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
CL (Clearance) 2.42 mL/min/kg Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 0.73 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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 10625.87 24.07 10948 153261 704418 62620395
Nausea 9027.17 24.07 10952 153257 843519 62481294
Product dose omission issue 7283.80 24.07 5488 158721 228825 63095988
Headache 6931.22 24.07 8291 155918 624950 62699863
Abdominal discomfort 1923.64 24.07 3169 161040 317716 63007097
Drug ineffective 1592.44 24.07 6085 158124 1038680 62286133
Therapy non-responder 1355.68 24.07 1299 162910 74602 63250211
Depression 1273.02 24.07 2013 162196 194479 63130334
Adverse drug reaction 1266.85 24.07 1280 162929 78434 63246379
Psoriatic arthropathy 1059.92 24.07 1244 162965 90276 63234537
Psoriasis 821.31 24.07 1067 163142 85890 63238923
Abdominal pain upper 724.52 24.07 1628 162581 204816 63119997
Gastric disorder 695.96 24.07 655 163554 36714 63288099
Weight decreased 638.69 24.07 1863 162346 274935 63049878
Acute kidney injury 634.74 24.07 9 164200 263406 63061407
Toxicity to various agents 585.01 24.07 11 164198 247239 63077574
Dyspnoea 556.71 24.07 536 163673 660777 62664036
Anaemia 511.78 24.07 75 164134 293355 63031458
Hypotension 493.60 24.07 62 164147 272542 63052271
Migraine 450.24 24.07 891 163318 102455 63222358
Drug interaction 440.38 24.07 42 164167 229089 63095724
Frequent bowel movements 425.61 24.07 402 163807 22620 63302193
Neutropenia 421.30 24.07 6 164203 174999 63149814
Pyrexia 358.47 24.07 414 163795 470064 62854749
Vomiting 345.27 24.07 2550 161659 557067 62767746
Thrombocytopenia 341.12 24.07 11 164198 151146 63173667
Rash 340.50 24.07 2546 161663 558325 62766488
Dyspepsia 328.11 24.07 779 163430 101417 63223396
Decreased appetite 300.80 24.07 1366 162843 249686 63075127
Haemoglobin decreased 278.53 24.07 27 164182 145458 63179355
Hypokalaemia 252.21 24.07 3 164206 103801 63221012
Therapeutic product effect decreased 249.28 24.07 1075 163134 192112 63132701
White blood cell count decreased 248.27 24.07 33 164176 139071 63185742
Tension headache 247.63 24.07 159 164050 5027 63319786
Fall 246.34 24.07 397 163812 391937 62932876
Stress 245.42 24.07 539 163670 66628 63258185
Product supply issue 238.87 24.07 108 164101 1647 63323166
Insomnia 235.53 24.07 1141 163068 214111 63110702
Pancytopenia 234.62 24.07 3 164206 96930 63227883
Product administration interrupted 227.78 24.07 147 164062 4689 63320124
Platelet count decreased 221.07 24.07 22 164187 116100 63208713
Enthesopathy 218.43 24.07 180 164029 8434 63316379
Disease progression 214.63 24.07 31 164178 122727 63202086
Pleural effusion 213.09 24.07 6 164203 93204 63231609
Cardiac arrest 207.80 24.07 7 164202 92538 63232275
Death 206.91 24.07 410 163799 373971 62950842
Sepsis 206.80 24.07 69 164140 153054 63171759
Upper respiratory tract infection 203.82 24.07 568 163641 81479 63243334
Respiratory failure 197.33 24.07 18 164191 101840 63222973
Seizure 197.02 24.07 50 164159 132584 63192229
Oxygen saturation decreased 194.43 24.07 8 164201 88577 63236236
Malignant neoplasm progression 192.64 24.07 4 164205 82117 63242696
Therapeutic response decreased 185.58 24.07 458 163751 61067 63263746
Therapeutic product effect incomplete 184.92 24.07 726 163483 124330 63200483
Gastrointestinal disorder 181.37 24.07 746 163463 130493 63194320
Arthralgia 181.19 24.07 2258 161951 567452 62757361
Confusional state 174.27 24.07 213 163996 236167 63088646
Bradycardia 174.07 24.07 3 164206 73224 63251589
Bone erosion 171.06 24.07 220 163989 17497 63307316
Asthenia 168.85 24.07 474 163735 383130 62941683
Loss of consciousness 167.03 24.07 49 164160 118072 63206741
Pulmonary embolism 165.74 24.07 48 164161 116636 63208177
Syncope 165.43 24.07 49 164160 117336 63207477
Intentional overdose 165.11 24.07 6 164203 74146 63250667
Faeces soft 163.59 24.07 128 164081 5564 63319249
Injection site pain 162.58 24.07 66 164143 129734 63195079
Renal failure 162.40 24.07 51 164158 117601 63207212
Leukopenia 157.11 24.07 11 164198 77279 63247534
Deep vein thrombosis 156.59 24.07 17 164192 83783 63241030
Rheumatic fever 152.97 24.07 342 163867 42769 63282044
Coma 151.51 24.07 3 164206 64361 63260452
Somnolence 145.93 24.07 148 164061 178537 63146276
Neuropathy peripheral 143.65 24.07 57 164152 113610 63211203
Exostosis 140.81 24.07 201 164008 17661 63307152
Joint dislocation 138.67 24.07 205 164004 18595 63306218
Injection site erythema 138.60 24.07 24 164185 83150 63241663
Tenosynovitis 137.44 24.07 174 164035 13621 63311192
Septic shock 136.84 24.07 9 164200 66620 63258193
Hypoxia 136.10 24.07 4 164205 59788 63265025
Cardiac failure 135.49 24.07 32 164177 89110 63235703
Overdose 133.91 24.07 65 164144 115013 63209800
Multiple organ dysfunction syndrome 132.18 24.07 3 164206 56749 63268064
Adverse event 127.67 24.07 425 163784 67134 63257679
Unevaluable event 126.84 24.07 355 163854 51031 63273782
Hyperkalaemia 125.72 24.07 3 164206 54200 63270613
Oedema peripheral 124.21 24.07 186 164023 189325 63135488
Tachycardia 122.62 24.07 77 164132 118079 63206734
Pneumonia 120.54 24.07 691 163518 456076 62868737
Atrial fibrillation 115.64 24.07 80 164129 116556 63208257
Gastrointestinal haemorrhage 114.15 24.07 34 164175 81142 63243671
Dehydration 112.77 24.07 171 164038 173183 63151630
Musculoskeletal stiffness 109.55 24.07 835 163374 183783 63141030
Interstitial lung disease 107.33 24.07 16 164193 61892 63262921
Balance disorder 107.21 24.07 42 164167 84380 63240433
Joint stiffness 107.03 24.07 293 163916 41576 63283237
International normalised ratio increased 106.05 24.07 3 164206 46422 63278391
Hypoglycaemia 105.35 24.07 15 164194 60050 63264763
Cardiac failure congestive 104.84 24.07 54 164155 92379 63232434
Mucosal inflammation 103.77 24.07 4 164205 46924 63277889
Pulmonary oedema 100.33 24.07 12 164197 54861 63269952
Cognitive disorder 100.12 24.07 13 164196 55802 63269011
Mood altered 99.14 24.07 154 164055 14589 63310224
Flatulence 99.02 24.07 253 163956 34449 63290364
Adverse reaction 98.97 24.07 127 164082 10076 63314737
Swollen joint count increased 98.91 24.07 259 163950 35795 63289018
Blood alkaline phosphatase increased 93.87 24.07 4 164205 42963 63281850
Constipation 93.68 24.07 285 163924 224658 63100155
Dysphagia 92.91 24.07 57 164152 88528 63236285
Retinitis 91.90 24.07 96 164113 6100 63318713
Tongue disorder 90.76 24.07 124 164085 10456 63314357
Anaphylactic reaction 90.57 24.07 29 164180 66071 63258742
Red blood cell sedimentation rate 90.14 24.07 85 164124 4769 63320044
Ascites 88.29 24.07 4 164205 40724 63284089
Dyspnoea exertional 87.10 24.07 24 164185 60278 63264535
