ascorbic acid ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4072 50-81-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vitamin c
  • L-Ascorbic acid
  • ascorbic acid
  • ascorbic acid (vit C)
  • sodium ascorbate
  • calcium ascorbate
  • ascorbic acid, monosodium salt
A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant. NIH COVID-19 Treatment Guidelines Panel states that there are insufficient data to recommend either for or against use of ascorbic acid for the treatment of COVID-19 in critically or noncritically ill patients.
  • Molecular weight: 176.12
  • Formula: C6H8O6
  • CLOGP: -1.76
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 107.22
  • ALOGS: 0.14
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P
0.25 g V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 333 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 567.77 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.35 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.05 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.26 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
None FDA

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
Pemphigus 1329.84 10.37 3882 529823 153330 55605032
Rheumatoid arthritis 1249.15 10.37 7014 526691 375590 55382772
Systemic lupus erythematosus 1217.80 10.37 4115 529590 175963 55582399
Glossodynia 1100.23 10.37 3562 530143 148896 55609466
Completed suicide 971.86 10.37 79 533626 133754 55624608
Hand deformity 874.90 10.37 3035 530670 131457 55626905
Arthropathy 848.31 10.37 3953 529752 196322 55562040
Abdominal discomfort 816.51 10.37 4950 528755 272324 55486038
Alopecia 791.89 10.37 5123 528582 288335 55470027
Toxicity to various agents 771.38 10.37 600 533105 223964 55534398
Wound 716.84 10.37 2909 530796 135895 55622467
Maternal exposure during pregnancy 654.42 10.37 3532 530173 186021 55572341
Pain 645.31 10.37 9322 524383 653862 55104500
Joint swelling 624.95 10.37 4792 528913 285008 55473354
Contraindicated product administered 557.88 10.37 3342 530363 182944 55575418
Pericarditis 555.95 10.37 2275 531430 106648 55651714
Synovitis 545.29 10.37 2989 530716 158316 55600046
Anti-cyclic citrullinated peptide antibody positive 540.58 10.37 2106 531599 96494 55661868
Death 538.74 10.37 1563 532142 339863 55418499
Infusion related reaction 535.17 10.37 3602 530103 205329 55553033
Discomfort 528.52 10.37 2699 531006 139062 55619300
Swelling 509.95 10.37 3953 529752 235818 55522544
Drug interaction 488.53 10.37 771 532934 208984 55549378
Drug abuse 439.21 10.37 60 533645 67550 55690812
Intentional overdose 407.50 10.37 76 533629 68041 55690321
Hepatic enzyme increased 347.71 10.37 2796 530909 168588 55589774
Product use issue 334.44 10.37 2954 530751 183087 55575275
Duodenal ulcer perforation 328.61 10.37 1402 532303 66940 55691422
Helicobacter infection 320.40 10.37 1461 532244 71807 55686555
Rheumatoid factor positive 316.19 10.37 1396 532309 67664 55690698
Arthralgia 293.13 10.37 6512 527193 495157 55263205
Suicide attempt 283.51 10.37 97 533608 57739 55700623
Febrile neutropenia 272.00 10.37 361 533344 105184 55653178
Acute kidney injury 269.00 10.37 1270 532435 239493 55518869
Cardiac arrest 253.70 10.37 266 533439 86048 55672314
Overdose 229.47 10.37 407 533298 105423 55652939
Therapeutic product effect decreased 209.25 10.37 2492 531213 166960 55591402
Nasopharyngitis 205.63 10.37 3087 530618 217872 55540490
Neutropenia 203.10 10.37 791 532914 157376 55600986
Hip arthroplasty 196.26 10.37 806 532899 37817 55720545
Hypersensitivity 193.26 10.37 3460 530245 252948 55505414
Musculoskeletal stiffness 192.92 10.37 2295 531410 153712 55604650
Lower respiratory tract infection 192.43 10.37 1796 531909 112998 55645364
Malignant neoplasm progression 185.20 10.37 256 533449 73331 55685031
Knee arthroplasty 184.90 10.37 871 532834 43388 55714974
Exposure during pregnancy 182.10 10.37 2036 531669 134306 55624056
Cardiac failure 181.32 10.37 312 533393 81781 55676581
Fatigue 179.68 10.37 9161 524544 779391 54978971
Psoriatic arthropathy 177.82 10.37 1257 532448 72751 55685611
Electrocardiogram QT prolonged 177.00 10.37 154 533551 54434 55703928
Drug intolerance 173.31 10.37 3497 530208 261321 55497041
Sinusitis 171.37 10.37 2728 530977 194853 55563509
Device expulsion 169.69 10.37 40 533665 30409 55727953
Impaired healing 165.79 10.37 1398 532307 85443 55672919
Lactic acidosis 161.95 10.37 66 533639 35280 55723082
Disease progression 158.54 10.37 491 533214 104682 55653680
Treatment failure 157.04 10.37 2377 531328 168015 55590347
Hyponatraemia 156.69 10.37 473 533232 101666 55656696
Nausea 147.04 10.37 5844 527861 758334 55000028
Drug reaction with eosinophilia and systemic symptoms 144.78 10.37 53 533652 30251 55728111
Bradycardia 141.47 10.37 265 533440 67239 55691123
Depressed level of consciousness 136.38 10.37 202 533503 56231 55702131
Renal failure 135.86 10.37 562 533143 109938 55648424
Rheumatic fever 134.35 10.37 586 533119 28241 55730121
Rash 132.45 10.37 5825 527880 487222 55271140
Hypotension 132.36 10.37 1629 532076 248879 55509483
Intentional self-injury 131.28 10.37 37 533668 24955 55733407
Sopor 130.23 10.37 21 533684 20901 55737461
Peripheral swelling 130.20 10.37 3027 530678 231699 55526663
Rhabdomyolysis 129.05 10.37 117 533588 40541 55717821
Respiratory arrest 128.12 10.37 65 533640 30560 55727802
Red blood cell sedimentation rate abnormal 127.80 10.37 429 533276 18244 55740118
Muscle injury 125.09 10.37 890 532815 51610 55706752
Folliculitis 123.52 10.37 919 532786 54060 55704302
Swollen joint count increased 123.10 10.37 505 533200 23679 55734683
Drug hypersensitivity 122.92 10.37 1852 531853 273353 55485009
Cardio-respiratory arrest 117.85 10.37 215 533490 55106 55703256
Agitation 114.78 10.37 223 533482 55813 55702549
Blister 113.36 10.37 1552 532153 107335 55651027
Sleep disorder due to general medical condition, insomnia type 112.31 10.37 750 532955 42588 55715774
Dyspnoea 109.76 10.37 4550 529155 588027 55170335
Drug dependence 108.34 10.37 39 533666 22494 55735868
Sickle cell anaemia with crisis 108.18 10.37 181 533524 4847 55753515
Hypoglycaemia 107.62 10.37 230 533475 55585 55702777
Syncope 107.46 10.37 594 533111 107605 55650757
Tachycardia 106.93 10.37 578 533127 105298 55653064
Renal impairment 105.88 10.37 400 533305 80313 55678049
Metabolic acidosis 105.56 10.37 137 533568 40317 55718045
Tremor 105.42 10.37 693 533012 120396 55637966
Immunodeficiency 104.27 10.37 364 533341 15793 55742569
Somnolence 101.54 10.37 1024 532681 162389 55595973
Seizure 101.54 10.37 731 532974 124388 55633974
Irritable bowel syndrome 100.94 10.37 1043 532662 67415 55690947
Hepatic failure 100.85 10.37 101 533604 33385 55724977
Thrombocytopenia 99.23 10.37 820 532885 135404 55622958
Osteoarthritis 97.72 10.37 1178 532527 79118 55679244
Serotonin syndrome 96.98 10.37 66 533639 26424 55731938
C-reactive protein abnormal 95.97 10.37 638 533067 36171 55722191
Anaemia 92.86 10.37 1883 531822 265628 55492734
Pregnancy 92.53 10.37 583 533122 32450 55725912
Anxiety 92.47 10.37 1282 532423 191890 55566472
Drug resistance 89.90 10.37 41 533664 20501 55737861
Respiratory failure 88.43 10.37 533 533172 94529 55663833
Multiple organ dysfunction syndrome 87.05 10.37 236 533469 52534 55705828
Arthritis 86.94 10.37 1380 532325 98472 55659890
Night sweats 84.27 10.37 674 533031 40539 55717823
Hypoxia 82.34 10.37 250 533455 53647 55704715
Hepatocellular injury 80.96 10.37 79 533626 26435 55731927
Pulmonary arterial hypertension 80.89 10.37 79 533626 26424 55731938
Cytomegalovirus infection 79.16 10.37 42 533663 19254 55739108
Cholestasis 78.98 10.37 83 533622 26830 55731532
Hepatic function abnormal 78.44 10.37 129 533576 34429 55723933
Drug withdrawal syndrome 76.72 10.37 79 533626 25778 55732584
Hyperkalaemia 76.23 10.37 238 533467 50627 55707735
Leukopenia 75.70 10.37 380 533325 70560 55687802
No adverse event 75.14 10.37 144 533561 36230 55722132
Temperature regulation disorder 74.57 10.37 144 533561 4324 55754038
Ear pain 74.35 10.37 525 533180 30365 55727997
Altered state of consciousness 73.35 10.37 66 533639 22955 55735407
Fibromyalgia 73.20 10.37 876 532829 58727 55699635
Coma 72.92 10.37 304 533401 59351 55699011
Diarrhoea 72.35 10.37 5147 528558 633360 55125002
Ill-defined disorder 72.13 10.37 979 532726 67564 55690798
Blood cholesterol increased 72.07 10.37 1026 532679 71553 55686809
Contusion 71.95 10.37 1659 532046 126771 55631591
Product quality issue 71.53 10.37 119 533586 31617 55726745
Hyperglycaemia 71.11 10.37 161 533544 38120 55720242
Muscle spasticity 70.74 10.37 375 533330 19585 55738777
Dizziness 70.73 10.37 2882 530823 373258 55385104
Encephalopathy 70.25 10.37 143 533562 35182 55723180
Vomiting 70.07 10.37 3937 529768 494291 55264071
Loss of consciousness 68.40 10.37 684 533021 108665 55649697
Anaphylactic reaction 67.63 10.37 308 533397 58687 55699675
Body temperature increased 67.30 10.37 555 533150 33687 55724675
Poisoning 67.24 10.37 19 533686 12794 55745568
Bursitis 67.10 10.37 470 533235 27112 55731250
Suicidal ideation 67.06 10.37 300 533405 57442 55700920
Hypokalaemia 66.70 10.37 573 533132 93864 55664498
Hallucination 66.13 10.37 241 533464 48908 55709454
Sedation 66.04 10.37 145 533560 34709 55723653
Angioedema 65.69 10.37 189 533516 41264 55717098
Metastases to bone 64.49 10.37 54 533651 19454 55738908
Ejection fraction decreased 64.27 10.37 56 533649 19785 55738577
Acute hepatic failure 63.83 10.37 39 533666 16539 55741823
Blood pressure fluctuation 63.37 10.37 623 533082 39737 55718625
Cardiac failure congestive 62.96 10.37 530 533175 87190 55671172
Neuropathy peripheral 62.95 10.37 647 533058 102246 55656116
Femur fracture 62.40 10.37 608 533097 38687 55719675
Schizophrenia 62.16 10.37 12 533693 10487 55747875
Live birth 61.90 10.37 357 533348 19248 55739114
Weight increased 61.66 10.37 2715 530990 226988 55531374
Myalgia 61.43 10.37 881 532824 131144 55627218
Palmar-plantar erythrodysaesthesia syndrome 60.66 10.37 66 533639 20999 55737363
Disorientation 60.19 10.37 164 533541 36449 55721913
Gamma-glutamyltransferase increased 58.74 10.37 129 533576 30876 55727486
Extrapyramidal disorder 58.36 10.37 22 533683 12334 55746028
Dehydration 58.36 10.37 1107 532598 157718 55600644
Osteoporosis 58.31 10.37 752 532953 51300 55707062
Hypothermia 57.58 10.37 23 533682 12447 55745915
Torsade de pointes 57.35 10.37 23 533682 12417 55745945
Shock 57.29 10.37 73 533632 21655 55736707
Abortion spontaneous 57.25 10.37 651 533054 43102 55715260
Mydriasis 57.02 10.37 17 533688 11054 55747308
Intentional product misuse 56.03 10.37 274 533431 51230 55707132
Diabetic ketoacidosis 55.59 10.37 58 533647 18813 55739549
Plasma cell myeloma 55.59 10.37 240 533465 46406 55711956
Joint effusion 54.93 10.37 283 533422 14615 55743747
Loss of personal independence in daily activities 54.90 10.37 1080 532625 80289 55678073
Intentional product use issue 54.82 10.37 1285 532420 98448 55659914
Drug level increased 54.26 10.37 70 533635 20655 55737707
Multiple sclerosis relapse 54.15 10.37 230 533475 44673 55713689
Neoplasm progression 53.69 10.37 142 533563 31874 55726488
Blood bilirubin increased 53.64 10.37 151 533554 33203 55725159
Abnormal behaviour 53.56 10.37 68 533637 20204 55738158
Metastases to liver 53.39 10.37 76 533629 21510 55736852
Foot deformity 53.35 10.37 398 533307 23427 55734935
Anaphylactic shock 53.32 10.37 77 533628 21663 55736699
Type 2 diabetes mellitus 52.48 10.37 677 533028 46185 55712177
Myocardial infarction 52.38 10.37 595 533110 92275 55666087
Blood creatine phosphokinase increased 52.37 10.37 117 533588 27835 55730527
Osteonecrosis of jaw 52.19 10.37 153 533552 33205 55725157
Condition aggravated 51.79 10.37 3867 529838 341031 55417331
Disseminated intravascular coagulation 51.54 10.37 56 533649 17829 55740533
Product use in unapproved indication 50.36 10.37 986 532719 139836 55618526
Disability assessment scale score increased 50.22 10.37 92 533613 2652 55755710
Mental status changes 49.71 10.37 185 533520 37316 55721046
Unresponsive to stimuli 49.28 10.37 146 533559 31579 55726783
Neuroleptic malignant syndrome 48.55 10.37 24 533681 11454 55746908
Blood pressure diastolic abnormal 48.24 10.37 228 533477 11370 55746992
Carpal tunnel syndrome 48.21 10.37 316 533389 17828 55740534
Grip strength decreased 48.09 10.37 291 533414 15965 55742397
Sepsis 47.35 10.37 988 532717 138852 55619510
Akathisia 46.97 10.37 12 533693 8640 55749722
Inappropriate antidiuretic hormone secretion 46.81 10.37 37 533668 13719 55744643
Sensitisation 46.68 10.37 82 533623 2286 55756076
Drug ineffective for unapproved indication 46.16 10.37 110 533595 25583 55732779
Accidental overdose 45.86 10.37 77 533628 20384 55737978
Coeliac disease 45.77 10.37 207 533498 10132 55748230
Psychotic disorder 45.47 10.37 97 533608 23461 55734901
Neutrophil count decreased 45.45 10.37 281 533424 49541 55708821
Dysphagia 45.44 10.37 527 533178 81420 55676942
