propranolol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
beta-adrenoreceptor antagonists 2303 525-66-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • propranolol
  • betalong
  • DL-Propranolol
  • racemic propranolol
  • beta-Propranolol
  • propranolol hydrochloride
  • hemangiol
  • propranolol HCl
A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.
  • Molecular weight: 259.35
  • Formula: C16H21NO2
  • CLOGP: 2.75
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 41.49
  • ALOGS: -3.51
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 35.25 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 26 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.285 Moderate 0.68
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.327 Moderate 0.68
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 40.832 10^-6 cm/s Moderate 0.68
dh-clint Dog hepatocyte intrinsic clearance 65.013 uL/min/10^6 cells Moderate 0.68
dppb Dog plasma protein binding (% unbound) 13.460 % Moderate 0.68
fcs-ppb Fetal calf serum protein binding (% unbound) 26.550 % Moderate 0.68
herg hERG pIC50 4.959 pIC50 Moderate 0.68
hh-clint Human hepatocyte intrinsic clearance 20.845 uL/min/10^6 cells Moderate 0.68
hlm-clint Human liver microsomal intrinsic clearance 12.162 uL/min/mg protein Moderate 0.68
hppb Human plasma protein binding (% unbound) 23.900 % Moderate 0.68
kinase-safety-class ACVR2A,ACVR2B,AKT2,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK12,MAPK7,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK 43
kinase-selectivity-class AXL,CDK4,PDK4,PIK3CB,PIK3CD 5
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.676 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.811 Moderate 0.68
mh-clint Mouse hepatocyte intrinsic clearance 271.019 Moderate 0.68
mppb Mouse plasma protein binding (% unbound) 22.590 Moderate 0.68
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.117 Moderate 0.68
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 31.670 % Moderate 0.68
rat-kpuu-brain Rat brain Kpuu 0.325 % High 1
rh-clint Rat hepatocyte intrinsic clearance 299.226 uL/min/10^6 cells Moderate 0.68
rh-fuinc Rat hepatocyte fraction unbound in incubation 63.690 % Moderate 0.68
rppb Rat plasma protein binding (% unbound) 27.960 % Moderate 0.68
solubility-dd Solubility at pH 7.4 in DMSO 912.011 uM Moderate 0.68

Approvals:

DateAgencyCompanyOrphan
Nov. 13, 1967 FDA BAXTER HLTHCARE CORP

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
Product administered to patient of inappropriate age 1824.96 10.15 507 100068 4146 90523726
Completed suicide 1288.92 10.15 1156 99419 143902 90383970
Off label use 936.07 10.15 3006 97569 1099246 89428626
Drug ineffective for unapproved indication 797.25 10.15 631 99944 66013 90461859
Toxicity to various agents 657.63 10.15 1159 99416 286687 90241185
Bradycardia 566.42 10.15 575 100000 83272 90444600
Product use in unapproved indication 516.04 10.15 1146 99429 335090 90192782
Product use issue 459.13 10.15 1082 99493 328837 90199035
Cardiac arrest 366.40 10.15 514 100061 104421 90423451
Inappropriate schedule of product administration 340.76 10.15 603 99972 149330 90378542
Intentional overdose 314.81 10.15 451 100124 93383 90434489
Glossodynia 308.41 10.15 11 100564 321768 90206104
Hand deformity 307.78 10.15 4 100571 296358 90231514
Wound 295.18 10.15 9 100566 302971 90224901
Systemic lupus erythematosus 291.89 10.15 31 100544 361865 90166007
Infantile spitting up 284.29 10.15 55 100520 49 90527823
Coma 282.55 10.15 375 100200 72257 90455615
Cardio-respiratory arrest 267.45 10.15 340 100235 62800 90465072
Pericarditis 259.67 10.15 9 100566 270142 90257730
Hypotension 250.37 10.15 862 99713 324535 90203337
Helicobacter infection 235.77 10.15 3 100572 226847 90301025
Overdose 218.59 10.15 517 100058 157192 90370680
Swollen tongue 209.85 10.15 257 100318 45699 90482173
Electrocardiogram QRS complex prolonged 208.20 10.15 119 100456 7229 90520643
Cardiogenic shock 199.19 10.15 186 100389 24282 90503590
Swelling 192.80 10.15 113 100462 418945 90108927
Electrocardiogram QT prolonged 189.00 10.15 310 100265 72146 90455726
Folliculitis 185.80 10.15 10 100565 204343 90323529
Lower respiratory tract infection 181.67 10.15 30 100545 250629 90277243
Impaired healing 181.41 10.15 23 100552 234176 90293696
Muscle injury 180.69 10.15 3 100572 176651 90351221
Drug interaction 178.41 10.15 692 99883 275761 90252111
Ulcerated haemangioma 162.54 10.15 28 100547 0 90527872
Suicidal ideation 154.85 10.15 287 100288 73568 90454304
Joint swelling 150.71 10.15 203 100372 503097 90024775
Peripheral coldness 147.91 10.15 123 100452 13769 90514103
Hypoglycaemia 147.16 10.15 272 100303 69576 90458296
Respiratory arrest 146.78 10.15 183 100392 33128 90494744
Type 2 diabetes mellitus 145.76 10.15 25 100550 203219 90324653
Stomatitis 144.39 10.15 62 100513 274636 90253236
Abdominal discomfort 136.43 10.15 199 100376 477129 90050743
Seizure 132.93 10.15 422 100153 152207 90375665
Blister 131.73 10.15 59 100516 254939 90272933
Mobility decreased 129.55 10.15 58 100517 250676 90277196
Infection 128.93 10.15 127 100448 361967 90165905
Swelling face 128.52 10.15 281 100294 81071 90446801
Suicide attempt 126.65 10.15 267 100308 75132 90452740
Irritable bowel syndrome 125.76 10.15 37 100538 207411 90320461
Sinus bradycardia 124.94 10.15 122 100453 16830 90511042
Sleep disorder due to general medical condition, insomnia type 124.61 10.15 4 100571 128690 90399182
Synovitis 124.05 10.15 110 100465 329642 90198230
Neovascularisation 121.12 10.15 51 100524 1579 90526293
Joint range of motion decreased 119.15 10.15 8 100567 135635 90392237
Infusion related reaction 115.91 10.15 177 100398 416603 90111269
Ill-defined disorder 115.75 10.15 31 100544 184860 90343012
Angioedema 113.94 10.15 234 100341 64642 90463230
Serotonin syndrome 112.43 10.15 172 100403 37715 90490157
Poisoning deliberate 111.08 10.15 113 100462 16373 90511499
Arthropathy 106.25 10.15 151 100424 366091 90161781
Dysphonia 104.33 10.15 222 100353 62862 90465010
Extrapyramidal disorder 103.09 10.15 108 100467 16195 90511677
General physical health deterioration 102.43 10.15 147 100428 354968 90172904
Paradoxical drug reaction 101.50 10.15 69 100506 5697 90522175
Alopecia 101.44 10.15 252 100323 494819 90033053
Nasopharyngitis 101.07 10.15 186 100389 406918 90120954
Sinusitis 100.96 10.15 140 100435 342948 90184924
Wound infection 100.60 10.15 4 100571 106398 90421474
Discomfort 100.20 10.15 94 100481 274241 90253631
Tremor 99.97 10.15 385 100190 152788 90375084
Thyrotoxic crisis 99.84 10.15 41 100534 1190 90526682
Somnolence 99.08 10.15 477 100098 208607 90319265
Nightmare 96.74 10.15 120 100455 21605 90506267
Fibromyalgia 95.63 10.15 55 100520 206214 90321658
Liver injury 95.33 10.15 35 100540 170532 90357340
Hepatic enzyme increased 92.96 10.15 161 100414 360575 90167297
Blood cholesterol increased 92.88 10.15 58 100517 207954 90319918
Pulseless electrical activity 92.84 10.15 78 100497 8854 90519018
Bursitis 92.62 10.15 17 100558 131637 90396235
Anuria 91.63 10.15 97 100478 14721 90513151
Lip dry 91.55 10.15 5 100570 100950 90426922
Circulatory collapse 91.33 10.15 125 100450 24779 90503093
Dissociation 89.82 10.15 68 100507 6647 90521225
Facet joint syndrome 88.82 10.15 5 100570 98384 90429488
Rheumatoid arthritis 88.81 10.15 167 100408 362447 90165425
Psoriatic arthropathy 86.03 10.15 76 100499 228259 90299613
Arthralgia 83.65 10.15 514 100061 778008 89749864
Hypoglycaemic seizure 83.07 10.15 29 100546 531 90527341
Granuloma skin 82.73 10.15 79 100496 10601 90517271
Grip strength decreased 82.67 10.15 5 100570 92571 90435301
Brain injury 81.31 10.15 68 100507 7670 90520202
Pyrexia 80.71 10.15 418 100157 660067 89867805
Irritability 80.33 10.15 143 100432 35519 90492353
Phaeochromocytoma 80.32 10.15 29 100546 588 90527284
Suspected suicide 80.31 10.15 74 100501 9494 90518378
Drug intolerance 79.90 10.15 803 99772 446788 90081084
Medication overuse headache 79.40 10.15 37 100538 1464 90526408
Shock 78.92 10.15 126 100449 28652 90499220
Hypercholesterolaemia 77.86 10.15 10 100565 100882 90426990
Injury 77.63 10.15 63 100512 197286 90330586
Blood parathyroid hormone decreased 77.37 10.15 81 100494 12135 90515737
Product administration interrupted 75.87 10.15 81 100494 12411 90515461
Peripheral swelling 74.29 10.15 224 100351 412882 90114990
Drug withdrawal syndrome 73.66 10.15 122 100453 28601 90499271
Drug titration error 73.31 10.15 33 100542 1204 90526668
C-reactive protein abnormal 73.16 10.15 25 100550 127404 90400468
Disturbance in attention 71.31 10.15 160 100415 46949 90480923
Panic attack 70.34 10.15 114 100461 26251 90501621
Lung disorder 69.41 10.15 40 100535 149843 90378029
Hyperthyroidism 68.80 10.15 93 100482 18217 90509655
Peripheral venous disease 68.05 10.15 7 100568 83914 90443958
Panniculitis 67.84 10.15 82 100493 14376 90513496
Osteoarthritis 66.93 10.15 71 100504 195659 90332213
Gastrointestinal disorder 65.69 10.15 115 100460 256572 90271300
Skin necrosis 65.11 10.15 87 100488 16854 90511018
Intentional product use issue 64.27 10.15 88 100487 216804 90311068
Pain in extremity 63.88 10.15 270 100305 450259 90077613
Respiratory depression 62.97 10.15 82 100493 15493 90512379
Pain 62.50 10.15 757 99818 995584 89532288
Breath sounds abnormal 62.20 10.15 81 100494 15305 90512567
Wheezing 61.52 10.15 106 100469 237974 90289898
Vascular malformation 60.83 10.15 25 100550 727 90527145
Generalised tonic-clonic seizure 60.22 10.15 125 100450 34778 90493094
Mydriasis 59.09 10.15 78 100497 14934 90512938
Musculoskeletal pain 58.68 10.15 62 100513 171189 90356683
Sciatica 58.01 10.15 20 100555 101362 90426510
Sleep terror 57.06 10.15 44 100531 4420 90523452
Metabolic acidosis 55.99 10.15 162 100413 55514 90472358
Paranasal cyst 55.73 10.15 24 100551 786 90527086
Headache 55.65 10.15 1300 99275 861446 89666426
Hip arthroplasty 55.44 10.15 9 100566 76199 90451673
Depressed level of consciousness 55.08 10.15 192 100383 72592 90455280
Oedema 54.71 10.15 86 100489 200209 90327663
Maternal exposure during pregnancy 54.67 10.15 210 100365 359853 90168019
Night sweats 54.62 10.15 38 100537 128728 90399144
Knee arthroplasty 53.86 10.15 13 100562 83169 90444703
Liver disorder 53.85 10.15 34 100541 121235 90406637
Rash 53.69 10.15 595 99980 795505 89732367
Lower limb fracture 53.67 10.15 14 100561 84999 90442873
Therapeutic product effect decreased 53.16 10.15 146 100429 277425 90250447
Akathisia 51.88 10.15 63 100512 11096 90516776
Nail disorder 50.38 10.15 4 100571 59063 90468809
Prescribed overdose 49.73 10.15 23 100552 97602 90430270
Autoimmune disorder 49.68 10.15 12 100563 76732 90451140
Weight increased 49 10.15 268 100307 417659 90110213
Galactorrhoea 48.97 10.15 41 100534 4631 90523241
Contusion 48.96 10.15 131 100444 251085 90276787
Retinal detachment 48.23 10.15 48 100527 6774 90521098
Agitation 48.20 10.15 174 100401 66924 90460948
Liver function test increased 48.10 10.15 17 100558 84838 90443034
Disease progression 46.93 10.15 63 100512 156552 90371320
Rheumatoid nodule 46.88 10.15 82 100493 20084 90507788
Loss of consciousness 46.84 10.15 291 100284 139947 90387925
Hypercalcaemia 46.02 10.15 111 100464 34129 90493743
