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

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 4595.33 13.20 1938 80248 41026 50481912
Lymphocyte count decreased 4123.67 13.20 1564 80622 24743 50498195
Central nervous system lesion 2315.62 13.20 784 81402 8705 50514233
Lymphopenia 1680.41 13.20 709 81477 14912 50508026
White blood cell count decreased 1313.67 13.20 1255 80931 115467 50407471
Expanded disability status scale score increased 956.56 13.20 199 81987 171 50522767
Macular oedema 918.84 13.20 309 81877 3345 50519593
Heart rate decreased 676.38 13.20 523 81663 35974 50486964
Visual impairment 657.04 13.20 675 81511 67600 50455338
Melanocytic naevus 618.19 13.20 234 81952 3650 50519288
Hypoaesthesia 585.53 13.20 867 81319 126390 50396548
Vision blurred 551.75 13.20 659 81527 77988 50444950
Rebound effect 503.45 13.20 191 81995 2998 50519940
Optic neuritis 473.77 13.20 229 81957 6661 50516277
Prescribed underdose 463.65 13.20 301 81885 15648 50507290
JC polyomavirus test positive 462.68 13.20 138 82048 971 50521967
Off label use 451.01 13.20 109 82077 474317 50048621
Gamma-glutamyltransferase increased 405.20 13.20 356 81830 29267 50493671
Muscular weakness 392.34 13.20 616 81570 94397 50428541
Alanine aminotransferase increased 381.78 13.20 585 81601 87774 50435164
Gait disturbance 381.28 13.20 787 81399 149218 50373720
Headache 366.52 13.20 1707 80479 504828 50018110
Drug ineffective 351.47 13.20 494 81692 818839 49704099
Fatigue 350.26 13.20 2147 80039 705454 49817484
Normal newborn 330.74 13.20 178 82008 6513 50516425
Toxicity to various agents 307.69 13.20 8 82178 212491 50310447
Balance disorder 297.29 13.20 462 81724 70128 50452810
Seborrhoeic keratosis 284.78 13.20 109 82077 1754 50521184
Paraesthesia 283.42 13.20 612 81574 119631 50403307
Atrioventricular block second degree 272.26 13.20 128 82058 3493 50519445
Rheumatoid arthritis 271.36 13.20 14 82172 202536 50320402
Atrioventricular block first degree 270.76 13.20 152 82034 6049 50516889
Death 259.76 13.20 102 82084 325277 50197661
Acute kidney injury 251.15 13.20 36 82150 228022 50294916
Memory impairment 247.19 13.20 454 81732 78906 50444032
Secondary progressive multiple sclerosis 237.18 13.20 86 82100 1180 50521758
Hemiparesis 235.01 13.20 221 81965 19827 50503111
Lentigo 233.11 13.20 59 82127 200 50522738
Infusion related reaction 229.38 13.20 11 82175 169546 50353392
Contraindicated product administered 226.10 13.20 3 82183 148955 50373983
CD4 lymphocytes decreased 225.15 13.20 84 82102 1255 50521683
Tumefactive multiple sclerosis 224.92 13.20 45 82141 24 50522914
Micturition urgency 223.19 13.20 149 82037 8115 50514823
Joint swelling 219.86 13.20 63 82123 245223 50277715
Drug hypersensitivity 218.58 13.20 68 82118 250942 50271996
Dizziness 216.42 13.20 1121 81065 345248 50177690
Haemangioma of skin 213.09 13.20 57 82129 253 50522685
Herpes zoster 210.47 13.20 397 81789 70389 50452549
Ataxia 209.43 13.20 176 82010 13610 50509328
Concomitant disease aggravated 204.47 13.20 140 82046 7951 50514987
Muscle spasticity 204.43 13.20 191 81995 16993 50505945
Limb discomfort 200.69 13.20 222 81964 24135 50498803
Eye pain 198.56 13.20 238 81948 28211 50494727
Therapeutic product effect decreased 197.30 13.20 5 82181 136045 50386893
Cognitive disorder 188.76 13.20 291 81895 43832 50479106
Arthropathy 188.35 13.20 19 82167 157887 50365051
Completed suicide 183.51 13.20 7 82179 131882 50391056
Synovitis 181.73 13.20 4 82182 123861 50399077
Systemic lupus erythematosus 178.40 13.20 13 82173 140609 50382329
Product use issue 178.24 13.20 18 82168 149457 50373481
Drug intolerance 174.16 13.20 69 82117 219035 50303903
Multiple sclerosis 172.67 13.20 189 81997 20304 50502634
Bradycardia 169.22 13.20 343 81843 64083 50458855
Sensory disturbance 167.39 13.20 145 82041 11684 50511254
Breast cancer 165.71 13.20 270 81916 42620 50480318
High density lipoprotein increased 163.67 13.20 57 82129 690 50522248
Pneumonia 162.39 13.20 227 81959 378174 50144764
Condition aggravated 153.25 13.20 154 82032 296904 50226034
Maternal exposure during pregnancy 153.14 13.20 588 81598 159190 50363748
Swelling 152.01 13.20 68 82118 200804 50322134
Glossodynia 151.55 13.20 9 82177 115560 50407378
Visual acuity reduced 149.66 13.20 174 82012 19965 50502973
Basal cell carcinoma 149.39 13.20 187 81999 23169 50499769
Progressive multifocal leukoencephalopathy 147.27 13.20 133 82053 11324 50511614
Blood alkaline phosphatase increased 137.92 13.20 231 81955 37295 50485643
Rash 136.18 13.20 320 81866 437151 50085787
Depression 133.30 13.20 577 81609 164846 50358092
Febrile neutropenia 133.11 13.20 6 82180 97661 50425277
Leukopenia 132.61 13.20 320 81866 67208 50455730
Solar lentigo 132.52 13.20 46 82140 551 50522387
Drug interaction 131.22 13.20 81 82105 199540 50323398
Immune reconstitution inflammatory syndrome 128.96 13.20 91 82095 5425 50517513
Fibrous histiocytoma 128.08 13.20 42 82144 417 50522521
Anaemia 127.74 13.20 133 82053 252323 50270615
Aspartate aminotransferase increased 127.63 13.20 345 81841 77653 50445285
Diplopia 124.44 13.20 155 82031 19105 50503833
Lymphocyte count increased 122.34 13.20 70 82116 2889 50520049
Maternal exposure timing unspecified 119.32 13.20 74 82112 3546 50519392
Vertigo 118.71 13.20 261 81925 51571 50471367
Treatment failure 118.41 13.20 38 82148 137599 50385339
Cervical dysplasia 118.15 13.20 67 82119 2718 50520220
Diarrhoea 113.76 13.20 531 81655 587945 49934993
Oropharyngeal pain 112.45 13.20 329 81857 77472 50445466
Injection site pain 112.18 13.20 22 82164 111002 50411936
Abortion spontaneous 111.55 13.20 224 81962 41548 50481390
Wound 111.12 13.20 19 82167 105775 50417163
Renal failure 110.15 13.20 20 82166 106613 50416325
Sensory loss 109.78 13.20 95 82091 7643 50515295
Blood pressure decreased 108.75 13.20 264 81922 55645 50467293
Trigeminal neuralgia 108.60 13.20 66 82120 3049 50519889
Malignant melanoma 108.17 13.20 106 82080 10002 50512936
Lymphocyte percentage decreased 108.01 13.20 63 82123 2697 50520241
Paraparesis 107.88 13.20 57 82129 2007 50520931
Low density lipoprotein increased 106.85 13.20 82 82104 5564 50517374
Migraine 106.56 13.20 316 81870 74964 50447974
Vomiting 106.26 13.20 388 81798 460370 50062568
Vitamin D deficiency 104.56 13.20 110 82076 11292 50511646
Cardiac failure congestive 103.63 13.20 9 82177 84373 50438565
Hypersensitivity 102.57 13.20 119 82067 215042 50307896
Urinary incontinence 101.46 13.20 172 82014 28036 50494902
Paresis 99.28 13.20 54 82132 2017 50520921
Maternal exposure before pregnancy 98.78 13.20 78 82108 5519 50517419
Blood alkaline phosphatase decreased 98.69 13.20 44 82142 1058 50521880
Stomatitis 98.44 13.20 22 82164 101322 50421616
Stress 97.23 13.20 247 81939 53546 50469392
Lymphocyte count abnormal 96.79 13.20 37 82149 593 50522345
Delivery 95.39 13.20 37 82149 618 50522320
Drug monitoring procedure not performed 95.22 13.20 34 82152 445 50522493
Sinus bradycardia 93.13 13.20 111 82075 13072 50509866
Palpitations 91.41 13.20 349 81837 94157 50428781
Gastrointestinal haemorrhage 89.55 13.20 8 82178 73313 50449625
Movement disorder 89.38 13.20 126 82060 17506 50505432
Hyponatraemia 89.19 13.20 23 82163 96116 50426822
Blood bilirubin decreased 89.18 13.20 35 82151 604 50522334
Malignant neoplasm progression 87.22 13.20 6 82180 68118 50454820
Exposure during pregnancy 86.83 13.20 44 82142 120971 50401967
Monocyte count increased 86.77 13.20 72 82114 5467 50517471
Dysplastic naevus 85.79 13.20 24 82162 130 50522808
Intentional product use issue 84.88 13.20 12 82174 76906 50446032
Therapeutic product effect incomplete 84.70 13.20 22 82164 91493 50431445
Back pain 83.89 13.20 628 81558 219402 50303536
Renal impairment 83.04 13.20 12 82174 75649 50447289
Dysarthria 82.99 13.20 186 82000 37217 50485721
Hypotension 82.43 13.20 161 82025 235308 50287630
Injection site erythema 81.97 13.20 12 82174 74924 50448014
Cervix carcinoma 81.21 13.20 51 82135 2499 50520439
Muscle spasms 80.55 13.20 410 81776 125143 50397795
Sepsis 80.50 13.20 59 82127 132866 50390072
Peripheral swelling 79.98 13.20 132 82054 205804 50317134
Aphasia 79.93 13.20 156 82030 28338 50494600
Optic atrophy 76.23 13.20 37 82149 1085 50521853
CD8 lymphocytes decreased 76.19 13.20 22 82164 136 50522802
Neutrophil count increased 74.27 13.20 103 82083 14092 50508846
Hospitalisation 71.77 13.20 12 82174 67925 50455013
Epilepsy 71.67 13.20 127 82059 21440 50501498
Cystoid macular oedema 71.32 13.20 38 82148 1361 50521577
Loss of personal independence in daily activities 70.50 13.20 14 82172 70036 50452902
Demyelination 69.78 13.20 66 82120 5960 50516978
Temperature intolerance 69.60 13.20 73 82113 7466 50515472
Arthralgia 69.45 13.20 423 81763 438279 50084659
Extensor plantar response 69.33 13.20 35 82151 1119 50521819
Drug abuse 69.26 13.20 8 82178 59838 50463100
Pruritus 69.10 13.20 233 81953 283335 50239603
Pericarditis 68.94 13.20 21 82165 78668 50444270
