fampridine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
4163 504-24-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fampyra
  • dalfampridine
  • ampyra
  • pyridin-4-amine
  • 4-aminopyridine
  • fampridine
One of the POTASSIUM CHANNEL BLOCKERS with secondary effect on calcium currents which is used mainly as a research tool and to characterize channel subtypes.
  • Molecular weight: 94.12
  • Formula: C5H6N2
  • CLOGP: 0.32
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 38.91
  • ALOGS: 0.46
  • ROTB: 0

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 90.30 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.04 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 2.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.60 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 112 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR1B,ACVR2A,ACVR2B,AKT3,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK1,GRK2,GRK3,GSK3B,ITK,JAK1,JAK2,MAP2K6,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK12,MAPK7,MAPK9,MARK4,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 55
kinase-selectivity-class ACVR1B,ACVR2A,ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK9,DDR1,DYRK1B,ERBB2,ERBB4,GRK2,MAP2K6,MAP3K21,MAPK7,MARK4,PRKCD,PRKDC,SIK2,SIK3,STK33,TEK,TTK,ULK1 25
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Jan. 22, 2010 FDA ACORDA

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 2329.97 14.56 883 40866 51422 90535276
Urinary tract infection 1704.15 14.56 1281 40468 304351 90282347
Laboratory test abnormal 957.59 14.56 440 41309 41414 90545284
Balance disorder 888.11 14.56 554 41195 96526 90490172
Multiple sclerosis 861.47 14.56 362 41387 27478 90559220
Fall 827.85 14.56 1060 40689 480750 90105948
Gait disturbance 653.24 14.56 697 41052 259799 90326899
Urine analysis abnormal 647.40 14.56 191 41558 5030 90581668
Therapy cessation 563.17 14.56 293 41456 36068 90550630
Seizure 440.70 14.56 441 41308 152188 90434510
Muscular weakness 375.75 14.56 469 41280 206197 90380501
Peroneal nerve palsy 273.19 14.56 102 41647 5646 90581052
Escherichia urinary tract infection 238.94 14.56 120 41629 13695 90573003
Muscle spasticity 231.45 14.56 164 41585 35158 90551540
Lymphocyte count decreased 223.35 14.56 160 41589 34890 90551808
Central nervous system lesion 203.88 14.56 102 41647 11544 90575154
Insomnia 192.67 14.56 454 41295 333020 90253678
Flushing 186.98 14.56 217 41532 88274 90498424
Secondary progressive multiple sclerosis 175.06 14.56 53 41696 1526 90585172
Dizziness 165.82 14.56 621 41128 588663 89998035
B-lymphocyte count decreased 161.54 14.56 49 41700 1420 90585278
Drug ineffective 152.50 14.56 1122 40627 1383176 89203522
Off label use 152.03 14.56 171 41578 1102081 89484617
Systemic lupus erythematosus 151.98 14.56 3 41746 361893 90224805
Therapeutic response unexpected 151.25 14.56 105 41644 21775 90564923
Asthenia 148.84 14.56 561 41188 533190 90053508
Lymphopenia 147.02 14.56 105 41644 22776 90563922
Culture urine positive 146.45 14.56 58 41691 3767 90582931
Urinary incontinence 143.58 14.56 127 41622 37439 90549259
Rheumatoid arthritis 141.40 14.56 6 41743 362608 90224090
Micturition urgency 136.14 14.56 77 41672 11156 90575542
Urine leukocyte esterase positive 129.98 14.56 51 41698 3231 90583467
Pollakiuria 126.97 14.56 112 41637 32893 90553805
Hand deformity 122.28 14.56 3 41746 296359 90290339
Product substitution issue 121.16 14.56 85 41664 17923 90568775
Glossodynia 120.10 14.56 7 41742 321772 90264926
Head injury 118.31 14.56 105 41644 31083 90555615
JC polyomavirus test positive 115.85 14.56 40 41709 1762 90584936
Trigeminal neuralgia 115.36 14.56 50 41699 4081 90582617
Pericarditis 110.45 14.56 3 41746 270148 90316550
Joint swelling 107.09 14.56 49 41700 503251 90083447
Inappropriate schedule of product administration 101.90 14.56 218 41531 149715 90436983
Wound 100.82 14.56 11 41738 302969 90283729
Memory impairment 99.33 14.56 255 41494 196989 90389709
Dysstasia 96.33 14.56 85 41664 24967 90561731
Paraesthesia 94.98 14.56 292 41457 250034 90336664
Neurogenic bladder 94.55 14.56 42 41707 3636 90583062
Infusion related reaction 94.36 14.56 37 41712 416743 90169955
Psoriatic arthropathy 91.64 14.56 3 41746 228332 90358366
Influenza like illness 88.43 14.56 144 41605 80467 90506231
Progressive multiple sclerosis 88.16 14.56 30 41719 1264 90585434
Hypoaesthesia 87.95 14.56 331 41418 313879 90272819
Toxicity to various agents 87.29 14.56 14 41735 287832 90298866
Bladder disorder 87.14 14.56 57 41692 10715 90575983
Exposure during pregnancy 86.51 14.56 6 41743 238404 90348294
Lower respiratory tract infection 86.25 14.56 8 41741 250651 90336047
Feeling abnormal 86.04 14.56 218 41531 167017 90419681
Dyspnoea 85.12 14.56 174 41575 880781 89705917
Product use issue 83.88 14.56 24 41725 329895 90256803
Maternal exposure during pregnancy 81.43 14.56 32 41717 360031 90226667
Folliculitis 80.90 14.56 3 41746 204350 90382348
Arthropathy 78.88 14.56 35 41714 366207 90220491
Depression 78.65 14.56 310 41439 300291 90286407
CD4 lymphocytes increased 76.26 14.56 18 41731 191 90586507
T-lymphocyte count decreased 76.19 14.56 20 41729 337 90586361
Stomatitis 75.56 14.56 17 41732 274681 90312017
Contraindicated product administered 74.81 14.56 27 41722 320112 90266586
Gait inability 73.34 14.56 189 41560 146267 90440431
Dysgraphia 72.65 14.56 35 41714 3648 90583050
T-lymphocyte count increased 71.94 14.56 18 41731 248 90586450
CD4 lymphocytes decreased 71.86 14.56 27 41722 1520 90585178
Tremor 70.93 14.56 192 41557 152981 90433717
Red blood cells urine positive 70.82 14.56 33 41716 3192 90583506