Musculoskeletal stiffness 44.96 10.15 173 100402 296359 90231513
Somatic delusion 44.92 10.15 19 100556 595 90527277
Atrioventricular block first degree 44.46 10.15 51 100524 8460 90519412
Ventricular tachycardia 44.41 10.15 90 100485 24618 90503254
Hepatic encephalopathy 44.39 10.15 65 100510 13707 90514165
Hyperhidrosis 43.14 10.15 279 100296 136026 90391846
Hypoaesthesia 42.25 10.15 192 100383 314018 90213854
Drug ineffective 42.22 10.15 1907 98668 1382391 89145481
Migraine 42.17 10.15 358 100217 190034 90337838
Migraine with aura 41.59 10.15 32 100543 3204 90524668
Brain death 41.56 10.15 35 100540 3986 90523886
Mental disorder 41.55 10.15 103 100472 32215 90495657
Obesity 41.08 10.15 34 100541 105473 90422399
Hallucination 40.73 10.15 163 100412 65796 90462076
Depressed mood 40.20 10.15 135 100440 50087 90477785
Hallucination, auditory 39.82 10.15 67 100508 15908 90511964
Abdominal pain upper 39.71 10.15 212 100363 332462 90195410
Mastoiditis 39.32 10.15 24 100551 1646 90526226
Basal cell carcinoma 37.35 10.15 101 100474 33288 90494584
Foot deformity 37.31 10.15 10 100565 59641 90468231
Coma scale abnormal 36.88 10.15 38 100537 5588 90522284
Onychomadesis 36.87 10.15 4 100571 45994 90481878
Electrocardiogram QRS complex shortened 36.82 10.15 16 100559 536 90527336
Feeling abnormal 36.79 10.15 314 100261 166921 90360951
Negative symptoms in schizophrenia 36.74 10.15 11 100564 120 90527752
Atrioventricular block 36.56 10.15 47 100528 8768 90519104
Adrenal suppression 35.92 10.15 19 100556 990 90526882
Palpitations 35.69 10.15 267 100308 136461 90391411
Bezoar 35.06 10.15 27 100548 2707 90525165
Vision blurred 35.05 10.15 226 100349 110067 90417805
Contraindicated product administered 34.97 10.15 210 100365 319929 90207943
Urticaria 34.76 10.15 204 100371 312530 90215342
Withdrawal syndrome 34.64 10.15 77 100498 22447 90505425
Blood prolactin increased 34.22 10.15 30 100545 3607 90524265
Insulin autoimmune syndrome 33.91 10.15 11 100564 159 90527713
Distributive shock 33.74 10.15 29 100546 3395 90524477
Middle insomnia 33.72 10.15 64 100511 16687 90511185
Lupus-like syndrome 32.89 10.15 7 100568 48839 90479033
Drug eruption 32.72 10.15 100 100475 35307 90492565
Live birth 32.68 10.15 24 100551 79083 90448789
Hallucination, visual 32.26 10.15 76 100499 23016 90504856
Pneumonia 31.92 10.15 507 100068 637552 89890320
Myelosuppression 31.66 10.15 10 100565 53581 90474291
Anxiety 31.59 10.15 501 100074 309271 90218601
Exostosis 31.23 10.15 10 100565 53124 90474748
Lip swelling 31.09 10.15 104 100471 38506 90489366
Poor quality sleep 31.01 10.15 78 100497 24615 90503257
Skin neoplasm excision 30.98 10.15 21 100554 1725 90526147
Laryngitis 30.83 10.15 9 100566 50744 90477128
Pre-existing condition improved 30.61 10.15 44 100531 9125 90518747
Lethargy 30.55 10.15 145 100430 62994 90464878
Foetal alcohol syndrome 29.81 10.15 7 100568 26 90527846
Varices oesophageal 29.36 10.15 28 100547 3751 90524121
Urine amphetamine positive 29.16 10.15 8 100567 62 90527810
Hyperprolactinaemia 29.13 10.15 33 100542 5400 90522472
Taste disorder 29.09 10.15 16 100559 61530 90466342
Haemodynamic instability 28.95 10.15 49 100526 11690 90516182
Myoclonus 28.89 10.15 65 100510 19103 90508769
Skin ulcer 28.75 10.15 121 100454 49954 90477918
Ulcer 28.66 10.15 91 100484 32791 90495081
Dizziness 28.62 10.15 856 99719 588428 89939444
Disease recurrence 28.20 10.15 99 100476 37554 90490318
Fatigue 28.20 10.15 1023 99552 1153000 89374872
Joint stiffness 28.16 10.15 27 100548 78015 90449857
Hyperthermia 27.99 10.15 45 100530 10290 90517582
Vertigo 27.94 10.15 152 100423 69659 90458213
Therapeutic product ineffective for unapproved indication 27.77 10.15 11 100564 290 90527582
Thyroxine free decreased 27.47 10.15 15 100560 833 90527039
Self-injurious ideation 27.32 10.15 25 100550 3178 90524694
Distractibility 27.17 10.15 13 100562 546 90527326
Oesophageal obstruction 27.13 10.15 14 100561 693 90527179
Electrocardiogram PR prolongation 27.11 10.15 15 100560 855 90527017
Congenital nystagmus 26.78 10.15 7 100568 44 90527828
Bradycardia foetal 26.76 10.15 13 100562 565 90527307
Phonophobia 26.75 10.15 12 100563 434 90527438
Unresponsive to stimuli 26.65 10.15 98 100477 38023 90489849
Myocardial oedema 26.63 10.15 12 100563 439 90527433
Salivary hypersecretion 26.58 10.15 41 100534 9051 90518821
Breast cancer stage II 26.09 10.15 4 100571 35330 90492542
Cyanosis 26.07 10.15 63 100512 19392 90508480
Onychomycosis 25.91 10.15 5 100570 37371 90490501
Rubber sensitivity 25.89 10.15 23 100552 2814 90525058
Panic reaction 25.89 10.15 29 100546 4688 90523184
Asthma 25.83 10.15 160 100415 242000 90285872
Neoplasm skin 25.79 10.15 24 100551 3118 90524754
Agranulocytosis 25.33 10.15 91 100484 34911 90492961
Back injury 25.31 10.15 10 100565 46612 90481260
Hyperreflexia 25.29 10.15 34 100541 6623 90521249
Pleural effusion 25.29 10.15 54 100521 111937 90415935
Accessory cardiac pathway 25.09 10.15 5 100570 6 90527866
Hyperammonaemic encephalopathy 24.87 10.15 22 100553 2677 90525195
Hepatocellular carcinoma 24.82 10.15 21 100554 2407 90525465
Thyroxine free increased 24.80 10.15 15 100560 1012 90526860
Derailment 24.79 10.15 7 100568 61 90527811
Insomnia 24.71 10.15 513 100062 332961 90194911
Eosinophilic myocarditis 24.67 10.15 13 100562 672 90527200
Dystonia 24.20 10.15 56 100519 16763 90511109
Nervousness 24.18 10.15 88 100487 33968 90493904
Psychotic symptom 24.07 10.15 20 100555 2236 90525636
Somnambulism 23.96 10.15 32 100543 6196 90521676
Negative cardiac inotropic effect 23.89 10.15 5 100570 9 90527863
Otitis media 23.88 10.15 31 100544 5839 90522033
Cataract subcapsular 23.88 10.15 13 100562 718 90527154
Therapeutic product effective for unapproved indication 23.80 10.15 8 100567 130 90527742
Hypothermia 23.68 10.15 53 100522 15522 90512350
Infusion site streaking 23.61 10.15 12 100563 575 90527297
Migraine without aura 23.48 10.15 13 100562 742 90527130
Road traffic accident 23.40 10.15 53 100522 107573 90420299
Heart rate decreased 23.13 10.15 119 100456 53386 90474486
Cerebral disorder 23.05 10.15 30 100545 5664 90522208
Essential tremor 22.74 10.15 16 100559 1396 90526476
Piloerection 22.53 10.15 12 100563 634 90527238
Haemoglobin decreased 22.33 10.15 98 100477 161858 90366014
Cerebral vasoconstriction 22.28 10.15 15 100560 1219 90526653
Poisoning 22.26 10.15 51 100524 15166 90512706
Haematemesis 22.16 10.15 85 100490 33641 90494231
Death 22.06 10.15 365 100210 456186 90071686
Neuropathy peripheral 21.99 10.15 78 100497 136892 90390980
Gait inability 21.82 10.15 86 100489 146370 90381502
Rheumatoid factor positive 21.81 10.15 107 100468 171543 90356329
Alcohol interaction 21.79 10.15 17 100558 1737 90526135
Narrow anterior chamber angle 21.70 10.15 6 100569 48 90527824
Osteoporosis 21.42 10.15 47 100528 96484 90431388
Oedema peripheral 21.42 10.15 183 100392 257732 90270140
Chromaturia 21.42 10.15 58 100517 19129 90508743
Nephropathy toxic 21.37 10.15 45 100530 12643 90515229
Frequent bowel movements 21.36 10.15 19 100556 56916 90470956
Communication disorder 21.30 10.15 22 100553 3244 90524628
Antipsychotic drug level decreased 21.29 10.15 10 100565 403 90527469
Herpes zoster 21.07 10.15 46 100529 94598 90433274
Tardive dyskinesia 21.07 10.15 41 100534 10889 90516983
Teething 20.78 10.15 6 100569 57 90527815
Porphyrins urine increased 20.44 10.15 5 100570 23 90527849
Ischaemic hepatitis 20.39 10.15 20 100555 2773 90525099
Abnormal dreams 20.22 10.15 41 100534 11216 90516656
Blepharospasm 20.21 10.15 19 100556 55426 90472446
Torsade de pointes 20.17 10.15 49 100526 15133 90512739
Toxic nodular goitre 20.16 10.15 6 100569 64 90527808
Stress 20.14 10.15 157 100418 81238 90446634
Exposure via transplant 20.09 10.15 5 100570 25 90527847
Starvation ketoacidosis 19.99 10.15 8 100567 217 90527655
Bundle branch block bilateral 19.93 10.15 5 100570 26 90527846
Retroperitoneal fibrosis 19.82 10.15 9 100566 335 90527537
Congenital gastric anomaly 19.77 10.15 5 100570 27 90527845
Interstitial lung disease 19.73 10.15 34 100541 76371 90451501
Acute lung injury 19.66 10.15 15 100560 1483 90526389
Ventricular arrhythmia 19.45 10.15 24 100551 4297 90523575
Hypoperfusion 19.41 10.15 16 100559 1768 90526104
Porphyrins stool increased 19.33 10.15 5 100570 30 90527842
Therapy non-responder 19.28 10.15 82 100493 136622 90391250
Pituitary apoplexy 19.25 10.15 7 100568 145 90527727
Myelocytosis 19.20 10.15 7 100568 146 90527726
Chemical burn 19.19 10.15 10 100565 505 90527367
Coeliac disease 19.13 10.15 13 100562 44597 90483275
Cholestasis of pregnancy 18.98 10.15 15 100560 1562 90526310
Hypermobility syndrome 18.91 10.15 12 100563 882 90526990
Mood swings 18.69 10.15 58 100517 20644 90507228
Pulse absent 18.68 10.15 28 100547 6027 90521845
Depression 18.66 10.15 451 100124 300150 90227722
Therapeutic response unexpected 18.57 10.15 60 100515 21820 90506052
Affective disorder 18.52 10.15 32 100543 7761 90520111
Intentional self-injury 18.52 10.15 73 100502 29261 90498611
Drug-induced liver injury 18.42 10.15 46 100529 90272 90437600
Aphasia 18.35 10.15 95 100480 42717 90485155
Agoraphobia 18.27 10.15 10 100565 558 90527314
Perseveration 18.16 10.15 8 100567 277 90527595
Breath holding 18.13 10.15 7 100568 172 90527700
Teratogenicity 18.00 10.15 8 100567 283 90527589
Restlessness 17.99 10.15 83 100492 35637 90492235
Calcitonin secretion disorder 17.97 10.15 5 100570 41 90527831
Dyspnoea 17.78 10.15 798 99777 880157 89647715
Incorrect route of product administration 17.70 10.15 18 100557 50608 90477264
Microencephaly 17.69 10.15 4 100571 12 90527860
Pregnancy 17.54 10.15 26 100549 62021 90465851
Oesophageal varices haemorrhage 17.54 10.15 14 100561 1478 90526394
Jaundice 17.45 10.15 77 100498 32440 90495432
Yellow skin 17.38 10.15 18 100557 2663 90525209
Aggression 17.35 10.15 67 100508 26601 90501271
Extra dose administered 17.33 10.15 34 100541 9084 90518788
Myocardial depression 17.26 10.15 10 100565 623 90527249
Febrile neutropenia 17.20 10.15 104 100471 158245 90369627
Disorientation 16.95 10.15 95 100480 44019 90483853
Cytokine release syndrome 16.92 10.15 5 100570 27968 90499904
Multiple lentigines syndrome 16.89 10.15 7 100568 208 90527664
Anger 16.87 10.15 43 100532 13677 90514195
Feeling guilty 16.76 10.15 10 100565 658 90527214
Adverse reaction 16.75 10.15 6 100569 29706 90498166
Productive cough 16.71 10.15 38 100537 77025 90450847
Deafness 16.69 10.15 59 100516 22455 90505417
Hyperacusis 16.67 10.15 18 100557 2793 90525079
Behaviour disorder 16.59 10.15 23 100552 4612 90523260
Bundle branch block right 16.52 10.15 25 100550 5428 90522444
Abnormal behaviour 16.52 10.15 59 100516 22569 90505303
Arteriospasm coronary 16.52 10.15 24 100551 5026 90522846
Visual field defect 16.48 10.15 29 100546 7137 90520735
Depersonalisation/derealisation disorder 16.44 10.15 14 100561 1618 90526254
Laryngeal dyspnoea 16.44 10.15 7 100568 223 90527649
Priapism 16.29 10.15 6 100569 129 90527743
Intentional dose omission 16.22 10.15 50 100525 17733 90510139
Apraxia 16.15 10.15 16 100559 2246 90525626
Postural orthostatic tachycardia syndrome 16.09 10.15 16 100559 2256 90525616
Muscle contractions involuntary 16.07 10.15 18 100557 2910 90524962
