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

Stem definitionDrug idCAS RN
immunomodulators, both stimulant/suppressive and stimulant 4167 162359-55-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • FTY-720
  • fingolimod
  • fingolimod hydrochloride
  • gilenya
  • fingolimod HCl
A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.
  • Molecular weight: 307.48
  • Formula: C19H33NO2
  • CLOGP: 5.06
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 3
  • TPSA: 66.48
  • ALOGS: -4.65
  • ROTB: 12

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.50 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 17.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.53 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 144 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.93 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Aug. 18, 2021 EMA MYLAN IRELAND LIMITED
Sept. 21, 2010 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
Multiple sclerosis relapse 5098.35 13.23 2055 84450 46423 63356094
Lymphocyte count decreased 4456.86 13.23 1640 84865 28617 63373900
Central nervous system lesion 2515.72 13.23 822 85683 9813 63392704
Lymphopenia 1998.50 13.23 799 85706 17528 63384989
White blood cell count decreased 1380.59 13.23 1290 85215 137814 63264703
Expanded disability status scale score increased 1258.44 13.23 263 86242 333 63402184
Macular oedema 995.01 13.23 319 86186 3558 63398959
Heart rate decreased 711.12 13.23 549 85956 45011 63357506
Visual impairment 695.53 13.23 708 85797 83738 63318779
Melanocytic naevus 642.50 13.23 239 86266 4269 63398248
Vision blurred 609.38 13.23 687 85818 91237 63311280
Hypoaesthesia 581.49 13.23 914 85591 167479 63235038
Rebound effect 537.27 13.23 210 86295 4316 63398201
Off label use 519.08 13.23 140 86365 674322 62728195
Optic neuritis 507.23 13.23 242 86263 8193 63394324
JC polyomavirus test positive 458.31 13.23 140 86365 1313 63401204
Gamma-glutamyltransferase increased 447.51 13.23 371 86134 33660 63368857
Gait disturbance 424.95 13.23 835 85670 182343 63220174
Alanine aminotransferase increased 401.19 13.23 594 85911 103176 63299341
Muscular weakness 393.01 13.23 643 85862 121710 63280807
Headache 362.19 13.23 1760 84745 631481 62771036
Fatigue 356.43 13.23 2241 84264 885787 62516730
Prescribed underdose 352.02 13.23 305 86200 29384 63373133
Normal newborn 334.31 13.23 182 86323 8159 63394358
Drug ineffective 333.32 13.23 573 85932 1044192 62358325
Balance disorder 318.68 13.23 478 86027 83944 63318573
Atrioventricular block second degree 306.67 13.23 135 86370 3779 63398738
Atrioventricular block first degree 300.69 13.23 162 86343 7111 63395406
Toxicity to various agents 299.59 13.23 8 86497 247242 63155275
Hemiparesis 287.83 13.23 245 86260 23037 63379480
Rheumatoid arthritis 287.58 13.23 14 86491 253805 63148712
Contraindicated product administered 280.27 13.23 3 86502 217645 63184872
Seborrhoeic keratosis 279.14 13.23 109 86396 2233 63400284
Infusion related reaction 276.69 13.23 14 86491 245507 63157010
Paraesthesia 276.43 13.23 640 85865 156326 63246191
Secondary progressive multiple sclerosis 264.82 13.23 92 86413 1335 63401182
Ataxia 263.21 13.23 195 86310 15000 63387517
Micturition urgency 258.71 13.23 162 86343 9449 63393068
Joint swelling 255.12 13.23 66 86439 327600 63074917
Progressive multifocal leukoencephalopathy 253.27 13.23 179 86326 12792 63389725
CD4 lymphocytes decreased 249.48 13.23 88 86417 1339 63401178
Arthropathy 247.79 13.23 19 86486 234773 63167744
Tumefactive multiple sclerosis 246.16 13.23 48 86457 29 63402488
Memory impairment 241.07 13.23 475 86030 103783 63298734
Acute kidney injury 238.44 13.23 37 86468 263378 63139139
Therapeutic product effect decreased 234.92 13.23 6 86499 193181 63209336
Synovitis 234.43 13.23 4 86501 186914 63215603
Herpes zoster 232.31 13.23 409 86096 82053 63320464
Systemic lupus erythematosus 231.96 13.23 13 86492 208905 63193612
Multiple sclerosis 231.29 13.23 221 86284 24151 63378366
Breast cancer 228.46 13.23 305 86200 48078 63354439
Drug hypersensitivity 226.27 13.23 71 86434 310616 63091901
Death 226.19 13.23 114 86391 374267 63028250
Lentigo 224.77 13.23 59 86446 297 63402220
Muscle spasticity 219.01 13.23 204 86301 21590 63380927
Dizziness 218.18 13.23 1157 85348 428768 62973749
Eye pain 217.19 13.23 249 86256 33605 63368912
Concomitant disease aggravated 216.55 13.23 142 86363 8970 63393547
Limb discomfort 213.71 13.23 232 86273 29484 63373033
Product use issue 208.84 13.23 27 86478 220493 63182024
Glossodynia 205.35 13.23 9 86496 178867 63223650
Haemangioma of skin 203.62 13.23 57 86448 380 63402137
Immune reconstitution inflammatory syndrome 201.08 13.23 117 86388 5967 63396550
Bradycardia 198.27 13.23 357 86148 72870 63329647
Cognitive disorder 197.77 13.23 307 86198 55508 63347009
Drug intolerance 197.12 13.23 87 86418 308574 63093943
Sensory disturbance 185.81 13.23 152 86353 13520 63388997
Swelling 183.24 13.23 73 86432 275305 63127212
Basal cell carcinoma 169.71 13.23 200 86305 27791 63374726
Completed suicide 168.28 13.23 7 86498 145666 63256851
Visual acuity reduced 166.80 13.23 176 86329 21650 63380867
High density lipoprotein increased 163.57 13.23 57 86448 835 63401682
Rash 163.31 13.23 324 86181 560547 62841970
Condition aggravated 161.80 13.23 186 86319 402031 63000486
Leukopenia 160.61 13.23 337 86168 76953 63325564
Pneumonia 158.38 13.23 236 86269 456531 62945986
Wound 156.94 13.23 19 86486 163244 63239273
Blood alkaline phosphatase increased 150.33 13.23 235 86270 42732 63359785
Solar lentigo 149.02 13.23 52 86453 765 63401752
Depression 146.12 13.23 592 85913 195900 63206617
Paraparesis 139.72 13.23 66 86439 2182 63400335
Aspartate aminotransferase increased 139.30 13.23 350 86155 89927 63312590
Cervical dysplasia 136.80 13.23 73 86432 3141 63399376
Hypersensitivity 132.74 13.23 122 86383 292563 63109954
Abortion spontaneous 132.73 13.23 234 86271 46961 63355556
Febrile neutropenia 132.56 13.23 7 86498 118442 63284075
Vertigo 132.50 13.23 268 86237 59619 63342898
Intentional product use issue 130.30 13.23 12 86493 127880 63274637
Fibrous histiocytoma 129.15 13.23 43 86462 544 63401973
Treatment failure 128.72 13.23 55 86450 198988 63203529
Maternal exposure during pregnancy 126.50 13.23 614 85891 219448 63183069
Lymphocyte count increased 123.63 13.23 70 86435 3388 63399129
Malignant melanoma 123.25 13.23 111 86394 11245 63391272
Blood pressure decreased 123.03 13.23 273 86232 64749 63337768
Diplopia 121.94 13.23 156 86349 23572 63378945
Drug interaction 119.54 13.23 83 86422 229048 63173469
Oropharyngeal pain 118.22 13.23 339 86166 94148 63308369
Trigeminal neuralgia 117.15 13.23 68 86437 3451 63399066
Lymphocyte percentage decreased 116.47 13.23 64 86441 2921 63399596
Anaemia 115.41 13.23 138 86367 293292 63109225
Drug monitoring procedure not performed 115.28 13.23 40 86465 578 63401939
Urinary incontinence 113.24 13.23 176 86329 31838 63370679
Sinus bradycardia 112.36 13.23 118 86387 14433 63388084
Diarrhoea 111.04 13.23 550 85955 714816 62687701
Low density lipoprotein increased 111.01 13.23 82 86423 6275 63396242
Stomatitis 109.63 13.23 27 86478 138698 63263819
Aphasia 109.24 13.23 176 86329 32824 63369693
Pericarditis 107.16 13.23 24 86481 131555 63270962
Injection site pain 107.08 13.23 23 86482 129777 63272740
Sensory loss 107.04 13.23 98 86407 10140 63392377
Vitamin D deficiency 104.32 13.23 111 86394 13781 63388736
Paresis 103.58 13.23 56 86449 2474 63400043
Vomiting 103.27 13.23 403 86102 559214 62843303
Dysarthria 102.75 13.23 198 86307 42513 63360004
Blood alkaline phosphatase decreased 102.34 13.23 44 86461 1161 63401356
Lymphocyte count abnormal 102.20 13.23 38 86467 677 63401840
Cervix carcinoma 99.29 13.23 58 86447 2979 63399538
Stress 99.01 13.23 256 86249 66911 63335606
Palpitations 97.02 13.23 356 86149 112414 63290103
Helicobacter infection 96.42 13.23 8 86497 92777 63309740
Maternal exposure before pregnancy 95.97 13.23 81 86424 7522 63394995
Exposure during pregnancy 95.82 13.23 46 86459 155501 63247016
Psoriatic arthropathy 94.81 13.23 8 86497 91512 63311005
Cardiac failure congestive 93.27 13.23 9 86496 92424 63310093
Movement disorder 92.32 13.23 130 86375 21531 63380986
Therapeutic product effect incomplete 91.94 13.23 28 86477 125028 63277489
Arthralgia 91.76 13.23 432 86073 569278 62833239
Back pain 91.09 13.23 644 85861 263501 63139016
Peripheral swelling 90.46 13.23 139 86366 265803 63136714
Migraine 88.68 13.23 326 86179 103020 63299497
Cystoid macular oedema 88.05 13.23 43 86462 1532 63400985
Blood bilirubin decreased 87.31 13.23 35 86470 770 63401747
Renal failure 87.11 13.23 26 86479 117626 63284891
Maternal exposure timing unspecified 86.38 13.23 74 86431 7013 63395504
Dysplastic naevus 85.86 13.23 24 86481 159 63402358
Malignant neoplasm progression 85.55 13.23 7 86498 82114 63320403
Monocyte count increased 84.80 13.23 75 86430 7418 63395099
Molluscum contagiosum 84.37 13.23 25 86480 209 63402308
Abdominal discomfort 84.30 13.23 196 86309 320689 63081828
Loss of personal independence in daily activities 82.81 13.23 16 86489 97274 63305243
Gastrointestinal haemorrhage 81.65 13.23 8 86497 81168 63321349
Muscle spasms 81.40 13.23 424 86081 155726 63246791
Neutrophil count increased 80.76 13.23 106 86399 16421 63386096
Discomfort 79.13 13.23 67 86438 167307 63235210
CD8 lymphocytes decreased 78.67 13.23 22 86483 146 63402371
Renal impairment 78.52 13.23 13 86492 88342 63314175
Optic atrophy 77.83 13.23 37 86468 1241 63401276
Demyelination 75.80 13.23 68 86437 6852 63395665
Hyponatraemia 75.42 13.23 29 86476 111871 63290646
Meningitis cryptococcal 75.21 13.23 37 86468 1340 63401177
Urinary tract infection 74.81 13.23 616 85889 264068 63138449
Delivery 74.55 13.23 37 86468 1366 63401151
Injection site erythema 74.44 13.23 12 86493 83162 63319355
Pruritus 74.01 13.23 249 86256 361204 63041313
Pain 73.96 13.23 650 85855 739978 62662539
Extensor plantar response 73.92 13.23 36 86469 1275 63401242
Muscle injury 72.67 13.23 4 86501 65341 63337176
Feeling abnormal 72.60 13.23 396 86109 147996 63254521
Epilepsy 71.99 13.23 131 86374 26934 63375583
Hypotension 71.98 13.23 166 86339 272438 63130079
Speech disorder 71.73 13.23 166 86339 40463 63362054
Temperature intolerance 71.55 13.23 74 86431 8890 63393627
Fall 71.14 13.23 832 85673 391502 63011015
Clumsiness 70.90 13.23 41 86464 2066 63400451
