73 12.72 12 61086 751 50543275
Blood pressure systolic increased 19.71 12.72 90 61008 35359 50508667
Urticaria 19.62 12.72 85 61013 129476 50414550
Cheilitis 19.62 12.72 23 61075 3587 50540439
Asthma 19.45 12.72 50 61048 89287 50454739
Angiosarcoma 19.33 12.72 8 61090 217 50543809
Oral herpes 19.29 12.72 62 61036 20663 50523363
Peripheral coldness 19.22 12.72 40 61058 10243 50533783
Tumour marker abnormal 19.20 12.72 8 61090 221 50543805
Drug level increased 19.18 12.72 59 61039 19209 50524817
Tongue ulceration 19.08 12.72 21 61077 3059 50540967
Crepitations 19.07 12.72 30 61068 6189 50537837
Red blood cell sedimentation rate increased 18.85 12.72 6 61092 29410 50514616
Rhabdomyolysis 18.72 12.72 12 61086 39015 50505011
Metastases to meninges 18.58 12.72 17 61081 1985 50542041
Cerebral ventricle collapse 18.50 12.72 5 61093 33 50543993
Aspartate aminotransferase increased 18.49 12.72 159 60939 77839 50466187
Invasive lobular breast carcinoma 18.44 12.72 11 61087 664 50543362
International normalised ratio increased 18.43 12.72 15 61083 43137 50500889
Wrong technique in product usage process 18.39 12.72 24 61074 55486 50488540
Sedation 18.32 12.72 7 61091 30603 50513423
Lymphangioleiomyomatosis 18.07 12.72 7 61091 159 50543867
No adverse event 18.00 12.72 9 61089 33569 50510457
Therapeutic product effective for unapproved indication 17.92 12.72 6 61092 88 50543938
Bowel movement irregularity 17.88 12.72 23 61075 3945 50540081
Vein disorder 17.86 12.72 24 61074 4295 50539731
Hepatic atrophy 17.76 12.72 8 61090 268 50543758
Urine output decreased 17.71 12.72 39 61059 10382 50533644
Amnesia 17.67 12.72 15 61083 42245 50501781
Generalised oedema 17.53 12.72 46 61052 13685 50530341
Hepatic function abnormal 17.46 12.72 82 61016 32599 50511427
Subileus 17.42 12.72 19 61079 2740 50541286
Hormone refractory breast cancer 17.35 12.72 4 61094 12 50544014
Mouth injury 17.35 12.72 11 61087 741 50543285
Congenital coronary artery malformation 17.33 12.72 6 61092 98 50543928
Presyncope 17.27 12.72 4 61094 24194 50519832
Febrile infection 17.13 12.72 13 61085 1171 50542855
Post transplant distal limb syndrome 17.09 12.72 7 61091 185 50543841
Anorexia nervosa 17.09 12.72 7 61091 185 50543841
Metastases to stomach 17.05 12.72 7 61091 186 50543840
Biliary dilatation 16.89 12.72 16 61082 1953 50542073
Neutrophilic panniculitis 16.86 12.72 5 61093 48 50543978
Transient ischaemic attack 16.73 12.72 9 61089 32201 50511825
Abdominal pain 16.72 12.72 388 60710 235840 50308186
Premature delivery 16.71 12.72 4 61094 23659 50520367
Tumour pain 16.69 12.72 13 61085 1217 50542809
Odynophagia 16.65 12.72 29 61069 6503 50537523
Neutropenia 16.65 12.72 261 60837 147704 50396322
Alveolar proteinosis 16.63 12.72 8 61090 312 50543714
Device dislocation 16.54 12.72 3 61095 21543 50522483
Injection site mass 16.54 12.72 49 61049 15631 50528395
Taste disorder 16.29 12.72 33 61065 8291 50535735
Toothache 16.14 12.72 51 61047 16843 50527183
Splenic lesion 16.14 12.72 7 61091 214 50543812
Anxiety 16.10 12.72 137 60961 177469 50366557
Renal failure 16.01 12.72 198 60900 106435 50437591
Bronchitis 15.98 12.72 68 61030 104091 50439935
Incorrect dose administered 15.97 12.72 21 61077 48393 50495633
Tinnitus 15.92 12.72 7 61091 28125 50515901
Oral mucosal blistering 15.86 12.72 24 61074 4788 50539238
Kidney fibrosis 15.75 12.72 14 61084 1575 50542451
Depressed level of consciousness 15.68 12.72 24 61074 51929 50492097
Mediastinal disorder 15.67 12.72 8 61090 355 50543671
Dysplasia 15.67 12.72 10 61088 681 50543345
Orthostatic hypotension 15.66 12.72 8 61090 29473 50514553
Oedema 15.56 12.72 141 60957 70040 50473986
Renal lymphocele 15.49 12.72 5 61093 65 50543961
Impaired insulin secretion 15.42 12.72 4 61094 22 50544004
Anal ulcer 15.39 12.72 9 61089 524 50543502
Tonic convulsion 15.37 12.72 12 61086 1127 50542899
Atrial fibrillation 15.25 12.72 67 61031 101678 50442348
Delayed graft function 15.23 12.72 11 61087 919 50543107
Carcinoid heart disease 15.13 12.72 4 61094 24 50544002
Hepatic failure 15.10 12.72 78 61020 32205 50511821
Vasoactive intestinal polypeptide increased 15.09 12.72 3 61095 3 50544023
Ovarian cyst torsion 15.09 12.72 3 61095 3 50544023
Primary pulmonary melanoma 15.09 12.72 3 61095 3 50544023
Pleural mass 15.09 12.72 3 61095 3 50544023
Sleep apnoea syndrome 15.06 12.72 5 61093 23863 50520163
Neutrophil count decreased 14.93 12.72 101 60997 45925 50498101
Cardiac failure congestive 14.93 12.72 52 61046 84330 50459696
Steatorrhoea 14.87 12.72 8 61090 396 50543630
Stevens-Johnson syndrome 14.74 12.72 4 61094 21748 50522278
Retinal detachment 14.71 12.72 24 61074 5105 50538921
Carbohydrate antigen 19-9 increased 14.56 12.72 6 61092 161 50543865
Atypical pneumonia 14.55 12.72 20 61078 3655 50540371
Basal cell carcinoma 14.55 12.72 5 61093 23351 50520675
Metastases to breast 14.48 12.72 7 61091 276 50543750
Noninfective gingivitis 14.42 12.72 12 61086 1234 50542792
Uterine mass 14.39 12.72 7 61091 280 50543746
Mucosal haemorrhage 14.34 12.72 10 61088 790 50543236
Cytomegalovirus infection 14.31 12.72 51 61047 17911 50526115
Gastrooesophageal reflux disease 14.27 12.72 46 61052 76382 50467644
Product quality issue 14.11 12.72 10 61088 30848 50513178
Peritoneal disorder 14.09 12.72 8 61090 440 50543586
Pneumothorax 14.00 12.72 43 61055 13991 50530035
Product prescribing error 13.93 12.72 4 61094 20957 50523069
Carcinoid tumour 13.92 12.72 7 61091 301 50543725
Ascariasis 13.87 12.72 3 61095 6 50544020
Varicella zoster virus infection 13.76 12.72 16 61082 2473 50541553
Pneumonitis chemical 13.72 12.72 6 61092 187 50543839
Radiation pneumonitis 13.70 12.72 12 61086 1323 50542703
Muscle spasms 13.67 12.72 92 61006 125461 50418565
Focal segmental glomerulosclerosis 13.66 12.72 12 61086 1329 50542697
Rash 13.62 12.72 652 60446 436819 50107207
Dermatitis 13.60 12.72 43 61055 14208 50529818
Skin lesion 13.51 12.72 66 61032 26661 50517365
Upper respiratory tract infection 13.50 12.72 38 61060 65860 50478166
