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

Stem definitionDrug idCAS RN
phosphodiesterase IV (PDE IV) inhibitors 4829 608141-41-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • apremilast
  • CC-10004
  • otezla
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.
  • Molecular weight: 460.50
  • Formula: C22H24N2O7S
  • CLOGP: 1.46
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 1
  • TPSA: 119.08
  • ALOGS: -4.13
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
60 mg O

ADMET properties:

PropertyValueReference
CL (Clearance) 2.38 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.32 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.03 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2019 PMDA Celgene K.K.
March 21, 2014 FDA CELGENE CORP
Nov. 20, 2014 EMA

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
Diarrhoea 11388.71 23.05 10288 117908 578188 49898740
Nausea 9854.86 23.05 10318 117878 695080 49781848
Headache 7460.98 23.05 7654 120542 498881 49978047
Product dose omission issue 7158.67 23.05 4893 123303 178945 50297983
Abdominal discomfort 2126.53 23.05 2765 125431 228876 50248052
Drug ineffective 1679.06 23.05 5188 123008 814145 49662783
Depression 1307.79 23.05 1839 126357 163584 50313344
Adverse drug reaction 1293.33 23.05 1091 127105 54131 50422797
Therapy non-responder 1076.85 23.05 950 127246 50072 50426856
Psoriatic arthropathy 1023.18 23.05 891 127305 46141 50430787
Psoriasis 830.26 23.05 947 127249 68053 50408875
Abdominal pain upper 788.04 23.05 1431 126765 157878 50319050
Weight decreased 781.19 23.05 1726 126470 219519 50257409
Gastric disorder 685.46 23.05 581 127615 28967 50447961
Frequent bowel movements 568.71 23.05 384 127812 13534 50463394
Acute kidney injury 536.76 23.05 8 128188 228050 50248878
Migraine 527.80 23.05 792 127404 74488 50402440
Dyspnoea 489.88 23.05 403 127793 547205 49929723
Toxicity to various agents 485.61 23.05 11 128185 212488 50264440
Anaemia 418.17 23.05 69 128127 252387 50224541
Hypotension 409.17 23.05 56 128140 235413 50241515
Rash 381.97 23.05 2142 126054 435329 50041599
Vomiting 364.58 23.05 2198 125998 458560 50018368
Drug interaction 362.53 23.05 41 128155 199580 50277348
Dyspepsia 350.90 23.05 654 127542 73443 50403485
Neutropenia 348.78 23.05 5 128191 147960 50328968
Tension headache 333.94 23.05 155 128041 2576 50474352
Pyrexia 332.91 23.05 285 127911 379918 50097010
Stress 307.87 23.05 516 127680 53277 50423651
Thrombocytopenia 289.99 23.05 7 128189 127666 50349262
Confusional state 285.98 23.05 61 128135 185867 50291061
Insomnia 277.52 23.05 1023 127173 173842 50303086
Haemoglobin decreased 238.90 23.05 23 128173 127193 50349735
Product supply issue 238.59 23.05 96 128100 1103 50475825
Upper respiratory tract infection 216.97 23.05 501 127695 65397 50411531
White blood cell count decreased 216.82 23.05 22 128174 116700 50360228
Therapeutic response decreased 214.93 23.05 410 127786 46821 50430107
Decreased appetite 214.66 23.05 1042 127154 199881 50277047
Enthesopathy 214.65 23.05 164 128032 7029 50469899
Hypokalaemia 207.17 23.05 3 128193 87989 50388939
Faeces soft 201.86 23.05 127 128069 3957 50472971
Product administration interrupted 199.98 23.05 81 128115 948 50475980
Pancytopenia 197.26 23.05 3 128193 84027 50392901
Fall 193.10 23.05 346 127850 334586 50142342
Gastrointestinal disorder 189.52 23.05 598 127598 93858 50383070
Arthralgia 187.59 23.05 1813 126383 436889 50040039
Cardiac arrest 184.69 23.05 6 128190 83645 50393283
Pleural effusion 182.90 23.05 5 128191 81449 50395479
Platelet count decreased 181.93 23.05 21 128175 100705 50376223
Respiratory failure 172.45 23.05 16 128180 91165 50385763
Sepsis 171.82 23.05 61 128135 132864 50344064
Oedema peripheral 170.36 23.05 94 128102 157867 50319061
Death 169.40 23.05 357 127839 325022 50151906
Seizure 168.70 23.05 45 128151 117829 50359099
Asthenia 168.66 23.05 347 127849 318695 50158233
Disease progression 165.83 23.05 23 128173 95843 50381085
Therapeutic product effect decreased 165.37 23.05 733 127463 135317 50341611
Therapeutic product effect incomplete 163.49 23.05 557 127639 90958 50385970
Malignant neoplasm progression 153.63 23.05 4 128192 68120 50408808
Oxygen saturation decreased 152.53 23.05 8 128188 73240 50403688
Maternal exposure during pregnancy 151.79 23.05 110 128086 159668 50317260
Overdose 150.63 23.05 34 128162 99693 50377235
Pneumonia 149.58 23.05 477 127719 377924 50099004
Unevaluable event 149.14 23.05 348 127848 45718 50431210
Bradycardia 148.32 23.05 3 128193 64423 50412505
Exposure during pregnancy 144.11 23.05 63 128133 120952 50355976
Tenosynovitis 142.31 23.05 154 128042 10411 50466517
Loss of consciousness 141.65 23.05 44 128152 104309 50372619
Renal failure 141.13 23.05 47 128149 106586 50370342
Syncope 140.59 23.05 43 128153 102959 50373969
Intentional overdose 139.72 23.05 4 128192 62500 50414428
Leukopenia 138.67 23.05 8 128188 67520 50409408
Injection site pain 133.47 23.05 57 128139 110967 50365961
Pulmonary embolism 132.56 23.05 46 128150 101658 50375270
Deep vein thrombosis 130.59 23.05 16 128180 73288 50403640
Coma 129.55 23.05 3 128193 56876 50420052
Injection site erythema 124.94 23.05 20 128176 74916 50402012
Tachycardia 121.87 23.05 50 128146 99713 50377215
Flatulence 117.44 23.05 242 127954 29216 50447712
Lower respiratory tract infection 114.22 23.05 49 128147 95152 50381776
Septic shock 113.74 23.05 8 128188 57167 50419761
Multiple organ dysfunction syndrome 113.33 23.05 3 128193 50334 50426594
Hypoxia 111.66 23.05 4 128192 51119 50425809
Somnolence 111.63 23.05 137 128059 154848 50322080
Mood altered 110.95 23.05 149 128047 12624 50464304
Neuropathy peripheral 109.57 23.05 54 128142 96703 50380225
Pruritus 109.28 23.05 1148 127048 282420 50194508
Hyperkalaemia 107.77 23.05 3 128193 48086 50428842
Cardiac failure 106.95 23.05 30 128166 76010 50400918
Hypoglycaemia 102.38 23.05 9 128187 53572 50423356
Chest pain 99.70 23.05 185 128011 176697 50300231
Weight increased 98.75 23.05 229 127967 201662 50275266
Gastrointestinal haemorrhage 97.56 23.05 32 128164 73289 50403639
Bone erosion 94.96 23.05 132 128064 11555 50465373