Pruritus 85.95 24.07 1362 162847 360091 62964722
Heart rate decreased 85.72 24.07 9 164200 45551 63279262
Flushing 84.95 24.07 44 164165 75043 63249770
Malaise 84.94 24.07 1529 162680 414425 62910388
Pulmonary hypertension 82.64 24.07 3 164206 37120 63287693
Hyperglycaemia 82.15 24.07 7 164202 41860 63282953
Type 2 diabetes mellitus 81.88 24.07 355 163854 63513 63261300
Dysarthria 81.50 24.07 8 164201 42703 63282110
Blood pressure decreased 81.49 24.07 33 164176 64989 63259824
Weight increased 80.82 24.07 373 163836 260419 63064394
Blood parathyroid hormone decreased 79.86 24.07 112 164097 9679 63315134
Plasma cell myeloma 79.59 24.07 3 164206 35902 63288911
Mental status changes 79.42 24.07 6 164203 39593 63285220
Chest discomfort 78.96 24.07 101 164108 109868 63214945
Liver function test abnormal 77.90 24.07 15 164194 48166 63276647
Hepatic cirrhosis 77.61 24.07 187 164022 24547 63300266
Deep vein thrombosis postoperative 76.79 24.07 119 164090 11250 63313563
Red blood cell count decreased 76.55 24.07 8 164201 40637 63284176
Injection site swelling 76.51 24.07 15 164194 47557 63277256
Multiple sclerosis relapse 76.48 24.07 16 164193 48462 63276351
Foot deformity 76.31 24.07 200 164009 27653 63297160
Pneumonia aspiration 76.18 24.07 3 164206 34537 63290276
Vision blurred 75.16 24.07 76 164133 91848 63232965
Angioedema 73.30 24.07 17 164192 47948 63276865
Injection site pruritus 73.04 24.07 14 164195 45102 63279711
Acute respiratory failure 72.80 24.07 4 164205 34481 63290332
Cerebrovascular accident 72.71 24.07 104 164105 107920 63216893
Rebound psoriasis 72.06 24.07 22 164187 98 63324715
Hallucination 71.72 24.07 26 164183 54791 63270022
Exposure during pregnancy 71.42 24.07 188 164021 155359 63169454
No adverse event 71.09 24.07 11 164198 41394 63283419
Paraesthesia 70.35 24.07 192 164017 156774 63168039
Acute myocardial infarction 70.14 24.07 3 164206 32121 63292692
Panniculitis 69.78 24.07 114 164095 11271 63313542
C-reactive protein abnormal 69.18 24.07 269 163940 45827 63278986
Arthritis 68.53 24.07 524 163685 115397 63209416
Drug reaction with eosinophilia and systemic symptoms 68.22 24.07 5 164204 33831 63290982
Blood pressure fluctuation 67.71 24.07 18 164191 46299 63278514
Chest pain 67.41 24.07 308 163901 215651 63109162
Dyskinesia 66.67 24.07 4 164205 31998 63292815
Foetal exposure during pregnancy 66.57 24.07 4 164205 31958 63292855
Lower respiratory tract infection 66.15 24.07 153 164056 132154 63192659
Muscle spasms 65.78 24.07 655 163554 155495 63169318
Respiratory distress 65.73 24.07 6 164203 33945 63290868
Hypothyroidism 65.37 24.07 15 164194 42617 63282196
Chills 65.22 24.07 121 164088 113257 63211556
Granuloma skin 65.12 24.07 94 164115 8343 63316470
Hepatic failure 64.69 24.07 8 164201 35648 63289165
Coronary artery disease 64.67 24.07 5 164204 32372 63292441
Hepatotoxicity 63.23 24.07 10 164199 37031 63287782
Urinary tract infection 63.09 24.07 413 163796 264271 63060542
Blood creatine phosphokinase increased 62.80 24.07 4 164205 30426 63294387
Therapy cessation 62.39 24.07 197 164012 30260 63294553
Therapy interrupted 62.03 24.07 205 164004 32250 63292563
Suicide attempt 61.41 24.07 41 164168 60877 63263936
Aphasia 60.86 24.07 7 164202 32993 63291820
Myocardial infarction 60.72 24.07 103 164106 99790 63225023
Red blood cell sedimentation rate increased 60.66 24.07 250 163959 43732 63281081
Ear infection 60.64 24.07 227 163982 37986 63286827
Renal impairment 60.52 24.07 84 164125 88271 63236542
Chronic kidney disease 60.30 24.07 21 164188 45377 63279436
Pallor 60.27 24.07 5 164204 30563 63294250
Tendonitis 60.15 24.07 147 164062 19468 63305345
Body tinea 59.89 24.07 45 164164 1840 63322973
Urinary retention 59.63 24.07 5 164204 30296 63294517
Lymphocyte count decreased 59.52 24.07 5 164204 30252 63294561
Orthostatic hypotension 59.00 24.07 11 164198 36149 63288664
Urinary incontinence 58.53 24.07 7 164202 32007 63292806
Blood cholesterol increased 58.36 24.07 430 163779 93602 63231211
Disorientation 58.30 24.07 15 164194 39437 63285376
Hepatic function abnormal 57.09 24.07 13 164196 37129 63287684
Fluid retention 56.45 24.07 43 164166 59643 63265170
Pericardial effusion 56.39 24.07 6 164203 30052 63294761
Gamma-glutamyltransferase increased 56.29 24.07 10 164199 34021 63290792
Haematoma 55.95 24.07 11 164198 34809 63290004
Thrombosis 55.88 24.07 51 164158 64704 63260109
Rash maculo-papular 55.85 24.07 8 164201 31888 63292925
Agitation 55.31 24.07 44 164165 59713 63265100
Drug effect less than expected 55.18 24.07 41 164168 1648 63323165
Epistaxis 55.15 24.07 64 164145 72661 63252152
Treatment failure 55.01 24.07 770 163439 198273 63126540
Discomfort 54.84 24.07 668 163541 166706 63158107
Pancreatitis acute 54.81 24.07 4 164205 27162 63297651
Melaena 54.63 24.07 7 164202 30358 63294455
Maternal exposure during pregnancy 54.15 24.07 340 163869 219722 63105091
Autoimmune disorder 54.03 24.07 130 164079 17047 63307766
Blood calcium decreased 53.07 24.07 4 164205 26447 63298366
Blood urea increased 52.89 24.07 4 164205 26375 63298438
Pneumonitis 52.81 24.07 13 164196 35209 63289604
Skin necrosis 52.10 24.07 113 164096 13837 63310976
Speech disorder 51.93 24.07 20 164189 40609 63284204
Loss of personal independence in daily activities 50.53 24.07 427 163782 96863 63227950
Haematuria 49.48 24.07 8 164201 29149 63295664
Femur fracture 49.45 24.07 23 164186 41733 63283080
Metastases to liver 49.11 24.07 3 164206 23636 63301177
Skin disorder 49.09 24.07 178 164031 29329 63295484
Mobility decreased 48.98 24.07 504 163705 120655 63204158
Cerebral haemorrhage 48.76 24.07 10 164199 30719 63294094
Blood creatinine increased 48.55 24.07 96 164113 87748 63237065
Alanine aminotransferase abnormal 48.37 24.07 59 164150 4445 63320368
Memory impairment 47.66 24.07 445 163764 103813 63221000
Anti-cyclic citrullinated peptide antibody 47.42 24.07 72 164137 6686 63318127
Sleep apnoea syndrome 47.24 24.07 9 164200 29124 63295689
White blood cell count increased 47.20 24.07 34 164175 48527 63276286
Cerebral infarction 46.86 24.07 4 164205 23889 63300924
Blood pressure diastolic decreased 46.81 24.07 3 164206 22703 63302110
Injection site bruising 46.75 24.07 25 164184 41885 63282928
Influenza 46.71 24.07 458 163751 108264 63216549
Laryngitis 46.65 24.07 122 164087 16845 63307968
Haemorrhage 45.95 24.07 54 164155 60968 63263845
Rash pruritic 45.77 24.07 288 163921 59511 63265302
Alanine aminotransferase increased 45.68 24.07 128 164081 103642 63221171
Drug dependence 45.64 24.07 5 164204 24478 63300335
Sinus headache 45.44 24.07 64 164145 5552 63319261
Accidental exposure to product 45.44 24.07 8 164201 27397 63297416
Macular degeneration 45.39 24.07 5 164204 24371 63300442