Burning sensation mucosal 13.43 12.72 4 61094 39 50543987
Perineal ulceration 13.43 12.72 4 61094 39 50543987
Central nervous system viral infection 13.36 12.72 5 61093 103 50543923
Joint range of motion decreased 13.33 12.72 3 61095 18509 50525517
Intestinal obstruction 13.22 12.72 65 61033 26318 50517708
Mental disorder 13.21 12.72 5 61093 21986 50522040
Therapeutic product ineffective for unapproved indication 13.18 12.72 6 61092 206 50543820
Ovarian cyst 13.14 12.72 42 61056 13954 50530072
Oxygen saturation decreased 13.05 12.72 45 61053 73203 50470823
Pancreatitis viral 13.01 12.72 3 61095 9 50544017
Eosinophil cationic protein increased 13.00 12.72 4 61094 44 50543982
Oral administration complication 12.97 12.72 5 61093 112 50543914
Blister 12.95 12.72 56 61042 85362 50458664
Oral disorder 12.93 12.72 29 61069 7815 50536211
Alveolar lung disease 12.89 12.72 5 61093 114 50543912
Breast inflammation 12.81 12.72 5 61093 116 50543910
Portal hypertension 12.75 12.72 18 61080 3374 50540652
Heart rate increased 12.75 12.72 49 61049 77201 50466825

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 935.77 13.01 797 40853 73062 29459815
Stomatitis 623.30 13.01 473 41177 36640 29496237
Neoplasm malignant 320.29 13.01 232 41418 16693 29516184
Neoplasm progression 276.83 13.01 221 41429 18391 29514486
Metastases to lung 189.32 13.01 125 41525 7730 29525147
Metastases to liver 185.31 13.01 145 41505 11711 29521166
Pneumonitis 164.24 13.01 200 41450 27844 29505033
Diarrhoea 153.69 13.01 893 40757 331805 29201072
Polyomavirus viraemia 143.08 13.01 48 41602 601 29532276
Kidney transplant rejection 125.60 13.01 93 41557 6912 29525965
Polyomavirus-associated nephropathy 122.68 13.01 70 41580 3326 29529551
Interstitial lung disease 120.49 13.01 257 41393 57461 29475416
Oral pain 114.37 13.01 99 41551 9208 29523669
BK virus infection 113.64 13.01 75 41575 4632 29528245
Cough 110.97 13.01 411 41239 126316 29406561
Mouth ulceration 107.20 13.01 100 41550 10255 29522622
Post transplant lymphoproliferative disorder 100.90 13.01 74 41576 5419 29527458
Proteinuria 97.87 13.01 116 41534 15688 29517189
Decreased appetite 95.24 13.01 431 41219 144911 29387966
Death 95.00 13.01 812 40838 341272 29191605
Viraemia 92.53 13.01 40 41610 1034 29531843
Drug abuse 92.07 13.01 5 41645 79878 29452999
Heart transplant rejection 86.68 13.01 39 41611 1112 29531765
Metastases to bone 84.49 13.01 86 41564 9812 29523065
Liver transplant rejection 83.09 13.01 45 41605 1929 29530948
Hepatitis E 81.34 13.01 42 41608 1632 29531245
Fatigue 78.56 13.01 734 40916 316087 29216790
Acne 78.50 13.01 80 41570 9140 29523737
Immunosuppressant drug level decreased 77.05 13.01 36 41614 1122 29531755
C-reactive protein increased 75.52 13.01 182 41468 44081 29488796
Renal impairment 74.64 13.01 268 41382 81065 29451812
Hyperglycaemia 74.20 13.01 155 41495 34132 29498745
Mucosal inflammation 73.29 13.01 147 41503 31448 29501429
Transplant rejection 66.13 13.01 73 41577 9139 29523738
Lung disorder 64.23 13.01 136 41514 30226 29502651
Product use in unapproved indication 63.96 13.01 267 41383 86608 29446269
Fall 63.07 13.01 95 41555 177083 29355794
Concomitant disease progression 62.84 13.01 40 41610 2321 29530556
Blood chromogranin A increased 61.03 13.01 19 41631 184 29532693
Pleural effusion 59.32 13.01 229 41421 71679 29461198
Gamma-glutamyltransferase increased 57.99 13.01 121 41529 26616 29506261
Immunosuppressant drug level increased 57.15 13.01 50 41600 4715 29528162
Drug ineffective 56.94 13.01 291 41359 362879 29169998
Blood creatinine increased 53.86 13.01 250 41400 84852 29448025
Aphthous ulcer 51.45 13.01 44 41606 4024 29528853
Cytomegalovirus infection 51.44 13.01 106 41544 23109 29509768
Lymphocele 49.57 13.01 28 41622 1304 29531573
Complications of transplanted kidney 48.45 13.01 42 41608 3912 29528965
Hypotension 47.17 13.01 130 41520 194224 29338653
Bradycardia 46.71 13.01 17 41633 65612 29467265
Cholangitis 46.12 13.01 55 41595 7482 29525395
Hepatic lesion 45.93 13.01 37 41613 3113 29529764
Atrial fibrillation 45.48 13.01 49 41601 105597 29427280
Lung infiltration 44.56 13.01 68 41582 11711 29521166
Myocardial infarction 44.40 13.01 54 41596 110242 29422635
Metastases to lymph nodes 43.91 13.01 40 41610 3977 29528900
Blood pressure increased 43.91 13.01 213 41437 73590 29459287
Oedema peripheral 43.57 13.01 272 41378 103285 29429592
Vascular hyalinosis 43.47 13.01 10 41640 24 29532853
Renal transplant failure 43.03 13.01 23 41627 960 29531917
Thrombotic microangiopathy 43.00 13.01 57 41593 8624 29524253
Acanthoma 42.62 13.01 10 41640 27 29532850
Renal tubular atrophy 41.79 13.01 23 41627 1018 29531859
Pyrexia 40.07 13.01 597 41053 287025 29245852
Epstein-Barr virus infection 39.95 13.01 48 41602 6581 29526296
Second primary malignancy 39.51 13.01 48 41602 6657 29526220
Bile duct stenosis 39.47 13.01 23 41627 1137 29531740
Metastasis 39.16 13.01 35 41615 3394 29529483
Blood pressure systolic increased 38.60 13.01 78 41572 16767 29516110
General physical health deterioration 37.69 13.01 261 41389 102596 29430281
Electrocardiogram QT prolonged 36.75 13.01 4 41646 36133 29496744
Osteonecrosis of jaw 36.12 13.01 75 41575 16435 29516442
Lymphangiosis carcinomatosa 35.54 13.01 19 41631 793 29532084
Drug hypersensitivity 35.05 13.01 27 41623 68379 29464498
Carcinoid crisis 34.95 13.01 13 41637 224 29532653
Human herpesvirus 8 infection 34.79 13.01 19 41631 828 29532049
Foetal exposure during pregnancy 33.80 13.01 4 41646 33863 29499014
Metastases to peritoneum 33.76 13.01 23 41627 1497 29531380
Anaemia 33.57 13.01 431 41219 200520 29332357
Epistaxis 33.50 13.01 153 41497 51551 29481326
Palmar-plantar erythrodysaesthesia syndrome 33.41 13.01 68 41582 14691 29518186
Pancreatic neuroendocrine tumour metastatic 33.38 13.01 10 41640 84 29532793
Depression 32.89 13.01 43 41607 85104 29447773
Metastases to central nervous system 32.55 13.01 45 41605 7086 29525791