Red blood cell sedimentation rate 94.54 23.05 76 128120 3510 50473418
Atrial fibrillation 91.53 23.05 74 128122 101671 50375257
Interstitial lung disease 89.07 23.05 14 128182 53162 50423766
Cardiac failure congestive 86.95 23.05 53 128143 84329 50392599
Impaired healing 86.81 23.05 34 128162 69752 50407176
Mucosal inflammation 84.79 23.05 4 128192 40138 50436790
Rebound psoriasis 84.55 23.05 22 128174 47 50476881
Dehydration 84.53 23.05 161 128035 152288 50324640
Swelling 84.33 23.05 246 127950 200626 50276302
Pulmonary oedema 84 23.05 12 128184 48926 50428002
Blood parathyroid hormone decreased 82.63 23.05 96 128100 7018 50469910
Blood alkaline phosphatase increased 81.73 23.05 3 128193 37523 50439405
Tongue disorder 80.80 23.05 108 128088 9108 50467820
Systemic lupus erythematosus 79.29 23.05 147 128049 140475 50336453
Adverse reaction 78.95 23.05 103 128093 8483 50468445
Muscle spasms 77.94 23.05 565 127631 124988 50351940
Ascites 77.64 23.05 3 128193 35858 50441070
Balance disorder 77.51 23.05 41 128155 70549 50406379
Dysphagia 75.36 23.05 52 128144 77466 50399462
Pemphigus 74.72 23.05 118 128078 120048 50356880
Exostosis 73.67 23.05 117 128079 11536 50465392
Cognitive disorder 73.04 23.05 12 128184 44111 50432817
Joint dislocation 72.76 23.05 120 128076 12213 50464715
Hyperglycaemia 72.68 23.05 5 128191 36400 50440528
Mental status changes 72.36 23.05 5 128191 36267 50440661
Panniculitis 72.04 23.05 98 128098 8405 50468523
Pulmonary hypertension 71.66 23.05 3 128193 33414 50443514
Paraesthesia 71.11 23.05 122 128074 120121 50356807
Arthritis 70.73 23.05 418 127778 86303 50390625
COVID-19 69.67 23.05 268 127928 46394 50430534
Anaphylactic reaction 69.47 23.05 25 128171 54030 50422898
Product use in unapproved indication 68.96 23.05 117 128079 115702 50361226
Dyspnoea exertional 68.79 23.05 22 128174 51211 50425717
Granuloma skin 68.39 23.05 79 128117 5739 50471189
Multiple sclerosis relapse 68.25 23.05 13 128183 42951 50433977
Flushing 67.78 23.05 43 128153 66972 50409956
Liver function test abnormal 67.16 23.05 15 128181 44324 50432604
Dysarthria 67.01 23.05 8 128188 37395 50439533
Infusion related reaction 66.62 23.05 214 127982 169343 50307585
Plasma cell myeloma 66.54 23.05 3 128193 31319 50445609
Medication error 66.50 23.05 7 128189 36097 50440831
Malaise 66.40 23.05 1206 126990 334326 50142602
Influenza 66.34 23.05 421 127775 89117 50387811
Muscular weakness 66.28 23.05 86 128110 94927 50382001
Pneumonia aspiration 65.77 23.05 3 128193 31001 50445927
Oedema 65.70 23.05 49 128147 70132 50406796
Joint stiffness 65.47 23.05 197 127999 30111 50446817
Heart rate decreased 64.91 23.05 8 128188 36489 50440439
Delirium 64.08 23.05 10 128186 38182 50438746
Injection site swelling 63.54 23.05 14 128182 41759 50435169
Injection site pruritus 62.58 23.05 13 128183 40398 50436530
Blood pressure decreased 62.08 23.05 32 128164 55877 50421051
Glossodynia 61.49 23.05 125 128071 115444 50361484
Rash pruritic 60.48 23.05 261 127935 47585 50429343
Acute respiratory failure 60.36 23.05 3 128193 28779 50448149
Hepatic failure 60.13 23.05 6 128190 32277 50444651
Drug hypersensitivity 58.96 23.05 383 127813 250627 50226301
Red blood cell count decreased 58.76 23.05 8 128188 33827 50443101
Adverse event 58.63 23.05 243 127953 43520 50433408
Tendonitis 57.13 23.05 129 128067 16576 50460352
Gastrooesophageal reflux disease 57.01 23.05 360 127836 76068 50400860
Cerebrovascular accident 56.95 23.05 95 128101 94585 50382343
Coronary artery disease 56.76 23.05 5 128191 29721 50447207
Respiratory distress 55.93 23.05 6 128190 30483 50446445
No adverse event 55.87 23.05 9 128187 33569 50443359
Dyskinesia 55.12 23.05 4 128192 27857 50449071
Sinus headache 55.00 23.05 63 128133 4535 50472393
Dactylitis 54.58 23.05 42 128154 1819 50475109
Hallucination 54.39 23.05 25 128171 46632 50430296
Vision blurred 54.01 23.05 72 128124 78575 50398353
Drug reaction with eosinophilia and systemic symptoms 53.69 23.05 5 128191 28419 50448509
Hepatotoxicity 53.60 23.05 4 128192 27222 50449706
Hepatitis 53.31 23.05 8 128188 31445 50445483
Angioedema 52.71 23.05 15 128181 37661 50439267
Fluid retention 51.91 23.05 32 128164 50617 50426311
Chronic kidney disease 51.78 23.05 18 128178 39753 50437175
Blood creatine phosphokinase increased 51.55 23.05 4 128192 26363 50450565
Skin necrosis 51.46 23.05 96 128100 10771 50466157
Hypothyroidism 50.77 23.05 12 128184 34113 50442815
Chest discomfort 50.43 23.05 99 128097 92623 50384305
Haematoma 48.96 23.05 9 128187 30501 50446427
Skin disorder 48.92 23.05 153 128043 23877 50453051
Aphasia 48.87 23.05 7 128189 28487 50448441
Lymphocyte count decreased 48.71 23.05 5 128191 26302 50450626
Femur fracture 48.70 23.05 17 128179 37447 50439481
Urinary retention 48.43 23.05 5 128191 26185 50450743
Urinary incontinence 48.21 23.05 7 128189 28201 50448727
Alanine aminotransferase abnormal 48.13 23.05 56 128140 4100 50472828
Disorientation 48.05 23.05 15 128181 35469 50441459
Loss of personal independence in daily activities 47.99 23.05 323 127873 69727 50407201
Memory impairment 47.99 23.05 355 127841 79005 50397923
Muscle injury 47.96 23.05 17 128179 37094 50439834
Constipation 46.88 23.05 277 127919 185431 50291497
Hepatic function abnormal 45.74 23.05 13 128183 32668 50444260
Body tinea 45.74 23.05 33 128163 1294 50475634
Pancreatitis acute 45.48 23.05 4 128192 23808 50453120
Ear infection 45.38 23.05 157 128039 25813 50451115
Blood pressure fluctuation 45.30 23.05 17 128179 35806 50441122
Osteonecrosis 45.22 23.05 3 128193 22514 50454414
Melaena 45.15 23.05 7 128189 26857 50450071
Musculoskeletal stiffness 45.11 23.05 511 127685 127970 50348958
Blood urea increased 44.94 23.05 4 128192 23581 50453347
Thrombosis 44.94 23.05 45 128151 55788 50421140
Gamma-glutamyltransferase increased 44.91 23.05 10 128186 29613 50447315
Pericardial effusion 44.56 23.05 6 128190 25583 50451345
Myocardial infarction 44.26 23.05 100 128096 88927 50388001
Renal impairment 43.59 23.05 78 128118 75583 50401345
Red blood cell sedimentation rate increased 43.12 23.05 168 128028 29248 50447680
Sleep disorder due to general medical condition, insomnia type 43.11 23.05 13 128183 31434 50445494