Blood alkaline phosphatase increased 44.82 10.37 203 533502 38742 55719620
Injection site erythema 44.77 10.37 1005 532700 76443 55681919
Food allergy 44.69 10.37 184 533521 8640 55749722
Dysarthria 44.42 10.37 208 533497 39342 55719020
Blood glucose increased 44.15 10.37 477 533228 74674 55683688
Liver injury 44.13 10.37 598 533107 41250 55717112
Wrong technique in product usage process 43.77 10.37 347 533358 57821 55700541
Joint laxity 43.67 10.37 81 533624 2358 55756004
Pulmonary embolism 43.66 10.37 733 532972 106391 55651971
Multiple fractures 43.63 10.37 161 533544 7180 55751182
Aspartate aminotransferase increased 43.21 10.37 538 533167 82064 55676298
Blood pressure decreased 43.17 10.37 355 533350 58695 55699667
Chest discomfort 43.10 10.37 668 533037 98189 55660173
Delirium 42.96 10.37 232 533473 42285 55716077
Basal cell carcinoma 42.91 10.37 396 533309 24825 55733537
Depression 42.90 10.37 1340 532365 178777 55579585
Blood creatinine increased 42.81 10.37 520 533185 79671 55678691
Eosinophilia 42.77 10.37 78 533627 19999 55738363
Injection site pruritus 42.52 10.37 595 533110 41336 55717026
Accidental exposure to product 42.34 10.37 108 533597 24539 55733823
Ascites 41.84 10.37 198 533507 37346 55721016
Posterior reversible encephalopathy syndrome 41.68 10.37 54 533651 15906 55742456
Transplant rejection 41.67 10.37 21 533684 9913 55748449
Respiratory depression 41.63 10.37 34 533671 12401 55745961
Alanine aminotransferase increased 41.47 10.37 631 533074 93031 55665331
Ejection fraction 41.33 10.37 65 533640 1650 55756712
Ventricular tachycardia 41.31 10.37 60 533645 16841 55741521
Blood pressure systolic abnormal 41.25 10.37 193 533512 9584 55748778
Polyneuropathy 40.88 10.37 38 533667 13012 55745350
Cerebral haemorrhage 40.67 10.37 137 533568 28469 55729893
Pleural effusion 40.60 10.37 568 533137 84912 55673450
Red blood cell sedimentation rate increased 40.55 10.37 528 533177 36095 55722267
Device difficult to use 40.49 10.37 26 533679 10735 55747627
Polycystic ovaries 40.43 10.37 94 533611 3220 55755142
Pulmonary oedema 40.40 10.37 301 533404 50842 55707520
Parkinsonism 40.32 10.37 20 533685 9526 55748836
Hyperhidrosis 40.26 10.37 638 533067 93450 55664912
Disturbance in attention 39.65 10.37 166 533539 32374 55725988
Dyskinesia 39.63 10.37 142 533563 28966 55729396
Pain in jaw 39.61 10.37 220 533485 39816 55718546
Thrombotic microangiopathy 39.32 10.37 20 533685 9391 55748971
Pulmonary hypertension 39.22 10.37 191 533514 35753 55722609
Hepatotoxicity 39.16 10.37 157 533548 30996 55727366
Agranulocytosis 39.15 10.37 99 533606 22560 55735802
Infection 39.01 10.37 2295 531410 197911 55560451
Product administration error 38.89 10.37 88 533617 20841 55737521
Melaena 38.53 10.37 138 533567 28152 55730210
Acute generalised exanthematous pustulosis 38.30 10.37 23 533682 9846 55748516
Speech disorder 38.21 10.37 204 533501 37289 55721073
Device dislocation 38.11 10.37 100 533605 22506 55735856
Injection site reaction 38.04 10.37 713 532992 52534 55705828
Restlessness 38.02 10.37 127 533578 26459 55731903
Obstructive airways disorder 37.85 10.37 66 533639 17216 55741146
Pyrexia 37.82 10.37 3437 530268 415336 55343026
Status epilepticus 37.75 10.37 53 533652 15088 55743274
Constipation 37.71 10.37 1548 532157 200395 55557967
Stomatitis 37.65 10.37 1451 532254 119359 55639003
Gastrointestinal disorder 37.37 10.37 1363 532342 111339 55647023
Face oedema 37.28 10.37 74 533631 18378 55739984
Nightmare 37.08 10.37 64 533641 16762 55741600
Acute myeloid leukaemia 37 10.37 65 533640 16907 55741455
Mania 36.73 10.37 33 533672 11487 55746875
Pancreatitis acute 36.63 10.37 119 533586 25005 55733357
Chronic kidney disease 36.41 10.37 241 533464 41815 55716547
Macular degeneration 36.37 10.37 78 533627 18830 55739532
Haematotoxicity 36.26 10.37 17 533688 8366 55749996
Arrhythmia 36.24 10.37 190 533515 34893 55723469
Platelet count decreased 36.19 10.37 751 532954 105632 55652730
Jaundice 35.95 10.37 135 533570 27159 55731203
Dyspnoea exertional 35.91 10.37 338 533367 54351 55704011
Respiratory distress 35.88 10.37 166 533539 31501 55726861
Aggression 35.85 10.37 99 533606 21907 55736455
Diabetes mellitus inadequate control 35.80 10.37 48 533657 13932 55744430
Bone erosion 35.74 10.37 254 533451 14720 55743642
Cardiogenic shock 35.16 10.37 63 533642 16262 55742100
Neurotoxicity 34.88 10.37 60 533645 15735 55742627
Haemorrhage 34.74 10.37 354 533351 56043 55702319
Toxic skin eruption 34.67 10.37 36 533669 11703 55746659
Caesarean section 34.45 10.37 266 533439 15825 55742537
Febrile bone marrow aplasia 34.02 10.37 10 533695 6562 55751800
Cognitive disorder 33.84 10.37 300 533405 48833 55709529
Atrial fibrillation 33.80 10.37 780 532925 108117 55650245
Cytokine release syndrome 33.67 10.37 32 533673 10843 55747519
Bone marrow failure 33.42 10.37 146 533559 28140 55730222
Cerebrovascular accident 33.41 10.37 702 533003 98568 55659794
Bronchospasm 33.27 10.37 61 533644 15608 55742754
Neck deformity 33.25 10.37 65 533640 1970 55756392
Maternal drugs affecting foetus 33.09 10.37 115 533590 4978 55753384
Stress cardiomyopathy 32.95 10.37 19 533686 8317 55750045
Joint range of motion decreased 32.55 10.37 376 533329 24989 55733373
Palpitations 32.33 10.37 709 532996 98963 55659399
Disability 32.21 10.37 258 533447 15522 55742840
Coagulopathy 32.16 10.37 82 533623 18634 55739728
Ear infection 32.10 10.37 445 533260 30850 55727512
Ischaemic stroke 31.96 10.37 70 533635 16772 55741590
Stevens-Johnson syndrome 31.90 10.37 109 533596 22554 55735808
Ventricular fibrillation 31.88 10.37 34 533671 10918 55747444
Metastases to central nervous system 31.76 10.37 41 533664 12095 55746267
Blood pressure systolic increased 31.70 10.37 554 533151 40282 55718080
International normalised ratio increased 31.63 10.37 266 533439 43775 55714587
Asthenia 31.50 10.37 2811 530894 340162 55418200
Asphyxia 31.48 10.37 8 533697 5781 55752581
Haemorrhage intracranial 31.45 10.37 45 533660 12710 55745652
Rash maculo-papular 31.31 10.37 154 533551 28753 55729609
Chest pain 31.29 10.37 1475 532230 188322 55570040
Metastases to lung 31.28 10.37 39 533666 11679 55746683
Cerebral infarction 31.17 10.37 109 533596 22396 55735966
Vision blurred 31.10 10.37 576 533129 82367 55675995
Haemophagocytic lymphohistiocytosis 31.02 10.37 27 533678 9545 55748817
Gestational diabetes 31.00 10.37 155 533550 7909 55750453
Withdrawal syndrome 30.87 10.37 82 533623 18380 55739982
Device use error 30.73 10.37 7 533698 5449 55752913
Myoclonus 30.69 10.37 61 533644 15142 55743220
Brain oedema 30.62 10.37 49 533656 13222 55745140
Injection site swelling 30.60 10.37 582 533123 42996 55715366
Graft versus host disease 30.51 10.37 13 533692 6768 55751594
Hemiparesis 30.50 10.37 103 533602 21387 55736975
Dystonia 30.45 10.37 44 533661 12377 55745985
Blood pressure diastolic decreased 30.19 10.37 298 533407 19025 55739337
Muscle rigidity 30.10 10.37 34 533671 10637 55747725
Maternal exposure before pregnancy 29.75 10.37 136 533569 6687 55751675
Hypomagnesaemia 29.62 10.37 129 533576 24886 55733476
Inflammation 29.53 10.37 861 532844 68210 55690152
Tardive dyskinesia 29.41 10.37 20 533685 8011 55750351
Proteinuria 29.40 10.37 78 533627 17492 55740870
Joint destruction 29.32 10.37 110 533595 4945 55753417
Decreased appetite 29.31 10.37 1740 531965 217491 55540871
Miosis 29.09 10.37 13 533692 6579 55751783
Haematoma 28.99 10.37 181 533524 31838 55726524
Acute graft versus host disease 28.85 10.37 3 533702 4172 55754190
Myelosuppression 28.83 10.37 78 533627 17377 55740985
Abdominal pain 28.69 10.37 2089 531616 256716 55501646
Gastrointestinal haemorrhage 28.61 10.37 527 533178 75424 55682938
Tachypnoea 28.57 10.37 65 533640 15365 55742997
Atrioventricular block complete 28.34 10.37 18 533687 7476 55750886
Hypomania 28.19 10.37 6 533699 4896 55753466
Bone pain 28.10 10.37 322 533383 49863 55708499
Genital haemorrhage 28.05 10.37 15 533690 6847 55751515
Laryngitis 28.03 10.37 227 533478 13703 55744659
Breast cancer metastatic 27.97 10.37 66 533639 15403 55742959
Second primary malignancy 27.69 10.37 18 533687 7384 55750978
Disease recurrence 27.68 10.37 124 533581 23736 55734626
Joint stiffness 27.64 10.37 481 533224 34944 55723418
Polyarthritis 27.60 10.37 159 533546 8569 55749793
Emotional distress 27.59 10.37 167 533538 29596 55728766
Vertigo 27.58 10.37 358 533347 54214 55704148
Hospitalisation 27.44 10.37 523 533182 74477 55683885
Hallucination, visual 27.41 10.37 80 533625 17388 55740974
Urinary retention 27.37 10.37 155 533550 27919 55730443
Bronchopulmonary aspergillosis 27.16 10.37 23 533682 8241 55750121
Substance abuse 27.16 10.37 5 533700 4520 55753842
Hallucination, auditory 27.11 10.37 42 533663 11482 55746880
Limb deformity 27.11 10.37 90 533615 3805 55754557
Intramedullary rod insertion 27.05 10.37 60 533645 1991 55756371
Immune reconstitution inflammatory syndrome 26.97 10.37 10 533695 5664 55752698
Pemphigoid 26.91 10.37 13 533692 6287 55752075
Premature labour 26.89 10.37 199 533506 11683 55746679
Drug tolerance decreased 26.69 10.37 218 533487 13193 55745169
Toxic epidermal necrolysis 26.51 10.37 113 533592 21929 55736433
Sinus tachycardia 26.42 10.37 116 533589 22328 55736034
Breast cancer stage I 26.39 10.37 13 533692 6217 55752145
Drug ineffective 26.32 10.37 9393 524312 909596 54848766
Tumour lysis syndrome 26.10 10.37 22 533683 7901 55750461
Psychomotor hyperactivity 25.88 10.37 33 533672 9787 55748575
Paradoxical drug reaction 25.75 10.37 3 533702 3817 55754545
Heart rate decreased 25.73 10.37 532 533173 39895 55718467
Anuria 25.67 10.37 45 533660 11715 55746647
Aspergillus infection 25.50 10.37 20 533685 7445 55750917
Aphasia 25.48 10.37 176 533529 30239 55728123
Erythema multiforme 25.29 10.37 32 533673 9522 55748840
Myocarditis 25.23 10.37 28 533677 8830 55749532
Malaise 25.22 10.37 3078 530627 364782 55393580
Lethargy 25.07 10.37 340 533365 51101 55707261
Pulmonary fibrosis 25.02 10.37 409 533296 29349 55729013
Tubulointerstitial nephritis 24.95 10.37 78 533627 16587 55741775
Bradyphrenia 24.90 10.37 16 533689 6604 55751758
Irritability 24.89 10.37 171 533534 29417 55728945
Complication of device insertion 24.89 10.37 15 533690 6409 55751953
Myopathy 24.81 10.37 34 533671 9778 55748584
Hypocalcaemia 24.80 10.37 165 533540 28595 55729767
Pain in extremity 24.80 10.37 3201 530504 294230 55464132
Deafness transitory 24.71 10.37 56 533649 1886 55756476
Respiratory disorder 24.70 10.37 456 533249 33501 55724861
Off label use 24.64 10.37 4774 528931 551406 55206956
Tenderness 24.64 10.37 296 533409 19859 55738503
Hepatic cytolysis 24.48 10.37 41 533664 10865 55747497
Psoriasis 24.47 10.37 1094 532611 91598 55666764
Forced expiratory volume decreased 24.29 10.37 7 533698 4653 55753709
Synovial cyst 24.19 10.37 160 533545 9054 55749308
Flushing 24.09 10.37 494 533211 69606 55688756
Deep vein thrombosis 23.98 10.37 551 533154 76426 55681936
Ventricular septal defect 23.96 10.37 90 533615 4048 55754314
Foetal exposure during pregnancy 23.84 10.37 452 533253 33371 55724991
Juvenile idiopathic arthritis 23.76 10.37 99 533606 4674 55753688
Cardiomyopathy 23.70 10.37 77 533628 16181 55742181
Mobility decreased 23.70 10.37 1157 532548 97834 55660528
Swollen tongue 23.70 10.37 179 533526 30145 55728217
Oliguria 23.69 10.37 27 533678 8413 55749949
Rheumatoid nodule 23.64 10.37 230 533475 14627 55743735
Enthesopathy 23.64 10.37 144 533561 7919 55750443
Diabetes mellitus 23.43 10.37 355 533350 52380 55705982
Latent tuberculosis 23.24 10.37 64 533641 2438 55755924
Cardiac failure acute 23.19 10.37 30 533675 8843 55749519
Orthostatic hypotension 23.18 10.37 202 533503 32997 55725365
Epilepsy 23.17 10.37 142 533563 25089 55733273
Acidosis 23.09 10.37 40 533665 10461 55747901
Premature rupture of membranes 23.07 10.37 98 533607 4667 55753695
Pancreatitis 23.05 10.37 295 533410 44785 55713577
Cyanosis 22.97 10.37 75 533630 15735 55742627
Tuberculosis 22.88 10.37 181 533524 10848 55747514
Blood pressure diastolic increased 22.68 10.37 149 533556 8412 55749950
Pre-eclampsia 22.67 10.37 148 533557 8338 55750024
Septic shock 22.63 10.37 423 533282 60412 55697950
Nephrectomy 22.62 10.37 41 533664 1172 55757190
Joint dislocation 22.61 10.37 239 533466 15534 55742828
Lip swelling 22.52 10.37 151 533554 26121 55732241
Tenosynovitis stenosans 22.46 10.37 65 533640 2549 55755813
Rotator cuff repair 22.40 10.37 53 533652 1837 55756525
Glycosylated haemoglobin increased 22.37 10.37 45 533660 11120 55747242
Fear 22.16 10.37 70 533635 14838 55743524
Epstein-Barr virus infection 21.91 10.37 23 533682 7440 55750922
Pathogen resistance 21.89 10.37 15 533690 5985 55752377
Circulatory collapse 21.86 10.37 112 533593 20691 55737671
Nodule 21.70 10.37 271 533434 18348 55740014
Muscle twitching 21.61 10.37 80 533625 16162 55742200
Small for dates baby 21.47 10.37 78 533627 3452 55754910
Feeling abnormal 21.47 10.37 1041 532664 132561 55625801
Ketoacidosis 21.46 10.37 6 533699 4069 55754293
Acute respiratory failure 21.45 10.37 189 533516 30805 55727557
