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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.213 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 27.479 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 4.853 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.421 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 49.710 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 60.770 % High 1
herg hERG pIC50 4.242 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.778 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 21.677 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 37.600 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK7,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,TEK,TTK 37
kinase-selectivity-class ACVR2B,AXL,BRAF,CAMK2D,CDK9,DDR1,GRK2,MAP2K6,MAP3K21,MAPK7,SIK2,STK33,TEK 13
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 7.638 High 1
mh-clint Mouse hepatocyte intrinsic clearance 32.810 High 1
mppb Mouse plasma protein binding (% unbound) 34.730 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 29.376 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 61.640 % High 1
rh-clint Rat hepatocyte intrinsic clearance 19.498 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 83.530 % High 1
rppb Rat plasma protein binding (% unbound) 35.200 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 387.258 uM High 1

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 7240.75 25.60 12552 320187 926638 89369070
Nausea 5689.24 25.60 12498 320241 1097818 89197890
Product dose omission issue 5426.34 25.60 5988 326751 285699 90010009
Headache 4457.21 25.60 9760 322979 852986 89442722
Abdominal discomfort 1531.46 25.60 4525 328214 472803 89822905
Therapy non-responder 1466.37 25.60 2138 330601 134566 90161142
Psoriatic arthropathy 1406.33 25.60 2788 329951 225547 90070161
Depression 1145.48 25.60 3036 329703 297565 89998143
Acute kidney injury 1115.94 25.60 11 332728 320376 89975332
Toxicity to various agents 997.25 25.60 11 332728 287835 90007873
Anaemia 967.49 25.60 90 332649 352712 89942996
Adverse drug reaction 947.88 25.60 1607 331132 115094 90180614
Hypotension 900.27 25.60 80 332659 325317 89970391
Drug interaction 818.88 25.60 49 332690 276404 90019304
Neutropenia 786.34 25.60 7 332732 224897 90070811
Abdominal pain upper 693.83 25.60 2734 330005 329940 89965768
Rheumatic fever 685.14 25.60 1645 331094 151476 90144232
Psoriasis 603.50 25.60 1533 331206 146221 90149487
Dyspnoea 582.53 25.60 1505 331234 879450 89416258
Type 2 diabetes mellitus 547.96 25.60 1817 330922 201427 90094281
Gastric disorder 517.76 25.60 626 332113 32758 90262950
Migraine 478.75 25.60 1663 331076 188729 90106979
Swollen joint count increased 468.81 25.60 1168 331571 110038 90185670
Drug ineffective 467.33 25.60 7391 325348 1376907 88918801
Haemoglobin decreased 463.80 25.60 34 332705 161922 90133786
Disease progression 448.14 25.60 33 332706 156582 90139126
Fall 436.80 25.60 684 332055 481126 89814582
Fibromyalgia 434.10 25.60 1701 331038 204568 90091140
White blood cell count decreased 433.67 25.60 52 332687 167057 90128651
Pancytopenia 423.86 25.60 3 332736 120260 90175448
Facet joint syndrome 417.45 25.60 1036 331703 97353 90198355
Platelet count decreased 409.27 25.60 23 332716 136946 90158762
Thrombocytopenia 406.31 25.60 130 332609 208595 90087113
Sepsis 403.50 25.60 84 332655 179730 90115978
Blood cholesterol increased 397.63 25.60 1665 331074 206347 90089361
Hypercholesterolaemia 391.36 25.60 1027 331712 99865 90195843
Hypokalaemia 388.76 25.60 23 332716 131093 90164615
Pleural effusion 375.91 25.60 7 332732 111984 90183724
Injection site pain 371.95 25.60 90 332649 173609 90122099
Joint range of motion decreased 371.90 25.60 1220 331519 134423 90161285
Wound infection 370.60 25.60 1041 331698 105361 90190347
Somnolence 366.83 25.60 154 332585 208930 90086778
Seizure 364.47 25.60 61 332678 152568 90143140
Constipation 359.13 25.60 301 332438 280094 90015614
Dyspepsia 357.75 25.60 1559 331180 196601 90099107
Malignant neoplasm progression 357.41 25.60 7 332732 106863 90188845
Death 356.85 25.60 711 332028 455840 89839868
Weight decreased 356.06 25.60 2501 330238 377409 89918299
Mobility decreased 354.02 25.60 1837 330902 248897 90046811
Respiratory failure 350.39 25.60 21 332718 118397 90177311
Oxygen saturation decreased 344.46 25.60 11 332728 107472 90188236
Lip dry 338.23 25.60 974 331765 99981 90195727
Grip strength decreased 337.49 25.60 921 331818 91655 90204053
Cardiac arrest 335.36 25.60 11 332728 104924 90190784
Injury 331.68 25.60 1520 331219 195829 90099879
Folliculitis 330.99 25.60 1557 331182 202796 90092912
Syncope 321.27 25.60 51 332688 132612 90163096
Sciatica 317.56 25.60 955 331784 100427 90195281
Pulmonary embolism 315.21 25.60 51 332688 130769 90164939
Intentional overdose 314.38 25.60 6 332733 93828 90201880
C-reactive protein abnormal 314.02 25.60 1106 331633 126323 90169385
Rheumatoid factor positive 310.96 25.60 1352 331387 170298 90125410
Duodenal ulcer perforation 310.75 25.60 1619 331120 219669 90076039
Neuropathy peripheral 307.24 25.60 64 332675 136906 90158802
Synovitis 304.86 25.60 2164 330575 327588 89968120
Decreased appetite 299.61 25.60 2385 330354 374155 89921553
Bone erosion 293.17 25.60 620 332119 52401 90243307
Renal failure 292.23 25.60 62 332677 130945 90164763
Bradycardia 291.09 25.60 3 332736 83844 90211864
Helicobacter infection 289.60 25.60 1617 331122 225233 90070475
Deep vein thrombosis postoperative 287.12 25.60 733 332006 70076 90225632
Loss of consciousness 284.35 25.60 81 332658 140157 90155551
Bursitis 278.64 25.60 1088 331651 130566 90165142
Irritable bowel syndrome 277.73 25.60 1498 331241 205950 90089758
Dehydration 276.81 25.60 187 332552 194260 90101448
Liver injury 274.97 25.60 1298 331441 169269 90126439
Cardiac failure 274.57 25.60 38 332701 109458 90186250
Breast cancer stage III 274.44 25.60 806 331933 83641 90212067
Urinary tract infection 273.72 25.60 437 332302 305195 89990513
Gait inability 271.71 25.60 1162 331577 145294 90150414
Road traffic accident 270.22 25.60 940 331799 106686 90189022
Autoimmune disorder 266.35 25.60 750 331989 75994 90219714
Gastrointestinal disorder 262.99 25.60 1728 331011 254959 90040749
Pyrexia 262.46 25.60 1391 331348 659094 89636614
Sleep disorder 262.38 25.60 1426 331313 196604 90099104
Exostosis 261.61 25.60 593 332146 52541 90243167
Septic shock 261.43 25.60 11 332728 84149 90211559
Rash 259.78 25.60 4232 328507 791868 89503840
Injection site erythema 259.64 25.60 29 332710 98473 90197235
Therapeutic product effect decreased 256.11 25.60 1821 330918 275750 90019958
Peripheral venous disease 254.80 25.60 782 331957 83139 90212569
Atrial fibrillation 253.32 25.60 87 332652 133524 90162184
Blepharospasm 245.91 25.60 594 332145 54851 90240857
Musculoskeletal stiffness 242.73 25.60 1891 330848 294641 90001067
Hypoaesthesia 242.61 25.60 1977 330762 312233 89983475
Coma 241.89 25.60 5 332734 72627 90223081
Hypoxia 241.05 25.60 5 332734 72394 90223314
Deep vein thrombosis 238.91 25.60 28 332711 91592 90204116
Frequent bowel movements 237.71 25.60 596 332143 56339 90239369
Memory impairment 237.25 25.60 1384 331355 195860 90099848
Vomiting 236.10 25.60 4133 328606 784160 89511548
Inflammation 235.86 25.60 1285 331454 177307 90118401
Multiple organ dysfunction syndrome 234.71 25.60 3 332736 68333 90227375
Joint dislocation 227.81 25.60 505 332234 44077 90251631
Retinitis 227.01 25.60 462 332277 37996 90257712
Dislocation of vertebra 224.43 25.60 577 332162 55391 90240317
Adjustment disorder with depressed mood 224.39 25.60 582 332157 56171 90239537
Cough 222.96 25.60 657 332082 368305 89927403
Hyperkalaemia 222.47 25.60 3 332736 64961 90230747
Chest discomfort 222.40 25.60 115 332624 138250 90157458
Dysphagia 221.86 25.60 68 332671 112210 90183498
Wound 220.89 25.60 1882 330857 301098 89994610
Anti-cyclic citrullinated peptide antibody positive 216.80 25.60 1549 331190 234884 90060824
Gastrointestinal haemorrhage 215.57 25.60 36 332703 90212 90205496
Onychomadesis 215.02 25.60 503 332236 45495 90250213
Lower limb fracture 213.81 25.60 743 331996 84270 90211438
Balance disorder 210.34 25.60 49 332690 97031 90198677
Anaphylactic reaction 208.86 25.60 35 332704 87489 90208219
Leukopenia 206.32 25.60 57 332682 100653 90195055
Osteoarthritis 204.86 25.60 1325 331414 194405 90101303
Cognitive disorder 200.29 25.60 14 332725 69393 90226315
Insomnia 199.89 25.60 1986 330753 331488 89964220
Pericarditis 199.48 25.60 1683 331056 268468 90027240
Vision blurred 198.63 25.60 78 332661 110215 90185493
Cardiac failure congestive 198.23 25.60 58 332681 98636 90197072
Hand deformity 197.45 25.60 1805 330934 294557 90001151
Mucosal inflammation 195.87 25.60 3 332736 57622 90238086
Interstitial lung disease 195.17 25.60 25 332714 76380 90219328
Product supply issue 194.86 25.60 127 332612 2865 90292843
Blood pressure increased 194.03 25.60 264 332475 196953 90098755
Dry mouth 191.39 25.60 1244 331495 182815 90112893
Blister 189.53 25.60 1591 331148 253407 90042301
Flushing 189.09 25.60 46 332693 88445 90207263
Hypoglycaemia 188.08 25.60 19 332720 69829 90225879
Hepatic cirrhosis 186.96 25.60 584 332155 62669 90233039
C-reactive protein 186.54 25.60 378 332361 30989 90264719
Muscle injury 183.09 25.60 1193 331546 175461 90120247
General physical health deterioration 182.84 25.60 2051 330688 353064 89942644
Chills 181.09 25.60 132 332607 131849 90163859
Laryngitis 181.00 25.60 501 332238 50252 90245456
Taste disorder 179.85 25.60 566 332173 60980 90234728
Pulmonary oedema 177.76 25.60 13 332726 62067 90233641
X-ray abnormal 177.70 25.60 464 332275 44960 90250748
Impaired healing 177.10 25.60 1467 331272 232732 90062976
Cerebrovascular accident 176.84 25.60 118 332621 123415 90172293
Adverse event 175.80 25.60 875 331864 116543 90179165
Discomfort 174.74 25.60 1655 331084 272680 90023028
Glossodynia 172.74 25.60 1874 330865 319905 89975803
Anti-cyclic citrullinated peptide antibody 170.22 25.60 335 332404 26886 90268822
Dyspnoea exertional 170.09 25.60 30 332709 72258 90223450
Joint stiffness 169.17 25.60 650 332089 77392 90218316
Night sweats 166.92 25.60 922 331817 127844 90167864
Back injury 165.05 25.60 459 332280 46163 90249545
Blood pressure decreased 163.85 25.60 37 332702 74858 90220850
Dysarthria 163.17 25.60 9 332730 54473 90241235
Renal impairment 163.00 25.60 92 332647 105329 90190379
Wheezing 161.54 25.60 1456 331283 236624 90059084
Heart rate decreased 159.75 25.60 9 332730 53496 90242212
Erythema 159.01 25.60 381 332358 228865 90066843
International normalised ratio increased 158.59 25.60 3 332736 47313 90248395
Nail disorder 157.95 25.60 527 332212 58540 90237168
Angioedema 156.90 25.60 25 332714 64851 90230857
Therapy interrupted 156.82 25.60 472 332267 49636 90246072