Suicidal ideation 32.51 13.01 5 41645 34711 29498166
Chronic allograft nephropathy 32.38 13.01 20 41630 1100 29531777
Cardiac arrest 32.27 13.01 44 41606 85547 29447330
Weight decreased 32.01 13.01 339 41311 150566 29382311
Metastases to gastrointestinal tract 31.98 13.01 9 41641 59 29532818
Dizziness 31.91 13.01 148 41502 189536 29343341
Kidney fibrosis 31.89 13.01 25 41625 2022 29530855
Needle issue 31.70 13.01 36 41614 4647 29528230
Isosporiasis 31.00 13.01 9 41641 67 29532810
International normalised ratio increased 30.72 13.01 12 41638 44360 29488517
Loss of consciousness 30.06 13.01 36 41614 74020 29458857
Metastases to pleura 29.55 13.01 13 41637 351 29532526
Drug level decreased 29.39 13.01 40 41610 6207 29526670
Agitation 29.27 13.01 18 41632 51286 29481591
Lactic acidosis 29.15 13.01 4 41646 30243 29502634
Hypercholesterolaemia 29.10 13.01 43 41607 7195 29525682
Condition aggravated 29.04 13.01 107 41543 146188 29386689
Intentional product misuse 28.24 13.01 7 41643 34654 29498223
Neoplasm 28.19 13.01 32 41618 4129 29528748
Paraesthesia 27.90 13.01 21 41629 53824 29479053
Angiomyolipoma 27.83 13.01 5 41645 0 29532877
Abdominal pain 27.73 13.01 302 41348 135055 29397822
Tachycardia 27.52 13.01 37 41613 72373 29460504
Somnolence 27.38 13.01 57 41593 93898 29438979
Psoriasis 27.26 13.01 6 41644 32221 29500656
Cardio-respiratory arrest 27.18 13.01 19 41631 50582 29482295
Metastases to pancreas 26.92 13.01 11 41639 246 29532631
Hallucination 26.48 13.01 15 41635 44697 29488180
Ascites 26.48 13.01 112 41538 36507 29496370
Anxiety 26.41 13.01 50 41600 85315 29447562
Metastases to adrenals 25.60 13.01 16 41634 899 29531978
Hyperhidrosis 25.53 13.01 32 41618 64508 29468369
Squamous cell carcinoma of skin 25.50 13.01 47 41603 9439 29523438
Disease progression 25.50 13.01 200 41450 81716 29451161
Blood alkaline phosphatase increased 25.49 13.01 93 41557 28313 29504564
Cardiac failure congestive 25.36 13.01 43 41607 76538 29456339
Neuropathy peripheral 25.30 13.01 38 41612 70989 29461888
Hypertriglyceridaemia 25.28 13.01 41 41609 7434 29525443
Product dose omission issue 25.22 13.01 62 41588 96321 29436556
Haemoglobin decreased 25.13 13.01 248 41402 108127 29424750
Hypoaesthesia 25.05 13.01 23 41627 53444 29479433
Pancreatic neuroendocrine tumour 24.92 13.01 10 41640 213 29532664
Syncope 24.88 13.01 48 41602 81323 29451554
Neuroendocrine tumour 24.78 13.01 14 41636 652 29532225
Cerebrovascular accident 24.73 13.01 44 41606 76867 29456010
Musculoskeletal stiffness 24.53 13.01 11 41639 37447 29495430
Pseudohypoaldosteronism 24.38 13.01 5 41645 5 29532872
Febrile neutropenia 24.35 13.01 79 41571 112161 29420716
Human polyomavirus infection 24.30 13.01 14 41636 677 29532200
Actinic keratosis 23.78 13.01 28 41622 3758 29529119
Parvovirus B19 infection 23.70 13.01 14 41636 710 29532167
Coma 23.70 13.01 13 41637 39437 29493440
Asthma 23.68 13.01 9 41641 33840 29499037
Overdose 23.61 13.01 48 41602 79771 29453106
Transitional cell carcinoma metastatic 23.58 13.01 6 41644 25 29532852
Blood gastrin increased 23.39 13.01 6 41644 26 29532851
Neutropenia 23.18 13.01 101 41549 131610 29401267
Dysgeusia 22.73 13.01 77 41573 22597 29510280
Blood lactate dehydrogenase increased 22.68 13.01 69 41581 19140 29513737
Plasma cell myeloma 22.63 13.01 12 41638 37103 29495774
Insulinoma 22.27 13.01 4 41646 0 29532877
COVID-19 22.16 13.01 105 41545 35909 29496968
Therapeutic product effect incomplete 22.13 13.01 14 41636 39291 29493586
Anorectal varices 22.07 13.01 6 41644 34 29532843
Hepatic artery stenosis 21.77 13.01 8 41642 133 29532744
Superinfection viral 21.73 13.01 5 41645 12 29532865
Cell marker increased 21.55 13.01 11 41639 417 29532460
Granulomatous rosacea 21.34 13.01 8 41642 141 29532736
Metastases to the mediastinum 21.28 13.01 9 41641 220 29532657
Chronic obstructive pulmonary disease 21.18 13.01 16 41634 40939 29491938
Rash 21.13 13.01 380 41270 189439 29343438
Renal cancer metastatic 20.62 13.01 11 41639 457 29532420
Metastases to spine 20.59 13.01 20 41630 2156 29530721
COVID-19 pneumonia 20.52 13.01 43 41607 9479 29523398
Donor specific antibody present 20.48 13.01 7 41643 93 29532784
Dyslipidaemia 20.17 13.01 33 41617 6028 29526849
Crepitations 20.17 13.01 22 41628 2717 29530160
Complications of transplanted heart 20.12 13.01 9 41641 253 29532624
Biliary anastomosis complication 19.96 13.01 7 41643 101 29532776
Anaphylactic reaction 19.85 13.01 7 41643 27566 29505311
Treatment noncompliance 19.53 13.01 5 41645 24222 29508655
Dehydration 19.48 13.01 247 41403 114501 29418376
Body temperature decreased 19.41 13.01 45 41605 10619 29522258
Muscle spasms 19.36 13.01 39 41611 65043 29467834
Blood cholesterol increased 19.34 13.01 57 41593 15538 29517339
Polyomavirus test positive 19.12 13.01 7 41643 115 29532762
Tumour compression 18.85 13.01 7 41643 120 29532757
Feeding disorder 18.26 13.01 31 41619 5836 29527041
Diabetes mellitus 18.23 13.01 107 41543 39724 29493153
Intentional product use issue 17.95 13.01 20 41630 42478 29490399
Bone pain 17.92 13.01 62 41588 18390 29514487
Concomitant disease aggravated 17.79 13.01 28 41622 4950 29527927
Off label use 17.61 13.01 308 41342 300492 29232385
Obstructive nephropathy 17.61 13.01 5 41645 34 29532843
Complex regional pain syndrome 17.41 13.01 10 41640 481 29532396
Loss of personal independence in daily activities 17.41 13.01 7 41643 25433 29507444
Gonococcal infection 17.36 13.01 5 41645 36 29532841
Transitional cell cancer of renal pelvis and ureter metastatic 17.27 13.01 4 41646 10 29532867
Oropharyngeal pain 17.02 13.01 84 41566 29201 29503676
Dyspnoea 17.01 13.01 590 41060 326142 29206735
Hepatic vein stenosis 17.00 13.01 4 41646 11 29532866
Rhabdomyoma 16.70 13.01 3 41647 0 29532877
Metastatic carcinoid tumour 16.50 13.01 4 41646 13 29532864
Balance disorder 16.43 13.01 16 41634 36154 29496723
Onychoclasis 16.37 13.01 16 41634 1737 29531140
Coronary artery disease 16.36 13.01 23 41627 44167 29488710