Drug abuse 70.75 13.23 8 86497 72510 63330007
Sepsis 70.32 13.23 63 86442 153060 63249457
Invasive ductal breast carcinoma 69.63 13.23 65 86440 6893 63395624
Depressed mood 68.54 13.23 162 86343 40029 63362488
Chest discomfort 68.31 13.23 314 86191 109655 63292862
Dysaesthesia 67.69 13.23 53 86452 4425 63398092
Decreased immune responsiveness 67.66 13.23 55 86450 4846 63397671
Gait spastic 67.28 13.23 22 86483 262 63402255
Expanded disability status scale 67.20 13.23 12 86493 0 63402517
Adverse event 67.06 13.23 7 86498 67552 63334965
Hospitalisation 66.35 13.23 17 86488 85064 63317453
Bladder dysfunction 66.08 13.23 30 86475 904 63401613
Decreased interest 66.06 13.23 46 86459 3208 63399309
Immune thrombocytopenia 64.92 13.23 76 86429 10480 63392037
Cafe au lait spots 64.84 13.23 13 86492 11 63402506
Haemangioma 63.79 13.23 42 86463 2670 63399847
Ocular discomfort 63.77 13.23 50 86455 4183 63398334
Magnetic resonance imaging abnormal 63.54 13.23 44 86461 3041 63399476
Electrocardiogram PR prolongation 63.35 13.23 27 86478 697 63401820
Lower respiratory tract infection 62.48 13.23 53 86452 132254 63270263
Neuropathy peripheral 62.17 13.23 39 86466 113628 63288889
Arthritis 61.73 13.23 41 86464 115880 63286637
Basophil count decreased 61.67 13.23 18 86487 142 63402375
Band sensation 61.64 13.23 28 86477 845 63401672
Blister 61.31 13.23 52 86453 129762 63272755
Oxygen saturation decreased 61.31 13.23 22 86483 88563 63313954
Knee arthroplasty 61.28 13.23 3 86502 54203 63348314
Intentional product misuse 61.27 13.23 6 86499 60911 63341606
CD4/CD8 ratio decreased 61.08 13.23 12 86493 8 63402509
Deep vein thrombosis 59.39 13.23 20 86485 83780 63318737
Skin lesion 59.23 13.23 130 86375 30591 63371926
Neurogenic bladder 58.77 13.23 43 86462 3242 63399275
Actinic keratosis 58.05 13.23 39 86466 2565 63399952
Cardiac arrest 57.54 13.23 27 86478 92518 63309999
Ill-defined disorder 57.09 13.23 20 86485 81735 63320782
Nystagmus 56.35 13.23 55 86450 6165 63396352
White matter lesion 56.23 13.23 34 86471 1861 63400656
Peroneal nerve palsy 55.92 13.23 49 86456 4786 63397731
Visual field defect 55.71 13.23 56 86449 6505 63396012
Cryptococcal cutaneous infection 54.98 13.23 14 86491 61 63402456
Pancytopenia 54.77 13.23 32 86473 96901 63305616
Dysgraphia 54.73 13.23 41 86464 3205 63399312
CSF protein increased 54.25 13.23 22 86483 499 63402018
Wrong technique in product usage process 53.58 13.23 10 86495 62330 63340187
T-lymphocyte count decreased 53.39 13.23 19 86486 297 63402220
Ophthalmoplegia 53.32 13.23 30 86475 1434 63401083
Product use in unapproved indication 53.15 13.23 102 86403 178978 63223539
Adverse drug reaction 53.15 13.23 21 86484 79693 63322824
Folliculitis 53.03 13.23 15 86490 70302 63332215
Pulmonary embolism 52.38 13.23 49 86456 116635 63285882
Dehydration 52.10 13.23 98 86407 173256 63229261
General physical health deterioration 52.05 13.23 124 86381 201278 63201239
Aspartate aminotransferase decreased 51.64 13.23 24 86481 764 63401753
Neuralgia 51.45 13.23 111 86394 25815 63376702
Interstitial lung disease 50.97 13.23 11 86494 61897 63340620
Hypoglycaemia 50.85 13.23 10 86495 60055 63342462
Progressive multiple sclerosis 50.82 13.23 27 86478 1151 63401366
Septic shock 50.65 13.23 14 86491 66615 63335902
Dizziness postural 50.26 13.23 56 86449 7320 63395197
Electrocardiogram abnormal 49.78 13.23 62 86443 9117 63393400
Pleural effusion 49.58 13.23 33 86472 93177 63309340
Respiratory failure 49.08 13.23 40 86465 101818 63300699
Impaired healing 48.50 13.23 41 86464 102501 63300016
Incontinence 48.37 13.23 69 86436 11563 63390954
International normalised ratio increased 48.23 13.23 4 86501 46421 63356096
Anaphylactic reaction 48.21 13.23 15 86490 66085 63336432
Medication error 48.02 13.23 7 86498 52277 63350240
C-reactive protein abnormal 47.81 13.23 4 86501 46092 63356425
Osteoarthritis 47.76 13.23 36 86469 95307 63307210
Coordination abnormal 47.69 13.23 75 86430 13698 63388819
Intentional overdose 47.08 13.23 21 86484 74131 63328386
Injection site swelling 47.03 13.23 5 86500 47567 63354950
Dysmetria 46.90 13.23 20 86485 517 63402000
Injection site pruritus 46.56 13.23 4 86501 45112 63357405
JC virus infection 46.40 13.23 31 86474 2020 63400497
JC polyomavirus test 46.39 13.23 11 86494 33 63402484
Mucosal inflammation 46.22 13.23 5 86500 46923 63355594
Papilloma viral infection 46.15 13.23 28 86477 1542 63400975
Superficial spreading melanoma stage unspecified 46.14 13.23 14 86491 128 63402389
Hemiplegia 45.87 13.23 60 86445 9263 63393254
Hemianaesthesia 45.72 13.23 18 86487 377 63402140
Muscle tightness 45.72 13.23 68 86437 11832 63390685
Cardiac failure 45.50 13.23 33 86472 89109 63313408
Irritable bowel syndrome 45.44 13.23 28 86477 82384 63320133
Vitreous floaters 45.38 13.23 48 86457 5918 63396599
Cryptococcal meningoencephalitis 45.05 13.23 13 86492 98 63402419
Oedema 45 13.23 40 86465 97582 63304935
Cardio-respiratory arrest 44.83 13.23 13 86492 59946 63342571
Seizure 44.83 13.23 322 86183 132312 63270205
Fibromyalgia 44.79 13.23 27 86478 80393 63322124
Thrombocytopenia 44.06 13.23 87 86418 151070 63251447
Amnesia 44.05 13.23 171 86334 55414 63347103
Disease progression 43.79 13.23 62 86443 122696 63279821
Urticaria 43.69 13.23 101 86404 165701 63236816
Papule 43.66 13.23 46 86459 5645 63396872
Skin cancer 43.18 13.23 65 86440 11430 63391087
Monoparesis 42.71 13.23 27 86478 1600 63400917
Neutrophil percentage increased 42.69 13.23 34 86471 2909 63399608
Injection site bruising 42.49 13.23 4 86501 41906 63360611
Type 2 diabetes mellitus 42.29 13.23 17 86488 63851 63338666
Post herpetic neuralgia 42.12 13.23 30 86475 2169 63400348
Blindness 42.03 13.23 92 86413 21607 63380910
Blood brain barrier defect 41.99 13.23 12 86493 87 63402430
Relapsing multiple sclerosis 41.98 13.23 14 86491 178 63402339
Therapeutic response decreased 41.36 13.23 16 86489 61509 63341008
Exposure via father 40.88 13.23 15 86490 257 63402260
Monocyte percentage increased 40.39 13.23 23 86482 1125 63401392
Quadriplegia 40.22 13.23 27 86478 1773 63400744
Influenza like illness 40.14 13.23 189 86316 66635 63335882
Cervix carcinoma stage 0 40.12 13.23 16 86489 347 63402170
Neuromyelitis optica spectrum disorder 39.87 13.23 22 86483 1012 63401505
Chronic kidney disease 39.62 13.23 7 86498 45391 63357126
Infection 39.62 13.23 169 86336 229004 63173513
Quadriparesis 39.60 13.23 28 86477 2001 63400516
Chronic obstructive pulmonary disease 39.41 13.23 18 86487 62668 63339849
Human papilloma virus test positive 39.21 13.23 18 86487 557 63401960
Malignant melanoma in situ 39.19 13.23 21 86484 911 63401606
Anxiety 39.17 13.23 461 86044 217080 63185437
Breast mass 39.00 13.23 51 86454 7871 63394646
Gamma-glutamyltransferase decreased 38.51 13.23 15 86490 305 63402212
Alanine aminotransferase decreased 38.44 13.23 19 86486 695 63401822
Neoplasm progression 38.23 13.23 3 86502 36425 63366092
Lactic acidosis 37.91 13.23 4 86501 38283 63364234
Skin papilloma 37.83 13.23 40 86465 4929 63397588
Motor dysfunction 37.82 13.23 59 86446 10702 63391815
Hypokinesia 37.75 13.23 68 86437 13868 63388649
Eosinophil count decreased 37.68 13.23 28 86477 2162 63400355
Injury 37.53 13.23 27 86478 73220 63329297
Hypokalaemia 37.45 13.23 52 86453 103752 63298765
Pain in extremity 37.43 13.23 647 85858 330839 63071678
JC virus CSF test positive 37.24 13.23 9 86496 30 63402487
Liver injury 37.09 13.23 18 86487 60502 63342015
Unevaluable event 36.87 13.23 12 86493 51374 63351143
Ophthalmic herpes zoster 36.78 13.23 27 86478 2046 63400471
Visual acuity tests abnormal 36.48 13.23 10 86495 61 63402456
Rubella antibody positive 36.34 13.23 10 86495 62 63402455
Gastrointestinal disorder 36.16 13.23 78 86427 131161 63271356
Genital herpes 36.11 13.23 25 86480 1727 63400790
Delirium 35.92 13.23 12 86493 50529 63351988
Rhabdomyolysis 35.80 13.23 8 86497 43943 63358574
Disturbance in attention 35.75 13.23 124 86381 38065 63364452
Burning sensation 35.74 13.23 158 86347 54249 63348268
Relapsing-remitting multiple sclerosis 35.68 13.23 17 86488 573 63401944
Tremor 34.76 13.23 303 86202 131936 63270581
Pollakiuria 34.68 13.23 100 86405 27837 63374680
Multiple organ dysfunction syndrome 34.60 13.23 17 86488 56735 63345782
Anogenital warts 34.56 13.23 16 86489 505 63402012
Asthenia 34.49 13.23 723 85782 382881 63019636
Wheezing 34.37 13.23 48 86457 95547 63306970
Intraductal proliferative breast lesion 34.37 13.23 30 86475 2915 63399602
Decreased vibratory sense 34.22 13.23 14 86491 325 63402192
Immunodeficiency 33.83 13.23 81 86424 20173 63382344
Decreased appetite 33.78 13.23 202 86303 250850 63151667
Cerebral atrophy 33.73 13.23 38 86467 5028 63397489
Injection site reaction 33.51 13.23 19 86486 58505 63344012
Photophobia 33.28 13.23 74 86431 17561 63384956
Metabolic acidosis 33.27 13.23 10 86495 45059 63357458
Pulmonary fibrosis 32.92 13.23 7 86498 39802 63362715
Pleocytosis 32.64 13.23 18 86487 827 63401690
Macular fibrosis 32.33 13.23 14 86491 376 63402141
Influenza 32.25 13.23 256 86249 108466 63294051
Hypoxia 32.02 13.23 21 86484 59771 63342746
Erythema 31.99 13.23 127 86378 175624 63226893
Hyperkalaemia 31.90 13.23 17 86488 54186 63348331
Retinal cyst 31.53 13.23 9 86496 65 63402452
Dysstasia 31.51 13.23 81 86424 21085 63381432
Menstruation irregular 31.28 13.23 43 86462 6961 63395556
Overdose 31.20 13.23 69 86436 115009 63287508
Dyspnoea 31.09 13.23 676 85829 660637 62741880
Brain stem syndrome 31.02 13.23 14 86491 416 63402101
Psoriasis 30.93 13.23 44 86461 86913 63315604
Exposure via partner 30.67 13.23 10 86495 118 63402399
Sebaceous hyperplasia 30.60 13.23 7 86498 17 63402500
Heart rate irregular 30.52 13.23 83 86422 22338 63380179
Melaena 30.51 13.23 3 86502 30362 63372155
Prescribed overdose 30.39 13.23 5 86500 34148 63368369
Product quality issue 30.29 13.23 6 86499 35859 63366658
Herpes zoster cutaneous disseminated 30.06 13.23 11 86494 187 63402330
Tinea versicolour 30.04 13.23 8 86497 43 63402474
Treatment noncompliance 29.99 13.23 7 86498 37318 63365199
Blood pressure increased 29.85 13.23 345 86160 161717 63240800
Hypocalcaemia 29.70 13.23 4 86501 31709 63370808
Pneumonitis 29.53 13.23 6 86499 35216 63367301
Asthma 29.51 13.23 83 86422 127478 63275039
Partial seizures 29.37 13.23 38 86467 5804 63396713
Eye disorder 28.93 13.23 82 86423 22603 63379914
Hyperreflexia 28.90 13.23 38 86467 5896 63396621
Urinary retention 28.89 13.23 99 86406 30202 63372315