Agitation 43.00 23.05 43 128153 53341 50423587
Therapy cessation 42.66 23.05 154 128042 25857 50451071
Orthostatic hypotension 42.63 23.05 11 128185 29470 50447458
Rash maculo-papular 42.44 23.05 8 128188 26633 50450295
Suicide attempt 42.44 23.05 41 128155 51691 50425237
Injection site bruising 42.40 23.05 20 128176 36748 50440180
Fear of injection 42.39 23.05 64 128132 6039 50470889
Haematuria 42.31 23.05 7 128189 25606 50451322
Chills 42.30 23.05 116 128080 96571 50380357
Intentional product use issue 41.93 23.05 82 128114 76836 50400092
Pallor 41.46 23.05 5 128191 23194 50453734
Cerebral haemorrhage 41.27 23.05 9 128187 27043 50449885
Hand deformity 41.06 23.05 124 128072 100075 50376853
Rheumatoid nodule 40.96 23.05 96 128100 12639 50464289
Blood calcium decreased 40.88 23.05 3 128193 20703 50456225
Haemorrhage 40.85 23.05 45 128151 53396 50423532
Mood swings 40.57 23.05 110 128086 15844 50461084
Gait disturbance 40.41 23.05 219 127977 149786 50327142
Rash macular 40.41 23.05 124 128072 19153 50457775
Cerebral infarction 40.27 23.05 4 128192 21600 50455328
Skin irritation 40.07 23.05 71 128125 7656 50469272
Speech disorder 39.98 23.05 20 128176 35528 50441400
Folliculitis 39.89 23.05 25 128171 39200 50437728
Epistaxis 39.55 23.05 63 128133 63891 50413037
Metastases to liver 39.44 23.05 3 128193 20101 50456827
Pneumonitis 39.03 23.05 13 128183 29497 50447431
Skin exfoliation 38.44 23.05 178 128018 33434 50443494
Dry skin 38.35 23.05 213 127983 42978 50433950
Device related infection 38.24 23.05 4 128192 20731 50456197
Nasopharyngitis 37.90 23.05 693 127503 192234 50284694
Rhinorrhoea 37.85 23.05 242 127954 51341 50425587
Gastroenteritis viral 37.67 23.05 119 128077 18667 50458261
Blood creatinine increased 37.49 23.05 86 128110 76074 50400854
Stomatitis 36.98 23.05 132 128064 101212 50375716
Visual acuity reduced 36.84 23.05 4 128192 20135 50456793
Accidental exposure to product 36.57 23.05 7 128189 23050 50453878
Alanine aminotransferase increased 36.46 23.05 109 128087 88250 50388678
White blood cell count increased 36.40 23.05 32 128164 42208 50434720
Drug dependence 35.96 23.05 4 128192 19755 50457173
Dandruff 35.90 23.05 15 128181 191 50476737
Ulcer 35.19 23.05 122 128074 20078 50456850
Injection site reaction 35.17 23.05 45 128151 49987 50426941
Aggression 34.37 23.05 6 128190 21110 50455818
Sleep apnoea syndrome 34.33 23.05 9 128187 23859 50453069
Drug resistance 34.16 23.05 4 128192 18985 50457943
Circulatory collapse 34.09 23.05 5 128191 19995 50456933
Bowel movement irregularity 34.02 23.05 46 128150 3922 50473006
Stevens-Johnson syndrome 33.67 23.05 7 128189 21745 50455183
Retinitis 33.62 23.05 32 128164 1855 50475073
Foot deformity 33.45 23.05 116 128080 19094 50457834
Epilepsy 33.26 23.05 7 128189 21560 50455368
Hepatic cirrhosis 33.13 23.05 109 128087 17468 50459460
Blood potassium decreased 33.05 23.05 27 128169 36918 50440010
Lung disorder 32.85 23.05 39 128157 44760 50432168
Arrhythmia 32.49 23.05 22 128174 33110 50443818
Wound 32.18 23.05 148 128048 105646 50371282
Abortion spontaneous 32.12 23.05 35 128161 41737 50435191
Product use issue 32.11 23.05 234 127962 149241 50327687
Transient ischaemic attack 32.11 23.05 21 128175 32189 50444739
Defaecation urgency 32.04 23.05 39 128157 2994 50473934
Psychotic disorder 31.80 23.05 8 128188 21804 50455124
Urinary tract infection 31.34 23.05 390 127806 223630 50253298
Proteinuria 31.13 23.05 3 128193 16594 50460334
Hallucination, visual 31.10 23.05 3 128193 16579 50460349
Intestinal obstruction 30.96 23.05 14 128182 26369 50450559
Inhibitory drug interaction 30.86 23.05 33 128163 2200 50474728
Red blood cell sedimentation rate abnormal 30.53 23.05 3 128193 16340 50460588
Body temperature increased 30.48 23.05 21 128175 31320 50445608
Infection susceptibility increased 30.23 23.05 35 128161 2549 50474379
Contusion 30.08 23.05 164 128032 112019 50364909
Electrolyte imbalance 29.95 23.05 4 128192 17165 50459763
Small intestinal obstruction 29.89 23.05 3 128193 16065 50460863
Therapy partial responder 29.69 23.05 57 128139 6534 50470394
Ischaemic stroke 29.61 23.05 3 128193 15945 50460983
Hypertension 29.42 23.05 368 127828 210835 50266093
Drug effect less than expected 29.32 23.05 17 128179 455 50476473
Abnormal behaviour 29.07 23.05 7 128189 19651 50457277
Asthma 28.97 23.05 122 128074 89215 50387713
Cardiomyopathy 28.76 23.05 3 128193 15583 50461345
Hospitalisation 28.61 23.05 83 128113 67854 50409074
Blood sodium decreased 28.53 23.05 9 128187 21138 50455790
Cholelithiasis 27.91 23.05 33 128163 37940 50438988
Crying 27.84 23.05 114 128082 20302 50456626
Hepatic enzyme increased 27.65 23.05 219 127977 137161 50339767
Suicidal ideation 27.59 23.05 237 127959 55148 50421780
Lethargy 27.54 23.05 52 128144 49380 50427548
Expired product administered 27.32 23.05 49 128147 5333 50471595
Off label use 27.30 23.05 956 127240 473470 50003458
Injection site haemorrhage 27.21 23.05 10 128186 21336 50455592
Prescribed underdose 27.16 23.05 4 128192 15945 50460983
Abdominal distension 26.96 23.05 293 127903 72610 50404318
Pharyngitis streptococcal 26.82 23.05 65 128131 8743 50468185
Underdose 26.70 23.05 9 128187 20269 50456659
Complication associated with device 26.58 23.05 3 128193 14652 50462276
Withdrawal syndrome 26.54 23.05 6 128190 17584 50459344
Haemoptysis 26.42 23.05 16 128180 25557 50451371
Basal cell carcinoma 26.20 23.05 123 128073 23233 50453695
Contraindicated product administered 26.17 23.05 246 127950 148712 50328216
Pain 26.11 23.05 1750 126446 577153 49899775
Device issue 26.06 23.05 9 128187 19963 50456965
Depressed mood 25.81 23.05 161 128035 33862 50443066
Adrenal insufficiency 25.62 23.05 3 128193 14240 50462688
Helicobacter infection 25.38 23.05 55 128141 49647 50427281
Candida infection 25.32 23.05 14 128182 23509 50453419
Eye pain 25.18 23.05 21 128175 28428 50448500
Pregnancy 25.02 23.05 144 128052 29433 50447495
Swelling face 24.60 23.05 61 128135 52534 50424394
Full blood count decreased 24.49 23.05 13 128183 22333 50454595
Multiple allergies 24.23 23.05 61 128135 8402 50468526
Disturbance in attention 24.12 23.05 26 128170 31160 50445768