Thyroid stimulating immunoglobulin increased 16.04 10.15 6 100569 135 90527737
Psychomotor retardation 16.01 10.15 23 100552 4766 90523106
Gynaecomastia 15.96 10.15 7 100568 240 90527632
Metastases to liver 15.93 10.15 6 100569 28801 90499071
Sprue-like enteropathy 15.82 10.15 11 100564 942 90526930
Gastrointestinal motility disorder 15.79 10.15 26 100549 6065 90521807
Upper respiratory tract infection 15.72 10.15 81 100494 128237 90399635
Exposure via ingestion 15.68 10.15 17 100558 2650 90525222
Paraganglion neoplasm 15.61 10.15 4 100571 23 90527849
Maternal exposure timing unspecified 15.60 10.15 3 100572 22480 90505392
Unmasking of previously unidentified disease 15.57 10.15 13 100562 1463 90526409
Intentional product misuse 15.56 10.15 160 100415 89444 90438428
Antipsychotic drug level increased 15.44 10.15 20 100555 3759 90524113
Tinnitus 15.37 10.15 91 100484 43011 90484861
Pancreatic neuroendocrine tumour metastatic 15.37 10.15 5 100570 73 90527799
Pharyngeal swelling 15.30 10.15 34 100541 9910 90517962
Encephalopathy 15.26 10.15 96 100479 46348 90481524
Red blood cell sedimentation rate abnormal 15.25 10.15 4 100571 24200 90503672
Drug level increased 15.10 10.15 66 100509 27696 90500176
Macular degeneration 15.07 10.15 12 100563 37958 90489914
Cerebellar syndrome 15.06 10.15 20 100555 3852 90524020
Violence-related symptom 14.95 10.15 9 100566 602 90527270
Suicidal behaviour 14.78 10.15 17 100558 2827 90525045
Pseudohallucination 14.71 10.15 6 100569 171 90527701
Hepatic pain 14.65 10.15 19 100556 3576 90524296
Accelerated idioventricular rhythm 14.56 10.15 5 100570 87 90527785
Tic 14.54 10.15 14 100561 1897 90525975
Foetal growth restriction 14.35 10.15 32 100543 9348 90518524
Joint dislocation 14.32 10.15 17 100558 44565 90483307
Stroke in evolution 14.30 10.15 5 100570 92 90527780
Inflammation 14.25 10.15 128 100447 178464 90349408
Food craving 14.20 10.15 14 100561 1953 90525919
Muscular weakness 14.04 10.15 154 100421 206512 90321360
Nephrolithiasis 14.04 10.15 98 100477 48987 90478885
Developmental delay 13.98 10.15 13 100562 1687 90526185
Malignant neoplasm progression 13.93 10.15 66 100509 106804 90421068
Drug dependence 13.93 10.15 67 100508 29260 90498612
Hyponatraemic seizure 13.76 10.15 8 100567 502 90527370
Tonic convulsion 13.73 10.15 13 100562 1725 90526147
Bundle branch block 13.66 10.15 10 100565 929 90526943
Thyrotoxic cardiomyopathy 13.53 10.15 3 100572 8 90527864
Lung neoplasm malignant 13.52 10.15 5 100570 24268 90503604
Bronchiectasis 13.49 10.15 4 100571 22326 90505546
Sinus tachycardia 13.44 10.15 65 100510 28448 90499424
Dysarthria 13.43 10.15 105 100470 54377 90473495
Non-cardiogenic pulmonary oedema 13.37 10.15 11 100564 1213 90526659
Conjunctival hyperaemia 13.30 10.15 17 100558 3152 90524720
Product complaint 13.30 10.15 39 100536 13461 90514411
Vasoplegia syndrome 13.27 10.15 16 100559 2798 90525074
Parkinsonism 13.25 10.15 40 100535 14025 90513847
Crying 13.22 10.15 60 100515 25585 90502287
Hepatic steatosis 13.17 10.15 78 100497 36867 90491005
Blood pressure diastolic abnormal 13.08 10.15 3 100572 19878 90507994
Defect conduction intraventricular 13.05 10.15 6 100569 230 90527642
Heart rate variability increased 13.01 10.15 4 100571 48 90527824
Ventricular failure 12.98 10.15 7 100568 379 90527493
Pleural infection 12.96 10.15 6 100569 234 90527638
Epileptic encephalopathy 12.93 10.15 7 100568 382 90527490
Bronchitis 12.92 10.15 108 100467 152819 90375053
Inappropriate affect 12.88 10.15 10 100565 1015 90526857
Wrong schedule 12.85 10.15 7 100568 387 90527485
Mast cell activation syndrome 12.74 10.15 12 100563 1582 90526290
Delusion of reference 12.73 10.15 5 100570 129 90527743
Stress ulcer 12.72 10.15 4 100571 52 90527820
Alveolar bone resorption 12.72 10.15 4 100571 52 90527820
Basilar migraine 12.72 10.15 4 100571 52 90527820
Pruritus 12.71 10.15 482 100093 541043 89986829
Palmar erythema 12.69 10.15 13 100562 1898 90525974
Illness 12.67 10.15 143 100432 81826 90446046
Tumour rupture 12.61 10.15 6 100569 249 90527623
Aspiration of gastric residual 12.60 10.15 3 100572 12 90527860
Cognitive disorder 12.56 10.15 125 100450 69282 90458590
Urine odour abnormal 12.56 10.15 26 100549 7218 90520654
Mental impairment 12.55 10.15 44 100531 16676 90511196
Injection site reaction 12.52 10.15 56 100519 92024 90435848
Chest pain 12.49 10.15 265 100310 319380 90208492
Diabetic retinal oedema 12.40 10.15 7 100568 415 90527457
Food aversion 12.39 10.15 11 100564 1344 90526528
Blood lactic acid increased 12.38 10.15 29 100546 8749 90519123
Infusion site reaction 12.27 10.15 3 100572 19036 90508836
Bradypnoea 12.23 10.15 20 100555 4638 90523234
Product quality issue 12.18 10.15 46 100529 79279 90448593
Thyroid cancer metastatic 12.18 10.15 5 100570 145 90527727
Sinus rhythm 12.18 10.15 11 100564 1375 90526497
Altered state of consciousness 12.18 10.15 68 100507 31464 90496408
Dyspepsia 12.17 10.15 151 100424 198009 90329863
Dermatitis atopic 12.16 10.15 55 100520 23417 90504455
Ear pain 12.07 10.15 29 100546 57673 90470199
Rectal haemorrhage 12.06 10.15 49 100526 82695 90445177
Colitis ulcerative 12.05 10.15 31 100544 60235 90467637
Monoclonal gammopathy 12.01 10.15 9 100566 866 90527006
Walking aid user 11.99 10.15 13 100562 35493 90492379
Restless legs syndrome 11.90 10.15 53 100522 22417 90505455
Pericarditis fungal 11.90 10.15 4 100571 65 90527807
Speech disorder 11.87 10.15 89 100486 45496 90482376
Psychotic disorder 11.83 10.15 67 100508 31163 90496709
Catheter site thrombosis 11.81 10.15 7 100568 455 90527417
Product temperature excursion issue 11.76 10.15 9 100566 894 90526978
Hyperkalaemia 11.76 10.15 117 100458 64847 90463025
Respiratory disorder 11.72 10.15 35 100540 64781 90463091
Jealous delusion 11.68 10.15 4 100571 69 90527803
Blood pressure systolic increased 11.68 10.15 30 100545 58315 90469557
Blood thyroid stimulating hormone decreased 11.64 10.15 22 100553 5718 90522154
Porphyria non-acute 11.63 10.15 6 100569 297 90527575
Broad ligament tear 11.60 10.15 3 100572 18 90527854
Leukoencephalopathy 11.57 10.15 20 100555 4853 90523019
Traumatic haematoma 11.54 10.15 12 100563 1783 90526089
Sleep disorder due to a general medical condition 11.47 10.15 20 100555 44718 90483154
Urine leukocyte esterase 11.46 10.15 5 100570 169 90527703
Nodal rhythm 11.41 10.15 12 100563 1806 90526066
Dermatitis diaper 11.41 10.15 6 100569 309 90527563
Skin cancer 11.41 10.15 37 100538 13482 90514390
Laboratory test abnormal 11.39 10.15 18 100557 41836 90486036
Obsessive-compulsive disorder 11.37 10.15 19 100556 4485 90523387
Electrocardiogram T wave inversion 11.32 10.15 17 100558 3666 90524206
Porphyria acute 11.27 10.15 3 100572 17972 90509900
Initial insomnia 11.26 10.15 29 100546 9281 90518591
Meconium in amniotic fluid 11.25 10.15 6 100569 318 90527554
Brain stem syndrome 11.19 10.15 8 100567 716 90527156
Female genital tract fistula 11.17 10.15 3 100572 17865 90510007
Ventricular dysfunction 11.15 10.15 17 100558 3714 90524158
Alanine aminotransferase increased 11.15 10.15 189 100386 118149 90409723
Thalamic infarction 11.15 10.15 7 100568 505 90527367
Status epilepticus 11.14 10.15 46 100529 18828 90509044
Sudden infant death syndrome 11.08 10.15 6 100569 328 90527544
Therapeutic response decreased 11.05 10.15 150 100425 89579 90438293
Oral discomfort 11.02 10.15 31 100544 10452 90517420
Electric shock sensation 11.01 10.15 11 100564 1559 90526313
Choanal atresia 10.96 10.15 3 100572 23 90527849
Accidental overdose 10.94 10.15 61 100514 28212 90499660
Myocardial ischaemia 10.93 10.15 37 100538 13777 90514095
Blood pressure systolic abnormal 10.87 10.15 4 100571 19474 90508398
Ulcer haemorrhage 10.85 10.15 8 100567 26313 90501559
Toxic goitre 10.85 10.15 3 100572 24 90527848
Haemorrhagic tumour necrosis 10.85 10.15 3 100572 24 90527848
Hyponatraemic coma 10.85 10.15 3 100572 24 90527848
Lipoedema 10.83 10.15 6 100569 343 90527529
Atrioventricular septal defect 10.80 10.15 6 100569 345 90527527
Electrocardiogram PR shortened 10.79 10.15 7 100568 534 90527338
Rash pruritic 10.77 10.15 139 100436 82075 90445797
Amenorrhoea 10.73 10.15 33 100542 11689 90516183
Exposure during pregnancy 10.72 10.15 193 100382 238217 90289655
Neuroleptic malignant syndrome 10.71 10.15 39 100536 15057 90512815
Underdose 10.64 10.15 28 100547 53989 90473883
Wrong patient received product 10.62 10.15 16 100559 3461 90524411
Wrong dose 10.55 10.15 12 100563 1972 90525900
Tearfulness 10.55 10.15 19 100556 4761 90523111
Chronotropic incompetence 10.53 10.15 4 100571 94 90527778
Ear infection 10.45 10.15 121 100454 69654 90458218
Abnormal faeces 10.45 10.15 23 100552 6659 90521213
Abdominal pain 10.42 10.15 538 100037 395183 90132689
Endocrine ophthalmopathy 10.39 10.15 9 100566 1065 90526807
Septic arthritis staphylococcal 10.38 10.15 7 100568 570 90527302
Creatinine renal clearance decreased 10.35 10.15 4 100571 18895 90508977
Pulmonary mass 10.32 10.15 10 100565 28762 90499110
Respiratory rate decreased 10.32 10.15 17 100558 3966 90523906
Groin infection 10.28 10.15 7 100568 579 90527293
Treatment noncompliance 10.27 10.15 95 100480 51632 90476240
Neonatal behavioural syndrome 10.26 10.15 4 100571 101 90527771
Tachycardia 10.21 10.15 238 100337 157435 90370437

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
Product administered to patient of inappropriate age 855.04 11.28 290 50914 4471 42565660
Product use issue 459.65 11.28 512 50692 76239 42493892
Completed suicide 421.11 11.28 548 50656 95917 42474214
Product use in unapproved indication 392.44 11.28 753 50451 183703 42386428
Bradycardia 312.82 11.28 446 50758 85038 42485093
Sedation 300.63 11.28 267 50937 30208 42539923
Nightmare 272.64 11.28 232 50972 24780 42545351
Off label use 262.99 11.28 1477 49727 636858 41933273
Toxicity to various agents 216.40 11.28 685 50519 228451 42341680
Hepatic encephalopathy 176.05 11.28 151 51053 16291 42553840
Hyperhidrosis 162.62 11.28 345 50859 90167 42479964
Nephrolithiasis 150.75 11.28 203 51001 36627 42533504
Intentional overdose 139.59 11.28 234 50970 51222 42518909
Cardiac arrest 118.05 11.28 343 50861 108977 42461154
Febrile neutropenia 104.77 11.28 46 51158 185657 42384474
Pneumonia 95.25 11.28 231 50973 421918 42148213
Reversible airways obstruction 93.76 11.28 33 51171 570 42569561
Infantile spitting up 88.41 11.28 20 51184 54 42570077
Suicidal ideation 88.05 11.28 185 51019 47976 42522155
Oesophageal varices haemorrhage 86.58 11.28 54 51150 3553 42566578
Hyperthyroidism 86.20 11.28 96 51108 14245 42555886
Serotonin syndrome 84.45 11.28 128 51076 25717 42544414
Hepatocellular carcinoma 81.15 11.28 72 51132 8122 42562009
Drug ineffective for unapproved indication 79.41 11.28 173 51031 45990 42524141
Thyrotoxic periodic paralysis 78.74 11.28 22 51182 168 42569963
Varices oesophageal 77.19 11.28 54 51150 4311 42565820
Parasomnia 74.20 11.28 26 51178 443 42569688
Brain scan abnormal 73.87 11.28 34 51170 1205 42568926
Cerebral artery thrombosis 73.61 11.28 34 51170 1215 42568916
Poisoning deliberate 73.57 11.28 75 51129 10059 42560072
Akathisia 66.34 11.28 72 51132 10379 42559752
Areflexia 65.48 11.28 46 51158 3697 42566434
Cardiogenic shock 65.24 11.28 137 51067 35503 42534628