Non-cardiac chest pain 28.76 13.23 39 86466 6233 63396284
Bladder disorder 28.63 13.23 47 86458 8899 63393618
Blepharospasm 28.59 13.23 38 86467 5958 63396559
Monoplegia 28.43 13.23 28 86477 3173 63399344
Maculopathy 28.34 13.23 24 86481 2238 63400279
CSF measles antibody positive 28.12 13.23 8 86497 57 63402460
Thrombosis 28.11 13.23 28 86477 64727 63337790
Hepatic failure 28.03 13.23 7 86498 35649 63366868
Anti-JC virus antibody index 28.00 13.23 5 86500 0 63402517
Sedation 27.95 13.23 9 86496 38800 63363717
Cerebellar syndrome 27.86 13.23 29 86476 3510 63399007
Macular cyst 27.78 13.23 7 86498 29 63402488
Progressive relapsing multiple sclerosis 27.78 13.23 7 86498 29 63402488
Milia 27.64 13.23 8 86497 61 63402456
Atrial fibrillation 27.64 13.23 75 86430 116561 63285956
Squamous cell carcinoma 27.15 13.23 45 86460 8587 63393930
Photopsia 26.96 13.23 32 86473 4477 63398040
Accidental exposure to product 26.78 13.23 3 86502 27402 63375115
Extrasystoles 26.62 13.23 34 86471 5126 63397391
Myelitis 26.55 13.23 19 86486 1384 63401133
Supraventricular extrasystoles 26.50 13.23 32 86473 4557 63397960
Transient tachypnoea of the newborn 26.46 13.23 9 86496 122 63402395
Surgery 26.45 13.23 8 86497 35904 63366613
Therapy non-responder 26.41 13.23 39 86466 75862 63326655
Chest wall mass 26.38 13.23 8 86497 73 63402444
Urge incontinence 26.20 13.23 16 86489 892 63401625
Neck pain 26.19 13.23 173 86332 69145 63333372
Vaginal dysplasia 26.19 13.23 8 86497 75 63402442
Blood creatinine increased 26.07 13.23 50 86455 87794 63314723
Blood bilirubin increased 26.03 13.23 110 86395 37030 63365487
Hepatotoxicity 25.96 13.23 9 86496 37032 63365485
Haematemesis 25.87 13.23 5 86500 30407 63372110
Pulmonary oedema 25.87 13.23 22 86483 54851 63347666
Haematocrit increased 25.76 13.23 23 86482 2303 63400214
Fluid retention 25.69 13.23 26 86479 59660 63342857
Paralysis 25.16 13.23 47 86458 9853 63392664
Cryptococcosis 25.01 13.23 17 86488 1140 63401377
Squamous cell carcinoma of skin 24.94 13.23 36 86469 6096 63396421
Metamorphopsia 24.93 13.23 17 86488 1146 63401371
Acne 24.80 13.23 79 86426 23214 63379303
Blindness transient 24.78 13.23 28 86477 3716 63398801
Varicella virus test positive 24.76 13.23 9 86496 150 63402367
Osteoporosis 24.66 13.23 25 86480 57313 63345204
Haematochezia 24.60 13.23 22 86483 53522 63348995
Retinal oedema 24.55 13.23 14 86491 687 63401830
Eye naevus 24.54 13.23 5 86500 5 63402512
Bone marrow failure 24.53 13.23 5 86500 29285 63373232
Pulmonary hypertension 24.38 13.23 10 86495 37113 63365404
Angioedema 24.16 13.23 18 86487 47947 63354570
Pregnancy 24.07 13.23 10 86495 36826 63365691
Hemiparaesthesia 23.83 13.23 8 86497 104 63402413
Drug eruption 23.82 13.23 5 86500 28689 63373828
Presbyopia 23.78 13.23 12 86493 459 63402058
Acrochordon 23.76 13.23 16 86489 1056 63401461
Liver function test increased 23.64 13.23 98 86407 32713 63369804
Anaplastic large cell lymphoma T- and null-cell types 23.47 13.23 7 86498 60 63402457
Coma 23.45 13.23 32 86473 64332 63338185
Hepatic cirrhosis 23.45 13.23 3 86502 24731 63377786
Colitis 23.44 13.23 19 86486 48509 63354008
Retinal vein occlusion 23.35 13.23 21 86484 2122 63400395
Upper respiratory tract infection 23.14 13.23 191 86314 81856 63320661
Tongue biting 22.99 13.23 18 86487 1502 63401015
Abnormal sensation in eye 22.83 13.23 19 86486 1730 63400787
Haemorrhagic adrenal infarction 22.73 13.23 6 86499 31 63402486
Saccadic eye movement 22.60 13.23 7 86498 69 63402448
Inflammation 22.57 13.23 49 86456 82224 63320293
Mood altered 22.54 13.23 57 86448 14686 63387831
Joint range of motion decreased 22.52 13.23 8 86497 32420 63370097
Borderline glaucoma 22.52 13.23 5 86500 10 63402507
Melanocytic hyperplasia 22.40 13.23 4 86501 0 63402517
Organic brain syndrome 22.28 13.23 9 86496 202 63402315
Ascites 22.22 13.23 14 86491 40714 63361803
Chest pain 22.03 13.23 415 86090 215544 63186973
Hyperglycaemia 22.02 13.23 15 86490 41852 63360665
Ventricular extrasystoles 22.01 13.23 49 86456 11638 63390879
Rash maculo-papular 21.93 13.23 8 86497 31888 63370629
Hypomagnesaemia 21.91 13.23 6 86499 28731 63373786
Shock 21.88 13.23 3 86502 23460 63379057
Colour blindness 21.73 13.23 10 86495 311 63402206
Herpes virus infection 21.70 13.23 32 86473 5524 63396993
CD30 expression 21.70 13.23 6 86499 38 63402479
Blindness unilateral 21.63 13.23 34 86471 6207 63396310
Plasma cell myeloma 21.51 13.23 11 86494 35894 63366623
Romberg test positive 21.49 13.23 8 86497 143 63402374
Hypercalcaemia 21.43 13.23 6 86499 28316 63374201
Sinus arrhythmia 21.33 13.23 17 86488 1456 63401061
Uterine leiomyoma 21.33 13.23 42 86463 9156 63393361
Focal dyscognitive seizures 21.33 13.23 23 86482 2898 63399619
Monocyte count decreased 21.33 13.23 20 86485 2133 63400384
Retinal disorder 21.32 13.23 18 86487 1672 63400845
Drug resistance 21.22 13.23 3 86502 22930 63379587
Extra dose administered 21.19 13.23 34 86471 6316 63396201
Blood chloride increased 21.14 13.23 22 86483 2662 63399855
Respiratory arrest 21.11 13.23 9 86496 32636 63369881
Varicella zoster virus infection 21.10 13.23 22 86483 2667 63399850
Benign neoplasm of skin 20.80 13.23 8 86497 157 63402360
Seborrhoeic dermatitis 20.80 13.23 15 86490 1106 63401411
Oedema peripheral 20.74 13.23 162 86343 189349 63213168
Hypertonic bladder 20.69 13.23 25 86480 3563 63398954
Vaccination failure 20.68 13.23 13 86492 763 63401754
Mitral valve atresia 20.61 13.23 5 86500 17 63402500
Hypoglossal nerve paralysis 20.61 13.23 5 86500 17 63402500
Rash pruritic 20.54 13.23 31 86474 59768 63342749
Red blood cell sedimentation rate increased 20.29 13.23 18 86487 43964 63358553
Lepromatous leprosy 20.17 13.23 4 86501 3 63402514
Muscle fatigue 20.16 13.23 21 86484 2543 63399974
Facial paralysis 20.14 13.23 53 86452 13988 63388529
Keratosis pilaris 20.06 13.23 6 86499 52 63402465
Asthenopia 19.94 13.23 20 86485 2317 63400200
Bursitis 19.84 13.23 13 86492 37028 63365489
Macular pigmentation 19.78 13.23 5 86500 21 63402496
Electrocardiogram PR shortened 19.74 13.23 9 86496 274 63402243
Hemianopia homonymous 19.70 13.23 12 86493 666 63401851
Oral herpes 19.67 13.23 79 86426 25995 63376522
Lymphogranuloma venereum 19.63 13.23 4 86501 4 63402513
Depressed level of consciousness 19.61 13.23 34 86471 62044 63340473
Drug ineffective for unapproved indication 19.58 13.23 11 86494 34052 63368465
Gastrointestinal carcinoma 19.51 13.23 19 86486 2124 63400393
Mean cell haemoglobin increased 19.46 13.23 22 86483 2921 63399596
White blood cell count increased 19.45 13.23 123 86382 48438 63354079
Gastrooesophageal reflux disease 19.44 13.23 66 86439 95573 63306944
Skin ulcer 19.40 13.23 18 86487 43027 63359490
Refraction disorder 19.38 13.23 6 86499 59 63402458
Central nervous system inflammation 19.27 13.23 8 86497 193 63402324
Herpes zoster meningoencephalitis 19.12 13.23 9 86496 295 63402222
Product prescribing error 19.10 13.23 6 86499 26283 63376234
Spinal cord disorder 19.01 13.23 15 86490 1266 63401251
Neutropenia 18.97 13.23 150 86355 174855 63227662
Lung disorder 18.86 13.23 35 86470 62226 63340291
Abortion 18.84 13.23 20 86485 2476 63400041
Pulmonary arterial hypertension 18.61 13.23 4 86501 22573 63379944
Protein total decreased 18.59 13.23 31 86474 5946 63396571
Fear-related avoidance of activities 18.56 13.23 7 86498 130 63402387
Vulval cancer stage 0 18.46 13.23 7 86498 132 63402385
Abdominal pain 18.42 13.23 285 86220 293171 63109346
Neoplasm skin 18.42 13.23 16 86489 1545 63400972
Live birth 18.36 13.23 6 86499 25624 63376893
Diabetic ketoacidosis 18.25 13.23 3 86502 20502 63382015
Thunderclap headache 18.20 13.23 8 86497 223 63402294
Nausea 18.16 13.23 966 85539 853505 62549012
Bone pain 18.12 13.23 29 86476 54612 63347905
Hypophagia 18.11 13.23 10 86495 31249 63371268
Anti-actin antibody positive 18.02 13.23 4 86501 8 63402509
Myelosuppression 17.97 13.23 5 86500 23698 63378819
Optic disc disorder 17.40 13.23 4 86501 10 63402507
Electrocardiogram T wave abnormal 17.40 13.23 19 86486 2428 63400089
Endometrial adenocarcinoma 17.34 13.23 14 86491 1222 63401295
Tinea pedis 17.33 13.23 15 86490 1441 63401076
Migraine with aura 17.30 13.23 20 86485 2720 63399797
Vibration test abnormal 17.29 13.23 5 86500 38 63402479
Swelling face 17.25 13.23 38 86467 63437 63339080
Ulcer 17.20 13.23 7 86498 26100 63376417
Panic attack 17.12 13.23 68 86437 22263 63380254
Platelet count decreased 16.91 13.23 91 86414 116031 63286486
Hemihyperaesthesia 16.80 13.23 3 86502 0 63402517
Magnetic resonance imaging head abnormal 16.76 13.23 17 86488 1996 63400521
Polycythaemia vera 16.71 13.23 7 86498 173 63402344
Cytomegalovirus infection 16.69 13.23 4 86501 20948 63381569
Rash erythematous 16.66 13.23 20 86485 42490 63360027
Cranial nerve disorder 16.58 13.23 10 86495 545 63401972
Status epilepticus 16.52 13.23 52 86453 15181 63387336
Hemianopia 16.51 13.23 13 86492 1094 63401423
Disseminated intravascular coagulation 16.49 13.23 3 86502 19048 63383469
Herpes simplex meningitis 16.35 13.23 5 86500 47 63402470
Rectal haemorrhage 16.28 13.23 26 86479 49004 63353513
C-reactive protein increased 16.25 13.23 70 86435 94637 63307880
Injection site rash 16.20 13.23 3 86502 18806 63383711
Acute respiratory distress syndrome 16.01 13.23 6 86499 23528 63378989
Injection site mass 16.01 13.23 3 86502 18653 63383864
Femur fracture 15.99 13.23 20 86485 41736 63360781
Dyschromatopsia 15.74 13.23 9 86496 444 63402073
Respiratory disorder 15.73 13.23 18 86487 39064 63363453
Bicuspid aortic valve 15.73 13.23 6 86499 115 63402402
Cellulitis 15.69 13.23 58 86447 81900 63320617
Head discomfort 15.67 13.23 47 86458 13368 63389149
Rosacea 15.52 13.23 25 86480 4659 63397858
Restless legs syndrome 15.49 13.23 58 86447 18473 63384044
Incorrect dose administered 15.41 13.23 37 86468 59931 63342586
Anal incontinence 15.33 13.23 47 86458 13529 63388988
Large for dates baby 15.20 13.23 9 86496 474 63402043
Swollen tongue 15.16 13.23 15 86490 34785 63367732
Vertigo positional 15.06 13.23 19 86486 2830 63399687
Device malfunction 15.05 13.23 3 86502 17854 63384663
Tension headache 14.94 13.23 26 86479 5160 63397357
Invasive breast carcinoma 14.86 13.23 10 86495 659 63401858
Macule 14.86 13.23 16 86489 2012 63400505
Amenorrhoea 14.82 13.23 38 86467 9876 63392641
Pyramidal tract syndrome 14.76 13.23 8 86497 355 63402162
Vaccination error 14.72 13.23 3 86502 3 63402514