Loss of control of legs 69.88 14.56 26 41723 1424 90585274
COVID-19 69.71 14.56 203 41546 168640 90418058
Movement disorder 67.76 14.56 75 41674 28944 90557754
Blister 67.73 14.56 17 41732 254981 90331717
Motor dysfunction 67.53 14.56 62 41687 19168 90567530
Fibromyalgia 67.31 14.56 8 41741 206261 90380437
Product dose omission issue 66.98 14.56 289 41460 291398 90295300
Type 2 diabetes mellitus 66.04 14.56 8 41741 203236 90383462
Swelling 65.52 14.56 58 41691 419000 90167698
Gait spastic 64.40 14.56 17 41732 293 90586405
White blood cells urine positive 64.13 14.56 39 41710 6459 90580239
Burning sensation 63.77 14.56 109 41640 63343 90523355
Product use in unapproved indication 63.66 14.56 38 41711 336198 90250500
Temperature intolerance 63.36 14.56 49 41700 11981 90574717
Sinusitis 63.25 14.56 40 41709 343048 90243650
Arthralgia 62.91 14.56 169 41580 778353 89808345
Treatment failure 62.41 14.56 31 41718 303897 90282801
Hemiparesis 62.14 14.56 75 41674 31744 90554954
Anaemia 61.20 14.56 44 41705 352758 90233940
Ataxia 61.09 14.56 57 41692 17985 90568713
Wheezing 61.08 14.56 17 41732 238063 90348635
Ankle fracture 60.74 14.56 60 41689 20310 90566388
Primary progressive multiple sclerosis 58.93 14.56 13 41736 99 90586599
Optic neuritis 58.93 14.56 43 41706 9635 90577063
Dysuria 58.35 14.56 81 41668 39320 90547378
Progressive multifocal leukoencephalopathy 57.96 14.56 52 41697 15603 90571095
Impaired healing 57.75 14.56 18 41731 234181 90352517
Irritable bowel syndrome 56.71 14.56 13 41736 207435 90379263
CD8 lymphocytes decreased 55.48 14.56 14 41735 200 90586498
Generalised tonic-clonic seizure 53.57 14.56 73 41676 34830 90551868
Urine abnormality 53.16 14.56 37 41712 7700 90578998
Weight increased 52.91 14.56 69 41680 417858 90168840
Rash 52.83 14.56 189 41560 795911 89790787
Invasive ductal breast carcinoma 52.81 14.56 37 41712 7781 90578917
Haemoglobin urine present 52.77 14.56 18 41731 764 90585934
Drug intolerance 52.56 14.56 78 41671 447513 90139185
Musculoskeletal disorder 52.10 14.56 57 41692 21712 90564986
Febrile neutropenia 52.01 14.56 6 41743 158343 90428355
Hepatic enzyme increased 51.63 14.56 54 41695 360682 90226016
Completed suicide 51.61 14.56 4 41745 145054 90441644
Status epilepticus 51.52 14.56 53 41696 18821 90567877
Fatigue 51.01 14.56 779 40970 1153244 89433454
General physical health deterioration 51.00 14.56 53 41696 355062 90231636
Magnetic resonance imaging abnormal 50.81 14.56 27 41722 3459 90583239
Lymphocyte count abnormal 50.59 14.56 18 41731 867 90585831
Breast cancer 49.66 14.56 89 41660 53672 90533026
Acute kidney injury 49.27 14.56 45 41704 320342 90266356
Asthma 49.25 14.56 25 41724 242135 90344563
Injury 48.95 14.56 15 41734 197334 90389364
Escherichia test positive 48.54 14.56 24 41725 2646 90584052
Neutropenia 47.60 14.56 22 41727 224882 90361816
Hip fracture 47.49 14.56 67 41682 33010 90553688
Cystitis 46.43 14.56 98 41651 66620 90520078
Hypokinesia 46.36 14.56 46 41703 15651 90571047
Cognitive disorder 46.06 14.56 100 41649 69307 90517391
Relapsing-remitting multiple sclerosis 44.72 14.56 16 41733 783 90585915
Back pain 44.59 14.56 274 41475 316901 90269797
Muscle spasms 44.25 14.56 231 41518 251652 90335046
Urine odour abnormal 43.69 14.56 32 41717 7212 90579486
Nitrite urine present 43.55 14.56 17 41732 1062 90585636
Inflammation 43.53 14.56 14 41735 178578 90408120
Blood immunoglobulin M decreased 42.86 14.56 18 41731 1359 90585339
Speech disorder 42.79 14.56 76 41673 45509 90541189
Muscle tightness 42.72 14.56 41 41708 13398 90573300
Mobility decreased 42.03 14.56 227 41522 250507 90336191
Urinary tract infection pseudomonal 41.89 14.56 16 41733 942 90585756
Stress 41.71 14.56 106 41643 81289 90505409
Sensory disturbance 39.77 14.56 42 41707 15371 90571327
Wheelchair user 39.46 14.56 31 41718 7754 90578944
Discomfort 39.31 14.56 41 41708 274294 90312404
Extra dose administered 39.24 14.56 33 41716 9085 90577613
Incontinence 38.99 14.56 39 41710 13396 90573302
Intentional product use issue 38.98 14.56 26 41723 216866 90369832
Therapy interrupted 38.88 14.56 77 41672 50031 90536667
Drug hypersensitivity 38.61 14.56 99 41650 463510 90123188
Bursitis 38.57 14.56 7 41742 131647 90455051
Pulmonary fibrosis 38.14 14.56 3 41746 107500 90479198
Lymphocyte percentage decreased 36.72 14.56 21 41728 3106 90583592
Urinary tract infection bacterial 36.19 14.56 27 41722 6258 90580440
Vomiting 35.71 14.56 215 41534 788078 89798620
Diplopia 35.21 14.56 54 41695 28660 90558038
Limb discomfort 35.14 14.56 63 41686 37997 90548701
Decreased appetite 34.86 14.56 76 41673 376464 90210234
Diarrhoea 34.72 14.56 272 41477 938918 89647780
Blood cholesterol increased 34.68 14.56 27 41722 207985 90378713
Oedema 34.68 14.56 25 41724 200270 90386428
Bacterial test positive 34.61 14.56 25 41724 5514 90581184
Dysarthria 34.45 14.56 77 41672 54405 90532293
Infection 34.42 14.56 72 41677 362022 90224676
Lung disorder 34.38 14.56 13 41736 149870 90436828
Acute disseminated encephalomyelitis 34.37 14.56 10 41739 250 90586448
Peripheral swelling 33.79 14.56 89 41660 413017 90173681
Abdominal pain 33.33 14.56 84 41665 395637 90191061
Urinary retention 32.97 14.56 61 41688 37683 90549015
Hypercholesterolaemia 32.69 14.56 4 41745 100888 90485810
Glycosylated haemoglobin increased 32.56 14.56 38 41711 15524 90571174
Paraparesis 32.55 14.56 19 41730 2919 90583779
Joint range of motion decreased 32.41 14.56 11 41738 135632 90451066
C-reactive protein increased 32.25 14.56 22 41727 181367 90405331
Vitamin B12 increased 31.97 14.56 16 41733 1810 90584888
Psoriasis 31.96 14.56 14 41735 147740 90438958
Pain 31.72 14.56 300 41449 996041 89590657