Product used for unknown indication 62.49 11.28 30 51174 1171 42568960
Hallucination, auditory 62.42 11.28 83 51121 14781 42555350
Myokymia 59.24 11.28 16 51188 106 42570025
Disease progression 57.15 11.28 53 51151 143603 42426528
Encapsulating peritoneal sclerosis 56.93 11.28 23 51181 589 42569542
Overdose 56.22 11.28 263 50941 105001 42465130
Cardio-respiratory arrest 55.71 11.28 176 51028 58460 42511671
Somnolence 52.42 11.28 319 50885 140786 42429345
Thyrotoxic crisis 50.08 11.28 23 51181 811 42569320
Drug interaction 49.97 11.28 515 50689 266484 42303647
Ascites 49.22 11.28 165 51039 56513 42513618
Foetal disorder 47.35 11.28 24 51180 1055 42569076
Drug level below therapeutic 46.71 11.28 48 51156 6497 42563634
Inappropriate schedule of product administration 46.44 11.28 233 50971 95669 42474462
Platelet count decreased 46.40 11.28 59 51145 138522 42431609
Hepatorenal syndrome 45.16 11.28 33 51171 2821 42567310
Neutropenia neonatal 44.91 11.28 22 51182 898 42569233
Hepatic cirrhosis 44.84 11.28 83 51121 19619 42550512
Dyspnoea 43.76 11.28 332 50872 442289 42127842
Peripheral coldness 43.49 11.28 52 51152 8323 42561808
Lethargy 42.95 11.28 139 51065 46751 42523380
Dysphemia 41.97 11.28 27 51177 1875 42568256
Sepsis 41.76 11.28 113 51091 199221 42370910
Psychotic disorder 40.91 11.28 101 51103 29107 42541024
Phonophobia 40.91 11.28 15 51189 293 42569838
Malignant neoplasm progression 40.78 11.28 42 51162 108358 42461773
Photophobia 39.86 11.28 49 51155 8070 42562061
Tardive dyskinesia 39.30 11.28 45 51159 6879 42563252
Respiratory arrest 38.46 11.28 97 51107 28327 42541804
Pulseless electrical activity 38.36 11.28 49 51155 8388 42561743
Granulomatous rosacea 37.44 11.28 12 51192 153 42569978
Death 37.42 11.28 374 50830 470811 42099320
Tremor 37.15 11.28 221 50983 96708 42473423
Sinus bradycardia 35.61 11.28 64 51140 14789 42555342
Premature baby 35.59 11.28 83 51121 23070 42547061
Depression 35.33 11.28 242 50962 111121 42459010
Growth hormone-producing pituitary tumour 34.48 11.28 11 51193 138 42569993
Hypoglycaemia 33.74 11.28 152 51052 59702 42510429
Interstitial lung disease 33.55 11.28 27 51177 78435 42491696
Low birth weight baby 33.50 11.28 50 51154 9905 42560226
Pyrexia 32.42 11.28 310 50894 393732 42176399
Myelosuppression 32.26 11.28 5 51199 40456 42529675
Disturbance in attention 31.49 11.28 93 51111 29773 42540358
Foetal growth restriction 31.11 11.28 35 51169 5248 42564883
Abnormal sleep-related event 30.96 11.28 14 51190 476 42569655
Neutrophil count decreased 30.83 11.28 19 51185 63396 42506735
Gastric hypomotility 30.48 11.28 11 51193 205 42569926
Neutropenia 30.23 11.28 130 51074 199301 42370830
White blood cell count decreased 30.17 11.28 54 51150 110342 42459789
Rash 29.59 11.28 203 51001 276751 42293380
Brain injury 29.49 11.28 41 51163 7614 42562517
Chronic obstructive pulmonary disease 29.20 11.28 20 51184 63094 42507037
Facial paralysis 28.68 11.28 53 51151 12510 42557621
Mucosal inflammation 28.16 11.28 12 51192 49362 42520769
Irritability 28.15 11.28 86 51118 28042 42542089
Hallucination 28.02 11.28 140 51064 57367 42512764
Status migrainosus 27.78 11.28 6 51198 12 42570119
Neuropathy peripheral 27.67 11.28 50 51154 101803 42468328
Shunt malfunction 27.66 11.28 11 51193 270 42569861
Hypertensive emergency 27.60 11.28 18 51186 1279 42568852
Suicide attempt 27.44 11.28 119 51085 45981 42524150
Pain 27.38 11.28 177 51027 244671 42325460
Suicidal behaviour 27.04 11.28 19 51185 1527 42568604
Agitation 26.83 11.28 150 51054 64164 42505967
Portal hypertensive gastropathy 26.78 11.28 15 51189 808 42569323
Breath odour 26.59 11.28 16 51188 987 42569144
Amblyopia 26.20 11.28 9 51195 144 42569987
Viral diarrhoea 26.08 11.28 11 51193 315 42569816
Hepatitis C 26.02 11.28 45 51159 10088 42560043
Granulocytopenia 25.77 11.28 37 51167 7077 42563054
Drug withdrawal syndrome 25.54 11.28 70 51134 21479 42548652
Prostate cancer 25.22 11.28 11 51193 44632 42525499
Anxiety 25.18 11.28 235 50969 118325 42451806
Drug titration error 25.17 11.28 14 51190 744 42569387
Peripheral swelling 24.80 11.28 44 51160 90226 42479905
Myocardial infarction 24.68 11.28 72 51132 123937 42446194
Stomatitis 24.57 11.28 15 51189 50314 42519817
Encephalopathy 24.07 11.28 106 51098 41227 42528904
Phaeochromocytoma malignant 23.56 11.28 7 51197 68 42570063
Insomnia 23.44 11.28 231 50973 118022 42452109
Renal impairment 23.42 11.28 62 51142 110166 42459965
Myocardial depression 23.41 11.28 8 51196 126 42570005
Atrial fibrillation 23.02 11.28 88 51116 139505 42430626
Hemiplegia 22.91 11.28 37 51167 7842 42562289
Pain in extremity 22.91 11.28 98 51106 150506 42419625
Thinking abnormal 22.72 11.28 35 51169 7126 42563005
Hallucination, visual 22.68 11.28 66 51138 20954 42549177
Arthralgia 22.61 11.28 149 51055 205089 42365042
Nausea 22.60 11.28 630 50574 396169 42173962
Pneumonitis 22.45 11.28 11 51193 41707 42528424
Gastroenteritis eosinophilic 22.40 11.28 9 51195 227 42569904
Electrocardiogram QRS complex prolonged 22.15 11.28 31 51173 5792 42564339
Suspected suicide 22.11 11.28 32 51172 6167 42563964
Sexually inappropriate behaviour 22.05 11.28 12 51192 611 42569520
Alcoholism 21.84 11.28 22 51182 2908 42567223
Alcohol interaction 21.62 11.28 19 51185 2116 42568015
Hepatitis C RNA positive 21.41 11.28 8 51196 165 42569966
Sleep disorder 21.28 11.28 114 51090 47981 42522150
Drug dispensed to wrong patient 21.24 11.28 11 51193 506 42569625
Hypertrophic cardiomyopathy 21.08 11.28 16 51188 1449 42568682
Blood creatinine increased 21.08 11.28 65 51139 109938 42460193
Antipsychotic drug level increased 21.06 11.28 27 51177 4639 42565492
Drug ineffective 21.05 11.28 941 50263 629256 41940875
Full blood count abnormal 21.05 11.28 5 51199 29871 42540260
Hypocalvaria 21.01 11.28 6 51198 50 42570081
Craniofacial fracture 20.91 11.28 10 51194 387 42569744
Acute stress disorder 20.85 11.28 8 51196 178 42569953
Panic attack 20.84 11.28 43 51161 11002 42559129
Rheumatoid arthritis 20.23 11.28 13 51191 42427 42527704
Foetal exposure during pregnancy 20.16 11.28 111 51093 47200 42522931
Cardiac failure congestive 19.86 11.28 46 51158 85556 42484575
Parkinsonian rest tremor 19.47 11.28 9 51195 322 42569809
Vitamin D abnormal 19.44 11.28 6 51198 67 42570064
Erectile dysfunction 19.42 11.28 70 51134 24843 42545288
Thyroxine free increased 19.32 11.28 9 51195 328 42569803
Genotype drug resistance test positive 19.23 11.28 14 51190 1190 42568941
Hypoaesthesia eye 19.23 11.28 5 51199 28 42570103
Thrombosis 19.17 11.28 33 51171 68478 42501653
COVID-19 19.17 11.28 73 51131 115875 42454256
Coma 19.17 11.28 120 51084 53434 42516697
Blood growth hormone increased 18.97 11.28 11 51193 633 42569498
Mycobacterium ulcerans infection 18.68 11.28 6 51198 77 42570054
Crying 18.56 11.28 30 51174 6364 42563767
Hypotension 18.46 11.28 422 50782 257209 42312922
Aggression 18.41 11.28 103 51101 44060 42526071
Gastric varices 18.27 11.28 11 51193 679 42569452
Torsade de pointes 18.06 11.28 35 51169 8559 42561572
Obstructive airways disorder 17.73 11.28 4 51200 24755 42545376
Thrombocytopenia 17.66 11.28 145 51059 190134 42379997
Patient dissatisfaction with treatment 17.65 11.28 6 51198 93 42570038
Electrocardiogram QT prolonged 17.52 11.28 108 51096 47837 42522294
Tinnitus 17.45 11.28 75 51129 28863 42541268
Infrequent bowel movements 17.41 11.28 13 51191 1149 42568982
Therapeutic product effect incomplete 17.38 11.28 37 51167 70902 42499229
Biliary anastomosis 17.37 11.28 4 51200 12 42570119
Hepatic failure 17.33 11.28 91 51113 38009 42532122
Haemoglobin decreased 17.33 11.28 91 51113 132380 42437751
Infusion related reaction 17.28 11.28 29 51175 60777 42509354
Productive cough 17.19 11.28 22 51182 51545 42518586
Dissociation 17.17 11.28 22 51182 3776 42566355
Joint swelling 17.06 11.28 35 51169 67987 42502144
Cytokine release syndrome 17.02 11.28 17 51187 44510 42525621
Pruritus 17.00 11.28 145 51059 188626 42381505
Portal vein thrombosis 16.98 11.28 24 51180 4525 42565606
Atrioventricular block first degree 16.89 11.28 29 51175 6462 42563669
Seizure 16.86 11.28 220 50984 120341 42449790
Acute encephalitis with refractory, repetitive partial seizures 16.27 11.28 5 51199 55 42570076
Dysmorphism 16.26 11.28 20 51184 3296 42566835
Social avoidant behaviour 16.03 11.28 20 51184 3344 42566787
Trigeminal neuralgia 15.96 11.28 14 51190 1555 42568576
Infection 15.79 11.28 75 51129 111993 42458138
Electrocardiogram QRS complex shortened 15.64 11.28 7 51197 232 42569899
Septic shock 15.62 11.28 57 51147 91615 42478516
Lupus-like syndrome 15.43 11.28 19 51185 3135 42566996
Drug-induced liver injury 15.34 11.28 14 51190 38259 42531872
Extrapyramidal disorder 15.33 11.28 49 51155 16363 42553768
Blood pressure systolic decreased 15.30 11.28 24 51180 4963 42565168
Acute myeloid leukaemia 15.14 11.28 4 51200 22252 42547879
Tumour lysis syndrome 15.12 11.28 4 51200 22227 42547904
Antithyroid arthritis syndrome 15.10 11.28 3 51201 3 42570128
Peritoneal fibrosis 15.10 11.28 3 51201 3 42570128
Drooling 15.05 11.28 22 51182 4277 42565854
Blunted affect 15.04 11.28 8 51196 389 42569742
Coronary artery disease 14.91 11.28 26 51178 53694 42516437
Drug hypersensitivity 14.90 11.28 65 51139 99324 42470807
Intentional product use issue 14.80 11.28 41 51163 71792 42498339
Alcoholic liver disease 14.77 11.28 9 51195 568 42569563
Differential white blood cell count abnormal 14.69 11.28 14 51190 1730 42568401
Bone marrow failure 14.63 11.28 11 51193 33082 42537049
Withdrawal syndrome 14.62 11.28 45 51159 14730 42555401
Meningitis streptococcal 14.62 11.28 5 51199 79 42570052
Phaeochromocytoma 14.61 11.28 7 51197 272 42569859
Shunt occlusion 14.30 11.28 11 51193 1016 42569115
Mania 14.27 11.28 36 51168 10511 42559620
Contraindicated product administered 14.10 11.28 64 51140 25208 42544923
Laryngeal erythema 13.89 11.28 3 51201 6 42570125
Micrographia 13.89 11.28 3 51201 6 42570125
Renal hamartoma 13.89 11.28 3 51201 6 42570125
Apathy 13.87 11.28 31 51173 8375 42561756
Ammonia increased 13.71 11.28 22 51182 4637 42565494
Acute kidney injury 13.54 11.28 337 50867 367000 42203131
Erythema 13.53 11.28 76 51128 108717 42461414
Hyperkalaemia 13.50 11.28 152 51052 80306 42489825
Electrocardiogram T wave amplitude increased 13.43 11.28 5 51199 102 42570029
Pseudoporphyria 13.40 11.28 8 51196 486 42569645
Oesophageal variceal ligation 13.34 11.28 5 51199 104 42570027
Disorientation 13.31 11.28 82 51122 36307 42533824
Essential tremor 13.30 11.28 10 51194 893 42569238
Portal hypertension 13.27 11.28 22 51182 4765 42565366
Plasma cell myeloma 13.23 11.28 23 51181 47555 42522576
Neuroleptic malignant syndrome 13.21 11.28 56 51148 21416 42548715
Pancytopenia 13.19 11.28 85 51119 117658 42452473
Reflux gastritis 13.01 11.28 7 51197 348 42569783
Memory impairment 12.98 11.28 104 51100 50118 42520013
Arthritis 12.96 11.28 19 51185 42046 42528085
Intentional self-injury 12.96 11.28 44 51160 15158 42554973
Pulmonary fibrosis 12.96 11.28 8 51196 26673 42543458
Negative thoughts 12.92 11.28 9 51195 713 42569418
Arthropathy 12.88 11.28 10 51194 29587 42540544
Loss of bladder sensation 12.78 11.28 4 51200 47 42570084
Sleep deficit 12.76 11.28 10 51194 949 42569182