Respiratory failure 67.14 13.20 32 82154 91149 50431789
Cardiac arrest 66.94 13.20 26 82160 83625 50439313
Dysaesthesia 65.80 13.20 52 82134 3683 50519255
Pancytopenia 65.80 13.20 27 82159 84003 50438935
Gait spastic 65.31 13.20 22 82164 239 50522699
Deep vein thrombosis 65.24 13.20 19 82167 73285 50449653
Depressed mood 64.37 13.20 159 82027 33864 50489074
Neuropathy peripheral 63.88 13.20 39 82147 96718 50426220
Pain 63.09 13.20 619 81567 578284 49944654
Dehydration 62.70 13.20 94 82092 152355 50370583
Cafe au lait spots 62.57 13.20 13 82173 11 50522927
Urinary tract infection 62.32 13.20 596 81590 223424 50299514
Basophil count decreased 62.06 13.20 17 82169 84 50522854
Chest discomfort 61.70 13.20 306 81880 92416 50430522
Molluscum contagiosum 61.59 13.20 20 82166 192 50522746
Feeling abnormal 61.36 13.20 381 81805 125111 50397827
Electrocardiogram PR prolongation 61.07 13.20 27 82159 636 50522302
Speech disorder 60.89 13.20 160 82026 35388 50487550
Decreased interest 60.25 13.20 45 82141 2931 50520007
Band sensation 60.04 13.20 27 82159 663 50522275
Oxygen saturation decreased 59.89 13.20 22 82164 73226 50449712
Expanded disability status scale 59.67 13.20 11 82175 0 50522938
Clumsiness 59.17 13.20 37 82149 1799 50521139
Wrong technique in product usage process 58.20 13.20 10 82176 55500 50467438
Ocular discomfort 57.37 13.20 46 82140 3327 50519611
Actinic keratosis 57.37 13.20 39 82147 2188 50520750
Pulmonary embolism 56.71 13.20 49 82137 101655 50421283
Helicobacter infection 56.64 13.20 7 82179 49695 50473243
Abdominal discomfort 56.62 13.20 190 81996 231451 50291487
Hypoglycaemia 55.42 13.20 10 82176 53571 50469367
Psoriatic arthropathy 55.15 13.20 6 82180 47026 50475912
Interstitial lung disease 54.84 13.20 10 82176 53166 50469772
Bladder dysfunction 54.80 13.20 26 82160 724 50522214
Magnetic resonance imaging abnormal 54.80 13.20 41 82145 2677 50520261
Cryptococcal cutaneous infection 54.75 13.20 14 82172 50 50522888
Intentional product misuse 54.70 13.20 6 82180 46728 50476210
International normalised ratio increased 54.66 13.20 4 82182 43148 50479790
CD4/CD8 ratio decreased 54.26 13.20 11 82175 7 50522931
Fall 54.13 13.20 803 81383 334129 50188809
Skin lesion 53.87 13.20 128 82058 26599 50496339
Peroneal nerve palsy 53.63 13.20 49 82137 4234 50518704
Haemangioma 53.58 13.20 39 82147 2441 50520497
Pleural effusion 53.53 13.20 33 82153 81421 50441517
Aspartate aminotransferase decreased 53.49 13.20 24 82162 586 50522352
Visual field defect 53.43 13.20 56 82130 5723 50517215
Meningitis cryptococcal 52.53 13.20 29 82157 1116 50521822
Septic shock 52.41 13.20 14 82172 57161 50465777
Invasive ductal breast carcinoma 52.30 13.20 56 82130 5865 50517073
Cardio-respiratory arrest 51.72 13.20 12 82174 53880 50469058
Progressive multiple sclerosis 51.60 13.20 25 82161 730 50522208
Decreased immune responsiveness 51.14 13.20 46 82140 3895 50519043
Dysgraphia 50.97 13.20 39 82147 2634 50520304
Dizziness postural 50.58 13.20 56 82130 6089 50516849
Arthritis 50.55 13.20 40 82146 86681 50436257
Injection site pruritus 50.46 13.20 4 82182 40407 50482531
Discomfort 50.46 13.20 61 82125 108319 50414619
White matter lesion 50.19 13.20 32 82154 1610 50521328
Disease progression 50.12 13.20 49 82137 95817 50427121
Injection site swelling 49.83 13.20 5 82181 41768 50481170
Cardiac failure 49.70 13.20 31 82155 76009 50446929
Immune thrombocytopenia 49.54 13.20 67 82119 8950 50513988
Intentional overdose 49.06 13.20 20 82166 62484 50460454
CSF protein increased 48.99 13.20 21 82165 458 50522480
Electrocardiogram abnormal 48.79 13.20 61 82125 7544 50515394
Ophthalmoplegia 48.28 13.20 29 82157 1311 50521627
Lower respiratory tract infection 48.23 13.20 50 82136 95151 50427787
Anaphylactic reaction 48.12 13.20 14 82172 54041 50468897
Nystagmus 48.07 13.20 52 82134 5509 50517429
Adverse event 47.87 13.20 7 82179 43756 50479182
Mucosal inflammation 47.38 13.20 5 82181 40137 50482801
Hypokalaemia 47.13 13.20 44 82142 87948 50434990
Neuralgia 46.57 13.20 107 82079 21756 50501182
Neurogenic bladder 46.56 13.20 38 82148 2819 50520119
Knee arthroplasty 46.34 13.20 3 82183 35843 50487095
Thrombocytopenia 45.75 13.20 86 82100 127587 50395351
T-lymphocyte count decreased 45.56 13.20 17 82169 254 50522684
Muscle injury 45.44 13.20 4 82182 37107 50485831
Papule 45.44 13.20 45 82141 4300 50518638
Coordination abnormal 45.05 13.20 73 82113 11461 50511477
Injection site bruising 44.92 13.20 4 82182 36764 50486174
JC polyomavirus test 44.47 13.20 11 82175 33 50522905
Adverse drug reaction 44.44 13.20 17 82169 55205 50467733
Superficial spreading melanoma stage unspecified 44.41 13.20 14 82172 121 50522817
Hyperkalaemia 43.65 13.20 12 82174 48077 50474861
Blepharospasm 43.45 13.20 37 82149 2911 50520027
Vitreous floaters 43.00 13.20 48 82138 5266 50517672
Hemianaesthesia 42.88 13.20 18 82168 372 50522566
Unevaluable event 42.75 13.20 11 82175 46055 50476883
Amnesia 42.43 13.20 158 82028 42102 50480836
Hemiplegia 42.32 13.20 56 82130 7325 50515613
Dysmetria 42.06 13.20 18 82168 391 50522547
Chronic kidney disease 42.06 13.20 7 82179 39764 50483174
Blindness 41.85 13.20 89 82097 17180 50505758
Product use in unapproved indication 41.51 13.20 78 82108 115741 50407197
Incontinence 41.48 13.20 65 82121 9920 50513018
Muscle tightness 41.43 13.20 66 82120 10214 50512724
Papilloma viral infection 41.27 13.20 26 82160 1281 50521657
Post herpetic neuralgia 40.96 13.20 30 82156 1896 50521042
Eosinophil count decreased 40.93 13.20 28 82158 1587 50521351
Blood brain barrier defect 40.65 13.20 12 82174 81 50522857
Ill-defined disorder 40.50 13.20 19 82167 54635 50468303
Chronic obstructive pulmonary disease 40.50 13.20 18 82168 53417 50469521
Lactic acidosis 39.76 13.20 4 82182 33351 50489587
Neutrophil percentage increased 39.73 13.20 34 82152 2693 50520245
Alanine aminotransferase decreased 39.63 13.20 19 82167 542 50522396
Anxiety 39.19 13.20 451 81735 177155 50345783
Urticaria 39.16 13.20 96 82090 129465 50393473
Rhabdomyolysis 38.84 13.20 8 82178 39019 50483919
Monoparesis 38.57 13.20 26 82160 1438 50521500
Exposure via father 38.54 13.20 15 82171 253 50522685
Osteoarthritis 38.30 13.20 33 82153 68573 50454365
Malignant melanoma in situ 38.13 13.20 21 82165 804 50522134
Multiple organ dysfunction syndrome 38.08 13.20 17 82169 50320 50472618
Ophthalmic herpes zoster 37.38 13.20 27 82159 1670 50521268
Therapeutic response decreased 37.25 13.20 15 82171 47216 50475722
Motor dysfunction 37.20 13.20 55 82131 7976 50514962
Quadriplegia 37.01 13.20 27 82159 1696 50521242
Disturbance in attention 36.82 13.20 123 82063 31063 50491875
Medication error 36.77 13.20 7 82179 36097 50486841
Pleocytosis 36.65 13.20 18 82168 542 50522396
Gamma-glutamyltransferase decreased 36.37 13.20 15 82171 296 50522642
Decreased vibratory sense 36.30 13.20 14 82172 230 50522708
Monocyte percentage increased 36.14 13.20 22 82164 1019 50521919
Neoplasm progression 36.09 13.20 3 82183 29154 50493784
Pain in extremity 36.07 13.20 633 81553 272232 50250706
Hypoxia 36.03 13.20 19 82167 51104 50471834
Blister 35.75 13.20 52 82134 85366 50437572
Anogenital warts 35.61 13.20 16 82170 392 50522546
Neuromyelitis optica spectrum disorder 35.38 13.20 20 82166 806 50522132
Burning sensation 35.35 13.20 157 82029 45289 50477649
Atrial fibrillation 35.17 13.20 70 82116 101675 50421263
Overdose 35.00 13.20 68 82118 99659 50423279
Visual acuity tests abnormal 34.88 13.20 10 82176 60 50522878
Cryptococcal meningoencephalitis 34.74 13.20 10 82176 61 50522877
Injection site reaction 34.67 13.20 19 82167 50013 50472925
Metabolic acidosis 34.66 13.20 10 82176 38815 50484123
General physical health deterioration 34.65 13.20 117 82069 142317 50380621
Rubella antibody positive 34.61 13.20 10 82176 62 50522876
Erythema 34.45 13.20 122 82064 146292 50376646
Ascites 34.38 13.20 8 82178 35853 50487085
Genital herpes 34.10 13.20 25 82161 1582 50521356
Dyspnoea 34.04 13.20 656 81530 546952 49975986
Breast mass 34.04 13.20 47 82139 6402 50516536
C-reactive protein abnormal 34.04 13.20 3 82183 27806 50495132
Product quality issue 33.60 13.20 5 82181 30853 50492085
Intraductal proliferative breast lesion 33.55 13.20 30 82156 2520 50520418
Oedema 33.19 13.20 39 82147 70142 50452796
Human papilloma virus test positive 32.88 13.20 16 82170 472 50522466
Melaena 32.61 13.20 3 82183 26861 50496077
Cervix carcinoma stage 0 32.42 13.20 14 82172 311 50522627
Skin cancer 32.09 13.20 56 82130 9338 50513600
Hypokinesia 31.98 13.20 65 82121 12152 50510786
Impaired healing 31.71 13.20 40 82146 69746 50453192
Herpes zoster cutaneous disseminated 31.60 13.20 11 82175 133 50522805
Infection 31.50 13.20 159 82027 172795 50350143
Seizure 31.43 13.20 311 81875 117563 50405375
JC virus infection 31.40 13.20 25 82161 1790 50521148
Hepatic failure 31.35 13.20 7 82179 32276 50490662
Thrombosis 30.99 13.20 27 82159 55806 50467132
Influenza 30.95 13.20 250 81936 89288 50433650