Upper respiratory tract infection 21.44 10.37 853 532852 70435 55687927
Product substitution issue 21.38 10.37 69 533636 14530 55743832
Labelled drug-drug interaction medication error 21.29 10.37 49 533656 11537 55746825
Device related infection 21.22 10.37 121 533584 21759 55736603
Hypertransaminasaemia 21.22 10.37 9 533696 4698 55753664
Paralysis 21.17 10.37 33 533672 8999 55749363
Subdural haematoma 21.05 10.37 62 533643 13437 55744925
Pulmonary congestion 21.03 10.37 80 533625 16035 55742327
Angina pectoris 20.99 10.37 167 533538 27809 55730553
Smear cervix abnormal 20.93 10.37 66 533639 2715 55755647
Cardiotoxicity 20.90 10.37 25 533680 7625 55750737
Complication associated with device 20.82 10.37 75 533630 15275 55743087
Cytopenia 20.69 10.37 38 533667 9717 55748645
Haemoptysis 20.65 10.37 157 533548 26403 55731959
Arthritis infective 20.49 10.37 111 533594 5845 55752517
Bradypnoea 20.42 10.37 3 533702 3200 55755162
Adverse event 20.41 10.37 678 533027 54698 55703664
Renal injury 20.33 10.37 33 533672 8854 55749508
Injection site rash 20.27 10.37 248 533457 16710 55741652
Wheelchair user 20.27 10.37 104 533601 5362 55753000
Shock haemorrhagic 20.24 10.37 34 533671 8999 55749363
Exposure to toxic agent 20.16 10.37 5 533700 3673 55754689
Delusion 20.16 10.37 48 533657 11167 55747195
Oral herpes 20.15 10.37 317 533388 22573 55735789
Sinus bradycardia 20.05 10.37 64 533641 13522 55744840
Transplant dysfunction 19.96 10.37 10 533695 4736 55753626
Interstitial lung disease 19.94 10.37 401 533304 56662 55701700
Panic attack 19.87 10.37 113 533592 20334 55738028
Fracture delayed union 19.73 10.37 58 533647 2295 55756067
Hepatitis cholestatic 19.71 10.37 19 533686 6395 55751967
Right ventricular failure 19.68 10.37 84 533621 16295 55742067
Muscle spasms 19.66 10.37 1083 532622 136288 55622074
Neck mass 19.49 10.37 74 533631 3346 55755016
Multiple sclerosis 19.48 10.37 169 533536 27633 55730729
Colitis 19.43 10.37 279 533426 41532 55716830
Dysgeusia 19.37 10.37 272 533433 40643 55717719
Oedema peripheral 19.33 10.37 1380 532325 169874 55588488
Injection site pain 19.21 10.37 1323 532382 115795 55642567
Pericardial effusion 19.12 10.37 165 533540 27010 55731352
Foot operation 19.06 10.37 113 533592 6154 55752208
Dysmorphism 18.99 10.37 55 533650 2158 55756204
Depressed mood 18.93 10.37 237 533468 36122 55722240
Pneumonia viral 18.92 10.37 24 533681 7134 55751228
Catatonia 18.82 10.37 7 533698 3957 55754405
Asthma 18.64 10.37 876 532829 111894 55646468
Presyncope 18.60 10.37 154 533551 25428 55732934
Acute pulmonary oedema 18.54 10.37 27 533678 7570 55750792
Gastroenteritis viral 18.41 10.37 284 533421 20140 55738222
Confusional state 18.36 10.37 1711 531994 206444 55551918
Generalised oedema 18.28 10.37 73 533632 14428 55743934
Graft versus host disease in gastrointestinal tract 18.18 10.37 3 533702 2936 55755426
Rebound effect 18.10 10.37 7 533698 3863 55754499
Mucosal inflammation 18.07 10.37 291 533414 42519 55715843
Uterine perforation 18.05 10.37 21 533684 6484 55751878
Developmental hip dysplasia 18.03 10.37 39 533666 1272 55757090
Crying 17.99 10.37 124 533581 21316 55737046
Clostridium difficile colitis 17.97 10.37 104 533601 18634 55739728
Potentiating drug interaction 17.97 10.37 8 533697 4058 55754304
Coronary artery disease 17.87 10.37 196 533509 30600 55727762
Localised infection 17.86 10.37 362 533343 27050 55731312
Loose body in joint 17.82 10.37 38 533667 1227 55757135
Device breakage 17.79 10.37 44 533661 10103 55748259
Peripheral sensory neuropathy 17.69 10.37 24 533681 6932 55751430
Musculoskeletal pain 17.68 10.37 940 532765 80212 55678150
Wound infection 17.65 10.37 221 533484 14972 55743390
Hemiplegia 17.59 10.37 33 533672 8371 55749991
Body temperature decreased 17.57 10.37 255 533450 17853 55740509
Injection site bruising 17.52 10.37 484 533221 38037 55720325
Personality disorder 17.50 10.37 14 533691 5159 55753203
Acute respiratory distress syndrome 17.33 10.37 129 533576 21797 55736565
Hepatitis acute 17.33 10.37 33 533672 8324 55750038
Maternal exposure timing unspecified 17.28 10.37 99 533606 5324 55753038
Atrioventricular block 17.28 10.37 24 533681 6863 55751499
Salivary hypersecretion 17.26 10.37 25 533680 7025 55751337
Ataxia 17.22 10.37 74 533631 14329 55744033
Spinal stenosis 17.21 10.37 206 533499 13808 55744554
Cytomegalovirus viraemia 17.14 10.37 14 533691 5106 55753256
Dementia 17.12 10.37 94 533611 17064 55741298
Dermatitis exfoliative 17.11 10.37 15 533690 5284 55753078
Skin papilloma 17.06 10.37 86 533619 4403 55753959
Peripheral venous disease 17.01 10.37 158 533547 9921 55748441
Paranoia 17.01 10.37 49 533656 10695 55747667
Mood altered 16.98 10.37 67 533638 13288 55745074
Treatment noncompliance 16.86 10.37 213 533492 32410 55725952
Complication of device removal 16.78 10.37 11 533694 4493 55753869
Exostosis 16.78 10.37 216 533489 14727 55743635
Chronic graft versus host disease 16.77 10.37 5 533700 3251 55755111
Affective disorder 16.75 10.37 17 533688 5586 55752776
Joint noise 16.72 10.37 76 533629 3728 55754634
Dislocation of vertebra 16.70 10.37 98 533607 5317 55753045
Acute myocardial infarction 16.63 10.37 196 533509 30197 55728165
Acute coronary syndrome 16.62 10.37 43 533662 9725 55748637
Embedded device 16.54 10.37 4 533701 2989 55755373
Neutropenic colitis 16.53 10.37 3 533702 2740 55755622
Dermatitis bullous 16.51 10.37 29 533676 7544 55750818
Hyperprolactinaemia 16.50 10.37 7 533698 3654 55754708
Catheter site erythema 16.49 10.37 9 533696 4061 55754301
Synovial fluid analysis 16.47 10.37 48 533657 1890 55756472
Placental disorder 16.42 10.37 40 533665 1413 55756949
Polyuria 16.39 10.37 29 533676 7522 55750840
Endodontic procedure 16.30 10.37 63 533642 2873 55755489
C-reactive protein increased 16.27 10.37 907 532798 77777 55680585
Lupus vasculitis 16.24 10.37 22 533683 486 55757876
Product prescribing error 16.22 10.37 141 533564 23045 55735317
Pulseless electrical activity 16.14 10.37 26 533679 6998 55751364
Tenosynovitis 16.11 10.37 185 533520 12276 55746086
White blood cell count decreased 16.11 10.37 1004 532701 124986 55633376
Ileus paralytic 15.97 10.37 10 533695 4185 55754177
Transaminases increased 15.95 10.37 185 533520 28585 55729777
Body tinea 15.95 10.37 39 533666 1381 55756981
Respiratory acidosis 15.94 10.37 21 533684 6142 55752220
Hyperammonaemia 15.93 10.37 14 533691 4926 55753436
Inadequate analgesia 15.93 10.37 3 533702 2668 55755694
Hypervolaemia 15.91 10.37 167 533538 26291 55732071
Skin ulcer 15.88 10.37 479 533226 38129 55720233
Multiple-drug resistance 15.79 10.37 9 533696 3965 55754397
Intracranial pressure increased 15.75 10.37 12 533693 4533 55753829
Polyhydramnios 15.74 10.37 50 533655 2065 55756297
Herpes zoster 15.73 10.37 875 532830 75014 55683348
Laryngospasm 15.66 10.37 4 533701 2880 55755482
Hyperuricaemia 15.62 10.37 15 533690 5058 55753304
Intervertebral disc degeneration 15.57 10.37 205 533500 14049 55744313
Foot fracture 15.56 10.37 292 533413 21517 55736845
Bradykinesia 15.36 10.37 14 533691 4840 55753522
Balance disorder 15.25 10.37 582 533123 75938 55682424
Rectal haemorrhage 15.22 10.37 289 533416 41178 55717184
Memory impairment 15.19 10.37 668 533037 85889 55672473
Catheter management 15.19 10.37 4 533701 2822 55755540
Malignant melanoma 15.17 10.37 162 533543 10557 55747805
Gallbladder polyp 15.15 10.37 26 533679 711 55757651
Incoherent 15.15 10.37 11 533694 4258 55754104
Hyperthyroidism 15.12 10.37 70 533635 13282 55745080
Pharyngitis streptococcal 15.09 10.37 147 533558 9351 55749011
Persecutory delusion 15.08 10.37 3 533702 2567 55755795
Hereditary angioedema 15.06 10.37 26 533679 6809 55751553
Crystal nephropathy 15.03 10.37 28 533677 818 55757544
Bone density decreased 14.99 10.37 186 533519 12574 55745788
Synovial disorder 14.98 10.37 33 533672 1090 55757272
Acute chest syndrome 14.98 10.37 25 533680 668 55757694
Breast feeding 14.93 10.37 28 533677 822 55757540
Hallucinations, mixed 14.93 10.37 12 533693 4412 55753950
Hepatic necrosis 14.93 10.37 17 533688 5299 55753063
Klebsiella infection 14.91 10.37 32 533673 7724 55750638
Oropharyngeal pain 14.90 10.37 953 532752 82835 55675527
Skin cancer 14.89 10.37 157 533548 10198 55748164
Infection susceptibility increased 14.87 10.37 59 533646 2724 55755638
Muscular weakness 14.85 10.37 824 532881 103628 55654734
Leukocytosis 14.79 10.37 149 533556 23642 55734720
Colorectal cancer 14.76 10.37 7 533698 3422 55754940
Hypernatraemia 14.75 10.37 25 533680 6595 55751767
Retinitis 14.72 10.37 79 533626 4145 55754217
Pregnancy with contraceptive device 14.66 10.37 11 533694 4188 55754174
Blood potassium decreased 14.66 10.37 268 533437 38404 55719958
Lip dry 14.63 10.37 149 533556 9591 55748771
Red blood cell sedimentation rate 14.63 10.37 80 533625 4228 55754134
Congenital arterial malformation 14.61 10.37 17 533688 320 55758042
Adenovirus infection 14.61 10.37 7 533698 3401 55754961
Hyperbilirubinaemia 14.56 10.37 49 533656 10186 55748176
Lupus-like syndrome 14.53 10.37 181 533524 12246 55746116
Breast cancer stage II 14.51 10.37 20 533685 5738 55752624
Hyperthermia 14.46 10.37 36 533669 8249 55750113
Sexual dysfunction 14.46 10.37 7 533698 3381 55754981
Body height below normal 14.31 10.37 47 533658 1976 55756386
Foetal anticonvulsant syndrome 14.23 10.37 22 533683 550 55757812
Lymphocyte count decreased 14.22 10.37 183 533522 27756 55730606
Mental disorder 14.19 10.37 149 533556 23455 55734907
Lymphopenia 14.08 10.37 97 533608 16677 55741685
Abortion incomplete 14.06 10.37 6 533699 3121 55755241
Catheter site pain 14.05 10.37 12 533693 4281 55754081
Affect lability 14.05 10.37 49 533656 10076 55748286
Device issue 14.04 10.37 130 533575 20976 55737386
Wrong product administered 14.00 10.37 20 533685 5652 55752710
Diabetes insipidus 13.98 10.37 3 533702 2434 55755928
Gastrointestinal toxicity 13.95 10.37 23 533682 6133 55752229
Blood iron increased 13.87 10.37 37 533668 1383 55756979
Product complaint 13.71 10.37 61 533644 11699 55746663
Malignant mediastinal neoplasm 13.70 10.37 28 533677 877 55757485
Amylase increased 13.61 10.37 21 533684 5750 55752612
Progressive multifocal leukoencephalopathy 13.59 10.37 63 533642 11950 55746412
Product administered to patient of inappropriate age 13.57 10.37 5 533700 2843 55755519
Therapy partial responder 13.46 10.37 34 533671 7751 55750611
Red blood cell count decreased 13.41 10.37 448 533257 36169 55722193
Pneumonia 13.37 10.37 3544 530161 403554 55354808
Nervousness 13.34 10.37 194 533511 28821 55729541
Ileus 13.34 10.37 77 533628 13805 55744557
Cestode infection 13.33 10.37 15 533690 272 55758090
Low turnover osteopathy 13.32 10.37 74 533631 3934 55754428
Device deployment issue 13.30 10.37 9 533696 3615 55754747
Lymphoedema 13.28 10.37 53 533652 10477 55747885
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.24 10.37 4 533701 2579 55755783
Clear cell renal cell carcinoma 13.23 10.37 34 533671 1242 55757120
Visual acuity reduced 13.22 10.37 129 533576 20597 55737765
Haemodynamic instability 13.17 10.37 38 533667 8291 55750071
Hepatitis fulminant 13.10 10.37 7 533698 3197 55755165
Jaundice cholestatic 13.09 10.37 20 533685 5499 55752863
Atrial septal defect 13.08 10.37 106 533599 6400 55751962
Infective pulmonary exacerbation of cystic fibrosis 13.06 10.37 37 533668 8120 55750242
Haematemesis 12.98 10.37 193 533512 28565 55729797
Visual impairment 12.95 10.37 573 533132 73629 55684733
Hypophosphataemia 12.77 10.37 48 533657 9654 55748708
Skin plaque 12.75 10.37 30 533675 7008 55751354
Facet joint syndrome 12.73 10.37 108 533597 6609 55751753
Knee operation 12.67 10.37 90 533615 5215 55753147
Metastases to meninges 12.61 10.37 3 533702 2267 55756095
Gonorrhoea 12.51 10.37 10 533695 115 55758247
Anhedonia 12.44 10.37 50 533655 9864 55748498
Rhinitis allergic 12.43 10.37 129 533576 8345 55750017
Colitis microscopic 12.40 10.37 36 533669 7839 55750523
Pulmonary haemorrhage 12.22 10.37 29 533676 6754 55751608
Drug screen positive 12.19 10.37 9 533696 3455 55754907
Drug abuser 12.06 10.37 6 533699 2853 55755509
Personality change 12.04 10.37 23 533682 5794 55752568
Cyst 12.03 10.37 179 533526 12599 55745763
Exomphalos 12.02 10.37 20 533685 533 55757829
Product adhesion issue 11.88 10.37 15 533690 4468 55753894
Lymphadenectomy 11.86 10.37 27 533678 912 55757450
Adjustment disorder with depressed mood 11.85 10.37 86 533619 5017 55753345
Mixed liver injury 11.76 10.37 12 533693 3932 55754430
Neutrophilia 11.68 10.37 12 533693 3921 55754441
Blood lactic acid increased 11.67 10.37 25 533680 6039 55752323
Metastases to lymph nodes 11.64 10.37 34 533671 7389 55750973
Blood test abnormal 11.61 10.37 178 533527 12606 55745756
Injection site haematoma 11.58 10.37 100 533605 6152 55752210
Somnambulism 11.56 10.37 19 533686 5073 55753289
Hypoglycaemic coma 11.54 10.37 4 533701 2363 55755999
Wrist fracture 11.53 10.37 169 533536 11857 55746505
Therapeutic response decreased 11.47 10.37 611 533094 52147 55706215