Product quality issue 45.27 24.07 18 164191 35847 63288966
Dactylitis 45.21 24.07 44 164165 2568 63322245
Synovitis 44.56 24.07 705 163504 186213 63138600
Blood potassium decreased 44.11 24.07 27 164182 41999 63282814
Inhibitory drug interaction 43.80 24.07 45 164164 2804 63322009
Osteonecrosis 43.30 24.07 6 164203 24524 63300289
Lupus-like syndrome 43.10 24.07 111 164098 15184 63309629
Fear of injection 42.91 24.07 71 164138 7093 63317720
Fibromyalgia 42.84 24.07 355 163854 80065 63244748
COVID-19 42.21 24.07 463 163746 112640 63212173
Arrhythmia 42.17 24.07 23 164186 38117 63286696
Stevens-Johnson syndrome 41.99 24.07 7 164202 24943 63299870
Drug resistance 41.96 24.07 5 164204 22928 63301885
Visual acuity reduced 41.87 24.07 4 164205 21822 63302991
Infection susceptibility increased 40.90 24.07 48 164161 3473 63321340
Aggression 40.89 24.07 6 164203 23492 63301321
Muscular weakness 40.89 24.07 170 164039 122183 63202630
Blood pressure increased 40.57 24.07 249 163960 161813 63163000
Body temperature increased 40.30 24.07 23 164186 37169 63287644
C-reactive protein 40.05 24.07 56 164153 4826 63319987
Transient ischaemic attack 39.98 24.07 24 164185 37729 63287084
Cytomegalovirus infection 39.77 24.07 4 164205 20948 63303865
Circulatory collapse 39.60 24.07 5 164204 21933 63302880
Psychotic disorder 39.51 24.07 9 164200 25703 63299110
Skin irritation 38.80 24.07 81 164128 9660 63315153
Hallucination, visual 38.48 24.07 3 164206 19295 63305518
Device related infection 38.41 24.07 7 164202 23385 63301428
Intestinal obstruction 38.20 24.07 16 164193 30883 63293930
Proteinuria 38.11 24.07 3 164206 19142 63305671
Disturbance in attention 38.09 24.07 26 164183 38163 63286650
Electrolyte imbalance 37.68 24.07 4 164205 20072 63304741
Abortion spontaneous 37.46 24.07 40 164169 47155 63277658
Gastrooesophageal reflux disease 37.30 24.07 395 163814 95244 63229569
Swelling face 37.15 24.07 67 164142 63408 63261405
Rheumatoid nodule 37.02 24.07 113 164096 17042 63307771
Muscle spasticity 36.94 24.07 6 164203 21788 63303025
Small intestinal obstruction 36.15 24.07 3 164206 18334 63306479
Colitis 35.41 24.07 44 164165 48484 63276329
Adrenal insufficiency 35.13 24.07 3 164206 17912 63306901
Swelling 34.77 24.07 502 163707 274876 63049937
Sciatica 34.63 24.07 178 164031 34146 63290667
Red blood cell sedimentation rate abnormal 34.54 24.07 5 164204 19777 63305036
Blood sodium decreased 34.37 24.07 10 164199 24242 63300571
Cardiomyopathy 34.33 24.07 3 164206 17581 63307232
Swollen tongue 34.30 24.07 24 164185 34776 63290037
Alopecia 34.01 24.07 1127 163082 336409 62988404
Abnormal behaviour 33.94 24.07 7 164202 21419 63303394
Eye pain 33.83 24.07 23 164186 33831 63290982
Bacteraemia 33.76 24.07 3 164206 17345 63307468
Chronic obstructive pulmonary disease 33.36 24.07 70 164139 62616 63262197
Paraesthesia oral 33.32 24.07 5 164204 19251 63305562
Diplopia 33.24 24.07 10 164199 23718 63301095
Liver injury 33.22 24.07 269 163940 60251 63264562
Candida infection 32.98 24.07 16 164193 28335 63296478
Full blood count decreased 32.94 24.07 13 164196 26011 63298802
Cholelithiasis 32.93 24.07 39 164170 43886 63280927
Lethargy 32.89 24.07 59 164150 55948 63268865
Complication associated with device 32.87 24.07 3 164206 16975 63307838
Mood swings 32.87 24.07 113 164096 18135 63306678
Withdrawal syndrome 32.80 24.07 6 164203 19991 63304822
Ischaemic stroke 32.64 24.07 4 164205 17953 63306860
Infusion site pain 32.60 24.07 3 164206 16866 63307947
Dandruff 32.47 24.07 15 164194 241 63324572
Rectal haemorrhage 32.20 24.07 48 164161 48982 63275831
Rheumatoid factor positive 32.16 24.07 347 163862 84059 63240754
Lower limb fracture 32.08 24.07 136 164073 24085 63300728
Device issue 31.58 24.07 11 164198 23770 63301043
Body temperature decreased 31.45 24.07 7 164202 20312 63304501
Hepatitis 31.27 24.07 34 164175 39754 63285059
Injection site haemorrhage 31.02 24.07 12 164197 24302 63300511
Haemoptysis 30.79 24.07 18 164191 28708 63296105
Gait disturbance 30.69 24.07 314 163895 182864 63141949
Blindness 30.66 24.07 9 164200 21690 63303123
Presyncope 30.37 24.07 17 164192 27768 63297045
Myoclonus 30.20 24.07 3 164206 15865 63308948
Aspartate aminotransferase increased 29.80 24.07 126 164083 90151 63234662
Injection site mass 29.75 24.07 6 164203 18650 63306163
Adjustment disorder with depressed mood 29.73 24.07 75 164134 10129 63314684
Ulcer 29.62 24.07 140 164069 25967 63298846
Gastroenteritis 29.45 24.07 16 164193 26574 63298239
Hypercholesterolaemia 29.20 24.07 121 164088 21213 63303600
Pregnancy 29.18 24.07 179 164030 36657 63288156
Hypertensive crisis 28.80 24.07 3 164206 15283 63309530
Onychomadesis 28.64 24.07 53 164156 5787 63319026
Procedural pain 28.60 24.07 10 164199 21559 63303254
Medication error 28.15 24.07 58 164151 52226 63272587
Ovarian cyst 27.91 24.07 4 164205 15941 63308872
Intentional product misuse 27.82 24.07 260 163949 60657 63264156
Skin exfoliation 27.82 24.07 199 164010 42903 63281910
Rash macular 27.77 24.07 127 164082 23237 63301576
Nasopharyngitis 27.69 24.07 857 163352 253400 63071413
Throat tightness 27.53 24.07 15 164194 24872 63299941
Ileus 27.47 24.07 3 164206 14722 63310091
Urosepsis 27.45 24.07 7 164202 18517 63306296
Bowel movement irregularity 27.37 24.07 49 164160 5215 63319598
Bronchospasm 26.65 24.07 6 164203 17274 63307539
Wrong technique in product usage process 26.62 24.07 78 164131 62262 63262551
Pneumothorax 26.41 24.07 5 164204 16256 63308557
Spinal compression fracture 26.41 24.07 3 164206 14280 63310533
Malnutrition 26.40 24.07 4 164205 15294 63309519
Haematemesis 26.18 24.07 24 164185 30388 63294425
Injection site warmth 26.17 24.07 4 164205 15191 63309622
Bronchiectasis 26.14 24.07 5 164204 16137 63308676
Accidental overdose 25.85 24.07 14 164195 23295 63301518
Colitis ulcerative 25.70 24.07 18 164191 26073 63298740
Restlessness 25.64 24.07 23 164186 29430 63295383
Basal cell carcinoma 25.40 24.07 141 164068 27850 63296963
Gastroenteritis viral 25.38 24.07 125 164084 23575 63301238
Hypophagia 25.36 24.07 26 164183 31233 63293580
Dystonia 25.31 24.07 3 164206 13816 63310997
Lip dry 24.62 24.07 92 164117 15378 63309435
Rib fracture 24.45 24.07 14 164195 22583 63302230
Acute myeloid leukaemia 24.43 24.07 7 164202 17140 63307673
Injection site reaction 24.43 24.07 74 164135 58450 63266363
Pancreatitis 24.28 24.07 57 164152 48998 63275815
Nodule 24.25 24.07 12 164197 21014 63303799
Clostridium difficile infection 24.15 24.07 25 164184 29897 63294916

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 7069.68 30.59 5615 56020 384297 34510999
Product dose omission issue 5319.07 30.59 3030 58605 116681 34778615