Amnesia 23.95 23.05 44 128152 42216 50434712
Body temperature decreased 23.93 23.05 6 128190 16389 50460539
Presyncope 23.82 23.05 16 128180 24182 50452746
Aspartate aminotransferase increased 23.78 23.05 109 128087 77889 50399039
Ill-defined disorder 23.58 23.05 66 128130 54588 50422340
C-reactive protein abnormal 23.27 23.05 135 128061 27674 50449254
Wrong technique in product usage process 23.24 23.05 68 128128 55442 50421486

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
Diarrhoea 6989.40 31.61 5351 50031 327347 29191798
Product dose omission issue 4771.87 31.61 2674 52708 93709 29425436
Headache 4238.96 31.61 3082 52300 170925 29348220
Nausea 3796.48 31.61 3574 51808 285681 29233464
Abdominal discomfort 3129.23 31.61 1603 53779 46300 29472845
Drug ineffective 2628.45 31.61 3283 52099 359887 29159258
Depression 941.38 31.61 967 54415 84180 29434965
Adverse drug reaction 849.29 31.61 540 54842 23480 29495665
Therapy non-responder 842.57 31.61 591 54791 30320 29488825
Abdominal pain upper 756.74 31.61 738 54644 60255 29458890
Therapeutic product effect decreased 613.20 31.61 479 54903 28972 29490173
Weight decreased 576.78 31.61 1020 54362 149885 29369260
Psoriasis 534.06 31.61 459 54923 31768 29487377
Frequent bowel movements 506.32 31.61 276 55106 8963 29510182
Psoriatic arthropathy 483.67 31.61 316 55066 14375 29504770
Gastric disorder 442.35 31.61 266 55116 10438 29508707
Acute kidney injury 402.06 31.61 24 55358 265243 29253902
Rash 380.08 31.61 987 54395 188832 29330313
Gastrointestinal disorder 310.62 31.61 323 55059 28383 29490762
Drug interaction 289.50 31.61 21 55361 197364 29321781
Anaemia 269.00 31.61 31 55351 200920 29318225
Hypotension 265.16 31.61 28 55354 194326 29324819
Therapeutic response decreased 263.64 31.61 276 55106 24435 29494710
Faeces soft 259.16 31.61 116 55266 2429 29516716
Dyspepsia 243.33 31.61 291 55091 29834 29489311
Arthralgia 233.99 31.61 681 54701 138936 29380209
Pyrexia 232.58 31.61 125 55257 287497 29231648
Neutropenia 222.68 31.61 5 55377 131706 29387439
Flatulence 198.22 31.61 203 55179 17506 29501639
Therapeutic product effect incomplete 194.19 31.61 299 55083 39006 29480139
Dyspnoea 193.16 31.61 197 55185 326535 29192610
Product supply issue 191.27 31.61 57 55325 339 29518806
Tension headache 181.24 31.61 75 55307 1286 29517859
Febrile neutropenia 179.74 31.61 7 55375 112233 29406912
Thrombocytopenia 177.27 31.61 22 55360 134801 29384344
Mood altered 168.73 31.61 132 55250 7979 29511166
Pruritus 163.04 31.61 535 54847 116314 29402831
Pneumonia 162.34 31.61 218 55164 319954 29199191
Respiratory failure 152.36 31.61 7 55375 97124 29422021
Migraine 149.18 31.61 148 55234 12282 29506863
Nasopharyngitis 147.24 31.61 337 55045 59328 29459817
Haemoglobin decreased 146.62 31.61 16 55366 108359 29410786
Enthesopathy 144.26 31.61 89 55293 3654 29515491
Memory impairment 143.00 31.61 250 55132 36220 29482925
Product administration interrupted 139.43 31.61 43 55339 292 29518853
Upper respiratory tract infection 137.77 31.61 210 55172 27139 29492006
Sepsis 133.82 31.61 50 55332 142632 29376513
Confusional state 133.74 31.61 37 55345 127840 29391305
Cardiac arrest 128.51 31.61 8 55374 85583 29433562
Platelet count decreased 128.38 31.61 21 55361 104651 29414494
Discomfort 126.41 31.61 147 55235 14616 29504529
Overdose 124.37 31.61 6 55376 79813 29439332
Completed suicide 122.87 31.61 13 55369 90233 29428912
Pleural effusion 120.40 31.61 3 55379 71905 29447240
Product use in unapproved indication 114.55 31.61 14 55368 86861 29432284
Oedema peripheral 111.99 31.61 28 55354 103529 29415616
Blood creatinine increased 111.51 31.61 14 55368 85088 29434057
Pancytopenia 110.64 31.61 13 55369 83155 29435990
Pain 107.94 31.61 617 54765 170815 29348330
Tenosynovitis 107.64 31.61 74 55308 3659 29515486
Bradycardia 105.33 31.61 4 55378 65625 29453520
Fall 105.30 31.61 106 55276 177072 29342073
Pulmonary embolism 104.24 31.61 11 55371 76523 29442622
Renal failure 103.95 31.61 46 55336 118553 29400592
Insomnia 100.02 31.61 379 55003 88382 29430763
Multiple organ dysfunction syndrome 97.49 31.61 5 55377 63111 29456034
Seizure 97.22 31.61 27 55355 93096 29426049
Hyperkalaemia 94.40 31.61 5 55377 61387 29457758
Unevaluable event 92.46 31.61 185 55197 29666 29489479
Arthritis 92.24 31.61 167 55215 24852 29494293
White blood cell count decreased 91.16 31.61 22 55360 83340 29435805
Gastrointestinal haemorrhage 88.93 31.61 20 55362 79513 29439632
Deep vein thrombosis 87.24 31.61 5 55377 57394 29461751
Syncope 86.04 31.61 23 55359 81348 29437797
Tachycardia 85.53 31.61 16 55366 72394 29446751
Interstitial lung disease 79.35 31.61 8 55374 57710 29461435
Tongue disorder 78.63 31.61 67 55315 4569 29514576
Asthenia 78.42 31.61 180 55202 215070 29304075
Disease progression 77.92 31.61 28 55354 81888 29437257
Septic shock 75.67 31.61 13 55369 62547 29456598
Death 74.43 31.61 359 55023 341725 29177420
Hypokalaemia 71.57 31.61 6 55376 50197 29468948
Tendonitis 71.04 31.61 81 55301 7880 29511265
Oxygen saturation decreased 68.02 31.61 4 55378 44933 29474212
Treatment failure 67.28 31.61 186 55196 36753 29482392
Mood swings 66.79 31.61 75 55307 7176 29511969
Rhinorrhoea 66.19 31.61 133 55249 21386 29497759
C-reactive protein abnormal 66.09 31.61 71 55311 6465 29512680
Drug intolerance 65.94 31.61 220 55162 48159 29470986
Sinus headache 65.90 31.61 33 55349 895 29518250
Neuropathy peripheral 64.67 31.61 26 55356 71001 29448144
Dehydration 64.34 31.61 72 55310 114676 29404469
Hypoxia 64.01 31.61 7 55375 47372 29471773
General physical health deterioration 63.97 31.61 59 55323 102798 29416347
Alanine aminotransferase abnormal 63.39 31.61 49 55333 2908 29516237
Decreased appetite 62.07 31.61 475 54907 144867 29374278
Acute myocardial infarction 60.97 31.61 9 55373 48429 29470716
Sinusitis 59.64 31.61 170 55212 34180 29484965
Feeling abnormal 59.22 31.61 230 55152 54215 29464930
Arthropathy 59.01 31.61 127 55255 21427 29497718
Loss of consciousness 58.40 31.61 33 55349 74023 29445122
Plasma cell myeloma 57.11 31.61 3 55379 37112 29482033
Synovitis 56.77 31.61 85 55297 10805 29508340
Cardiac failure congestive 56.38 31.61 37 55345 76544 29442601