Injection site swelling 156.72 25.60 18 332721 59821 90235887
Ascites 156.20 25.60 4 332735 47736 90247972
Tension headache 156.04 25.60 164 332575 7345 90288363
Adverse reaction 155.68 25.60 340 332399 29372 90266336
Therapeutic product effect incomplete 155.47 25.60 1231 331508 192665 90103043
Encephalopathy 155.44 25.60 3 332736 46441 90249267
Overdose 155.23 25.60 211 332528 157498 90138210
Alanine aminotransferase increased 155.14 25.60 124 332615 118214 90177494
Sleep disorder due to general medical condition, insomnia type 154.64 25.60 903 331836 127791 90167917
Lupus vulgaris 154.01 25.60 438 332301 44621 90251087
Hyperglycaemia 153.96 25.60 8 332731 50962 90244746
Suicide attempt 153.83 25.60 43 332696 75356 90220352
Blood alkaline phosphatase increased 153.75 25.60 5 332734 48074 90247634
Lupus-like syndrome 151.82 25.60 459 332280 48387 90247321
C-reactive protein increased 151.18 25.60 1162 331577 180227 90115481
Hallucination 149.58 25.60 30 332709 65929 90229779
Upper respiratory tract infection 148.16 25.60 891 331848 127427 90168281
Obesity 146.59 25.60 770 331969 104737 90190971
Blood bilirubin increased 144.71 25.60 3 332736 43467 90252241
Liver function test increased 141.97 25.60 653 332086 84202 90211506
Live birth 141.53 25.60 621 332118 78486 90217222
Pulmonary hypertension 141.30 25.60 3 332736 42520 90253188
Enthesopathy 140.36 25.60 173 332566 9231 90286477
Blood creatinine increased 139.60 25.60 101 332638 101285 90194423
Myocardial infarction 138.97 25.60 111 332628 105861 90189847
Epistaxis 137.89 25.60 70 332669 85055 90210653
Off label use 136.98 25.60 3046 329693 1099206 89196502
Hypocalcaemia 136.94 25.60 4 332735 42364 90253344
Pneumonia aspiration 135.60 25.60 3 332736 40937 90254771
Red blood cell sedimentation rate increased 135.52 25.60 632 332107 81963 90213745
Plasma cell myeloma 135.20 25.60 3 332736 40825 90254883
Mental status changes 135.00 25.60 7 332732 44672 90251036
Foot deformity 134.37 25.60 503 332236 59148 90236560
Hypothyroidism 134.21 25.60 18 332721 53109 90242599
Injection site pruritus 134.20 25.60 19 332720 53815 90241893
Multiple sclerosis relapse 133.87 25.60 17 332722 52288 90243420
Acute respiratory failure 132.00 25.60 6 332733 42912 90252796
Red blood cell count decreased 131.87 25.60 10 332729 46341 90249367
Blood pressure fluctuation 131.83 25.60 18 332721 52395 90243313
Drug reaction with eosinophilia and systemic symptoms 131.43 25.60 6 332733 42752 90252956
Ill-defined disorder 131.19 25.60 1142 331597 183749 90111959
Aphasia 128.44 25.60 7 332732 42805 90252903
Colitis 126.69 25.60 49 332690 69893 90225815
Ear infection 124.25 25.60 547 332192 69228 90226480
Breast cancer stage II 123.23 25.60 346 332393 34988 90260720
Liver function test abnormal 122.05 25.60 20 332719 50825 90244883
Swelling face 120.12 25.60 75 332664 81277 90214431
Full blood count abnormal 119.99 25.60 3 332736 36594 90259114
Agitation 119.90 25.60 48 332691 67050 90228658
Systemic lupus erythematosus 119.38 25.60 1929 330810 359967 89935741
Gastrooesophageal reflux disease 119.35 25.60 1030 331709 165307 90130401
Cholestasis 118.92 25.60 3 332736 36296 90259412
Urticaria 118.17 25.60 1706 331033 311028 89984680
Aspartate aminotransferase increased 118.08 25.60 122 332617 102815 90192893
Respiratory distress 117.99 25.60 6 332733 38940 90256768
Back pain 117.97 25.60 682 332057 316493 89979215
Thrombosis 117.50 25.60 61 332678 73190 90222518
Hyperhidrosis 117.14 25.60 200 332539 136105 90159603
Urinary retention 116.99 25.60 5 332734 37739 90257969
Pneumonitis 116.39 25.60 13 332726 44157 90251551
Dyskinesia 116.11 25.60 4 332735 36530 90259178
Pneumonia 116.09 25.60 1647 331092 636412 89659296
Onychomycosis 115.00 25.60 350 332389 37026 90258682
Hepatotoxicity 114.69 25.60 16 332723 45826 90249882
Macular degeneration 114.56 25.60 6 332733 37964 90257744
Muscle spasms 114.56 25.60 1421 331318 250462 90045246
Stomatitis 114.51 25.60 1525 331214 273173 90022535
Generalised tonic-clonic seizure 113.91 25.60 3 332736 34900 90260808
Hepatic function abnormal 113.84 25.60 17 332722 46271 90249437
Orthostatic hypotension 113.60 25.60 11 332728 41816 90253892
Hepatic failure 111.82 25.60 9 332730 39719 90255989
Pericardial effusion 110.57 25.60 6 332733 36827 90258881
Rash maculo-papular 110.55 25.60 11 332728 40922 90254786
Accidental exposure to product 110.31 25.60 13 332726 42353 90253355
Product label confusion 110.21 25.60 253 332486 22597 90273111
Urinary incontinence 110.08 25.60 7 332732 37559 90258149
Chronic kidney disease 109.37 25.60 25 332714 50166 90245542
Disorientation 108.96 25.60 16 332723 44098 90251610
Lung disorder 108.52 25.60 930 331809 148953 90146755
Lymphocyte count decreased 107.47 25.60 5 332734 35045 90260663
Blood creatine phosphokinase increased 107.17 25.60 4 332735 34019 90261689
Arthralgia 107.17 25.60 3672 329067 774850 89520858
Speech disorder 107.06 25.60 19 332720 45566 90250142
Hepatic enzyme increased 106.99 25.60 1890 330849 358846 89936862
Acute myocardial infarction 106.90 25.60 5 332734 34885 90260823
Inappropriate schedule of product administration 105.67 25.60 247 332492 149686 90146022
Jaundice 105.35 25.60 3 332736 32514 90263194
Walking aid user 105.07 25.60 328 332411 35178 90260530
Respiratory arrest 104.64 25.60 4 332735 33307 90262401
Arthropathy 104.43 25.60 1907 330832 364335 89931373
Pallor 104.35 25.60 5 332734 34160 90261548
Melaena 103.43 25.60 6 332733 34791 90260917
Treatment failure 102.82 25.60 1627 331112 302301 89993407
Haemorrhage 102.35 25.60 64 332675 69305 90226403
Faeces soft 102.28 25.60 132 332607 7379 90288329
Haematoma 101.62 25.60 12 332727 39036 90256672
Gamma-glutamyltransferase increased 100.44 25.60 11 332728 37941 90257767
Hemiparesis 99.34 25.60 4 332735 31815 90263893
Injection site bruising 99.22 25.60 34 332705 52273 90243435
Seronegative arthritis 98.20 25.60 211 332528 18023 90277685
Chronic obstructive pulmonary disease 97.21 25.60 77 332662 73752 90221956
Pancreatitis acute 97.13 25.60 5 332734 32110 90263598
Coronary artery disease 96.38 25.60 7 332732 33616 90262092
Blood potassium decreased 95.91 25.60 28 332711 47699 90248009
Disturbance in attention 95.85 25.60 27 332712 47082 90248626
Haematuria 95.38 25.60 9 332730 34928 90260780
Oropharyngeal pain 95.36 25.60 173 332566 115014 90180694
Liver disorder 94.46 25.60 765 331974 120504 90175204
Stress 93.81 25.60 565 332174 80830 90214878
Blood calcium decreased 93.54 25.60 4 332735 30178 90265530
Leukocytosis 93.17 25.60 5 332734 30985 90264723
Femur fracture 92.67 25.60 27 332712 46055 90249653
Hepatocellular injury 92.63 25.60 3 332736 28955 90266753
Paraesthesia oral 92.47 25.60 6 332733 31653 90264055
Swollen tongue 92.28 25.60 27 332712 45929 90249779
Metastases to liver 92.09 25.60 3 332736 28804 90266904
Heart rate increased 91.31 25.60 172 332567 112730 90182978
Rheumatoid arthritis 90.73 25.60 1851 330888 360763 89934945
Cholelithiasis 89.90 25.60 40 332699 52466 90243242
Alopecia 89.72 25.60 2416 330323 492655 89803053
Arrhythmia 88.50 25.60 23 332716 42309 90253399
Abortion spontaneous 88.22 25.60 44 332695 54012 90241696
Blood urea increased 88.14 25.60 6 332733 30407 90265301
Lethargy 88.09 25.60 62 332677 63077 90232631
Hip arthroplasty 87.83 25.60 529 332210 75679 90220029
Procedural pain 87.45 25.60 10 332729 33350 90262358
Drug dependence 87.34 25.60 5 332734 29322 90266386
Eye pain 86.78 25.60 27 332712 44141 90251567
Cerebral haemorrhage 86.48 25.60 12 332727 34510 90261198
Pulmonary fibrosis 86.37 25.60 683 332056 106820 90188888
Haematochezia 86.00 25.60 80 332659 70833 90224875
Drug resistance 85.41 25.60 7 332732 30442 90265266
Epilepsy 84.99 25.60 555 332184 81651 90214057
Blood glucose increased 84.38 25.60 137 332602 95109 90200599
Pemphigus 83.91 25.60 1675 331064 325189 89970519
Pustular psoriasis 82.47 25.60 199 332540 18357 90277351
Product administration interrupted 82.08 25.60 157 332582 12335 90283373
Asthenia 81.09 25.60 1425 331314 532326 89763382
Productive cough 81.08 25.60 98 332641 76965 90218743
Vertigo 80.90 25.60 82 332657 69729 90225979
Cytomegalovirus infection 80.90 25.60 4 332735 26598 90269110
Prescribed underdose 80.33 25.60 511 332228 74508 90221200
Transient ischaemic attack 80.29 25.60 29 332710 43147 90252561
Infection 80.18 25.60 1816 330923 360278 89935430
Foetal exposure during pregnancy 79.68 25.60 29 332710 42946 90252762
Myalgia 79.63 25.60 351 332388 174774 90120934
Stevens-Johnson syndrome 79.06 25.60 8 332731 29368 90266340
No adverse event 78.61 25.60 80 332659 67902 90227806
Blood pressure diastolic decreased 78.60 25.60 5 332734 26821 90268887
Wrong technique in product usage process 78.55 25.60 88 332651 71483 90224225
Psychotic disorder 77.89 25.60 11 332728 31219 90264489
Subcutaneous drug absorption impaired 77.89 25.60 161 332578 13384 90282324
Tenosynovitis 77.80 25.60 168 332571 14399 90281309
Drug-induced liver injury 77.66 25.60 583 332156 89735 90205973
Sleep apnoea syndrome 77.29 25.60 12 332727 31735 90263973
Therapeutic response decreased 77.04 25.60 579 332160 89150 90206558
Intestinal obstruction 76.06 25.60 21 332718 37110 90258598
Cerebral infarction 74.92 25.60 6 332733 26590 90269118
Dry eye 74.30 25.60 62 332677 57869 90237839
Osteonecrosis 73.70 25.60 6 332733 26235 90269473
Atelectasis 73.19 25.60 4 332735 24405 90271303
Tachycardia 72.92 25.60 314 332425 157359 90138349
Proteinuria 72.47 25.60 3 332736 23288 90272420
Aggression 72.46 25.60 7 332732 26661 90269047
Prescribed overdose 72.35 25.60 609 332130 97016 90198692
Finger deformity 72.09 25.60 275 332464 32622 90263086
Hallucination, visual 71.77 25.60 3 332736 23089 90272619
Tremor 71.47 25.60 304 332435 152869 90142839
Cataract 71.36 25.60 96 332643 71996 90223712
Lymphopenia 71.02 25.60 3 332736 22878 90272830
Haemoptysis 69.86 25.60 18 332721 33302 90262406
Clostridium difficile infection 69.72 25.60 23 332716 36222 90259486
Visual acuity reduced 69.69 25.60 4 332735 23406 90272302
Diplopia 69.58 25.60 11 332728 28703 90267005
Device related infection 69.45 25.60 7 332732 25779 90269929
Rash erythematous 69.34 25.60 82 332657 65022 90230686
Bacteraemia 68.96 25.60 3 332736 22297 90273411
Dysphonia 68.76 25.60 78 332661 63006 90232702
Candida infection 68.40 25.60 20 332719 34037 90261671
Full blood count decreased 68.37 25.60 13 332726 29676 90266032
Electrolyte imbalance 67.90 25.60 5 332734 23740 90271968
Presyncope 67.03 25.60 17 332722 31788 90263920
Nasopharyngitis 66.78 25.60 1962 330777 405142 89890566
Circulatory collapse 66.46 25.60 7 332732 24897 90270811
Rebound psoriasis 66.37 25.60 24 332715 131 90295577
Device issue 65.80 25.60 14 332725 29523 90266185
Body temperature decreased 65.37 25.60 6 332733 23810 90271898