Decreased appetite 30.51 13.20 196 81990 200727 50322211
Delirium 30.33 13.20 12 82174 38180 50484758
Sebaceous hyperplasia 30.30 13.20 7 82179 14 50522924
Macular fibrosis 30.22 13.20 14 82172 369 50522569
Hypocalcaemia 30.01 13.20 4 82182 26812 50496126
Milia 30.00 13.20 8 82178 35 50522903
Plasma cell myeloma 30.00 13.20 7 82179 31315 50491623
Retinal cyst 29.97 13.20 9 82177 65 50522873
Photophobia 29.68 13.20 71 82115 14816 50508122
Influenza like illness 29.67 13.20 177 82009 57282 50465656
Vaginal dysplasia 29.64 13.20 8 82178 37 50522901
Partial seizures 29.59 13.20 38 82148 4827 50518111
Pneumonitis 29.47 13.20 6 82180 29504 50493434
Tinea versicolour 29.46 13.20 8 82178 38 50522900
Dysstasia 29.29 13.20 79 82107 17740 50505198
Pulmonary oedema 29.24 13.20 22 82164 48916 50474022
Haematemesis 29.05 13.20 5 82181 27720 50495218
Exposure via partner 29.02 13.20 10 82176 117 50522821
Pollakiuria 28.98 13.20 95 82091 23756 50499182
Bone marrow failure 28.90 13.20 5 82181 27619 50495319
Psoriasis 28.87 13.20 42 82144 68958 50453980
Immunodeficiency 28.79 13.20 70 82116 14758 50508180
Blood creatinine increased 28.44 13.20 50 82136 76110 50446828
Blood pressure increased 28.42 13.20 336 81850 132796 50390142
Treatment noncompliance 28.36 13.20 7 82179 30143 50492795
Menstruation irregular 28.26 13.20 42 82144 6120 50516818
Progressive relapsing multiple sclerosis 27.82 13.20 7 82179 23 50522915
Eye disorder 27.77 13.20 80 82106 18659 50504279
Coma 27.55 13.20 31 82155 56848 50466090
Fluid retention 27.50 13.20 25 82161 50624 50472314
Pulmonary hypertension 27.37 13.20 10 82176 33407 50489531
Skin papilloma 27.25 13.20 34 82152 4195 50518743
Urge incontinence 27.17 13.20 16 82170 697 50522241
Macular cyst 27.16 13.20 7 82179 26 50522912
Anti-JC virus antibody index 27.12 13.20 5 82181 0 50522938
Bladder disorder 27.12 13.20 46 82140 7497 50515441
Sedation 27.11 13.20 8 82178 30602 50492336
Folliculitis 27.03 13.20 15 82171 39210 50483728
Asthenia 26.84 13.20 693 81493 318349 50204589
Tremor 26.78 13.20 295 81891 114608 50408330
CSF measles antibody positive 26.73 13.20 8 82178 57 50522881
Surgery 26.56 13.20 8 82178 30197 50492741
Blood cholesterol increased 26.55 13.20 167 82019 55048 50467890
Cerebral atrophy 26.52 13.20 35 82151 4566 50518372
Neck pain 26.46 13.20 171 82015 56896 50466042
Transient tachypnoea of the newborn 26.30 13.20 9 82177 103 50522835
Non-cardiac chest pain 26.19 13.20 39 82147 5693 50517245
Supraventricular extrasystoles 25.89 13.20 32 82154 3912 50519026
Upper respiratory tract infection 25.55 13.20 189 81997 65709 50457229
Maculopathy 25.53 13.20 23 82163 1951 50520987
Haematocrit increased 25.53 13.20 23 82163 1951 50520987
Brain stem syndrome 25.47 13.20 12 82174 329 50522609
Heart rate irregular 25.24 13.20 79 82107 19281 50503657
Hyperreflexia 25.09 13.20 36 82150 5082 50517856
Metamorphopsia 25.00 13.20 17 82169 954 50521984
Varicella virus test positive 24.98 13.20 9 82177 121 50522817
Irritable bowel syndrome 24.95 13.20 28 82158 51413 50471525
Respiratory arrest 24.54 13.20 9 82177 30000 50492938
Injury 24.43 13.20 26 82160 48899 50474039
Acrochordon 24.41 13.20 16 82170 844 50522094
Liver function test increased 24.26 13.20 94 82092 25512 50497426
Relapsing-remitting multiple sclerosis 24.19 13.20 13 82173 474 50522464
Blindness transient 24.09 13.20 28 82158 3210 50519728
Monoplegia 24.01 13.20 26 82160 2757 50520181
Eye naevus 23.67 13.20 5 82181 5 50522933
Blood bilirubin increased 23.66 13.20 109 82077 31929 50491009
Cerebellar syndrome 23.58 13.20 28 82158 3283 50519655
Hyperglycaemia 23.56 13.20 15 82171 36390 50486548
Therapy non-responder 23.43 13.20 29 82157 50993 50471945
Osteoporosis 23.37 13.20 23 82163 44856 50478082
Gastrointestinal disorder 23.37 13.20 77 82109 94379 50428559
Squamous cell carcinoma of skin 23.32 13.20 35 82151 5143 50517795
Shock 23.30 13.20 3 82183 20647 50502291
Extrasystoles 23.19 13.20 33 82153 4622 50518316
Drug eruption 23.16 13.20 5 82181 23601 50499337
Oedema peripheral 23.00 13.20 156 82030 157805 50365133
Seborrhoeic dermatitis 22.88 13.20 15 82171 792 50522146
Acne 22.87 13.20 77 82109 19518 50503420
Hypercalcaemia 22.80 13.20 5 82181 23347 50499591
Neutropenia 22.62 13.20 144 82042 147821 50375117
Photopsia 22.60 13.20 30 82156 3936 50519002
Hepatotoxicity 22.55 13.20 8 82178 27218 50495720
Extra dose administered 22.42 13.20 34 82152 5042 50517896
Pulmonary fibrosis 22.36 13.20 6 82180 24431 50498507
Pregnancy 22.35 13.20 10 82176 29567 50493371
Urinary retention 22.30 13.20 93 82093 26097 50496841
Colitis 22.16 13.20 18 82168 38511 50484427
Nausea 21.99 13.20 930 81256 704468 49818470
Drug ineffective for unapproved indication 21.94 13.20 4 82182 21277 50501661
Presbyopia 21.90 13.20 12 82174 455 50522483
Chest pain 21.81 13.20 406 81780 176476 50346462
Rash maculo-papular 21.77 13.20 8 82178 26633 50496305
Melanocytic hyperplasia 21.70 13.20 4 82182 0 50522938
Neoplasm skin 21.67 13.20 16 82170 1024 50521914
Borderline glaucoma 21.65 13.20 5 82181 10 50522928
Retinal oedema 21.40 13.20 13 82173 600 50522338
Mean cell haemoglobin increased 21.40 13.20 22 82164 2198 50520740
Paralysis 21.39 13.20 45 82141 8619 50514319
Saccadic eye movement 21.39 13.20 7 82179 69 50522869
Hemiparaesthesia 21.39 13.20 7 82179 69 50522869
Fibromyalgia 21.26 13.20 25 82161 44953 50477985
Squamous cell carcinoma 21.25 13.20 42 82144 7697 50515241
Angioedema 21.18 13.20 18 82168 37658 50485280
Colour blindness 21.13 13.20 10 82176 277 50522661
Abnormal sensation in eye 21.07 13.20 19 82167 1614 50521324
Tension headache 20.96 13.20 24 82162 2707 50520231
Romberg test positive 20.71 13.20 8 82178 132 50522806
Retinal disorder 20.68 13.20 18 82168 1459 50521479
Hypomagnesaemia 20.60 13.20 6 82180 23150 50499788
Monocyte count decreased 20.59 13.20 20 82166 1866 50521072
Platelet count decreased 20.45 13.20 89 82097 100637 50422301
Oral herpes 20.39 13.20 77 82109 20648 50502290
Blindness unilateral 20.26 13.20 33 82153 5202 50517736
Benign neoplasm of skin 20.18 13.20 8 82178 142 50522796
Keratosis pilaris 20.14 13.20 6 82180 42 50522896
Haematochezia 20.13 13.20 21 82165 39861 50483077
Hypophagia 19.99 13.20 10 82176 27718 50495220
Type 2 diabetes mellitus 19.84 13.20 16 82170 34359 50488579
Hypoglossal nerve paralysis 19.74 13.20 5 82181 17 50522921
Mitral valve atresia 19.74 13.20 5 82181 17 50522921
Skin ulcer 19.70 13.20 17 82169 35301 50487637
Asthenopia 19.63 13.20 20 82166 1977 50520961
Macular pigmentation 19.52 13.20 5 82181 18 50522920
Bone pain 19.51 13.20 29 82157 47200 50475738
Depressed level of consciousness 19.49 13.20 34 82152 51919 50471019
Thunderclap headache 19.49 13.20 8 82178 156 50522782
Lepromatous leprosy 19.46 13.20 4 82182 3 50522935
Cellulitis 19.44 13.20 55 82131 70743 50452195
Mood altered 19.38 13.20 55 82131 12718 50510220
Hemianopia homonymous 19.23 13.20 12 82174 581 50522357
Granulocyte count increased 19.22 13.20 11 82175 454 50522484
Diabetic ketoacidosis 19.22 13.20 3 82183 17869 50505069
Rash pruritic 19.17 13.20 30 82156 47816 50475122
Cranial nerve disorder 19.03 13.20 10 82176 348 50522590
Refraction disorder 19.02 13.20 6 82180 52 50522886
Lymphogranuloma venereum 18.93 13.20 4 82182 4 50522934
Hepatic cirrhosis 18.79 13.20 3 82183 17574 50505364
Rectal haemorrhage 18.69 13.20 21 82165 38537 50484401
Central nervous system inflammation 18.68 13.20 8 82178 174 50522764
Femur fracture 18.60 13.20 20 82166 37444 50485494
Abortion 18.60 13.20 20 82166 2104 50520834
Abdominal pain 18.53 13.20 271 81915 235957 50286981
JC virus CSF test positive 18.37 13.20 5 82181 24 50522914
Quadriparesis 18.37 13.20 18 82168 1698 50521240
Swelling face 18.33 13.20 36 82150 52559 50470379
Organic brain syndrome 18.23 13.20 8 82178 185 50522753
Tongue biting 18.20 13.20 16 82170 1314 50521624
Disseminated intravascular coagulation 18.15 13.20 3 82183 17132 50505806
Vulval cancer stage 0 18.04 13.20 7 82179 117 50522821
Rash erythematous 17.99 13.20 18 82168 34834 50488104
Herpes zoster meningoencephalitis 17.91 13.20 9 82177 285 50522653
Herpes virus infection 17.86 13.20 30 82156 4851 50518087
Acute respiratory distress syndrome 17.82 13.20 6 82180 21093 50501845
Sinus arrhythmia 17.80 13.20 16 82170 1353 50521585
Relapsing multiple sclerosis 17.67 13.20 7 82179 124 50522814
Ventricular extrasystoles 17.66 13.20 47 82139 10469 50512469
Focal dyscognitive seizures 17.66 13.20 22 82164 2710 50520228
Product prescribing error 17.63 13.20 6 82180 20955 50501983
Facial paralysis 17.61 13.20 53 82133 12662 50510276
Hypertonic bladder 17.57 13.20 23 82163 2977 50519961
Device related infection 17.33 13.20 6 82180 20729 50502209
Anti-actin antibody positive 17.32 13.20 4 82182 8 50522930
Cytomegalovirus infection 17.23 13.20 4 82182 17958 50504980
Uterine leiomyoma 17.22 13.20 39 82147 7852 50515086
Myelitis 17.20 13.20 15 82171 1219 50521719
Wheezing 17.19 13.20 48 82138 61999 50460939