Arthropathy 16.35 13.01 5 41645 21549 29511328
Brain neoplasm 16.33 13.01 20 41630 2796 29530081
Bacteriuria 16.29 13.01 8 41642 279 29532598
Contraindicated product administered 16.28 13.01 3 41647 18263 29514614
Respiratory arrest 16.27 13.01 8 41642 25825 29507052
Astrocytoma, low grade 16.19 13.01 5 41645 47 29532830
Toxic epidermal necrolysis 16.14 13.01 3 41647 18150 29514727
Oesophageal obstruction 16.07 13.01 9 41641 412 29532465
Tumour pain 16.05 13.01 12 41638 904 29531973
Blood triglycerides increased 16 13.01 47 41603 12787 29520090
Eating disorder 15.94 13.01 33 41617 7214 29525663
Unresponsive to stimuli 15.50 13.01 8 41642 25118 29507759
Pulmonary toxicity 15.43 13.01 26 41624 4864 29528013
Alveolitis necrotising 15.13 13.01 4 41646 20 29532857
Procedural hypertension 15.02 13.01 5 41645 61 29532816
Productive cough 14.97 13.01 85 41565 31174 29501703
Oedema 14.96 13.01 103 41547 40380 29492497
Malaise 14.85 13.01 311 41339 159291 29373586
Chimerism 14.81 13.01 7 41643 224 29532653
Asthenia 14.73 13.01 402 41248 214848 29318029
Muscular weakness 14.64 13.01 42 41608 62010 29470867
Renal hamartoma 14.63 13.01 3 41647 3 29532874
Prostate cancer 14.49 13.01 9 41641 25518 29507359
Tremor 14.43 13.01 54 41596 73484 29459393
Therapy cessation 14.39 13.01 49 41601 14413 29518464
Hernial eventration 14.33 13.01 5 41645 71 29532806
Orthostatic hypotension 14.27 13.01 7 41643 22622 29510255
Acquired phimosis 14.26 13.01 5 41645 72 29532805
Malignant ascites 14.23 13.01 8 41642 369 29532508
Acute respiratory distress syndrome 14.20 13.01 67 41583 22868 29510009
Subdural haematoma 14.20 13.01 4 41646 18189 29514688
Oxygen saturation decreased 14.17 13.01 26 41624 44911 29487966
Blood glucose increased 14.15 13.01 136 41514 58848 29474029
Dysphonia 14.09 13.01 59 41591 19137 29513740
Oligoarthritis 14.08 13.01 5 41645 75 29532802
Hepatic neoplasm 13.96 13.01 15 41635 1821 29531056
Metastases to eye 13.96 13.01 5 41645 77 29532800
Drug withdrawal syndrome 13.95 13.01 4 41646 17980 29514897
Oral discomfort 13.88 13.01 17 41633 2376 29530501
Insomnia 13.88 13.01 71 41579 88690 29444187
Incisional hernia 13.87 13.01 12 41638 1114 29531763
Unevaluable event 13.79 13.01 13 41637 29838 29503039
Bile output abnormal 13.75 13.01 4 41646 30 29532847
Restlessness 13.74 13.01 7 41643 22138 29510739
Dysarthria 13.66 13.01 14 41636 30897 29501980
Metastases to pelvis 13.65 13.01 7 41643 268 29532609
Tumour associated fever 13.63 13.01 7 41643 269 29532608
Cardiogenic shock 13.60 13.01 5 41645 19185 29513692
Renal cell carcinoma 13.55 13.01 24 41626 4672 29528205
Metastases to kidney 13.41 13.01 7 41643 278 29532599
Peritoneal lesion 13.41 13.01 3 41647 6 29532871
Croup infectious 13.39 13.01 7 41643 279 29532598
Premature baby 13.12 13.01 4 41646 17276 29515601
Dermatosis 13.10 13.01 7 41643 292 29532585

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 2540.11 12.65 1596 73234 111275 64312627
Stomatitis 1337.91 12.65 1068 73762 108537 64315365
Metastases to liver 840.64 12.65 453 74377 23488 64400414
Metastases to bone 803.39 12.65 417 74413 20018 64403884
Pneumonitis 497.63 12.65 435 74395 49930 64373972
Metastases to lung 459.31 12.65 261 74569 15003 64408899
Neoplasm progression 405.00 12.65 354 74476 40610 64383292
Mucosal inflammation 295.97 12.65 364 74466 62220 64361682
Metastases to lymph nodes 254.02 12.65 146 74684 8571 64415331
Disease progression 253.41 12.65 528 74302 141152 64282750
BK virus infection 250.97 12.65 137 74693 7275 64416627
Interstitial lung disease 243.99 12.65 420 74410 97312 64326590
Polyomavirus viraemia 243.98 12.65 79 74751 1083 64422819
Hyperglycaemia 225.14 12.65 314 74516 60654 64363248
Polyomavirus-associated nephropathy 221.91 12.65 110 74720 4778 64419124
Pleural effusion 194.73 12.65 444 74386 126115 64297787
Kidney transplant rejection 187.11 12.65 124 74706 9387 64414515
Tumour marker increased 184.92 12.65 87 74743 3363 64420539
Aphthous ulcer 181.35 12.65 137 74693 12769 64411133
Cough 178.23 12.65 758 74072 301390 64122512
Post transplant lymphoproliferative disorder 174.73 12.65 119 74711 9425 64414477
Mouth ulceration 165.21 12.65 196 74634 32248 64391654
Osteonecrosis of jaw 165.06 12.65 217 74613 39608 64384294
Transplant rejection 157.25 12.65 143 74687 17258 64406644
Death 152.42 12.65 1019 73811 481686 63942216
Decreased appetite 147.88 12.65 682 74148 280607 64143295
Infusion related reaction 143.10 12.65 13 74817 164454 64259448
Hepatic lesion 139.57 12.65 86 74744 5738 64418164
Viraemia 134.47 12.65 62 74768 2287 64421615
Renal impairment 133.92 12.65 402 74428 134615 64289287
Drug abuse 128.27 12.65 6 74824 132368 64291534
Thrombotic microangiopathy 125.91 12.65 124 74706 16531 64407371
Lung disorder 122.44 12.65 238 74592 60462 64363440
Fall 122.40 12.65 184 74646 416642 64007260
Immunosuppressant drug level increased 122.29 12.65 86 74744 7173 64416729
Drug ineffective 120.75 12.65 534 74296 839713 63584189
Metastases to skin 114.48 12.65 48 74782 1404 64422498
Product use in unapproved indication 113.30 12.65 455 74375 176163 64247739
Ascites 109.44 12.65 230 74600 61771 64362131
Neoplasm malignant 109.29 12.65 139 74691 24549 64399353
Immunosuppressant drug level decreased 107.33 12.65 49 74781 1766 64422136
Acne 105.42 12.65 132 74698 22949 64400953
Proteinuria 104.10 12.65 144 74686 27579 64396323
Arthropathy 104.04 12.65 10 74820 120957 64302945
Musculoskeletal stiffness 103.85 12.65 11 74819 123195 64300707
Oedema peripheral 102.44 12.65 499 74331 209818 64214084
Condition aggravated 102.10 12.65 172 74658 372254 64051648
Diarrhoea 100.85 12.65 1279 73551 721425 63702477
Oral pain 100.54 12.65 141 74689 27352 64396550
Therapeutic product effect decreased 97.99 12.65 10 74820 115341 64308561
Hypotension 94.58 12.65 187 74643 380787 64043115
Synovitis 94.37 12.65 5 74825 99085 64324817
Breast cancer metastatic 93.91 12.65 73 74757 7096 64416806
Pyrexia 93.44 12.65 1024 73806 557620 63866282