Ischaemic stroke 65.34 25.60 4 332735 22162 90273546
Infusion site reaction 64.98 25.60 185 332554 18854 90276854
Blindness 64.78 25.60 10 332729 26558 90269150
Platelet count increased 63.87 25.60 3 332736 20856 90274852
Throat irritation 63.84 25.60 51 332688 48644 90247064
Restlessness 63.09 25.60 26 332713 35694 90260014
Body temperature increased 62.24 25.60 44 332695 44666 90251042
Knee arthroplasty 62.22 25.60 520 332219 82662 90213046
Small intestinal obstruction 62.09 25.60 4 332735 21230 90274478
Blood sodium decreased 61.69 25.60 13 332726 27600 90268108
Throat tightness 61.67 25.60 16 332723 29468 90266240
Disability 61.20 25.60 304 332435 40441 90255267
Withdrawal syndrome 60.96 25.60 6 332733 22518 90273190
Gastroenteritis 60.88 25.60 16 332723 29213 90266495
Hypophagia 60.55 25.60 28 332711 35909 90259799
Product quality issue 60.46 25.60 498 332241 78827 90216881
Bronchiectasis 60.30 25.60 6 332733 22324 90273384
Infusion site pain 59.92 25.60 3 332736 19735 90275973
Immunodeficiency 59.59 25.60 43 332696 43191 90252517
Injection site mass 59.49 25.60 6 332733 22084 90273624
Blood pressure systolic increased 59.49 25.60 76 332663 58269 90237439
Malaise 58.85 25.60 2672 330067 583314 89712394
Musculoskeletal pain 58.69 25.60 919 331820 170332 90125376
Staphylococcal infection 58.32 25.60 55 332684 48384 90247324
Injection site haemorrhage 58.04 25.60 16 332723 28302 90267406
Eye irritation 57.99 25.60 26 332713 33952 90261756
Red blood cell sedimentation rate 57.48 25.60 78 332661 4580 90291128
Cystitis 57.21 25.60 98 332641 66620 90229088
Unevaluable event 57.11 25.60 371 332368 54477 90241231
Cardiomegaly 57.06 25.60 3 332736 18922 90276786
Abdominal pain 56.41 25.60 1068 331671 394653 89901055
Abnormal behaviour 56.36 25.60 8 332731 22620 90273088
Oral candidiasis 56.16 25.60 30 332709 35425 90260283
Pulmonary mass 55.79 25.60 18 332721 28754 90266954
Cardiomyopathy 55.71 25.60 5 332734 20201 90275507
Spondylitis 55.61 25.60 145 332594 14033 90281675
Rash vesicular 55.60 25.60 170 332569 18027 90277681
Radiculopathy 55.59 25.60 3 332736 18502 90277206
Oedema peripheral 55.56 25.60 642 332097 257273 90038435
Motor dysfunction 55.13 25.60 4 332735 19226 90276482
Myoclonus 54.91 25.60 4 332735 19164 90276544
Pneumothorax 54.91 25.60 4 332735 19163 90276545
Muscle twitching 54.89 25.60 11 332728 24191 90271517
Sinusitis 54.21 25.60 1646 331093 341442 89954266
Rib fracture 54.06 25.60 15 332724 26420 90269288
Product administration error 54.02 25.60 15 332724 26408 90269300
Angina pectoris 53.91 25.60 39 332700 39121 90256587
Injection site urticaria 53.85 25.60 3 332736 18008 90277700
Product substitution issue 53.84 25.60 3 332736 18005 90277703
Dementia 53.79 25.60 11 332728 23850 90271858
Dysuria 53.26 25.60 40 332699 39361 90256347
Bone pain 53.19 25.60 91 332648 61892 90233816
Mood altered 53.16 25.60 161 332578 16983 90278725
Complication associated with device 53.12 25.60 5 332734 19444 90276264
Food allergy 52.96 25.60 14 332725 25464 90270244
Malnutrition 52.80 25.60 4 332735 18554 90277154
Amnesia 52.25 25.60 619 332120 107886 90187822
Acute myeloid leukaemia 52.11 25.60 7 332732 20633 90275075
Transfusion 52.02 25.60 3 332736 17485 90278223
Cytopenia 51.89 25.60 3 332736 17446 90278262
Osteoporosis 51.58 25.60 562 332177 95969 90199739
Chronic sinusitis 51.57 25.60 12 332727 23790 90271918
General symptom 51.50 25.60 144 332595 14524 90281184
Eye pruritus 51.47 25.60 21 332718 29006 90266702
Lip swelling 51.16 25.60 40 332699 38570 90257138
Vaginal discharge 50.60 25.60 6 332733 19458 90276250
Diabetes mellitus 50.56 25.60 101 332638 64774 90230934
Hypertensive crisis 50.13 25.60 4 332735 17780 90277928
Head injury 49.97 25.60 26 332713 31162 90264546
Haematemesis 49.91 25.60 31 332708 33695 90262013
Pregnancy 49.71 25.60 394 332345 61653 90234055
Palpitations 49.70 25.60 296 332443 136432 90159276
Dystonia 49.68 25.60 3 332736 16816 90278892
Gastritis 49.58 25.60 48 332691 41705 90254003
Clostridium difficile colitis 49.55 25.60 18 332721 26688 90269020
Urosepsis 49.53 25.60 9 332730 21223 90274485
Hiatus hernia 48.94 25.60 16 332723 25345 90270363
Infusion related reaction 48.91 25.60 1932 330807 414848 89880860
Ileus 48.73 25.60 3 332736 16543 90279165
Ovarian cyst 48.52 25.60 4 332735 17314 90278394
Mouth ulceration 47.41 25.60 46 332693 39928 90255780
Glomerular filtration rate decreased 47.20 25.60 4 332735 16928 90278780
Feeling cold 46.90 25.60 21 332718 27444 90268264
Device difficult to use 46.57 25.60 5 332734 17520 90278188
Hypertension 46.48 25.60 2089 330650 455443 89840265
Nodule 46.21 25.60 20 332719 26666 90269042
Blood potassium increased 45.88 25.60 10 332729 20739 90274969
Bronchospasm 45.75 25.60 10 332729 20699 90275009
Lacrimation increased 45.73 25.60 21 332718 27041 90268667
Back disorder 45.66 25.60 201 332538 25430 90270278
Injection site rash 45.35 25.60 16 332723 24157 90271551
Haemophagocytic lymphohistiocytosis 44.94 25.60 3 332736 15456 90280252
Delirium 44.93 25.60 583 332156 103776 90191932
Sputum discoloured 44.74 25.60 10 332729 20381 90275327
Device malfunction 44.62 25.60 11 332728 20966 90274742
Tongue disorder 44.59 25.60 113 332626 10747 90284961
Blood albumin decreased 44.13 25.60 5 332734 16798 90278910
Injection site warmth 44.08 25.60 6 332733 17509 90278199
Cellulitis 44.01 25.60 179 332560 91158 90204550
Metastases to lung 43.97 25.60 4 332735 15987 90279721
Spinal compression fracture 43.96 25.60 3 332736 15175 90280533
Tenderness 43.64 25.60 22 332717 26846 90268862
Schizophrenia 43.05 25.60 3 332736 14911 90280797
Body tinea 43.01 25.60 46 332693 2102 90293606
Anuria 42.71 25.60 3 332736 14815 90280893
Vasculitis 42.61 25.60 15 332724 22678 90273030
Joint swelling 42.33 25.60 2256 330483 501044 89794664
Ocular hyperaemia 42.33 25.60 37 332702 33761 90261947
Product storage error 42.31 25.60 11 332728 20230 90275478
Adrenal insufficiency 42.24 25.60 29 332710 29892 90265816
Hepatic steatosis 42.12 25.60 44 332695 36901 90258807
Influenza like illness 42.04 25.60 153 332586 80458 90215250
Poor venous access 42 25.60 10 332729 19517 90276191
Osteopenia 41.84 25.60 16 332723 22986 90272722
Hip fracture 41.68 25.60 36 332703 33041 90262667
Toxic skin eruption 40.67 25.60 5 332734 15769 90279939
Disease recurrence 40.55 25.60 47 332692 37606 90258102
Iron deficiency anaemia 40.55 25.60 18 332721 23644 90272064
Loss of personal independence in daily activities 40.22 25.60 713 332026 135392 90160316
Anal incontinence 39.82 25.60 6 332733 16224 90279484
Movement disorder 39.82 25.60 29 332710 28990 90266718
Pain in jaw 39.77 25.60 72 332667 47913 90247795
Cardiac murmur 39.76 25.60 9 332730 18185 90277523
Neutrophil count increased 39.65 25.60 11 332728 19379 90276329
Lymphadenopathy 39.46 25.60 67 332672 45708 90250000
Heart rate irregular 39.23 25.60 20 332719 24248 90271460
Emotional distress 39.23 25.60 46 332693 36616 90259092
Fear 38.87 25.60 7 332732 16615 90279093
Oesophagitis 38.78 25.60 8 332731 17241 90278467
Pharyngitis 38.72 25.60 16 332723 21931 90273777
Post procedural complication 38.57 25.60 11 332728 19031 90276677
Vaginal haemorrhage 38.24 25.60 35 332704 31236 90264472
Petechiae 38.21 25.60 6 332733 15735 90279973
Pruritus 38.17 25.60 2389 330350 539136 89756572
Tinnitus 38.17 25.60 62 332677 43040 90252668
Hypokinesia 38.06 25.60 6 332733 15691 90280017
Blood magnesium decreased 38.05 25.60 6 332733 15687 90280021
Supraventricular tachycardia 37.95 25.60 7 332732 16329 90279379
Anaphylactic shock 37.94 25.60 36 332703 31581 90264127
Accidental overdose 37.83 25.60 29 332710 28244 90267464
COVID-19 pneumonia 37.76 25.60 10 332729 18167 90277541
Pseudomonas infection 37.63 25.60 5 332734 14860 90280848
Mania 37.61 25.60 4 332735 14120 90281588
Swollen joint count 37.60 25.60 92 332647 8561 90287147
Affect lability 37.40 25.60 10 332729 18053 90277655
Flank pain 37.32 25.60 12 332727 19210 90276498
Rhinitis allergic 37.30 25.60 8 332731 16777 90278931
Therapy cessation 37.27 25.60 245 332494 36116 90259592
Coeliac disease 37.24 25.60 286 332453 44324 90251384
Generalised oedema 36.80 25.60 12 332727 19041 90276667
Multiple sclerosis 36.69 25.60 29 332710 27811 90267897
Delusion 36.65 25.60 4 332735 13836 90281872
Escherichia infection 36.52 25.60 7 332732 15888 90279820
Poisoning 36.49 25.60 6 332733 15211 90280497
Splenomegaly 36.17 25.60 3 332736 12921 90282787
Cholecystitis 36.12 25.60 9 332730 17031 90278677
Deafness 35.73 25.60 19 332720 22495 90273213
Fatigue 35.73 25.60 3702 329037 1150321 89145387
Pneumonia bacterial 35.71 25.60 3 332736 12787 90282921
Hyperthyroidism 34.55 25.60 12 332727 18298 90277410
Arterial occlusive disease 34.53 25.60 3 332736 12443 90283265
Fracture 34.50 25.60 19 332720 22057 90273651
Hypoacusis 34.26 25.60 31 332708 27819 90267889
Arthritis 34.16 25.60 830 331909 166485 90129223
Ecchymosis 34.11 25.60 3 332736 12320 90283388
Breast cancer metastatic 34.06 25.60 7 332732 15125 90280583
Swelling 33.94 25.60 1872 330867 417186 89878522
Sensory loss 33.84 25.60 12 332727 18063 90277645
Acute generalised exanthematous pustulosis 33.77 25.60 5 332734 13698 90282010
Eating disorder 33.65 25.60 32 332707 28041 90267667
Mental impairment 33.25 25.60 10 332729 16710 90278998
Abdominal pain lower 33.22 25.60 37 332702 30140 90265568
Skin laceration 33.21 25.60 28 332711 26007 90269701
Nervous system disorder 33.14 25.60 19 332720 21574 90274134
Product complaint 33.10 25.60 5 332734 13495 90282213
Cardiovascular disorder 33.07 25.60 5 332734 13487 90282221
Mental disorder 33.04 25.60 42 332697 32276 90263432
Drug effect less than expected 33.02 25.60 71 332668 6067 90289641
Spinal fracture 32.90 25.60 20 332719 21996 90273712
Vascular device infection 32.84 25.60 3 332736 11949 90283759
Drug ineffective for unapproved indication 32.49 25.60 130 332609 66514 90229194
Needle issue 32.30 25.60 6 332733 13928 90281780
Dactylitis 32.28 25.60 54 332685 3819 90291889
Ventricular extrasystoles 32.27 25.60 5 332734 13245 90282463
Flatulence 32.21 25.60 261 332478 41106 90254602
Red blood cell sedimentation rate abnormal 32.16 25.60 25 332714 24179 90271529
Metastases to lymph nodes 31.94 25.60 3 332736 11686 90284022
Central nervous system lesion 31.79 25.60 3 332736 11643 90284065
Blood parathyroid hormone decreased 31.77 25.60 108 332631 12108 90283600
Colitis ischaemic 31.62 25.60 4 332735 12342 90283366
Aphthous ulcer 31.49 25.60 12 332727 17275 90278433
Carpal tunnel syndrome 31.44 25.60 25 332714 23903 90271805
Pulmonary toxicity 31.40 25.60 3 332736 11528 90284180
Feeling abnormal 31.24 25.60 429 332310 166806 90128902
Emphysema 30.98 25.60 4 332735 12151 90283557
Pelvic pain 30.87 25.60 9 332730 15348 90280360
Diverticulum 30.84 25.60 4 332735 12109 90283599
Incontinence 30.69 25.60 6 332733 13429 90282279