Hepatic encephalopathy 11.45 10.37 53 533652 10057 55748305
Haemorrhage in pregnancy 11.45 10.37 40 533665 1736 55756626
Bone disorder 11.41 10.37 254 533451 19289 55739073
Pulmonary tuberculosis 11.31 10.37 77 533628 4399 55753963
Pseudomonas infection 11.29 10.37 53 533652 10018 55748344
Endophthalmitis 11.28 10.37 8 533697 3135 55755227
Swelling face 11.27 10.37 426 533279 55643 55702719
Pallor 11.27 10.37 161 533544 23988 55734374
Kidney transplant rejection 11.27 10.37 14 533691 4199 55754163
Prescribed overdose 11.25 10.37 284 533421 22012 55736350
Eosinophil count increased 11.23 10.37 50 533655 9587 55748775
Electrolyte imbalance 11.18 10.37 113 533592 17920 55740442
Granulocytopenia 11.17 10.37 21 533684 5323 55753039
Induced labour 11.14 10.37 26 533679 893 55757469
Blood prolactin increased 11.14 10.37 9 533696 3300 55755062
Generalised tonic-clonic seizure 11.10 10.37 189 533516 27377 55730985
Abdominal distension 11.10 10.37 612 533093 77014 55681348
Respiration abnormal 11.07 10.37 23 533682 5618 55752744
Obesity 11.05 10.37 285 533420 22163 55736199
Medication error 11.05 10.37 311 533394 42024 55716338
Toxic encephalopathy 11.00 10.37 25 533680 5913 55752449
Squamous cell carcinoma 11.00 10.37 122 533583 8026 55750336
Blood phosphorus decreased 10.99 10.37 13 533692 3984 55754378
Renal tubular necrosis 10.98 10.37 59 533646 10769 55747593
Electrocardiogram QRS complex prolonged 10.98 10.37 22 533683 5445 55752917
Skin exfoliation 10.97 10.37 266 533439 36634 55721728
Injection site warmth 10.97 10.37 193 533512 14050 55744312
Coronary arterial stent insertion 10.97 10.37 6 533699 2704 55755658
Haematochezia 10.94 10.37 323 533382 43395 55714967
Premature delivery 10.93 10.37 335 533370 26725 55731637
Eosinophilic granulomatosis with polyangiitis 10.92 10.37 3 533702 2058 55756304
Cartilage injury 10.91 10.37 40 533665 1778 55756584
Gestational hypertension 10.91 10.37 47 533658 2252 55756110
Skin toxicity 10.90 10.37 14 533691 4139 55754223
Blood glucose decreased 10.87 10.37 122 533583 18965 55739397
Bundle branch block left 10.83 10.37 28 533677 6334 55752028
Implant site pain 10.82 10.37 4 533701 2270 55756092
Tendonitis 10.82 10.37 236 533469 17861 55740501
Vascular device infection 10.80 10.37 23 533682 5567 55752795
Surgery 10.79 10.37 393 533312 32093 55726269
Hepatitis C 10.78 10.37 23 533682 5563 55752799
Human antichimeric antibody positive 10.77 10.37 36 533669 1527 55756835
Gastrointestinal pain 10.77 10.37 129 533576 8648 55749714
Cervical incompetence 10.74 10.37 20 533685 584 55757778
Talipes 10.65 10.37 34 533671 1408 55756954
Immunosuppression 10.64 10.37 119 533586 7845 55750517
Drug-induced liver injury 10.64 10.37 247 533458 34215 55724147
Postoperative wound infection 10.62 10.37 135 533570 9178 55749184
Cystitis haemorrhagic 10.62 10.37 13 533692 3924 55754438
Musculoskeletal disorder 10.60 10.37 247 533458 18900 55739462
Carotid artery thrombosis 10.59 10.37 4 533701 2240 55756122
Coordination abnormal 10.59 10.37 73 533632 12548 55745814
Activated partial thromboplastin time prolonged 10.58 10.37 30 533675 6582 55751780
Neurological decompensation 10.58 10.37 5 533700 2449 55755913
Liver transplant 10.53 10.37 4 533701 2232 55756130
Breast cancer female 10.53 10.37 71 533634 12267 55746095
Pneumatosis intestinalis 10.51 10.37 4 533701 2229 55756133
Fear of injection 10.43 10.37 101 533604 6414 55751948
Atrial flutter 10.43 10.37 48 533657 9121 55749241
Catheter site haemorrhage 10.42 10.37 8 533697 3010 55755352

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
Rheumatoid arthritis 380.02 10.33 863 187767 46946 31461768
Toxicity to various agents 339.33 10.33 348 188282 181139 31327575
Drug abuse 304.18 10.33 74 188556 87684 31421030
Completed suicide 279.05 10.33 98 188532 91416 31417298
Foetal exposure during pregnancy 239.49 10.33 657 187973 40219 31468495
Arthralgia 215.27 10.33 1590 187040 149834 31358880
Drug interaction 209.00 10.33 596 188034 207947 31300767
Psoriatic arthropathy 139.45 10.33 342 188288 19541 31489173
Intentional overdose 126.63 10.33 44 188586 41345 31467369
Joint swelling 120.38 10.33 632 187998 52799 31455915
Dysmorphism 112.96 10.33 114 188516 2958 31505756
Acute kidney injury 103.18 10.33 1116 187514 278598 31230116
Sickle cell anaemia with crisis 96.30 10.33 102 188528 2805 31505909
Nasopharyngitis 92.42 10.33 669 187961 62576 31446138
Suicide attempt 85.97 10.33 58 188572 37190 31471524
Musculoskeletal stiffness 82.44 10.33 473 188157 40852 31467862
Drug reaction with eosinophilia and systemic symptoms 75.88 10.33 42 188588 29976 31478738
Overdose 75.35 10.33 255 188375 84409 31424305
Rhabdomyolysis 72.47 10.33 170 188460 63411 31445303
Premature baby 71.94 10.33 254 188376 17812 31490902
Blood pressure fluctuation 71.10 10.33 296 188334 22440 31486274
Enthesopathy 70.51 10.33 106 188524 4181 31504533
Pain 70.29 10.33 1528 187102 185231 31323483
Serotonin syndrome 68.67 10.33 14 188616 18759 31489955
Coma 67.92 10.33 87 188543 41063 31467651
Exposure during pregnancy 65.78 10.33 153 188477 8445 31500269
Product use in unapproved indication 65.64 10.33 335 188295 98836 31409878
Hepatic function abnormal 64.13 10.33 91 188539 41131 31467583
Speech disorder developmental 63.36 10.33 70 188560 2021 31506693
Febrile neutropenia 62.08 10.33 447 188183 121402 31387312
Tenosynovitis 60.74 10.33 98 188532 4112 31504602
Neonatal respiratory distress syndrome 58.19 10.33 92 188538 3793 31504921
Arthritis 56.28 10.33 316 188314 27069 31481645
Foetal anticonvulsant syndrome 53.62 10.33 49 188581 1120 31507594
Death 52.32 10.33 1692 186938 358877 31149837
Renal failure 51.57 10.33 477 188153 122853 31385861
Cytomegalovirus infection 51.19 10.33 43 188587 24664 31484050
Infusion related reaction 50.58 10.33 472 188158 47583 31461131
Cardiac failure 49.96 10.33 303 188327 85650 31423064
Hypospadias 49.76 10.33 76 188554 3040 31505674
Atrial septal defect 49.46 10.33 120 188510 6807 31501907
Arthropathy 49.07 10.33 277 188353 23774 31484940
Drug resistance 48.37 10.33 41 188589 23412 31485302
Synovitis 48.31 10.33 172 188458 12111 31496603
Peripheral swelling 46.78 10.33 613 188017 67252 31441462
Hypoglycaemia neonatal 46.14 10.33 55 188575 1727 31506987
Foot deformity 46.02 10.33 86 188544 4063 31504651
Pain in extremity 45.97 10.33 958 187672 115245 31393469
Psoriasis 45.77 10.33 452 188178 46267 31462447
Coombs positive haemolytic anaemia 45.70 10.33 38 188592 762 31507952
Autism spectrum disorder 44.55 10.33 60 188570 2135 31506579
Angioedema 44.08 10.33 83 188547 33535 31475179
Respiratory arrest 43.85 10.33 55 188575 26202 31482512
Maternal exposure during pregnancy 43.75 10.33 90 188540 4566 31504148
Haemoglobin decreased 43.62 10.33 926 187704 111749 31396965
Maternal drugs affecting foetus 43.42 10.33 81 188549 3822 31504892
Cryptorchism 42.92 10.33 56 188574 1931 31506783
C-reactive protein abnormal 42.63 10.33 122 188508 7647 31501067
Learning disorder 42.18 10.33 41 188589 1015 31507699
Small for dates baby 42.10 10.33 77 188553 3578 31505136
Maternal exposure during breast feeding 42.08 10.33 49 188581 1500 31507214
Blood pressure systolic increased 41.56 10.33 227 188403 19243 31489471
Blood pressure diastolic abnormal 41.08 10.33 80 188550 3899 31504815
Blood pressure systolic abnormal 40.69 10.33 69 188561 3018 31505696
Depressed level of consciousness 40.25 10.33 108 188522 38493 31470221
Low birth weight baby 39.76 10.33 111 188519 6859 31501855
Bradycardia 39.44 10.33 246 188384 69081 31439633
Sedation 39.30 10.33 33 188597 18932 31489782
Alanine aminotransferase abnormal 38.84 10.33 78 188552 3889 31504825
Grip strength decreased 38.73 10.33 62 188568 2584 31506130
Fatigue 38.50 10.33 2397 186233 332809 31175905
Osteoarthritis 37.85 10.33 218 188412 18849 31489865
Juvenile idiopathic arthritis 37.68 10.33 49 188581 1684 31507030
Basal cell carcinoma 37.50 10.33 210 188420 17969 31490745
Syndactyly 37.24 10.33 35 188595 830 31507884
Rheumatoid nodule 36.77 10.33 61 188569 2620 31506094
Lactic acidosis 36.69 10.33 85 188545 31852 31476862
Haemolysis 36.42 10.33 110 188520 7106 31501608
Ventricular septal defect 35.64 10.33 72 188558 3605 31505109
Suicidal ideation 35.63 10.33 105 188525 36301 31472413
Altered state of consciousness 35.25 10.33 44 188586 21007 31487707
Tongue disorder 34.85 10.33 86 188544 4931 31503783
Renal impairment 34.77 10.33 337 188293 86012 31422702
Immune reconstitution inflammatory syndrome 34.68 10.33 4 188626 8174 31500540
Psychotic disorder 33.89 10.33 50 188580 22243 31486471
Poisoning 33.63 10.33 10 188620 10381 31498333
Blood pressure increased 33.62 10.33 663 187967 78970 31429744
Delirium 32.72 10.33 131 188499 41290 31467424
Cardiac arrest 32.02 10.33 357 188273 88705 31420009
Victim of child abuse 32.00 10.33 33 188597 879 31507835
Intentional self-injury 31.71 10.33 20 188610 13295 31495419
Substance abuse 31.64 10.33 3 188627 7155 31501559
Developmental delay 31.43 10.33 56 188574 2549 31506165
Joint laxity 30.99 10.33 23 188607 388 31508326
Palmar-plantar erythrodysaesthesia syndrome 30.80 10.33 28 188602 15455 31493259
Blood creatine phosphokinase increased 30.53 10.33 137 188493 41837 31466877
Shock 30.49 10.33 55 188575 22590 31486124
Intellectual disability 30.30 10.33 37 188593 1192 31507522
Pulmonary fibrosis 30.19 10.33 186 188444 16474 31492240
Weight decreased 30.01 10.33 1200 187430 158752 31349962
Neuroleptic malignant syndrome 29.59 10.33 34 188596 16835 31491879
Toxic epidermal necrolysis 29.48 10.33 44 188586 19480 31489234
Talipes 29.44 10.33 45 188585 1801 31506913
Lymphadenitis 29.15 10.33 43 188587 1667 31507047
Lower respiratory tract infection 29.02 10.33 276 188354 27961 31480753
Hypoglycaemia 28.85 10.33 181 188449 50765 31457949
Hand deformity 28.75 10.33 59 188571 2988 31505726
Agitation 28.39 10.33 197 188433 53972 31454742
Astigmatism 27.89 10.33 33 188597 1028 31507686
Exposure via breast milk 27.79 10.33 44 188586 1816 31506898
Congenital hand malformation 27.59 10.33 25 188605 565 31508149
Acute hepatic failure 27.11 10.33 22 188608 12837 31495877
Electrocardiogram QT prolonged 27.03 10.33 125 188505 37862 31470852
Cholestasis 27.02 10.33 69 188561 25006 31483708
Joint effusion 26.98 10.33 74 188556 4525 31504189
Hypermobility syndrome 26.82 10.33 20 188610 340 31508374
Rash maculo-papular 26.77 10.33 72 188558 25647 31483067
Heart rate decreased 26.48 10.33 271 188359 27995 31480719
Disease progression 26.40 10.33 379 188251 90085 31418629
Therapeutic product effect decreased 25.83 10.33 295 188335 31327 31477387
Plagiocephaly 25.78 10.33 23 188607 509 31508205
Tendonitis 25.64 10.33 110 188520 8448 31500266
Jaundice neonatal 25.57 10.33 35 188595 1265 31507449
Sinusitis 25.07 10.33 331 188299 36365 31472349
Somnolence 24.86 10.33 429 188201 99016 31409698
Drug withdrawal syndrome 24.83 10.33 46 188584 18704 31490010
Muscle swelling 24.80 10.33 19 188611 337 31508377
Drug intolerance 24.64 10.33 441 188189 51592 31457122
Oropharyngeal pain 24.52 10.33 291 188339 31192 31477522
Blood pressure diastolic increased 24.32 10.33 68 188562 4205 31504509
Knee arthroplasty 24.24 10.33 90 188540 6468 31502246
Foetal growth restriction 24.01 10.33 63 188567 3752 31504962
Language disorder 23.54 10.33 44 188586 2079 31506635
Blood pressure diastolic decreased 23.25 10.33 102 188528 7911 31500803
Localised infection 23.15 10.33 163 188467 15102 31493612
Mucormycosis 22.94 10.33 3 188627 5567 31503147
Post procedural infection 22.88 10.33 69 188561 4454 31504260
Aspergillus infection 22.75 10.33 21 188609 11507 31497207
Polyarthritis 22.58 10.33 66 188564 4186 31504528
Intentional product misuse 22.45 10.33 133 188497 37818 31470896
Vitamin D deficiency 22.42 10.33 82 188548 5850 31502864
Large for dates baby 22.28 10.33 27 188603 863 31507851
Neurotoxicity 22.21 10.33 39 188591 16187 31492527
Drug level increased 22.17 10.33 55 188575 20131 31488583
Hepatic enzyme increased 22.13 10.33 318 188312 35590 31473124
Selective eating disorder 22.08 10.33 38 188592 1682 31507032
Hepatocellular injury 21.91 10.33 61 188569 21483 31487231
Scoliosis 21.83 10.33 48 188582 2551 31506163
Inflammation 21.77 10.33 238 188392 25003 31483711
Cellulitis 21.69 10.33 404 188226 47614 31461100
Knee deformity 21.51 10.33 22 188608 580 31508134
Dysgraphia 21.46 10.33 43 188587 2140 31506574
Diabetic ketoacidosis 21.06 10.33 43 188587 16862 31491852
Hyperbilirubinaemia neonatal 21.05 10.33 24 188606 718 31507996
Venoocclusive liver disease 20.81 10.33 9 188621 7403 31501311
Wound 20.76 10.33 140 188490 12788 31495926
Appendicolith 20.64 10.33 78 188552 5653 31503061
Agranulocytosis 20.27 10.33 62 188568 21185 31487529
Pyrexia 20.02 10.33 1547 187083 302293 31206421
Strabismus 19.99 10.33 35 188595 1571 31507143
Hyperglycaemia 19.93 10.33 131 188499 36345 31472369
Aggression 19.84 10.33 135 188495 37156 31471558
Motor developmental delay 19.84 10.33 22 188608 638 31508076