Lymphangiosis carcinomatosa 91.72 12.65 44 74786 1777 64422125
Needle issue 91.31 12.65 80 74750 9192 64414710
Metastasis 90.24 12.65 65 74765 5630 64418272
Heart transplant rejection 89.75 12.65 39 74791 1248 64422654
Second primary malignancy 84.36 12.65 87 74743 12250 64411652
Liver transplant rejection 84.10 12.65 49 74781 2950 64420952
Metastases to peritoneum 81.51 12.65 51 74779 3496 64420406
Metastases to pleura 80.70 12.65 36 74794 1228 64422674
Blood chromogranin A increased 80.12 12.65 26 74804 359 64423543
Infusion site coldness 80.07 12.65 23 74807 204 64423698
Drug hypersensitivity 79.84 12.65 95 74735 237720 64186182
Complications of transplanted kidney 79.25 12.65 59 74771 5376 64418526
Bradycardia 78.74 12.65 20 74810 118199 64305703
Lymphocele 77.67 12.65 38 74792 1603 64422299
Exposure during pregnancy 76.96 12.65 3 74827 77672 64346230
Lung infiltration 74.70 12.65 106 74724 20783 64403119
Cytomegalovirus infection 73.95 12.65 145 74685 37054 64386848
Gamma-glutamyltransferase decreased 73.65 12.65 24 74806 336 64423566
Blood creatinine increased 71.02 12.65 329 74501 135453 64288449
Bone pain 70.97 12.65 165 74665 47407 64376495
Cell marker increased 70.69 12.65 27 74803 615 64423287
Gamma-glutamyltransferase increased 68.83 12.65 165 74665 48345 64375557
Somnolence 68.72 12.65 81 74749 203564 64220338
PIK3CA-activated mutation 68.48 12.65 25 74805 500 64423402
Blood triglycerides increased 67.85 12.65 96 74734 18770 64405132
Systemic lupus erythematosus 67.84 12.65 6 74824 77606 64346296
Hypertriglyceridaemia 67.72 12.65 74 74756 11131 64412771
Weight decreased 67.05 12.65 563 74267 285176 64138726
General physical health deterioration 66.90 12.65 436 74394 203989 64219913
Body temperature decreased 66.68 12.65 113 74717 25815 64398087
Pancreatic neuroendocrine tumour 66.50 12.65 24 74806 464 64423438
Suicide attempt 66.32 12.65 4 74826 71003 64352899
Therapy cessation 66.24 12.65 128 74702 32361 64391541
Renal transplant failure 65.94 12.65 34 74796 1606 64422296
Metastases to central nervous system 65.83 12.65 81 74749 13831 64410071
Metastases to spine 65.68 12.65 45 74785 3598 64420304
Parvovirus B19 infection 65.65 12.65 31 74799 1208 64422694
Dysgeusia 64.59 12.65 158 74672 46889 64377013
Drug level decreased 64.42 12.65 73 74757 11430 64412472
Epistaxis 63.81 12.65 254 74576 97877 64326025
Blood cholesterol increased 63.35 12.65 163 74667 49903 64373999
Hypersensitivity 61.22 12.65 83 74747 196369 64227533
Blood lactate dehydrogenase increased 59.86 12.65 124 74706 32954 64390948
Carbohydrate antigen 15-3 increased 59.48 12.65 27 74803 960 64422942
Blood glucose increased 59.13 12.65 248 74582 97825 64326077
Diabetes mellitus 58.52 12.65 190 74640 66284 64357618
Bone lesion 58.11 12.65 48 74782 5089 64418813
Anaemia 57.21 12.65 681 74149 377999 64045903
Intentional product misuse 57.11 12.65 8 74822 72287 64351615
Pancreatic neuroendocrine tumour metastatic 57.04 12.65 15 74815 92 64423810
Maternal exposure during pregnancy 56.98 12.65 20 74810 95864 64328038
Hypercholesterolaemia 56.43 12.65 79 74751 15294 64408608
Joint swelling 55.74 12.65 103 74727 215279 64208623
Cardiac arrest 55.56 12.65 58 74772 154006 64269896
Kidney fibrosis 55.18 12.65 38 74792 3063 64420839
Atrial fibrillation 53.59 12.65 72 74758 171017 64252885
Hepatitis E 53.47 12.65 34 74796 2397 64421505
Blood pressure systolic increased 52.55 12.65 151 74679 49302 64374600
Eating disorder 52.46 12.65 80 74750 16725 64407177
Product dose omission issue 52.31 12.65 91 74739 194656 64229246
Nail disorder 52.20 12.65 57 74773 8567 64415335
Therapeutic product effect incomplete 51.35 12.65 28 74802 103454 64320448
Drug reaction with eosinophilia and systemic symptoms 50.80 12.65 3 74827 54214 64369688
Loss of personal independence in daily activities 50.73 12.65 11 74819 72443 64351459
Hypophosphataemia 50.14 12.65 73 74757 14647 64409255
Vascular hyalinosis 50.05 12.65 11 74819 26 64423876
Neuroendocrine tumour 49.79 12.65 25 74805 1116 64422786
Cardio-respiratory arrest 49.74 12.65 26 74804 98367 64325535
Myocardial infarction 49.72 12.65 72 74758 165749 64258153
Arthralgia 49.22 12.65 306 74524 441954 63981948
Suicidal ideation 48.89 12.65 9 74821 66533 64357369
International normalised ratio increased 47.93 12.65 16 74814 79151 64344751
Infusion site induration 47.72 12.65 22 74808 811 64423091
Lymphoedema 47.40 12.65 58 74772 9847 64414055
Dizziness 47.16 12.65 299 74531 429864 63994038
Epstein-Barr virus infection 47.07 12.65 65 74765 12423 64411479
Metastases to the mediastinum 46.66 12.65 19 74811 515 64423387
Concomitant disease progression 46.58 12.65 35 74795 3234 64420668
Renal tubular atrophy 45.59 12.65 26 74804 1503 64422399
Syncope 44.79 12.65 71 74759 157564 64266338
Depression 44.51 12.65 91 74739 183200 64240702
Dyslipidaemia 44.03 12.65 54 74776 9188 64414714
Cerebrovascular accident 44.00 12.65 57 74773 137526 64286376
Hepatic neoplasm 43.97 12.65 33 74797 3044 64420858
Overdose 43.35 12.65 74 74756 159492 64264410
Fatigue 42.99 12.65 1154 73676 747576 63676326
Pericarditis 42.74 12.65 10 74820 62506 64361396
Feeding disorder 42.35 12.65 63 74767 12886 64411016
Acanthoma 42.17 12.65 10 74820 37 64423865
Concomitant disease aggravated 41.90 12.65 59 74771 11483 64412419
Lactic acidosis 41.64 12.65 10 74820 61400 64362502
Anaphylactic reaction 41.35 12.65 14 74816 68650 64355252
Arthritis 41.12 12.65 23 74807 83791 64340111
Palmar-plantar erythrodysaesthesia syndrome 40.85 12.65 98 74732 28721 64395181
Weight increased 40.75 12.65 120 74710 213228 64210674
Hyperhidrosis 40.72 12.65 51 74779 124869 64299033
Pneumocystis jirovecii pneumonia 40.28 12.65 95 74735 27539 64396363
Neoplasm 40.02 12.65 45 74785 6986 64416916
Drug level increased 39.86 12.65 108 74722 34088 64389814
Agitation 39.54 12.65 27 74803 88340 64335562
Chronic obstructive pulmonary disease 38.62 12.65 17 74813 71031 64352871
Loss of consciousness 38.32 12.65 71 74759 148294 64275608