Bone disorder 30.57 25.60 24 332715 23096 90272612
Porphyria acute 30.54 25.60 139 332600 17836 90277872
Grip strength 30.48 25.60 87 332652 8878 90286830
Fluid retention 30.29 25.60 194 332545 87897 90207811
Herpes zoster 30.26 25.60 213 332526 94431 90201277
Haemorrhoids 30.22 25.60 32 332707 26670 90269038
Product dose omission in error 30.12 25.60 19 332720 20484 90275224
Intestinal perforation 30.07 25.60 7 332732 13874 90281834
Product prescribing error 29.98 25.60 40 332699 30105 90265603
Limb discomfort 29.88 25.60 59 332680 38001 90257707
Eye disorder 29.70 25.60 34 332705 27356 90268352
Blood triglycerides increased 29.69 25.60 7 332732 13754 90281954
Drug intolerance 29.59 25.60 1964 330775 445627 89850081
Hypersensitivity 29.33 25.60 1991 330748 452686 89843022
Sudden death 29.28 25.60 3 332736 10906 90284802
Scar 29.21 25.60 10 332729 15385 90280323
Hepatitis acute 29.21 25.60 3 332736 10884 90284824
Eczema 29.15 25.60 98 332641 52772 90242936
Paranoia 28.99 25.60 6 332733 12902 90282806
Erythema multiforme 28.98 25.60 5 332734 12241 90283467
Inhibitory drug interaction 28.94 25.60 46 332693 3117 90292591
Postoperative wound infection 28.63 25.60 7 332732 13419 90282289
Dental caries 28.46 25.60 4 332735 11393 90284315
Pyelonephritis 28.35 25.60 22 332717 21294 90274414
Skin abrasion 27.92 25.60 4 332735 11231 90284477
Dysgeusia 27.91 25.60 99 332640 52461 90243247
Hepatic enzyme 27.82 25.60 61 332678 5283 90290425
Abortion induced 27.82 25.60 5 332734 11883 90283825
Injection site induration 27.78 25.60 3 332736 10465 90285243
Spinal osteoarthritis 27.78 25.60 18 332721 19130 90276578
Bacterial infection 27.78 25.60 27 332712 23417 90272291
Sensory disturbance 27.57 25.60 11 332728 15402 90280306
Second primary malignancy 27.48 25.60 3 332736 10375 90285333
Musculoskeletal chest pain 27.40 25.60 28 332711 23722 90271986
Amenorrhoea 27.28 25.60 5 332734 11717 90283991
Spinal stenosis 27.22 25.60 15 332724 17409 90278299
Electrocardiogram abnormal 27.21 25.60 3 332736 10295 90285413
Hot flush 27.16 25.60 119 332620 59369 90236339
Toothache 27.04 25.60 25 332714 22205 90273503
Dermatitis 27.02 25.60 25 332714 22195 90273513
Pelvic fracture 27.00 25.60 11 332728 15208 90280500
Photophobia 26.98 25.60 23 332716 21246 90274462
Gastric ulcer 26.71 25.60 37 332702 27411 90268297
Burning sensation 26.56 25.60 131 332608 63321 90232387
Restless legs syndrome 26.48 25.60 26 332713 22444 90273264
Viral infection 26.24 25.60 72 332667 41342 90254366
Myositis 26.22 25.60 165 332574 23963 90271745
Hypogammaglobulinaemia 26.06 25.60 4 332735 10670 90285038
Urine output decreased 26.05 25.60 7 332732 12596 90283112
Tooth fracture 26.04 25.60 7 332732 12593 90283115
Dialysis 26.00 25.60 5 332734 11324 90284384
Dandruff 25.85 25.60 16 332723 329 90295379

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 7439.48 28.83 5925 61334 454924 42099152
Product dose omission issue 5694.44 28.83 3330 63929 151035 42403041
Headache 4388.39 28.83 3342 63917 236027 42318049
Nausea 3956.51 28.83 3908 63351 392891 42161185
Abdominal discomfort 3194.86 28.83 1786 65473 73469 42480607
Drug ineffective 2535.23 28.83 3933 63326 626264 41927812
Therapy non-responder 1751.84 28.83 1074 66185 52285 42501791
Depression 1062.84 28.83 1080 66179 110283 42443793
Abdominal pain upper 799.79 28.83 808 66451 81801 42472275
Therapeutic product effect decreased 798.43 28.83 587 66672 38563 42515513
Adverse drug reaction 792.24 28.83 574 66685 36860 42517216
Psoriasis 669.97 28.83 579 66680 48025 42506051
Psoriatic arthropathy 621.54 28.83 423 66836 24544 42529532
Weight decreased 564.38 28.83 1101 66158 206847 42347229
Gastric disorder 503.51 28.83 283 66976 11639 42542437
Acute kidney injury 460.15 28.83 31 67228 367306 42186770
Rash 395.66 28.83 1142 66117 275812 42278264
Frequent bowel movements 359.17 28.83 286 66973 21121 42532955
Arthralgia 333.90 28.83 888 66371 204350 42349726
Gastrointestinal disorder 321.29 28.83 382 66877 46271 42507805
Pain 319.26 28.83 978 66281 243870 42310206
Drug interaction 315.88 28.83 29 67230 266970 42287106
Toxicity to various agents 302.97 28.83 14 67245 229122 42324954
Hypotension 294.26 28.83 32 67227 257599 42296477
Anaemia 293.36 28.83 46 67213 280232 42273844
Dyspepsia 273.89 28.83 332 66927 41020 42513056
Pyrexia 268.88 28.83 144 67115 393898 42160178
Neutropenia 264.20 28.83 12 67247 199419 42354657
Febrile neutropenia 260.52 28.83 7 67252 185696 42368380
Therapeutic response decreased 248.11 28.83 299 66960 36713 42517363
Therapeutic product effect incomplete 240.08 28.83 414 66845 70525 42483551
Therapy interrupted 233.93 28.83 228 67031 22022 42532054
Thrombocytopenia 218.75 28.83 23 67236 190256 42363820
Dyspnoea 215.76 28.83 229 67030 442392 42111684
Faeces soft 211.13 28.83 118 67141 4794 42549282
Upper respiratory tract infection 194.99 28.83 284 66975 41889 42512187
Flatulence 193.26 28.83 218 67041 24934 42529142
Discomfort 187.70 28.83 215 67044 25004 42529072
Pruritus 181.90 28.83 682 66577 188089 42365987
Mood altered 179.30 28.83 143 67116 10575 42543501
Product supply issue 175.96 28.83 72 67187 1435 42552641
Enthesopathy 165.14 28.83 100 67159 4728 42549348
Pneumonia 163.73 28.83 259 67000 421890 42132186
Sepsis 162.41 28.83 56 67203 199278 42354798
Confusional state 151.20 28.83 39 67220 167558 42386518
Platelet count decreased 148.78 28.83 21 67238 138560 42415516
Haemoglobin decreased 147.18 28.83 18 67241 132453 42421623
Respiratory failure 143.36 28.83 17 67242 128115 42425961
Memory impairment 139.26 28.83 269 66990 49953 42504123
Pulmonary embolism 135.99 28.83 15 67244 119597 42434479
Treatment failure 134.49 28.83 302 66957 62322 42491754
Cardiac arrest 134.23 28.83 10 67249 109310 42444766
Tension headache 133.22 28.83 77 67182 3337 42550739
Product administration interrupted 132.72 28.83 88 67171 4878 42549198
Product use in unapproved indication 130.53 28.83 64 67195 184392 42369684
Disease progression 128.47 28.83 34 67225 143622 42410454
Nasopharyngitis 126.66 28.83 354 66905 83642 42470434
Pleural effusion 124.89 28.83 7 67252 97159 42456917
Oedema peripheral 123.99 28.83 31 67228 136045 42418031
Tenosynovitis 122.58 28.83 82 67177 4613 42549463
Alanine aminotransferase abnormal 118.74 28.83 82 67177 4862 42549214
Unevaluable event 117.04 28.83 201 67058 34087 42519989
C-reactive protein abnormal 116.73 28.83 105 67154 9156 42544920
Overdose 115.21 28.83 15 67244 105249 42448827
Bradycardia 110.35 28.83 6 67253 85478 42468598
Infection 110.32 28.83 408 66851 111660 42442416
Migraine 110.02 28.83 166 67093 25248 42528828
Pancytopenia 106.91 28.83 27 67232 117716 42436360
Tachycardia 106.88 28.83 16 67243 101071 42453005
Fall 105.56 28.83 129 67130 234391 42319685
Hyperkalaemia 102.76 28.83 6 67253 80452 42473624
Completed suicide 102.61 28.83 15 67244 96450 42457626
Seizure 101.40 28.83 32 67227 120529 42433547
White blood cell count decreased 100.84 28.83 25 67234 110371 42443705
Multiple organ dysfunction syndrome 98.90 28.83 17 67242 97018 42457058
Blood creatinine increased 98.39 28.83 26 67233 109977 42444099
Renal failure 96.98 28.83 53 67206 143673 42410403
Arthropathy 96.45 28.83 170 67089 29427 42524649
Insomnia 95.79 28.83 405 66854 117848 42436228
Synovitis 94.97 28.83 120 67139 15447 42538629
Tongue disorder 94.71 28.83 74 67185 5309 42548767
Septic shock 93.56 28.83 16 67243 91656 42462420
Off label use 93.05 28.83 609 66650 637726 41916350
Deep vein thrombosis 91.78 28.83 8 67251 76949 42477127
Arthritis 87.10 28.83 200 67059 41865 42512211
Hypoxia 83.92 28.83 7 67252 69779 42484297
Gastrointestinal haemorrhage 83.86 28.83 25 67234 97701 42456375
Tendonitis 81.56 28.83 89 67170 9805 42544271
Adverse reaction 81.54 28.83 60 67199 3933 42550143
Asthenia 80.52 28.83 205 67054 280588 42273488
Oxygen saturation decreased 79.15 28.83 6 67253 64681 42489395
Mood swings 79.11 28.83 83 67176 8743 42545333
Syncope 79.04 28.83 29 67230 99377 42454699
Hypokalaemia 79.00 28.83 10 67249 71711 42482365
Vomiting 77.57 28.83 747 66512 288976 42265100
Neuropathy peripheral 77.21 28.83 32 67227 101821 42452255
Drug intolerance 76.76 28.83 290 66969 80134 42473942
General physical health deterioration 74.76 28.83 77 67182 151169 42402907
Feeling abnormal 73.65 28.83 260 66999 69526 42484550
Interstitial lung disease 73.15 28.83 17 67242 78445 42475631
Death 72.34 28.83 442 66817 470743 42083333
Adverse event 72.18 28.83 132 67127 23508 42530568
Loss of personal independence in daily activities 67.36 28.83 202 67057 49614 42504462
Pneumonia aspiration 66.26 28.83 3 67256 50075 42504001
Decreased appetite 64.01 28.83 522 66737 192615 42361461
Sinus headache 62.62 28.83 33 67226 1190 42552886
Dehydration 61.60 28.83 80 67179 141687 42412389
Sinusitis 59.50 28.83 187 67072 47105 42506971
Drug effect less than expected 59.30 28.83 49 67210 3808 42550268
Cardiac failure 59.18 28.83 49 67210 106807 42447269
Rhinorrhoea 59.12 28.83 145 67114 31649 42522427
Loss of consciousness 58.11 28.83 37 67222 92317 42461759
Coma 57.70 28.83 8 67251 53546 42500530
Therapy cessation 57.21 28.83 110 67149 20340 42533736
Somnolence 55.95 28.83 85 67174 141020 42413056
Lactic acidosis 55.93 28.83 4 67255 45257 42508819
Dyspnoea exertional 55.20 28.83 7 67252 50141 42503935
Musculoskeletal stiffness 54.03 28.83 207 67052 57558 42496518
Renal impairment 53.45 28.83 57 67202 110171 42443905
Weight increased 53.31 28.83 55 67204 107928 42446148
Leukopenia 52.70 28.83 26 67233 74720 42479356
Intentional product use issue 52.16 28.83 24 67235 71809 42482267
Atrial fibrillation 51.67 28.83 88 67171 139505 42414571
Acute myocardial infarction 51.51 28.83 14 67245 58151 42495925
Plasma cell myeloma 51.51 28.83 7 67252 47571 42506505
Anaphylactic reaction 49.47 28.83 5 67254 42738 42511338
Haematuria 49.18 28.83 15 67244 57784 42496292
Skin irritation 48.78 28.83 60 67199 7514 42546562
Pulmonary oedema 48.75 28.83 12 67247 53260 42500816
Depressed mood 48.19 28.83 111 67148 23273 42530803
Skin injury 47.97 28.83 37 67222 2604 42551472
Encephalopathy 47.41 28.83 5 67254 41328 42512748
Hyperglycaemia 46.78 28.83 8 67251 45851 42508225
Epistaxis 45.98 28.83 24 67235 66802 42487274
Respiratory distress 45.63 28.83 6 67253 41814 42512262
Pneumonitis 45.49 28.83 6 67253 41712 42512364
Hepatic function abnormal 44.57 28.83 13 67246 51554 42502522
Chronic kidney disease 44.49 28.83 10 67249 47231 42506845
Cardiogenic shock 44.47 28.83 3 67256 35637 42518439
Rash maculo-papular 44.43 28.83 4 67255 37499 42516577
Blood bilirubin increased 43.93 28.83 7 67252 42245 42511831
Acute respiratory failure 43.81 28.83 5 67254 38853 42515223
Wheezing 43.49 28.83 16 67243 54765 42499311
Haematocrit decreased 43.38 28.83 3 67256 34905 42519171
Stomatitis 42.93 28.83 13 67246 50316 42503760