Body temperature decreased 19.83 10.33 129 188501 11641 31497073
Influenza 19.70 10.33 372 188258 43953 31464761
Hypotonia neonatal 19.61 10.33 31 188599 1278 31507436
Otitis media 19.41 10.33 46 188584 2570 31506144
Serum ferritin increased 19.36 10.33 77 188553 5715 31502999
Crystal nephropathy 19.29 10.33 17 188613 370 31508344
Encephalitis toxic 19.25 10.33 15 188615 273 31508441
Lung hernia 19.20 10.33 9 188621 60 31508654
Caesarean section 18.87 10.33 38 188592 1898 31506816
Mass 18.81 10.33 90 188540 7241 31501473
Poor venous access 18.57 10.33 60 188570 4020 31504694
Akathisia 18.54 10.33 10 188620 7243 31501471
Anaphylactic shock 18.47 10.33 35 188595 14110 31494604
Haematocrit decreased 18.44 10.33 266 188364 29795 31478919
Skin cancer 18.42 10.33 107 188523 9278 31499436
Proteinuria 18.16 10.33 46 188584 16717 31491997
Dyspraxia 18.13 10.33 17 188613 402 31508312
Hepatic failure 18.09 10.33 117 188513 32585 31476129
Nasal disorder 18.05 10.33 35 188595 1700 31507014
Back disorder 18.01 10.33 78 188552 6015 31502699
Joint range of motion decreased 17.98 10.33 83 188547 6578 31502136
Anal fistula 17.98 10.33 66 188564 4717 31503997
Progressive multifocal leukoencephalopathy 17.92 10.33 17 188613 9196 31499518
Musculoskeletal pain 17.92 10.33 263 188367 29565 31479149
C-reactive protein increased 17.89 10.33 397 188233 48253 31460461
Skin lesion 17.71 10.33 186 188444 19341 31489373
Second primary malignancy 17.54 10.33 10 188620 7022 31501692
Dyslexia 17.31 10.33 15 188615 319 31508395
Ear infection 17.27 10.33 101 188529 8780 31499934
Upper respiratory tract infection 17.13 10.33 258 188372 29164 31479550
Stevens-Johnson syndrome 17.07 10.33 50 188580 17322 31491392
Diaphragmatic disorder 17.06 10.33 27 188603 1114 31507600
Pathogen resistance 16.99 10.33 16 188614 8685 31500029
Immunodeficiency 16.88 10.33 64 188566 4645 31504069
Colorectal cancer 16.85 10.33 4 188626 4825 31503889
Product quality issue 16.85 10.33 45 188585 16066 31492648
Ear disorder 16.81 10.33 30 188600 1367 31507347
Bronchopulmonary aspergillosis 16.71 10.33 35 188595 13599 31495115
Metabolic acidosis 16.54 10.33 153 188477 39424 31469290
Back pain 16.54 10.33 803 187827 108610 31400104
Acute graft versus host disease 16.45 10.33 8 188622 6145 31502569
Cardio-respiratory arrest 16.41 10.33 213 188417 51513 31457201
Behaviour disorder 16.35 10.33 60 188570 4287 31504427
Malignant neoplasm progression 16.30 10.33 352 188278 78646 31430068
Myoclonus 16.25 10.33 37 188593 13953 31494761
Foetal disorder 16.22 10.33 22 188608 788 31507926
Arthritis bacterial 16.14 10.33 62 188568 4528 31504186
Multiple congenital abnormalities 16.07 10.33 18 188612 528 31508186
Incorrect route of product administration 16.03 10.33 28 188602 11645 31497069
Nephrolithiasis 16.01 10.33 240 188390 27099 31481615
Haemorrhage intracranial 15.88 10.33 42 188588 15046 31493668
Pancytopenia 15.87 10.33 653 187977 86663 31422051
Multiple organ dysfunction syndrome 15.84 10.33 298 188332 67905 31440809
Medical device implantation 15.83 10.33 19 188611 601 31508113
Lacrimal disorder 15.72 10.33 14 188616 309 31508405
Congenital bladder anomaly 15.66 10.33 13 188617 260 31508454
Red blood cell sedimentation rate increased 15.64 10.33 94 188536 8252 31500462
Limb reduction defect 15.62 10.33 13 188617 261 31508453
Cleft lip 15.61 10.33 14 188616 312 31508402
Tachycardia 15.60 10.33 340 188290 75867 31432847
Drug withdrawal syndrome neonatal 15.57 10.33 51 188579 3441 31505273
Radiation inflammation 15.49 10.33 18 188612 550 31508164
Osteonecrosis of jaw 15.45 10.33 51 188579 17020 31491694
Hypokalaemia 15.42 10.33 225 188405 53349 31455365
Blood parathyroid hormone decreased 15.41 10.33 28 188602 1294 31507420
Agitation neonatal 15.34 10.33 25 188605 1058 31507656
Weight decrease neonatal 15.28 10.33 14 188616 321 31508393
Posterior reversible encephalopathy syndrome 15.25 10.33 20 188610 9347 31499367
Malignant melanoma 15.21 10.33 88 188542 7619 31501095
Hepatic encephalopathy 15.21 10.33 37 188593 13634 31495080
Joint stiffness 15.19 10.33 107 188523 9914 31498800
Suspected suicide 15.15 10.33 3 188627 4104 31504610
Eosinophilia 15.11 10.33 79 188551 23174 31485540
Synovial cyst 14.98 10.33 36 188594 2029 31506685
Interstitial lung disease 14.97 10.33 266 188364 61137 31447577
Hyperammonaemia 14.97 10.33 8 188622 5825 31502889
Microcephaly 14.93 10.33 21 188609 779 31507935
Hydrocele 14.85 10.33 35 188595 1948 31506766
Red blood cell count decreased 14.81 10.33 233 188397 26574 31482140
Red blood cell sedimentation rate 14.79 10.33 24 188606 1012 31507702
Congenital foot malformation 14.71 10.33 15 188615 394 31508320
Ankyloglossia congenital 14.71 10.33 13 188617 284 31508430
Mean cell volume increased 14.70 10.33 44 188586 2828 31505886
Inguinal hernia 14.67 10.33 81 188549 6894 31501820
Spinal disorder 14.66 10.33 54 188576 3866 31504848
Chronic graft versus host disease 14.63 10.33 4 188626 4388 31504326
Cerebral haemorrhage 14.52 10.33 125 188505 32687 31476027
Attention deficit hyperactivity disorder 14.48 10.33 39 188591 2359 31506355
Loss of consciousness 14.46 10.33 350 188280 77005 31431709
Neck mass 14.42 10.33 30 188600 1534 31507180
Finger deformity 14.35 10.33 26 188604 1199 31507515
Kidney infection 14.27 10.33 62 188568 4788 31503926
Congenital anomaly 13.98 10.33 27 188603 1308 31507406
Renal aplasia 13.96 10.33 19 188611 683 31508031
Cystitis haemorrhagic 13.95 10.33 7 188623 5282 31503432
Haemangioma 13.95 10.33 32 188598 1750 31506964
Haemangioma congenital 13.92 10.33 16 188614 483 31508231
Obsessive-compulsive disorder 13.85 10.33 6 188624 4931 31503783
Electrocardiogram QRS complex prolonged 13.81 10.33 4 188626 4225 31504489
Plasma cell myeloma 13.75 10.33 245 188385 56286 31452428
Hallucination, visual 13.74 10.33 48 188582 15746 31492968
Oxygen saturation decreased 13.66 10.33 386 188244 48729 31459985
Septic arthritis staphylococcal 13.66 10.33 16 188614 493 31508221
Vitamin B12 deficiency 13.60 10.33 49 188581 3470 31505244
Cytomegalovirus viraemia 13.57 10.33 12 188618 6713 31502001
Bronchiolitis 13.48 10.33 43 188587 2861 31505853
Wrong technique in product usage process 13.46 10.33 130 188500 33213 31475501
Pectus excavatum 13.42 10.33 11 188619 216 31508498
Mobility decreased 13.42 10.33 234 188396 27235 31481479
Urinary tract infection 13.31 10.33 572 188058 76297 31432417
Arnold-Chiari malformation 13.27 10.33 13 188617 325 31508389
Arthrodesis 13.25 10.33 15 188615 445 31508269
Granuloma skin 13.25 10.33 24 188606 1107 31507607
Disseminated intravascular coagulation 13.21 10.33 70 188560 20467 31488247
Acute generalised exanthematous pustulosis 13.15 10.33 10 188620 6030 31502684
Oesophageal fibrosis 13.12 10.33 10 188620 176 31508538
BK virus infection 13.06 10.33 7 188623 5088 31503626
Hypocalcaemia 13.00 10.33 77 188553 21901 31486813
Respiratory disorder neonatal 13 10.33 28 188602 1467 31507247
Pharyngeal disorder 12.97 10.33 18 188612 659 31508055
Tooth malformation 12.88 10.33 10 188620 181 31508533
Stiff person syndrome 12.82 10.33 8 188622 100 31508614
Cardiotoxicity 12.75 10.33 7 188623 5020 31503694
Abdominal discomfort 12.64 10.33 399 188231 51168 31457546
Hyperkalaemia 12.63 10.33 289 188341 64062 31444652
Rhinocerebral mucormycosis 12.62 10.33 14 188616 406 31508308
Endophthalmitis 12.61 10.33 3 188627 3613 31505101
Asthma 12.60 10.33 178 188452 42433 31466281
Ventricular tachycardia 12.51 10.33 86 188544 23615 31485099
Hypertransaminasaemia 12.45 10.33 5 188625 4299 31504415
Skin abrasion 12.41 10.33 74 188556 6477 31502237
Pleural fibrosis 12.40 10.33 26 188604 1337 31507377
Cystatin C increased 12.39 10.33 3 188627 0 31508714
Hypertelorism 12.39 10.33 16 188614 546 31508168
Hallucination, auditory 12.36 10.33 27 188603 10333 31498381
Epidural lipomatosis 12.35 10.33 19 188611 765 31507949
Appendicitis 12.25 10.33 113 188517 11352 31497362
Extrapyramidal disorder 12.24 10.33 33 188597 11745 31496969
Bradycardia neonatal 12.21 10.33 21 188609 929 31507785
Restlessness 12.21 10.33 85 188545 23276 31485438
Gastric haemorrhage 12.16 10.33 25 188605 9780 31498934
Child abuse 12.14 10.33 13 188617 362 31508352
Maternal exposure timing unspecified 12.14 10.33 13 188617 362 31508352
Respiratory failure 12.13 10.33 487 188143 100962 31407752
Nocardiosis 12.05 10.33 3 188627 3504 31505210
Foetal heart rate deceleration abnormality 12.05 10.33 15 188615 493 31508221
Contusion 11.98 10.33 269 188361 32759 31475955
Foetal distress syndrome 11.97 10.33 22 188608 1026 31507688
Spinal stenosis 11.97 10.33 58 188572 4690 31504024
Headache 11.96 10.33 1258 187372 182394 31326320
Patent ductus arteriosus 11.95 10.33 44 188586 3149 31505565
Dystonia 11.91 10.33 27 188603 10198 31498516
Graft versus host disease in gastrointestinal tract 11.91 10.33 3 188627 3476 31505238
Drug dependence 11.88 10.33 82 188548 22497 31486217
Hepatitis E antibody positive 11.87 10.33 11 188619 256 31508458
Acute graft versus host disease in skin 11.87 10.33 7 188623 4825 31503889
Transplant rejection 11.83 10.33 25 188605 9683 31499031
Status epilepticus 11.78 10.33 35 188595 12071 31496643
Umbilical hernia 11.74 10.33 53 188577 4161 31504553
Hernia pain 11.66 10.33 11 188619 262 31508452
Nerve compression 11.59 10.33 41 188589 2877 31505837
Adenovirus infection 11.52 10.33 7 188623 4747 31503967
Pulmonary alveolar haemorrhage 11.48 10.33 14 188616 6752 31501962
Cardiac failure chronic 11.47 10.33 16 188614 7287 31501427
Pneumonia 11.47 10.33 2212 186418 333100 31175614
Thrombotic microangiopathy 11.47 10.33 24 188606 9327 31499387
Hypotension 11.46 10.33 1055 187575 203563 31305151
C-reactive protein decreased 11.45 10.33 30 188600 1785 31506929
Hepatitis fulminant 11.42 10.33 4 188626 3742 31504972
Tubulointerstitial nephritis 11.37 10.33 64 188566 18432 31490282
Hallucination 11.33 10.33 201 188429 46209 31462505
Infection 11.28 10.33 596 188034 81335 31427379
Full blood count decreased 11.21 10.33 149 188481 16391 31492323
Meningeal disorder 11.21 10.33 12 188618 334 31508380
Aphasia 11.18 10.33 71 188559 19860 31488854
Polydactyly 11.12 10.33 23 188607 1171 31507543
Cytokine release syndrome 11.11 10.33 56 188574 16586 31492128
Therapeutic response shortened 11.10 10.33 66 188564 5771 31502943
Vascular insufficiency 11.07 10.33 12 188618 339 31508375
Graft versus host disease 11.06 10.33 29 188601 10418 31498296
Gamma-glutamyltransferase increased 11.02 10.33 109 188521 27716 31480998
Accidental overdose 11.01 10.33 64 188566 18286 31490428
Renal injury 10.99 10.33 30 188600 10635 31498079
Neutrophil count decreased 10.99 10.33 202 188428 46192 31462522
Spina bifida 10.99 10.33 12 188618 342 31508372
Vomiting 10.98 10.33 1166 187464 222807 31285907
Developmental coordination disorder 10.97 10.33 9 188621 177 31508537
Blood folate decreased 10.96 10.33 17 188613 689 31508025
Neutropenia 10.95 10.33 704 187926 139660 31369054
Subdural haematoma 10.94 10.33 67 188563 18904 31489810
Hepatitis E virus test positive 10.94 10.33 11 188619 284 31508430
Anal atresia 10.94 10.33 11 188619 284 31508430
Drug use disorder 10.92 10.33 5 188625 3978 31504736
Tuberculosis 10.91 10.33 86 188544 8255 31500459
Crohn's disease 10.87 10.33 51 188579 4070 31504644
Abdominal distension 10.85 10.33 386 188244 50298 31458416
Blood insulin increased 10.85 10.33 12 188618 347 31508367
Respiratory rate increased 10.84 10.33 93 188537 9152 31499562
Coccydynia 10.84 10.33 14 188616 478 31508236
Urticaria 10.81 10.33 260 188370 57257 31451457
Loss of personal independence in daily activities 10.77 10.33 232 188398 28056 31480658
Bronchitis 10.69 10.33 304 188326 38413 31470301
Psychomotor retardation 10.68 10.33 43 188587 3209 31505505
Heart rate irregular 10.65 10.33 131 188499 14158 31494556
Cholelithiasis 10.64 10.33 169 188461 19310 31489404
Nodule 10.61 10.33 64 188566 5626 31503088
Cerebral infarction 10.61 10.33 101 188529 25876 31482838
Lipase increased 10.59 10.33 23 188607 8820 31499894
Palindromic rheumatism 10.56 10.33 9 188621 187 31508527
Ear malformation 10.52 10.33 11 188619 298 31508416
Catatonia 10.44 10.33 8 188622 4806 31503908
Abnormal behaviour 10.44 10.33 91 188539 23737 31484977
Hypertriglyceridaemia 10.44 10.33 19 188611 7779 31500935
Hyperthermia 10.42 10.33 28 188602 9976 31498738
Arthritis infective 10.38 10.33 40 188590 2925 31505789
Gangrene neonatal 10.36 10.33 9 188621 192 31508522

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
Rheumatoid arthritis 1399.12 9.88 5166 539235 286639 70097404
Completed suicide 1170.63 9.88 174 544227 226961 70157082
Toxicity to various agents 1034.46 9.88 850 543551 381322 70002721
Joint swelling 880.85 9.88 4063 540338 249148 70134895
Arthropathy 781.83 9.88 2732 541669 147325 70236718
Drug abuse 739.82 9.88 121 544280 147135 70236908
Pemphigus 727.30 9.88 1819 542582 81217 70302826
Hand deformity 704.13 9.88 1843 542558 84639 70299404
Systemic lupus erythematosus 693.54 9.88 2034 542367 99868 70284175