Hemianopia 17.11 13.20 13 82173 869 50522069
Gastrooesophageal reflux disease 17.10 13.20 65 82121 76363 50446575
Facial pain 17.05 13.20 38 82148 7571 50515367
Incorrect dose administered 16.99 13.20 33 82153 48381 50474557
Coronary artery disease 16.95 13.20 14 82172 29712 50493226
Swollen tongue 16.94 13.20 13 82173 28617 50494321
Asthma 16.90 13.20 81 82105 89256 50433682
Tinea pedis 16.84 13.20 15 82171 1254 50521684
Electrocardiogram PR shortened 16.82 13.20 8 82178 224 50522714
Hepatic enzyme increased 16.81 13.20 315 81871 137065 50385873
Optic disc disorder 16.70 13.20 4 82182 10 50522928
Tandem gait test abnormal 16.70 13.20 4 82182 10 50522928
Haemorrhage 16.61 13.20 39 82147 53402 50469536
Vibration test abnormal 16.43 13.20 5 82181 38 50522900
Herpes zoster infection neurological 16.27 13.20 7 82179 154 50522784
Hallucination 16.20 13.20 32 82154 46625 50476313
Injection site mass 16.05 13.20 3 82183 15677 50507261
Blood chloride increased 16.03 13.20 20 82166 2468 50520470
Macule 16.01 13.20 16 82170 1546 50521392
Electrocardiogram T wave abnormal 15.96 13.20 19 82167 2234 50520704
Haemoptysis 15.92 13.20 11 82175 25562 50497376
Migraine with aura 15.74 13.20 19 82167 2266 50520672
White blood cell count increased 15.72 13.20 120 82066 42120 50480818
Haemoglobin decreased 15.50 13.20 132 82054 127084 50395854
Dyschromatopsia 15.35 13.20 9 82177 389 50522549
Head discomfort 15.33 13.20 46 82140 10973 50511965
Bladder discomfort 15.30 13.20 10 82176 525 50522413
Retinal vein occlusion 15.24 13.20 17 82169 1864 50521074
Respiratory disorder 15.10 13.20 17 82169 31170 50491768
Rosacea 15.10 13.20 24 82162 3707 50519231
Diabetes mellitus 15.06 13.20 36 82150 48997 50473941
Protein total decreased 15.01 13.20 29 82157 5227 50517711
Bicuspid aortic valve 15.01 13.20 6 82180 109 50522829
Ulcer 15.00 13.20 7 82179 20193 50502745
Endometrial adenocarcinoma 14.85 13.20 13 82173 1062 50521876
Upper motor neurone lesion 14.81 13.20 6 82180 113 50522825
Osteomyelitis 14.76 13.20 9 82177 22344 50500594
Invasive breast carcinoma 14.49 13.20 10 82176 575 50522363
Autoimmune hypothyroidism 14.48 13.20 6 82180 120 50522818
Varicella zoster virus infection 14.45 13.20 19 82167 2470 50520468
Fear-related avoidance of activities 14.43 13.20 6 82180 121 50522817
Intestinal obstruction 14.35 13.20 13 82173 26370 50496568
Respiratory distress 14.35 13.20 17 82169 30472 50492466
Inappropriate schedule of product administration 14.32 13.20 179 82007 71652 50451286
Vaccination error 14.20 13.20 3 82183 3 50522935
Hiatus hernia 14.18 13.20 6 82180 18338 50504600
Vertigo CNS origin 14.10 13.20 4 82182 23 50522915
Uveitis 14.04 13.20 40 82146 9270 50513668
Dyspnoea exertional 13.92 13.20 40 82146 51193 50471745
Epistaxis 13.91 13.20 55 82131 63899 50459039
Heart rate abnormal 13.90 13.20 24 82162 3968 50518970
Infection susceptibility increased 13.89 13.20 19 82167 2565 50520373
Large for dates baby 13.88 13.20 9 82177 466 50522472
Xerosis 13.72 13.20 10 82176 627 50522311
Panic attack 13.69 13.20 65 82121 19277 50503661
Nasal sinus cancer 13.68 13.20 4 82182 26 50522912
Sinus rhythm 13.68 13.20 10 82176 630 50522308
Solar dermatitis 13.66 13.20 6 82180 139 50522799
Mean platelet volume increased 13.64 13.20 9 82177 480 50522458
Agranulocytosis 13.62 13.20 9 82177 21412 50501526
Osteonecrosis 13.61 13.20 10 82176 22507 50500431
Acute respiratory failure 13.60 13.20 16 82170 28766 50494172
Hypoaesthesia eye 13.57 13.20 5 82181 72 50522866
Agitation 13.56 13.20 43 82143 53341 50469597
Proteinuria 13.53 13.20 5 82181 16592 50506346
Lung adenocarcinoma stage IV 13.51 13.20 6 82180 143 50522795
Intention tremor 13.43 13.20 8 82178 356 50522582
Bladder pain 13.41 13.20 15 82171 1649 50521289
Dermatosis 13.34 13.20 7 82179 243 50522695
Tonic clonic movements 13.29 13.20 13 82173 1224 50521714
Body temperature decreased 13.27 13.20 5 82181 16390 50506548
Malaise 13.26 13.20 669 81517 334863 50188075

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 1782.62 17.00 558 21841 10861 29541267
Lymphocyte count decreased 1050.01 17.00 432 21967 18839 29533289
Central nervous system lesion 784.90 17.00 253 22146 5395 29546733
Expanded disability status scale score increased 438.85 17.00 86 22313 169 29551959
Lymphopenia 366.97 17.00 187 22212 13346 29538782
Macular oedema 344.91 17.00 111 22288 2347 29549781
Alanine aminotransferase increased 311.71 17.00 323 22076 70621 29481507
Gait disturbance 244.37 17.00 289 22110 73060 29479068
Gamma-glutamyltransferase increased 240.69 17.00 183 22216 26554 29525574
White blood cell count decreased 239.83 17.00 305 22094 83057 29469071
Heart rate decreased 234.20 17.00 175 22224 24737 29527391
Visual impairment 223.64 17.00 183 22216 29525 29522603
Vision blurred 194.55 17.00 193 22206 39983 29512145
JC polyomavirus test positive 187.57 17.00 50 22349 526 29551602
Hypoaesthesia 181.77 17.00 213 22186 53254 29498874
Balance disorder 160.90 17.00 166 22233 36004 29516124
Melanocytic naevus 154.04 17.00 57 22342 1849 29550279
Acute kidney injury 153.11 17.00 13 22386 265254 29286874
Secondary progressive multiple sclerosis 144.58 17.00 37 22362 327 29551801
Prescribed underdose 142.52 17.00 83 22316 7703 29544425
Muscle spasticity 139.64 17.00 70 22329 4813 29547315
Muscular weakness 137.17 17.00 200 22199 61852 29490276
Aspartate aminotransferase increased 134.20 17.00 194 22205 59531 29492597
Fatigue 133.47 17.00 532 21867 316289 29235839
Hepatic enzyme increased 132.38 17.00 145 22254 33654 29518474
Off label use 120.79 17.00 39 22360 300761 29251367
Optic neuritis 120.72 17.00 55 22344 3054 29549074
Headache 107.44 17.00 332 22067 173675 29378453
Memory impairment 102.34 17.00 132 22267 36338 29515790
Death 102.30 17.00 67 22332 342017 29210111
Paraesthesia 90.36 17.00 153 22246 53692 29498436
Depression 86.76 17.00 196 22203 84951 29467177
Cognitive disorder 85.42 17.00 97 22302 23402 29528726
Toxicity to various agents 84.26 17.00 15 22384 173646 29378482
Herpes zoster 81.53 17.00 107 22292 29945 29522183
Progressive multifocal leukoencephalopathy 81.29 17.00 61 22338 8658 29543470
Ataxia 79.53 17.00 69 22330 12034 29540094
Hypotension 78.21 17.00 25 22374 194329 29357799
Seborrhoeic keratosis 77.28 17.00 28 22371 854 29551274
Multiple sclerosis 75.56 17.00 49 22350 5505 29546623
Anaemia 75.46 17.00 29 22370 200922 29351206
Drug interaction 74.92 17.00 28 22371 197357 29354771
Limb discomfort 74.14 17.00 60 22339 9508 29542620
Movement disorder 64.52 17.00 57 22342 10180 29541948
Bradycardia 64.50 17.00 149 22250 65480 29486648
Drug monitoring procedure not performed 63.48 17.00 18 22381 242 29551886
Sensory disturbance 63.43 17.00 44 22355 5525 29546603
Depressed mood 63.37 17.00 70 22329 16378 29535750
Lymphocyte percentage decreased 60.87 17.00 30 22369 1987 29550141
Diplopia 58.17 17.00 61 22338 13457 29538671
Rebound effect 57.72 17.00 29 22370 2002 29550126
Micturition urgency 56.88 17.00 40 22359 5133 29546995
Concomitant disease aggravated 55.92 17.00 39 22360 4939 29547189
Liver function test increased 55.42 17.00 56 22343 11829 29540299
Eye pain 52.91 17.00 54 22345 11541 29540587
Paraparesis 52.53 17.00 26 22373 1738 29550390
Tumefactive multiple sclerosis 52.32 17.00 10 22389 16 29552112
Low density lipoprotein increased 52.02 17.00 34 22365 3870 29548258
Sinus bradycardia 51.07 17.00 53 22346 11550 29540578
Magnetic resonance imaging abnormal 49.89 17.00 24 22375 1507 29550621
Malignant melanoma 49.42 17.00 42 22357 7119 29545009
Vitamin D deficiency 47.83 17.00 37 22362 5492 29546636
Blood cholesterol increased 47.76 17.00 59 22340 15536 29536592
Oropharyngeal pain 47.48 17.00 82 22317 29203 29522925
Basal cell carcinoma 47.07 17.00 61 22338 16849 29535279
Visual acuity reduced 45.11 17.00 56 22343 14820 29537308
Decreased vibratory sense 44.91 17.00 15 22384 357 29551771
Hemiparesis 44.68 17.00 55 22344 14431 29537697
Renal failure 44.64 17.00 17 22382 118582 29433546
Blood alkaline phosphatase decreased 43.71 17.00 17 22382 633 29551495
Gastrointestinal haemorrhage 42.86 17.00 5 22394 79528 29472600
Pneumonia 42.82 17.00 114 22285 320058 29232070
Paresis 42.72 17.00 23 22376 1831 29550297
Cardiac failure congestive 40.81 17.00 5 22394 76576 29475552
Atrioventricular block second degree 40.77 17.00 27 22372 3141 29548987
Meningitis cryptococcal 40.04 17.00 23 22376 2077 29550051
Hyponatraemia 39.76 17.00 3 22396 67630 29484498
Progressive multiple sclerosis 38.76 17.00 12 22387 222 29551906
Drug abuse 38.47 17.00 7 22392 79876 29472252
Cardiac failure 38.07 17.00 7 22392 79280 29472848
Thrombocytopenia 38.01 17.00 28 22371 134795 29417333
Dehydration 37.63 17.00 20 22379 114728 29437400
CD4 lymphocytes decreased 37.32 17.00 20 22379 1578 29550550
Pancytopenia 36.54 17.00 9 22390 83159 29468969
Multiple organ dysfunction syndrome 36.54 17.00 3 22396 63113 29489015
Overdose 36.34 17.00 8 22391 79811 29472317