Headache 4252.54 30.59 3193 58442 197442 34697854
Nausea 3795.33 30.59 3743 57892 336165 34559131
Abdominal discomfort 3182.70 30.59 1711 59924 58124 34837172
Drug ineffective 2765.45 30.59 3667 57968 453084 34442212
Therapy non-responder 1177.25 30.59 777 60858 38369 34856927
Depression 977.51 30.59 1020 60615 96078 34799218
Adverse drug reaction 803.84 30.59 550 61085 28792 34866504
Abdominal pain upper 747.46 30.59 767 60868 70723 34824573
Therapeutic product effect decreased 715.96 30.59 548 61087 34195 34861101
Psoriasis 574.34 30.59 505 61130 38307 34856989
Psoriatic arthropathy 555.95 30.59 377 61258 19421 34875875
Weight decreased 552.05 30.59 1057 60578 175244 34720052
Gastric disorder 468.35 30.59 285 61350 12156 34883140
Frequent bowel movements 448.47 30.59 280 61355 12507 34882789
Acute kidney injury 432.10 30.59 27 61608 304961 34590335
Rash 379.83 30.59 1051 60584 221701 34673595
Gastrointestinal disorder 309.34 30.59 339 61296 33609 34861687
Toxicity to various agents 298.29 30.59 13 61622 200349 34694947
Drug interaction 297.15 30.59 28 61607 225918 34669378
Anaemia 293.80 30.59 34 61601 233301 34661995
Hypotension 284.86 30.59 30 61605 221619 34673677
Therapeutic response decreased 276.26 30.59 298 61337 29015 34866281
Arthralgia 276.21 30.59 789 60846 169252 34726044
Dyspepsia 266.18 30.59 326 61309 36406 34858890
Pyrexia 261.35 30.59 131 61504 332882 34562414
Therapeutic product effect incomplete 243.64 30.59 368 61267 50173 34845123
Faeces soft 236.21 30.59 118 61517 3390 34891906
Neutropenia 230.54 30.59 11 61624 156767 34738529
Dyspnoea 216.50 30.59 208 61427 376574 34518722
Febrile neutropenia 206.48 30.59 8 61627 136841 34758455
Product supply issue 203.60 30.59 67 61568 615 34894681
Pruritus 198.32 30.59 625 61010 141356 34753940
Thrombocytopenia 195.90 30.59 23 61612 156224 34739072
Product administration interrupted 190.47 30.59 83 61552 1732 34893564
Flatulence 188.37 30.59 209 61426 20989 34874307
Upper respiratory tract infection 175.53 30.59 252 61383 32807 34862489
Mood altered 172.80 30.59 136 61499 8816 34886480
Pneumonia 171.51 30.59 234 61401 362393 34532903
Enthesopathy 159.12 30.59 100 61535 4513 34890783
Haemoglobin decreased 150.78 30.59 18 61617 120754 34774542
Sepsis 150.40 30.59 53 61582 166508 34728788
Pain 146.99 30.59 731 60904 203944 34691352
Confusional state 146.26 30.59 37 61598 144123 34751173
Platelet count decreased 141.91 30.59 21 61614 119696 34775600
Respiratory failure 135.97 30.59 16 61619 108556 34786740
Nasopharyngitis 135.63 30.59 347 61288 69621 34825675
Migraine 134.49 30.59 160 61475 17318 34877978
Cardiac arrest 134.33 30.59 9 61626 96150 34799146
Memory impairment 133.93 30.59 259 61376 43059 34852237
Tension headache 133.55 30.59 77 61558 2965 34892331
Product use in unapproved indication 131.71 30.59 24 61611 117475 34777821
Oedema peripheral 126.94 30.59 28 61607 119784 34775512
Completed suicide 126.64 30.59 13 61622 98155 34797141
Pleural effusion 125.61 30.59 4 61631 81542 34813754
Discomfort 124.22 30.59 160 61475 18778 34876518
Tenosynovitis 118.68 30.59 83 61552 4487 34890809
Alanine aminotransferase abnormal 114.47 30.59 82 61553 4606 34890690
Pulmonary embolism 112.92 30.59 13 61622 89733 34805563
Overdose 112.57 30.59 14 61621 91045 34804251
Bradycardia 111.70 30.59 5 61630 75413 34819883
Fall 111.56 30.59 116 61519 202769 34692527
C-reactive protein abnormal 110.35 30.59 104 61531 8606 34886690
Renal failure 107.21 30.59 48 61587 130509 34764787
Arthritis 103.77 30.59 193 61442 31153 34864143
Disease progression 101.67 30.59 32 61603 108045 34787251
Hyperkalaemia 101.47 30.59 5 61630 69384 34825912
Treatment failure 101.45 30.59 242 61393 46455 34848841
Seizure 98.72 30.59 31 61604 104826 34790470
Tachycardia 97.86 30.59 16 61619 84756 34810540
Blood creatinine increased 97.00 30.59 24 61611 94952 34800344
White blood cell count decreased 95.78 30.59 25 61610 95420 34799876
Gastrointestinal haemorrhage 93.04 30.59 21 61614 88456 34806840
Insomnia 92.81 30.59 396 61239 103511 34791785
Synovitis 92.50 30.59 119 61516 13947 34881349
Unevaluable event 92.44 30.59 188 61447 32402 34862894
Tongue disorder 92.18 30.59 76 61559 5263 34890033
Pancytopenia 91.62 30.59 27 61608 95130 34800166
Drug intolerance 91.12 30.59 271 61364 59299 34835997
Asthenia 89.15 30.59 187 61448 245064 34650232
Deep vein thrombosis 88.54 30.59 7 61628 65241 34830055
Syncope 86.14 30.59 27 61608 91424 34803872
Multiple organ dysfunction syndrome 84.99 30.59 16 61619 76550 34818746
Arthropathy 84.50 30.59 162 61473 26745 34868551
Septic shock 84.17 30.59 13 61622 71821 34823475
Death 82.30 30.59 392 61243 397657 34497639
Tendonitis 80.96 30.59 90 61545 9050 34886246
Interstitial lung disease 76.06 30.59 12 61623 65270 34830026
Oxygen saturation decreased 75.24 30.59 5 61630 53813 34841483
Hypokalaemia 74.30 30.59 8 61627 58206 34837090
Hypoxia 71.80 30.59 7 61628 55088 34840208
Mood swings 68.61 30.59 77 61558 7824 34887472
Dehydration 68.37 30.59 77 61558 129892 34765404
Neuropathy peripheral 67.71 30.59 31 61604 83232 34812064
General physical health deterioration 67.47 30.59 76 61559 128193 34767103
Renal impairment 64.17 30.59 44 61591 94469 34800827
Sinus headache 62.93 30.59 33 61602 1051 34894245
Adverse reaction 62.73 30.59 48 61587 2983 34892313
Atrial fibrillation 60.64 30.59 76 61559 122317 34772979
Feeling abnormal 60.32 30.59 246 61389 62989 34832307
Decreased appetite 60.30 30.59 500 61135 165892 34729404
Acute myocardial infarction 60.09 30.59 11 61624 53708 34841588
Rhinorrhoea 60.07 30.59 137 61498 25531 34869765
Cardiac failure 59.95 30.59 44 61591 91204 34804092
Infection 59.65 30.59 317 61318 90598 34804698
Musculoskeletal stiffness 59.11 30.59 199 61436 46481 34848815
Cardiac failure congestive 58.92 30.59 37 61598 83233 34812063
Loss of consciousness 58.12 30.59 37 61598 82630 34812666
Weight increased 54.74 30.59 50 61585 92983 34802313
Haematuria 54.42 30.59 11 61624 50055 34845241
Coma 54.11 30.59 8 61627 45670 34849626
Plasma cell myeloma 53.07 30.59 6 61629 42031 34853265
Sinusitis 52.86 30.59 177 61458 41225 34854071
Dyspnoea exertional 52.63 30.59 7 61628 43272 34852024
Vomiting 52.27 30.59 666 60969 246955 34648341
Loss of personal independence in daily activities 51.71 30.59 152 61483 33027 34862269
Off label use 51.37 30.59 483 61152 419041 34476255
Respiratory distress 50.79 30.59 3 61632 35662 34859634
Intentional product use issue 50.63 30.59 21 61614 59795 34835501
Leukopenia 50.17 30.59 24 61611 62832 34832464
Oedema 49.81 30.59 10 61625 45731 34849565
Hyperglycaemia 48.94 30.59 6 61629 39474 34855822
Pulmonary oedema 48.52 30.59 12 61623 47517 34847779
Drug effect less than expected 48.14 30.59 29 61606 1212 34894084