Cardiac failure congestive 42.93 28.83 43 67216 85559 42468517
Oedema 41.60 28.83 15 67244 51986 42502090
Constipation 41.57 28.83 125 67134 162166 42391910
Skin burning sensation 41.42 28.83 55 67204 7432 42546644
Red blood cell sedimentation rate 41.19 28.83 24 67235 1056 42553020
Injection site pain 40.90 28.83 20 67239 57778 42496298
Bowel movement irregularity 40.86 28.83 38 67221 3458 42550618
Asthma 40.53 28.83 24 67235 62290 42491786
Chills 39.90 28.83 54 67205 94012 42460064
Suicidal ideation 39.75 28.83 166 67093 47995 42506081
Muscular weakness 39.56 28.83 44 67215 83454 42470622
No adverse event 39.38 28.83 7 67252 39014 42515062
Granuloma skin 39.31 28.83 24 67235 1151 42552925
Chest pain 39.04 28.83 103 67156 139427 42414649
Coronary artery disease 38.91 28.83 18 67241 53702 42500374
Skin plaque 38.65 28.83 47 67212 5816 42548260
Thrombosis 38.43 28.83 31 67228 68480 42485596
Cerebral infarction 37.81 28.83 3 67256 31166 42522910
Cholestasis 37.65 28.83 4 67255 32875 42521201
Red blood cell count decreased 37.41 28.83 4 67255 32711 42521365
Drug resistance 37.16 28.83 5 67254 34243 42519833
Influenza 36.44 28.83 194 67065 61981 42492095
Bone cyst 36.42 28.83 26 67233 1625 42552451
Acute respiratory distress syndrome 36.24 28.83 3 67256 30105 42523971
Joint ankylosis 36.06 28.83 26 67233 1651 42552425
Infusion related reaction 36.04 28.83 26 67233 60780 42493296
Red blood cell sedimentation rate abnormal 36.04 28.83 37 67222 3799 42550277
Blood urea increased 35.08 28.83 5 67254 32788 42521288
Colitis 34.68 28.83 15 67244 46557 42507519
Suicide attempt 34.09 28.83 15 67244 46085 42507991
Muscle swelling 34.08 28.83 16 67243 448 42553628
Hepatic fibrosis 33.66 28.83 40 67219 4832 42549244
Cerebral haemorrhage 33.35 28.83 10 67249 38956 42515120
Full blood count abnormal 33.29 28.83 4 67255 29872 42524204
Haemorrhage 33.23 28.83 28 67231 60535 42493541
Jaundice 33.22 28.83 7 67252 34582 42519494
Joint swelling 33.12 28.83 202 67057 67820 42486256
Anti-cyclic citrullinated peptide antibody positive 33.02 28.83 26 67233 1886 42552190
Nasal congestion 32.91 28.83 112 67147 29389 42524687
Dysphagia 32.64 28.83 40 67219 72679 42481397
Agitation 32.59 28.83 32 67227 64282 42489794
Gamma-glutamyltransferase increased 32.42 28.83 6 67253 32491 42521585
Hallucination 32.28 28.83 26 67233 57481 42496595
Blood parathyroid hormone decreased 32.00 28.83 24 67235 1619 42552457
Lung disorder 31.81 28.83 18 67241 47905 42506171
Fatigue 31.63 28.83 905 66354 434736 42119340
Rash macular 31.36 28.83 77 67182 16814 42537262
Rash pruritic 31.06 28.83 120 67139 33483 42520593
Urinary retention 30.80 28.83 14 67245 42200 42511876
Localised infection 30.79 28.83 86 67173 20287 42533789
Leukocytosis 30.70 28.83 5 67254 29703 42524373
Mental status changes 30.68 28.83 14 67245 42101 42511975
Visual impairment 30.38 28.83 15 67244 43098 42510978
Blood lactate dehydrogenase increased 30.31 28.83 3 67256 26078 42527998
Haemoptysis 29.71 28.83 18 67241 46149 42507927
Fluid retention 29.16 28.83 7 67252 31612 42522464
Hepatotoxicity 28.98 28.83 3 67256 25164 42528912
Disability 28.92 28.83 41 67218 5892 42548184

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 8230.55 27.74 12568 289706 1126937 109160088
Product dose omission issue 6050.53 27.74 5795 296479 315987 109971038
Nausea 5794.28 27.74 11271 291003 1224419 109062606
Headache 5383.30 27.74 9035 293239 873342 109413683
Abdominal discomfort 2946.46 27.74 4440 297834 389418 109897607
Psoriatic arthropathy 2019.74 27.74 2586 299688 194175 110092850
Acute kidney injury 1562.21 27.74 37 302237 635393 109651632
Therapy non-responder 1290.22 27.74 1855 300419 155452 110131573
Toxicity to various agents 1212.58 27.74 20 302254 480535 109806490
Drug interaction 1181.79 27.74 42 302232 500141 109786884
Anaemia 1158.52 27.74 89 302185 546997 109740028
Hypotension 1126.99 27.74 79 302195 523770 109763255
Depression 1067.61 27.74 2546 299728 314789 109972236
Rheumatic fever 974.93 27.74 1425 300849 121154 110165871
Abdominal pain upper 967.91 27.74 2603 299671 346508 109940517
Neutropenia 938.96 27.74 17 302257 374603 109912422
Febrile neutropenia 816.94 27.74 9 302265 316758 109970267
Type 2 diabetes mellitus 736.69 27.74 1548 300726 175684 110111341
Synovitis 710.71 27.74 1995 300279 272097 110014928
Psoriasis 708.59 27.74 1328 300946 138665 110148360
Swollen joint count increased 696.28 27.74 994 301280 82667 110204358
Adverse drug reaction 686.01 27.74 1118 301156 104441 110182584
Fibromyalgia 669.10 27.74 1457 300817 169452 110117573
Facet joint syndrome 651.67 27.74 1042 301232 95786 110191239
Folliculitis 610.99 27.74 1389 300885 166264 110120761
Completed suicide 603.07 27.74 12 302262 242369 110044656
Migraine 597.88 27.74 1397 300877 170255 110116770
Glossodynia 596.15 27.74 1637 300637 220367 110066658
C-reactive protein abnormal 579.07 27.74 1167 301107 128528 110158497
Sepsis 578.85 27.74 99 302175 327247 109959778
Duodenal ulcer perforation 577.68 27.74 1408 300866 176292 110110733
Mobility decreased 577.34 27.74 1689 300585 235733 110051292
Dyspnoea 576.22 27.74 1368 300906 1105504 109181521
Hand deformity 569.69 27.74 1594 300680 216912 110070113
Blood cholesterol increased 557.44 27.74 1423 300851 183362 110103663
Therapeutic product effect decreased 545.91 27.74 1687 300587 242629 110044396
Wound 533.30 27.74 1629 300645 232808 110054217
Haemoglobin decreased 532.93 27.74 38 302236 248689 110038336
Thrombocytopenia 532.82 27.74 147 302127 348738 109938287
Helicobacter infection 531.50 27.74 1384 300890 180493 110106532
Disease progression 529.52 27.74 35 302239 243999 110043026
Platelet count decreased 528.06 27.74 24 302250 230419 110056606
Gastric disorder 524.56 27.74 547 301727 32810 110254215
Rheumatoid factor positive 522.81 27.74 1129 301145 130511 110156514
Dyspepsia 514.45 27.74 1410 300864 189555 110097470
Lip dry 510.77 27.74 953 301321 99130 110187895
Anti-cyclic citrullinated peptide antibody positive 509.58 27.74 1363 300911 180621 110106404
Systemic lupus erythematosus 501.84 27.74 1683 300591 252655 110034370
Irritable bowel syndrome 487.39 27.74 1257 301017 162958 110124067
Bursitis 470.59 27.74 1074 301200 128844 110158181
Respiratory failure 469.79 27.74 30 302244 215302 110071723
Pancytopenia 463.95 27.74 27 302247 209586 110077439
Cardiac arrest 455.71 27.74 19 302255 196734 110090291
White blood cell count decreased 453.64 27.74 49 302225 229341 110057684
Gastrointestinal disorder 451.83 27.74 1572 300702 240380 110046645
Malignant neoplasm progression 449.72 27.74 5 302269 174562 110112463
Joint range of motion decreased 445.52 27.74 1011 301263 120821 110166204
Injury 441.27 27.74 1272 301002 175993 110111032
Pleural effusion 437.28 27.74 10 302264 177699 110109326
Pemphigus 426.85 27.74 1424 300850 213146 110073879
Sciatica 423.82 27.74 841 301433 91558 110195467
Pericarditis 420.75 27.74 1437 300837 217677 110069348
Somnolence 413.63 27.74 148 302126 297301 109989724
Musculoskeletal stiffness 406.62 27.74 1678 300596 278144 110008881
Seizure 404.14 27.74 61 302213 221124 110065901
Pulmonary embolism 403.92 27.74 54 302220 214420 110072605
Discomfort 401.69 27.74 1396 300878 213311 110073714
Inflammation 400.06 27.74 1300 300974 191938 110095087
Wound infection 398.70 27.74 841 301433 95624 110191401
Bradycardia 398.15 27.74 5 302269 155512 110131513
Grip strength decreased 392.38 27.74 750 301524 79424 110207601
Fall 392.12 27.74 654 301620 602828 109684197
Deep vein thrombosis postoperative 390.53 27.74 632 301642 58659 110228366
Peripheral venous disease 389.87 27.74 769 301505 83348 110203677
Death 385.31 27.74 836 301438 698033 109588992
Hypokalaemia 384.73 27.74 30 302244 182418 110104607
Pyrexia 381.03 27.74 1225 301049 897040 109389985
Breast cancer stage III 380.92 27.74 735 301539 78382 110208643
Renal failure 371.98 27.74 82 302192 226492 110060533
Oxygen saturation decreased 370.91 27.74 13 302261 156969 110130056
Syncope 369.70 27.74 56 302218 202480 110084545
Sleep disorder 369.34 27.74 1289 300985 197355 110089670
Frequent bowel movements 364.45 27.74 680 301594 70710 110216315
Road traffic accident 362.80 27.74 864 301410 106534 110180491
Constipation 362.56 27.74 269 302005 357517 109929508
Treatment failure 362.29 27.74 1610 300664 275624 110011401
Liver injury 360.54 27.74 1065 301209 149348 110137677
Muscle injury 359.69 27.74 1020 301254 139787 110147238
Blepharospasm 356.27 27.74 581 301693 54270 110232755
Hypercholesterolaemia 350.23 27.74 770 301504 90067 110196958
Alopecia 345.94 27.74 1934 300340 362819 109924206
Rash 344.92 27.74 3592 298682 817372 109469653
Hyperkalaemia 344.86 27.74 5 302269 135791 110151234
Impaired healing 344.75 27.74 1252 301022 195465 110091560
Multiple organ dysfunction syndrome 343.63 27.74 17 302257 151693 110135332
Arthropathy 343.27 27.74 1626 300648 285896 110001129
Intentional overdose 335.96 27.74 5 302269 132496 110154529
Septic shock 334.69 27.74 25 302249 157503 110129522
Gait inability 333.91 27.74 973 301301 135403 110151622
Autoimmune disorder 332.10 27.74 622 301652 64861 110222164
Cardiac failure 328.77 27.74 58 302216 187568 110099457
Hypoaesthesia 320.07 27.74 1699 300575 312524 109974501
Osteoarthritis 319.74 27.74 1162 301112 181461 110105564
Sleep disorder due to general medical condition, insomnia type 314.69 27.74 810 301464 104833 110182192
Insomnia 314.53 27.74 1870 300404 358720 109928305
Ill-defined disorder 314.51 27.74 1044 301230 155809 110131216
Rhabdomyolysis 312.18 27.74 3 302271 120398 110166627
Hypoxia 312.15 27.74 9 302265 129506 110157519
Onychomadesis 310.65 27.74 494 301780 45169 110241856
Neuropathy peripheral 306.43 27.74 59 302215 179218 110107807
Gastrointestinal haemorrhage 303.83 27.74 45 302229 165473 110121552
Dehydration 303.24 27.74 195 302079 279316 110007709
Blister 301.92 27.74 1327 300947 226049 110060976
Dry mouth 299.76 27.74 1211 301063 198737 110088288
Memory impairment 298.60 27.74 1197 301077 195747 110091278
Weight decreased 298.39 27.74 2245 300029 465812 109821213
Lower limb fracture 295.33 27.74 643 301631 74705 110212320
Rheumatoid arthritis 294.93 27.74 1605 300669 298008 109989017
Night sweats 294.18 27.74 920 301354 133063 110153962
Arthralgia 293.93 27.74 3339 298935 776293 109510732
Therapy interrupted 289.33 27.74 502 301772 49320 110237705
Atrial fibrillation 288.71 27.74 133 302141 229509 110057516
Coma 288.53 27.74 7 302267 117862 110169163
Hepatic enzyme increased 282.91 27.74 1669 300605 319223 109967802
Bone erosion 280.81 27.74 476 301798 45895 110241130
Deep vein thrombosis 276.21 27.74 30 302244 139857 110147168
Decreased appetite 273.83 27.74 2229 300045 473617 109813408
Loss of consciousness 272.26 27.74 98 302176 196208 110090817
Product supply issue 272.20 27.74 154 302120 3632 110283393