Dysarthria 35.79 17.00 75 22324 30836 29521292
Dizziness 35.26 17.00 255 22144 189429 29362699
Bladder dysfunction 35.07 17.00 12 22387 308 29551820
Respiratory failure 34.79 17.00 15 22384 97116 29455012
Sensory loss 34.49 17.00 27 22372 4077 29548051
Cystoid macular oedema 33.66 17.00 14 22385 622 29551506
Monocyte count increased 33.60 17.00 26 22373 3860 29548268
Trigeminal neuralgia 33.24 17.00 16 22383 1006 29551122
Immune reconstitution inflammatory syndrome 33.19 17.00 35 22364 7767 29544361
Hyperkalaemia 32.73 17.00 4 22395 61388 29490740
Diarrhoea 32.41 17.00 136 22263 332562 29219566
Renal impairment 31.71 17.00 11 22388 81322 29470806
Lymphocyte count increased 31.64 17.00 22 22377 2772 29549356
Haemangioma of skin 31.53 17.00 8 22391 68 29552060
Drug ineffective 31.48 17.00 155 22244 363015 29189113
CD4/CD8 ratio decreased 31.24 17.00 6 22393 10 29552118
Drug hypersensitivity 30.84 17.00 7 22392 68399 29483729
Sepsis 30.46 17.00 38 22361 142644 29409484
High density lipoprotein increased 30.19 17.00 11 22388 341 29551787
Interstitial lung disease 30.18 17.00 4 22395 57714 29494414
Neutrophil percentage increased 30.00 17.00 18 22381 1763 29550365
Back pain 29.41 17.00 154 22245 102130 29449998
Bladder disorder 29.32 17.00 21 22378 2773 29549355
Urinary incontinence 29.16 17.00 48 22351 16433 29535695
Fibrous histiocytoma 28.46 17.00 8 22391 104 29552024
Blood alkaline phosphatase increased 28.43 17.00 65 22334 28341 29523787
Visual field defect 28.11 17.00 24 22375 4092 29548036
Mobility decreased 28.05 17.00 61 22338 25719 29526409
Cardio-respiratory arrest 27.71 17.00 3 22396 50598 29501530
Nasopharyngitis 27.12 17.00 103 22296 59562 29492566
Septic shock 27.03 17.00 7 22392 62553 29489575
Neurogenic bladder 26.60 17.00 16 22383 1574 29550554
Electrocardiogram abnormal 26.21 17.00 30 22369 7292 29544836
Lentigo 25.75 17.00 10 22389 371 29551757
Muscle spasms 25.30 17.00 107 22292 64975 29487153
Anogenital warts 25.14 17.00 11 22388 554 29551574
Blood creatinine increased 24.85 17.00 17 22382 85085 29467043
Expanded disability status scale 24.75 17.00 4 22395 0 29552128
Atrioventricular block first degree 24.68 17.00 25 22374 5294 29546834
Condition aggravated 24.46 17.00 46 22353 146249 29405879
Disease progression 24.41 17.00 16 22383 81900 29470228
Platelet count decreased 24.35 17.00 26 22373 104646 29447482
Rhabdomyolysis 24.08 17.00 8 22391 60800 29491328
Exposure via father 23.33 17.00 7 22392 116 29552012
Infusion related reaction 23.04 17.00 3 22396 43883 29508245
Monocyte percentage increased 22.94 17.00 12 22387 901 29551227
Urinary tract infection 22.93 17.00 112 22287 72242 29479886
Hypokalaemia 22.90 17.00 5 22394 50198 29501930
Immunodeficiency 22.69 17.00 22 22377 4418 29547710
Skin lesion 22.59 17.00 46 22353 18526 29533602
Cardiac arrest 22.55 17.00 19 22380 85572 29466556
Motor dysfunction 22.42 17.00 25 22374 5905 29546223
Temperature intolerance 21.95 17.00 18 22381 2903 29549225
Cryptococcal cutaneous infection 21.94 17.00 6 22393 70 29552058
Testicular seminoma (pure) stage I 21.83 17.00 5 22394 26 29552102
Neutropenia 21.50 17.00 42 22357 131669 29420459
Pleural effusion 21.48 17.00 14 22385 71894 29480234
Dysplastic naevus 21.22 17.00 9 22390 420 29551708
Feeling abnormal 20.76 17.00 89 22310 54356 29497772
White matter lesion 20.61 17.00 10 22389 640 29551488
Acrochordon 20.52 17.00 8 22391 300 29551828
Globulins decreased 20.41 17.00 7 22392 181 29551947
T-lymphocyte count decreased 20.37 17.00 7 22392 182 29551946
Dysdiadochokinesis 20.05 17.00 7 22392 191 29551937
Squamous cell carcinoma 19.70 17.00 31 22368 10220 29541908
Neuropathy peripheral 19.67 17.00 15 22384 71012 29481116
Hepatobiliary disease 19.22 17.00 8 22391 356 29551772
Hypoxia 19.17 17.00 6 22393 47373 29504755
Urobilinogen urine increased 19.05 17.00 8 22391 364 29551764
Vitreous floaters 18.91 17.00 17 22382 3104 29549024
Coordination abnormal 18.76 17.00 25 22374 7089 29545039
Expanded disability status scale score decreased 18.56 17.00 3 22396 0 29552128
Laryngeal papilloma 18.56 17.00 3 22396 0 29552128
Haemangioma 18.39 17.00 13 22386 1681 29550447
Brain stem syndrome 18.36 17.00 8 22391 399 29551729
Eye disorder 18.36 17.00 26 22373 7808 29544320
Anti-thyroid antibody positive 18.31 17.00 5 22394 58 29552070
Peripheral swelling 18.25 17.00 13 22386 63726 29488402
Influenza like illness 18.18 17.00 50 22349 24420 29527708
Solar lentigo 18.17 17.00 8 22391 409 29551719
Musculoskeletal stiffness 18.13 17.00 66 22333 37392 29514736
Lymphocyte count abnormal 17.95 17.00 9 22390 618 29551510
Chronic kidney disease 17.94 17.00 3 22396 36413 29515715
Spinal cord injury cauda equina 17.84 17.00 6 22393 146 29551982
Therapeutic product effect incomplete 17.76 17.00 4 22395 39301 29512827
Somatosensory evoked potentials abnormal 17.61 17.00 6 22393 152 29551976
Albumin globulin ratio increased 17.43 17.00 4 22395 21 29552107
Photophobia 17.26 17.00 22 22377 5973 29546155
Completed suicide 17.26 17.00 26 22373 90220 29461908
Gait spastic 17.14 17.00 9 22390 681 29551447
Halo vision 17.04 17.00 6 22393 168 29551960

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 4119.20 13.87 1628 76245 39507 64381352
Lymphocyte count decreased 4034.19 13.87 1599 76274 39100 64381759
Central nervous system lesion 1885.82 13.87 660 77213 11189 64409670
Lymphopenia 1429.37 13.87 672 77201 24985 64395874
White blood cell count decreased 1242.48 13.87 1220 76653 156617 64264242
Expanded disability status scale score increased 966.26 13.87 199 77674 275 64420584
Melanocytic naevus 813.84 13.87 270 77603 3850 64417009
Macular oedema 812.11 13.87 281 77592 4586 64416273
Heart rate decreased 692.85 13.87 556 77317 54511 64366348
Hypoaesthesia 641.36 13.87 814 77059 138294 64282565
Vision blurred 612.38 13.87 645 77228 89671 64331188
Alanine aminotransferase increased 600.88 13.87 788 77085 138243 64282616
Visual impairment 559.97 13.87 561 77312 73516 64347343
Gamma-glutamyltransferase increased 482.71 13.87 428 77445 48082 64372777
Fatigue 481.55 13.87 1977 75896 746753 63674106
Headache 471.99 13.87 1555 76318 527912 63892947
Optic neuritis 440.61 13.87 209 77664 7907 64412952
Prescribed underdose 439.80 13.87 273 77600 17742 64403117
Off label use 428.31 13.87 118 77755 632688 63788171
Acute kidney injury 415.89 13.87 34 77839 449206 63971653
Seborrhoeic keratosis 408.10 13.87 135 77738 1905 64418954
Muscular weakness 401.10 13.87 621 77252 126717 64294142
Gait disturbance 400.44 13.87 733 77140 171422 64249437
Toxicity to various agents 361.37 13.87 19 77854 363494 64057365
JC polyomavirus test positive 353.78 13.87 108 77765 1154 64419705
Paraesthesia 324.36 13.87 582 77291 133940 64286919
Balance disorder 302.29 13.87 436 77437 83490 64337369
Rebound effect 299.07 13.87 137 77736 4780 64416079
Drug ineffective 295.95 13.87 349 77524 839898 63580961
Death 295.89 13.87 107 77766 482598 63938261
Muscle spasticity 270.45 13.87 196 77677 16473 64404386
Haemangioma of skin 269.92 13.87 63 77810 203 64420656
Micturition urgency 263.02 13.87 161 77712 10198 64410661
Tumefactive multiple sclerosis 255.13 13.87 49 77824 33 64420826
Secondary progressive multiple sclerosis 251.61 13.87 83 77790 1160 64419699
Lentigo 251.06 13.87 66 77807 386 64420473
Normal newborn 246.13 13.87 125 77748 5492 64415367
Eye pain 234.12 13.87 237 77636 31388 64389471
Dizziness 232.83 13.87 1081 76792 429082 63991777
Atrioventricular block second degree 229.78 13.87 125 77748 6329 64414530
Memory impairment 224.91 13.87 385 77488 85297 64335562
Atrioventricular block first degree 215.82 13.87 144 77729 10590 64410269
Limb discomfort 214.71 13.87 211 77662 26964 64393895
Drug interaction 212.13 13.87 86 77787 361997 64058862
Concomitant disease aggravated 211.03 13.87 146 77727 11396 64409463
Aspartate aminotransferase increased 208.30 13.87 452 77421 119336 64301523
Ataxia 206.02 13.87 188 77685 21896 64398963
Hemiparesis 198.26 13.87 211 77662 29616 64391243
Herpes zoster 196.32 13.87 347 77526 78840 64342019
High density lipoprotein increased 193.50 13.87 65 77808 964 64419895
Febrile neutropenia 192.13 13.87 8 77865 187649 64233210
Completed suicide 191.62 13.87 23 77850 224391 64196468
Sensory disturbance 191.14 13.87 145 77728 13063 64407796
Cognitive disorder 186.41 13.87 278 77595 54809 64366050
Pneumonia 179.24 13.87 249 77624 559327 63861532
Anaemia 176.08 13.87 121 77752 378559 64042300
Hypotension 170.24 13.87 127 77746 380847 64040012
Progressive multifocal leukoencephalopathy 169.66 13.87 155 77718 18077 64402782
Maternal exposure during pregnancy 166.86 13.87 362 77511 95522 64325337
Depression 165.46 13.87 542 77331 182749 64238110
Low density lipoprotein increased 163.27 13.87 107 77766 7633 64413226
Visual acuity reduced 159.53 13.87 180 77693 26961 64393898
Infusion related reaction 158.91 13.87 10 77863 164457 64256402
Rheumatoid arthritis 158.72 13.87 10 77863 164284 64256575