Device related thrombosis 38.17 12.65 26 74804 2059 64421843
Confusional state 37.83 12.65 165 74665 260979 64162923
Toxicity to various agents 37.63 12.65 257 74573 363256 64060646
Mean cell haemoglobin decreased 37.48 12.65 34 74796 4088 64419814
Balance disorder 37.07 12.65 26 74804 83900 64340002
C-reactive protein increased 37.06 12.65 212 74618 94697 64329205
Blood alkaline phosphatase increased 36.83 12.65 146 74684 56133 64367769
Human herpesvirus 8 infection 36.78 12.65 20 74810 1053 64422849
Intentional product use issue 36.56 12.65 34 74796 95330 64328572
Thrombocytopenia 36.19 12.65 408 74422 223393 64200509
Mobility decreased 36.10 12.65 28 74802 85812 64338090
Cholangitis 35.97 12.65 53 74777 10749 64413153
Granulomatous rosacea 35.06 12.65 12 74818 197 64423705
Sinusitis 34.96 12.65 73 74757 145855 64278047
Human polyomavirus infection 34.95 12.65 19 74811 1000 64422902
Insulinoma 34.78 12.65 10 74820 89 64423813
Wound 34.70 12.65 23 74807 76454 64347448
Metastases to chest wall 34.47 12.65 14 74816 377 64423525
Serotonin syndrome 34.42 12.65 3 74827 39279 64384623
Crepitations 34.13 12.65 44 74786 7871 64416031
Metastases to pelvis 33.32 12.65 15 74815 523 64423379
Cachexia 33.29 12.65 47 74783 9170 64414732
Post-traumatic neck syndrome 33.12 12.65 23 74807 1879 64422023
Dry skin 32.89 12.65 132 74698 51029 64372873
Hallucination 32.88 12.65 22 74808 72766 64351136
Metastases to thorax 32.76 12.65 11 74819 170 64423732
Oxygen saturation decreased 32.64 12.65 46 74784 107130 64316772
Cardiac failure congestive 32.40 12.65 64 74766 130516 64293386
Irritable bowel syndrome 32.35 12.65 3 74827 37366 64386536
Toxic epidermal necrolysis 32.13 12.65 3 74827 37163 64386739
Accidental exposure to product packaging 32.13 12.65 6 74824 3 64423899
Respiratory arrest 31.56 12.65 11 74819 52974 64370928
Rash 31.35 12.65 724 74106 457825 63966077
Depressed level of consciousness 31.26 12.65 29 74801 81407 64342495
West Nile viral infection 31.18 12.65 17 74813 900 64423002
Actinic keratosis 31.02 12.65 34 74796 5131 64418771
Polyomavirus test positive 30.90 12.65 11 74819 204 64423698
Injection site reaction 30.86 12.65 8 74822 46656 64377246
Abdominal lymphadenopathy 30.53 12.65 18 74812 1108 64422794
Asthenia 30.24 12.65 679 74151 427365 63996537
Complications of transplanted heart 30.19 12.65 12 74818 305 64423597
Hormone receptor positive breast cancer 30.15 12.65 12 74818 306 64423596
Renal tubular necrosis 30.07 12.65 74 74756 22036 64401866
Metastases to muscle 29.87 12.65 12 74818 314 64423588
Bile duct stenosis 29.73 12.65 21 74809 1763 64422139
Treatment noncompliance 29.63 12.65 7 74823 43475 64380427
Vasodilatation 29.63 12.65 26 74804 2992 64420910
Carcinoid crisis 29.21 12.65 13 74817 441 64423461
Pericardial effusion 29.12 12.65 106 74724 39148 64384754
Isosporiasis 28.73 12.65 9 74821 110 64423792
Renal lymphocele 28.59 12.65 9 74821 112 64423790
Spinal pain 28.55 12.65 52 74778 12569 64411333
Abdominal distension 28.51 12.65 200 74630 95794 64328108
Oncologic complication 28.26 12.65 11 74819 264 64423638
Impaired insulin secretion 28.16 12.65 7 74823 33 64423869
Psoriasis 28.16 12.65 25 74805 71678 64352224
Therapy change 28.11 12.65 36 74794 6398 64417504
Injection site pruritus 28.03 12.65 5 74825 37821 64386081
Tachycardia 27.92 12.65 85 74745 149494 64274408
Chronic allograft nephropathy 27.92 12.65 19 74811 1502 64422400
Pseudocirrhosis 27.76 12.65 14 74816 631 64423271
COVID-19 pneumonia 27.69 12.65 60 74770 16444 64407458
Treatment failure 27.50 12.65 59 74771 116757 64307145
Unresponsive to stimuli 27.48 12.65 12 74818 50381 64373521
Infusion site haemorrhage 26.96 12.65 22 74808 2293 64421609
Haemoglobin decreased 26.87 12.65 345 74485 194718 64229184
Oral herpes 26.86 12.65 71 74759 22081 64401821
Cheilitis 26.84 12.65 30 74800 4626 64419276
Hepatic mass 26.46 12.65 21 74809 2103 64421799
Platelet count decreased 26.30 12.65 304 74526 167407 64256495
Focal segmental glomerulosclerosis 26.21 12.65 24 74806 2920 64420982
Carcinoid heart disease 26.08 12.65 7 74823 47 64423855
Headache 26.01 12.65 445 74385 529022 63894880
Tumour pain 26.01 12.65 20 74810 1913 64421989
Biliary anastomosis complication 25.95 12.65 9 74821 154 64423748
Lymphadenopathy mediastinal 25.90 12.65 27 74803 3849 64420053
Sedation 25.76 12.65 8 74822 41454 64382448
Electrocardiogram QT prolonged 25.30 12.65 33 74797 79415 64344487
Metastases to pancreas 25.14 12.65 12 74818 479 64423423
Skin sensitisation 24.92 12.65 14 74816 786 64423116
Breast cancer recurrent 24.86 12.65 22 74808 2561 64421341
Anaphylactic shock 24.81 12.65 3 74827 30325 64393577
Transitional cell carcinoma metastatic 24.74 12.65 6 74824 25 64423877
Reflux gastritis 24.55 12.65 15 74815 985 64422917
Unevaluable event 24.55 12.65 14 74816 50475 64373427
Sleep apnoea syndrome 24.28 12.65 3 74827 29829 64394073
Pulmonary mass 24.23 12.65 72 74758 23944 64399958
Metastases to gastrointestinal tract 24.17 12.65 8 74822 118 64423784
Orthostatic hypotension 24.14 12.65 12 74818 46726 64377176
Cancer pain 23.81 12.65 27 74803 4230 64419672
Osteoarthritis 23.78 12.65 23 74807 63313 64360589
Tumour necrosis 23.69 12.65 18 74812 1691 64422211
Plasma cell myeloma 23.54 12.65 12 74818 46063 64377839
Drug withdrawal syndrome 23.49 12.65 4 74826 31287 64392615
Discomfort 23.37 12.65 36 74794 80842 64343060
Anorectal varices 23.22 12.65 6 74824 34 64423868
Memory impairment 23.02 12.65 40 74790 85642 64338260
Glomerular filtration rate decreased 22.99 12.65 62 74768 19510 64404392
Injection site erythema 22.97 12.65 29 74801 70771 64353131
Lung transplant rejection 22.94 12.65 16 74814 1316 64422586
Febrile neutropenia 22.86 12.65 126 74704 187531 64236371
Metastases to kidney 22.75 12.65 11 74819 452 64423450
Donor specific antibody present 22.75 12.65 9 74821 226 64423676
Pleural neoplasm 22.60 12.65 9 74821 230 64423672
Steatorrhoea 22.46 12.65 13 74817 773 64423129