Drug tolerance decreased 14.60 13.23 3 86502 17470 63385047
Neurological decompensation 14.59 13.23 18 86487 2620 63399897
Obstructive airways disorder 14.56 13.23 5 86500 20694 63381823
Heart rate abnormal 14.51 13.23 25 86480 4922 63397595
Lung adenocarcinoma 14.51 13.23 24 86481 4573 63397944
Granulocyte count increased 14.49 13.23 11 86494 877 63401640
Solar dermatitis 14.48 13.23 6 86499 144 63402373
Spinal cord injury 14.44 13.23 11 86494 882 63401635
Retinal haemorrhage 14.43 13.23 25 86480 4944 63397573
Cerebellar ataxia 14.34 13.23 11 86494 891 63401626
Atrioventricular block 14.33 13.23 32 86473 7615 63394902
Herpes zoster infection neurological 14.27 13.23 7 86498 252 63402265
Device related infection 14.27 13.23 7 86498 23385 63379132
Nasal sinus cancer 14.25 13.23 4 86501 27 63402490
Haemoptysis 14.18 13.23 11 86494 28715 63373802
Multiple lentigines syndrome 14.18 13.23 6 86499 152 63402365
Body temperature decreased 14.13 13.23 5 86500 20314 63382203
Vertigo CNS origin 14.12 13.23 4 86501 28 63402489
Carcinoid crisis 14.09 13.23 7 86498 259 63402258
Intention tremor 14.07 13.23 8 86497 390 63402127
Mean platelet volume increased 14.06 13.23 9 86496 545 63401972
Personality change 14.00 13.23 30 86475 6943 63395574
Hallucination 13.94 13.23 34 86471 54783 63347734
Hiatus hernia 13.89 13.23 6 86499 21588 63380929
Dysphagia 13.88 13.23 183 86322 88402 63314115
Central nervous system immune reconstitution inflammatory response 13.88 13.23 4 86501 30 63402487
Mediastinal abscess 13.88 13.23 4 86501 30 63402487
Bladder discomfort 13.87 13.23 10 86495 737 63401780
Intestinal obstruction 13.83 13.23 13 86492 30886 63371631
Optic nerve injury 13.71 13.23 9 86496 569 63401948
Lung adenocarcinoma stage IV 13.66 13.23 6 86499 167 63402350
Tonic clonic movements 13.58 13.23 13 86492 1422 63401095
Blood pressure diastolic decreased 13.54 13.23 7 86498 22699 63379818
Heavy menstrual bleeding 13.53 13.23 54 86451 17719 63384798
Hepatitis E 13.52 13.23 13 86492 1431 63401086
Eye movement disorder 13.51 13.23 25 86480 5203 63397314
Optic nerve cupping 13.51 13.23 3 86502 6 63402511
Congenital megacolon 13.51 13.23 3 86502 6 63402511
Ovarian cancer 13.51 13.23 27 86478 5949 63396568
Anti-thyroid antibody positive 13.50 13.23 8 86497 422 63402095
Facial pain 13.29 13.23 38 86467 10523 63391994
Dermatosis 13.27 13.23 7 86498 294 63402223

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
Multiple sclerosis relapse 1965.13 16.68 605 23043 12528 34920755
Lymphocyte count decreased 1114.70 16.68 457 23191 22165 34911118
Central nervous system lesion 816.17 16.68 262 23386 6201 34927082
Expanded disability status scale score increased 588.76 16.68 113 23535 224 34933059
Lymphopenia 480.26 16.68 230 23418 16105 34917178
Macular oedema 350.79 16.68 114 23534 2800 34930483
Alanine aminotransferase increased 332.29 16.68 337 23311 80478 34852805
Gamma-glutamyltransferase increased 264.84 16.68 192 23456 29039 34904244
Gait disturbance 262.29 16.68 305 23343 84835 34848448
White blood cell count decreased 243.78 16.68 311 23337 95134 34838149
Heart rate decreased 228.98 16.68 182 23466 31563 34901720
Visual impairment 226.18 16.68 190 23458 35612 34897671
JC polyomavirus test positive 216.85 16.68 57 23591 640 34932643
Hypoaesthesia 193.88 16.68 223 23425 61221 34872062
Vision blurred 191.01 16.68 193 23455 45770 34887513
Balance disorder 176.81 16.68 175 23473 40479 34892804
Secondary progressive multiple sclerosis 176.00 16.68 43 23605 350 34932933
Acute kidney injury 152.78 16.68 15 23633 304973 34628310
Melanocytic naevus 152.42 16.68 58 23590 2286 34930997
Muscle spasticity 152.19 16.68 76 23572 5812 34927471
Off label use 149.91 16.68 49 23599 419475 34513808
Aspartate aminotransferase increased 145.39 16.68 203 23445 67580 34865703
Prescribed underdose 140.62 16.68 83 23565 8850 34924433
Muscular weakness 139.79 16.68 207 23441 72690 34860593
Hepatic enzyme increased 137.14 16.68 150 23498 38930 34894353
Fatigue 129.14 16.68 543 23105 370110 34563173
Optic neuritis 128.78 16.68 58 23590 3516 34929767
Multiple sclerosis 110.55 16.68 64 23584 6581 34926702
Headache 106.07 16.68 337 23311 200298 34732985
Tumefactive multiple sclerosis 104.19 16.68 19 23629 24 34933259
Memory impairment 100.76 16.68 135 23513 43183 34890100
Progressive multifocal leukoencephalopathy 99.58 16.68 69 23579 9695 34923588
Death 96.67 16.68 77 23571 397972 34535311
Herpes zoster 90.59 16.68 114 23534 34285 34898998
Paraesthesia 89.81 16.68 158 23490 64014 34869269
Depression 88.76 16.68 200 23448 96898 34836385
Toxicity to various agents 87.83 16.68 15 23633 200347 34732936
Ataxia 86.31 16.68 73 23575 13780 34919503
Hypotension 80.49 16.68 25 23623 221624 34711659
Cognitive disorder 80.22 16.68 98 23550 28595 34904688
Anaemia 78.38 16.68 30 23618 233305 34699978
Sensory disturbance 75.85 16.68 49 23599 6128 34927155
Limb discomfort 74.61 16.68 61 23587 10986 34922297
Movement disorder 71.13 16.68 62 23586 12186 34921097
Drug interaction 71.12 16.68 32 23616 225914 34707369
Seborrhoeic keratosis 70.41 16.68 28 23620 1243 34932040
Bradycardia 69.61 16.68 156 23492 75262 34858021
Rebound effect 63.84 16.68 35 23613 3239 34930044
Lymphocyte percentage decreased 62.51 16.68 30 23618 2102 34931181
Depressed mood 62.31 16.68 71 23577 19246 34914037
Drug monitoring procedure not performed 61.41 16.68 18 23630 309 34932974
Concomitant disease aggravated 59.80 16.68 41 23607 5660 34927623
Paraparesis 56.66 16.68 27 23621 1862 34931421
Basal cell carcinoma 56.33 16.68 68 23580 19590 34913693
Diplopia 56.18 16.68 63 23585 16780 34916503
Malignant melanoma 55.32 16.68 45 23603 8045 34925238
Micturition urgency 54.82 16.68 41 23607 6484 34926799
Sinus bradycardia 54.80 16.68 55 23593 12908 34920375
Hemiparesis 54.32 16.68 60 23588 15718 34917565
Decreased vibratory sense 53.87 16.68 17 23631 378 34932905
Liver function test increased 52.95 16.68 57 23591 14508 34918775
Low density lipoprotein increased 51.55 16.68 34 23614 4402 34928881
Eye pain 51.27 16.68 54 23594 13408 34919875
Magnetic resonance imaging abnormal 50.68 16.68 24 23624 1632 34931651
Meningitis cryptococcal 50.50 16.68 27 23621 2377 34930906
Visual acuity reduced 48.14 16.68 57 23591 16092 34917191
Vitamin D deficiency 47.82 16.68 38 23610 6570 34926713
Immunodeficiency 44.97 16.68 34 23614 5464 34927819
Decreased immune responsiveness 44.53 16.68 22 23626 1642 34931641
Paresis 44.37 16.68 24 23624 2162 34931121
Drug abuse 44.30 16.68 7 23641 99089 34834194
Hyponatraemia 44.22 16.68 3 23645 82688 34850595
Oropharyngeal pain 44.05 16.68 83 23565 35402 34897881
Pneumonia 42.79 16.68 116 23532 362511 34570772
Blood cholesterol increased 41.70 16.68 60 23588 20483 34912800
Atrioventricular block second degree 41.53 16.68 28 23620 3760 34929523
Blood alkaline phosphatase decreased 41.47 16.68 17 23631 817 34932466
CD4 lymphocytes decreased 40.69 16.68 21 23627 1720 34931563
Cystoid macular oedema 40.47 16.68 16 23632 699 34932584
Multiple organ dysfunction syndrome 40.30 16.68 3 23645 76563 34856720
Renal failure 40.23 16.68 19 23629 130538 34802745
Thrombocytopenia 39.32 16.68 29 23619 156218 34777065
Progressive multiple sclerosis 38.54 16.68 12 23636 255 34933028
Dehydration 38.41 16.68 20 23628 129949 34803334
Dysarthria 37.88 16.68 77 23571 34705 34898578
Cardiac failure 37.44 16.68 8 23640 91240 34842043
Overdose 37.33 16.68 8 23640 91051 34842232
Immune reconstitution inflammatory syndrome 36.72 16.68 37 23611 8722 34924561
Drug ineffective 36.63 16.68 172 23476 456579 34476704
Vaccination failure 36.27 16.68 17 23631 1129 34932154
Diarrhoea 36.06 16.68 139 23509 389773 34543510
Bladder dysfunction 35.21 16.68 12 23636 342 34932941
Trigeminal neuralgia 35.14 16.68 17 23631 1212 34932071
Dizziness 34.90 16.68 260 23388 218261 34715022
Lymphocyte count increased 34.82 16.68 24 23624 3341 34929942
Cardiac failure congestive 34.79 16.68 7 23641 83263 34850020
Sensory loss 34.16 16.68 27 23621 4632 34928651
Gastrointestinal haemorrhage 33.86 16.68 9 23639 88468 34844815
Renal impairment 33.64 16.68 11 23637 94502 34838781
Sepsis 33.49 16.68 38 23610 166523 34766760
Drug hypersensitivity 33.16 16.68 7 23641 80522 34852761
Hyperkalaemia 33.13 16.68 4 23644 69385 34863898
Anogenital warts 32.54 16.68 13 23635 584 34932699
Pancytopenia 32.27 16.68 12 23636 95145 34838138
Monocyte count increased 31.89 16.68 26 23622 4661 34928622
Neutrophil percentage increased 31.40 16.68 18 23630 1815 34931468
Urinary incontinence 31.05 16.68 50 23598 18824 34914459
Visual field defect 30.78 16.68 25 23623 4458 34928825
High density lipoprotein increased 30.61 16.68 11 23637 368 34932915
Interstitial lung disease 30.59 16.68 4 23644 65278 34868005
Blood alkaline phosphatase increased 30.43 16.68 66 23582 31109 34902174
Respiratory failure 30.20 16.68 18 23630 108554 34824729
Mobility decreased 29.66 16.68 64 23584 30064 34903219
Neurogenic bladder 28.93 16.68 17 23631 1796 34931487
Motor dysfunction 28.39 16.68 29 23619 6945 34926338
Bladder disorder 28.29 16.68 21 23627 3283 34930000
Septic shock 28.07 16.68 7 23641 71827 34861456
Coordination abnormal 27.93 16.68 30 23618 7614 34925669
CD4/CD8 ratio decreased 27.77 16.68 6 23642 26 34933257
Condition aggravated 26.97 16.68 56 23592 192140 34741143
Cardio-respiratory arrest 26.85 16.68 3 23645 55270 34878013
Haemangioma of skin 26.24 16.68 8 23640 158 34933125
Back pain 26.10 16.68 156 23492 121633 34811650
Muscle spasms 25.93 16.68 110 23538 74891 34858392
Fibrous histiocytoma 25.52 16.68 8 23640 174 34933109
Squamous cell carcinoma 25.49 16.68 35 23613 11440 34921843
Infusion related reaction 25.47 16.68 3 23645 53054 34880229
Nasopharyngitis 25.27 16.68 104 23544 69864 34863419
Expanded disability status scale 25.20 16.68 4 23644 0 34933283
Platelet count decreased 24.39 16.68 27 23621 119690 34813593
Urinary tract infection 24.34 16.68 117 23531 83964 34849319
T-lymphocyte count decreased 24.28 16.68 8 23640 205 34933078
Atrioventricular block first degree 24.20 16.68 25 23623 6067 34927216
Lentigo 24.13 16.68 10 23638 494 34932789
Rhabdomyolysis 24.13 16.68 8 23640 68155 34865128
Hypokalaemia 24.09 16.68 5 23643 58209 34875074
Monocyte percentage increased 23.55 16.68 12 23636 957 34932326
Exposure via father 23.42 16.68 7 23641 129 34933154
Electrocardiogram abnormal 23.30 16.68 30 23618 9217 34924066
Acrochordon 23.08 16.68 9 23639 379 34932904