Renal impairment 56.31 31.61 42 55340 81291 29437854
Loss of personal independence in daily activities 54.37 31.61 136 55246 25304 29493841
Haematuria 53.75 31.61 9 55373 44130 29475015
Cardiac failure 53.54 31.61 42 55340 79245 29439900
Atrial fibrillation 52.20 31.61 73 55309 105573 29413572
Hepatic function abnormal 50.10 31.61 7 55375 39252 29479893
Vomiting 49.59 31.61 611 54771 211649 29307496
Product use issue 48.20 31.61 18 55364 51426 29467719
Respiratory distress 48.16 31.61 3 55379 32103 29487042
Coma 48.13 31.61 8 55374 39442 29479703
Dyspnoea exertional 47.77 31.61 6 55376 36484 29482661
Oedema 47.67 31.61 9 55373 40474 29478671
Pulmonary oedema 47.24 31.61 11 55371 42724 29476421
Influenza 47.23 31.61 179 55203 41702 29477443
Adverse reaction 46.84 31.61 40 55342 2735 29516410
Depressed mood 46.27 31.61 98 55284 16350 29502795
Mental status changes 45.10 31.61 6 55376 34921 29484224
Leukopenia 44.38 31.61 24 55358 55179 29463966
Hyperglycaemia 44.02 31.61 6 55376 34281 29484864
Coronary artery disease 43.92 31.61 14 55368 44176 29474969
Chest pain 43.69 31.61 90 55292 111883 29407262
Encephalopathy 43.45 31.61 4 55378 31039 29488106
Infusion related reaction 43.45 31.61 14 55368 43872 29475273
Blood bilirubin increased 43.35 31.61 6 55376 33887 29485258
Epistaxis 42.27 31.61 22 55360 51682 29467463
Stomatitis 42.14 31.61 9 55373 37104 29482041
Lactic acidosis 42.07 31.61 4 55378 30243 29488902
Weight increased 41.98 31.61 49 55333 76618 29442527
Bowel movement irregularity 41.65 31.61 35 55347 2341 29516804
Therapy partial responder 41.56 31.61 50 55332 5149 29513996
Chronic kidney disease 41.00 31.61 9 55373 36407 29482738
Pneumonitis 40.95 31.61 3 55379 28041 29491104
Dysphagia 39.80 31.61 27 55355 54899 29464246
Intentional product use issue 39.59 31.61 15 55367 42483 29476662
Blood urea increased 38.36 31.61 4 55378 28108 29491037
Muscular weakness 38.07 31.61 36 55346 62016 29457129
Somnolence 37.95 31.61 74 55308 93881 29425264
Stress 37.92 31.61 107 55275 21383 29497762
Jaundice 37.91 31.61 5 55377 29291 29489854
Rash macular 37.66 31.61 69 55313 10356 29508789
Chills 37.51 31.61 47 55335 71253 29447892
Myocardial infarction 37.10 31.61 96 55286 110200 29408945
Skin exfoliation 36.35 31.61 109 55273 22536 29496609
Adverse event 36.15 31.61 85 55297 15206 29503939
Skin irritation 35.82 31.61 43 55339 4418 29514727
Muscle swelling 35.69 31.61 16 55366 336 29518809
Acute respiratory failure 35.40 31.61 4 55378 26398 29492747
Skin fissures 35.18 31.61 40 55342 3879 29515266
Cerebral infarction 35.02 31.61 3 55379 24672 29494473
Anaphylactic reaction 34.98 31.61 5 55377 27568 29491577
Therapy cessation 34.85 31.61 81 55301 14381 29504764
Injection site pain 34.60 31.61 9 55373 32437 29486708
Rash maculo-papular 34.34 31.61 3 55379 24286 29494859
Nasal congestion 34.29 31.61 95 55287 18784 29500361
Blood alkaline phosphatase increased 34.12 31.61 6 55376 28400 29490745
Off label use 34.02 31.61 380 55002 300420 29218725
Urinary retention 33.72 31.61 9 55373 31889 29487256
Gamma-glutamyltransferase increased 33.57 31.61 5 55377 26732 29492413
Suicidal ideation 33.23 31.61 141 55241 34575 29484570
Haemorrhage 32.86 31.61 22 55360 45050 29474095
Liver function test abnormal 32.85 31.61 7 55375 28911 29490234
Drug effect less than expected 31.84 31.61 13 55369 215 29518930

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
Diarrhoea 12608.15 25.83 10434 110055 712270 63665973
Nausea 9652.44 25.83 9327 111162 776473 63601770
Headache 8268.17 25.83 7211 113278 522256 63855987
Product dose omission issue 7956.38 25.83 4772 115717 189975 64188268
Abdominal discomfort 3569.34 25.83 2849 117640 179473 64198770
Psoriatic arthropathy 1350.02 25.83 899 119590 42382 64335861
Depression 1065.33 25.83 1501 118988 181790 64196453
Drug ineffective 1025.86 25.83 3659 116830 836588 63541655
Psoriasis 958.50 25.83 904 119585 70799 64307444
Abdominal pain upper 947.46 25.83 1386 119103 173644 64204599
Therapy non-responder 837.33 25.83 808 119681 65091 64313152
Adverse drug reaction 802.27 25.83 671 119818 44793 64333450
Frequent bowel movements 783.59 25.83 465 120024 17840 64360403
Weight decreased 777.42 25.83 1673 118816 284066 64094177
Acute kidney injury 722.18 25.83 27 120462 449213 63929030
Gastric disorder 669.85 25.83 503 119986 28694 64349549
Toxicity to various agents 628.76 25.83 10 120479 363503 64014740
Drug interaction 548.50 25.83 32 120457 362051 64016192
Hypotension 525.45 25.83 52 120437 380922 63997321
Migraine 516.59 25.83 611 119878 62066 64316177
Anaemia 493.77 25.83 63 120426 378617 63999626
Dyspepsia 439.44 25.83 640 119849 79672 64298571
Dyspnoea 436.87 25.83 421 120068 718253 63659990
Neutropenia 408.25 25.83 8 120481 239616 64138627
Product supply issue 386.33 25.83 131 120358 1248 64376995
Tension headache 386.24 25.83 167 120322 3216 64375027
Completed suicide 368.87 25.83 11 120478 224403 64153840
Enthesopathy 366.48 25.83 227 120262 9411 64368832
Pyrexia 359.55 25.83 310 120179 558334 63819909
Rash 355.82 25.83 1744 118745 456805 63921438
Thrombocytopenia 334.92 25.83 21 120468 223780 64154463
Arthralgia 334.45 25.83 1670 118819 440590 63937653
Faeces soft 326.81 25.83 177 120312 5678 64372565
Febrile neutropenia 320.65 25.83 6 120483 187651 64190592
Insomnia 317.88 25.83 950 119539 196886 64181357
Confusional state 294.60 25.83 64 120425 261080 64117163
Product administration interrupted 275.75 25.83 97 120392 1041 64377202
Therapeutic product effect decreased 272.92 25.83 640 119849 114711 64263532
Haemoglobin decreased 272.89 25.83 25 120464 195038 64183205
Gastrointestinal disorder 264.71 25.83 544 119945 89165 64289078
Vomiting 261.88 25.83 1842 118647 549275 63828968
Tenosynovitis 260.54 25.83 199 120290 11634 64366609
Respiratory failure 241.45 25.83 15 120474 161168 64217075
Flatulence 241.22 25.83 315 120174 35351 64342892
Cardiac arrest 234.85 25.83 13 120476 154051 64224192
Sepsis 228.32 25.83 73 120416 230268 64147975
Platelet count decreased 227.99 25.83 24 120465 167687 64210556
Decreased appetite 225.54 25.83 1081 119408 280208 64098035