Hepatopulmonary syndrome 12.72 11.28 5 51199 119 42570012
Restlessness 12.71 11.28 69 51135 29180 42540951
Coma scale abnormal 12.68 11.28 21 51183 4544 42565587
Wrong strength 12.64 11.28 5 51199 121 42570010
Withdrawal hypertension 12.62 11.28 6 51198 229 42569902
Lymphocyte count decreased 12.61 11.28 9 51195 27800 42542331
Hepatic cancer 12.59 11.28 30 51174 8450 42561681
Maternal drugs affecting foetus 12.51 11.28 19 51185 3820 42566311
Musculoskeletal pain 12.43 11.28 13 51191 33327 42536804
Salivary hypersecretion 12.42 11.28 35 51169 10908 42559223
Respiratory acidosis 12.36 11.28 25 51179 6306 42563825
Vital functions abnormal 12.35 11.28 7 51197 386 42569745
Hypnagogic hallucination 12.34 11.28 4 51200 53 42570078
Concussion 12.31 11.28 16 51188 2786 42567345
Bronchopulmonary aspergillosis 12.29 11.28 4 51200 19425 42550706
Myelodysplastic syndrome 12.23 11.28 6 51198 22739 42547392
Depressed level of consciousness 12.21 11.28 99 51105 47871 42522260
Persecutory delusion 12.13 11.28 18 51186 3546 42566585
Parkinsonism 12.08 11.28 34 51170 10589 42559542
Genital swelling 11.96 11.28 6 51198 258 42569873
Necrotising colitis 11.96 11.28 11 51193 1300 42568831
Transient acantholytic dermatosis 11.94 11.28 6 51198 259 42569872
Osteonecrosis of jaw 11.91 11.28 4 51200 19045 42551086
Ischaemic cerebral infarction 11.63 11.28 12 51192 1631 42568500
Localised infection 11.54 11.28 5 51199 20368 42549763
Poor quality sleep 11.52 11.28 31 51173 9409 42560722
Product administration interrupted 11.40 11.28 21 51183 4945 42565186
Chronic spontaneous urticaria 11.39 11.28 6 51198 286 42569845
Ventricular arrhythmia 11.32 11.28 24 51180 6255 42563876

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
Completed suicide 1743.55 10.46 1735 123810 240646 110223108
Toxicity to various agents 806.15 10.46 1720 123825 478835 109984919
Bradycardia 779.13 10.46 921 124624 154596 110309158
Product administered to patient of inappropriate age 743.41 10.46 296 125249 7740 110456014
Product use issue 726.92 10.46 1283 124262 310412 110153342
Product use in unapproved indication 705.21 10.46 1562 123983 445815 110017939
Drug ineffective for unapproved indication 689.89 10.46 710 124835 102128 110361626
Intentional overdose 495.92 10.46 679 124866 131822 110331932
Cardiac arrest 490.92 10.46 835 124710 195918 110267836
Off label use 375.56 10.46 2942 122603 1497243 108966511
Nightmare 342.71 10.46 312 125233 38551 110425203
Cardio-respiratory arrest 340.88 10.46 530 125015 115306 110348448
Coma 281.63 10.46 491 125054 117378 110346376
Overdose 271.82 10.46 727 124818 233067 110230687
Cardiogenic shock 240.73 10.46 311 125234 57027 110406727
Hypotension 231.57 10.46 1190 124355 522659 109941095
Hand deformity 227.78 10.46 4 125541 218502 110245252
Drug interaction 219.49 10.46 1134 124411 499049 109964705
Wound 211.17 10.46 14 125531 234423 110229331
Electrocardiogram QRS complex prolonged 207.82 10.46 148 125397 12873 110450881
Hepatic encephalopathy 207.44 10.46 205 125340 28051 110435703
Respiratory arrest 200.42 10.46 287 125258 58012 110405742
Glossodynia 197.79 10.46 14 125531 221990 110241764
Systemic lupus erythematosus 191.07 10.46 30 125515 254308 110209446
Hyperhidrosis 187.70 10.46 552 124993 186746 110277008
Pericarditis 186.35 10.46 17 125528 219097 110244657
Sedation 185.91 10.46 305 125240 69378 110394376
Poisoning deliberate 184.03 10.46 186 125359 26145 110437609
Electrocardiogram QT prolonged 182.98 10.46 391 125154 108569 110355185
Swollen tongue 170.29 10.46 271 125274 60091 110403663
Suicidal ideation 168.10 10.46 346 125199 93591 110370163
Folliculitis 160.34 10.46 7 125538 167646 110296108
Suicide attempt 156.60 10.46 356 125189 103038 110360716
Helicobacter infection 152.29 10.46 15 125530 181862 110281892
Sinus bradycardia 149.68 10.46 176 125369 29307 110434447
Lower respiratory tract infection 149.58 10.46 45 125500 243061 110220693
Serotonin syndrome 148.55 10.46 252 125293 58901 110404853
Thyrotoxic crisis 144.15 10.46 62 125483 1978 110461776
Impaired healing 143.73 10.46 25 125520 196692 110267062
Muscle injury 141.19 10.46 4 125541 140803 110322951
Stomatitis 141.16 10.46 65 125480 270177 110193577
Hypoglycaemia 139.82 10.46 366 125179 115738 110348016
Swelling 132.41 10.46 122 125423 350919 110112835
Nephrolithiasis 128.14 10.46 252 125293 65960 110397794
Hyperthyroidism 124.82 10.46 160 125385 29101 110434653
Nasopharyngitis 124.43 10.46 159 125386 394202 110069552
Brain injury 114.51 10.46 106 125439 13370 110450384
Mobility decreased 113.68 10.46 64 125481 237358 110226396
Neovascularisation 113.63 10.46 50 125495 1687 110462067
Seizure 113.62 10.46 525 125020 220660 110243094
Joint range of motion decreased 113.55 10.46 6 125539 121826 110341928
Hepatocellular carcinoma 110.75 10.46 91 125454 9789 110453965
Swelling face 110.10 10.46 290 125255 92031 110371723
Pulseless electrical activity 109.18 10.46 114 125431 16643 110447111
Somnolence 107.89 10.46 641 124904 296808 110166946
Drug intolerance 104.85 10.46 805 124740 405707 110058047
Dissociation 104.81 10.46 88 125457 9754 110454000
Pyrexia 103.83 10.46 597 124948 897668 109566086
Infection 103.28 10.46 157 125388 362043 110101711
Bursitis 102.99 10.46 13 125532 129905 110333849
Sleep disorder due to general medical condition, insomnia type 102.38 10.46 4 125541 105639 110358115
Joint swelling 102.07 10.46 219 125326 442626 110021128
Type 2 diabetes mellitus 101.65 10.46 37 125508 177195 110286559
Irritable bowel syndrome 99.90 10.46 31 125514 164184 110299570
Varices oesophageal 94.89 10.46 73 125472 7142 110456612
Suspected suicide 94.75 10.46 101 125444 15098 110448656
Hypoglycaemic seizure 94.07 10.46 37 125508 935 110462819
Tremor 93.70 10.46 466 125079 201766 110261988
Febrile neutropenia 93.53 10.46 134 125411 316633 110147121
Facet joint syndrome 92.71 10.46 4 125541 96824 110366930
Synovitis 92.26 10.46 105 125440 273987 110189767
Ill-defined disorder 91.23 10.46 32 125513 156821 110306933
Extrapyramidal disorder 90.36 10.46 136 125409 28731 110435023
Oesophageal varices haemorrhage 90.15 10.46 61 125484 4884 110458870
Lip dry 90.02 10.46 6 125539 100077 110363677
Infusion related reaction 89.07 10.46 187 125358 380975 110082779
Blood cholesterol increased 88.18 10.46 50 125495 184735 110279019
Hallucination, auditory 87.85 10.46 128 125417 26269 110437485
Abdominal discomfort 85.66 10.46 201 125344 393657 110070097
C-reactive protein abnormal 85.40 10.46 21 125524 129674 110334080
Drug ineffective 85.29 10.46 2292 123253 1518248 108945506
Pneumonia 84.31 10.46 616 124929 876098 109587656
Dysphonia 83.99 10.46 232 125313 75697 110388057
Akathisia 83.30 10.46 100 125445 17013 110446741
Disturbance in attention 81.43 10.46 202 125343 61793 110401961
Sinusitis 81.33 10.46 132 125413 296556 110167198
Musculoskeletal pain 78.45 10.46 56 125489 182967 110280787
Thyrotoxic periodic paralysis 78.21 10.46 22 125523 184 110463570
Fibromyalgia 77.68 10.46 49 125496 170860 110292894
Disease progression 77.32 10.46 98 125447 243936 110219818
Intentional product use issue 76.04 10.46 102 125443 247804 110215950
Blister 75.54 10.46 88 125457 227288 110236466
Pain in extremity 74.80 10.46 292 125253 486826 109976928
Granuloma skin 73.94 10.46 77 125468 11206 110452548
Lung disorder 73.42 10.46 58 125487 179989 110283765
Wound infection 73.27 10.46 11 125534 96454 110367300
Circulatory collapse 72.96 10.46 155 125390 42838 110420916
Depressed level of consciousness 72.70 10.46 286 125259 111992 110351762
Peripheral swelling 72.22 10.46 227 125318 403807 110059947
Arthralgia 71.96 10.46 554 124991 779078 109684676
Generalised tonic-clonic seizure 71.64 10.46 178 125367 54502 110409252
Grip strength decreased 71.54 10.46 5 125540 80169 110383585
Myelosuppression 71.10 10.46 11 125534 94329 110369425
Phaeochromocytoma 70.82 10.46 29 125516 816 110462938
Wheezing 70.47 10.46 113 125432 255117 110208637
Parasomnia 69.91 10.46 28 125517 743 110463011
Hypercholesterolaemia 69.82 10.46 10 125535 90827 110372927
Angioedema 68.78 10.46 257 125288 98243 110365511
Blood parathyroid hormone decreased 67.87 10.46 79 125466 13010 110450744
Peripheral venous disease 67.69 10.46 8 125537 84109 110379645
Shock 67.65 10.46 172 125373 53416 110410338
Areflexia 66.93 10.46 58 125487 6711 110457043
Arthropathy 66.35 10.46 142 125403 287380 110176374
Osteoarthritis 65.86 10.46 66 125479 182557 110281197
Rheumatoid arthritis 65.84 10.46 152 125393 299461 110164293
Hallucination 65.37 10.46 258 125287 101174 110362580
Brain scan abnormal 65.08 10.46 33 125512 1538 110462216
Drug withdrawal syndrome 64.35 10.46 137 125408 37917 110425837
Psoriatic arthropathy 63.39 10.46 78 125467 196683 110267071
Liver injury 63.18 10.46 47 125498 150366 110313388
Anuria 62.83 10.46 105 125440 24236 110439518
Medication overuse headache 62.33 10.46 32 125513 1531 110462223
Phonophobia 62.26 10.46 25 125520 668 110463086
Agitation 62.24 10.46 274 125271 112777 110350977
General physical health deterioration 62.08 10.46 260 125285 425035 110038719
Myokymia 60.77 10.46 17 125528 139 110463615
Cerebral artery thrombosis 60.37 10.46 32 125513 1636 110462118
Gastrointestinal disorder 58.78 10.46 116 125429 241836 110221918
Vascular malformation 58.37 10.46 25 125520 789 110462965
Alopecia 58.32 10.46 215 125330 364538 110099216
Pain 57.85 10.46 751 124794 954204 109509550
Paradoxical drug reaction 57.28 10.46 63 125482 9754 110454000
Panic attack 57.02 10.46 111 125434 28829 110434925
Panniculitis 56.93 10.46 79 125466 15503 110448251
Paranasal cyst 55.85 10.46 25 125520 879 110462875
Product used for unknown indication 55.49 10.46 32 125513 1931 110461823
Headache 55.03 10.46 1350 124195 881027 109582727
Rash 54.86 10.46 632 124913 820332 109643422
Lethargy 53.96 10.46 230 125315 93346 110370408
Nail disorder 53.52 10.46 3 125542 57932 110405822
Atrioventricular block first degree 53.29 10.46 73 125472 14152 110449602
Reversible airways obstruction 53.28 10.46 34 125511 2465 110461289
Irritability 52.78 10.46 146 125399 47663 110416091
Night sweats 52.34 10.46 45 125500 133938 110329816
Electrocardiogram QRS complex shortened 51.70 10.46 23 125522 797 110462957
Injury 51.30 10.46 76 125469 177189 110286565
Hallucination, visual 49.86 10.46 127 125418 39478 110424276
Hepatic enzyme increased 48.17 10.46 194 125351 320698 110143056
Neuropathy peripheral 47.95 10.46 81 125464 179196 110284558
Discomfort 47.91 10.46 108 125437 214599 110249155
Peripheral coldness 47.88 10.46 80 125465 18460 110445294
Sciatica 47.02 10.46 23 125522 92376 110371378
Encapsulating peritoneal sclerosis 46.84 10.46 22 125523 866 110462888
Ascites 46.65 10.46 219 125326 92589 110371165
Autoimmune disorder 46.35 10.46 9 125536 65474 110398280
Lower limb fracture 46.22 10.46 14 125531 75334 110388420
Tardive dyskinesia 45.41 10.46 66 125479 13513 110450241
Liver disorder 45.17 10.46 57 125488 142186 110321568
Oedema 44.94 10.46 108 125437 209868 110253886
Mydriasis 44.89 10.46 86 125459 22071 110441683
Somatic delusion 44.74 10.46 20 125525 701 110463053
Loss of consciousness 44.68 10.46 378 125167 195928 110267826
Hepatorenal syndrome 44.67 10.46 39 125506 4558 110459196