Solar lentigo 158.38 13.87 54 77819 840 64420019
Vitamin D deficiency 157.47 13.87 123 77750 11569 64409290
Blood alkaline phosphatase increased 155.74 13.87 259 77614 56020 64364839
Fibrous histiocytoma 154.81 13.87 47 77826 492 64420367
Blood alkaline phosphatase decreased 149.13 13.87 60 77813 1512 64419347
Multiple sclerosis 145.78 13.87 145 77728 18796 64402063
CD4 lymphocytes decreased 145.43 13.87 67 77806 2368 64418491
Bradycardia 144.14 13.87 389 77484 117830 64303029
Renal failure 142.50 13.87 24 77849 181664 64239195
Lymphocyte percentage decreased 140.87 13.87 81 77792 4568 64416291
Diplopia 139.72 13.87 167 77706 26598 64394261
Condition aggravated 138.89 13.87 147 77726 372279 64048580
Drug hypersensitivity 138.31 13.87 57 77816 237758 64183101
Migraine 135.56 13.87 259 77614 62418 64358441
Gastrointestinal haemorrhage 134.21 13.87 6 77867 132306 64288553
Lymphocyte count increased 133.18 13.87 80 77793 4895 64415964
Cardiac failure congestive 132.19 13.87 6 77867 130574 64290285
Immune reconstitution inflammatory syndrome 127.87 13.87 112 77761 12358 64408501
Vertigo 125.35 13.87 242 77631 58769 64362090
Joint swelling 124.62 13.87 52 77821 215330 64205529
Basal cell carcinoma 122.48 13.87 168 77705 30670 64390189
Drug abuse 122.25 13.87 10 77863 132364 64288495
Therapeutic product effect decreased 117.75 13.87 5 77868 115346 64305513
Product use issue 116.86 13.87 21 77852 151694 64269165
Contraindicated product administered 115.98 13.87 3 77870 107826 64313033
Hyponatraemia 115.42 13.87 20 77853 148319 64272540
Renal impairment 114.79 13.87 14 77859 135003 64285856
Sinus bradycardia 113.23 13.87 139 77734 22754 64398105
Monocyte count increased 113.17 13.87 87 77786 7992 64412867
Back pain 112.37 13.87 597 77276 249574 64171285
Malignant neoplasm progression 111.65 13.87 6 77867 112865 64307994
Muscle spasms 111.39 13.87 399 77474 140624 64280235
Breast cancer 110.09 13.87 155 77718 28993 64391866
Paraparesis 108.74 13.87 62 77811 3440 64417419
Trigeminal neuralgia 107.31 13.87 59 77814 3050 64417809
Blood cholesterol increased 107.16 13.87 206 77667 49860 64370999
Sepsis 106.40 13.87 74 77799 230267 64190592
Urinary incontinence 106.26 13.87 171 77702 35980 64384879
Sensory loss 105.61 13.87 92 77781 10077 64410782
Paresis 105.58 13.87 61 77812 3471 64417388
Malignant melanoma 104.89 13.87 102 77771 12862 64407997
Urinary tract infection 102.16 13.87 550 77323 231046 64189813
Synovitis 102.13 13.87 4 77869 99086 64321773
Thrombocytopenia 101.92 13.87 73 77800 223728 64197131
Drug intolerance 101.53 13.87 50 77823 187942 64232917
Blood bilirubin decreased 98.02 13.87 37 77836 782 64420077
Movement disorder 96.78 13.87 126 77747 21874 64398985
Pancytopenia 96.01 13.87 27 77846 143282 64277577
Oropharyngeal pain 95.11 13.87 279 77594 88588 64332271
Delivery 93.66 13.87 32 77841 501 64420358
Respiratory failure 93.07 13.87 39 77834 161144 64259715
Cardiac failure 92.36 13.87 23 77850 132350 64288509
Arthropathy 90.47 13.87 18 77855 120949 64299910
Treatment failure 90.32 13.87 16 77857 116800 64304059
Interstitial lung disease 88.55 13.87 8 77865 97724 64323135
Cardiac arrest 86.22 13.87 39 77834 154025 64266834
Abortion spontaneous 85.18 13.87 127 77746 25016 64395843
Diarrhoea 83.17 13.87 522 77351 722182 63698677
Hyperkalaemia 82.34 13.87 12 77861 101117 64319742
International normalised ratio increased 82.25 13.87 3 77870 79164 64341695
Cystoid macular oedema 82.18 13.87 41 77832 1733 64419126
Meningitis cryptococcal 82.13 13.87 49 77824 2960 64417899
Stress 80.67 13.87 206 77667 60328 64360531
Injection site pain 80.39 13.87 18 77855 111390 64309469
Temperature intolerance 80.37 13.87 72 77801 8183 64412676
Septic shock 80.30 13.87 15 77858 105422 64315437
Expanded disability status scale 80.09 13.87 14 77859 0 64420859
Palpitations 79.39 13.87 292 77581 104196 64316663
Cardio-respiratory arrest 79.36 13.87 12 77861 98381 64322478
Dehydration 77.99 13.87 88 77785 216675 64204184
Multiple organ dysfunction syndrome 76.02 13.87 15 77858 101398 64319461
Dysplastic naevus 75.75 13.87 27 77846 482 64420377
Hypoglycaemia 74.75 13.87 10 77863 89882 64330977
Stomatitis 74.62 13.87 20 77853 109585 64311274
Disease progression 74.51 13.87 39 77834 141641 64279218
Cafe au lait spots 74.37 13.87 13 77860 0 64420859
Rash 73.99 13.87 294 77579 458255 63962604
Haemangioma 73.63 13.87 42 77831 2332 64418527
Demyelination 73.34 13.87 63 77810 6771 64414088
Drug monitoring procedure not performed 73.26 13.87 30 77843 792 64420067
Maternal exposure before pregnancy 73.09 13.87 48 77825 3435 64417424
Neutrophil count increased 72.50 13.87 118 77755 25056 64395803
Vomiting 72.48 13.87 381 77492 550736 63870123
Systemic lupus erythematosus 71.26 13.87 6 77867 77606 64343253
Leukopenia 71.18 13.87 276 77597 100966 64319893
Oxygen saturation decreased 70.29 13.87 21 77852 107155 64313704
Therapeutic product effect incomplete 70.23 13.87 19 77854 103463 64317396
Rhabdomyolysis 69.96 13.87 13 77860 91713 64329146
Visual field defect 69.50 13.87 66 77807 8080 64412779
Pain in extremity 69.07 13.87 612 77261 302473 64118386
Hypokalaemia 67.98 13.87 31 77842 121872 64298987
Magnetic resonance imaging abnormal 67.89 13.87 44 77829 3079 64417780
Intentional product use issue 67.63 13.87 16 77857 95348 64325511
Overdose 67.58 13.87 56 77817 159510 64261349
Cryptococcal cutaneous infection 67.35 13.87 19 77854 150 64420709
Blood pressure decreased 67.25 13.87 243 77630 85956 64334903
Neutropenia 66.58 13.87 117 77756 239507 64181352
General physical health deterioration 66.18 13.87 90 77783 204335 64216524
White matter lesion 65.91 13.87 35 77838 1687 64419172
Cervical dysplasia 65.49 13.87 36 77837 1860 64418999
Aphasia 64.98 13.87 149 77724 40757 64380102
Skin lesion 64.85 13.87 139 77734 36343 64384516
Depressed mood 64.73 13.87 149 77724 40863 64379996
Gait spastic 64.31 13.87 28 77845 864 64419995
Dysaesthesia 63.93 13.87 51 77822 4944 64415915
CD8 lymphocytes decreased 63.25 13.87 20 77853 242 64420617
Hand deformity 63.13 13.87 3 77870 62768 64358091
Feeling abnormal 62.75 13.87 323 77550 133279 64287580
Dysarthria 61.15 13.87 184 77689 59222 64361637
Intentional product misuse 60.21 13.87 8 77865 72287 64348572
Neuropathy peripheral 59.39 13.87 34 77839 117491 64303368
Pleural effusion 59.27 13.87 40 77833 126519 64294340
CD4/CD8 ratio decreased 59.16 13.87 13 77860 29 64420830
Muscle tightness 59.06 13.87 70 77803 11045 64409814
Hospitalisation 58.78 13.87 10 77863 75197 64345662
Ocular discomfort 58.07 13.87 44 77829 3955 64416904
Product use in unapproved indication 57.93 13.87 77 77796 176541 64244318
Swelling 57.66 13.87 65 77808 160153 64260706
Decreased vibratory sense 57.48 13.87 23 77850 571 64420288
Wrong technique in product usage process 57.06 13.87 6 77867 64968 64355891
Extensor plantar response 56.26 13.87 31 77842 1609 64419250
Actinic keratosis 56.21 13.87 48 77825 5117 64415742
Dizziness postural 56.14 13.87 64 77809 9688 64411171
Lactic acidosis 55.69 13.87 5 77868 61405 64359454
Peripheral swelling 55.52 13.87 105 77768 209048 64211811
Neurogenic bladder 55.18 13.87 41 77832 3578 64417281
Invasive ductal breast carcinoma 55.16 13.87 47 77826 4995 64415864
Hypoxia 54.74 13.87 19 77854 88130 64332729
Blood creatinine increased 54.65 13.87 50 77823 135732 64285127
Chronic kidney disease 54.51 13.87 4 77869 57915 64362944
Mucosal inflammation 54.39 13.87 6 77867 62578 64358281
Metabolic acidosis 54.23 13.87 10 77863 70948 64349911
Upper respiratory tract infection 54.09 13.87 202 77671 72583 64348276
Injection site erythema 54.06 13.87 10 77863 70790 64350069
Chest discomfort 54.03 13.87 280 77593 115826 64305033
Deep vein thrombosis 53.77 13.87 30 77843 105152 64315707
Intentional overdose 53.14 13.87 21 77852 89923 64330936
Atrial fibrillation 52.71 13.87 78 77795 171011 64249848
Pulmonary oedema 52.34 13.87 15 77858 78659 64342200
Bladder dysfunction 52.21 13.87 25 77848 965 64419894
Hemianaesthesia 52.02 13.87 20 77853 445 64420414
Pulmonary embolism 51.98 13.87 60 77813 146296 64274563
Lymphocyte count abnormal 51.86 13.87 24 77849 857 64420002
Neutrophil percentage increased 51.86 13.87 43 77830 4402 64416457
Loss of personal independence in daily activities 51.68 13.87 12 77861 72442 64348417
Band sensation 51.51 13.87 22 77851 647 64420212
Clumsiness 51.45 13.87 35 77838 2656 64418203
Motor dysfunction 51.37 13.87 66 77807 11307 64409552
Progressive multiple sclerosis 50.99 13.87 23 77850 773 64420086
Hypersensitivity 50.94 13.87 100 77773 196352 64224507
Aspartate aminotransferase decreased 50.37 13.87 24 77849 916 64419943
Cervix carcinoma 50.20 13.87 30 77843 1818 64419041
Optic atrophy 49.81 13.87 29 77844 1674 64419185
Glossodynia 49.69 13.87 9 77864 64687 64356172
Ascites 49.00 13.87 8 77865 61993 64358866
Acrochordon 48.86 13.87 23 77850 854 64420005
Molluscum contagiosum 48.76 13.87 19 77854 439 64420420
Monocyte percentage increased 48.01 13.87 30 77843 1970 64418889