Immune reconstitution inflammatory syndrome 31.44 14.56 26 41723 6993 90579705
Hypersensitivity 30.71 14.56 107 41642 454570 90132128
Pancytopenia 30.07 14.56 9 41740 120254 90466444
Hypotension 29.84 14.56 66 41683 325331 90261367
Tongue biting 29.63 14.56 16 41733 2117 90584581
Urine ketone body present 29.59 14.56 17 41732 2535 90584163
Protein urine present 29.48 14.56 25 41724 6959 90579739
Headache 29.44 14.56 559 41190 862187 89724511
Pneumonia 29.41 14.56 173 41576 637886 89948812
Blood thyroid stimulating hormone decreased 29.40 14.56 23 41726 5717 90580981
Urinary sediment present 29.34 14.56 16 41733 2158 90584540
Therapeutic product effect incomplete 28.89 14.56 28 41721 193868 90392830
Vertigo 28.84 14.56 84 41665 69727 90516971
Adverse drug reaction 28.58 14.56 118 41631 116583 90470115
Rectal haemorrhage 27.51 14.56 3 41746 82741 90503957
Paralysis 27.37 14.56 30 41719 11448 90575250
Vitamin D deficiency 27.36 14.56 37 41712 17519 90569179
Invasive lobular breast carcinoma 27.25 14.56 12 41737 1017 90585681
White blood cell count decreased 27.11 14.56 150 41599 166959 90419739
Urinary tract infection enterococcal 26.97 14.56 17 41732 2999 90583699
Walking aid user 26.87 14.56 54 41695 35452 90551246
Assisted suicide 26.73 14.56 4 41745 0 90586698
B-lymphocyte count abnormal 26.66 14.56 7 41742 118 90586580
Wound infection 26.53 14.56 8 41741 106394 90480304
Urosepsis 26.13 14.56 40 41709 21192 90565506
Coordination abnormal 25.95 14.56 40 41709 21316 90565382
Thrombocytopenia 25.83 14.56 35 41714 208690 90378008
Decreased interest 25.52 14.56 19 41730 4388 90582310
Urge incontinence 25.31 14.56 12 41737 1207 90585491
Depressed mood 25.30 14.56 65 41684 50157 90536541
Pleural effusion 25.20 14.56 10 41739 111981 90474717
Prescribed overdose 24.97 14.56 7 41742 97618 90489080
Contraindicated product prescribed 24.88 14.56 13 41736 1609 90585089
Pyrexia 24.48 14.56 191 41558 660294 89926404
Gastrointestinal haemorrhage 23.98 14.56 6 41743 90242 90496456
Skin laceration 23.91 14.56 43 41706 25992 90560706
Hypertonic bladder 23.53 14.56 18 41731 4330 90582368
Peripheral venous disease 23.45 14.56 5 41744 83916 90502782
Lymphocyte percentage abnormal 23.16 14.56 5 41744 34 90586664
Bladder dysfunction 23.14 14.56 11 41738 1113 90585585
Cystitis klebsiella 22.15 14.56 7 41742 233 90586465
Neutrophil percentage increased 22.14 14.56 15 41734 2988 90583710
Osteoarthritis 22.08 14.56 35 41714 195695 90391003
Coronavirus infection 21.77 14.56 19 41730 5496 90581202
Product quality issue 21.61 14.56 5 41744 79320 90507378
Urinary tract infection staphylococcal 21.59 14.56 8 41741 433 90586265
Red blood cell count abnormal 21.53 14.56 11 41738 1300 90585398
Loss of consciousness 21.50 14.56 124 41625 140114 90446584
Urinary tract disorder 21.49 14.56 16 41733 3695 90583003
Vitamin D decreased 21.39 14.56 27 41722 11952 90574746
Vision blurred 21.34 14.56 104 41645 110189 90476509
Gastrointestinal disorder 21.20 14.56 55 41694 256632 90330066
Aphasia 21.15 14.56 55 41694 42757 90543941
Human papilloma virus test positive 21.14 14.56 9 41740 703 90585995
Cerebral thrombosis 20.88 14.56 12 41737 1791 90584907
Neutrophil count increased 20.39 14.56 34 41715 19356 90567342
Intraductal proliferative breast lesion 20.25 14.56 15 41734 3438 90583260
Lymphocyte count increased 20.22 14.56 16 41733 4043 90582655
Intervertebral disc protrusion 20.15 14.56 41 41708 27155 90559543
Platelet count decreased 20.14 14.56 20 41729 136949 90449749
Bacterial test 20.05 14.56 10 41739 1123 90585575
Expanded disability status scale score increased 19.88 14.56 9 41740 814 90585884
Liver disorder 19.88 14.56 16 41733 121253 90465445
Arthritis 19.76 14.56 29 41720 167286 90419412
Focal dyscognitive seizures 19.21 14.56 14 41735 3130 90583568
Dysphagia 19.02 14.56 102 41647 112176 90474522
Respiratory failure 18.94 14.56 16 41733 118402 90468296
Proteus test positive 18.77 14.56 7 41742 386 90586312
Autoimmune disorder 18.72 14.56 6 41743 76738 90509960
Night sweats 18.71 14.56 19 41730 128747 90457951
Therapeutic response changed 18.63 14.56 10 41739 1307 90585391
Wrist fracture 18.62 14.56 29 41720 15595 90571103
Intentional overdose 18.60 14.56 10 41739 93824 90492874
Muscle twitching 18.54 14.56 37 41712 24165 90562533
Impaired self-care 18.49 14.56 11 41738 1751 90584947
Living in residential institution 18.26 14.56 8 41741 670 90586028
Decreased gait velocity 18.19 14.56 4 41745 30 90586668
Dysmetria 18.07 14.56 8 41741 687 90586011
Constipation 18.01 14.56 203 41546 280192 90306506
Overdose 17.98 14.56 28 41721 157681 90429017
CD4 lymphocyte percentage decreased 17.97 14.56 3 41746 3 90586695
Hyperkalaemia 17.89 14.56 4 41745 64960 90521738
Oxygen saturation decreased 17.84 14.56 14 41735 107469 90479229
Red blood cell sedimentation rate increased 17.58 14.56 8 41741 82587 90504111
Fibula fracture 17.54 14.56 15 41734 4222 90582476
Mean cell haemoglobin decreased 17.39 14.56 17 41732 5678 90581020
Malignant melanoma 17.35 14.56 25 41724 12551 90574147
Haematocrit abnormal 17.35 14.56 9 41740 1098 90585600
B-lymphocyte count increased 17.30 14.56 5 41744 122 90586576
Eye contusion 16.79 14.56 12 41737 2604 90584094
Mean cell haemoglobin increased 16.53 14.56 14 41735 3891 90582807
Urticaria 16.47 14.56 81 41668 312653 90274045
Abdominal discomfort 16.31 14.56 141 41608 477187 90109511
Injection site scar 16.27 14.56 9 41740 1248 90585450
Metabolic acidosis 16.22 14.56 3 41746 55673 90531025
Eye movement disorder 16.19 14.56 17 41732 6181 90580517
Foot fracture 16.14 14.56 37 41712 26569 90560129
Tachycardia 16.13 14.56 30 41719 157643 90429055