White blood cell count decreased 224.07 25.83 19 120470 157818 64220425
Upper respiratory tract infection 223.75 25.83 449 120040 72336 64305907
Pancytopenia 215.66 25.83 13 120476 143296 64234947
Pleural effusion 208.60 25.83 6 120483 126553 64251690
Therapeutic product effect incomplete 205.45 25.83 537 119952 102945 64275298
Bradycardia 205.14 25.83 3 120486 118216 64260027
Overdose 204.16 25.83 28 120461 159538 64218705
Hypokalaemia 196.55 25.83 7 120482 121896 64256347
Fall 193.48 25.83 300 120189 416526 63961717
Pneumonia 191.52 25.83 482 120007 559094 63819149
Seizure 183.88 25.83 43 120446 166849 64211394
Stress 183.14 25.83 371 120118 60163 64318080
Disease progression 176.27 25.83 27 120462 141653 64236590
Renal failure 170.63 25.83 63 120426 181625 64196618
Tongue disorder 170.19 25.83 157 120332 11923 64366320
Hyperkalaemia 169.64 25.83 4 120485 101125 64277118
Multiple organ dysfunction syndrome 166.42 25.83 5 120484 101408 64276835
Syncope 165.20 25.83 45 120444 157590 64220653
Oxygen saturation decreased 163.45 25.83 9 120480 107167 64271076
Therapeutic response decreased 159.23 25.83 321 120168 51867 64326376
Mood altered 159.16 25.83 172 120317 15807 64362436
Oedema peripheral 155.05 25.83 101 120388 210216 64168027
Asthenia 151.54 25.83 362 120127 427682 63950561
Intentional overdose 145.56 25.83 5 120484 89939 64288304
Pulmonary embolism 143.86 25.83 47 120442 146309 64231934
Tachycardia 143.61 25.83 50 120439 149529 64228714
Coma 141.34 25.83 5 120484 87610 64290633
Gastrointestinal haemorrhage 140.09 25.83 37 120452 132275 64245968
COVID-19 139.56 25.83 348 120141 64792 64313451
Deep vein thrombosis 138.02 25.83 17 120472 105165 64273078
Hypoglycaemia 135.68 25.83 8 120481 89884 64288359
Septic shock 133.66 25.83 19 120470 105418 64272825
Death 132.93 25.83 460 120029 482245 63895998
Hypoxia 132.58 25.83 8 120481 88141 64290102
Tendonitis 132.28 25.83 176 120313 20106 64358137
Loss of consciousness 130.21 25.83 57 120432 148308 64229935
Leukopenia 128.91 25.83 18 120471 101224 64277019
Alanine aminotransferase abnormal 128.33 25.83 105 120384 6783 64371460
Cardiac failure 127.50 25.83 44 120445 132329 64245914
Interstitial lung disease 120.69 25.83 19 120470 97713 64280530
Red blood cell sedimentation rate 120.12 25.83 79 120410 3635 64374608
Treatment failure 120.06 25.83 484 120005 116332 64261911
Musculoskeletal stiffness 113.75 25.83 494 119995 122712 64255531
Somnolence 111.10 25.83 130 120359 203515 64174728
Arthritis 108.43 25.83 374 120115 83440 64294803
Unevaluable event 108.42 25.83 270 120219 50219 64328024
Blood parathyroid hormone decreased 108.18 25.83 98 120391 7268 64370975
Nasopharyngitis 103.70 25.83 674 119815 195399 64182844
Pruritus 103.52 25.83 963 119526 311437 64066806
Chest pain 102.61 25.83 177 120312 235803 64142440
Lactic acidosis 100.84 25.83 3 120486 61407 64316836
Neuropathy peripheral 100.22 25.83 47 120442 117478 64260765
Loss of personal independence in daily activities 96.95 25.83 327 120162 72127 64306116
Synovitis 96.62 25.83 404 120085 98686 64279557
Delirium 96.34 25.83 9 120480 69185 64309058
Panniculitis 96.27 25.83 100 120389 8779 64369464
Product use in unapproved indication 96.05 25.83 113 120376 176505 64201738
Cardiac failure congestive 95.78 25.83 63 120426 130517 64247726
Acute myocardial infarction 94.63 25.83 10 120479 69708 64308535
Dysarthria 93.73 25.83 4 120485 59402 64318841
Mental status changes 93.66 25.83 5 120484 61157 64317086
Pneumonia aspiration 93.49 25.83 4 120485 59267 64318976
Hyperglycaemia 93.31 25.83 5 120484 60963 64317280
Encephalopathy 92.67 25.83 4 120485 58815 64319428
Atrial fibrillation 92.46 25.83 110 120379 170979 64207264
Discomfort 91.94 25.83 346 120143 80532 64297711
Renal impairment 91.36 25.83 71 120418 134946 64243297
Granuloma skin 89.57 25.83 81 120408 5993 64372250
Blood creatine phosphokinase increased 89.01 25.83 5 120484 58553 64319690
Dehydration 88.49 25.83 169 120320 216594 64161649
Injection site pain 88.36 25.83 49 120440 111359 64266884
Muscle spasms 87.95 25.83 506 119983 140517 64237726
Rash pruritic 87.59 25.83 271 120218 57133 64321110
Pulmonary oedema 87.15 25.83 20 120469 78654 64299589
Rhinorrhoea 86.81 25.83 278 120211 59691 64318552
Respiratory arrest 85.53 25.83 3 120486 52982 64325261
Blood creatinine increased 84.99 25.83 77 120412 135705 64242538
Blood alkaline phosphatase increased 84.95 25.83 5 120484 56274 64321969
Adverse event 83.54 25.83 210 120279 39279 64338964
Dyspnoea exertional 83.16 25.83 18 120471 73712 64304531
Blood bilirubin increased 81.43 25.83 7 120482 57546 64320697
Pain 81.27 25.83 1468 119021 552043 63826200
C-reactive protein abnormal 80.75 25.83 172 120317 28875 64349368
Adverse reaction 80.53 25.83 85 120404 7602 64370641
Drug reaction with eosinophilia and systemic symptoms 78.36 25.83 6 120483 54211 64324032
Hepatic function abnormal 78.28 25.83 13 120476 64300 64313943
Dysphagia 77.70 25.83 52 120437 106760 64271483
Liver function test abnormal 76.94 25.83 10 120479 59391 64318852
Injection site erythema 76.45 25.83 19 120470 70781 64307462
Coronary artery disease 76.32 25.83 11 120478 60422 64317821
Rheumatic fever 75.48 25.83 90 120399 9204 64369039
Anaphylactic reaction 74.97 25.83 18 120471 68646 64309597
Melaena 74.45 25.83 7 120482 53541 64324702
Memory impairment 74.10 25.83 337 120152 85345 64292898
Plasma cell myeloma 73.03 25.83 3 120486 46072 64332171
Hallucination 72.16 25.83 23 120466 72765 64305478
Sinus headache 71.87 25.83 61 120428 4146 64374097
Red blood cell count decreased 70.95 25.83 5 120484 48381 64329862
Haematuria 69.77 25.83 14 120475 60457 64317786
Respiratory distress 69.77 25.83 8 120481 52323 64325920
Jaundice 68.36 25.83 6 120483 48506 64329737
Hepatocellular injury 68.33 25.83 4 120485 45231 64333012
Acute respiratory failure 68.18 25.83 7 120482 49927 64328316
Weight increased 67.98 25.83 190 120299 213158 64165085
Swollen joint count increased 66.67 25.83 77 120412 7612 64370631
Hepatic failure 65.66 25.83 12 120477 55382 64322861
Rheumatoid nodule 65.04 25.83 98 120391 12553 64365690
Oedema 63.90 25.83 47 120442 91888 64286355
Gastrooesophageal reflux disease 63.87 25.83 316 120173 82827 64295416