Adverse event 47.82 30.59 104 61531 18773 34876523
Pneumonitis 47.79 30.59 3 61632 33875 34861421
Hepatic function abnormal 47.69 30.59 10 61625 44353 34850943
Encephalopathy 47.32 30.59 4 61631 35315 34859981
Somnolence 47.12 30.59 77 61558 111039 34784257
Therapy cessation 47.03 30.59 97 61538 16876 34878420
Blood bilirubin increased 47.03 30.59 6 61629 38290 34857006
Chest pain 46.51 30.59 96 61539 126666 34768630
Lactic acidosis 46.42 30.59 4 61631 34768 34860528
Skin injury 46.05 30.59 36 61599 2309 34892987
Epistaxis 45.34 30.59 23 61612 58228 34837068
Depressed mood 45.08 30.59 103 61532 19214 34876082
Haematocrit decreased 45.00 30.59 3 61632 32213 34863083
Chronic kidney disease 44.90 30.59 9 61626 41201 34854095
Coronary artery disease 44.16 30.59 15 61620 48290 34847006
Muscular weakness 43.08 30.59 39 61596 72858 34822438
Chills 42.60 30.59 48 61587 80995 34814301
Influenza 41.77 30.59 186 61449 49480 34845816
Red blood cell sedimentation rate 41.59 30.59 26 61609 1162 34894134
Stomatitis 41.01 30.59 12 61623 42502 34852794
Constipation 40.58 30.59 116 61519 136866 34758430
Acute respiratory failure 40.10 30.59 4 61631 30924 34864372
Therapy interrupted 39.99 30.59 80 61555 13617 34881679
Granuloma skin 39.83 30.59 26 61609 1253 34894043
Anaphylactic reaction 39.81 30.59 5 61630 32296 34863000
Red blood cell count decreased 39.79 30.59 3 61632 29087 34866209
Skin irritation 39.54 30.59 49 61586 5528 34889768
Blood urea increased 39.18 30.59 4 61631 30360 34864936
Rash maculo-papular 38.73 30.59 3 61632 28448 34866848
Cerebral infarction 37.08 30.59 3 61632 27452 34867844
Jaundice 36.81 30.59 6 61629 31876 34863420
Bowel movement irregularity 36.38 30.59 35 61600 2970 34892326
Rash macular 36.30 30.59 74 61561 12768 34882528
Injection site pain 35.85 30.59 12 61623 38993 34856303
Muscle swelling 35.04 30.59 16 61619 374 34894922
Haemorrhage 34.74 30.59 24 61611 51346 34843950
Rash pruritic 34.22 30.59 115 61520 26826 34868470
Speech disorder 34.16 30.59 3 61632 25683 34869613
Blood parathyroid hormone decreased 34.11 30.59 25 61610 1455 34893841
Myocardial infarction 34.08 30.59 105 61530 120980 34774316
Dysphagia 33.83 30.59 36 61599 62345 34832951
Suicidal ideation 33.76 30.59 151 61484 40237 34855059
Cholestasis 33.63 30.59 4 61631 26944 34868352
Agitation 33.57 30.59 31 61604 57368 34837928
Skin plaque 33.46 30.59 41 61594 4573 34890723
Cerebral haemorrhage 33.44 30.59 10 61625 34927 34860369
Liver function test abnormal 33.40 30.59 7 61628 31067 34864229
Skin exfoliation 33.01 30.59 115 61520 27317 34867979
Asthma 32.96 30.59 17 61618 42639 34852657
Red blood cell sedimentation rate abnormal 32.92 30.59 36 61599 3553 34891743
Joint ankylosis 32.76 30.59 25 61610 1547 34893749
Wheezing 32.74 30.59 16 61619 41386 34853910
Gamma-glutamyltransferase increased 32.65 30.59 6 61629 29225 34866071
Bone cyst 32.37 30.59 25 61610 1575 34893721
Hallucination 32.32 30.59 26 61609 51472 34843824
Thrombosis 32.27 30.59 25 61610 50433 34844863
Joint swelling 32.14 30.59 198 61437 59692 34835604
Drug resistance 31.98 30.59 4 61631 25923 34869373
Urinary retention 31.92 30.59 12 61623 36276 34859020
Hepatic fibrosis 31.90 30.59 40 61595 4567 34890729
Infusion related reaction 31.81 30.59 28 61607 53029 34842267
Skin burning sensation 31.65 30.59 40 61595 4603 34890693
Blood alkaline phosphatase increased 31.57 30.59 8 61627 31167 34864129
Leukocytosis 31.50 30.59 3 61632 24062 34871234
Mental status changes 31.22 30.59 14 61621 38069 34857227
Suicide attempt 31.11 30.59 15 61620 39101 34856195
Hepatic failure 31.08 30.59 11 61624 34520 34860776
Localised infection 30.74 30.59 84 61551 17503 34877793

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 11538.98 24.80 11052 144365 869437 78719534
Nausea 8761.18 24.80 9934 145483 947262 78641709
Product dose omission issue 7853.54 24.80 5256 150161 242281 79346690
Headache 7666.96 24.80 7757 147660 646015 78942956
Abdominal discomfort 3457.78 24.80 3269 152148 247458 79341513
Psoriatic arthropathy 1535.33 24.80 1248 154169 76751 79512220
Depression 1054.12 24.80 1671 153746 215119 79373852
Therapy non-responder 1000.68 24.80 1059 154358 91246 79497725
Psoriasis 936.09 24.80 1008 154409 88579 79500392
Abdominal pain upper 883.66 24.80 1572 153845 222247 79366724
Acute kidney injury 876.33 24.80 31 155386 519373 79069598
Drug ineffective 843.74 24.80 4235 151182 1076678 78512293
Adverse drug reaction 832.43 24.80 824 154593 65568 79523403
Toxicity to various agents 725.63 24.80 21 155396 421519 79167452
Gastric disorder 692.08 24.80 578 154839 36855 79552116
Drug interaction 659.94 24.80 37 155380 415146 79173825
Hypotension 640.58 24.80 60 155357 440257 79148714
Anaemia 628.25 24.80 68 155349 444947 79144024
Weight decreased 614.36 24.80 1798 153619 353400 79235571
Frequent bowel movements 602.50 24.80 483 154934 29056 79559915
Dyspnoea 506.73 24.80 556 154861 856469 78732502
Neutropenia 492.37 24.80 15 155402 287695 79301276
Migraine 465.66 24.80 704 154713 86789 79502182
Dyspepsia 454.86 24.80 784 154633 107903 79481068
Completed suicide 427.18 24.80 11 155406 245756 79343215
Therapeutic product effect decreased 423.92 24.80 966 154451 162897 79426074
Pyrexia 417.83 24.80 425 154992 678284 78910687
Febrile neutropenia 414.69 24.80 7 155410 230992 79357979
Thrombocytopenia 411.04 24.80 27 155390 265232 79323739
Enthesopathy 378.23 24.80 252 155165 11356 79577615
Product supply issue 365.66 24.80 141 155276 1907 79587064
Arthralgia 351.36 24.80 2105 153312 569698 79019273
Rash 348.94 24.80 2119 153298 576239 79012732
Haemoglobin decreased 320.69 24.80 31 155386 222088 79366883
Decreased appetite 295.26 24.80 1385 154032 341033 79247938
Product administration interrupted 290.23 24.80 145 155272 3754 79585217
Sepsis 289.62 24.80 83 155334 269345 79319626
Platelet count decreased 289.54 24.80 24 155393 194640 79394331
Rheumatic fever 287.18 24.80 315 155102 28210 79560761
Cardiac arrest 277.27 24.80 14 155403 172082 79416889
Insomnia 273.19 24.80 1072 154345 244098 79344873
Tension headache 270.42 24.80 171 155246 7040 79581931
Gastrointestinal disorder 264.87 24.80 673 154744 121532 79467439
Faeces soft 264.70 24.80 178 155239 8145 79580826
White blood cell count decreased 259.72 24.80 31 155386 188257 79400714
Therapeutic product effect incomplete 259.53 24.80 733 154684 140912 79448059
Respiratory failure 259.14 24.80 26 155391 180885 79408086
Tenosynovitis 256.45 24.80 225 155192 15329 79573642
Malignant neoplasm progression 248.81 24.80 3 155414 135987 79452984
Musculoskeletal stiffness 248.20 24.80 828 154589 174180 79414791
Fall 247.92 24.80 354 155063 487275 79101696