Synovitis 657.70 9.88 2335 542066 126893 70257150
Pain 655.65 9.88 7537 536864 621279 69762764
Glossodynia 642.66 9.88 1782 542619 84705 70299338
Drug interaction 620.73 9.88 1245 543156 380196 70003847
Arthralgia 608.06 9.88 6215 538186 497175 69886868
Infusion related reaction 549.83 9.88 2977 541424 194557 70189486
Anti-cyclic citrullinated peptide antibody positive 530.17 9.88 1455 542946 68730 70315313
Wound 517.75 9.88 1802 542599 96930 70287113
Pericarditis 507.31 9.88 1617 542784 83088 70300955
Maternal exposure during pregnancy 502.56 9.88 1983 542418 113362 70270681
Abdominal discomfort 488.88 9.88 3068 541333 211590 70172453
Alopecia 444.51 9.88 2825 541576 195665 70188378
Intentional overdose 428.20 9.88 113 544288 98322 70285721
Nasopharyngitis 424.25 9.88 3040 541361 219166 70164877
Contraindicated product administered 398.44 9.88 2064 542337 132548 70251495
Discomfort 392.90 9.88 1728 542673 103708 70280335
Therapeutic product effect decreased 388.67 9.88 2142 542259 140876 70243167
Acute kidney injury 385.02 9.88 2106 542295 472518 69911525
Swelling 383.04 9.88 2619 541782 185920 70198123
Hepatic enzyme increased 382.62 9.88 2284 542117 154706 70229337
Death 364.71 9.88 2356 542045 507705 69876338
Sinusitis 355.43 9.88 2370 542031 166825 70217218
Helicobacter infection 320.05 9.88 1048 543353 54608 70329435
Duodenal ulcer perforation 319.05 9.88 990 543411 50122 70333921
Rheumatoid factor positive 301.66 9.88 937 543464 47463 70336580
Peripheral swelling 297.16 9.88 2947 541454 233616 70150427
Febrile neutropenia 297.06 9.88 709 543692 203609 70180434
Musculoskeletal stiffness 295.50 9.88 2045 542356 145715 70238328
Lower respiratory tract infection 283.40 9.88 1645 542756 110268 70273775
Drug intolerance 273.55 9.88 2791 541610 222896 70161147
Suicide attempt 273.32 9.88 134 544267 79376 70304667
Cardiac arrest 261.78 9.88 519 543882 159315 70224728
Overdose 258.02 9.88 575 543826 169170 70214873
Exposure during pregnancy 245.73 9.88 1325 543076 86392 70297651
Impaired healing 239.38 9.88 1168 543233 73206 70310837
Hypersensitivity 236.01 9.88 2750 541651 227062 70156981
Psoriatic arthropathy 228.75 9.88 1045 543356 63726 70320317
Drug reaction with eosinophilia and systemic symptoms 211.49 9.88 90 544311 57923 70326120
Cardiac failure 210.23 9.88 496 543905 143045 70240998
Rhabdomyolysis 209.20 9.88 256 544145 95504 70288539
Fatigue 196.67 9.88 7958 536443 816361 69567682
Muscle injury 192.54 9.88 692 543709 37802 70346241
C-reactive protein abnormal 186.59 9.88 686 543715 37893 70346150
Renal failure 182.41 9.88 788 543613 188282 70195761
Irritable bowel syndrome 179.98 9.88 821 543580 50029 70334014
Lactic acidosis 178.71 9.88 142 544259 64882 70319161
Respiratory arrest 177.75 9.88 96 544305 53837 70330206
Product use issue 176.61 9.88 2135 542266 177802 70206241
Arthritis 176.10 9.88 1322 543079 96658 70287385
Folliculitis 175.75 9.88 720 543681 41850 70342193
Bradycardia 172.74 9.88 443 543958 124172 70259871
Sleep disorder due to general medical condition, insomnia type 171.66 9.88 634 543767 35098 70348945
Weight increased 171.02 9.88 2711 541690 239620 70144423
Sopor 170.33 9.88 20 544381 31247 70352796
Blister 164.96 9.88 1328 543073 99198 70284845
Red blood cell sedimentation rate abnormal 163.78 9.88 418 543983 18885 70365158
Blood pressure fluctuation 161.58 9.88 886 543515 58126 70325917
Hepatic function abnormal 161.32 9.88 170 544231 67826 70316217
Depressed level of consciousness 155.39 9.88 270 544131 87161 70296882
Neutropenia 154.63 9.88 1247 543154 255909 70128134
Malignant neoplasm progression 151.47 9.88 456 543945 121283 70262760
Serotonin syndrome 149.30 9.88 68 544333 42046 70341997
Sickle cell anaemia with crisis 149.27 9.88 206 544195 5772 70378271
Osteoarthritis 149.16 9.88 1028 543373 73119 70310924
Knee arthroplasty 148.66 9.88 589 543812 33712 70350331
Treatment failure 147.44 9.88 1724 542677 142418 70241625
Immunodeficiency 146.72 9.88 378 544023 17177 70366866
Hip arthroplasty 144.44 9.88 509 543892 27531 70356512
Cytomegalovirus infection 144.40 9.88 62 544339 39696 70344347
Renal impairment 143.67 9.88 592 543809 143345 70240698
Hypoglycaemia 133.45 9.88 332 544069 94032 70290011
Cardio-respiratory arrest 133.37 9.88 366 544035 100311 70283732
Electrocardiogram QT prolonged 131.73 9.88 277 544124 83240 70300803
Contusion 131.21 9.88 1532 542869 126504 70257539
Pregnancy 130.61 9.88 441 543960 23340 70360703
Ill-defined disorder 124.08 9.88 782 543619 53959 70330084
Fibromyalgia 122.59 9.88 706 543695 47168 70336875
Intentional self-injury 122.09 9.88 45 544356 31605 70352438
Drug resistance 121.50 9.88 71 544330 38119 70345924
Coma 120.83 9.88 335 544066 91509 70292534
Rash 119.62 9.88 4922 539479 505640 69878403
Hypotension 118.68 9.88 2288 542113 402093 69981950
Disease progression 118.11 9.88 711 543690 155961 70228082
Hepatic failure 114.67 9.88 165 544236 57460 70326583
Hyponatraemia 113.20 9.88 741 543660 159346 70224697
Agitation 111.71 9.88 356 544045 93019 70291024
Poisoning 106.20 9.88 22 544379 22600 70361443
Bursitis 106.06 9.88 446 543955 26227 70357816
Metabolic acidosis 104.00 9.88 263 544138 74083 70309960
Abortion spontaneous 103.92 9.88 441 543960 26038 70358005
Respiratory failure 103.31 9.88 814 543587 167921 70216122
Infection 102.85 9.88 2227 542174 208558 70175485
Blood pressure diastolic abnormal 102.04 9.88 306 544095 15198 70368845
Rheumatic fever 101.89 9.88 333 544068 17327 70366716
Thrombocytopenia 100.96 9.88 1262 543139 237848 70146195
Multiple organ dysfunction syndrome 100.52 9.88 459 543942 108056 70275987
Cholestasis 100.35 9.88 132 544269 47740 70336303
Grip strength decreased 99.88 9.88 306 544095 15379 70368664
Tachycardia 98.39 9.88 762 543639 157784 70226259
Product use in unapproved indication 97.26 9.88 1070 543331 206408 70177635
Pain in extremity 96.54 9.88 3245 541156 324837 70059206
Somnolence 95.94 9.88 1125 543276 214481 70169562
Altered state of consciousness 95.00 9.88 100 544301 39922 70344121
Hepatocellular injury 94.67 9.88 129 544272 45962 70338081
Temperature regulation disorder 91.81 9.88 140 544261 4304 70379739
Blood pressure systolic increased 90.96 9.88 751 543650 56508 70327535
Blood pressure systolic abnormal 90.91 9.88 261 544140 12648 70371395
Hyperglycaemia 89.52 9.88 230 544171 64442 70319601
Hyperkalaemia 88.84 9.88 468 543933 106123 70277920
Angioedema 88.32 9.88 242 544159 66368 70317675
Disseminated intravascular coagulation 86.64 9.88 78 544323 33520 70350523
Shock 86.25 9.88 110 544291 40315 70343728
Gastrointestinal disorder 85.37 9.88 1208 543193 104219 70279824
Red blood cell sedimentation rate increased 84.46 9.88 547 543854 38095 70345948
Swollen joint count increased 84.20 9.88 264 544137 13436 70370607
Syncope 83.16 9.88 841 543560 164868 70219175
Acute hepatic failure 83.11 9.88 55 544346 27617 70356426
Osteoporosis 82.87 9.88 651 543750 48256 70335787
Seizure 81.33 9.88 923 543478 177039 70207004
Joint effusion 80.62 9.88 282 544119 15195 70368848
Device expulsion 80.29 9.88 35 544366 22211 70361832
Enthesopathy 79.70 9.88 223 544178 10646 70373397
Foot deformity 79.51 9.88 342 544059 20313 70363730
Blood creatine phosphokinase increased 79.43 9.88 225 544176 61038 70323005
Neuroleptic malignant syndrome 79.04 9.88 51 544350 25956 70358087
Loss of personal independence in daily activities 77.00 9.88 993 543408 83917 70300126
Leukopenia 76.95 9.88 490 543911 106070 70277973
Ear pain 76.63 9.88 416 543985 27183 70356860
Injection site erythema 75.75 9.88 875 543526 72049 70311994
Drug dependence 75.10 9.88 106 544295 37215 70346828
Plasma cell myeloma 74.94 9.88 298 544103 72903 70311140
Coeliac disease 72.92 9.88 192 544209 8841 70375202
Night sweats 72.66 9.88 579 543822 43105 70340938
Injection site reaction 72.42 9.88 641 543760 49211 70334832
Blood pressure diastolic decreased 71.18 9.88 388 544013 25392 70358651
Delirium 70.66 9.88 313 544088 74301 70309742
Injection site pruritus 70.38 9.88 529 543872 38681 70345362
Inflammation 70.08 9.88 917 543484 77748 70306295
Sedation 69.55 9.88 160 544241 46571 70337472
Intentional product misuse 69.42 9.88 344 544057 79251 70304792
Disability assessment scale score increased 69.16 9.88 99 544302 2872 70381171
Myocardial infarction 68.69 9.88 916 543485 170729 70213314
Pulmonary arterial hypertension 68.45 9.88 91 544310 32764 70351279
Post transplant lymphoproliferative disorder 68.06 9.88 3 544398 10542 70373501
Femur fracture 68.00 9.88 493 543908 35639 70348404
Condition aggravated 67.93 9.88 3970 540431 423665 69960378
Immune reconstitution inflammatory syndrome 66.71 9.88 10 544391 12980 70371063
Disorientation 65.71 9.88 226 544175 57697 70326346
Food allergy 65.59 9.88 178 544223 8346 70375697
Heart rate decreased 65.26 9.88 746 543655 61269 70322774
Juvenile idiopathic arthritis 64.93 9.88 140 544261 5660 70378383
Mobility decreased 64.70 9.88 1131 543270 101868 70282175
Rheumatoid nodule 64.69 9.88 258 544143 14809 70369234
Hypokalaemia 64.08 9.88 670 543731 130518 70253525
Anaemia 63.81 9.88 2491 541910 400932 69983111
Psychotic disorder 63.77 9.88 120 544281 37581 70346462
Live birth 63.27 9.88 241 544160 13538 70370505
Drug withdrawal syndrome 62.82 9.88 96 544305 32619 70351424
Stomatitis 62.38 9.88 1357 543044 127154 70256889
Blood cholesterol increased 62.18 9.88 764 543637 63840 70320203
Diabetic ketoacidosis 61.93 9.88 91 544310 31421 70352622
Anaphylactic shock 61.75 9.88 96 544305 32394 70351649
Musculoskeletal pain 61.53 9.88 1005 543396 89322 70294721
Cerebral haemorrhage 61.22 9.88 210 544191 53654 70330389
Drug level increased 60.88 9.88 117 544284 36352 70347691
Agranulocytosis 60.77 9.88 137 544264 40161 70343882
Mydriasis 60.58 9.88 24 544377 16129 70367914
Joint stiffness 60.02 9.88 469 543932 34707 70349336
Suicidal ideation 60.00 9.88 302 544099 69294 70314749
Tenosynovitis 59.75 9.88 239 544162 13737 70370306
Ventricular tachycardia 58.95 9.88 119 544282 36304 70347739
Blood pressure increased 58.81 9.88 1878 542523 186639 70197404
Extrapyramidal disorder 58.68 9.88 44 544357 20706 70363337
Aspergillus infection 58.58 9.88 32 544369 17836 70366207
Hallucination 58.53 9.88 344 544057 75916 70308127
Encephalopathy 58.18 9.88 259 544142 61402 70322641
Palmar-plantar erythrodysaesthesia syndrome 57.84 9.88 89 544312 30158 70353885
Venoocclusive liver disease 57.74 9.88 7 544394 10671 70373372
Torsade de pointes 57.17 9.88 34 544367 18082 70365961
Ear infection 57.04 9.88 393 544008 27943 70356100
Myoclonus 56.96 9.88 71 544330 26284 70357759
Substance abuse 56.93 9.88 5 544396 9832 70374211
Tremor 56.76 9.88 846 543555 154778 70229265
Loss of consciousness 56.63 9.88 847 543554 154869 70229174
Cerebral infarction 56.46 9.88 157 544244 42852 70341191
Cardiac failure congestive 56.34 9.88 717 543684 134740 70249303
Eosinophilia 56.09 9.88 143 544258 40176 70343867
Psoriasis 55.91 9.88 1064 543337 97369 70286674
Aggression 55.65 9.88 188 544213 48258 70335785
Rash maculo-papular 55.47 9.88 200 544201 50345 70333698
Bone erosion 55.18 9.88 247 544154 14926 70369117
Upper respiratory tract infection 55.10 9.88 885 543516 78389 70305654
Carpal tunnel syndrome 54.93 9.88 268 544133 16789 70367254
Localised infection 54.87 9.88 439 543962 32719 70351324
Joint laxity 54.54 9.88 78 544323 2261 70381782
Polycystic ovaries 54.49 9.88 87 544314 2785 70381258
Joint range of motion decreased 54.20 9.88 364 544037 25662 70358381
Muscle spasticity 54.14 9.88 296 544105 19393 70364650
Drug ineffective 53.53 9.88 8103 536298 931649 69452394
Oropharyngeal pain 53.32 9.88 1037 543364 95273 70288770
Abnormal behaviour 53.15 9.88 117 544284 34592 70349451
Bronchopulmonary aspergillosis 52.68 9.88 50 544351 20952 70363091
Sensitisation 52.64 9.88 79 544322 2394 70381649
Accidental overdose 52.47 9.88 120 544281 35001 70349042
Blood pressure diastolic increased 52.26 9.88 211 544190 12180 70371863
Intentional product use issue 52.19 9.88 1249 543152 118893 70265150
Neurotoxicity 52.17 9.88 93 544308 29733 70354310
Injection site pain 52.08 9.88 1226 543175 116393 70267650
Transplant rejection 52.07 9.88 38 544363 18133 70365910
Akathisia 51.77 9.88 15 544386 12278 70371765
Hypoxia 51.37 9.88 463 543938 92881 70291162
Injection site swelling 50.86 9.88 531 543870 42626 70341417
C-reactive protein increased 50.48 9.88 1157 543244 109360 70274683
Posterior reversible encephalopathy syndrome 50.41 9.88 68 544333 24334 70359709
Toxic epidermal necrolysis 50.01 9.88 147 544254 39410 70344633
Respiratory distress 49.50 9.88 233 544168 54417 70329626
Hypothermia 49.39 9.88 51 544350 20543 70363500
Interstitial lung disease 49.36 9.88 539 543862 104146 70279897
Thrombotic microangiopathy 49.00 9.88 39 544362 17809 70366234
Gamma-glutamyltransferase increased 48.97 9.88 211 544190 50474 70333569
Proteinuria 48.37 9.88 95 544306 29279 70354764
Neuropathy peripheral 48.31 9.88 684 543717 126212 70257831
Status epilepticus 48.03 9.88 71 544330 24455 70359588