Enthesopathy 270.30 27.74 244 302030 12234 110274791
Renal impairment 268.37 27.74 90 302184 188355 110098670
Live birth 267.83 27.74 589 301685 68895 110218130
Taste disorder 266.59 27.74 567 301707 64820 110222205
Interstitial lung disease 257.77 27.74 37 302237 139297 110147728
C-reactive protein 257.56 27.74 364 301910 29967 110257058
Nail disorder 255.66 27.74 519 301755 57416 110229609
Adverse event 255.52 27.74 765 301509 108044 110178981
Retinitis 252.68 27.74 373 301901 31954 110255071
Injection site pain 251.58 27.74 86 302188 177836 110109189
Hypoglycaemia 247.84 27.74 18 302256 116086 110170939
Exostosis 243.65 27.74 445 301829 45511 110241514
Obesity 242.09 27.74 771 301503 112580 110174445
Therapeutic product effect incomplete 239.40 27.74 1227 301047 222578 110064447
Blood creatinine increased 237.63 27.74 101 302173 182788 110104237
Lactic acidosis 237.47 27.74 3 302271 92808 110194217
Ascites 237.46 27.74 3 302271 92805 110194220
Joint swelling 234.31 27.74 2036 300238 440809 109846216
Back injury 233.83 27.74 445 301829 46954 110240071
Dislocation of vertebra 230.08 27.74 422 301852 43299 110243726
X-ray abnormal 229.11 27.74 390 301884 37727 110249298
Urinary tract infection 228.35 27.74 336 301938 325946 109961079
Adjustment disorder with depressed mood 222.69 27.74 417 301857 43466 110243559
Anaphylactic reaction 219.44 27.74 27 302247 114273 110172752
Chills 217.76 27.74 125 302149 190455 110096570
International normalised ratio increased 216.93 27.74 4 302270 86768 110200257
Leukopenia 215.48 27.74 69 302205 148722 110138303
Cardiac failure congestive 215.20 27.74 72 302202 150928 110136097
Lupus vulgaris 212.05 27.74 353 301921 33530 110253495
Drug intolerance 210.86 27.74 1861 300413 404651 109882374
Dysphagia 210.74 27.74 78 302196 153522 110133503
Stomatitis 210.68 27.74 1362 300912 268880 110018145
Swelling 206.42 27.74 1653 300621 349388 109937637
Pneumonia 205.01 27.74 1479 300795 875235 109411790
Adverse reaction 203.82 27.74 322 301952 29272 110257753
Blood pressure increased 199.03 27.74 248 302026 258125 110028900
Dyspnoea exertional 198.75 27.74 25 302249 104035 110182990
Dysarthria 198.57 27.74 7 302267 84114 110202911
Cough 198.39 27.74 625 301649 461016 109826009
Infection 198.19 27.74 1678 300596 360522 109926503
Pneumonia aspiration 198.15 27.74 5 302269 81228 110205797
Pulmonary oedema 197.66 27.74 22 302252 100637 110186388
Drug reaction with eosinophilia and systemic symptoms 196.74 27.74 6 302268 82089 110204936
Anti-cyclic citrullinated peptide antibody 195.89 27.74 257 302017 19707 110267318
Gastrooesophageal reflux disease 195.42 27.74 991 301283 178985 110108040
Encephalopathy 193.97 27.74 6 302268 81049 110205976
Vomiting 193.48 27.74 3528 298746 907147 109379878
Overdose 193.42 27.74 212 302062 233582 110053443
Laryngitis 191.97 27.74 384 301890 42027 110244998
Hyperglycaemia 191.19 27.74 10 302264 85080 110201945
Cerebrovascular accident 189.12 27.74 132 302142 181152 110105873
Epistaxis 186.07 27.74 62 302212 130310 110156715
C-reactive protein increased 185.86 27.74 1124 301150 216795 110070230
Muscle spasms 185.41 27.74 1349 300925 276808 110010217
Drug ineffective 185.25 27.74 5447 296827 1515093 108771932
Hallucination 185.15 27.74 28 302246 101404 110185621
Hepatic cirrhosis 184.56 27.74 502 301772 67124 110219901
Tension headache 183.06 27.74 175 302099 9443 110277582
Onychomycosis 183.01 27.74 356 301918 38175 110248850
Injection site erythema 176.56 27.74 24 302250 94152 110192873
Blood creatine phosphokinase increased 176.37 27.74 5 302269 73072 110213953
Balance disorder 176.12 27.74 50 302224 116510 110170515
Wheezing 174.82 27.74 1246 301028 253984 110033041
Nasopharyngitis 174.76 27.74 1746 300528 392615 109894410
Tenosynovitis 174.52 27.74 219 302055 16064 110270961
Colitis 174.13 27.74 34 302240 102289 110184736
Blood bilirubin increased 173.67 27.74 8 302266 75964 110211061
Faeces soft 172.95 27.74 182 302092 11028 110275997
General physical health deterioration 172.38 27.74 1849 300425 423446 109863579
Agitation 169.88 27.74 49 302225 113002 110174023
Cognitive disorder 169.64 27.74 20 302254 87491 110199534
Infusion related reaction 169.58 27.74 1689 300585 379473 109907552
Hepatic function abnormal 169.21 27.74 22 302252 89273 110197752
Tachycardia 168.91 27.74 223 302051 226422 110060603
Joint dislocation 168.65 27.74 321 301953 33869 110253156
Chest discomfort 167.98 27.74 137 302137 173711 110113314
Sinusitis 165.68 27.74 1381 300893 295307 109991718
Haematocrit decreased 165.48 27.74 3 302271 66114 110220911
Heart rate decreased 165.27 27.74 17 302257 82739 110204286
Product label confusion 164.90 27.74 253 302021 22424 110264601
Hypocalcaemia 163.46 27.74 3 302271 65363 110221662
Haematuria 163.34 27.74 18 302256 82987 110204038
Lupus-like syndrome 163.12 27.74 351 301923 40441 110246584
Acute myocardial infarction 162.77 27.74 19 302255 83758 110203267
Acute respiratory failure 162.56 27.74 11 302263 75249 110211776
Urticaria 162.28 27.74 1454 300820 317403 109969622
Melaena 161.32 27.74 6 302268 68751 110218274
Pneumonitis 160.13 27.74 13 302261 76518 110210507
Myocardial infarction 159.06 27.74 174 302100 191909 110095116
Rash maculo-papular 157.00 27.74 12 302262 74210 110212815
Mental status changes 156.34 27.74 14 302260 76108 110210917
Flushing 156.27 27.74 46 302228 104690 110182335
Contraindicated product administered 155.75 27.74 1187 301087 247080 110039945
Vision blurred 155.59 27.74 79 302195 128943 110158082
Mucosal inflammation 155.31 27.74 36 302238 96105 110190920
Upper respiratory tract infection 155.27 27.74 741 301533 130587 110156438
Blood pressure decreased 155.27 27.74 60 302214 115031 110171994
Suicide attempt 155.02 27.74 45 302229 103349 110183676
Maternal exposure during pregnancy 154.00 27.74 1208 301066 253675 110033350
Blood alkaline phosphatase increased 151.38 27.74 11 302263 70924 110216101
Cholestasis 146.81 27.74 7 302267 64511 110222514
Lung disorder 146.77 27.74 918 301356 179129 110107896
Respiratory distress 146.07 27.74 11 302263 68863 110218162
Angioedema 145.61 27.74 44 302230 98456 110188569
Ear infection 143.42 27.74 437 301837 62295 110224730
Haemorrhage 143.31 27.74 56 302218 106636 110180389
Plasma cell myeloma 142.66 27.74 7 302267 62929 110224096
Cardiogenic shock 141.89 27.74 3 302271 57335 110229690
Red blood cell count decreased 141.32 27.74 10 302264 65913 110221112
Respiratory arrest 140.65 27.74 4 302270 58295 110228730
Urinary retention 139.97 27.74 14 302260 69669 110217356
Coronary artery disease 139.92 27.74 16 302258 71674 110215351
Red blood cell sedimentation rate increased 138.42 27.74 500 301774 77802 110209223
Hepatic failure 137.58 27.74 14 302260 68725 110218300
Hip arthroplasty 137.27 27.74 399 301875 55414 110231611
Orthostatic hypotension 136.56 27.74 12 302262 66237 110220788
Product quality issue 136.14 27.74 493 301781 76806 110210219
Product administration interrupted 135.83 27.74 161 302113 11131 110275894
Full blood count abnormal 134.66 27.74 4 302270 56048 110230977
Lymphocyte count decreased 134.28 27.74 5 302269 57238 110229787
Pain 134.09 27.74 3486 298788 951469 109335556
Musculoskeletal pain 133.22 27.74 907 301367 182116 110104909
Liver disorder 133.10 27.74 752 301522 141491 110145534
Liver function test abnormal 133.05 27.74 16 302258 68934 110218091
Chronic kidney disease 132.69 27.74 24 302250 76267 110210758
Disorientation 132.50 27.74 18 302256 70653 110216372
Foot deformity 132.40 27.74 360 301914 48120 110238905
Pericardial effusion 130.87 27.74 6 302268 57211 110229814
Thrombosis 130.33 27.74 67 302207 108595 110178430
Jaundice 129.89 27.74 8 302266 59228 110227797
Hypersensitivity 129.35 27.74 1679 300595 402319 109884706
Aphasia 129.27 27.74 8 302266 58989 110228036
Blood pressure fluctuation 129.15 27.74 24 302250 74800 110212225
Joint stiffness 128.88 27.74 441 301833 66802 110220223
Liver function test increased 128.38 27.74 531 301743 88017 110199008
Generalised tonic-clonic seizure 127.50 27.74 5 302269 54675 110232350
Chronic obstructive pulmonary disease 126.96 27.74 70 302204 109088 110177937
Cytomegalovirus infection 126.88 27.74 5 302269 54439 110232586
Dyskinesia 126.11 27.74 3 302271 51443 110235582
Pallor 125.73 27.74 7 302267 56460 110230565
Drug resistance 125.48 27.74 7 302267 56367 110230658
Hyperhidrosis 124.12 27.74 200 302074 187098 110099927
Acute respiratory distress syndrome 123.59 27.74 5 302269 53193 110233832
Cerebral haemorrhage 123.11 27.74 16 302258 64952 110222073
Breast cancer stage II 122.85 27.74 247 302027 27128 110259897
Finger deformity 121.30 27.74 275 301999 32817 110254208
Hypervolaemia 120.79 27.74 3 302271 49457 110237568
Alanine aminotransferase abnormal 120.49 27.74 138 302136 9196 110277829
Alanine aminotransferase increased 120.13 27.74 198 302076 183575 110103450
Speech disorder 119.51 27.74 14 302260 61555 110225470
Haematoma 119.43 27.74 11 302263 58465 110228560
Blood urea increased 118.79 27.74 8 302266 54949 110232076
Hypothyroidism 118.34 27.74 27 302247 72872 110214153
Hepatotoxicity 116.86 27.74 17 302257 63383 110223642
Hepatocellular injury 116.85 27.74 5 302269 50637 110236388
Gamma-glutamyltransferase increased 116.41 27.74 15 302259 61294 110225731
Pancreatitis acute 116.27 27.74 14 302260 60260 110226765
Injection site swelling 115.22 27.74 16 302258 61774 110225251
Tongue disorder 113.20 27.74 166 302108 14132 110272893
Leukocytosis 113.01 27.74 9 302265 53819 110233206
Prescribed overdose 112.98 27.74 507 301767 87074 110199951
Haemoptysis 112.73 27.74 28 302246 71326 110215699
Epilepsy 110.97 27.74 555 301719 99654 110187371
Off label use 108.89 27.74 3198 299076 1496987 108790038
Tubulointerstitial nephritis 108.79 27.74 11 302263 54273 110232752
Haematochezia 107.94 27.74 94 302180 115430 110171595
Blood lactate dehydrogenase increased 107.11 27.74 3 302271 44331 110242694
Swelling face 106.22 27.74 60 302214 92261 110194764
Hemiparesis 105.96 27.74 3 302271 43900 110243125
Knee arthroplasty 105.82 27.74 404 301870 64544 110222481
Blood glucose increased 105.35 27.74 124 302150 132372 110154653
Cerebral infarction 105.21 27.74 10 302264 51828 110235197
Arrhythmia 104.81 27.74 30 302244 69545 110217480
Erythema 102.95 27.74 428 301846 291019 109996006
Stevens-Johnson syndrome 100.87 27.74 7 302267 46894 110240131
Disseminated intravascular coagulation 98.99 27.74 3 302271 41283 110245742
Swollen tongue 98.70 27.74 22 302252 60340 110226685
Urinary incontinence 96.97 27.74 10 302264 48577 110238448
Flatulence 96.44 27.74 338 301936 51811 110235214
Mood altered 96.08 27.74 193 302081 21182 110265843
Heart rate increased 95.85 27.74 153 302121 143681 110143344
Proteinuria 95.61 27.74 3 302271 40015 110247010
Accidental exposure to product 95.52 27.74 12 302262 49996 110237029