Stevens-Johnson syndrome 22.40 12.65 6 74824 34243 64389659
Tumour compression 22.34 12.65 8 74822 151 64423751
Emotional distress 22.31 12.65 7 74823 36031 64387871
Hallucination, visual 22.17 12.65 3 74827 27831 64396071
Lower respiratory tract infection 22.09 12.65 48 74782 94566 64329336
Ill-defined disorder 21.73 12.65 12 74818 44040 64379862
Metastatic carcinoid tumour 21.65 12.65 5 74825 16 64423886
Pulmonary toxicity 21.60 12.65 37 74793 8524 64415378
Injury 21.41 12.65 20 74810 55972 64367930
Post transplant distal limb syndrome 21.34 12.65 11 74819 519 64423383
Gait disturbance 21.29 12.65 115 74715 172040 64251862
Toothache 21.21 12.65 56 74774 17403 64406499
Biliary dilatation 21.20 12.65 19 74811 2249 64421653
Exposed bone in jaw 21.02 12.65 23 74807 3464 64420438
Bone cancer 20.91 12.65 16 74814 1519 64422383
Squamous cell carcinoma of skin 20.87 12.65 44 74786 11832 64412070
Asthma 20.86 12.65 50 74780 95175 64328727
Off label use 20.86 12.65 567 74263 632239 63791663
Coma 20.83 12.65 44 74786 87571 64336331
Lymphocyte count decreased 20.79 12.65 98 74732 40601 64383301
Epstein-Barr viraemia 20.76 12.65 17 74813 1780 64422122
Urticaria 20.75 12.65 94 74736 147223 64276679
Hepatic enzyme increased 20.74 12.65 79 74751 129864 64294038
Dysarthria 20.69 12.65 23 74807 59383 64364519
Hyponatraemia 20.69 12.65 95 74735 148244 64275658
Cognitive disorder 20.69 12.65 20 74810 55067 64368835
Hypoaesthesia 20.67 12.65 87 74743 139021 64284881
Adverse event 20.60 12.65 10 74820 39479 64384423
Injection site mass 20.58 12.65 55 74775 17215 64406687
Sleep disorder due to general medical condition, insomnia type 20.53 12.65 3 74827 26267 64397635
Joint stiffness 20.51 12.65 5 74825 30399 64393503
Tumour marker abnormal 20.44 12.65 8 74822 195 64423707
Visual impairment 20.43 12.65 34 74796 74043 64349859
Alveolar proteinosis 20.41 12.65 11 74819 569 64423333
Vasoactive intestinal polypeptide increased 20.27 12.65 4 74826 4 64423898
Carcinoembryonic antigen increased 20.15 12.65 17 74813 1856 64422046
Pseudohypoaldosteronism 20.04 12.65 5 74825 24 64423878
Amnesia 19.97 12.65 16 74814 48253 64375649
Muscular weakness 19.95 12.65 78 74752 127260 64296642
Oedema 19.85 12.65 178 74652 91757 64332145
Cell death 19.82 12.65 24 74806 4030 64419872
Congenital coronary artery malformation 19.73 12.65 6 74824 66 64423836
Wrong technique in product usage process 19.67 12.65 28 74802 64946 64358956
Vein disorder 19.66 12.65 24 74806 4063 64419839
Helicobacter infection 19.58 12.65 10 74820 38352 64385550
Red blood cell sedimentation rate increased 19.45 12.65 6 74824 31229 64392673
Vision blurred 19.33 12.65 48 74782 90268 64333634
Blood pressure fluctuation 19.29 12.65 19 74811 51852 64372050
Hypophagia 19.27 12.65 94 74736 39493 64384409
Liver abscess 19.18 12.65 27 74803 5253 64418649
Anxiety 19.13 12.65 147 74683 202502 64221400
Flatulence 19.05 12.65 87 74743 35579 64388323
COVID-19 18.92 12.65 135 74695 65005 64358897
Insomnia 18.91 12.65 143 74687 197693 64226209
Acute respiratory distress syndrome 18.63 12.65 92 74738 38843 64385059
Recurrent cancer 18.55 12.65 18 74812 2355 64421547
Abdominal pain 18.54 12.65 484 74346 311891 64112011
Pulmonary tumour thrombotic microangiopathy 18.41 12.65 6 74824 84 64423818
Drug intolerance 18.39 12.65 135 74695 187857 64236045
Nephritic syndrome 18.35 12.65 8 74822 258 64423644
Drug-induced liver injury 18.24 12.65 17 74813 47626 64376276
Tongue oedema 17.97 12.65 28 74802 5962 64417940
Dysplasia 17.89 12.65 13 74817 1141 64422761
Superinfection viral 17.86 12.65 5 74825 40 64423862
Transient ischaemic attack 17.84 12.65 15 74815 44167 64379735
Transitional cell cancer of renal pelvis and ureter metastatic 17.77 12.65 4 74826 11 64423891
Anorexia nervosa 17.68 12.65 7 74823 176 64423726
Cornea verticillata 17.56 12.65 6 74824 98 64423804
Obstructive nephropathy 17.54 12.65 5 74825 43 64423859
Metastases to adrenals 17.54 12.65 13 74817 1176 64422726
Onychoclasis 17.45 12.65 24 74806 4568 64419334
Complex regional pain syndrome 17.44 12.65 15 74815 1681 64422221
Neutropenic sepsis 17.41 12.65 3 74827 23269 64400633
Intentional self-injury 17.35 12.65 6 74824 29038 64394864
Gonococcal infection 17.34 12.65 5 74825 45 64423857
Throat tightness 17.30 12.65 3 74827 23157 64400745
Blood creatinine decreased 17.17 12.65 30 74800 7020 64416882
Therapeutic product effective for unapproved indication 17.13 12.65 6 74824 106 64423796
Gastric antral vascular ectasia 17.03 12.65 11 74819 797 64423105
Angiomyolipoma 17.01 12.65 7 74823 195 64423707
Muscle spasms 17.00 12.65 95 74735 140928 64282974
Febrile convulsion 16.94 12.65 11 74819 804 64423098
Hydrothorax 16.90 12.65 13 74817 1244 64422658
Jejunal ulcer perforation 16.82 12.65 6 74824 112 64423790
Malignant ascites 16.79 12.65 12 74818 1026 64422876
Restlessness 16.69 12.65 13 74817 39772 64384130
Mental disorder 16.61 12.65 5 74825 26440 64397462
Gastrointestinal haemorrhage 16.57 12.65 88 74742 132224 64291678
Mucosal toxicity 16.39 12.65 9 74821 483 64423419
Therapeutic product ineffective for unapproved indication 16.34 12.65 6 74824 122 64423780
Nephrotic syndrome 16.30 12.65 35 74795 9532 64414370
Metastases to eye 16.25 12.65 7 74823 219 64423683
Renal cancer metastatic 16.07 12.65 10 74820 679 64423223
Burning sensation mucosal 16.05 12.65 5 74825 60 64423842
Oral administration complication 16.03 12.65 6 74824 129 64423773
Ventricular tachycardia 15.96 12.65 10 74820 34255 64389647
Dyspnoea 15.94 12.65 1001 73829 717673 63706229
Alveolitis necrotising 15.90 12.65 4 74826 20 64423882
Hernial eventration 15.83 12.65 5 74825 63 64423839
Alopecia 15.72 12.65 120 74710 165570 64258332
Dehydration 15.62 12.65 345 74485 216418 64207484
Withdrawal syndrome 15.58 12.65 4 74826 23488 64400414
Tongue ulceration 15.39 12.65 20 74810 3606 64420296
Gastrointestinal disorder 15.33 12.65 53 74777 89656 64334246
Presyncope 15.32 12.65 11 74819 35078 64388824