Ejection fraction decreased 47.68 9.88 103 544298 30659 70353384
Polyarthritis 47.65 9.88 186 544215 10570 70373473
Caesarean section 47.64 9.88 196 544205 11411 70372632
Drug use disorder 47.57 9.88 4 544397 8147 70375896
Ejection fraction 47.46 9.88 63 544338 1699 70382344
Ischaemic stroke 47.11 9.88 104 544297 30716 70353327
Neutrophil count decreased 47.06 9.88 412 543989 83144 70300899
Asphyxia 46.64 9.88 11 544390 10331 70373712
Mucormycosis 46.58 9.88 4 544397 8010 70376033
Haemorrhage intracranial 46.34 9.88 74 544327 24703 70359340
Psychomotor hyperactivity 45.90 9.88 31 544370 15402 70368641
Gestational diabetes 45.86 9.88 125 544276 5876 70378167
Tongue disorder 45.63 9.88 212 544189 13015 70371028
Haematotoxicity 45.55 9.88 24 544377 13650 70370393
Acute graft versus host disease 45.51 9.88 9 544392 9553 70374490
Miosis 45.16 9.88 26 544375 14075 70369968
Blood creatinine increased 44.98 9.88 799 543602 142202 70241841
Melaena 44.97 9.88 251 544150 56104 70327939
Disturbance in attention 44.93 9.88 173 544228 42721 70341322
Headache 44.87 9.88 5099 539302 575306 69808737
Restlessness 44.72 9.88 169 544232 41959 70342084
Joint destruction 44.66 9.88 106 544295 4572 70379471
Laryngitis 44.49 9.88 215 544186 13416 70370627
Basal cell carcinoma 44.24 9.88 424 543977 33274 70350769
Cytokine release syndrome 44.10 9.88 85 544316 26382 70357661
Body temperature decreased 43.90 9.88 373 544028 28299 70355744
Graft versus host disease 43.59 9.88 31 544370 14992 70369051
Synovial cyst 43.57 9.88 157 544244 8585 70375458
Second primary malignancy 43.34 9.88 23 544378 13028 70371015
Herpes zoster 43.27 9.88 906 543495 84329 70299714
Unresponsive to stimuli 43.26 9.88 228 544173 51703 70332340
Multiple fractures 43.09 9.88 132 544269 6633 70377410
Disability 42.38 9.88 227 544174 14756 70369287
Arrhythmia 42.16 9.88 255 544146 55888 70328155
Dyspnoea 41.82 9.88 5225 539176 764835 69619208
Adverse event 41.74 9.88 571 543830 48890 70335153
Nodule 41.41 9.88 279 544122 19690 70364353
Osteonecrosis of jaw 41.28 9.88 168 544233 40834 70343209
Inappropriate antidiuretic hormone secretion 41.23 9.88 72 544329 23204 70360839
Drug ineffective for unapproved indication 40.65 9.88 155 544246 38383 70345660
Acute generalised exanthematous pustulosis 40.59 9.88 35 544366 15362 70368681
Oral herpes 40.45 9.88 321 544080 23865 70360178
Colorectal cancer 40.25 9.88 8 544393 8462 70375581
Haemophagocytic lymphohistiocytosis 40.16 9.88 55 544346 19557 70364486
Tendonitis 40.00 9.88 299 544102 21823 70362220
Injection site bruising 39.78 9.88 457 543944 37575 70346468
Mental status changes 39.71 9.88 302 544099 62799 70321244
Anaphylactic reaction 39.48 9.88 376 544025 74598 70309445
Red blood cell sedimentation rate 39.26 9.88 104 544297 4806 70379237
Atrial fibrillation 39.09 9.88 1096 543305 183252 70200791
Blood bilirubin increased 38.98 9.88 284 544117 59617 70324426
Irritability 38.87 9.88 156 544245 38069 70345974
Stevens-Johnson syndrome 38.79 9.88 143 544258 35764 70348279
Pyrexia 38.77 9.88 4073 540328 602879 69781164
Tenderness 38.54 9.88 287 544114 20923 70363120
Jaundice 38.47 9.88 226 544175 49882 70334161
Maternal exposure before pregnancy 38.10 9.88 88 544313 3728 70380315
Dehydration 37.98 9.88 1386 543015 224756 70159287
Product administration error 37.84 9.88 109 544292 29414 70354629
Hallucination, visual 37.83 9.88 108 544293 29229 70354814
Pathogen resistance 37.75 9.88 28 544373 13251 70370792
Unintentional medical device removal 37.72 9.88 5 544396 7119 70376924
Acute myeloid leukaemia 37.67 9.88 117 544284 30823 70353220
Pulmonary fibrosis 37.57 9.88 416 543985 33894 70350149
Schizophrenia 37.48 9.88 44 544357 16724 70367319
Myalgia 37.46 9.88 991 543410 166901 70217142
Dyskinesia 37.27 9.88 175 544226 40899 70343144
Tachypnoea 37.25 9.88 105 544296 28533 70355510
Hyperthermia 36.99 9.88 44 544357 16627 70367416
Pancreatitis acute 36.87 9.88 200 544201 45024 70339019
Vomiting 36.68 9.88 3989 540412 589122 69794921
Sepsis 36.45 9.88 1520 542881 243025 70141018
Face oedema 36.39 9.88 90 544311 25549 70358494
Polyneuropathy 36.36 9.88 68 544333 21347 70362696
Alanine aminotransferase abnormal 36.22 9.88 140 544261 7919 70376124
Spinal stenosis 36.15 9.88 214 544187 14439 70369604
Acute respiratory distress syndrome 36.13 9.88 178 544223 41076 70342967
Bronchitis 36.02 9.88 1166 543235 116077 70267966
Brain oedema 35.81 9.88 79 544322 23339 70360704
Dystonia 35.78 9.88 60 544341 19646 70364397
Neck deformity 35.71 9.88 55 544346 1706 70382337
Muscle rigidity 35.54 9.88 55 544346 18595 70365448
Coagulopathy 35.54 9.88 133 544268 33116 70350927
Product quality issue 35.51 9.88 118 544283 30443 70353600
Pre-eclampsia 35.38 9.88 120 544281 6365 70377678
Body temperature increased 35.32 9.88 464 543937 39370 70344673
Neoplasm progression 35.25 9.88 203 544198 45025 70339018
Dysarthria 35.20 9.88 307 544094 62006 70322037
Toxic skin eruption 35.14 9.88 63 544338 20099 70363944
Injection site rash 35.07 9.88 231 544170 16179 70367864
BK virus infection 35.05 9.88 9 544392 7980 70376063
Subdural haematoma 34.82 9.88 112 544289 29186 70354857
Wrong technique in product usage process 34.71 9.88 348 544053 68350 70315693
Febrile bone marrow aplasia 34.46 9.88 25 544376 11966 70372077
Joint injury 34.44 9.88 337 544064 26595 70357448
Exostosis 34.43 9.88 208 544193 14137 70369906
Cytomegalovirus viraemia 34.05 9.88 24 544377 11661 70372382
Hypertransaminasaemia 34.01 9.88 13 544388 8930 70375113
Bradyphrenia 33.81 9.88 17 544384 9929 70374114
Limb deformity 33.61 9.88 79 544322 3386 70380657
Tumour lysis syndrome 33.54 9.88 71 544330 21289 70362754
Latent tuberculosis 33.42 9.88 74 544327 3047 70380996
Acute graft versus host disease in skin 33.38 9.88 7 544394 7130 70376913
Anxiety 33.36 9.88 1367 543034 218963 70165080
Gastroenteritis viral 33.32 9.88 280 544121 21175 70362868
Influenza 33.20 9.88 1124 543277 112576 70271467
Septic shock 33.18 9.88 634 543767 111624 70272419
Crystal nephropathy 33.03 9.88 45 544356 1245 70382798
Hyperammonaemia 32.93 9.88 19 544382 10274 70373769
No adverse event 32.83 9.88 131 544270 32022 70352021
Speech disorder 32.82 9.88 240 544161 50340 70333703
Foot fracture 32.70 9.88 260 544141 19340 70364703
Premature rupture of membranes 32.64 9.88 84 544317 3814 70380229
Coombs positive haemolytic anaemia 32.58 9.88 38 544363 895 70383148
Forced expiratory volume decreased 32.55 9.88 8 544393 7306 70376737
Blood glucose increased 32.50 9.88 575 543826 102407 70281636
Erythema multiforme 32.39 9.88 48 544353 16516 70367527
Hypomagnesaemia 32.29 9.88 182 544219 40582 70343461
Pemphigoid 32.20 9.88 36 544365 13986 70370057
Skin ulcer 32.15 9.88 534 543867 47611 70336432
Poor venous access 32.15 9.88 211 544190 14760 70369283
Pulmonary embolism 31.94 9.88 931 543470 154936 70229107
Rhinorrhoea 31.92 9.88 700 543701 65671 70318372
Hepatic encephalopathy 31.90 9.88 77 544324 22041 70362002
Graft versus host disease in gastrointestinal tract 31.89 9.88 4 544397 5940 70378103
Chronic kidney disease 31.81 9.88 307 544094 60750 70323293
Tubulointerstitial nephritis 31.76 9.88 138 544263 32938 70351105
Gastrointestinal haemorrhage 31.45 9.88 808 543593 136600 70247443
Hyperbilirubinaemia 31.42 9.88 80 544321 22488 70361555
Fracture 31.35 9.88 261 544140 19683 70364360
Arthritis infective 31.09 9.88 126 544275 7286 70376757
Bone disorder 30.84 9.88 235 544166 17255 70366788
Neck mass 30.81 9.88 86 544315 4100 70379943
Pulmonary oedema 30.78 9.88 445 543956 81833 70302210
Pleural effusion 30.76 9.88 780 543621 132084 70251959
Aphasia 30.63 9.88 200 544201 43049 70340994
Blood alkaline phosphatase increased 30.59 9.88 294 544107 58227 70325816
Red blood cell count decreased 30.35 9.88 566 543835 51595 70332448
Shock haemorrhagic 30.30 9.88 58 544343 18048 70365995
Labelled drug-drug interaction medication error 30.25 9.88 90 544311 24037 70360006
Hepatitis B reactivation 30.25 9.88 3 544398 5352 70378691
Epstein-Barr virus infection 30.19 9.88 34 544367 13164 70370879
Nightmare 29.74 9.88 80 544321 22076 70361967
Mania 29.63 9.88 54 544347 17120 70366923
Fear 29.58 9.88 73 544328 20738 70363305
Coronary artery disease 29.57 9.88 323 544078 62413 70321630
Hallucination, auditory 29.55 9.88 60 544341 18268 70365775
Hypocalcaemia 29.52 9.88 212 544189 44647 70339396
Anuria 29.48 9.88 67 544334 19586 70364457
Tardive dyskinesia 29.46 9.88 20 544381 9909 70374134
Premature delivery 29.44 9.88 271 544130 21033 70363010
Hepatotoxicity 29.37 9.88 207 544194 43779 70340264
Smear cervix abnormal 29.34 9.88 60 544341 2336 70381707
Metastases to liver 29.33 9.88 101 544300 25777 70358266
Back pain 29.25 9.88 2439 541962 268713 70115330
Potentiating drug interaction 29.22 9.88 13 544388 8151 70375892
Stress cardiomyopathy 29.08 9.88 20 544381 9842 70374201
Clostridium difficile colitis 29.07 9.88 119 544282 28877 70355166
Chronic graft versus host disease 29.00 9.88 8 544393 6762 70377281
Acute coronary syndrome 28.88 9.88 70 544331 20009 70364034
Device use error 28.52 9.88 8 544393 6688 70377355
Hepatocellular carcinoma 28.41 9.88 22 544379 10186 70373857
Adenovirus infection 28.39 9.88 12 544389 7756 70376287
Sinus bradycardia 28.28 9.88 90 544311 23533 70360510
Delusion 28.21 9.88 66 544335 19099 70364944
Haematoma 28.03 9.88 237 544164 48181 70335862
Hyperuricaemia 27.63 9.88 26 544375 10940 70373103
Catatonia 27.50 9.88 14 544387 8119 70375924
Cardiac failure chronic 27.49 9.88 23 544378 10246 70373797
Hemiplegia 27.43 9.88 40 544361 13855 70370188
Maternal exposure timing unspecified 27.34 9.88 85 544316 4306 70379737
Joint dislocation 27.18 9.88 198 544203 14333 70369710
Wheelchair user 27.15 9.88 95 544306 5119 70378924
Exposure to toxic agent 27.13 9.88 7 544394 6187 70377856
Tenosynovitis stenosans 26.91 9.88 57 544344 2276 70381767
Pulmonary hypertension 26.85 9.88 228 544173 46308 70337735
Respiratory depression 26.75 9.88 99 544302 24732 70359311
Weight decreased 26.59 9.88 2747 541654 307741 70076302
Bronchospasm 26.48 9.88 88 544313 22704 70361339
Oliguria 26.26 9.88 47 544354 15004 70369039
Haemoptysis 26.25 9.88 260 544141 51192 70332851
Nocardiosis 26.22 9.88 4 544397 5125 70378918
Nausea 26.18 9.88 5967 538434 846121 69537922
Premature labour 25.98 9.88 126 544275 7874 70376169
Cardiac failure acute 25.92 9.88 60 544341 17427 70366616
Joint noise 25.76 9.88 71 544330 3360 70380683
Fracture delayed union 25.74 9.88 52 544349 2007 70382036
Foot operation 25.73 9.88 89 544312 4768 70379275
Urinary retention 25.72 9.88 268 544133 52252 70331791
Blood test abnormal 25.70 9.88 196 544205 14394 70369649
Endophthalmitis 25.68 9.88 8 544393 6247 70377796
Progressive multifocal leukoencephalopathy 25.32 9.88 70 544331 19144 70364899
Fear of injection 25.31 9.88 110 544291 6562 70377481
Cataract 25.23 9.88 582 543819 55063 70328980
Ileus 25.22 9.88 98 544303 24139 70359904
Metastases to bone 24.91 9.88 88 544313 22288 70361755
Renal injury 24.85 9.88 54 544347 16040 70368003
Mass 24.80 9.88 209 544192 15817 70368226
Dizziness 24.77 9.88 3152 541249 460989 69923054
Device difficult to use 24.76 9.88 28 544373 10821 70373222
Rotator cuff repair 24.70 9.88 45 544356 1606 70382437
Breast cancer stage I 24.70 9.88 8 544393 6094 70377949
Dysphagia 24.64 9.88 668 543733 112166 70271877
Cystitis haemorrhagic 24.58 9.88 18 544383 8575 70375468
Dry eye 24.57 9.88 366 544035 31916 70352127
Hepatic cytolysis 24.49 9.88 71 544330 19121 70364922
Nephrectomy 24.31 9.88 47 544354 1756 70382287
Haemorrhage 24.26 9.88 475 543926 83340 70300703
Lip dry 24.20 9.88 143 544258 9642 70374401
Post procedural infection 24.14 9.88 149 544252 10204 70373839
Pancreatitis 24.12 9.88 337 544064 62331 70321712
Metastases to lung 24.08 9.88 57 544344 16427 70367616
Ascites 23.99 9.88 369 544032 67178 70316865
Leukocytosis 23.95 9.88 192 544209 39476 70344567
Glycosylated haemoglobin increased 23.94 9.88 62 544339 17329 70366714
Sinus tachycardia 23.93 9.88 157 544244 33756 70350287
Rebound effect 23.87 9.88 8 544393 5963 70378080
Cardiotoxicity 23.74 9.88 30 544371 11040 70373003
Angina pectoris 23.65 9.88 247 544154 48136 70335907
Bone marrow failure 23.63 9.88 251 544150 48759 70335284
Acute myocardial infarction 23.63 9.88 405 543996 72482 70311561
Surgery 23.61 9.88 342 544059 29647 70354396
Sciatica 23.59 9.88 291 544110 24336 70359707
Skin papilloma 23.55 9.88 93 544308 5313 70378730
Platelet count decreased 23.42 9.88 1123 543278 177099 70206944
Lupus vasculitis 23.20 9.88 24 544377 492 70383551
Musculoskeletal disorder 23.19 9.88 245 544156 19726 70364317
Type 2 diabetes mellitus 23.17 9.88 471 543930 43609 70340434
Blood parathyroid hormone decreased 23.04 9.88 133 544268 8891 70375152
Ileus paralytic 22.99 9.88 20 544381 8741 70375302
Haemodynamic instability 22.98 9.88 54 544347 15604 70368439
Aspartate aminotransferase increased 22.96 9.88 771 543630 126207 70257836
Mouth ulceration 22.94 9.88 381 544020 33968 70350075