JC polyomavirus test 47.47 13.87 11 77862 34 64420825
Eosinophil count decreased 47.19 13.87 33 77840 2619 64418240
Melaena 46.88 13.87 5 77868 53543 64367316
Basophil count decreased 46.32 13.87 15 77858 197 64420662
Respiratory arrest 46.25 13.87 5 77868 52980 64367879
Platelet count decreased 45.56 13.87 83 77790 167628 64253231
Hepatic enzyme increased 45.16 13.87 290 77583 129653 64291206
Pollakiuria 44.82 13.87 110 77763 31420 64389439
Delirium 44.57 13.87 14 77859 69180 64351679
Blepharospasm 44.35 13.87 35 77838 3340 64417519
Anogenital warts 44.33 13.87 21 77852 791 64420068
Electrocardiogram PR prolongation 44.26 13.87 25 77848 1362 64419497
Anaphylactic reaction 44.03 13.87 14 77859 68650 64352209
Peroneal nerve palsy 43.29 13.87 42 77831 5279 64415580
Coordination abnormal 42.89 13.87 70 77803 14894 64405965
Pruritus 42.64 13.87 213 77660 312187 64108672
Speech disorder 42.49 13.87 142 77731 48299 64372560
Papule 42.32 13.87 45 77828 6305 64414554
Skin papilloma 42.20 13.87 41 77832 5162 64415697
Anxiety 41.94 13.87 401 77472 202248 64218611
Post herpetic neuralgia 41.76 13.87 29 77844 2276 64418583
Infection 41.43 13.87 102 77771 184778 64236081
Neuralgia 41.17 13.87 95 77778 26089 64394770
Neck pain 41.01 13.87 165 77708 61368 64359491
Influenza like illness 40.76 13.87 165 77708 61537 64359322
Dyspnoea 40.72 13.87 617 77256 718057 63702802
Bone marrow failure 40.67 13.87 5 77868 47947 64372912
Burning sensation 40.43 13.87 142 77731 49522 64371337
Exposure during pregnancy 39.92 13.87 22 77851 77653 64343206
Decreased immune responsiveness 39.79 13.87 37 77836 4411 64416448
Chronic obstructive pulmonary disease 39.70 13.87 18 77855 71030 64349829
Photophobia 39.27 13.87 73 77800 17220 64403639
Liver function test increased 38.79 13.87 103 77770 30867 64389992
Pneumonitis 38.69 13.87 7 77866 50358 64370501
Vitreous floaters 38.69 13.87 43 77830 6330 64414529
Injection site swelling 38.51 13.87 3 77870 41350 64379509
Epilepsy 38.49 13.87 108 77765 33423 64387436
Nystagmus 38.43 13.87 51 77822 9017 64411842
Sebaceous hyperplasia 38.40 13.87 10 77863 56 64420803
Cryptococcal meningoencephalitis 38.32 13.87 13 77860 199 64420660
Medication error 38.27 13.87 7 77866 49959 64370900
CSF protein increased 38.22 13.87 21 77852 1084 64419775
Treatment noncompliance 38.22 13.87 4 77869 43478 64377381
Pleocytosis 38.18 13.87 21 77852 1086 64419773
Coma 38.01 13.87 30 77843 87585 64333274
Rubella antibody positive 37.96 13.87 10 77863 59 64420800
Hepatic failure 37.90 13.87 10 77863 55384 64365475
Immunodeficiency 37.79 13.87 69 77804 16055 64404804
T-lymphocyte count decreased 37.45 13.87 16 77857 471 64420388
Rash maculo-papular 37.31 13.87 6 77867 47020 64373839
Milia 37.25 13.87 9 77864 35 64420824
Influenza 37.16 13.87 238 77635 106293 64314566
Alanine aminotransferase decreased 37.16 13.87 22 77851 1310 64419549
Retinal cyst 36.77 13.87 11 77862 109 64420750
Incontinence 36.66 13.87 58 77815 12023 64408836
Hypocalcaemia 36.29 13.87 4 77869 41749 64379110
Menstruation irregular 36.07 13.87 35 77838 4400 64416459
Wound 36.03 13.87 24 77849 76453 64344406
Amnesia 35.89 13.87 134 77739 48135 64372724
Coronary artery disease 35.87 13.87 14 77859 60419 64360440
Oedema 35.64 13.87 35 77838 91900 64328959
Angioedema 35.59 13.87 15 77858 61806 64359053
Psoriatic arthropathy 35.54 13.87 5 77868 43276 64377583
Fall 35.50 13.87 703 77170 416123 64004736
Pulmonary hypertension 35.38 13.87 5 77868 43134 64377725
Blood brain barrier defect 35.26 13.87 11 77862 127 64420732
Papilloma viral infection 35.24 13.87 22 77851 1442 64419417
Gamma-glutamyltransferase decreased 35.05 13.87 14 77859 346 64420513
Hypervolaemia 35.03 13.87 3 77870 38282 64382577
Shock 34.98 13.87 3 77870 38237 64382622
Decreased appetite 34.92 13.87 198 77675 281091 64139768
Superficial spreading melanoma stage unspecified 34.56 13.87 13 77860 272 64420587
Injection site pruritus 34.51 13.87 3 77870 37823 64383036
Breast mass 34.27 13.87 37 77836 5273 64415586
Colitis 34.16 13.87 14 77859 58660 64362199
Plasma cell myeloma 34.14 13.87 7 77866 46068 64374791
Disturbance in attention 33.91 13.87 118 77755 40956 64379903
Dysmetria 33.70 13.87 18 77855 878 64419981
Hyperglycaemia 33.21 13.87 16 77857 60952 64359907
Progressive relapsing multiple sclerosis 32.93 13.87 8 77865 32 64420827
Therapeutic response decreased 32.83 13.87 11 77862 52177 64368682
Erythema 32.64 13.87 116 77757 186954 64233905
Oral herpes 32.25 13.87 78 77795 22074 64398785
Haematocrit increased 32.21 13.87 29 77844 3316 64417543
Haemorrhage 32.18 13.87 29 77844 79322 64341537
Thrombosis 32.17 13.87 23 77850 70619 64350240
Electrocardiogram abnormal 31.99 13.87 58 77815 13423 64407436
Therapy non-responder 31.97 13.87 20 77853 65879 64354980
Presbyopia 31.92 13.87 15 77858 555 64420304
Ophthalmic herpes zoster 31.64 13.87 24 77849 2160 64418699
Neuromyelitis optica spectrum disorder 31.62 13.87 17 77856 840 64420019
Haemoptysis 31.45 13.87 10 77863 49038 64371821
Neoplasm skin 31.40 13.87 19 77854 1178 64419681
Haematemesis 31.19 13.87 9 77864 46990 64373869
Haematochezia 31.04 13.87 21 77852 66352 64354507
Urticaria 30.90 13.87 84 77789 147233 64273626
Quadriplegia 30.76 13.87 27 77846 2986 64417873
Tinea pedis 30.64 13.87 23 77850 2038 64418821
Extrasystoles 30.64 13.87 39 77834 6619 64414240
Hemiplegia 30.38 13.87 55 77818 12713 64408146
Sinus arrhythmia 30.35 13.87 22 77851 1848 64419011
Injection site bruising 30.34 13.87 4 77869 36369 64384490
Decreased interest 30.15 13.87 28 77845 3332 64417527
Monocyte count decreased 29.97 13.87 26 77847 2831 64418028
Keratosis pilaris 29.84 13.87 8 77865 51 64420808
Rectal haemorrhage 29.66 13.87 19 77854 61798 64359061
Refraction disorder 29.58 13.87 8 77865 53 64420806
Benign neoplasm of skin 29.49 13.87 9 77864 96 64420763
Unevaluable event 29.47 13.87 12 77861 50477 64370382
Tinea versicolour 29.26 13.87 12 77861 318 64420541
Ophthalmoplegia 29.18 13.87 25 77848 2677 64418182
CSF measles antibody positive 29.07 13.87 8 77865 57 64420802
Fluid retention 29.04 13.87 18 77855 59588 64361271
Blood bilirubin increased 29.01 13.87 142 77731 57411 64363448
Photopsia 28.95 13.87 32 77841 4682 64416177
Macular pigmentation 28.84 13.87 6 77867 9 64420850
Malignant melanoma in situ 28.60 13.87 21 77852 1799 64419060
Nasopharyngitis 28.58 13.87 362 77511 195711 64225148
Cerebrovascular accident 28.45 13.87 79 77794 137504 64283355
Human papilloma virus test positive 28.41 13.87 13 77860 452 64420407
Blindness 28.36 13.87 74 77799 21945 64398914
Non-cardiac chest pain 28.19 13.87 43 77830 8637 64412222
Protein total decreased 28.19 13.87 41 77832 7895 64412964
Respiratory distress 28.10 13.87 14 77859 52317 64368542
Hypokinesia 28.08 13.87 62 77811 16534 64404325
Anti-thyroid antibody positive 27.97 13.87 13 77860 469 64420390
Cerebral atrophy 27.89 13.87 39 77834 7246 64413613
Hallucination 27.88 13.87 28 77845 72760 64348099
Intraductal proliferative breast lesion 27.61 13.87 22 77851 2129 64418730
Urge incontinence 27.54 13.87 16 77857 920 64419939
Dyspnoea exertional 27.52 13.87 29 77844 73701 64347158
Herpes zoster cutaneous disseminated 27.48 13.87 12 77861 373 64420486
Metamorphopsia 27.22 13.87 17 77856 1115 64419744
Acne 27.14 13.87 75 77798 23006 64397853
Blindness transient 27.09 13.87 29 77844 4093 64416766
Hypomagnesaemia 27.03 13.87 6 77867 37370 64383489
Arthritis 26.99 13.87 37 77836 83777 64337082
Facial pain 26.91 13.87 40 77833 7855 64413004
Tubulointerstitial nephritis 26.76 13.87 3 77870 30906 64389953
Asthenopia 26.41 13.87 21 77852 2026 64418833
Pericarditis 26.38 13.87 22 77851 62494 64358365
Eye naevus 26.28 13.87 6 77867 17 64420842
Adverse drug reaction 26.22 13.87 11 77862 45453 64375406
Anaphylactic shock 26.12 13.87 3 77870 30325 64390534
Oedema peripheral 26.10 13.87 148 77725 210169 64210690
Macular cyst 25.93 13.87 7 77866 46 64420813
Drug eruption 25.73 13.87 6 77867 36130 64384729
Genital herpes 25.65 13.87 20 77853 1875 64418984
Diabetic ketoacidosis 25.58 13.87 3 77870 29842 64391017
Monoparesis 25.46 13.87 24 77849 2910 64417949
Immune thrombocytopenia 25.17 13.87 56 77817 15010 64405849
Hypoglossal nerve paralysis 25.11 13.87 6 77867 22 64420837
Vaginal dysplasia 25.11 13.87 6 77867 22 64420837
Acute respiratory distress syndrome 24.85 13.87 8 77865 38927 64381932
Rash erythematous 24.66 13.87 14 77859 48619 64372240
Drug ineffective for unapproved indication 24.63 13.87 4 77869 31129 64389730
Electrocardiogram PR shortened 24.49 13.87 10 77863 262 64420597
Helicobacter infection 24.28 13.87 8 77865 38354 64382505
Rosacea 24.20 13.87 25 77848 3388 64417471
Agranulocytosis 24.15 13.87 8 77865 38221 64382638
Blood pressure increased 24.06 13.87 316 77557 172236 64248623
Eosinophilia 23.99 13.87 8 77865 38068 64382791
Sedation 23.96 13.87 10 77863 41452 64379407
Disseminated intravascular coagulation 23.79 13.87 5 77868 32343 64388516