Cerebrovascular accident 63.67 25.83 99 120390 137484 64240759
Blood urea increased 63.49 25.83 5 120484 44148 64334095
Agitation 62.96 25.83 44 120445 88323 64289920
Cholestasis 62.03 25.83 6 120483 44866 64333377
Medication error 61.03 25.83 10 120479 49956 64328287
Dyskinesia 61.00 25.83 3 120486 39385 64338858
Heart rate decreased 60.98 25.83 14 120475 55053 64323190
Epistaxis 60.98 25.83 56 120433 98075 64280168
Acute respiratory distress syndrome 60.19 25.83 3 120486 38932 64339311
Mucosal inflammation 59.90 25.83 21 120468 62563 64315680
Urinary retention 59.76 25.83 10 120479 49191 64329052
Sinusitis 59.33 25.83 471 120018 145457 64232786
Generalised tonic-clonic seizure 58.78 25.83 4 120485 39853 64338390
Haemorrhage 58.56 25.83 38 120451 79313 64298930
Joint stiffness 58.46 25.83 156 120333 30248 64347995
Rash maculo-papular 58.37 25.83 9 120480 47017 64331226
Leukocytosis 58.05 25.83 3 120486 37737 64340506
Chronic kidney disease 57.95 25.83 18 120471 57901 64320342
Illness 57.66 25.83 127 120362 21811 64356432
Mood swings 57.55 25.83 111 120378 17357 64360886
Fatigue 57.32 25.83 1815 118674 746915 63631328
Skin irritation 57.22 25.83 78 120411 9116 64369127
Cognitive disorder 57.16 25.83 16 120473 55071 64323172
Myocardial infarction 57.13 25.83 142 120347 165679 64212564
Haematoma 57.07 25.83 9 120480 46241 64332002
Alopecia 56.90 25.83 515 119974 165175 64213068
Muscular weakness 56.69 25.83 94 120395 127244 64250999
Cerebral haemorrhage 56.55 25.83 13 120476 51077 64327166
Ear infection 56.51 25.83 131 120358 23273 64354970
Disorientation 56.49 25.83 17 120472 55811 64322432
Speech disorder 56.34 25.83 11 120478 48430 64329813
Hepatotoxicity 56.16 25.83 5 120484 39957 64338286
Fear of injection 56.02 25.83 62 120427 5850 64372393
Skin necrosis 55.97 25.83 98 120391 14231 64364012
Balance disorder 55.66 25.83 45 120444 83881 64294362
Pneumonitis 55.38 25.83 13 120476 50352 64327891
Pericardial effusion 54.92 25.83 5 120484 39249 64338994
Hepatitis 53.76 25.83 10 120479 45572 64332671
Flushing 53.64 25.83 41 120448 78607 64299636
Orthostatic hypotension 53.55 25.83 11 120478 46727 64331516
Body tinea 53.10 25.83 32 120457 1261 64376982
Chills 52.57 25.83 111 120378 137153 64241090
Gamma-glutamyltransferase increased 52.40 25.83 13 120476 48497 64329746
Drug intolerance 51.28 25.83 557 119932 187435 64190808
Cerebral infarction 50.61 25.83 8 120481 41036 64337207
Paraesthesia 50.50 25.83 110 120379 134412 64243831
Aphasia 50.38 25.83 8 120481 40898 64337345
Lower respiratory tract infection 49.85 25.83 62 120427 94552 64283691
White blood cell count increased 49.55 25.83 31 120458 65983 64312260
Pallor 49.11 25.83 7 120482 38774 64339469
Constipation 48.34 25.83 242 120247 229095 64149148
Blood pressure decreased 48.08 25.83 54 120435 86145 64292098
Drug resistance 47.72 25.83 5 120484 35097 64343146
Rebound psoriasis 47.60 25.83 16 120473 148 64378095
Fluid retention 47.56 25.83 26 120463 59580 64318663
Pancreatitis acute 47.24 25.83 11 120478 42844 64335399
Colitis 46.23 25.83 26 120463 58648 64319595
Dactylitis 45.78 25.83 34 120455 1904 64376339
Arthropathy 45.68 25.83 384 120105 120583 64257660
Circulatory collapse 45.36 25.83 5 120484 33727 64344516
Ulcer 45.25 25.83 119 120370 22871 64355372
Feeling abnormal 45.21 25.83 414 120075 133188 64245055
Epilepsy 45.01 25.83 5 120484 33526 64344717
Multiple sclerosis relapse 44.48 25.83 11 120478 41124 64337119
Full blood count abnormal 43.84 25.83 3 120486 29754 64348489
Stevens-Johnson syndrome 43.79 25.83 6 120483 34243 64344000
Abdominal distension 43.57 25.83 318 120171 95676 64282567
Injection site swelling 42.92 25.83 12 120477 41341 64336902
Intentional self-injury 42.58 25.83 3 120486 29041 64349202
Therapy partial responder 42.53 25.83 72 120417 10176 64368067
Urinary incontinence 42.48 25.83 8 120481 36143 64342100
Suicide attempt 42.38 25.83 42 120447 70965 64307278
Blood pressure fluctuation 42.31 25.83 22 120467 51849 64326394
Joint dislocation 41.69 25.83 76 120413 11389 64366854
Angioedema 41.18 25.83 33 120456 61788 64316455
Therapy interrupted 40.76 25.83 105 120384 19931 64358312
Proteinuria 40.25 25.83 3 120486 27720 64350523
Influenza 40.13 25.83 338 120151 106193 64272050
Hypothyroidism 39.71 25.83 13 120476 40444 64337799
Visual acuity reduced 39.23 25.83 3 120486 27138 64351105
Bone erosion 38.59 25.83 74 120415 11521 64366722
Drug effect less than expected 38.23 25.83 19 120470 508 64377735
Defaecation urgency 38.08 25.83 42 120447 3947 64374296
Infection susceptibility increased 37.56 25.83 35 120454 2691 64375552
Ischaemic stroke 37.33 25.83 5 120484 29030 64349213
Retinitis 37.20 25.83 31 120458 2054 64376189
Aggression 37.13 25.83 20 120469 46212 64332031
Exostosis 36.84 25.83 72 120417 11366 64366877
Bowel movement irregularity 36.62 25.83 45 120444 4748 64373495
Asthma 36.46 25.83 77 120412 95148 64283095
Blood calcium decreased 36.44 25.83 3 120486 25551 64352692
Skin plaque 36.03 25.83 62 120427 8878 64369365
Impaired healing 35.82 25.83 36 120453 60437 64317806
Nasal congestion 35.81 25.83 212 120277 59446 64318797
Red blood cell sedimentation rate increased 35.78 25.83 134 120355 31101 64347142
Device related infection 35.52 25.83 7 120482 30619 64347624
Acute myeloid leukaemia 34.67 25.83 5 120484 27458 64350785
Depressed mood 34.47 25.83 160 120329 40852 64337391
Thrombosis 34.45 25.83 49 120440 70593 64307650
Rash macular 34.44 25.83 110 120379 23575 64354668
Arrhythmia 34.35 25.83 29 120460 52915 64325328
Diabetic ketoacidosis 34.24 25.83 7 120482 29838 64348405
Psychotic disorder 34.13 25.83 11 120478 34567 64343676
Injection site pruritus 34.01 25.83 14 120475 37812 64340431
Exposure during pregnancy 33.95 25.83 58 120431 77617 64300626
Lung disorder 33.87 25.83 38 120451 60662 64317581
Vision blurred 33.77 25.83 74 120415 90242 64288001
Blood sodium decreased 33.65 25.83 7 120482 29475 64348768
Cardiomyopathy 33.49 25.83 4 120485 25352 64352891
Electrolyte imbalance 33.30 25.83 4 120485 25239 64353004
Cardiomegaly 33.18 25.83 3 120486 23681 64354562
Stomatitis 33.13 25.83 100 120389 109505 64268738