Disease progression 247.86 24.80 33 155384 184329 79404642
Pleural effusion 246.82 24.80 8 155409 145254 79443717
Bradycardia 243.65 24.80 4 155413 135553 79453418
Hypokalaemia 241.00 24.80 9 155408 144031 79444940
Vomiting 239.15 24.80 2157 153260 663671 78925300
Treatment failure 234.15 24.80 798 154619 169688 79419283
Upper respiratory tract infection 233.92 24.80 536 154881 90632 79498339
Pancytopenia 229.30 24.80 27 155390 165718 79423253
Swollen joint count increased 227.01 24.80 251 155166 22676 79566295
Synovitis 225.22 24.80 726 154691 150008 79438963
Seizure 216.56 24.80 51 155366 188783 79400188
Oxygen saturation decreased 209.44 24.80 10 155407 129037 79459934
Renal failure 204.95 24.80 68 155349 200900 79388071
Hyperkalaemia 203.03 24.80 4 155413 114394 79474577
Flatulence 201.03 24.80 325 155092 42399 79546572
Syncope 197.01 24.80 53 155364 179396 79409575
Pulmonary embolism 191.68 24.80 49 155368 171605 79417366
Tongue disorder 187.22 24.80 180 155237 13795 79575176
C-reactive protein abnormal 184.24 24.80 335 155082 48032 79540939
Confusional state 184.12 24.80 209 155208 317788 79271183
Death 183.26 24.80 534 154883 565980 79022991
Overdose 183.20 24.80 65 155352 184141 79404830
Intentional overdose 183.04 24.80 5 155412 105955 79483016
Discomfort 180.38 24.80 597 154820 125020 79463951
Multiple organ dysfunction syndrome 175.56 24.80 16 155401 120230 79468741
Gastrointestinal haemorrhage 173.15 24.80 38 155379 147681 79441290
Coma 172.93 24.80 5 155412 100644 79488327
Alanine aminotransferase abnormal 172.31 24.80 141 155276 8726 79580245
Septic shock 169.84 24.80 20 155397 122781 79466190
Deep vein thrombosis 168.97 24.80 19 155398 120900 79468071
Pneumonia 168.55 24.80 689 154728 659557 78929414
Hypoxia 167.54 24.80 8 155409 103235 79485736
Cardiac failure 165.74 24.80 48 155369 154794 79434177
Therapeutic response decreased 162.63 24.80 385 155032 66468 79522503
Asthenia 161.32 24.80 488 154929 511201 79077770
Somnolence 160.24 24.80 138 155279 238843 79350128
Adverse event 159.95 24.80 359 155058 59855 79529116
Leukopenia 156.22 24.80 21 155396 116492 79472479
Loss of consciousness 155.85 24.80 66 155351 167877 79421094
Tachycardia 153.89 24.80 77 155340 177691 79411280
Mood altered 150.74 24.80 180 155237 17667 79571304
Hypoglycaemia 147.02 24.80 14 155403 101580 79487391
International normalised ratio increased 146.32 24.80 4 155413 84717 79504254
Bone erosion 145.83 24.80 177 155240 17670 79571301
Alopecia 143.51 24.80 855 154562 230500 79358471
Mobility decreased 142.22 24.80 542 154875 121633 79467338
Interstitial lung disease 140.27 24.80 25 155392 112575 79476396
Tendonitis 138.54 24.80 200 155217 23630 79565341
Drug intolerance 137.19 24.80 933 154484 263186 79325785
Type 2 diabetes mellitus 136.82 24.80 327 155090 56795 79532176
Neuropathy peripheral 135.22 24.80 53 155364 141252 79447719
Ascites 132.65 24.80 3 155414 75559 79513412
Therapy interrupted 132.16 24.80 227 155190 31114 79557857
Red blood cell sedimentation rate 130.79 24.80 99 155318 5466 79583505
Atrial fibrillation 130.54 24.80 116 155301 197770 79391201
Dehydration 126.07 24.80 180 155237 248007 79340964
Renal impairment 124.06 24.80 77 155340 157706 79431265
Stress 123.88 24.80 389 155028 79223 79509748
Oedema peripheral 123.25 24.80 188 155229 252100 79336871
Lactic acidosis 122.72 24.80 3 155414 70356 79518615
Cardiac failure congestive 121.26 24.80 63 155354 142339 79446632
Blood parathyroid hormone decreased 119.55 24.80 124 155293 10412 79578559
Blood cholesterol increased 119.34 24.80 397 155020 83323 79505648
Rheumatoid factor positive 118.75 24.80 319 155098 59520 79529451
Arthropathy 118.55 24.80 668 154749 176443 79412528
Retinitis 114.44 24.80 92 155325 5551 79583420
Dysarthria 113.86 24.80 4 155413 67618 79521353
Encephalopathy 113.44 24.80 4 155413 67393 79521578
Arthritis 113.23 24.80 484 154933 114396 79474575
Pneumonia aspiration 112.63 24.80 4 155413 66963 79522008
Joint dislocation 111.64 24.80 151 155266 16788 79572183
Injection site pain 109.73 24.80 58 155359 129780 79459191
Hyperglycaemia 109.31 24.80 7 155410 70328 79518643
Dyspnoea exertional 109.17 24.80 19 155398 87054 79501917
Panniculitis 108.16 24.80 127 155290 12244 79576727
Blood creatine phosphokinase increased 107.61 24.80 5 155412 66085 79522886
Pulmonary oedema 106.91 24.80 21 155396 88233 79500738
Exostosis 106.15 24.80 147 155270 16711 79572260
Deep vein thrombosis postoperative 105.20 24.80 117 155300 10635 79578336
Constipation 104.08 24.80 250 155167 282800 79306171
Acute myocardial infarction 102.98 24.80 14 155403 77022 79511949
Granuloma skin 102.35 24.80 107 155310 9067 79579904
Blood bilirubin increased 101.73 24.80 7 155410 66225 79522746
Drug reaction with eosinophilia and systemic symptoms 101.02 24.80 6 155411 64238 79524733
Joint stiffness 100.22 24.80 236 155181 40594 79548377
Anti-cyclic citrullinated peptide antibody positive 99.33 24.80 372 155045 82771 79506200
Adverse reaction 99.23 24.80 106 155311 9208 79579763
Anaphylactic reaction 99.21 24.80 21 155396 83722 79505249
Loss of personal independence in daily activities 98.65 24.80 429 154988 102151 79486820
Respiratory arrest 98.34 24.80 3 155414 57547 79531424
Blood creatinine increased 97.40 24.80 95 155322 154962 79434009
Fibromyalgia 97.00 24.80 311 155106 64029 79524942
Blood alkaline phosphatase increased 94.19 24.80 8 155409 63656 79525315
Hepatic cirrhosis 93.67 24.80 209 155208 34697 79554274
Hallucination 92.80 24.80 26 155391 85719 79503252
Melaena 91.90 24.80 7 155410 60883 79528088
Pain 91.65 24.80 1900 153517 701902 78887069
Hepatic function abnormal 91.55 24.80 16 155401 73091 79515880
Rheumatoid arthritis 90.68 24.80 706 154711 207764 79381207
Liver function test abnormal 90.39 24.80 10 155407 64465 79524506
Nasopharyngitis 90.38 24.80 822 154595 253059 79335912
Dysphagia 90.07 24.80 64 155353 122072 79466899
Unevaluable event 89.60 24.80 275 155142 55310 79533661
Mental status changes 87.56 24.80 13 155404 66946 79522025
Coronary artery disease 87.28 24.80 12 155405 65462 79523509
Acute respiratory failure 86.68 24.80 8 155409 59533 79529438
Injection site erythema 85.96 24.80 23 155394 78174 79510797
Red blood cell count decreased 85.71 24.80 7 155410 57506 79531465
Epistaxis 85.48 24.80 56 155361 111459 79477512
Heart rate decreased 84.61 24.80 17 155400 70299 79518672
Respiratory distress 84.50 24.80 8 155409 58331 79530640
Haematuria 84.18 24.80 16 155401 68820 79520151
Agitation 83.58 24.80 45 155372 99670 79489301
Ear infection 83.40 24.80 198 155219 34234 79554737
Hand deformity 83.25 24.80 412 155005 103507 79485464
Chills 82.53 24.80 115 155302 160119 79428852
Cognitive disorder 81.89 24.80 18 155399 69908 79519063