Surgery 23.78 13.87 3 77870 28210 64392649
Hypophagia 23.78 13.87 9 77864 39578 64381281
Epistaxis 23.69 13.87 52 77821 98079 64322780
Romberg test positive 23.42 13.87 9 77864 200 64420659
Myocardial infarction 23.20 13.87 112 77761 165709 64255150
Macular fibrosis 23.14 13.87 13 77860 701 64420158
Acute respiratory failure 23.08 13.87 16 77857 49918 64370941
Muscle strain 23.04 13.87 38 77835 8156 64412703
Postmature baby 22.88 13.87 4 77869 0 64420859
Anti-JC virus antibody index 22.88 13.87 4 77869 0 64420859
Expanded disability status scale score decreased 22.88 13.87 4 77869 0 64420859
Agitation 22.87 13.87 45 77828 88322 64332537
Injection site reaction 22.86 13.87 14 77859 46650 64374209
Diabetes mellitus 22.79 13.87 28 77845 66446 64354413
Haemoglobin decreased 22.75 13.87 140 77733 194923 64225936
Hyperreflexia 22.64 13.87 35 77838 7113 64413746
Tension headache 22.59 13.87 24 77849 3359 64417500
Squamous cell carcinoma 22.55 13.87 51 77822 13818 64407041
Knee arthroplasty 22.45 13.87 3 77870 26996 64393863
C-reactive protein abnormal 22.39 13.87 4 77869 29043 64391816
Depressed level of consciousness 22.37 13.87 40 77833 81396 64339463
Retinal disorder 22.27 13.87 18 77855 1778 64419081
Quadriparesis 22.21 13.87 22 77851 2835 64418024
Vitamin D decreased 22.09 13.87 36 77837 7651 64413208
Brain stem syndrome 22.07 13.87 13 77860 767 64420092
Partial seizures 22.06 13.87 35 77838 7272 64413587
Seborrhoeic dermatitis 22.00 13.87 18 77855 1808 64419051
Eye disorder 21.87 13.87 61 77812 18808 64402051
Urobilinogen urine increased 21.83 13.87 12 77861 620 64420239
Granulocyte count increased 21.38 13.87 13 77860 813 64420046
Maternal exposure timing unspecified 21.34 13.87 21 77852 2686 64418173
Dysstasia 21.20 13.87 69 77804 23146 64397713
Uterine leiomyoma 20.93 13.87 29 77844 5340 64415519
Squamous cell carcinoma of skin 20.81 13.87 45 77828 11831 64409028
Laryngeal papilloma 20.65 13.87 4 77869 3 64420856
Hypertonic bladder 20.64 13.87 23 77850 3395 64417464
Intestinal obstruction 20.57 13.87 9 77864 36277 64384582
Monoplegia 20.51 13.87 23 77850 3420 64417439
Bladder disorder 20.48 13.87 35 77838 7732 64413127
Incorrect dose administered 20.41 13.87 26 77847 60739 64360120
Hemianopia 20.31 13.87 16 77857 1523 64419336
Testicular seminoma (pure) stage I 20.20 13.87 5 77868 22 64420837
Mean cell haemoglobin increased 20.12 13.87 22 77851 3180 64417679
Device related infection 20.07 13.87 6 77867 30620 64390239
Blindness unilateral 19.88 13.87 32 77841 6729 64414130
Rash pruritic 19.87 13.87 24 77849 57380 64363479
Aggression 19.84 13.87 16 77857 46216 64374643
Dysdiadochokinesis 19.80 13.87 9 77864 308 64420551
Lower respiratory tract infection 19.80 13.87 54 77819 94560 64326299
Head discomfort 19.78 13.87 44 77829 11790 64409069
Coagulopathy 19.61 13.87 7 77866 31913 64388946
Product prescribing error 19.60 13.87 9 77864 35260 64385599
Anal incontinence 19.49 13.87 51 77822 15145 64405714
Pulmonary fibrosis 19.32 13.87 6 77867 29872 64390987
Thunderclap headache 19.30 13.87 8 77865 218 64420641
JC virus infection 19.28 13.87 22 77851 3333 64417526
Electrocardiogram T wave abnormal 19.28 13.87 22 77851 3334 64417525
Product quality issue 19.24 13.87 6 77867 29793 64391066
Birth mark 19.22 13.87 4 77869 6 64420853
Hypercalcaemia 19.11 13.87 7 77866 31409 64389450
Maculopathy 19 13.87 19 77854 2477 64418382
Encephalopathy 18.90 13.87 26 77847 58793 64362066
Lymphogranuloma venereum 18.84 13.87 4 77869 7 64420852
Prosopagnosia 18.77 13.87 5 77868 31 64420828
Migraine with aura 18.34 13.87 18 77855 2294 64418565
Obstructive airways disorder 18.30 13.87 3 77870 23182 64397677
Herpes zoster meningoencephalitis 18.22 13.87 11 77862 679 64420180
Carcinoma in situ 18.18 13.87 6 77867 84 64420775
Paralysis 18.15 13.87 42 77831 11553 64409306
Cerebral haemorrhage 18.07 13.87 21 77852 51069 64369790
Ill-defined disorder 17.98 13.87 16 77857 44036 64376823
Skin ulcer 17.91 13.87 16 77857 43958 64376901
Relapsing-remitting multiple sclerosis 17.90 13.87 13 77860 1095 64419764
Ligament sprain 17.75 13.87 40 77833 10812 64410047
Fear-related avoidance of activities 17.74 13.87 6 77867 91 64420768
Melanocytic hyperplasia 17.61 13.87 4 77869 11 64420848
Subdural haematoma 17.49 13.87 6 77867 28048 64392811
Asthenia 17.38 13.87 656 77217 427388 63993471
Tremor 17.26 13.87 263 77610 147967 64272892
Impaired healing 17.25 13.87 29 77844 60444 64360415
Product administration error 17.08 13.87 6 77867 27637 64393222
Dysgraphia 17.04 13.87 21 77852 3450 64417409
Osteomyelitis 17.03 13.87 6 77867 27581 64393278
Heavy menstrual bleeding 17.02 13.87 42 77831 12035 64408824
Pancreatitis acute 16.97 13.87 16 77857 42839 64378020
Cardiogenic shock 16.93 13.87 9 77864 32418 64388441
Vibration test abnormal 16.88 13.87 4 77869 14 64420845
Glioblastoma 16.77 13.87 14 77859 1447 64419412
Orthostatic hypotension 16.76 13.87 19 77854 46719 64374140
Abnormal sensation in eye 16.69 13.87 15 77858 1712 64419147
Varicella zoster virus infection 16.68 13.87 22 77851 3866 64416993
Cerebellar syndrome 16.50 13.87 25 77848 4991 64415868
Unresponsive to stimuli 16.47 13.87 22 77851 50371 64370488
Myopia 16.46 13.87 15 77858 1743 64419116
High density lipoprotein decreased 16.42 13.87 22 77851 3924 64416935
Visual acuity tests abnormal 16.39 13.87 6 77867 116 64420743
Cellulitis 16.37 13.87 58 77815 93599 64327260
Invasive breast carcinoma 16.37 13.87 9 77864 465 64420394
Myoclonus 16.32 13.87 5 77868 25113 64395746
Swelling face 16.30 13.87 29 77844 59137 64361722
Hemiparaesthesia 16.16 13.87 6 77867 121 64420738
Hepatic encephalopathy 16.03 13.87 3 77870 21063 64399796
Diabetic retinal oedema 16.02 13.87 8 77865 339 64420520
Abdominal pain 15.99 13.87 273 77600 312102 64108757
Acute myocardial infarction 15.97 13.87 38 77835 69680 64351179
Facial spasm 15.93 13.87 10 77863 662 64420197
Myelitis 15.92 13.87 16 77857 2098 64418761
Muscle injury 15.90 13.87 6 77867 26431 64394428
Hepatic cirrhosis 15.76 13.87 6 77867 26292 64394567
Osteoarthritis 15.75 13.87 33 77840 63303 64357556
Restless legs syndrome 15.74 13.87 51 77822 17065 64403794
Psoriasis 15.70 13.87 40 77833 71663 64349196
Intention tremor 15.61 13.87 10 77863 686 64420173
Pneumothorax 15.49 13.87 5 77868 24293 64396566
Body temperature decreased 15.40 13.87 6 77867 25922 64394937
Myelodysplastic syndrome 15.39 13.87 7 77866 27572 64393287
Amenorrhoea 15.35 13.87 28 77845 6511 64414348
White blood cell count increased 15.34 13.87 134 77739 65880 64354979
Borderline glaucoma 15.13 13.87 4 77869 24 64420835
CSF immunoglobulin increased 15.13 13.87 4 77869 24 64420835
Macular hole 15.12 13.87 10 77863 724 64420135
Swollen tongue 15.12 13.87 12 77861 34942 64385917
Spinal cord injury cauda equina 15.11 13.87 6 77867 146 64420713
Renal artery dissection 15.09 13.87 3 77870 3 64420856
Haemorrhage intracranial 15.08 13.87 5 77868 23879 64396980
Trigeminal nerve disorder 15.07 13.87 6 77867 147 64420712
Herpes zoster infection neurological 14.99 13.87 6 77867 149 64420710
Eye movement disorder 14.98 13.87 29 77844 7050 64413809
Drug dependence 14.96 13.87 11 77862 33301 64387558
Leiomyosarcoma 14.89 13.87 7 77866 259 64420600
Vitamin B12 deficiency 14.88 13.87 25 77848 5447 64415412
Localised infection 14.84 13.87 9 77864 30152 64390707
Cardiomyopathy 14.84 13.87 6 77867 25350 64395509
Small intestinal obstruction 14.77 13.87 5 77868 23568 64397291
Hemianopia homonymous 14.74 13.87 12 77861 1197 64419662
Extra dose administered 14.71 13.87 28 77845 6722 64414137
Asthma 14.70 13.87 62 77811 95163 64325696
Cystitis 14.66 13.87 95 77778 42580 64378279
Hypoaesthesia eye 14.48 13.87 5 77868 81 64420778
Vertigo CNS origin 14.36 13.87 4 77869 30 64420829
Ulcer 14.19 13.87 5 77868 22985 64397874
Ileus 14.17 13.87 5 77868 22961 64397898
Macule 14.10 13.87 16 77857 2410 64418449
Hepatitis E 14.07 13.87 16 77857 2415 64418444
Anxiety disorder 14.02 13.87 20 77853 3785 64417074
Autoimmune hypothyroidism 14.00 13.87 6 77867 178 64420681
Acute hepatic failure 14.00 13.87 7 77866 26105 64394754
Strabismus 13.98 13.87 15 77858 2122 64418737
Organic brain syndrome 13.93 13.87 8 77865 450 64420409
Somatosensory evoked potentials abnormal 13.91 13.87 6 77867 181 64420678
Anti-actin antibody positive 13.87 13.87 3 77870 6 64420853

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 (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)

None

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
C1699926 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
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 32 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0607 CAPSULE 0.50 mg ORAL NDA 32 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 32 sections
Gilenya HUMAN PRESCRIPTION DRUG LABEL 1 0078-0965 CAPSULE 0.25 mg ORAL NDA 32 sections
FINGOLIMOD HUMAN PRESCRIPTION DRUG LABEL 1 64380-776 CAPSULE 0.50 mg ORAL ANDA 27 sections