Haemoptysis 32.89 25.83 26 120463 49022 64329221
Candida infection 32.83 25.83 9 120480 31410 64346833
Abnormal behaviour 32.66 25.83 11 120478 33611 64344632
Myelodysplastic syndrome 32.63 25.83 6 120483 27573 64350670
Body temperature decreased 32.09 25.83 5 120484 25923 64352320
Rectal haemorrhage 32.05 25.83 41 120448 61776 64316467
Gastroenteritis viral 31.82 25.83 95 120394 19634 64358609
Intentional product misuse 31.38 25.83 237 120252 72058 64306185
Adrenal insufficiency 31.10 25.83 3 120486 22484 64355759
Skin disorder 31.08 25.83 118 120371 27562 64350681
Skin fissures 30.95 25.83 63 120426 10243 64368000
Accidental exposure to product 30.63 25.83 6 120483 26358 64351885
Skin exfoliation 30.57 25.83 165 120324 44720 64333523
Suicidal ideation 30.51 25.83 221 120268 66321 64311922
Sleep apnoea syndrome 30.33 25.83 9 120480 29823 64348420
Basal cell carcinoma 30.24 25.83 126 120363 30712 64347531
Haematemesis 30.17 25.83 26 120463 46973 64331270
Femur fracture 30.10 25.83 13 120476 34122 64344121
Presyncope 29.95 25.83 14 120475 35075 64343168
Gastrointestinal pain 29.84 25.83 52 120437 7522 64370721
Bronchospasm 29.70 25.83 3 120486 21679 64356564
Feeling jittery 29.58 25.83 63 120426 10572 64367671
Intentional product use issue 28.83 25.83 87 120402 95277 64282966
Hepatic encephalopathy 28.64 25.83 3 120486 21063 64357180
Tubulointerstitial nephritis 28.51 25.83 11 120478 30898 64347345
Multiple allergies 28.42 25.83 44 120445 5770 64372473
Blood potassium increased 27.99 25.83 7 120482 25973 64352270
Osteonecrosis 27.83 25.83 9 120480 28220 64350023
Blood potassium decreased 27.62 25.83 21 120468 40378 64337865
Iron deficiency anaemia 27.60 25.83 4 120485 21885 64356358
Bacteraemia 27.58 25.83 8 120481 26903 64351340
Chronic obstructive pulmonary disease 27.57 25.83 57 120432 70991 64307252
Urinary tract infection 27.53 25.83 288 120201 231308 64146935
Lymphopenia 27.47 25.83 7 120482 25650 64352593
Intestinal obstruction 27.28 25.83 17 120472 36269 64341974
Ileus 27.16 25.83 5 120484 22961 64355282
Chest discomfort 26.50 25.83 119 120370 115987 64262256
Hepatic cirrhosis 26.22 25.83 108 120381 26190 64352053
Sinus disorder 25.94 25.83 80 120409 16828 64361415
Generalised oedema 25.86 25.83 4 120485 20849 64357394

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA32 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D058988 Phosphodiesterase 4 Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:68844 phosphodiesterase IV inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Psoriasis with arthropathy indication 33339001
Plaque psoriasis indication 200965009
Behçet's disease affecting oral mucosa indication 403443000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7208516 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8802717 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7208516 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8802717 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 6962940 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7208516 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 7659302 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8455536 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 8802717 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9018243 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 TREATMENT OF PATIENTS WITH PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9724330 March 19, 2023 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE USING A DOSAGE TITRATION SCHEDULE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE USING A DOSAGE TITRATION SCHEDULE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE USING A DOSAGE TITRATION SCHEDULE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 10092541 May 29, 2034 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS USING A DOSAGE TITRATION SCHEDULE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 9872854 May 29, 2034 TREATMENT OF PSORIATIC ARTHRITIS WITH APREMILAST USING A DOSAGE TITRATION SCHEDULE AND A SECOND ACTIVE AGENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2022 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2022 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2022 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 10, 2023 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 10, 2023 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 10, 2023 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Dec. 20, 2024 REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Dec. 20, 2024 REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Dec. 20, 2024 REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2026 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2026 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 19, 2026 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
cAMP-specific 3',5'-cyclic phosphodiesterase 4D Enzyme INHIBITOR IC50 7.13 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
cAMP-specific 3',5'-cyclic phosphodiesterase 4B Enzyme INHIBITOR IC50 7.57 IUPHAR
cAMP-specific 3',5'-cyclic phosphodiesterase 4A Enzyme INHIBITOR IC50 7.85 IUPHAR
cAMP-specific 3',5'-cyclic phosphodiesterase 4C Enzyme INHIBITOR IC50 6.93 IUPHAR

External reference:

IDSource
UP7QBP99PN UNII
D08860 KEGG_DRUG
4033216 VUID
N0000190644 NUI
4033216 VANDF
C1678805 UMLSCUI
CHEBI:78540 CHEBI
A9L PDB_CHEM_ID
CHEMBL514800 ChEMBL_ID
11561674 PUBCHEM_CID
DB05676 DRUGBANK_ID
8872 INN_ID
C505730 MESH_SUPPLEMENTAL_RECORD_UI
7372 IUPHAR_LIGAND_ID
1492727 RXNORM
213427 MMSL
30225 MMSL
d08247 MMSL
015411 NDDF
703350008 SNOMEDCT_US
714684002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 55513-137 TABLET, FILM COATED 30 mg ORAL NDA 28 sections
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 55513-137 TABLET, FILM COATED 30 mg ORAL NDA 28 sections
OTEZLA HUMAN PRESCRIPTION DRUG LABEL 1 59572-631 TABLET, FILM COATED 30 mg ORAL NDA 25 sections
APREMILAST HUMAN PRESCRIPTION DRUG LABEL 1 60219-1410 TABLET, FILM COATED 30 mg ORAL ANDA 24 sections
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 70518-3155 TABLET, FILM COATED 30 mg ORAL NDA 28 sections