Transferrin saturation decreased 16.00 14.56 8 41741 903 90585795
Hyponatraemia 15.91 14.56 23 41726 133515 90453183
Glucose urine present 15.90 14.56 8 41741 916 90585782
Ill-defined disorder 15.73 14.56 39 41710 184852 90401846
Decreased vibratory sense 15.62 14.56 6 41743 359 90586339
Encephalopathy 15.59 14.56 52 41697 46392 90540306
Myoclonus 15.53 14.56 30 41719 19138 90567560
Grip strength decreased 15.44 14.56 12 41737 92564 90494134
Hypoxia 15.43 14.56 7 41742 72392 90514306
Postictal state 15.41 14.56 9 41740 1384 90585314
Blood thyroid stimulating hormone increased 15.35 14.56 20 41729 9135 90577563
Concussion 15.23 14.56 22 41727 11069 90575629
Dry skin 15.23 14.56 11 41738 88062 90498636
Extensor plantar response 15.21 14.56 9 41740 1418 90585280
Femoral neck fracture 15.09 14.56 21 41728 10212 90576486
Initial insomnia 15.09 14.56 20 41729 9290 90577408
Neuralgia 15.08 14.56 40 41709 31460 90555238
Red cell distribution width increased 15.02 14.56 23 41726 12184 90574514
Gastrooesophageal reflux disease 15.02 14.56 34 41715 166303 90420395
Drug interaction 14.91 14.56 71 41678 276382 90310316
Haematochezia 14.89 14.56 7 41742 70906 90515792
Citrobacter infection 14.87 14.56 7 41742 693 90586005
Crystal urine present 14.85 14.56 9 41740 1481 90585217
Epilepsy 14.83 14.56 76 41673 82130 90504568
Hand fracture 14.76 14.56 17 41732 6848 90579850
Bladder spasm 14.63 14.56 10 41739 2020 90584678

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 1105.61 20.44 342 14877 13922 42592194
Multiple sclerosis 570.43 20.44 178 15041 7420 42598696
Balance disorder 379.62 20.44 227 14992 47418 42558698
Muscle spasticity 374.13 20.44 126 15093 6696 42599420
Gait disturbance 354.04 20.44 287 14932 97713 42508403
Fall 338.24 20.44 416 14803 234104 42372012
Urinary tract infection 309.32 20.44 267 14952 99017 42507099
Laboratory test abnormal 297.67 20.44 151 15068 22827 42583289
Relapsing-remitting multiple sclerosis 228.71 20.44 61 15158 1434 42604682
Gait spastic 194.43 20.44 53 15166 1356 42604760
Central nervous system lesion 184.23 20.44 78 15141 7792 42598324
Muscular weakness 179.64 20.44 183 15036 83315 42522801
Needle fatigue 173.79 20.44 47 15172 1166 42604950
Movement disorder 165.58 20.44 88 15131 14610 42591506
Insomnia 158.83 20.44 203 15016 118050 42488066
Mobility decreased 156.63 20.44 117 15102 35189 42570927
Hypertonic bladder 146.53 20.44 48 15171 2333 42603783
Drug ineffective 140.94 20.44 517 14702 629680 41976436
Ataxia 133.83 20.44 79 15140 16046 42590070
Therapy cessation 133.60 20.44 86 15133 20364 42585752
Monoparesis 132.48 20.44 47 15172 2913 42603203
Memory impairment 132.14 20.44 123 15096 50099 42556017
Hypoaesthesia 115.81 20.44 135 15084 71328 42534788
Micturition urgency 111.25 20.44 63 15156 11835 42594281
Seizure 107.07 20.44 170 15049 120391 42485725
Pollakiuria 105.20 20.44 77 15142 22428 42583688
Gait inability 95.31 20.44 73 15146 22760 42583356
Peroneal nerve palsy 89.63 20.44 37 15182 3465 42602651
B-lymphocyte count decreased 89.47 20.44 26 15193 843 42605273
Secondary progressive multiple sclerosis 88.01 20.44 22 15197 396 42605720
Nocturia 76.78 20.44 50 15169 12062 42594054
JC polyomavirus test positive 72.49 20.44 23 15196 1008 42605108
Flushing 70.27 20.44 76 15143 36952 42569164
Acute kidney injury 68.51 20.44 23 15196 367314 42238802
Dizziness 67.75 20.44 219 15000 249035 42357081
Dysarthria 67.44 20.44 77 15142 39730 42566386
Therapeutic response unexpected 67.32 20.44 45 15174 11336 42594780
Anaemia 65.05 20.44 11 15208 280267 42325849
Product substitution issue 62.87 20.44 43 15176 11247 42594869
Neurogenic bladder 61.66 20.44 25 15194 2235 42603881
Lymphocyte count decreased 61.58 20.44 62 15157 27747 42578369
Paraesthesia 58.90 20.44 99 15120 73360 42532756
Influenza like illness 58.05 20.44 64 15155 31776 42574340
Off label use 57.80 20.44 87 15132 638248 41967868
Trigeminal neuralgia 55.68 20.44 21 15198 1548 42604568
Upper motor neurone lesion 55.60 20.44 13 15206 174 42605942
Progressive multifocal leukoencephalopathy 55.09 20.44 40 15179 11496 42594620
Hypotension 53.76 20.44 13 15206 257618 42348498
Erectile dysfunction 50.55 20.44 53 15166 24860 42581256
Asthenia 48.94 20.44 214 15005 280579 42325537
COVID-19 48.24 20.44 119 15100 115829 42490287
Progressive multiple sclerosis 46.49 20.44 12 15207 247 42605869
Toxicity to various agents 45.06 20.44 13 15206 229123 42376993
Paraparesis 43.43 20.44 19 15200 2052 42604064
Drug interaction 42.75 20.44 21 15198 266978 42339138
Expanded disability status scale score increased 39.82 20.44 12 15207 442 42605674
Dyspnoea 39.29 20.44 61 15158 442560 42163556
Lymphocyte percentage decreased 38.71 20.44 18 15201 2241 42603875
Urinary incontinence 38.53 20.44 43 15176 21625 42584491
Muscular dystrophy 37.54 20.44 9 15210 135 42605981
Cystitis 37.36 20.44 32 15187 11666 42594450
Muscle spasms 36.50 20.44 89 15130 85955 42520161
Urine analysis abnormal 36.11 20.44 17 15202 2177 42603939
T-lymphocyte count decreased 35.84 20.44 10 15209 279 42605837
Neutropenia 34.55 20.44 14 15205 199417 42406699
Burning sensation 32.82 20.44 39 15180 20974 42585142
White blood cells urine positive 32.77 20.44 14 15205 1427 42604689
Vitamin B12 increased 32.18 20.44 10 15209 409 42605707
Thrombocytopenia 31.93 20.44 14 15205 190265 42415851
Decreased vibratory sense 31.69 20.44 10 15209 430 42605686
CD8 lymphocytes decreased 30.88 20.44 7 15212 81 42606035
Bladder disorder 30.35 20.44 18 15201 3681 42602435
Motor dysfunction 29.57 20.44 24 15195 8122 42597994
Fatigue 29.47 20.44 260 14959 435381 42170735
Herpes zoster 29.29 20.44 51 15168 38826 42567290