Relapsing-remitting multiple sclerosis 22.64 16.68 12 23636 1038 34932245
Testicular necrosis 22.43 16.68 4 23644 4 34933279
Testicular seminoma (pure) stage I 22.23 16.68 5 23643 27 34933256
Blood creatinine increased 22.15 16.68 19 23629 94957 34838326
Therapeutic product effect incomplete 21.63 16.68 4 23644 50537 34882746
Neuropathy peripheral 21.52 16.68 15 23633 83248 34850035
Temperature intolerance 21.24 16.68 18 23630 3404 34929879
Cryptococcal cutaneous infection 21.10 16.68 6 23642 92 34933191
Dysplastic naevus 20.94 16.68 9 23639 487 34932796
Skin lesion 20.87 16.68 46 23602 21915 34911368
Gamma-glutamyltransferase abnormal 20.83 16.68 8 23640 323 34932960
Feeling abnormal 20.52 16.68 91 23557 63144 34870139
Hypoxia 20.33 16.68 6 23642 55089 34878194
Dysdiadochokinesis 20.30 16.68 7 23641 207 34933076
Disease progression 20.28 16.68 26 23622 108051 34825232
Demyelination 20.11 16.68 17 23631 3204 34930079
Globulins decreased 20.11 16.68 7 23641 213 34933070
Neutropenia 20.08 16.68 48 23600 156730 34776553
Urobilinogen urine increased 19.72 16.68 8 23640 374 34932909
White matter lesion 19.55 16.68 10 23638 804 34932479
Intentional product use issue 19.52 16.68 8 23640 59808 34873475
Peripheral swelling 19.50 16.68 14 23634 76527 34856756
Pleural effusion 19.39 16.68 16 23632 81530 34851753
Hepatobiliary disease 19.35 16.68 8 23640 393 34932890
Romberg test positive 19.19 16.68 5 23643 54 34933229
Gait inability 19.18 16.68 43 23605 20715 34912568
Visceral leishmaniasis 19.13 16.68 9 23639 603 34932680
Expanded disability status scale score decreased 18.90 16.68 3 23645 0 34933283
Laryngeal papilloma 18.90 16.68 3 23645 0 34933283
Anti-thyroid antibody positive 18.79 16.68 5 23643 59 34933224
Neutrophil count increased 18.71 16.68 38 23610 17108 34916175
Vitreous floaters 18.53 16.68 17 23631 3568 34929715
Haemangioma 18.39 16.68 13 23635 1884 34931399
Spinal cord injury cauda equina 18.27 16.68 6 23642 152 34933131
Chronic kidney disease 18.20 16.68 3 23645 41207 34892076
Molluscum contagiosum 18.17 16.68 7 23641 285 34932998
Speech disorder 18.17 16.68 48 23600 25638 34907645
Decreased interest 18.00 16.68 14 23634 2346 34930937
Hospitalisation 17.95 16.68 8 23640 56894 34876389
Influenza like illness 17.91 16.68 50 23598 27584 34905699
Somatosensory evoked potentials abnormal 17.81 16.68 6 23642 165 34933118
Varicella virus test positive 17.75 16.68 5 23643 74 34933209
Albumin globulin ratio increased 17.73 16.68 4 23644 22 34933261
Halo vision 17.41 16.68 6 23642 177 34933106
Pollakiuria 17.34 16.68 40 23608 19634 34913649
Aphasia 17.16 16.68 42 23606 21412 34911871
Solar lentigo 16.93 16.68 8 23640 541 34932742
CSF glucose decreased 16.90 16.68 4 23644 28 34933255
Renal artery dissection 16.82 16.68 3 23645 3 34933280
Monkeypox 16.78 16.68 4 23644 29 34933254
Vitamin B6 deficiency 16.74 16.68 6 23642 199 34933084
Eye disorder 16.72 16.68 26 23622 9502 34923781
Brain stem syndrome 16.71 16.68 8 23640 557 34932726

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
Multiple sclerosis relapse 4586.28 13.47 1742 80221 44791 79617634
Lymphocyte count decreased 4244.48 13.47 1654 80309 45635 79616790
Central nervous system lesion 2048.49 13.47 695 81268 12673 79649752
Lymphopenia 1737.88 13.47 773 81190 29784 79632641
Expanded disability status scale score increased 1359.05 13.47 272 81691 389 79662036
White blood cell count decreased 1272.85 13.47 1245 80718 187043 79475382
Macular oedema 879.20 13.47 295 81668 5179 79657246
Melanocytic naevus 835.38 13.47 274 81689 4467 79657958
Heart rate decreased 718.52 13.47 588 81375 69728 79592697
Vision blurred 652.94 13.47 667 81296 105231 79557194
Hypoaesthesia 642.39 13.47 854 81109 178498 79483927
Alanine aminotransferase increased 623.97 13.47 801 81162 161769 79500656
Visual impairment 589.26 13.47 592 81371 91539 79570886
Gamma-glutamyltransferase increased 522.55 13.47 440 81523 54240 79608185
Off label use 510.31 13.47 151 81812 907064 78755361
Optic neuritis 487.37 13.47 224 81739 9296 79653129
Fatigue 483.16 13.47 2057 79906 927670 78734755
Headache 463.62 13.47 1598 80365 652174 79010251
Gait disturbance 451.89 13.47 784 81179 206722 79455703
Seborrhoeic keratosis 410.12 13.47 135 81828 2225 79660200
Acute kidney injury 402.30 13.47 36 81927 519368 79143057
Muscular weakness 400.16 13.47 645 81318 160084 79502341
JC polyomavirus test positive 375.04 13.47 115 81848 1487 79660938
Prescribed underdose 364.14 13.47 276 81687 29238 79633187
Toxicity to various agents 355.91 13.47 19 81944 421521 79240904
Rebound effect 329.59 13.47 157 81806 7069 79655356
Balance disorder 328.00 13.47 454 81509 98403 79564022
Tumefactive multiple sclerosis 311.40 13.47 59 81904 49 79662376
Paraesthesia 309.06 13.47 607 81356 175716 79486709
Drug ineffective 296.32 13.47 409 81554 1080504 78581921
Secondary progressive multiple sclerosis 292.21 13.47 92 81871 1305 79661120
Progressive multifocal leukoencephalopathy 286.34 13.47 207 81756 20393 79642032
Death 285.36 13.47 113 81850 566401 79096024
Muscle spasticity 283.12 13.47 209 81754 21266 79641159
Micturition urgency 282.86 13.47 171 81792 12470 79649955
Haemangioma of skin 271.44 13.47 63 81900 242 79662183
Ataxia 256.78 13.47 210 81753 24829 79637596
Lentigo 254.86 13.47 66 81897 435 79661990
Atrioventricular block second degree 251.04 13.47 131 81832 7181 79655244
Eye pain 248.35 13.47 246 81717 37332 79625093
Normal newborn 246.52 13.47 128 81835 6944 79655481
Atrioventricular block first degree 244.06 13.47 155 81808 12336 79650089
Dizziness 235.02 13.47 1116 80847 525325 79137100
Limb discomfort 230.07 13.47 222 81741 32628 79629797
Hemiparesis 228.81 13.47 224 81739 33509 79628916
Concomitant disease aggravated 222.07 13.47 149 81814 13018 79649407
Memory impairment 220.79 13.47 405 81558 111329 79551096
Aspartate aminotransferase increased 219.84 13.47 458 81505 138183 79524242
Sensory disturbance 217.55 13.47 155 81808 14922 79647503
Herpes zoster 217.16 13.47 363 81600 92720 79569705
Multiple sclerosis 214.17 13.47 180 81783 22102 79640323
Febrile neutropenia 199.29 13.47 9 81954 230990 79431435
High density lipoprotein increased 196.45 13.47 65 81898 1089 79661336
Drug interaction 195.80 13.47 91 81872 415092 79247333
Immune reconstitution inflammatory syndrome 192.16 13.47 139 81824 13702 79648723
Cognitive disorder 186.71 13.47 290 81673 69636 79592789
Infusion related reaction 183.36 13.47 14 81949 230223 79432202
Solar lentigo 177.71 13.47 60 81903 1073 79661352
Visual acuity reduced 174.80 13.47 182 81781 29287 79633138
Pneumonia 174.14 13.47 256 81707 659990 79002435
Rheumatoid arthritis 173.88 13.47 10 81953 208460 79453965
Completed suicide 172.43 13.47 24 81939 245743 79416682
Depression 172.25 13.47 552 81411 216238 79446187
Anaemia 169.62 13.47 126 81837 444889 79217536
Low density lipoprotein increased 168.47 13.47 107 81856 8515 79653910
Bradycardia 167.99 13.47 406 81557 135151 79527274
Blood alkaline phosphatase increased 167.14 13.47 262 81701 63402 79599023
Breast cancer 162.73 13.47 187 81776 33594 79628831
Hypotension 159.80 13.47 131 81832 440186 79222239
Vitamin D deficiency 155.37 13.47 124 81839 14155 79648270
CD4 lymphocytes decreased 153.94 13.47 68 81895 2566 79659859
Fibrous histiocytoma 153.09 13.47 48 81915 671 79661754
Drug hypersensitivity 152.92 13.47 58 81905 298858 79363567
Joint swelling 149.34 13.47 55 81908 288591 79373834
Blood alkaline phosphatase decreased 149.34 13.47 60 81903 1780 79660645
Condition aggravated 148.64 13.47 178 81785 500946 79161479
Lymphocyte percentage decreased 147.90 13.47 81 81882 4895 79657530
Contraindicated product administered 143.27 13.47 4 81959 157534 79504891
Therapeutic product effect decreased 142.58 13.47 6 81957 163857 79498568
Basal cell carcinoma 141.21 13.47 183 81780 37192 79625233
Synovitis 136.44 13.47 4 81959 150730 79511695
Paraparesis 135.90 13.47 70 81893 3733 79658692
Vertigo 135.88 13.47 250 81713 68832 79593593
Lymphocyte count increased 134.65 13.47 81 81882 5851 79656574
Diplopia 134.54 13.47 169 81794 33297 79629128
Product use issue 132.78 13.47 27 81936 209795 79452630
Sinus bradycardia 132.25 13.47 146 81817 25101 79637324
Maternal exposure during pregnancy 131.31 13.47 372 81591 136166 79526259
Drug abuse 129.20 13.47 10 81953 162681 79499744
Renal failure 128.97 13.47 25 81938 200943 79461482
Arthropathy 122.55 13.47 18 81945 177093 79485332
Hyponatraemia 118.71 13.47 20 81943 177828 79484597
Malignant melanoma 117.36 13.47 107 81856 14634 79647791
Migraine 115.87 13.47 269 81694 87224 79575201
Urinary incontinence 115.28 13.47 174 81789 40735 79621690
Cardiac failure congestive 115.23 13.47 8 81955 142394 79520031
Renal impairment 114.01 13.47 14 81949 157769 79504656
Drug intolerance 113.81 13.47 65 81898 264054 79398371
Meningitis cryptococcal 112.37 13.47 60 81903 3446 79658979
Back pain 112.26 13.47 612 81351 303568 79358857
Gastrointestinal haemorrhage 112.08 13.47 11 81952 147708 79514717
Malignant neoplasm progression 111.92 13.47 7 81956 135983 79526442
Trigeminal neuralgia 110.74 13.47 60 81903 3549 79658876
Urinary tract infection 110.67 13.47 566 81397 273946 79388479
Paresis 109.37 13.47 63 81900 4198 79658227
Monocyte count increased 108.41 13.47 89 81874 10572 79651853
Muscle spasms 108.36 13.47 410 81553 174320 79488105
Treatment failure 107.72 13.47 22 81941 170464 79491961
Sensory loss 104.80 13.47 95 81868 12896 79649529
Intentional product use issue 103.99 13.47 16 81947 152096 79510329
Thrombocytopenia 102.38 13.47 74 81889 265185 79397240
Movement disorder 102.24 13.47 133 81830 27126 79635299
Systemic lupus erythematosus 100.41 13.47 6 81957 121143 79541282
Sepsis 100.34 13.47 78 81885 269350 79393075
Cystoid macular oedema 99.48 13.47 46 81917 1934 79660491
Oropharyngeal pain 96.52 13.47 289 81674 109064 79553361
Abortion spontaneous 95.49 13.47 134 81829 29373 79633052
Blood bilirubin decreased 94.03 13.47 37 81926 1038 79661387
Hand deformity 93.16 13.47 3 81960 103916 79558509
Rash 91.90 13.47 297 81666 578061 79084364
Cardiac failure 89.86 13.47 24 81939 154818 79507607
Drug monitoring procedure not performed 89.14 13.47 35 81928 976 79661449
Delivery 88.34 13.47 32 81931 710 79661715
Expanded disability status scale 88.22 13.47 15 81948 0 79662425
Diarrhoea 86.46 13.47 541 81422 879948 78782477
Leukopenia 85.53 13.47 289 81674 116224 79546201