COVID-19 81.18 24.80 556 154861 157118 79431853
Plasma cell myeloma 80.73 24.80 6 155411 53253 79535718
Hepatic failure 79.78 24.80 12 155405 61200 79527771
Cerebrovascular accident 79.43 24.80 112 155305 155180 79433791
Balance disorder 79.43 24.80 47 155370 98810 79490161
Cholestasis 78.61 24.80 6 155411 52103 79536868
Jaundice 78.12 24.80 7 155410 53342 79535629
Rash maculo-papular 77.85 24.80 9 155408 56069 79532902
Memory impairment 77.76 24.80 426 154991 111308 79477663
Pruritus 77.40 24.80 1138 154279 393510 79195461
Rash pruritic 77.01 24.80 310 155107 71319 79517652
Pneumonitis 76.91 24.80 13 155404 60847 79528124
Myocardial infarction 76.42 24.80 152 155265 183977 79404994
Hepatocellular injury 76.21 24.80 4 155413 47589 79541382
Blood urea increased 75.39 24.80 5 155412 48785 79540186
Muscle spasms 75 24.80 590 154827 174140 79414831
Dyskinesia 74.17 24.80 3 155414 44770 79544201
Anti-cyclic citrullinated peptide antibody 73.93 24.80 73 155344 5779 79583192
Autoimmune disorder 73.58 24.80 123 155294 16489 79572482
Orthostatic hypotension 73.22 24.80 11 155406 56153 79532818
Rheumatoid nodule 73.12 24.80 126 155291 17312 79571659
Lymphocyte count decreased 72.62 24.80 5 155412 47284 79541687
Pemphigus 72.23 24.80 384 155033 99198 79489773
Joint swelling 72.19 24.80 870 154547 287776 79301195
Pallor 72.15 24.80 7 155410 50055 79538916
Disorientation 71.83 24.80 17 155400 62759 79526212
Urinary retention 71.77 24.80 12 155405 56618 79532353
Leukocytosis 71.69 24.80 3 155414 43452 79545519
Haemorrhage 70.87 24.80 45 155372 91073 79497898
Pericardial effusion 70.68 24.80 5 155412 46232 79542739
Glossodynia 70.58 24.80 392 155025 102945 79486026
Hypervolaemia 70.25 24.80 3 155414 42687 79546284
Chronic kidney disease 69.86 24.80 21 155396 66133 79522838
Skin necrosis 69.78 24.80 126 155291 17961 79571010
Acute respiratory distress syndrome 69.64 24.80 4 155413 44063 79544908
Blood pressure decreased 69.63 24.80 55 155362 99411 79489560
Body tinea 69.60 24.80 44 155373 1810 79587161
Generalised tonic-clonic seizure 69.35 24.80 4 155413 43906 79545065
Cerebral haemorrhage 69.27 24.80 14 155403 57659 79531312
Haematoma 68.56 24.80 10 155407 52185 79536786
Chest pain 68.45 24.80 300 155117 282004 79306967
Pericarditis 68.28 24.80 391 155026 103845 79485126
Red blood cell sedimentation rate increased 68.27 24.80 221 155196 45721 79543250
Flushing 68.09 24.80 44 155373 88224 79500747
Speech disorder 67.98 24.80 12 155405 54433 79534538
Laryngitis 67.39 24.80 116 155301 15923 79573048
Foot deformity 66.69 24.80 146 155271 23928 79565043
Blood pressure fluctuation 66.19 24.80 24 155393 67121 79521850
Full blood count abnormal 66.09 24.80 3 155414 40471 79548500
Colitis 66.09 24.80 30 155387 73277 79515694
Hepatotoxicity 64.82 24.80 11 155406 51341 79537630
Gamma-glutamyltransferase increased 64.18 24.80 14 155403 54666 79534305
Angioedema 64.18 24.80 34 155383 76001 79512970
Cytomegalovirus infection 64.08 24.80 5 155412 42639 79546332
Duodenal ulcer perforation 63.71 24.80 277 155140 65934 79523037
Aphasia 63.64 24.80 8 155409 46724 79542247
Infection 63.26 24.80 735 154682 240977 79347994
Fear of injection 62.49 24.80 75 155342 7399 79581572
Sinusitis 62.09 24.80 618 154799 194883 79394088
White blood cell count increased 62.08 24.80 34 155383 74599 79514372
Cerebral infarction 61.77 24.80 8 155409 45668 79543303
Suicide attempt 61.74 24.80 43 155374 82889 79506082
Sinus headache 59.82 24.80 61 155356 5019 79583952
Lupus-like syndrome 59.25 24.80 101 155316 13756 79575215
Liver injury 59.25 24.80 243 155174 56371 79532600
Drug resistance 58.04 24.80 7 155410 42206 79546765
Mucosal inflammation 57.85 24.80 38 155379 75542 79513429
Pancreatitis acute 57.61 24.80 13 155404 49591 79539380
Wound 57.02 24.80 405 155012 115774 79473197
Grip strength decreased 55.40 24.80 128 155289 21741 79567230
Stevens-Johnson syndrome 55.09 24.80 6 155411 39160 79549811
Circulatory collapse 54.99 24.80 5 155412 37663 79551308
Urinary tract infection 54.91 24.80 312 155105 274200 79314771
Fluid retention 53.57 24.80 35 155382 69774 79519197
Skin irritation 53.53 24.80 86 155331 11154 79577817
Injection site swelling 53.46 24.80 13 155404 47119 79541852
Urinary incontinence 53.35 24.80 8 155409 40901 79548070
Sciatica 53.20 24.80 164 155253 33058 79555913
Vision blurred 52.54 24.80 78 155339 105820 79483151
Hallucination, visual 51.63 24.80 3 155414 32726 79556245
Chest discomfort 51.42 24.80 121 155296 137923 79451048
Proteinuria 51.21 24.80 3 155414 32499 79556472
Hypothyroidism 51.18 24.80 19 155398 52373 79536598
Intentional self-injury 51.05 24.80 3 155414 32416 79556555
Adjustment disorder with depressed mood 50.98 24.80 75 155342 9011 79579960
Multiple sclerosis relapse 50.55 24.80 14 155403 46519 79542452
C-reactive protein 50.13 24.80 55 155362 4924 79584047
Infection susceptibility increased 49.97 24.80 48 155369 3673 79585298
Weight increased 49.87 24.80 326 155091 277060 79311911
Rhinorrhoea 49.57 24.80 285 155132 75789 79513182
Lower limb fracture 49.34 24.80 127 155290 23088 79565883
Paraesthesia 49.30 24.80 177 155240 176146 79412825
Contraindicated product administered 49.04 24.80 496 154921 157042 79431929
Systemic lupus erythematosus 48.66 24.80 403 155014 120746 79468225
Blood pressure increased 48.58 24.80 229 155188 211131 79377840
Fatigue 48.23 24.80 2243 153174 927484 78661487
Arrhythmia 48.00 24.80 30 155387 61242 79527729
Thrombosis 47.80 24.80 56 155361 84044 79504927
Mood swings 47.79 24.80 114 155303 19766 79569205
Aggression 47.28 24.80 20 155397 50938 79538033
Ulcer 47.10 24.80 147 155270 29825 79559146
Blood calcium decreased 47.06 24.80 4 155413 31815 79557156
Drug tolerance decreased 47.02 24.80 88 155329 12890 79576081
Inflammation 46.10 24.80 327 155090 93426 79495545
Psychotic disorder 45.84 24.80 12 155405 41390 79547581
Visual acuity reduced 45.59 24.80 3 155414 29466 79559505
Rectal haemorrhage 45.34 24.80 49 155368 76251 79512720
Candida infection 44.41 24.80 10 155407 38204 79550767
Hip arthroplasty 44.38 24.80 162 155255 35594 79553377
Ischaemic stroke 44.33 24.80 6 155411 33125 79555846
Adrenal insufficiency 43.77 24.80 3 155414 28484 79560487
Rebound psoriasis 43.59 24.80 16 155401 187 79588784
Sleep apnoea syndrome 43.51 24.80 9 155408 36469 79552502
Chronic obstructive pulmonary disease 43.27 24.80 62 155355 85357 79503614
Haemoptysis 43.07 24.80 28 155389 55971 79533000
Peritonitis 42.94 24.80 3 155414 28033 79560938
Acute myeloid leukaemia 42.76 24.80 5 155412 30880 79558091
Electrolyte imbalance 42.76 24.80 5 155412 30876 79558095
Product use in unapproved indication 42.62 24.80 299 155118 250060 79338911