Dysstasia 28.63 20.44 30 15189 14056 42592060
Clonus 28.54 20.44 17 15202 3503 42602613
Cognitive disorder 27.28 20.44 46 15173 34126 42571990
Lymphopenia 27.25 20.44 36 15183 21527 42584589
Pancytopenia 26.44 20.44 5 15214 117738 42488378
Hyponatraemia 25.79 20.44 3 15216 101459 42504657
Cardiac failure 25.17 20.44 4 15215 106852 42499264
Renal failure 25.02 20.44 10 15209 143716 42462400
Walking aid user 24.76 20.44 14 15205 2619 42603497
Temperature intolerance 23.77 20.44 17 15202 4771 42601345
Urosepsis 23.65 20.44 28 15191 14992 42591124
Diarrhoea 23.62 20.44 85 15134 460764 42145352
Platelet count decreased 23.55 20.44 10 15209 138571 42467545
Primary progressive multiple sclerosis 23.10 20.44 5 15214 46 42606070
Back pain 23.06 20.44 106 15113 141670 42464446
Adverse drug reaction 23.03 20.44 45 15174 37389 42568727
Musculoskeletal stiffness 22.64 20.44 58 15161 57707 42548409
Spinal cord injury cauda equina 22.13 20.44 6 15213 150 42605966
Anxiety 21.83 20.44 92 15127 118468 42487648
Somatosensory evoked potentials abnormal 21.69 20.44 6 15213 162 42605954
Depression 20.95 20.44 87 15132 111276 42494840
Tremor 20.87 20.44 79 15140 96850 42509266
T-lymphocyte count increased 20.81 20.44 3 15216 0 42606116
Therapy interrupted 20.55 20.44 32 15187 22218 42583898
Escherichia urinary tract infection 20.53 20.44 15 15204 4348 42601768

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 2564.81 15.48 894 41522 49346 110497537
Urinary tract infection 1901.07 15.48 1307 41109 324975 110221908
Laboratory test abnormal 1508.93 15.48 585 41831 43494 110503389
Multiple sclerosis 907.08 15.48 349 42067 25349 110521534
Fall 823.58 15.48 1080 41336 602402 109944481
Balance disorder 788.56 15.48 514 41902 116046 110430837
Urine analysis abnormal 681.22 15.48 203 42213 6694 110540189
Gait disturbance 545.71 15.48 600 41816 277608 110269275
Muscle spasticity 379.05 15.48 211 42205 35704 110511179
Therapy cessation 376.33 15.48 227 42189 44630 110502253
Muscular weakness 339.07 15.48 446 41970 248022 110298861
Seizure 326.78 15.48 413 42003 220772 110326111
Central nervous system lesion 301.67 15.48 138 42278 15415 110531468
Escherichia urinary tract infection 287.32 15.48 135 42281 16027 110530856
B-lymphocyte count decreased 258.43 15.48 73 42343 1982 110544901
Relapsing-remitting multiple sclerosis 248.48 15.48 71 42345 2011 110544872
Peroneal nerve palsy 241.28 15.48 95 42321 7319 110539564
Gait spastic 240.82 15.48 65 42351 1484 110545399
Lymphocyte count decreased 229.44 15.48 184 42232 57059 110489824
Pollakiuria 209.65 15.48 157 42259 44038 110502845
Micturition urgency 202.42 15.48 113 42303 19207 110527676
Insomnia 185.78 15.48 420 41996 360170 110186713
Movement disorder 185.44 15.48 135 42281 36269 110510614
Secondary progressive multiple sclerosis 167.21 15.48 49 42367 1520 110545363
Culture urine positive 161.50 15.48 63 42353 4733 110542150
Needle fatigue 159.39 15.48 45 42371 1219 110545664
Off label use 151.28 15.48 214 42202 1499971 109046912
Urine leukocyte esterase positive 150.02 15.48 56 42360 3730 110543153
Dizziness 149.09 15.48 595 41821 697598 109849285
Urinary incontinence 143.25 15.48 131 42285 48456 110498427
JC polyomavirus test positive 139.83 15.48 47 42369 2300 110544583
Hypertonic bladder 135.07 15.48 57 42359 5245 110541638
Ataxia 134.04 15.48 103 42313 30005 110516878
Therapeutic response unexpected 131.93 15.48 93 42323 23750 110523133
COVID-19 130.05 15.48 289 42127 244771 110302112
Memory impairment 129.94 15.48 254 42162 196690 110350193
Asthenia 128.14 15.48 563 41853 688436 109858447
Lymphopenia 127.68 15.48 113 42303 40057 110506826
Hypoaesthesia 123.44 15.48 330 42086 313893 110232990
Monoparesis 119.50 15.48 50 42366 4503 110542380
Trigeminal neuralgia 118.29 15.48 49 42367 4303 110542580
Neurogenic bladder 117.49 15.48 51 42365 5028 110541855
T-lymphocyte count decreased 115.09 15.48 30 42386 596 110546287
Flushing 114.18 15.48 169 42247 104567 110442316
Toxicity to various agents 107.69 15.48 26 42390 480529 110066354
Gait inability 107.61 15.48 190 42226 136186 110410697
Progressive multifocal leukoencephalopathy 105.92 15.48 83 42333 24873 110522010
Head injury 104.06 15.48 104 42312 42913 110503970
Anaemia 103.88 15.48 40 42376 547046 109999837
Febrile neutropenia 100.70 15.48 5 42411 316762 110230121
White blood cells urine positive 98.39 15.48 51 42365 7473 110539410
Rheumatoid arthritis 97.63 15.48 4 42412 299609 110247274
Acute kidney injury 95.87 15.48 63 42353 635367 109911516
Product substitution issue 94.22 15.48 75 42341 22986 110523897
T-lymphocyte count increased 92.78 15.48 21 42395 223 110546660
CD8 lymphocytes decreased 87.58 15.48 21 42395 292 110546591
Dysarthria 86.35 15.48 132 42284 83989 110462894
Red blood cells urine positive 85.08 15.48 41 42375 5144 110541739
Dysstasia 83.96 15.48 82 42334 32904 110513979
CD4 lymphocytes increased 83.75 15.48 21 42395 355 110546528
Paraesthesia 83.11 15.48 264 42152 276257 110270626
Dyspnoea 80.03 15.48 193 42223 1106679 109440204
Nocturia 79.75 15.48 60 42356 16930 110529953
Lymphocyte percentage decreased 75.25 15.48 38 42378 5272 110541611
Influenza like illness 74.71 15.48 127 42289 88285 110458598
Joint swelling 73.67 15.48 39 42377 442806 110104077
CD4 lymphocytes decreased 72.53 15.48 31 42385 2943 110543940
Dysuria 71.17 15.48 101 42315 60130 110486753
Hand deformity 70.89 15.48 3 42413 218503 110328380
Lower respiratory tract infection 70.87 15.48 6 42410 243100 110303783
Progressive multiple sclerosis 69.05 15.48 24 42392 1300 110545583
Motor dysfunction 68.43 15.48 64 42352 24342 110522541