Psychotic disorder 95.43 27.74 13 302261 50924 110236101
Hallucination, visual 94.51 27.74 3 302271 39602 110247423
Transaminases increased 94.27 27.74 28 302246 63362 110223663
Aggression 94.00 27.74 23 302251 59187 110227838
Infusion site reaction 93.43 27.74 171 302103 17511 110269514
Circulatory collapse 90.79 27.74 7 302267 42986 110244039
Productive cough 89.78 27.74 108 302166 114197 110172828
Multiple sclerosis relapse 89.13 27.74 15 302259 50225 110236800
Intentional self-injury 88.73 27.74 3 302271 37426 110249599
Red blood cell sedimentation rate 88.29 27.74 89 302185 5125 110281900
Presyncope 88.06 27.74 14 302260 48873 110238152
Aspartate aminotransferase increased 87.28 27.74 192 302082 159744 110127281
Ischaemic stroke 86.35 27.74 7 302267 41256 110245769
Therapeutic response decreased 86.21 27.74 504 301770 95995 110191030
Coeliac disease 86.07 27.74 287 301987 42900 110244125
Lower respiratory tract infection 85.72 27.74 1029 301245 242077 110044948
Blood pressure diastolic decreased 84.64 27.74 3 302271 35882 110251143
Peripheral swelling 84.26 27.74 1562 300712 402472 109884553
Blood potassium decreased 84.01 27.74 22 302252 54092 110232933
Transient ischaemic attack 83.61 27.74 35 302239 63947 110223078
Restlessness 83.39 27.74 25 302249 56234 110230791
Candida infection 81.58 27.74 16 302258 47993 110239032
Bacteraemia 81.39 27.74 10 302264 42380 110244645
Blood calcium decreased 81.20 27.74 4 302270 35841 110251184
Injection site pruritus 81.19 27.74 20 302254 51238 110235787
Body temperature decreased 80.94 27.74 5 302269 36930 110250095
Diabetic ketoacidosis 80.56 27.74 10 302264 42048 110244977
Atelectasis 80.36 27.74 5 302269 36707 110250318
Oedema peripheral 80.17 27.74 547 301727 328113 109958912
Inappropriate schedule of product administration 79.62 27.74 287 301987 203350 110083675
Myelodysplastic syndrome 79.45 27.74 6 302268 37478 110249547
Prescribed underdose 78.65 27.74 370 301904 64804 110222221
Electrolyte imbalance 78.27 27.74 6 302268 37022 110250003
Intestinal obstruction 78.26 27.74 24 302250 53203 110233822
Bronchiectasis 76.90 27.74 6 302268 36487 110250538
Pulmonary fibrosis 76.19 27.74 509 301765 101533 110185492
Clostridium difficile infection 75.76 27.74 24 302250 52105 110234920
Paraesthesia oral 75.50 27.74 4 302270 33667 110253358
Angina pectoris 75.31 27.74 38 302236 62257 110224768
Visual acuity reduced 74.82 27.74 3 302271 32170 110254855
Haematemesis 74.60 27.74 34 302240 59074 110227951
Anaphylactic shock 74.44 27.74 24 302250 51522 110235503
Polyneuropathy 74.39 27.74 3 302271 32009 110255016
Myoclonus 73.74 27.74 4 302270 32994 110254031
Hypophagia 73.39 27.74 26 302248 52600 110234425
Hypertension 72.17 27.74 1865 300409 508219 109778806
Tremor 72.00 27.74 296 301978 201936 110085089
Sleep apnoea syndrome 71.92 27.74 12 302262 40435 110246590
Device related infection 71.91 27.74 11 302263 39508 110247517
Lethargy 71.81 27.74 90 302184 93486 110193539
Procedural pain 71.81 27.74 7 302267 35558 110251467
Clostridium difficile colitis 71.48 27.74 16 302258 43762 110243263
Lymphopenia 71.25 27.74 12 302262 40158 110246867
Pustular psoriasis 71.16 27.74 131 302143 13474 110273551
Diplopia 71.10 27.74 14 302260 41880 110245145
Renal tubular necrosis 70.34 27.74 3 302271 30472 110256553
Haemophagocytic lymphohistiocytosis 69.99 27.74 4 302270 31555 110255470
Blood pressure systolic increased 69.99 27.74 74 302200 82917 110204108
Peritonitis 69.73 27.74 5 302269 32602 110254423
Eye pain 69.44 27.74 25 302249 50074 110236951
Myalgia 69.27 27.74 342 301932 222039 110064986
Myocarditis 69.23 27.74 3 302271 30052 110256973
Disturbance in attention 68.89 27.74 42 302232 61953 110225072
Brain oedema 68.79 27.74 4 302270 31094 110255931
Bronchopulmonary aspergillosis 68.72 27.74 3 302271 29860 110257165
Tendonitis 68.54 27.74 191 302083 25892 110261133
Walking aid user 68.26 27.74 186 302088 24889 110262136
Seronegative arthritis 67.82 27.74 126 302148 13051 110273974
Staphylococcal infection 67.69 27.74 55 302219 69889 110217136
Vertigo 67.24 27.74 83 302191 86787 110200238
Pregnancy 66.88 27.74 297 301977 50770 110236255
Dysuria 66.66 27.74 41 302233 60190 110226835
Cardiomyopathy 66.64 27.74 7 302267 33518 110253507
Abnormal behaviour 66.35 27.74 13 302261 39026 110247999
Acute myeloid leukaemia 66.25 27.74 12 302262 38098 110248927
Pneumothorax 66.11 27.74 9 302265 35276 110251749
Wrong technique in product usage process 66.00 27.74 85 302189 87263 110199762
Loss of personal independence in daily activities 64.77 27.74 661 301613 149359 110137666
Blood sodium decreased 64.63 27.74 13 302261 38306 110248719
Hepatic encephalopathy 64.50 27.74 3 302271 28253 110258772
Blindness 64.18 27.74 11 302263 36348 110250677
Oesophagitis 62.59 27.74 4 302270 28711 110258314
Oropharyngeal pain 62.42 27.74 177 302097 135099 110151926
Diabetes mellitus 62.24 27.74 110 302164 99271 110187754
Neutrophil count increased 62.24 27.74 10 302264 34642 110252383
Pulmonary mass 62.19 27.74 13 302261 37288 110249737
Ileus 62.17 27.74 6 302268 30723 110256302
Drug tolerance decreased 62.14 27.74 191 302083 27349 110259676
Dementia 61.98 27.74 7 302267 31666 110255359
Shock haemorrhagic 61.85 27.74 3 302271 27244 110259781
Asthenia 61.83 27.74 1423 300851 687576 109599449
Cholelithiasis 61.21 27.74 50 302224 63372 110223653
Small intestinal obstruction 60.87 27.74 8 302266 32205 110254820
Pseudomonas infection 60.36 27.74 4 302270 27849 110259176
Platelet count increased 59.45 27.74 3 302271 26331 110260694
Accidental overdose 59.17 27.74 34 302240 51800 110235225
Blood potassium increased 58.82 27.74 10 302264 33239 110253786
Femur fracture 58.63 27.74 24 302250 44445 110242580
Blood parathyroid hormone decreased 58.61 27.74 118 302156 12971 110274054
Bronchospasm 58.38 27.74 7 302267 30232 110256793
Cardiomegaly 58.12 27.74 6 302268 29124 110257901
Cytopenia 58.07 27.74 7 302267 30109 110256916
Dystonia 58.07 27.74 3 302271 25802 110261223
Injection site bruising 57.99 27.74 34 302240 51229 110235796
Back pain 57.41 27.74 693 301581 370303 109916722
Arthritis 57.15 27.74 705 301569 166881 110120144
Vasculitis 56.81 27.74 14 302260 35859 110251166
Respiratory rate increased 56.18 27.74 3 302271 25080 110261945
Disease recurrence 56.12 27.74 50 302224 60734 110226291
COVID-19 pneumonia 55.97 27.74 16 302258 37127 110249898
Osteonecrosis 55.76 27.74 12 302262 33729 110253296
Device issue 55.63 27.74 13 302261 34522 110252503
Poisoning 55.55 27.74 7 302267 29098 110257927
Pruritus 55.15 27.74 2025 300249 579535 109707490
Subcutaneous drug absorption impaired 55.05 27.74 85 302189 7574 110279451
Lung infiltration 54.99 27.74 3 302271 24625 110262400
Neck pain 54.82 27.74 546 301728 122584 110164441
Urosepsis 54.77 27.74 9 302265 30666 110256359
Splenomegaly 54.65 27.74 3 302271 24495 110262530
Cataract 54.42 27.74 83 302191 79402 110207623
Gastroenteritis 54.39 27.74 19 302255 38781 110248244
Transfusion 54.20 27.74 4 302270 25468 110261557
Spondylitis 54.13 27.74 105 302169 11233 110275792
Swollen joint count 53.77 27.74 90 302184 8584 110278441
Lymphadenopathy 53.73 27.74 57 302217 63778 110223247
Pneumonia bacterial 53.47 27.74 5 302269 26256 110260769
Disability 53.40 27.74 193 302081 30030 110256995
Arteriosclerosis coronary artery 53.29 27.74 4 302270 25114 110261911
Dysphonia 53.23 27.74 78 302196 75851 110211174
Body tinea 53.13 27.74 45 302229 2070 110284955
Drug hypersensitivity 52.93 27.74 1620 300654 452470 109834555
Bacterial infection 52.83 27.74 30 302244 46006 110241019
Delusion 52.71 27.74 3 302271 23752 110263273
Iron deficiency anaemia 52.62 27.74 11 302263 31548 110255477
Head injury 52.36 27.74 26 302248 42991 110244034
Blood albumin decreased 51.93 27.74 7 302267 27645 110259380
Porphyria acute 51.81 27.74 140 302134 18640 110268385
Oral candidiasis 51.61 27.74 29 302245 44731 110242294
Malnutrition 51.01 27.74 7 302267 27272 110259753
Muscle twitching 50.81 27.74 10 302264 29925 110257100
Fluid retention 50.80 27.74 114 302160 94193 110192832
Throat irritation 50.72 27.74 43 302231 53509 110233516
Glomerular filtration rate decreased 50.59 27.74 9 302265 28947 110258078
Body temperature increased 50.52 27.74 45 302229 54668 110232357
Full blood count decreased 49.92 27.74 13 302261 32086 110254939
Intentional product use issue 49.75 27.74 953 301321 246953 110040072
Toxic skin eruption 49.29 27.74 8 302266 27507 110259518
Product administration error 49.21 27.74 20 302254 37197 110249828
Activated partial thromboplastin time prolonged 49.10 27.74 3 302271 22365 110264660
Lip swelling 48.83 27.74 40 302234 50627 110236398
Sudden death 48.73 27.74 5 302269 24390 110262635
Generalised oedema 48.59 27.74 12 302262 30692 110256333
Gastritis 48.59 27.74 45 302229 53654 110233371
Osteoporosis 48.20 27.74 405 301869 86747 110200278
Metastases to lung 48.01 27.74 4 302270 23059 110263966
Panniculitis 47.94 27.74 121 302153 15461 110271564
Cardiac failure acute 47.93 27.74 5 302269 24073 110262952
Palpitations 47.78 27.74 248 302026 158964 110128061
Schizophrenia 47.69 27.74 3 302271 21823 110265202
Creatinine renal clearance decreased 47.66 27.74 3 302271 21812 110265213
Throat tightness 47.64 27.74 16 302258 33473 110253552
Granuloma skin 47.31 27.74 99 302175 11184 110275841
Hemiplegia 47.30 27.74 4 302270 22778 110264247
Nervous system disorder 47.18 27.74 14 302260 31707 110255318
Grip strength 46.54 27.74 87 302187 9054 110277971
Hypertensive crisis 46.18 27.74 6 302268 24366 110262659
No adverse event 45.99 27.74 82 302192 73757 110213268
Eosinophil count increased 45.70 27.74 3 302271 21055 110265970
Adrenal insufficiency 45.34 27.74 30 302244 42360 110244665
Hyperthyroidism 45.22 27.74 12 302262 29249 110257776
Cystitis 45.17 27.74 69 302205 65967 110221058
Escherichia infection 44.80 27.74 6 302268 23810 110263215
Cardiac murmur 44.48 27.74 7 302267 24621 110262404
Acute generalised exanthematous pustulosis 44.44 27.74 4 302270 21660 110265365
Macular degeneration 44.43 27.74 4 302270 21655 110265370
Heart rate irregular 44.38 27.74 19 302255 34255 110252770
Nodule 44.02 27.74 17 302257 32614 110254411
Petechiae 43.56 27.74 6 302268 23311 110263714
Fear 43.25 27.74 6 302268 23187 110263838
Hypoacusis 43.24 27.74 21 302253 35170 110251855
Normal newborn 43.17 27.74 145 302129 21751 110265274
Unevaluable event 42.75 27.74 293 301981 58934 110228091
Dry eye 42.45 27.74 54 302220 55739 110231286
Hepatic enzyme 42.41 27.74 61 302213 5102 110281923
Injection site mass 42.25 27.74 8 302266 24605 110262420
Mania 42.23 27.74 4 302270 20792 110266233
Sputum discoloured 42.18 27.74 12 302262 27933 110259092
Ventricular extrasystoles 41.89 27.74 6 302268 22635 110264390
Duodenal ulcer 41.71 27.74 3 302271 19511 110267514