Interstitial lung disease 83.82 13.47 9 81954 112591 79549834
Stomatitis 82.82 13.47 24 81939 146733 79515692
Aphasia 81.85 13.47 161 81802 46571 79615854
Decreased immune responsiveness 80.62 13.47 57 81906 5418 79657007
Temperature intolerance 80.31 13.47 72 81891 9633 79652792
Pancytopenia 80.08 13.47 35 81928 165710 79496715
Haemangioma 80.01 13.47 43 81920 2502 79659923
Demyelination 79.54 13.47 66 81897 7957 79654468
Septic shock 79.34 13.47 15 81948 122786 79539639
Palpitations 79.21 13.47 298 81665 126312 79536113
Dysarthria 78.89 13.47 198 81765 67424 79595001
Therapeutic product effect incomplete 78.41 13.47 24 81939 141621 79520804
Cervical dysplasia 77.87 13.47 40 81923 2121 79660304
Blood pressure decreased 77.72 13.47 252 81711 99214 79563211
Injection site pain 77.49 13.47 19 81944 129819 79532606
Respiratory failure 77.22 13.47 45 81918 180866 79481559
Molluscum contagiosum 77.10 13.47 26 81937 463 79661962
Multiple organ dysfunction syndrome 77.03 13.47 15 81948 120231 79542194
Vomiting 76.72 13.47 388 81575 665440 78996985
Cafe au lait spots 76.46 13.47 13 81950 0 79662425
Dysplastic naevus 75.88 13.47 27 81936 568 79661857
Neutrophil count increased 75.77 13.47 120 81843 29276 79633149
Glossodynia 75.06 13.47 9 81954 103328 79559097
Maternal exposure before pregnancy 74.96 13.47 50 81913 4323 79658102
Visual field defect 74.65 13.47 67 81896 8978 79653447
Invasive ductal breast carcinoma 74.63 13.47 56 81907 5836 79656589
Swelling 74.21 13.47 68 81895 216643 79445782
General physical health deterioration 74.02 13.47 105 81858 275133 79387292
International normalised ratio increased 74.02 13.47 3 81960 84718 79577707
Stress 73.67 13.47 214 81749 79398 79583027
Oxygen saturation decreased 73.01 13.47 21 81942 129026 79533399
Magnetic resonance imaging abnormal 72.79 13.47 45 81918 3414 79659011
White matter lesion 71.62 13.47 37 81926 1985 79660440
Hypoglycaemia 71.02 13.47 10 81953 101584 79560841
Feeling abnormal 71.02 13.47 338 81625 158861 79503564
Cardio-respiratory arrest 70.65 13.47 13 81950 108497 79553928
Pain in extremity 69.86 13.47 625 81338 363913 79298512
Intentional product misuse 69.83 13.47 8 81955 95157 79567268
Hyperkalaemia 69.73 13.47 16 81947 114382 79548043
Depressed mood 69.66 13.47 154 81809 48326 79614099
Hypersensitivity 69.57 13.47 101 81862 262138 79400287
Dehydration 69.43 13.47 92 81871 248095 79414330
Dysaesthesia 68.39 13.47 53 81910 5795 79656630
Skin lesion 68.30 13.47 140 81823 41704 79620721
Neurogenic bladder 67.05 13.47 46 81917 4166 79658259
Cryptococcal cutaneous infection 67.02 13.47 19 81944 183 79662242
Cardiac arrest 66.38 13.47 48 81915 172048 79490377
CD8 lymphocytes decreased 65.91 13.47 20 81943 249 79662176
Rhabdomyolysis 65.77 13.47 13 81950 103118 79559307
Decreased vibratory sense 65.38 13.47 25 81938 648 79661777
Loss of personal independence in daily activities 65.28 13.47 13 81950 102567 79559858
Overdose 65.22 13.47 56 81907 184150 79478275
Cervix carcinoma 65.10 13.47 36 81927 2217 79660208
Extensor plantar response 63.58 13.47 33 81930 1788 79660637
Bladder dysfunction 63.53 13.47 29 81934 1183 79661242
Neutropenia 63.26 13.47 125 81838 287585 79374840
Peripheral swelling 62.92 13.47 113 81850 269504 79392921
Ocular discomfort 62.32 13.47 47 81916 4936 79657489
Neuropathy peripheral 61.94 13.47 34 81929 141271 79521154
Disease progression 61.75 13.47 59 81904 184303 79478122
Clumsiness 61.57 13.47 39 81924 3088 79659337
Muscle tightness 61.36 13.47 71 81892 12843 79649582
Psoriatic arthropathy 61.33 13.47 5 81958 77994 79584431
Blood cholesterol increased 60.84 13.47 207 81756 83513 79578912
Gait spastic 60.73 13.47 28 81935 1169 79661256
CD4/CD8 ratio decreased 60.69 13.47 14 81949 52 79662373
Product use in unapproved indication 59.25 13.47 104 81859 250255 79412170
Immunodeficiency 57.68 13.47 90 81873 21678 79640747
Hypokalaemia 57.10 13.47 39 81924 144001 79518424
Wound 56.96 13.47 24 81939 116155 79546270
Pleural effusion 56.69 13.47 40 81923 145222 79517203
Chest discomfort 56.49 13.47 286 81677 137758 79524667
Pollakiuria 56.41 13.47 121 81842 37196 79625229
Actinic keratosis 56.38 13.47 48 81915 5994 79656431
Mucosal inflammation 56.35 13.47 6 81957 75574 79586851
Neutrophil percentage increased 55.94 13.47 43 81920 4646 79657779
Hospitalisation 55.82 13.47 14 81949 94222 79568203
Dizziness postural 55.72 13.47 64 81899 11485 79650940
Motor dysfunction 55.42 13.47 72 81891 14661 79647764
Wrong technique in product usage process 54.73 13.47 6 81957 73869 79588556
Hemianaesthesia 54.54 13.47 20 81943 460 79661965
Hypoxia 54.48 13.47 19 81944 103224 79559201
Lactic acidosis 53.99 13.47 5 81958 70354 79592071
Coordination abnormal 53.62 13.47 77 81886 17235 79645190
Metabolic acidosis 53.48 13.47 10 81953 82519 79579906
Intentional overdose 53.39 13.47 21 81942 105939 79556486
Chronic kidney disease 52.69 13.47 4 81959 66150 79596275
Speech disorder 51.95 13.47 148 81815 54297 79608128
Vaccination failure 51.88 13.47 29 81934 1824 79660601
Pulmonary embolism 51.80 13.47 60 81903 171594 79490831
Ascites 51.51 13.47 8 81955 75554 79586871
Band sensation 51.45 13.47 22 81941 766 79661659
Skin papilloma 51.36 13.47 45 81918 5841 79656584
Progressive multiple sclerosis 51.13 13.47 25 81938 1192 79661233
Anogenital warts 51.02 13.47 23 81940 911 79661514
Influenza like illness 50.97 13.47 176 81787 71531 79590894
Optic atrophy 50.73 13.47 29 81934 1904 79660521
Infection 50.59 13.47 108 81855 241604 79420821
Monocyte percentage increased 50.58 13.47 30 81933 2111 79660314
Blood creatinine increased 50.33 13.47 51 81912 155006 79507419
Deep vein thrombosis 50.29 13.47 31 81932 120888 79541537
Aspartate aminotransferase decreased 50.11 13.47 24 81939 1093 79661332
Cryptococcal meningoencephalitis 49.74 13.47 16 81947 244 79662181
Injection site erythema 49.56 13.47 10 81953 78187 79584238
JC polyomavirus test 48.99 13.47 11 81952 35 79662390
Pulmonary oedema 48.75 13.47 15 81948 88239 79574186
Upper respiratory tract infection 48.49 13.47 204 81759 90964 79571461
Acrochordon 48.24 13.47 23 81940 1037 79661388
Quadriparesis 48.22 13.47 35 81928 3466 79658959
Basophil count decreased 47.97 13.47 16 81947 275 79662150
Exposure during pregnancy 47.82 13.47 22 81941 101110 79561315
Pruritus 47.64 13.47 226 81737 394422 79268003
Medication error 47.40 13.47 7 81956 68635 79593790
Nystagmus 46.30 13.47 54 81909 9850 79652575
Helicobacter infection 46.13 13.47 8 81955 69696 79592729
Fall 46.03 13.47 730 81233 486899 79175526
Pericarditis 45.80 13.47 25 81938 104211 79558214
Delirium 45.65 13.47 15 81948 84612 79577813
Melaena 44.97 13.47 5 81958 60885 79601540
Electrocardiogram PR prolongation 44.93 13.47 25 81938 1558 79660867
Anaphylactic reaction 44.90 13.47 15 81948 83728 79578697
Eosinophil count decreased 44.63 13.47 33 81930 3363 79659062
Peroneal nerve palsy 44.50 13.47 42 81921 6000 79656425
Papule 44.37 13.47 46 81917 7361 79655064
Oedema 43.99 13.47 35 81928 119545 79542880
Lymphocyte count abnormal 43.38 13.47 24 81939 1479 79660946
Papilloma viral infection 42.81 13.47 25 81938 1709 79660716
Post herpetic neuralgia 42.61 13.47 29 81934 2592 79659833
Photophobia 42.51 13.47 76 81887 20452 79641973
Incontinence 42.41 13.47 62 81901 14102 79648323
Platelet count decreased 42.40 13.47 85 81878 194579 79467846
CSF protein increased 41.94 13.47 22 81941 1218 79661207
Respiratory arrest 41.82 13.47 5 81958 57545 79604880
Atrial fibrillation 41.75 13.47 88 81875 197798 79464627
Chronic obstructive pulmonary disease 41.30 13.47 18 81945 85401 79577024
T-lymphocyte count decreased 40.93 13.47 17 81946 550 79661875
Burning sensation 40.88 13.47 143 81820 58489 79603936
Dyspnoea 40.77 13.47 628 81335 856397 78806028
Breast mass 40.55 13.47 42 81921 6712 79655713
Pneumonitis 40.24 13.47 7 81956 60853 79601572
Neuralgia 40.24 13.47 99 81864 33285 79629140
Epilepsy 39.89 13.47 112 81851 40748 79621677
Vitreous floaters 39.80 13.47 43 81920 7213 79655212
Anxiety 39.59 13.47 410 81553 248102 79414323
Rubella antibody positive 39.56 13.47 10 81953 59 79662366
Treatment noncompliance 39.35 13.47 4 81959 52264 79610161
Menstruation irregular 39.00 13.47 36 81927 5000 79657425
Neck pain 38.74 13.47 167 81796 75250 79587175
Sebaceous hyperplasia 38.73 13.47 10 81953 65 79662360
Retinal cyst 38.43 13.47 11 81952 110 79662315
Angioedema 38.42 13.47 15 81948 76020 79586405
Quadriplegia 38.31 13.47 30 81933 3330 79659095
Influenza 38.18 13.47 246 81717 129360 79533065
Arthritis 38.18 13.47 37 81926 114843 79547582
Rash maculo-papular 38.08 13.47 6 81957 56072 79606353
Alanine aminotransferase decreased 37.77 13.47 22 81941 1497 79660928
Relapsing-remitting multiple sclerosis 37.77 13.47 22 81941 1497 79660928
Monocyte count decreased 37.41 13.47 29 81934 3172 79659253
Hypocalcaemia 37.12 13.47 4 81959 49920 79612505
Injection site swelling 37.11 13.47 3 81960 47129 79615296
Haematochezia 37.10 13.47 22 81941 87623 79574802
Decreased appetite 36.83 13.47 204 81759 342214 79320211
Relapsing multiple sclerosis 36.69 13.47 11 81952 131 79662294
Therapy non-responder 36.56 13.47 25 81938 92280 79570145
JC virus infection 36.56 13.47 31 81932 3850 79658575
Gamma-glutamyltransferase decreased 36.36 13.47 14 81949 370 79662055
Dysmetria 36.22 13.47 19 81944 1052 79661373
Pleocytosis 36.20 13.47 21 81942 1418 79661007
Colitis 36.16 13.47 15 81948 73292 79589133
Superficial spreading melanoma stage unspecified 36.03 13.47 13 81950 285 79662140
Blood brain barrier defect 35.96 13.47 11 81952 141 79662284
Therapeutic response decreased 35.79 13.47 12 81951 66841 79595584
Bone marrow failure 35.78 13.47 5 81958 51102 79611323
Adverse drug reaction 35.40 13.47 12 81951 66380 79596045
Ophthalmoplegia 35.39 13.47 27 81936 2885 79659540
Urticaria 35.30 13.47 87 81876 185114 79477311
Amnesia 35.01 13.47 143 81820 62914 79599511
Liver function test increased 34.95 13.47 105 81858 39668 79622757
Hepatic failure 34.54 13.47 10 81953 61202 79601223
Blepharospasm 34.44 13.47 36 81927 5815 79656610
Cerebral atrophy 34.41 13.47 42 81921 8033 79654392
Extrasystoles 33.93 13.47 40 81923 7379 79655046
Neuromyelitis optica spectrum disorder 33.87 13.47 18 81945 1024 79661401
Disturbance in attention 33.78 13.47 122 81841 50679 79611746
Decreased interest 33.74 13.47 29 81934 3668 79658757
Shock 33.66 13.47 3 81960 43545 79618880
Presbyopia 33.54 13.47 15 81948 583 79661842