Tremor 68.14 15.48 201 42215 202031 110344852
Mobility decreased 67.99 15.48 223 42193 237199 110309684
Pericarditis 67.94 15.48 4 42412 219110 110327773
Bladder disorder 67.62 15.48 46 42370 11091 110535792
Cystitis 66.89 15.48 103 42313 65933 110480950
Paraparesis 65.66 15.48 33 42383 4533 110542350
Feeling abnormal 65.11 15.48 184 42232 180527 110366356
Status epilepticus 64.97 15.48 70 42346 31501 110515382
Product use issue 63.91 15.48 20 42396 311675 110235208
Neutropenia 63.77 15.48 32 42384 374588 110172295
Glossodynia 63.31 15.48 6 42410 221998 110324885
Hypotension 61.66 15.48 66 42350 523783 110023100
Upper motor neurone lesion 60.90 15.48 16 42400 328 110546555
Drug intolerance 60.31 15.48 41 42375 406471 110140412
Loss of control of legs 57.93 15.48 24 42392 2108 110544775
Generalised tonic-clonic seizure 57.80 15.48 87 42329 54593 110492290
Inappropriate schedule of product administration 57.16 15.48 190 42226 203447 110343436
Haemoglobin urine present 56.85 15.48 19 42397 913 110545970
Treatment failure 56.45 15.48 18 42398 277216 110269667
Urine abnormality 56.25 15.48 38 42378 9058 110537825
Vitamin B12 increased 55.39 15.48 23 42393 2032 110544851
Drug hypersensitivity 54.79 15.48 56 42360 454034 110092849
Erectile dysfunction 54.62 15.48 50 42366 18506 110528377
Stomatitis 54.23 15.48 18 42398 270224 110276659
Invasive ductal breast carcinoma 54.07 15.48 33 42383 6613 110540270
Ankle fracture 53.70 15.48 51 42365 19768 110527115
Fibromyalgia 53.35 15.48 3 42413 170906 110375977
Expanded disability status scale score increased 53.17 15.48 18 42398 900 110545983
Completed suicide 52.53 15.48 14 42402 242367 110304516
Nitrite urine present 51.62 15.48 19 42397 1216 110545667
Hemiparesis 50.95 15.48 73 42343 43830 110503053
Bacterial test positive 50.95 15.48 34 42382 7943 110538940
Infusion related reaction 50.70 15.48 43 42373 381119 110165764
Primary progressive multiple sclerosis 49.66 15.48 11 42405 105 110546778
Asthma 49.64 15.48 17 42399 250274 110296609
Hip fracture 49.19 15.48 64 42352 35087 110511796
Blood thyroid stimulating hormone decreased 49.01 15.48 32 42384 7207 110539676
Escherichia test positive 48.90 15.48 25 42391 3559 110543324
Blood immunoglobulin M decreased 48.87 15.48 21 42395 2020 110544863
Musculoskeletal disorder 47.95 15.48 51 42365 22613 110524270
Glycosylated haemoglobin increased 47.95 15.48 52 42364 23567 110523316
Wheezing 46.20 15.48 20 42396 255210 110291673
Pancytopenia 45.63 15.48 12 42404 209601 110337282
Diarrhoea 45.06 15.48 255 42161 1139250 109407633
Depression 44.83 15.48 240 42176 317095 110229788
Breast cancer 44.60 15.48 64 42352 38478 110508405
Immune reconstitution inflammatory syndrome 44.43 15.48 42 42374 16184 110530699
Exposure during pregnancy 44.03 15.48 6 42410 167418 110379465
Urinary tract infection pseudomonal 43.97 15.48 20 42396 2202 110544681
Magnetic resonance imaging abnormal 43.85 15.48 24 42392 3921 110542962
Temperature intolerance 43.83 15.48 39 42377 13911 110532972
Swelling 43.81 15.48 42 42374 350999 110195884
Urinary tract infection bacterial 43.54 15.48 31 42385 8036 110538847
Urosepsis 43.16 15.48 56 42360 30619 110516264
Optic neuritis 42.87 15.48 35 42381 11112 110535771
Weight increased 42.87 15.48 59 42357 419585 110127298
Burning sensation 42.86 15.48 87 42329 69125 110477758
Arthropathy 42.62 15.48 29 42387 287493 110259390
Muscle tightness 41.94 15.48 39 42377 14723 110532160
Maternal exposure during pregnancy 41.54 15.48 23 42393 254860 110292023
Product dose omission issue 41.21 15.48 237 42179 321545 110225338
Type 2 diabetes mellitus 40.82 15.48 9 42407 177223 110369660
Irritable bowel syndrome 40.64 15.48 7 42409 164208 110382675
General physical health deterioration 40.30 15.48 63 42353 425232 110121651
Sensory disturbance 40.06 15.48 41 42375 17388 110529495
Thrombocytopenia 39.87 15.48 45 42371 348840 110198043
Back pain 39.79 15.48 261 42155 370735 110176148
Lymphocyte count abnormal 39.25 15.48 19 42397 2407 110544476
Decreased appetite 39.19 15.48 77 42339 475769 110071114
Neutrophil percentage increased 38.96 15.48 24 42392 4889 110541994
Urine ketone body present 38.93 15.48 22 42394 3824 110543059
Urine odour abnormal 38.89 15.48 28 42388 7387 110539496
Drug interaction 38.61 15.48 84 42332 500099 110046784
Multiple organ dysfunction syndrome 38.59 15.48 6 42410 151704 110395179
Wound 38.43 15.48 21 42395 234416 110312467
Abdominal pain 38.09 15.48 88 42328 512901 110033982
Protein urine present 37.87 15.48 33 42383 11451 110535432
B-lymphocyte count abnormal 37.61 15.48 9 42407 124 110546759
Muscle spasms 37.01 15.48 207 42209 277950 110268933
Contraindicated product administered 36.85 15.48 25 42391 248242 110298641
Sinusitis 36.43 15.48 36 42380 296652 110250231
Urinary retention 35.57 15.48 81 42335 69602 110477281
Cognitive disorder 35.39 15.48 93 42323 87418 110459465
Acute disseminated encephalomyelitis 35.37 15.48 11 42405 419 110546464
Gastrointestinal haemorrhage 35.04 15.48 10 42406 165508 110381375
Impaired healing 34.68 15.48 16 42400 196701 110350182
Product use in unapproved indication 34.63 15.48 75 42341 447302 110099581
Hepatic enzyme increased 33.89 15.48 44 42372 320848 110226035
Rash 33.87 15.48 181 42235 820783 109726100
Speech disorder 33.03 15.48 73 42343 61496 110485387
Intentional product use issue 32.91 15.48 28 42388 247878 110299005
Lung disorder 32.75 15.48 14 42402 180033 110366850
Therapeutic product effect incomplete 32.60 15.48 23 42393 223782 110323101
Extra dose administered 32.39 15.48 31 42385 12128 110534755
Fatigue 32.23 15.48 649 41767 1215309 109331574
Muscular dystrophy 32.05 15.48 9 42407 239 110546644