Coma scale abnormal 44.36 10.46 55 125490 9671 110454083
Skin necrosis 44.21 10.46 84 125461 21428 110442326
Maternal exposure during pregnancy 43.57 10.46 146 125399 254737 110209017
Alcohol interaction 43.46 10.46 35 125510 3659 110460095
Obesity 43.16 10.46 39 125506 113312 110350442
Interstitial lung disease 43.04 10.46 57 125488 139277 110324477
Suicidal behaviour 42.99 10.46 34 125511 3463 110460291
Photophobia 42.68 10.46 92 125453 25679 110438075
Withdrawal syndrome 42.00 10.46 103 125442 31277 110432477
Rheumatoid nodule 41.40 10.46 79 125466 20217 110443537
Atrioventricular block 41.17 10.46 71 125474 16806 110446948
Hip arthroplasty 40.95 10.46 7 125538 55806 110407948
Metabolic acidosis 40.74 10.46 222 125323 99522 110364232
Mental disorder 40.41 10.46 116 125429 38675 110425079
Psychotic disorder 39.89 10.46 138 125407 50799 110412955
Galactorrhoea 39.87 10.46 35 125510 4120 110459634
Depressed mood 39.43 10.46 155 125390 60654 110403100
Product administration interrupted 39.39 10.46 56 125489 11236 110452518
Urticaria 39.39 10.46 207 125338 318650 110145104
Thyroxine free increased 39.20 10.46 23 125522 1434 110462320
Frequent bowel movements 39.10 10.46 16 125529 71374 110392380
Respiratory depression 38.62 10.46 101 125444 31900 110431854
Encephalopathy 38.37 10.46 188 125357 80867 110382887
Tinnitus 38.20 10.46 153 125392 60387 110403367
Myocardial depression 38.19 10.46 18 125527 714 110463040
Vision blurred 37.47 10.46 263 125282 128759 110334995
Ventricular tachycardia 37.02 10.46 133 125412 49876 110413878
Agranulocytosis 36.53 10.46 153 125392 61607 110402147
Weight increased 36.40 10.46 303 125242 419341 110044413
Distributive shock 36.39 10.46 39 125506 5865 110457889
Prescribed overdose 35.96 10.46 28 125517 87553 110376201
Therapeutic product effect decreased 35.84 10.46 149 125396 244167 110219587
Live birth 35.81 10.46 17 125528 69467 110394287
Salivary hypersecretion 35.77 10.46 68 125477 17353 110446401
Platelet count decreased 35.41 10.46 138 125407 230305 110233449
Contusion 35.06 10.46 141 125404 233220 110230534
Malignant neoplasm progression 34.86 10.46 93 125452 174474 110289280
Knee arthroplasty 34.86 10.46 15 125530 64933 110398821
Growth hormone-producing pituitary tumour 34.67 10.46 11 125534 144 110463610
Granulomatous rosacea 34.40 10.46 12 125533 214 110463540
Accessory cardiac pathway 34.28 10.46 7 125538 10 110463744
Dyspnoea 34.27 10.46 976 124569 1105896 109357858
Taste disorder 33.69 10.46 16 125529 65371 110398383
Anxiety 33.41 10.46 564 124981 344514 110119240
Hypermobility syndrome 33.05 10.46 15 125530 545 110463209
Bezoar 32.74 10.46 31 125514 4023 110459731
Haemoglobin decreased 32.69 10.46 158 125387 248569 110215185
Antipsychotic drug level increased 32.53 10.46 40 125505 6975 110456779
Asthma 32.31 10.46 160 125385 250131 110213623
Torsade de pointes 32.20 10.46 76 125469 22524 110441230
Productive cough 32.10 10.46 50 125495 114255 110349499
Herpes zoster 31.80 10.46 46 125499 108333 110355421
Migraine 31.69 10.46 316 125229 171336 110292418
Breath sounds abnormal 31.50 10.46 81 125464 25323 110438431
Brain death 31.32 10.46 38 125507 6535 110457219
Mastoiditis 31.27 10.46 25 125520 2586 110461168
Negative symptoms in schizophrenia 30.89 10.46 11 125534 209 110463545
Rubber sensitivity 30.79 10.46 24 125521 2394 110461360
Intentional self-injury 30.71 10.46 103 125442 37326 110426428
Therapeutic product ineffective for unapproved indication 30.55 10.46 12 125533 302 110463452
Granulocytopenia 30.38 10.46 53 125492 12662 110451092
Onychomycosis 30.18 10.46 4 125541 38527 110425227
Mucosal inflammation 30.03 10.46 39 125506 96102 110367652
Skin neoplasm excision 29.67 10.46 22 125523 2036 110461718
Musculoskeletal stiffness 29.56 10.46 191 125354 279631 110184123
Thyroxine free decreased 29.55 10.46 18 125527 1202 110462552
Hepatitis C 29.51 10.46 52 125493 12521 110451233
Cytokine release syndrome 29.48 10.46 22 125523 70284 110393470
Haematemesis 29.35 10.46 139 125406 58969 110404785
Hypertrophic cardiomyopathy 29.07 10.46 26 125519 3137 110460617
Unresponsive to stimuli 28.81 10.46 146 125399 63644 110400110
Drug-induced liver injury 28.77 10.46 58 125487 120009 110343745
Migraine with aura 28.77 10.46 27 125518 3465 110460289
Depression 28.32 10.46 512 125033 316823 110146931
Hypoaesthesia 28.10 10.46 225 125320 313998 110149756
Ventricular arrhythmia 28.04 10.46 45 125500 10042 110453712
Alcoholism 27.40 10.46 27 125518 3680 110460074
Gastric hypomotility 27.39 10.46 11 125534 294 110463460
Exostosis 27.36 10.46 9 125536 45947 110417807
Myoclonus 27.24 10.46 91 125454 32907 110430847
Hypercalcaemia 27.14 10.46 115 125430 46542 110417212
Essential tremor 27.10 10.46 20 125525 1838 110461916
Sepsis 26.75 10.46 240 125305 327106 110136648
Neutropenia 26.69 10.46 284 125261 374336 110089418
Neuroleptic malignant syndrome 26.43 10.46 92 125453 33967 110429787
Hyperreflexia 25.94 10.46 42 125503 9443 110454311
Somnambulism 25.72 10.46 34 125511 6371 110457383
Aggression 25.68 10.46 134 125411 59076 110404678
Poisoning 25.59 10.46 82 125463 29023 110434731
Violence-related symptom 25.44 10.46 15 125530 944 110462810
Disorientation 25.38 10.46 152 125393 70519 110393235
Shunt malfunction 25.34 10.46 11 125534 359 110463395
Chronic obstructive pulmonary disease 25.08 10.46 54 125491 109104 110354650
Parkinsonism 24.73 10.46 68 125477 22119 110441635
Altered state of consciousness 24.71 10.46 130 125415 57496 110406258
Blepharospasm 24.54 10.46 16 125529 54835 110408919
Basal cell carcinoma 24.36 10.46 109 125436 45161 110418593
Insomnia 24.30 10.46 558 124987 360032 110103722
Obstructive airways disorder 24.23 10.46 11 125534 46138 110417616
Blood prolactin increased 24.04 10.46 28 125517 4614 110459140
Phaeochromocytoma malignant 23.95 10.46 7 125538 68 110463686
Back injury 23.81 10.46 12 125533 47387 110416367
Palpitations 23.78 10.46 281 125264 158931 110304823
Bradycardia foetal 23.74 10.46 8 125537 128 110463626
Neutrophil count decreased 23.71 10.46 65 125480 120876 110342878
Cyanosis 23.65 10.46 81 125464 29660 110434094
Lip swelling 23.61 10.46 117 125428 50550 110413204
Abnormal sleep-related event 23.58 10.46 14 125531 892 110462862
Infusion site streaking 23.30 10.46 12 125533 578 110463176
Gastrooesophageal reflux disease 23.25 10.46 115 125430 179861 110283893
Urine amphetamine positive 23.18 10.46 8 125537 138 110463616
Derailment 23.17 10.46 7 125538 77 110463677
Toxic nodular goitre 23.17 10.46 7 125538 77 110463677
Atrial fibrillation 23.12 10.46 159 125386 229483 110234271
Heart rate decreased 23.04 10.46 167 125378 82589 110381165
Dystonia 22.96 10.46 73 125472 25732 110438022
Pneumonitis 22.93 10.46 32 125513 76499 110387255
Dizziness 22.92 10.46 990 124555 697203 109766551
Electrocardiogram PR prolongation 22.83 10.46 18 125527 1825 110461929
Intentional product misuse 22.78 10.46 241 125304 132663 110331091
Liver function test increased 22.77 10.46 41 125504 88507 110375247
Pregnancy 22.70 10.46 15 125530 51052 110412702
Obsessive-compulsive disorder 22.50 10.46 34 125511 7207 110456547
Laryngitis 22.44 10.46 10 125535 42401 110421353
Renal impairment 22.34 10.46 124 125421 188321 110275433
Therapeutic product effective for unapproved indication 22.32 10.46 8 125537 155 110463599
Blood pressure systolic decreased 22.27 10.46 48 125497 13393 110450361
Hypertensive emergency 22.19 10.46 23 125522 3328 110460426
Hyperprolactinaemia 22.05 10.46 32 125513 6543 110457211
Affective disorder 22.00 10.46 43 125502 11198 110452556
Adrenal suppression 21.95 10.46 17 125528 1679 110462075
Sexually inappropriate behaviour 21.85 10.46 12 125533 659 110463095
Otitis media 21.68 10.46 34 125511 7442 110456312
Abdominal pain upper 21.62 10.46 273 125272 348838 110114916
Coeliac disease 21.59 10.46 11 125534 43176 110420578
Gastroenteritis eosinophilic 21.59 10.46 10 125535 381 110463373
Blood growth hormone increased 21.46 10.46 14 125531 1054 110462700
Drooling 21.44 10.46 33 125512 7106 110456648
Prostate cancer 21.33 10.46 8 125537 37633 110426121
Blood lactic acid increased 21.25 10.46 52 125493 15769 110447985
Hypothermia 21.24 10.46 72 125473 26230 110437524
Psychotic symptom 21.16 10.46 24 125521 3843 110459911
Facial paralysis 21.09 10.46 68 125477 24146 110439608
Distractibility 21.07 10.46 13 125532 888 110462866
Breast cancer stage II 21.07 10.46 3 125542 27372 110436382
Bronchitis 21.07 10.46 99 125446 156933 110306821
Therapeutic product effect incomplete 21.06 10.46 158 125387 223647 110240107
Pleural effusion 21.03 10.46 117 125428 177592 110286162
Thrombosis 20.86 10.46 59 125486 108603 110355151
Erectile dysfunction 20.81 10.46 57 125488 18499 110445255
Haemodynamic instability 20.59 10.46 65 125480 22823 110440931
Gross motor delay 20.53 10.46 8 125537 197 110463557
Vasoplegia syndrome 20.51 10.46 28 125517 5411 110458343
Self-injurious ideation 20.51 10.46 25 125520 4321 110459433
Full blood count abnormal 20.49 10.46 20 125525 56032 110407722
Hyperkalaemia 20.43 10.46 240 125305 135556 110328198
Viral diarrhoea 20.39 10.46 11 125534 583 110463171
Portal vein thrombosis 20.33 10.46 32 125513 7026 110456728
Respiratory acidosis 20.25 10.46 47 125498 13779 110449975
Drug titration error 20.22 10.46 16 125529 1631 110462123
Dysarthria 20.20 10.46 164 125381 83957 110379797
Portal hypertensive gastropathy 20.19 10.46 17 125528 1891 110461863
Negative cardiac inotropic effect 20.15 10.46 5 125540 24 110463730
Osteoporosis 20.12 10.46 43 125502 87109 110376645
Nodal rhythm 20.03 10.46 22 125523 3401 110460353
Incorrect route of product administration 19.99 10.46 26 125519 64035 110399719
Exposure via transplant 19.98 10.46 5 125540 25 110463729
Inflammation 19.85 10.46 133 125412 193105 110270649
Cerebral disorder 19.73 10.46 31 125514 6795 110456959
Drug withdrawal syndrome neonatal 19.60 10.46 9 125536 336 110463418
Vertigo 19.60 10.46 167 125378 86703 110377051
Oesophageal obstruction 19.54 10.46 14 125531 1229 110462525
Gait inability 19.48 10.46 84 125461 136292 110327462
Neoplasm skin 19.46 10.46 21 125524 3183 110460571
Porphyrins urine increased 19.36 10.46 5 125540 29 110463725
Cholestasis of pregnancy 19.32 10.46 14 125531 1251 110462503
Death 19.16 10.46 626 124919 698243 109765511
Hyperammonaemic encephalopathy 19.03 10.46 27 125518 5407 110458347
Teratogenicity 19.03 10.46 8 125537 241 110463513
Piloerection 18.97 10.46 12 125533 857 110462897
Hepatitis C RNA positive 18.93 10.46 8 125537 244 110463510
Mood swings 18.91 10.46 63 125482 22749 110441005
Breath holding 18.70 10.46 7 125538 154 110463600
Bronchiectasis 18.69 10.46 9 125536 36484 110427270
Upper respiratory tract infection 18.69 10.46 81 125464 131247 110332507
Pruritus 18.65 10.46 510 125035 581050 109882704
Decreased appetite 18.61 10.46 405 125140 475441 109988313
Sleep disorder due to a general medical condition 18.59 10.46 19 125526 52093 110411661
Bacterial infection 18.54 10.46 15 125530 46021 110417733
Muscle contractions involuntary 18.48 10.46 24 125521 4420 110459334
Thyrotoxic cardiomyopathy 18.42 10.46 4 125541 9 110463745
Dry mouth 18.41 10.46 142 125403 199806 110263948
Needle issue 18.24 10.46 53 125492 17787 110445967