Appendicitis 41.55 27.74 13 302261 28451 110258574
Skin irritation 41.41 27.74 118 302156 16201 110270824
Eye pruritus 41.13 27.74 19 302255 32756 110254269
Product use issue 40.96 27.74 1129 301145 310566 109976459
Contusion 40.83 27.74 879 301395 232482 110054543
Feeling cold 40.68 27.74 21 302253 33966 110253059
Pulmonary congestion 40.36 27.74 17 302257 30949 110256076
Treatment noncompliance 40.32 27.74 87 302187 72903 110214122
Emotional distress 40.09 27.74 38 302236 44809 110242216
Blood test abnormal 40.00 27.74 14 302260 28540 110258485
Cardiovascular disorder 39.92 27.74 7 302267 22753 110264272
Hypokinesia 39.88 27.74 6 302268 21820 110265205
Tinnitus 39.75 27.74 65 302209 60475 110226550
Epstein-Barr virus infection 39.71 27.74 3 302271 18735 110268290
Eczema 39.25 27.74 87 302187 72206 110214819
Post procedural complication 39.23 27.74 12 302262 26646 110260379
Lower gastrointestinal haemorrhage 39.06 27.74 3 302271 18483 110268542
Rebound psoriasis 38.99 27.74 17 302257 223 110286802
Drug ineffective for unapproved indication 38.83 27.74 147 302127 102691 110184334
Amnesia 38.81 27.74 450 301824 104958 110182067
Product prescribing error 38.73 27.74 50 302224 51281 110235744
Injection site haemorrhage 38.66 27.74 21 302253 33007 110254018
Movement disorder 38.62 27.74 26 302248 36378 110250647
Overlap syndrome 38.59 27.74 80 302194 8979 110278046
Enteritis 38.08 27.74 4 302270 19152 110267873
Poor venous access 38.01 27.74 10 302264 24512 110262513
Anal incontinence 38.00 27.74 7 302267 21957 110265068
Second primary malignancy 37.99 27.74 3 302271 18065 110268960
Drug-induced liver injury 37.91 27.74 498 301776 119569 110167456
Hypogammaglobulinaemia 37.90 27.74 5 302269 20071 110266954
Motor dysfunction 37.74 27.74 10 302264 24396 110262629
Blood magnesium decreased 37.70 27.74 5 302269 19991 110267034
Hypocholesterolaemia 37.66 27.74 65 302209 6356 110280669
Enterocolitis 37.55 27.74 4 302270 18945 110268080
Chronic sinusitis 37.44 27.74 11 302263 25073 110261952
Atrial flutter 37.40 27.74 10 302264 24252 110262773
Injection site rash 37.36 27.74 9 302265 23410 110263615
Bone pain 37.35 27.74 76 302198 65057 110221968
Colitis ischaemic 37.17 27.74 3 302271 17747 110269278
Pulmonary toxicity 37.16 27.74 3 302271 17743 110269282
Emphysema 37.11 27.74 5 302269 19751 110267274
Blood uric acid increased 36.95 27.74 7 302267 21522 110265503
Paranoia 36.89 27.74 8 302266 22366 110264659
Withdrawal syndrome 36.66 27.74 20 302254 31360 110255665
Sinus headache 36.61 27.74 62 302212 5970 110281055
Enterococcal infection 36.31 27.74 6 302268 20360 110266665
Mouth ulceration 36.20 27.74 47 302227 48091 110238934
Spinal compression fracture 36.15 27.74 4 302270 18388 110268637
Rib fracture 35.98 27.74 24 302250 33746 110253279
Supraventricular tachycardia 35.92 27.74 11 302263 24411 110262614
Deafness 35.89 27.74 14 302260 26695 110260330
Cellulitis 35.75 27.74 200 302074 125816 110161209
Ocular hyperaemia 35.45 27.74 33 302241 39253 110247772
Arteriosclerosis 34.94 27.74 12 302262 24755 110262270
Aspiration 34.89 27.74 20 302254 30513 110256512
Abdominal distension 34.73 27.74 672 301602 174431 110112594
Hiatus hernia 34.65 27.74 16 302258 27590 110259435
Large intestine perforation 34.30 27.74 3 302271 16626 110270399
Rash erythematous 34.22 27.74 112 302162 81720 110205305
Cholecystitis 34.07 27.74 14 302260 25868 110261157
Eye irritation 34.02 27.74 25 302249 33427 110253598
Iron deficiency 33.94 27.74 5 302269 18471 110268554
Injection site warmth 33.67 27.74 4 302270 17401 110269624
Mental impairment 33.66 27.74 10 302264 22629 110264396
Device malfunction 33.36 27.74 14 302260 25544 110261481
Malaise 33.35 27.74 2196 300078 669623 109617402
Hypertriglyceridaemia 33.09 27.74 3 302271 16151 110270874
Exposure during pregnancy 33.03 27.74 642 301632 166782 110120243
Acute pulmonary oedema 32.65 27.74 4 302270 16992 110270033
Dyslipidaemia 32.61 27.74 3 302271 15962 110271063
Device difficult to use 32.52 27.74 6 302268 18799 110268226
Dialysis 32.38 27.74 7 302267 19612 110267413
Atrioventricular block 32.35 27.74 4 302270 16873 110270152
Mental disorder 32.24 27.74 35 302239 38756 110248269
Maternal exposure timing unspecified 32.02 27.74 128 302146 20885 110266140
Respiratory disorder 31.99 27.74 317 301957 71065 110215960
Erythema multiforme 31.95 27.74 9 302265 21088 110265937
Infection susceptibility increased 31.88 27.74 49 302225 4349 110282676
Neuralgia 31.88 27.74 52 302222 48426 110238599
Peripheral sensory neuropathy 31.86 27.74 4 302270 16676 110270349
Neurological symptom 31.70 27.74 3 302271 15605 110271420
Complication associated with device 31.47 27.74 8 302266 20065 110266960
Eating disorder 31.46 27.74 23 302251 30835 110256190
Post procedural haemorrhage 31.46 27.74 3 302271 15509 110271516
Vascular device infection 31.44 27.74 4 302270 16508 110270517
Abdominal pain 31.33 27.74 1117 301157 511872 109775153
Immunodeficiency 31.23 27.74 36 302238 38802 110248223
Ecchymosis 31.15 27.74 5 302269 17333 110269692
Urine output decreased 31.01 27.74 8 302266 19868 110267157
Renal cyst 30.99 27.74 6 302268 18166 110268859
Fistula 30.92 27.74 3 302271 15296 110271729
Embolism 30.89 27.74 4 302270 16285 110270740
Ulcer haemorrhage 30.87 27.74 133 302141 22438 110264587
Pain in jaw 30.83 27.74 58 302216 51119 110235906
Abortion spontaneous 30.70 27.74 29 302245 34253 110252772
Blood calcium increased 30.67 27.74 6 302268 18034 110268991
Escherichia urinary tract infection 30.57 27.74 4 302270 16158 110270867
Pleuritic pain 30.52 27.74 4 302270 16136 110270889
Vaginal discharge 30.36 27.74 6 302268 17902 110269123
Metastases to lymph nodes 30.24 27.74 3 302271 15029 110271996
Gastric haemorrhage 29.96 27.74 4 302270 15911 110271114
Tenderness 29.94 27.74 22 302252 29415 110257610
Gastric ulcer 29.83 27.74 39 302235 39788 110247237
Blood triglycerides increased 29.82 27.74 14 302260 23912 110263113
Intestinal perforation 29.80 27.74 10 302264 20934 110266091
Pharyngitis 29.31 27.74 16 302258 25082 110261943
Hot flush 29.29 27.74 88 302186 65948 110221077
Sensory loss 29.24 27.74 11 302263 21446 110265579
Dysgeusia 29.12 27.74 96 302178 69889 110217136
Hyperuricaemia 28.97 27.74 3 302271 14528 110272497
Hip fracture 28.90 27.74 32 302242 35119 110251906
Eye disorder 28.89 27.74 22 302252 28884 110258141
Viral infection 28.81 27.74 64 302210 53075 110233950
Cholangitis 28.70 27.74 5 302269 16330 110270695
Spinal fracture 28.59 27.74 13 302261 22620 110264405
Rhinitis allergic 28.37 27.74 7 302267 17915 110269110
Needle issue 28.18 27.74 7 302267 17833 110269192
Affect lability 28.13 27.74 8 302266 18629 110268396
Burning sensation 28.07 27.74 96 302178 69116 110217909

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 D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D058988 Phosphodiesterase 4 Inhibitors
FDA MoA N0000182960 Phosphodiesterase 4 Inhibitors
FDA EPC N0000182961 Phosphodiesterase 4 Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:35845 gout suppressant
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:68844 phosphodiesterase IV inhibitor

Related Drugs by ATC class:

L04AA Selective immunosuppressants 10 drugs
abataceptalefaceptbelataceptbelumosudilcladribinegusperimusimlifidasemycophenolic acidnerandomilastremibrutinib

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 12576034 Nov. 30, 2033 TREATMENT OF ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF PLAQUE PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF PSORIATIC ARTHRITIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF PLAQUE PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF PSORIATIC ARTHRITIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 TREATMENT OF PLAQUE PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL 12576034 Nov. 30, 2033 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
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 10092541 May 29, 2034 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE USING A DOSAGE TITRATION SCHEDULE
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 11752129 May 27, 2042 TREATMENT OF ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE BY ADMINISTERING APREMILAST WITH FOOD
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 11752129 May 27, 2042 TREATMENT OF PLAQUE PSORIASIS BY ADMINISTERING APREMILAST WITH FOOD
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 11752129 May 27, 2042 TREATMENT OF PSORIATIC ARTHRITIS BY ADMINISTERING APREMILAST WITH FOOD
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 12427136 May 27, 2042 TREATMENT OF ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 12427136 May 27, 2042 TREATMENT OF PLAQUE PSORIASIS
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL 12427136 May 27, 2042 TREATMENT OF PSORIATIC ARTHRITIS

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, 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
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL July 19, 2026 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 20, 2026 CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 20, 2026 CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL July 20, 2026 CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL July 20, 2026 CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 19, 2027 PEDIATRIC EXCLUSIVITY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 19, 2027 PEDIATRIC EXCLUSIVITY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 19, 2027 PEDIATRIC EXCLUSIVITY
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL Jan. 19, 2027 PEDIATRIC EXCLUSIVITY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 20, 2027 PEDIATRIC EXCLUSIVITY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 20, 2027 PEDIATRIC EXCLUSIVITY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Jan. 20, 2027 PEDIATRIC EXCLUSIVITY
75MG OTEZLA XR AMGEN INC N210745 Aug. 29, 2025 RX TABLET, EXTENDED RELEASE ORAL Jan. 20, 2027 PEDIATRIC EXCLUSIVITY
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 25, 2027 NEW PATIENT POPULATION
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 25, 2027 NEW PATIENT POPULATION
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL April 25, 2027 NEW PATIENT POPULATION
10MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Oct. 25, 2027 PEDIATRIC EXCLUSIVITY
20MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Oct. 25, 2027 PEDIATRIC EXCLUSIVITY
30MG OTEZLA AMGEN INC N205437 March 21, 2014 RX TABLET ORAL Oct. 25, 2027 PEDIATRIC EXCLUSIVITY

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 29 sections
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 55513-497 TABLET, FILM COATED 20 mg ORAL NDA 29 sections
Otezla HUMAN PRESCRIPTION DRUG LABEL 1 55513-519 TABLET, FILM COATED 75 mg ORAL NDA 29 sections