Urinary tract infection enterococcal 31.71 15.48 19 42397 3683 110543200
Cystitis klebsiella 31.22 15.48 10 42406 420 110546463
Herpes zoster 31.17 15.48 102 42314 108277 110438606
Inflammation 30.68 15.48 18 42398 193220 110353663
Urinary sediment present 29.83 15.48 16 42400 2512 110544371
Decreased vibratory sense 29.81 15.48 11 42405 709 110546174
Hyponatraemia 29.60 15.48 24 42392 217629 110329254
Neutrophil count increased 29.56 15.48 50 42366 34602 110512281
Vomiting 29.20 15.48 217 42199 910458 109636425
Hyperkalaemia 29.12 15.48 8 42408 135788 110411095
Hypoxia 28.98 15.48 7 42409 129508 110417375
Injury 28.87 15.48 16 42400 177249 110369634
Blister 28.60 15.48 27 42389 227349 110319534
Limb discomfort 28.50 15.48 54 42362 40800 110506083
Pulmonary fibrosis 28.45 15.48 3 42413 102039 110444844
Monocyte percentage increased 28.37 15.48 15 42401 2288 110544595
CD8 lymphocytes increased 28.26 15.48 6 42410 46 110546837
Platelet count decreased 28.24 15.48 28 42388 230415 110316468
Arthralgia 27.83 15.48 180 42236 779452 109767431
Rectal haemorrhage 27.76 15.48 6 42410 119827 110427056
Metabolic acidosis 27.63 15.48 3 42413 99741 110447142
Oedema 27.52 15.48 24 42392 209952 110336931
CD8 lymphocyte percentage decreased 27.47 15.48 4 42412 0 110546883
Wheelchair user 26.80 15.48 23 42393 7819 110539064
Vitamin D decreased 26.75 15.48 28 42388 12187 110534696
Cardiac failure 26.39 15.48 20 42396 187606 110359277
Intervertebral disc protrusion 26.37 15.48 42 42374 27656 110519227
Hypersensitivity 26.34 15.48 74 42342 403924 110142959
Haematochezia 26.33 15.48 6 42410 115518 110431365
Pleural effusion 26.22 15.48 18 42398 177691 110369192
C-reactive protein increased 26.11 15.48 27 42389 217892 110328991
Paralysis 25.99 15.48 31 42385 15569 110531314
Urinary tract infection staphylococcal 25.96 15.48 11 42405 1022 110545861
Pneumonia 25.73 15.48 214 42202 876500 109670383
Bursitis 25.45 15.48 9 42407 129909 110416974
Dysgraphia 25.21 15.48 18 42398 4687 110542196
Coordination abnormal 25.05 15.48 39 42377 25189 110521694
Hypokinesia 24.89 15.48 36 42380 21790 110525093
Cerebral thrombosis 24.77 15.48 14 42402 2434 110544449
Invasive lobular breast carcinoma 24.75 15.48 10 42406 824 110546059
Crystal urine present 24.72 15.48 13 42403 1961 110544922
Decreased interest 24.53 15.48 18 42398 4890 110541993
Therapy interrupted 24.42 15.48 57 42359 49765 110497118
Incontinence 24.39 15.48 31 42385 16604 110530279
Oxygen saturation decreased 24.39 15.48 15 42401 156967 110389916
Rhabdomyolysis 24.17 15.48 8 42408 120393 110426490
Hepatic function abnormal 23.96 15.48 3 42413 89292 110457591
Red blood cell count abnormal 23.89 15.48 12 42404 1646 110545237
Fear of falling 23.87 15.48 10 42406 903 110545980
Walking aid user 23.84 15.48 38 42378 25037 110521846
Haematocrit decreased 23.47 15.48 67 42349 66050 110480833
Blood urine present 23.41 15.48 37 42379 24208 110522675
Human papilloma virus test positive 23.35 15.48 9 42407 654 110546229
Lymphocyte percentage abnormal 23.25 15.48 5 42411 41 110546842
Vitamin D deficiency 23.23 15.48 32 42384 18520 110528363
Demyelination 23.17 15.48 23 42393 9406 110537477
Joint range of motion decreased 22.92 15.48 9 42407 121823 110425060
Nephrolithiasis 22.45 15.48 66 42350 66146 110480737
Mean cell haemoglobin increased 22.37 15.48 18 42398 5599 110541284
Lymphocyte count increased 22.36 15.48 20 42396 7183 110539700
Vitamin B12 abnormal 22.35 15.48 6 42410 134 110546749
Respiratory failure 22.24 15.48 30 42386 215302 110331581
B-lymphocyte count increased 21.98 15.48 6 42410 143 110546740
Urinary sediment abnormal 21.82 15.48 6 42410 147 110546736
Overdose 21.78 15.48 35 42381 233759 110313124
Urinary tract disorder 21.74 15.48 18 42398 5826 110541057
Diplopia 21.72 15.48 49 42367 41845 110505038
Spinal cord injury cauda equina 21.71 15.48 6 42410 150 110546733
Infection 21.69 15.48 69 42347 362131 110184752
Drug ineffective 21.43 15.48 747 41669 1519793 109027090
Pyrexia 21.34 15.48 231 42185 898034 109648849
Bacterial test 21.34 15.48 10 42406 1179 110545704
Coronavirus infection 21.12 15.48 22 42394 9523 110537360
International normalised ratio increased 20.82 15.48 4 42412 86768 110460115
Ascites 20.79 15.48 5 42411 92803 110454080
Red blood cell count decreased 20.74 15.48 64 42352 65859 110481024
Glucose urine present 20.26 15.48 12 42404 2277 110544606
Liver disorder 20.21 15.48 15 42401 142228 110404655
Stress 20.16 15.48 87 42329 105261 110441622
Cardiac failure congestive 20.10 15.48 17 42399 150983 110395900
Headache 20.09 15.48 461 41955 881916 109664967
CD4 lymphocyte percentage decreased 19.99 15.48 4 42412 22 110546861
Urobilinogen urine increased 19.99 15.48 8 42408 643 110546240
Peripheral venous disease 19.92 15.48 4 42412 84113 110462770
Tongue biting 19.92 15.48 13 42403 2926 110543957
Tibia fracture 19.88 15.48 18 42398 6567 110540316
Somatosensory evoked potentials abnormal 19.86 15.48 6 42410 207 110546676
Wrist fracture 19.78 15.48 26 42390 14391 110532492
Blood thyroid stimulating hormone increased 19.76 15.48 24 42392 12277 110534606
Psoriasis 19.58 15.48 15 42401 139978 110406905
Femoral neck fracture 19.35 15.48 24 42392 12543 110534340
Vitamin D abnormal 19.31 15.48 6 42410 228 110546655
Skin laceration 19.22 15.48 41 42375 33712 110513171
Renal failure 19.21 15.48 36 42380 226538 110320345
Frustration tolerance decreased 19.10 15.48 20 42396 8711 110538172
Prescribed overdose 19.08 15.48 5 42411 87576 110459307
Angioedema 18.99 15.48 7 42409 98493 110448390
Focal dyscognitive seizures 18.97 15.48 14 42402 3835 110543048
General symptom 18.88 15.48 20 42396 8826 110538057