Rhinorrhoea 18.09 10.46 58 125487 102608 110361146
Feeling guilty 18.04 10.46 12 125533 934 110462820
Drug dispensed to wrong patient 18.01 10.46 11 125534 738 110463016
Colitis ulcerative 18 10.46 38 125507 77325 110386429
Psychomotor retardation 17.99 10.46 32 125513 7760 110455994
Septic shock 17.94 10.46 105 125440 157423 110306331
Calcitonin secretion disorder 17.86 10.46 5 125540 41 110463713
Sleep disorder 17.86 10.46 142 125403 198502 110265252
Pneumonia bacterial 17.78 10.46 4 125541 26257 110437497
Porphyrins stool increased 17.55 10.46 5 125540 44 110463710
Myelocytosis 17.50 10.46 7 125538 185 110463569
Thinking abnormal 17.47 10.46 47 125498 15093 110448661
Skin ulcer 17.46 10.46 128 125417 63517 110400237
Persecutory delusion 17.40 10.46 28 125517 6263 110457491
Status migrainosus 17.36 10.46 6 125539 104 110463650
Blood pressure diastolic abnormal 17.34 10.46 4 125541 25811 110437943
Ear pain 17.24 10.46 21 125524 53205 110410549
Acute myeloid leukaemia 17.20 10.46 11 125534 38099 110425655
Oral discomfort 17.17 10.46 39 125506 11272 110452482
Congenital nystagmus 17.15 10.46 6 125539 108 110463646
Disease recurrence 17.11 10.46 123 125422 60661 110403093
Atrioventricular septal defect 17.10 10.46 6 125539 109 110463645
Hepatic failure 17.04 10.46 135 125410 68604 110395150
Foot deformity 16.93 10.46 18 125527 48462 110415292
Migraine without aura 16.90 10.46 10 125535 633 110463121
Yellow skin 16.82 10.46 22 125523 4080 110459674
Basedow's disease 16.74 10.46 7 125538 208 110463546
Alcohol use 16.73 10.46 22 125523 4100 110459654
Drug level increased 16.73 10.46 102 125443 47617 110416137
Bundle branch block bilateral 16.70 10.46 6 125539 117 110463637
White blood cell count decreased 16.69 10.46 173 125372 229217 110234537
Abnormal behaviour 16.69 10.46 88 125457 38951 110424803
Drug eruption 16.53 10.46 111 125434 53548 110410206
Back pain 16.52 10.46 309 125236 370687 110093067
Syncope 16.41 10.46 322 125223 202214 110261540
Pupil fixed 16.39 10.46 21 125524 3817 110459937
Apathy 16.37 10.46 48 125497 16191 110447563
Lung neoplasm malignant 16.36 10.46 9 125536 33833 110429921
Cutaneous lupus erythematosus 16.35 10.46 20 125525 3468 110460286
Antithyroid arthritis syndrome 16.33 10.46 4 125541 18 110463736
Hypnagogic hallucination 16.31 10.46 7 125538 222 110463532
Ulcer 16.30 10.46 94 125451 43022 110420732
Mycobacterium ulcerans infection 16.29 10.46 6 125539 126 110463628
Impulse-control disorder 16.25 10.46 16 125529 2178 110461576
Poor quality sleep 16.17 10.46 69 125476 28008 110435746
Communication disorder 16.14 10.46 24 125521 5015 110458739
Cytopenia 16.09 10.46 7 125538 30109 110433645
Wrong strength 16.08 10.46 7 125538 230 110463524
Cerebellar syndrome 16.02 10.46 27 125518 6275 110457479
Blood pressure systolic increased 15.97 10.46 45 125500 82946 110380808
Agoraphobia 15.91 10.46 10 125535 706 110463048
Blood creatinine increased 15.86 10.46 132 125413 182757 110280997
Underdose 15.83 10.46 30 125515 63524 110400230
Sputum discoloured 15.74 10.46 6 125539 27939 110435815
Nervousness 15.71 10.46 83 125462 36768 110426986
Ventricular failure 15.59 10.46 9 125536 544 110463210
Insulin autoimmune syndrome 15.58 10.46 10 125535 732 110463022
Multiple lentigines syndrome 15.56 10.46 7 125538 249 110463505
Parkinsonian rest tremor 15.41 10.46 8 125537 392 110463362
Acute stress disorder 15.38 10.46 9 125536 558 110463196
Aspergillus infection 15.28 10.46 5 125540 25611 110438143
Meconium in amniotic fluid 15.24 10.46 6 125539 152 110463602
Thrombotic microangiopathy 15.22 10.46 7 125538 29142 110434612
Pulmonary mass 15.22 10.46 12 125533 37289 110426465
Exposure via ingestion 15.21 10.46 23 125522 4877 110458877
Oral candidiasis 15.20 10.46 17 125528 44743 110419011
Panic reaction 15.15 10.46 24 125521 5298 110458456
Transfusion 15.14 10.46 5 125540 25467 110438287
Cytomegalovirus infection 15.11 10.46 24 125521 54420 110409334
Amaurosis fugax 15.11 10.46 16 125529 2374 110461380
End stage renal disease 15.09 10.46 3 125542 21470 110442284
Jaundice 15.05 10.46 117 125428 59119 110404635
Anhedonia 14.98 10.46 45 125500 15383 110448371
Cataract subcapsular 14.95 10.46 12 125533 1249 110462505
Perseveration 14.91 10.46 8 125537 419 110463335
Joint stiffness 14.85 10.46 34 125511 67209 110396545
Blood test abnormal 14.69 10.46 7 125538 28547 110435207
Ischaemic hepatitis 14.69 10.46 22 125523 4626 110459128
Multiple sclerosis 14.68 10.46 63 125482 25635 110438119
Bone marrow failure 14.68 10.46 27 125518 57821 110405933
Electrocardiogram T wave amplitude increased 14.61 10.46 5 125540 84 110463670
Oesophageal variceal ligation 14.58 10.46 6 125539 171 110463583
Narrow anterior chamber angle 14.55 10.46 6 125539 172 110463582
Chromaturia 14.54 10.46 69 125476 29291 110434463
Apraxia 14.54 10.46 19 125526 3521 110460233
Joint effusion 14.53 10.46 3 125542 20902 110442852
Thyroid stimulating immunoglobulin increased 14.52 10.46 6 125539 173 110463581
Bacteraemia 14.51 10.46 16 125529 42374 110421380
Hypoglycaemic coma 14.45 10.46 24 125521 5509 110458245
Hypotonia 14.43 10.46 45 125500 15700 110448054
Hyperthermia 14.42 10.46 55 125490 21217 110442537
Tachycardia 14.42 10.46 348 125197 226297 110237457
Unmasking of previously unidentified disease 14.35 10.46 17 125528 2851 110460903
Transplant rejection 14.30 10.46 5 125540 24562 110439192
Pituitary apoplexy 14.18 10.46 7 125538 308 110463446
Myelodysplastic syndrome 14.14 10.46 13 125532 37471 110426283
Deafness 14.14 10.46 64 125481 26645 110437109
Pancytopenia 14.08 10.46 161 125384 209452 110254302
Abnormal dreams 14.08 10.46 39 125506 12741 110451013
Right aortic arch 14.06 10.46 3 125542 6 110463748
Aplastic anaemia 14.06 10.46 5 125540 24303 110439451
Dysphemia 14.05 10.46 20 125525 4017 110459737
Renal pain 13.97 10.46 33 125512 9784 110453970
Hyperacusis 13.96 10.46 17 125528 2935 110460819
Hunger 13.83 10.46 26 125519 6578 110457176
Craniofacial fracture 13.82 10.46 10 125535 891 110462863
Breath odour 13.79 10.46 14 125531 1978 110461776
Cognitive disorder 13.75 10.46 156 125389 87355 110376399
Oxygen saturation decreased 13.75 10.46 113 125432 156869 110306885
Abdominal cavity drainage 13.72 10.46 10 125535 901 110462853
Ischaemic stroke 13.71 10.46 87 125458 41176 110422578
Hypovolaemic shock 13.66 10.46 42 125503 14541 110449213
Sleep paralysis 13.66 10.46 10 125535 908 110462846
Road traffic accident 13.65 10.46 69 125476 107329 110356425
Palmar erythema 13.63 10.46 15 125530 2323 110461431
Feeling abnormal 13.54 10.46 284 125261 180427 110283327
Pharyngeal swelling 13.53 10.46 37 125508 11995 110451759
Accidental overdose 13.52 10.46 103 125442 51731 110412023
Foetal growth restriction 13.51 10.46 17 125528 3033 110460721
Sudden infant death syndrome 13.50 10.46 7 125538 342 110463412
Bleeding varicose vein 13.49 10.46 9 125536 704 110463050
Pseudohallucination 13.46 10.46 6 125539 209 110463545
Product quality issue 13.39 10.46 44 125501 77255 110386499
Sinoatrial block 13.38 10.46 12 125533 1453 110462301
Laryngeal dyspnoea 13.37 10.46 7 125538 349 110463405
Relapsing multiple sclerosis 13.35 10.46 6 125539 213 110463541
Blood thyroid stimulating hormone decreased 13.34 10.46 27 125518 7212 110456542
Eosinophilic myocarditis 13.25 10.46 14 125531 2071 110461683
Gastrointestinal motility disorder 13.24 10.46 27 125518 7249 110456505
Hallucinations, mixed 13.23 10.46 30 125515 8663 110455091
Blood uric acid increased 13.20 10.46 4 125541 21525 110442229
Tubulointerstitial nephritis 13.19 10.46 26 125519 54258 110409496
Strabismus 13.17 10.46 18 125527 3481 110460273
Chronic sinusitis 13.13 10.46 6 125539 25078 110438676
Cerebral vasoconstriction 13.13 10.46 12 125533 1489 110462265
Malaise 13.13 10.46 626 124919 671193 109792561
Chest pain 13.12 10.46 326 125219 376049 110087705
Chemical burn 13.10 10.46 9 125536 739 110463015
Muscle rigidity 13.03 10.46 58 125487 23973 110439781
Muscular weakness 12.99 10.46 201 125344 248267 110215487
Vitamin D abnormal 12.97 10.46 6 125539 228 110463526
Retroperitoneal fibrosis 12.97 10.46 9 125536 751 110463003
Peritoneal fibrosis 12.96 10.46 3 125542 10 110463744
Hypoperfusion 12.95 10.46 17 125528 3164 110460590
Respiratory tract infection 12.94 10.46 40 125505 71577 110392177
Blood pressure systolic abnormal 12.93 10.46 6 125539 24844 110438910
Acute encephalitis with refractory, repetitive partial seizures 12.92 10.46 4 125541 48 110463706
Heart rate variability increased 12.92 10.46 4 125541 48 110463706
Patient dissatisfaction with treatment 12.92 10.46 7 125538 374 110463380
Muscle spasms 12.91 10.46 230 125315 277927 110185827
Urine odour abnormal 12.89 10.46 27 125518 7388 110456366
Mania 12.67 10.46 52 125493 20744 110443010
Delusion 12.63 10.46 57 125488 23698 110440056
Hypervolaemia 12.63 10.46 23 125522 49437 110414317
Red blood cell sedimentation rate abnormal 12.62 10.46 6 125539 24503 110439251
Lipoedema 12.61 10.46 6 125539 243 110463511
Psychomotor hyperactivity 12.59 10.46 51 125494 20226 110443528
Gynaecomastia 12.54 10.46 31 125514 9459 110454295
Hypoaesthesia eye 12.52 10.46 7 125538 398 110463356
Pseudoporphyria 12.52 10.46 9 125536 794 110462960
Tinea versicolour 12.51 10.46 8 125537 582 110463172
Anaemia 12.49 10.46 501 125044 546585 109917169
Paraganglion neoplasm 12.49 10.46 4 125541 54 110463700
Ulcer haemorrhage 12.46 10.46 5 125540 22566 110441188
Stroke in evolution 12.44 10.46 5 125540 134 110463620
Right ventricular failure 12.41 10.46 7 125538 25947 110437807
Enuresis 12.40 10.46 19 125526 4077 110459677
Ischaemic cerebral infarction 12.39 10.46 16 125529 2929 110460825
Arrhythmia 12.31 10.46 127 125418 69448 110394306
Withdrawal hypertension 12.24 10.46 7 125538 416 110463338
Tri-iodothyronine free increased 12.24 10.46 6 125539 260 110463494
Bradypnoea 12.23 10.46 29 125516 8620 110455134
Differential white blood cell count abnormal 12.20 10.46 14 125531 2270 110461484
Monocyte count abnormal 12.15 10.46 6 125539 264 110463490
International normalised ratio increased 12.05 10.46 54 125491 86718 110377036
Amenorrhoea 12.04 10.46 30 125515 9201 110454553
Aspiration of gastric residual 11.99 10.46 3 125542 15 110463739
Food craving 11.94 10.46 13 125532 1990 110461764
Diabetic retinal oedema 11.92 10.46 7 125538 437 110463317
Diverticulitis 11.87 10.46 27 125518 53495 110410259
Hypogammaglobulinaemia 11.83 10.46 4 125541 20072 110443682
Genotype drug resistance test positive 11.83 10.46 11 125534 1395 110462359
Basilar migraine 11.81 10.46 4 125541 65 110463689
Gastric varices 11.79 10.46 9 125536 870 110462884
Cardiotoxicity 11.74 10.46 44 125501 16837 110446917
Neoplasm progression 11.72 10.46 36 125509 64559 110399195
Drug tolerance decreased 11.72 10.46 62 125483 27478 110436276
Therapy non-responder 11.70 10.46 118 125427 157189 110306565
Bronchopulmonary aspergillosis 11.70 10.46 10 125535 29853 110433901
Metastases to bone 11.69 10.46 11 125534 31361 110432393
Fall 11.67 10.46 815 124730 602667 109861087
Shunt occlusion 11.64 10.46 12 125533 1725 110462029
Myocardial infarction 11.59 10.46 151 125394 191932 110271822
Trigeminal neuralgia 11.53 10.46 19 125526 4333 110459421
Sexually transmitted disease 11.47 10.46 5 125540 165 110463589