Photopsia 33.52 13.47 34 81929 5302 79657123
Sinus arrhythmia 33.48 13.47 23 81940 2087 79660338
Progressive relapsing multiple sclerosis 33.45 13.47 8 81955 36 79662389
Knee arthroplasty 33.37 13.47 3 81960 43245 79619180
C-reactive protein abnormal 33.24 13.47 5 81958 48362 79614063
Hemiplegia 33.13 13.47 57 81906 14882 79647543
Milia 33.12 13.47 9 81954 73 79662352
Thrombosis 33.01 13.47 23 81940 84077 79578348
Hypervolaemia 32.84 13.47 3 81960 42687 79619738
Coma 32.78 13.47 33 81930 100616 79561809
Injection site pruritus 32.45 13.47 3 81960 42280 79620145
Hyperglycaemia 32.18 13.47 16 81947 70319 79592106
Blood bilirubin increased 32.00 13.47 144 81819 66088 79596337
Human papilloma virus test positive 31.75 13.47 14 81949 526 79661899
Haematocrit increased 31.56 13.47 29 81934 4005 79658420
Hypokinesia 31.37 13.47 64 81899 18996 79643429
Coronary artery disease 31.33 13.47 14 81949 65460 79596965
Muscle injury 31.21 13.47 6 81957 48555 79613870
Erythema 31.12 13.47 121 81842 223169 79439256
Electrocardiogram abnormal 30.93 13.47 59 81904 16678 79645747
Keratosis pilaris 30.85 13.47 8 81955 53 79662372
Pulmonary hypertension 30.78 13.47 6 81957 48074 79614351
Ophthalmic herpes zoster 30.68 13.47 24 81939 2660 79659765
Oral herpes 30.56 13.47 79 81884 27375 79635050
Tinea pedis 30.48 13.47 23 81940 2417 79660008
Non-cardiac chest pain 30.43 13.47 43 81920 9481 79652944
CSF measles antibody positive 30.35 13.47 8 81955 57 79662368
Tinea versicolour 30.28 13.47 12 81951 343 79662082
Benign neoplasm of skin 30.11 13.47 9 81954 106 79662319
Haemoptysis 30.07 13.47 10 81953 55989 79606436
Squamous cell carcinoma 30.02 13.47 56 81907 15566 79646859
Macular pigmentation 29.80 13.47 6 81957 9 79662416
Hypomagnesaemia 29.72 13.47 6 81957 46905 79615520
Immune thrombocytopenia 29.56 13.47 60 81903 17745 79644680
Anti-thyroid antibody positive 29.49 13.47 13 81950 488 79661937
Refraction disorder 29.32 13.47 8 81955 66 79662359
Neoplasm skin 29.02 13.47 19 81944 1592 79660833
Acne 29.00 13.47 77 81886 27113 79635312
Protein total decreased 28.98 13.47 41 81922 9051 79653374
Monoparesis 28.96 13.47 26 81937 3485 79658940
Fluid retention 28.88 13.47 18 81945 69791 79592634
Injection site bruising 28.73 13.47 4 81959 40998 79621427
Haematemesis 28.65 13.47 9 81954 52255 79610170
Tubulointerstitial nephritis 28.59 13.47 3 81960 38232 79624193
Lower respiratory tract infection 28.49 13.47 56 81907 129164 79533261
Haemorrhage 28.40 13.47 31 81932 91087 79571338
Asthenopia 28.39 13.47 22 81941 2405 79660020
Anaplastic large cell lymphoma T- and null-cell types 28.18 13.47 9 81954 134 79662291
Electrocardiogram PR shortened 28.11 13.47 11 81952 304 79662121
Myelosuppression 28.08 13.47 4 81959 40292 79622133
Intraductal proliferative breast lesion 27.88 13.47 22 81941 2469 79659956
Romberg test positive 27.81 13.47 10 81953 217 79662208
Metamorphopsia 27.66 13.47 17 81946 1276 79661149
Blindness transient 27.42 13.47 29 81934 4747 79657678
Urge incontinence 27.42 13.47 16 81947 1092 79661333
Brain stem syndrome 27.29 13.47 15 81948 913 79661512
Eye naevus 27.24 13.47 6 81957 17 79662408
Ill-defined disorder 27.23 13.47 17 81946 65858 79596567
Pulmonary fibrosis 27.21 13.47 6 81957 44106 79618319
Drug eruption 27.06 13.47 6 81957 43929 79618496
Macular cyst 27.05 13.47 7 81956 46 79662379
Blister 27.02 13.47 51 81912 119425 79543000
Herpes zoster cutaneous disseminated 27.01 13.47 12 81951 459 79661966
Hyperreflexia 27.00 13.47 38 81925 8347 79654078
Genital herpes 26.82 13.47 20 81943 2064 79660361
Hepatic enzyme increased 26.61 13.47 296 81667 182314 79480111
Anaphylactic shock 26.47 13.47 3 81960 35993 79626432
CD30 expression 26.42 13.47 7 81956 51 79662374
Unevaluable event 26.42 13.47 12 81951 55573 79606852
JC virus CSF test positive 26.35 13.47 9 81954 167 79662258
Plasma cell myeloma 26.10 13.47 11 81952 53248 79609177
Asthma 26.10 13.47 63 81900 135032 79527393
Hypoglossal nerve paralysis 26.07 13.47 6 81957 22 79662403
Drug ineffective for unapproved indication 26.06 13.47 10 81953 51228 79611197
Malignant melanoma in situ 26.05 13.47 21 81942 2431 79659994
Impaired healing 26.04 13.47 31 81932 87624 79574801
Rectal haemorrhage 26.02 13.47 24 81939 76276 79586149
Blindness 25.96 13.47 76 81887 28307 79634118
Dyspnoea exertional 25.65 13.47 31 81932 87042 79575383
Respiratory distress 25.61 13.47 14 81949 58325 79604100
Wheezing 25.34 13.47 51 81912 116613 79545812
Cryptococcosis 25.19 13.47 24 81939 3469 79658956
Rosacea 25.15 13.47 26 81937 4146 79658279
Oedema peripheral 25.13 13.47 154 81809 252134 79410291
Uterine leiomyoma 25.04 13.47 32 81931 6411 79656014
Sedation 24.98 13.47 11 81952 51884 79610541
Macular fibrosis 24.95 13.47 13 81950 710 79661715
Arthralgia 24.79 13.47 426 81537 571377 79091048
Hallucination 24.76 13.47 31 81932 85714 79576711
Diabetic ketoacidosis 24.70 13.47 3 81960 34119 79628306
Vaginal dysplasia 24.57 13.47 6 81957 30 79662395
Monoplegia 24.40 13.47 25 81938 3946 79658479
Varicella zoster virus infection 23.80 13.47 26 81937 4415 79658010
Dysdiadochokinesis 23.69 13.47 10 81953 337 79662088
Postmature baby 23.53 13.47 4 81959 0 79662425
Anti-JC virus antibody index 23.53 13.47 4 81959 0 79662425
Expanded disability status scale score decreased 23.53 13.47 4 81959 0 79662425
Surgery 23.43 13.47 3 81960 32763 79629662
Muscle strain 23.24 13.47 38 81925 9517 79652908
Discomfort 23.16 13.47 60 81903 125557 79536868
Anal incontinence 23.09 13.47 55 81908 18113 79644312
Injection site reaction 22.84 13.47 14 81949 54771 79607654
Hypophagia 22.83 13.47 9 81954 45358 79617067
Eosinophilia 22.82 13.47 9 81954 45336 79617089
Urobilinogen urine increased 22.77 13.47 12 81951 671 79661754
Vibration test abnormal 22.75 13.47 5 81958 14 79662411
Retinal disorder 22.74 13.47 18 81945 2029 79660396
Eye disorder 22.68 13.47 64 81899 23348 79639077
Tremor 22.68 13.47 271 81692 169812 79492613
Agranulocytosis 22.55 13.47 9 81954 45021 79617404
Seborrhoeic dermatitis 22.54 13.47 18 81945 2055 79660370
Acute respiratory failure 22.43 13.47 17 81946 59524 79602901
Rash erythematous 22.41 13.47 16 81947 57753 79604672
Product prescribing error 22.37 13.47 9 81954 44804 79617621
Myelitis 22.32 13.47 19 81944 2372 79660053
Dysstasia 22.29 13.47 71 81892 27675 79634750
Obstructive airways disorder 22.21 13.47 3 81960 31456 79630969
Asthenia 22.10 13.47 685 81278 511004 79151421
Depressed level of consciousness 22.08 13.47 41 81922 96611 79565814
Fear-related avoidance of activities 22.06 13.47 7 81956 102 79662323
Blindness unilateral 22.02 13.47 34 81929 8112 79654313
Diabetes mellitus 21.95 13.47 29 81934 78361 79584064
Chest wall mass 21.94 13.47 8 81955 181 79662244
Folliculitis 21.93 13.47 15 81948 55365 79607060
Disseminated intravascular coagulation 21.86 13.47 5 81958 35837 79626588
Osteoarthritis 21.80 13.47 35 81928 87274 79575151
Cerebrovascular accident 21.73 13.47 84 81879 155208 79507217
Bladder disorder 21.69 13.47 36 81927 9129 79653296
Blood pressure increased 21.64 13.47 321 81642 211039 79451386
Rash pruritic 21.64 13.47 25 81938 71604 79590821
Epistaxis 21.54 13.47 52 81911 111463 79550962
Maculopathy 21.50 13.47 20 81943 2805 79659620
Hypertonic bladder 21.49 13.47 24 81939 4177 79658248
Paralysis 21.39 13.47 44 81919 13133 79649292
Laryngeal papilloma 21.29 13.47 4 81959 3 79662422
Seizure 21.00 13.47 291 81672 188543 79473882
Testicular seminoma (pure) stage I 21.00 13.47 5 81958 22 79662403
Hemianopia 20.95 13.47 16 81947 1712 79660713
Intestinal obstruction 20.90 13.47 9 81954 43011 79619414
Partial seizures 20.89 13.47 35 81928 8943 79653482
Squamous cell carcinoma of skin 20.63 13.47 45 81918 13988 79648437
Intervertebral disc protrusion 20.42 13.47 62 81901 23559 79638866
Hypercalcaemia 20.39 13.47 7 81956 38423 79624002
Abdominal pain 20.34 13.47 280 81683 389289 79273136
Migraine with aura 20.30 13.47 19 81944 2686 79659739
Electrocardiogram T wave abnormal 20.24 13.47 22 81941 3716 79658709
Vitamin D decreased 20.13 13.47 36 81927 9689 79652736
Spinal cord disorder 20.10 13.47 16 81947 1819 79660606
Cardiogenic shock 20.00 13.47 9 81954 41905 79620520
Fibromyalgia 19.93 13.47 22 81941 64318 79598107
Nasopharyngitis 19.87 13.47 369 81594 253512 79408913
Skin ulcer 19.72 13.47 16 81947 54134 79608291
Head discomfort 19.63 13.47 45 81918 14457 79647968
Lymphogranuloma venereum 19.49 13.47 4 81959 7 79662418
Cerebellar syndrome 19.40 13.47 26 81937 5454 79656971
Haemoglobin decreased 19.40 13.47 141 81822 221978 79440447
Glioblastoma 19.31 13.47 15 81948 1645 79660780
Amenorrhoea 19.27 13.47 31 81932 7661 79654764
Hepatic cirrhosis 19.15 13.47 6 81957 34900 79627525
Liver injury 19.08 13.47 18 81945 56596 79605829
Intention tremor 19.07 13.47 11 81952 735 79661690
Dysgraphia 18.87 13.47 22 81941 4010 79658415
Incorrect dose administered 18.87 13.47 31 81932 76599 79585826
Herpes zoster meningoencephalitis 18.86 13.47 11 81952 750 79661675
Acute respiratory distress syndrome 18.73 13.47 11 81952 44056 79618369
White blood cell count increased 18.61 13.47 136 81827 74497 79587928
Facial pain 18.61 13.47 40 81923 12310 79650115
Restless legs syndrome 18.56 13.47 54 81909 20038 79642387
Prosopagnosia 18.46 13.47 5 81958 40 79662385
Heavy menstrual bleeding 18.44 13.47 43 81920 13968 79648457
Coagulopathy 18.36 13.47 7 81956 35999 79626426
Eye movement disorder 18.34 13.47 31 81932 7980 79654445
Type 2 diabetes mellitus 18.29 13.47 19 81944 57103 79605322
Prescribed overdose 18.28 13.47 8 81955 37875 79624550
Melanocytic hyperplasia 18.25 13.47 4 81959 11 79662414
Urinary retention 18.24 13.47 110 81853 56520 79605905
Granulocyte count increased 18.05 13.47 13 81950 1272 79661153
Encephalopathy 17.81 13.47 26 81937 67371 79595054
Mean cell haemoglobin increased 17.79 13.47 22 81941 4263 79658162
Retention cyst 17.64 13.47 3 81960 0 79662425
Concentric sclerosis 17.64 13.47 3 81960 0 79662425
Hemihyperaesthesia 17.64 13.47 3 81960 0 79662425
Orthostatic hypotension 17.62 13.47 19 81944 56145 79606280
Organic brain syndrome 17.56 13.47 9 81954 475 79661950
Aggression 17.41 13.47 16 81947 50942 79611483
Carcinoma in situ 17.38 13.47 6 81957 115 79662310
Visual acuity tests abnormal 17.33 13.47 6 81957 116 79662309
Abnormal sensation in eye 17.30 13.47 15 81948 1920 79660505
Myopia 17.16 13.47 15 81948 1941 79660484
Diabetic retinal oedema 16.98 13.47 8 81955 351 79662074