Intentional overdose 18.79 15.48 14 42402 132487 110414396
Hypercholesterolaemia 18.30 15.48 6 42410 90831 110456052
Hypoglycaemia 18.16 15.48 11 42405 116093 110430790
Foot fracture 18.11 15.48 34 42382 25512 110521371
Urine uric acid decreased 18.09 15.48 5 42411 125 110546758
Pulmonary oedema 18.03 15.48 8 42408 100651 110446232
Red blood cell count increased 17.99 15.48 15 42401 4903 110541980
Visual impairment 17.83 15.48 100 42316 134328 110412555
Cardiac arrest 17.81 15.48 30 42386 196723 110350160
Peripheral swelling 17.80 15.48 87 42329 403947 110142936
Arthritis 17.66 15.48 23 42393 167563 110379320
Anaphylactic reaction 17.64 15.48 11 42405 114289 110432594
Product quality issue 17.64 15.48 4 42412 77295 110469588
Urinary tract obstruction 17.32 15.48 15 42401 5162 110541721
Urine cannabinoids increased 17.31 15.48 3 42413 6 110546877
Vitamin B6 deficiency 17.18 15.48 7 42409 589 110546294
Citrobacter infection 17.14 15.48 9 42407 1353 110545530
Vision blurred 17.13 15.48 96 42320 128926 110417957
Dry skin 17.12 15.48 10 42406 107643 110439240
Neuralgia 17.09 15.48 49 42367 48429 110498454
Sensory loss 17.04 15.48 30 42386 21427 110525456
Dysmetria 16.92 15.48 9 42407 1390 110545493
Urge incontinence 16.82 15.48 9 42407 1406 110545477
Vertigo 16.82 15.48 72 42344 86798 110460085
Cardio-respiratory arrest 16.73 15.48 12 42404 115824 110431059
Mean cell haemoglobin decreased 16.71 15.48 17 42399 7157 110539726
Femur fracture 16.71 15.48 46 42370 44423 110502460
Rash maculo-papular 16.63 15.48 4 42412 74218 110472665
Neuropathy peripheral 16.54 15.48 27 42389 179250 110367633
Anal incontinence 16.53 15.48 30 42386 21934 110524949
Intentional product misuse 16.45 15.48 16 42400 132888 110413995
Osteoarthritis 16.39 15.48 28 42388 182595 110364288
Hypokalaemia 16.35 15.48 28 42388 182420 110364463
Septic shock 16.21 15.48 22 42394 157506 110389377
Concussion 16.13 15.48 21 42395 11517 110535366
Dyspnoea exertional 16.08 15.48 10 42406 104050 110442833
White matter lesion 15.83 15.48 11 42405 2743 110544140
Dysphagia 15.80 15.48 107 42309 153493 110393390
Discomfort 15.77 15.48 37 42379 214670 110332213
Lung cancer metastatic 15.76 15.48 13 42403 4185 110542698
Therapeutic response changed 15.69 15.48 9 42407 1609 110545274
Lactic acidosis 15.66 15.48 8 42408 92803 110454080
Clonus 15.65 15.48 18 42398 8698 110538185
Proteus test positive 15.65 15.48 7 42409 741 110546142
Relapsing multiple sclerosis 15.52 15.48 5 42411 214 110546669
Pneumonitis 15.51 15.48 5 42411 76526 110470357

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N07XX07 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
OTHER NERVOUS SYSTEM DRUGS
Other nervous system drugs
FDA MoA N0000175448 Potassium Channel Antagonists
MeSH PA D002317 Cardiovascular Agents
MeSH PA D026902 Potassium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
FDA EPC N0000192795 Potassium Channel Blocker
CHEBI has role CHEBI:33289 avicide
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:50509 potassium channel blocker
CHEBI has role CHEBI:71031 orphan drug
CHEBI has role CHEBI:73336 vulnerary

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

DiseaseRelationSNOMED_IDDOID
Multiple sclerosis indication 24700007 DOID:2377
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.58 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Voltage-gated potassium channel Ion channel BLOCKER IC50 4.05 CHEMBL CHEMBL
Potassium voltage-gated channel subfamily C member 1 Ion channel BLOCKER IC50 4.50 IUPHAR
Potassium voltage-gated channel subfamily C member 2 Ion channel BLOCKER IC50 4.60 IUPHAR

External reference:

IDSource
4029704 VUID
N0000180628 NUI
D04127 KEGG_DRUG
4025700 VANDF
4025705 VANDF
4029704 VANDF
C0000477 UMLSCUI
CHEBI:34385 CHEBI
4AP PDB_CHEM_ID
CHEMBL284348 ChEMBL_ID
DB06637 DRUGBANK_ID
2416 IUPHAR_LIGAND_ID
1727 PUBCHEM_CID
897018 RXNORM
170373 MMSL
26967 MMSL
NOCODE MMSL
d07546 MMSL
006829 NDDF
413355004 SNOMEDCT_US
80994002 SNOMEDCT_US
D015761 MESH_DESCRIPTOR_UI
7283 INN_ID
BH3B64OKL9 UNII
BH3B64OKL9 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AMPYRA HUMAN PRESCRIPTION DRUG LABEL 1 0259-5010 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA 27 sections
Dalfampridine HUMAN PRESCRIPTION DRUG LABEL 1 0591-2533 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 27 sections
AMPYRA HUMAN PRESCRIPTION DRUG LABEL 1 10144-427 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL NDA 27 sections
Dalfampridine HUMAN PRESCRIPTION DRUG LABEL 1 16729-292 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 28 sections
Dalfampridine HUMAN PRESCRIPTION DRUG LABEL 1 16729-292 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 28 sections
DALFAMPRIDINE HUMAN PRESCRIPTION DRUG LABEL 1 42571-275 TABLET, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
Dalfampridine HUMAN PRESCRIPTION DRUG LABEL 1 51407-876 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
Dalfampridine Human Prescription Drug Label 1 62756-429 TABLET, EXTENDED RELEASE 10 mg ORAL ANDA 27 sections
Dalfampridine HUMAN PRESCRIPTION DRUG LABEL 1 63629-9450 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
DALFAMPRIDINE Human Prescription Drug Label 1 65862-863 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
Dalfampridine Human Prescription Drug Label 1 67877-444 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
DALFAMPRIDINE HUMAN PRESCRIPTION DRUG LABEL 1 72162-2459 TABLET, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections
Dalfampridine Human Prescription Drug Label 1 82249-702 TABLET, FILM COATED, EXTENDED RELEASE 10 mg ORAL ANDA 26 sections