Electrocardiogram T wave inversion 11.45 10.46 22 125523 5658 110458096
Developmental delay 11.45 10.46 11 125534 1454 110462300
Treatment noncompliance 11.42 10.46 130 125415 72860 110390894
Sluggishness 11.39 10.46 26 125519 7541 110456213
Diplopia 11.35 10.46 84 125461 41810 110421944
Alveolar bone resorption 11.33 10.46 4 125541 74 110463680
Procedural hypotension 11.16 10.46 14 125531 2491 110461263
Photosensitivity reaction 11.16 10.46 58 125487 25531 110438223
Bundle branch block right 11.14 10.46 35 125510 12256 110451498
Respiratory rate decreased 11.13 10.46 23 125522 6235 110457519
Thyroid cancer metastatic 11.11 10.46 5 125540 178 110463576
Infrequent bowel movements 11.06 10.46 13 125532 2162 110461592
Depersonalisation/derealisation disorder 11.04 10.46 13 125532 2168 110461586
Cellulitis 10.90 10.46 91 125454 125925 110337829
Hyponatraemic seizure 10.88 10.46 8 125537 731 110463023
Fatigue 10.83 10.46 1212 124333 1214746 109249008
Blood pressure diastolic decreased 10.75 10.46 15 125530 35870 110427884
COVID-19 pneumonia 10.66 10.46 16 125529 37127 110426627
Fluid retention 10.66 10.46 63 125482 94244 110369510
Proctitis 10.65 10.46 3 125542 16924 110446830
Hyponatraemia 10.65 10.46 323 125222 217330 110246424
Stereotypy 10.64 10.46 9 125536 1008 110462746
Nausea 10.64 10.46 1578 123967 1234112 109229642
Porphyria acute 10.63 10.46 4 125541 18776 110444978
Restlessness 10.58 10.46 104 125441 56155 110407599
Drug hypersensitivity 10.54 10.46 415 125130 453675 110010079
Urine leukocyte esterase 10.50 10.46 5 125540 203 110463551
Dyspnoea exertional 10.49 10.46 72 125473 103988 110359766

FDA Adverse Event Reporting System (Pediatric)

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
Product administered to patient of inappropriate age 89.05 39.54 30 427 119 113377
Product use in unapproved indication 77.71 39.54 24 433 66 113430
Treatment failure 60.28 39.54 24 433 165 113331
Off label use 55.85 39.54 45 412 1362 112134

Pharmacologic Action:

SourceCodeDescription
ATC C07AA05 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS
Beta blocking agents, non-selective
ATC C07BA05 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS AND THIAZIDES
Beta blocking agents, non-selective, and thiazides
ATC C07FX01 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
FDA MoA N0000000161 Adrenergic beta-Antagonists
FDA EPC N0000175556 beta-Adrenergic Blocker
MeSH PA D000319 Adrenergic beta-Antagonists
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D018674 Adrenergic Antagonists
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35530 ฮฒ-adrenergic antagonist
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:66980 nootropic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76916 hyperglycemic agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:85234 human blood serum metabolite
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

C07AA Beta blocking agents, non-selective 13 drugs
alprenololbopindololbupranololcarteololcloranololmepindololnadololoxprenololpenbutololpindololsotaloltertatolol show all 13 →
C07BA Beta blocking agents, non-selective, and thiazides 5 drugs
metipranololnadololoxprenololsotaloltimolol
C07FX Beta blocking agents, other combinations 6 drugs
acetylsalicylic acidbisoprololcarvedilolivabradinemetoprololsotalol

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

DiseaseRelationSNOMED_IDDOID
Supraventricular tachycardia indication 6456007
Hypertensive disorder indication 38341003 DOID:10763
Atrial fibrillation indication 49436004 DOID:0060224
Angina pectoris indication 194828000
Hypertrophic cardiomyopathy indication 233873004 DOID:11984
Idiopathic hypertrophic subaortic stenosis indication 360465008
Hemangioma indication 400210000 DOID:255
Essential tremor indication 609558009 DOID:4990
Life-Threatening Ventricular Tachycardia indication
Ulcerated haemangioma indication
Proliferating infantile haemangioma requiring systemic therapy indication
Life or functionthreatening haemangioma indication
Haemangioma with a risk of permanent scars or disfigurement indication
Arrhythmias During Surgery indication
Pheochromocytoma Adjunct Therapy indication
Migraine Prevention indication
Myocardial Reinfarction Prevention indication
Thyrotoxicosis off-label use 90739004 DOID:7997
Mitral valve prolapse off-label use 409712001
Prevention of Congenital Long QT Syndrome associated Ventricular Arrhythmia off-label use
Prevention of Post Cardio-Thoracic Surgery Atrial Fibrillation off-label use
Prevention of Bleeding Esophageal Varices off-label use
Anuria contraindication 2472002 DOID:2983
Bronchospasm contraindication 4386001
Hypercholesterolemia contraindication 13644009
Secondary angle-closure glaucoma contraindication 21571006
Complete atrioventricular block contraindication 27885002
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Hyperuricemia contraindication 35885006 DOID:1920
Sick sinus syndrome contraindication 36083008 DOID:13884
Hypokalemia contraindication 43339004
Sinus bradycardia contraindication 49710005
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Chronic bronchitis contraindication 63480004 DOID:6132
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Pulmonary emphysema contraindication 87433001
Cardiogenic shock contraindication 89138009
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Disorder of muscle contraindication 129565002 DOID:423
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Raynaud's phenomenon contraindication 266261006
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
Azotemia contraindication 445009001
Smokes tobacco daily contraindication 449868002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.19 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
4.28MG/ML HEMANGEOL ETON N205410 March 14, 2014 RX SOLUTION ORAL 8338489 Oct. 16, 2028 METHOD TO TREAT HEMANGIOMA.
4.28MG/ML HEMANGEOL ETON N205410 March 14, 2014 RX SOLUTION ORAL 8987262 Oct. 16, 2028 METHOD TO TREAT INFANTILE HEMANGIOMA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 8.71 WOMBAT-PK DRUG LABEL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 8.25 WOMBAT-PK DRUG LABEL
Sodium-dependent serotonin transporter Transporter Ki 6.70 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 6.91 PDSP
5-hydroxytryptamine receptor 2A GPCR Ki 5.38 PDSP
5-hydroxytryptamine receptor 2B GPCR Ki 6.66 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.92 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.85 DRUG MATRIX
Histamine H1 receptor GPCR Ki 4.70 WOMBAT-PK
Beta-3 adrenergic receptor GPCR ANTAGONIST Ki 6.22 WOMBAT-PK
5-hydroxytryptamine receptor 1B GPCR Ki 6.20 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 5.35 PDSP
Cytochrome P450 2D6 Enzyme IC50 5.70 DRUG MATRIX
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel Ki 4.32 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 5.40 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.20 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.92 DRUG MATRIX
Nuclear receptor subfamily 2 group E member 1 Nuclear hormone receptor Kd 6.30 CHEMBL
Transmembrane protein 97 Enzyme Ki 6.45 CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 4.30 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 4.32 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 7.30 CHEMBL
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.67 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 4.89 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 7.05 CHEMBL
Beta-2 adrenergic receptor GPCR Kd 9.01 CHEMBL
Beta-2 adrenergic receptor GPCR Kd 9.05 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 8.52 CHEMBL
Beta-2 adrenergic receptor GPCR IC50 7.77 CHEMBL
Beta-1 adrenergic receptor GPCR Kd 8.76 CHEMBL
Adrenergic receptor beta GPCR Ki 8.62 CHEMBL
Beta-3 adrenergic receptor GPCR ANTAGONIST Ki 6.60 IUPHAR
Beta-1 adrenergic receptor GPCR Ki 8.62 CHEMBL

External reference:

IDSource
4019916 VUID
N0000148001 NUI
D00483 KEGG_DRUG
318-98-9 SECONDARY_CAS_RN
4017831 VANDF
4019916 VANDF
C0033497 UMLSCUI
CHEBI:8499 CHEBI
CHEMBL27 ChEMBL_ID
CHEMBL1671 ChEMBL_ID
DB00571 DRUGBANK_ID
D011433 MESH_DESCRIPTOR_UI
4946 PUBCHEM_CID
564 IUPHAR_LIGAND_ID
1940 INN_ID
9Y8NXQ24VQ UNII
82084 RXNORM
2240 MMSL
5375 MMSL
d00032 MMSL
001850 NDDF
004740 NDDF
372772003 SNOMEDCT_US
55745002 SNOMEDCT_US
65088001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3727 SOLUTION 20 mg ORAL ANDA 11 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-3730 SOLUTION 40 mg ORAL ANDA 11 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1693 TABLET 60 mg ORAL ANDA 19 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-0908 SOLUTION 20 mg ORAL ANDA 11 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9872 INJECTION 1 mg INTRAVENOUS ANDA 23 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2778 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 19 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2779 CAPSULE, EXTENDED RELEASE 80 mg ORAL ANDA 19 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2780 CAPSULE, EXTENDED RELEASE 120 mg ORAL ANDA 19 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2781 CAPSULE, EXTENDED RELEASE 160 mg ORAL ANDA 19 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-0182 TABLET 10 mg ORAL ANDA 21 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-0183 TABLET 20 mg ORAL ANDA 21 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-0184 TABLET 40 mg ORAL ANDA 21 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-0185 TABLET 80 mg ORAL ANDA 21 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-0187 TABLET 60 mg ORAL ANDA 21 sections
PROPRANOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0404-9999 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 12 sections
PROPRANOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0404-9999 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 12 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4116 CAPSULE, EXTENDED RELEASE 60 mg ORAL ANDA 23 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4117 CAPSULE, EXTENDED RELEASE 80 mg ORAL ANDA 23 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4118 CAPSULE, EXTENDED RELEASE 120 mg ORAL ANDA 23 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-4119 CAPSULE, EXTENDED RELEASE 160 mg ORAL ANDA 23 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-5482 TABLET 10 mg ORAL ANDA 26 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-5483 TABLET 20 mg ORAL ANDA 26 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-5484 TABLET 40 mg ORAL ANDA 26 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-5485 TABLET 60 mg ORAL ANDA 26 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-5486 TABLET 80 mg ORAL ANDA 26 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8413 TABLET 40 mg ORAL ANDA 18 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8417 TABLET 10 mg ORAL ANDA 18 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8426 TABLET 20 mg ORAL ANDA 18 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7467 TABLET 10 mg ORAL ANDA 18 sections
Propranolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7468 TABLET 20 mg ORAL ANDA 18 sections