Device related infection 16.94 13.47 7 81956 34287 79628138
Lung disorder 16.83 13.47 36 81927 80521 79581904
Ulcer 16.72 13.47 5 81958 29967 79632458
Hemiparaesthesia 16.67 13.47 7 81956 233 79662192
Product quality issue 16.65 13.47 7 81956 33933 79628492
Invasive breast carcinoma 16.63 13.47 9 81954 531 79661894
Product administration error 16.56 13.47 6 81957 31840 79630585
Localised infection 16.52 13.47 9 81954 37566 79624859
Irritable bowel syndrome 16.45 13.47 24 81939 62217 79600208
Pancreatitis acute 16.45 13.47 16 81947 49588 79612837
Psoriasis 16.35 13.47 43 81920 89544 79572881
High density lipoprotein decreased 16.35 13.47 22 81941 4633 79657792
Ligament sprain 16.30 13.47 40 81923 13424 79649001
Drug dependence 16.20 13.47 11 81952 40758 79621667
Joint range of motion decreased 16.11 13.47 7 81956 33275 79629150
Thunderclap headache 16.06 13.47 8 81955 397 79662028
Facial spasm 16.03 13.47 10 81953 771 79661654
Gastrointestinal disorder 15.90 13.47 68 81895 122137 79540288
Spinal cord injury cauda equina 15.82 13.47 6 81957 152 79662273
Borderline glaucoma 15.77 13.47 4 81959 24 79662401
Heart rate irregular 15.74 13.47 71 81892 32608 79629817
Spinal cord injury 15.72 13.47 12 81951 1283 79661142
Swelling face 15.57 13.47 31 81932 71181 79591244
Macular hole 15.57 13.47 10 81953 811 79661614
Renal artery dissection 15.57 13.47 3 81960 3 79662422
Hepatic enzyme decreased 15.53 13.47 6 81957 160 79662265
B-cell lymphoma 15.50 13.47 25 81938 6190 79656235
Hepatic encephalopathy 15.50 13.47 3 81960 24163 79638262
Cervix disorder 15.49 13.47 7 81956 279 79662146
Cerebral haemorrhage 15.48 13.47 22 81941 57651 79604774
Gastrointestinal carcinoma 15.44 13.47 18 81945 3281 79659144
Optic nerve injury 15.39 13.47 9 81954 617 79661808
Hemianopia homonymous 15.35 13.47 12 81951 1329 79661096
Wound infection 15.34 13.47 3 81960 23988 79638437
Saccadic eye movement 15.26 13.47 6 81957 168 79662257
Agitation 15.22 13.47 52 81911 99663 79562762
Blood pressure diastolic decreased 15.20 13.47 6 81957 30210 79632215
Body temperature decreased 15.18 13.47 7 81956 32138 79630287
Hepatitis E 15.17 13.47 17 81946 2969 79659456
Monkeypox 15.11 13.47 4 81959 29 79662396
Injury 15.07 13.47 36 81927 77460 79584965
Myocardial infarction 15.07 13.47 119 81844 184010 79478415
Anxiety disorder 15.03 13.47 20 81943 4167 79658258
Lip swelling 15.01 13.47 12 81951 40899 79621526
Trigeminal nerve disorder 14.90 13.47 6 81957 179 79662246
Acute disseminated encephalomyelitis 14.88 13.47 7 81956 306 79662119
Lung adenocarcinoma 14.87 13.47 28 81935 7836 79654589
No adverse event 14.82 13.47 10 81953 37182 79625243
Cutaneous T-cell lymphoma 14.79 13.47 16 81947 2687 79659738
Myoclonus 14.74 13.47 5 81958 27655 79634770
Urinary hesitation 14.74 13.47 20 81943 4246 79658179
Magnetic resonance imaging head abnormal 14.68 13.47 16 81947 2710 79659715
Mood altered 14.64 13.47 46 81917 17801 79644624
Ventricular extrasystoles 14.55 13.47 49 81914 19655 79642770
Vertigo CNS origin 14.45 13.47 4 81959 35 79662390
Multiple lentigines syndrome 14.45 13.47 6 81957 194 79662231
Somatosensory evoked potentials abnormal 14.45 13.47 6 81957 194 79662231
Ovarian cancer 14.44 13.47 19 81944 3915 79658510
Small intestinal obstruction 14.42 13.47 5 81958 27267 79635158
Anti-actin antibody positive 14.35 13.47 3 81960 6 79662419
Panic attack 14.31 13.47 56 81907 24160 79638265
Personality change 14.26 13.47 32 81931 10138 79652287
Inflammation 14.24 13.47 49 81914 93704 79568721
CSF immunoglobulin increased 14.16 13.47 4 81959 38 79662387
Birth mark 14.07 13.47 4 81959 39 79662386
Pregnancy 14.06 13.47 5 81958 26846 79635579
Tension headache 14.05 13.47 26 81937 7185 79655240
Leiomyosarcoma 14.03 13.47 7 81956 349 79662076
Cardiomyopathy 14.01 13.47 6 81957 28768 79633657
Fine motor skill dysfunction 13.98 13.47 22 81941 5335 79657090
Vitamin B12 deficiency 13.97 13.47 26 81937 7215 79655210
Blood folate increased 13.96 13.47 8 81955 528 79661897
Strabismus 13.93 13.47 15 81948 2506 79659919
Skin exfoliation 13.84 13.47 22 81941 55078 79607347
Swollen tongue 13.81 13.47 14 81949 42556 79619869
Cerebral artery stenosis 13.73 13.47 9 81954 756 79661669
Retinal vein occlusion 13.70 13.47 17 81946 3306 79659119
Myelodysplastic syndrome 13.70 13.47 7 81956 30294 79632131
Optic nerve disorder 13.70 13.47 11 81952 1266 79661159
Pneumothorax 13.64 13.47 6 81957 28317 79634108
Macule 13.62 13.47 16 81947 2941 79659484
Musculoskeletal chest pain 13.62 13.47 56 81907 24708 79637717
Vitreous adhesions 13.55 13.47 4 81959 45 79662380
Abdominal distension 13.55 13.47 70 81893 119580 79542845
Acute hepatic failure 13.55 13.47 7 81956 30106 79632319
Extra dose administered 13.54 13.47 28 81935 8387 79654038
Ventricular fibrillation 13.53 13.47 8 81955 31918 79630507
Ileus 13.52 13.47 5 81958 26206 79636219
Haemorrhage intracranial 13.51 13.47 5 81958 26188 79636237
Ear lobe infection 13.49 13.47 3 81960 9 79662416

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA27 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D000081243 Sphingosine 1 Phosphate Receptor Modulators
FDA MoA N0000181815 Sphingosine 1-Phosphate Receptor Modulators
FDA EPC N0000181816 Sphingosine 1-phosphate Receptor Modulator
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:63114 SIP agonist
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:73416 CB1 receptor antagonists

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

DiseaseRelationSNOMED_IDDOID
Relapsing remitting multiple sclerosis indication 426373005 DOID:2378
Disorder of lung contraindication 19829001 DOID:850
Complete atrioventricular block contraindication 27885002
Sick sinus syndrome contraindication 36083008 DOID:13884
Macular retinal edema contraindication 37231002 DOID:4449
Bradycardia contraindication 48867003
Hepatic failure contraindication 59927004
Acute infectious disease contraindication 63171007
Diabetes mellitus contraindication 73211009 DOID:9351
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Uveitis contraindication 128473001 DOID:13141
Liver function tests abnormal contraindication 166603001
Chronic infectious disease contraindication 177010002
Second degree atrioventricular block contraindication 195042002
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.57 acidic
pKa2 13.18 acidic
pKa3 8.51 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.5MG BASE GILENYA NOVARTIS N022527 Sept. 21, 2010 RX CAPSULE ORAL 9187405 June 25, 2027 TREATMENT OF RELAPSING-REMITTING SCLEROSIS (MS)
EQ 0.5MG BASE GILENYA NOVARTIS N022527 Sept. 21, 2010 RX CAPSULE ORAL 10543179 Dec. 25, 2027 TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT
EQ 0.25MG BASE GILENYA NOVARTIS N022527 May 11, 2018 RX CAPSULE ORAL 9592208 March 30, 2032 TREATMENT OF MULTIPLE SCLEROSIS IN THE PEDIATRIC PATIENT POPULATION WITH 0.25 MG FINGOLIMOD

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.5MG BASE FINGOLIMOD HYDROCHLORIDE STRIDES PHARMA A207971 June 29, 2020 DISCN CAPSULE ORAL March 20, 2023 PATENT CHALLENGE
EQ 0.5MG BASE FINGOLIMOD HYDROCHLORIDE GLENMARK PHARMS LTD A207985 June 18, 2020 RX CAPSULE ORAL March 20, 2023 PATENT CHALLENGE
EQ 0.5MG BASE FINGOLIMOD HYDROCHLORIDE ACCORD HLTHCARE A207991 Oct. 28, 2020 RX CAPSULE ORAL March 20, 2023 PATENT CHALLENGE
EQ 0.5MG BASE FINGOLIMOD HYDROCHLORIDE TEVA PHARMS USA A208008 July 2, 2020 DISCN CAPSULE ORAL March 20, 2023 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sphingosine 1-phosphate receptor 4 GPCR AGONIST EC50 9.52 CHEMBL CHEMBL
Sphingosine 1-phosphate receptor 1 GPCR AGONIST EC50 9.52 CHEMBL CHEMBL
Sphingosine 1-phosphate receptor 5 GPCR AGONIST EC50 9.52 CHEMBL CHEMBL
Sphingosine 1-phosphate receptor 3 GPCR AGONIST EC50 8.52 CHEMBL CHEMBL
Sphingosine-1-phosphate lyase 1 Enzyme IC50 4.77 CHEMBL
Sphingosine-1-phosphate lyase 1, S1PL, SP-lyase 1, SPL 1, mSPL, EC 4.1.2.27 Unclassified IC50 4.28 CHEMBL
Transient receptor potential cation channel subfamily M member 7 Ion channel BLOCKER IC50 6.14 IUPHAR

External reference:

IDSource
4030216 VUID
N0000181834 NUI
D04187 KEGG_DRUG
162359-56-0 SECONDARY_CAS_RN
4030216 VANDF
C0388087 UMLSCUI
CHEBI:63115 CHEBI
CHEMBL544665 ChEMBL_ID
CHEMBL314854 ChEMBL_ID
D000068876 MESH_DESCRIPTOR_UI
DB08868 DRUGBANK_ID
2407 IUPHAR_LIGAND_ID
8341 INN_ID
3QN8BYN5QF UNII
107970 PUBCHEM_CID
1012891 RXNORM
177212 MMSL
253713 MMSL
27529 MMSL
d07692 MMSL
013519 NDDF
013520 NDDF
449000008 SNOMEDCT_US
703109008 SNOMEDCT_US
715640009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0607 CAPSULE 0.50 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0607 CAPSULE 0.50 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0607 CAPSULE 0.50 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0607 CAPSULE 0.50 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 34 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 34 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 0378-4525 CAPSULE 0.50 mg ORAL ANDA 32 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 0378-4525 CAPSULE 0.50 mg ORAL ANDA 32 sections
FINGOLIMOD HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16729-342 CAPSULE 0.50 mg ORAL ANDA 30 sections
Fingolimod Human Prescription Drug Label 1 31722-889 CAPSULE 0.50 mg ORAL ANDA 27 sections
FINGOLIMOD HUMAN PRESCRIPTION DRUG LABEL 1 43547-003 CAPSULE 0.50 mg ORAL ANDA 27 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 43598-285 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 60505-4332 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 60505-4332 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod Human Prescription Drug Label 1 62756-064 CAPSULE 0.50 mg ORAL ANDA 30 sections
FINGOLIMOD HUMAN PRESCRIPTION DRUG LABEL 1 64380-776 CAPSULE 0.50 mg ORAL ANDA 27 sections
FINGOLIMOD HUMAN PRESCRIPTION DRUG LABEL 1 64380-776 CAPSULE 0.50 mg ORAL ANDA 27 sections
fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 64980-449 CAPSULE 0.50 mg ORAL ANDA 31 sections
Fingolimod Human Prescription Drug Label 1 67877-476 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 68382-912 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 68382-912 CAPSULE 0.50 mg ORAL ANDA 28 sections
fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 68462-166 CAPSULE 0.50 mg ORAL ANDA 28 sections
Fingolimod HUMAN PRESCRIPTION DRUG LABEL 1 70771-1603 CAPSULE 0.50 mg ORAL ANDA 1 sections