Body temperature decreased 42.58 24.80 6 155411 32139 79556832
Tubulointerstitial nephritis 42.49 24.80 11 155406 38224 79550747
Myoclonus 42.25 24.80 3 155414 27657 79561314
Osteoarthritis 42.05 24.80 303 155114 87006 79501965
Cardiomyopathy 41.53 24.80 4 155413 28770 79560201
Gastrooesophageal reflux disease 41.45 24.80 346 155071 103900 79485071
Haematemesis 40.38 24.80 26 155391 52238 79536733
Helicobacter infection 40.22 24.80 253 155164 69451 79519520
Drug effect less than expected 40.20 24.80 33 155384 2051 79586920
Injection site pruritus 40.20 24.80 16 155401 42267 79546704
Presyncope 39.91 24.80 15 155402 41039 79547932
Dactylitis 39.77 24.80 37 155380 2720 79586251
Transaminases increased 39.62 24.80 26 155391 51717 79537254
Abnormal behaviour 39.48 24.80 11 155406 36410 79552561
Myelodysplastic syndrome 39.34 24.80 6 155411 30295 79558676
Blood potassium decreased 38.95 24.80 21 155396 46491 79542480
Accidental exposure to product 38.89 24.80 7 155410 31315 79557656
Lip dry 38.79 24.80 90 155327 15328 79573643
Blood sodium decreased 38.05 24.80 9 155408 33246 79555725
Device related infection 37.85 24.80 10 155407 34284 79554687
Brain oedema 37.85 24.80 3 155414 25260 79563711
Diabetic ketoacidosis 37.57 24.80 10 155407 34112 79554859
Renal tubular necrosis 37.44 24.80 3 155414 25036 79563935
Bacteraemia 37.33 24.80 9 155408 32815 79556156
Knee arthroplasty 37.16 24.80 175 155242 43073 79545898
No adverse event 37.16 24.80 13 155404 37179 79551792
Cardiomegaly 37.16 24.80 4 155413 26348 79562623
Bronchospasm 37.11 24.80 3 155414 24856 79564115
Intestinal obstruction 36.65 24.80 19 155398 43001 79545970
Skin plaque 36.64 24.80 71 155346 10674 79578297
Rheumatoid lung 36.15 24.80 43 155374 4202 79584769
Inhibitory drug interaction 36.11 24.80 44 155373 4409 79584562
Restlessness 36.09 24.80 23 155394 46469 79542502
Oesophagitis 36.07 24.80 3 155414 24286 79564685
Swollen tongue 35.97 24.80 19 155398 42551 79546420
Iron deficiency anaemia 35.93 24.80 4 155413 25668 79563303
Hepatic encephalopathy 35.84 24.80 3 155414 24163 79564808
Polyneuropathy 35.82 24.80 3 155414 24148 79564823
Swelling face 35.76 24.80 52 155365 71160 79517811
Lupus vulgaris 35.50 24.80 38 155379 3308 79585663
Muscular weakness 35.27 24.80 177 155240 160552 79428419
Basal cell carcinoma 34.91 24.80 155 155262 37220 79551751
Hepatitis 33.99 24.80 35 155382 55692 79533279
Hypersensitivity 33.63 24.80 707 154710 261532 79327439
Lung infiltration 33.56 24.80 3 155414 22909 79566062
Lymphopenia 33.56 24.80 9 155408 30548 79558423
Transient ischaemic attack 33.40 24.80 32 155385 52663 79536308
Blood potassium increased 33.35 24.80 8 155409 29267 79559704
Hypophagia 33.14 24.80 24 155393 45343 79543628
Diplopia 32.92 24.80 12 155405 33454 79555517
Sudden death 32.83 24.80 3 155414 22508 79566463
Poisoning 32.82 24.80 5 155412 25267 79563704
Bronchopulmonary aspergillosis 32.44 24.80 3 155414 22291 79566680
Ileus 32.24 24.80 6 155411 26205 79562766
Small intestinal obstruction 31.97 24.80 7 155410 27265 79561706
Facet joint syndrome 31.82 24.80 69 155348 11233 79577738
Body temperature increased 31.79 24.80 24 155393 44396 79544575
Accidental overdose 31.53 24.80 19 155398 39562 79549409
Myocarditis 31.42 24.80 3 155414 21730 79567241
X-ray abnormal 31.20 24.80 47 155370 5766 79583205
Granuloma 30.99 24.80 57 155360 8240 79580731
Delirium 30.86 24.80 75 155342 84552 79504419
Dystonia 30.81 24.80 3 155414 21396 79567575
Transfusion 30.69 24.80 3 155414 21327 79567644
Urosepsis 30.66 24.80 7 155410 26488 79562483
Clostridium difficile infection 30.63 24.80 23 155394 42662 79546309
Blood glucose increased 30.44 24.80 118 155299 114857 79474114
Generalised oedema 30.09 24.80 5 155412 23704 79565267
Bronchiectasis 30.08 24.80 4 155413 22382 79566589
Dementia 29.58 24.80 6 155411 24653 79564318
Road traffic accident 29.37 24.80 165 155252 43499 79545472
Pulmonary mass 29.26 24.80 10 155407 29024 79559947
Osteonecrosis 29.18 24.80 12 155405 31083 79557888
Haemophagocytic lymphohistiocytosis 29.11 24.80 4 155413 21833 79567138
Dysuria 28.87 24.80 34 155383 50917 79538054
Blood albumin decreased 28.87 24.80 6 155411 24237 79564734
Femur fracture 28.82 24.80 20 155397 38632 79550339
Aspiration 28.57 24.80 3 155414 20155 79568816
Shock haemorrhagic 28.40 24.80 3 155414 20057 79568914
Hyperhidrosis 28.24 24.80 176 155241 151316 79437655
Blindness 28.22 24.80 10 155407 28373 79560598
Illness 28.20 24.80 171 155246 46340 79542631
Bowel movement irregularity 28.18 24.80 47 155370 6287 79582684
Skin disorder 28.18 24.80 136 155281 33807 79555164
Neutrophil count increased 28.15 24.80 11 155406 29385 79559586
Pneumothorax 28.12 24.80 10 155407 28313 79560658
Pancreatitis 28.09 24.80 57 155360 68518 79520453
Prescribed overdose 28.08 24.80 147 155270 37736 79551235
Onychomadesis 27.59 24.80 42 155375 5200 79583771
Pseudomonas infection 27.46 24.80 4 155413 20899 79568072
Hypertensive crisis 27.23 24.80 4 155413 20766 79568205
Epilepsy 26.86 24.80 24 155393 40836 79548135
Live birth 26.79 24.80 89 155328 18655 79570316
Aspergillus infection 26.78 24.80 3 155414 19158 79569813
Sleep disorder 26.76 24.80 270 155147 85407 79503564
Paraesthesia oral 26.70 24.80 4 155413 20467 79568504
Creatinine renal clearance decreased 26.50 24.80 3 155414 18999 79569972
Cardiac failure acute 26.37 24.80 3 155414 18926 79570045
Device issue 26.19 24.80 10 155407 27098 79561873
Intentional dose omission 26.17 24.80 55 155362 8762 79580209
Product quality issue 26.06 24.80 17 155400 33923 79555048
Injury 26.05 24.80 248 155169 77248 79511723
Gait inability 25.83 24.80 200 155217 58717 79530254
Medication error 25.69 24.80 60 155357 68582 79520389
Depressed mood 25.54 24.80 172 155245 48308 79540663
Joint ankylosis 25.35 24.80 26 155391 2154 79586817
Hepatic enzyme increased 25.27 24.80 498 154919 182112 79406859
Hypoaesthesia 25.12 24.80 490 154927 178862 79410109
Fear 25.06 24.80 6 155411 21980 79566991
Influenza 25.03 24.80 373 155044 129233 79459738
Clostridium difficile colitis 25.02 24.80 16 155401 32267 79556704
Procedural pain 24.97 24.80 7 155410 23077 79565894

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
FDA MoA N0000182960 Phosphodiesterase 4 Inhibitors
FDA EPC N0000182961 Phosphodiesterase 4 Inhibitor
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:68844 phosphodiesterase IV inhibitors

Drug Use | Suggest Off label Use Form| |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 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 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
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 70518-3155 TABLET, FILM COATED 30 mg ORAL NDA 28 sections