Inferior vena cava syndrome 15.29 12.65 4 74826 24 64423878
Primary pulmonary melanoma 15.21 12.65 3 74827 3 64423899
Rhabdomyolysis 15.13 12.65 55 74775 91671 64332231
Palpitations 15.12 12.65 66 74764 104422 64319480
Angina pectoris 15.11 12.65 18 74812 45063 64378839
Panic attack 15.04 12.65 3 74827 20950 64402952
Odynophagia 14.99 12.65 34 74796 9607 64414295
Urinary fistula 14.97 12.65 5 74825 76 64423826
Chimerism 14.91 12.65 7 74823 269 64423633
Lymphadenopathy 14.89 12.65 99 74731 46587 64377315
Hepatic atrophy 14.84 12.65 8 74822 414 64423488
Graft loss 14.84 12.65 11 74819 996 64422906
Angiosarcoma 14.82 12.65 8 74822 415 64423487
Skin toxicity 14.68 12.65 27 74803 6575 64417327
Neutrophilic panniculitis 14.62 12.65 5 74825 82 64423820
Nephropathy toxic 14.46 12.65 49 74781 17465 64406437
Biliary obstruction 14.39 12.65 20 74810 3844 64420058
Urine output decreased 14.38 12.65 47 74783 16445 64407457
Cardiogenic shock 14.38 12.65 10 74820 32417 64391485
Adverse drug reaction 14.35 12.65 19 74811 45445 64378457
Mental status changes 14.30 12.65 31 74799 61131 64362771
Varicella zoster virus infection 14.30 12.65 20 74810 3868 64420034
Shock 14.22 12.65 14 74816 38226 64385676
Bile output abnormal 14.18 12.65 4 74826 33 64423869
Ventricular fibrillation 14.13 12.65 5 74825 23855 64400047
Poisoning 14.00 12.65 4 74826 21875 64402027
Renal failure 13.99 12.65 292 74538 181396 64242506
Ascariasis 13.99 12.65 3 74827 6 64423896
Pyelonephritis 13.98 12.65 48 74782 17218 64406684
Anal ulcer 13.89 12.65 11 74819 1098 64422804
Delirium 13.87 12.65 38 74792 69156 64354746
Coronary artery disease 13.82 12.65 31 74799 60402 64363500
Bowel movement irregularity 13.82 12.65 22 74808 4771 64419131
Haemolytic uraemic syndrome 13.78 12.65 20 74810 4001 64419901
Carcinoid tumour pulmonary 13.67 12.65 7 74823 326 64423576
Renal cell carcinoma 13.62 12.65 25 74805 6079 64417823
Malignant pleural effusion 13.59 12.65 17 74813 2950 64420952
Central nervous system viral infection 13.51 12.65 5 74825 104 64423798
Dermatosis 13.48 12.65 8 74822 498 64423404
Intestinal obstruction 13.47 12.65 80 74750 36206 64387696
Product quality issue 13.46 12.65 9 74821 29790 64394112
Bone neoplasm 13.46 12.65 9 74821 691 64423211
Blood gastrin increased 13.41 12.65 4 74826 41 64423861
Glossodynia 13.37 12.65 35 74795 64661 64359241
Breast cancer 13.33 12.65 68 74762 29080 64394822
Subdural haematoma 13.33 12.65 8 74822 28046 64395856
Delayed graft function 13.28 12.65 17 74813 3019 64420883
Bacteriuria 13.23 12.65 10 74820 932 64422970
Myalgia 13.18 12.65 119 74711 158498 64265404
Eosinophil cationic protein increased 13.15 12.65 4 74826 44 64423858
Renal disorder 13.15 12.65 78 74752 35287 64388615
Nightmare 13.13 12.65 4 74826 20989 64402913
Pneumonia aspiration 13.08 12.65 31 74799 59240 64364662
Ovarian cyst 13.04 12.65 35 74795 10983 64412919
Skin laceration 13.02 12.65 6 74824 24411 64399491
Product administration error 12.97 12.65 8 74822 27635 64396267
Disseminated varicella zoster vaccine virus infection 12.93 12.65 5 74825 118 64423784
Renal hamartoma 12.93 12.65 5 74825 118 64423784
Metastases to bladder 12.92 12.65 6 74824 225 64423677
Cerebral ventricle collapse 12.77 12.65 5 74825 122 64423780
Premature delivery 12.65 12.65 3 74827 18586 64405316

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 D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
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 (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




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 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 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
2MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 ADJUNCTIVE TREATMENT OF PATIENTS WITH TSC-ASSOCIATED PARTIAL-ONSET SEIZURES
2MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
3MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 ADJUNCTIVE TREATMENT OF PATIENTS WITH TSC-ASSOCIATED PARTIAL-ONSET SEIZURES
3MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
5MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 ADJUNCTIVE TREATMENT OF PATIENTS WITH TSC-ASSOCIATED PARTIAL-ONSET SEIZURES
5MG AFINITOR DISPERZ NOVARTIS PHARM N203985 Aug. 29, 2012 RX TABLET, FOR SUSPENSION ORAL 8778962 Feb. 18, 2022 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
10MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8436010 Feb. 22, 2022 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
2.5MG AFINITOR NOVARTIS N022334 July 9, 2010 RX TABLET ORAL 8436010 Feb. 22, 2022 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
5MG AFINITOR NOVARTIS N022334 March 30, 2009 RX TABLET ORAL 8436010 Feb. 22, 2022 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
7.5MG AFINITOR NOVARTIS N022334 March 30, 2012 RX TABLET ORAL 8436010 Feb. 22, 2022 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
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 PROGESSIVE 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 PROGESSIVE 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 PROGESSIVE 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 PROGESSIVE 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 0078-0415 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 0078-0422 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 0078-0567 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 0078-0620 TABLET 7.50 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0626 TABLET, FOR SUSPENSION 2 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0627 TABLET, FOR SUSPENSION 3 mg ORAL NDA 33 sections
AfinitorDisperz HUMAN PRESCRIPTION DRUG LABEL 1 0078-0628 TABLET, FOR SUSPENSION 5 mg ORAL NDA 33 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7766 TABLET 2.50 mg ORAL ANDA 30 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7767 TABLET 5 mg ORAL ANDA 30 sections
Everolimus HUMAN PRESCRIPTION DRUG LABEL 1 0093-7768 TABLET 7.50 mg ORAL ANDA 30 sections