Victim of child abuse 22.94 9.88 32 544369 906 70383137
Klebsiella infection 22.86 9.88 47 544354 14245 70369798
Pruritus 22.84 9.88 3007 541394 342553 70041490
Granuloma skin 22.83 9.88 118 544283 7564 70376479
Cerebrovascular accident 22.81 9.88 885 543516 142585 70241458
Cyanosis 22.79 9.88 96 544305 23110 70360933
Generalised tonic-clonic seizure 22.76 9.88 207 544194 41454 70342589
Hepatitis fulminant 22.75 9.88 11 544390 6570 70377473
Electrocardiogram QRS complex prolonged 22.71 9.88 25 544376 9781 70374262
Endodontic procedure 22.63 9.88 56 544345 2481 70381562
Myelosuppression 22.59 9.88 137 544264 30008 70354035
Peripheral venous disease 22.57 9.88 150 544251 10537 70373506
Hepatitis cholestatic 22.52 9.88 39 544362 12611 70371432
Cyst 22.48 9.88 171 544230 12548 70371495
Cellulitis 22.42 9.88 951 543450 97977 70286066
Polyuria 22.38 9.88 43 544358 13363 70370680
Hyperthyroidism 22.37 9.88 79 544322 20012 70364031
Pulmonary alveolar haemorrhage 22.34 9.88 28 544373 10341 70373702
Acute chest syndrome 22.31 9.88 32 544369 930 70383113
Affective disorder 22.28 9.88 15 544386 7464 70376579
Withdrawal syndrome 22.07 9.88 107 544294 24797 70359246
Pharyngitis streptococcal 22.04 9.88 136 544265 9312 70374731
Synovial fluid analysis 21.95 9.88 46 544355 1823 70382220
Therapeutic response decreased 21.93 9.88 596 543805 57857 70326186
Haematemesis 21.91 9.88 254 544147 48543 70335500
Loose body in joint 21.87 9.88 37 544364 1244 70382799
Transplant dysfunction 21.75 9.88 13 544388 6896 70377147
Intracranial pressure increased 21.58 9.88 15 544386 7341 70376702
Gastric haemorrhage 21.57 9.88 48 544353 14137 70369906
Myopathy 21.53 9.88 72 544329 18540 70365503
Decreased appetite 21.36 9.88 2031 542370 302749 70081294
Cytomegalovirus chorioretinitis 21.35 9.88 7 544394 5291 70378752
Blood lactic acid increased 21.24 9.88 33 544368 11140 70372903
Injection site warmth 21.24 9.88 180 544221 13645 70370398
Metastases to central nervous system 21.16 9.88 53 544348 14981 70369062
Nephropathy toxic 21.16 9.88 72 544329 18442 70365601
Infection susceptibility increased 21.03 9.88 60 544341 2897 70381146
Transaminases increased 21.01 9.88 245 544156 46773 70337270
Retinitis 20.98 9.88 75 544326 4085 70379958
Atrioventricular block 20.92 9.88 41 544360 12647 70371396
Acidosis 20.88 9.88 71 544330 18192 70365851
Ulcer 20.79 9.88 295 544106 25459 70358584
Muscle twitching 20.74 9.88 80 544321 19747 70364296
Cytopenia 20.74 9.88 66 544335 17257 70366786
Skin cancer 20.67 9.88 176 544225 13360 70370683
Epilepsy 20.63 9.88 194 544207 38590 70345453
Acute lymphocytic leukaemia recurrent 20.62 9.88 6 544395 4898 70379145
Lupus-like syndrome 20.46 9.88 155 544246 11360 70372683
Hyperhidrosis 20.41 9.88 814 543587 130772 70253271
Facet joint syndrome 20.37 9.88 97 544304 6016 70378027
Depression 20.36 9.88 1285 543116 197689 70186354
Accidental exposure to product 20.23 9.88 129 544272 27922 70356121
Bone density decreased 20.14 9.88 154 544247 11320 70372723
Hypoalbuminaemia 20.10 9.88 77 544324 19045 70364998
Pneumatosis intestinalis 20.10 9.88 10 544391 5877 70378166
Graft versus host disease in skin 20.09 9.88 9 544392 5621 70378422
Pulmonary congestion 20.08 9.88 112 544289 25042 70359001
Hyperlactacidaemia 19.92 9.88 7 544394 5065 70378978
Deafness transitory 19.77 9.88 30 544371 918 70383125
Hepatitis C 19.75 9.88 43 544358 12764 70371279
Deep vein thrombosis 19.67 9.88 676 543725 110366 70273677
Oesophageal carcinoma 19.45 9.88 26 544375 9340 70374703
Obstructive airways disorder 19.40 9.88 119 544282 25994 70358049
Kidney transplant rejection 19.34 9.88 29 544372 9932 70374111
Parkinsonism 19.34 9.88 57 544344 15268 70368775
Hemiparesis 19.15 9.88 152 544249 31317 70352726
Lip swelling 19.13 9.88 168 544233 33886 70350157
Abdominal pain upper 19.08 9.88 1730 542671 191872 70192171
Bradypnoea 19.06 9.88 9 544392 5450 70378593
Haematocrit decreased 19.05 9.88 575 543826 56683 70327360
Wound infection 18.89 9.88 212 544189 17330 70366713
Bradykinesia 18.65 9.88 18 544383 7484 70376559
Spinal disorder 18.63 9.88 128 544273 9092 70374951
Cystitis 18.58 9.88 482 543919 46459 70337584
Aplasia 18.49 9.88 17 544384 7234 70376809
Enterocolitis 18.44 9.88 46 544355 13020 70371023
Presyncope 18.35 9.88 191 544210 37247 70346796
Malignant melanoma 18.30 9.88 175 544226 13725 70370318
Myocarditis 18.29 9.88 78 544323 18715 70365328
Persecutory delusion 18.15 9.88 6 544395 4511 70379532
Myocardial ischaemia 18.12 9.88 110 544291 24090 70359953
Tuberculosis 18.11 9.88 184 544217 14664 70369379
Haemoglobin decreased 18.10 9.88 1819 542582 203340 70180703
Haemolysis 18.07 9.88 151 544250 11400 70372643
Respiratory acidosis 18.03 9.88 32 544369 10249 70373794
Scleritis 18.01 9.88 65 544336 3557 70380486
Dislocation of vertebra 17.99 9.88 80 544321 4820 70379223
Foetal death 17.97 9.88 95 544306 6144 70377899
Sexual dysfunction 17.84 9.88 15 544386 6666 70377377
Cognitive disorder 17.78 9.88 345 544056 60611 70323432
Synovial disorder 17.70 9.88 31 544370 1072 70382971
Spinal osteoarthritis 17.69 9.88 188 544213 15160 70368883
Polyhydramnios 17.61 9.88 37 544364 1469 70382574
Virologic failure 17.55 9.88 4 544397 3846 70380197
Hyperprolactinaemia 17.49 9.88 6 544395 4407 70379636
Panniculitis 17.47 9.88 141 544260 10535 70373508
Diabetes insipidus 17.42 9.88 7 544394 4664 70379379
Dermatitis acneiform 17.41 9.88 26 544375 8919 70375124
Multiple sclerosis relapse 17.39 9.88 229 544172 42788 70341255
Breast feeding 17.37 9.88 24 544377 673 70383370
Body tinea 17.37 9.88 35 544366 1348 70382695
Right ventricular failure 17.34 9.88 100 544301 22174 70361869
Atrioventricular block complete 17.30 9.88 59 544342 15104 70368939
Malignant mediastinal neoplasm 17.28 9.88 27 544374 848 70383195
Dermatitis bullous 17.17 9.88 46 544355 12711 70371332
Lipase increased 16.94 9.88 60 544341 15186 70368857
Orthostatic hypotension 16.93 9.88 287 544114 51456 70332587
Breast cancer stage II 16.92 9.88 10 544391 5336 70378707
Tooth disorder 16.91 9.88 268 544133 23670 70360373
Pneumonia bacterial 16.86 9.88 68 544333 16573 70367470
Hepatitis acute 16.85 9.88 53 544348 13909 70370134
Peripheral sensory neuropathy 16.80 9.88 43 544358 12067 70371976
Pulseless electrical activity 16.78 9.88 49 544352 13166 70370877
Multiple-drug resistance 16.76 9.88 19 544382 7336 70376707
Strongyloidiasis 16.71 9.88 4 544397 3719 70380324
Jaundice cholestatic 16.64 9.88 28 544373 9156 70374887
Ataxia 16.63 9.88 107 544294 23110 70360933
Bladder cancer 16.52 9.88 72 544329 17170 70366873
Induced labour 16.47 9.88 26 544375 824 70383219
Haematuria 16.42 9.88 367 544034 63206 70320837
Adjustment disorder with depressed mood 16.31 9.88 70 544331 4153 70379890
Cardiogenic shock 16.29 9.88 189 544212 36118 70347925
Renal cancer 16.28 9.88 42 544359 11754 70372289
Foetal distress syndrome 16.24 9.88 19 544382 449 70383594
Acute respiratory failure 16.18 9.88 302 544099 53363 70330680
Kidney infection 16.17 9.88 224 544177 19231 70364812
Sudden death 16.17 9.88 95 544306 20969 70363074
Acute pulmonary oedema 16.13 9.88 51 544350 13361 70370682
Personality change 16.11 9.88 27 544374 8843 70375200
International normalised ratio increased 16.07 9.88 484 543917 80242 70303801
Accidental death 16.04 9.88 5 544396 3903 70380140
Cholangitis 16.03 9.88 41 544360 11508 70372535
Cytomegalovirus infection reactivation 16.03 9.88 17 544384 6764 70377279
Disease recurrence 16.01 9.88 198 544203 37405 70346638
Blood pressure decreased 16.00 9.88 558 543843 90957 70293086
Coronary arterial stent insertion 15.99 9.88 13 544388 5874 70378169
Amylase increased 15.97 9.88 34 544367 10174 70373869
Bone pain 15.95 9.88 284 544117 50538 70333505
Pain in jaw 15.87 9.88 231 544170 42438 70341605
Drug abuser 15.87 9.88 13 544388 5851 70378192
Frequent bowel movements 15.78 9.88 239 544162 20914 70363129
Emotional distress 15.77 9.88 196 544205 36992 70347051
Obesity 15.75 9.88 291 544110 26480 70357563
Alcohol interaction 15.75 9.88 8 544393 4645 70379398
Antinuclear antibody positive 15.72 9.88 98 544303 6735 70377308
Eye infection 15.68 9.88 132 544269 9986 70374057
Mean cell volume increased 15.62 9.88 85 544316 5559 70378484
Genital haemorrhage 15.60 9.88 13 544388 5802 70378241
Ingrown hair 15.58 9.88 22 544379 630 70383413
Alcohol abuse 15.54 9.88 10 544391 5097 70378946
Vertigo 15.51 9.88 364 544037 62279 70321764
Burning sensation 15.51 9.88 523 543878 52347 70331696
Pseudomonas infection 15.48 9.88 84 544317 18910 70365133
Incoherent 15.46 9.88 20 544381 7286 70376757
Acute graft versus host disease in intestine 15.45 9.88 5 544396 3811 70380232
Stillbirth 15.42 9.88 64 544337 3741 70380302
Diabetes mellitus inadequate control 15.39 9.88 106 544295 22539 70361504
Anti-cyclic citrullinated peptide antibody 15.37 9.88 59 544342 3326 70380717
Erectile dysfunction 15.32 9.88 53 544348 13509 70370534
Polydipsia 15.32 9.88 14 544387 5974 70378069
Gastrooesophageal reflux disease 15.26 9.88 848 543553 89991 70294052
Toxic encephalopathy 15.18 9.88 36 544365 10370 70373673
Blood folate increased 15.17 9.88 19 544382 483 70383560
Paralysis 15.16 9.88 45 544356 12027 70372016
Visual acuity reduced 15.16 9.88 139 544262 27791 70356252
Oxygen saturation decreased 15.15 9.88 1063 543338 115366 70268677
Tooth infection 15.11 9.88 193 544208 16270 70367773
End stage renal disease 15.09 9.88 40 544361 11093 70372950
Heparin-induced thrombocytopenia 15.07 9.88 29 544372 9008 70375035
Pulmonary haemorrhage 15.07 9.88 54 544347 13619 70370424
Confusional state 15.06 9.88 1932 542469 282466 70101577
Postoperative wound infection 15.05 9.88 143 544258 11195 70372848
Ventricular arrhythmia 15.01 9.88 23 544378 7807 70376236
Capillary leak syndrome 15.00 9.88 4 544397 3458 70380585
Muscle swelling 14.81 9.88 24 544377 778 70383265
Immune effector cell-associated neurotoxicity syndrome 14.77 9.88 6 544395 3972 70380071
Impaired work ability 14.76 9.88 191 544210 16149 70367894
Compartment syndrome 14.76 9.88 8 544393 4478 70379565
Knee operation 14.64 9.88 77 544324 4970 70379073
Dactylitis 14.62 9.88 44 544357 2189 70381854
Therapy partial responder 14.60 9.88 48 544353 12426 70371617
Nephrotic syndrome 14.60 9.88 38 544363 10602 70373441
Osteopenia 14.60 9.88 194 544207 16503 70367540
Tooth fracture 14.59 9.88 135 544266 10492 70373551
Generalised oedema 14.57 9.88 102 544299 21606 70362437
Drug screen positive 14.53 9.88 14 544387 5826 70378217
Lymphopenia 14.49 9.88 137 544264 27222 70356821
Human antichimeric antibody positive 14.48 9.88 34 544367 1456 70382587
Cestode infection 14.47 9.88 14 544387 264 70383779
Hypoxic-ischaemic encephalopathy 14.46 9.88 21 544380 7287 70376756
Liver transplant rejection 14.39 9.88 3 544398 3069 70380974
Cartilage injury 14.37 9.88 33 544368 1393 70382650
Increased tendency to bruise 14.36 9.88 125 544276 9550 70374493
Paranoia 14.34 9.88 76 544325 17212 70366831
Hypernatraemia 14.33 9.88 50 544351 12711 70371332
Left ventricular dysfunction 14.31 9.88 80 544321 17877 70366166
Ketoacidosis 14.27 9.88 21 544380 7248 70376795
Device related infection 14.26 9.88 168 544233 32017 70352026
Lymphadenitis 14.21 9.88 66 544335 4051 70379992
Diabetes mellitus 14.21 9.88 431 543970 71393 70312650
Osteonecrosis 14.20 9.88 149 544252 29011 70355032
Wound infection pseudomonas 14.17 9.88 35 544366 1549 70382494
Pharyngitis 14.06 9.88 227 544174 20124 70363919
Sickle cell anaemia 14.05 9.88 21 544380 634 70383409
Electrolyte imbalance 14.01 9.88 135 544266 26726 70357317
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.93 9.88 4 544397 3293 70380750
Circulatory collapse 13.92 9.88 190 544211 35284 70348759
Lacrimal disorder 13.92 9.88 18 544383 473 70383570
Urinary tract infection 13.91 9.88 2144 542257 246625 70137418
Encephalitis toxic 13.85 9.88 14 544387 279 70383764
Coronary artery bypass 13.81 9.88 15 544386 5905 70378138
Heart rate irregular 13.76 9.88 312 544089 29431 70354612
Disturbance in social behaviour 13.75 9.88 7 544394 4060 70379983
Rhinitis allergic 13.75 9.88 120 544281 9175 70374868
Intestinal ischaemia 13.73 9.88 47 544354 12017 70372026
Hypoaesthesia 13.68 9.88 1364 543037 152375 70231668
Hypotonia 13.65 9.88 46 544355 11819 70372224
Hiatus hernia 13.59 9.88 233 544168 20901 70363142
Hepatitis B 13.57 9.88 26 544375 8088 70375955
Drug tolerance decreased 13.54 9.88 125 544276 9708 70374335
Immunosuppressant drug level increased 13.52 9.88 25 544376 7882 70376161
Diarrhoea 13.51 9.88 5616 538785 777725 69606318
Motor dysfunction 13.50 9.88 53 544348 13017 70371026
Lower limb fracture 13.49 9.88 192 544209 16580 70367463
Hypertriglyceridaemia 13.45 9.88 46 544355 11765 70372278
Product substitution issue 13.42 9.88 85 544316 18428 70365615
Immune thrombocytopenia 13.41 9.88 72 544329 16252 70367791
Chest pain 13.41 9.88 1706 542695 249554 70134489
Linear IgA disease 13.41 9.88 3 544398 2921 70381122
Immunosuppression 13.35 9.88 141 544260 11351 70372692
Cross sensitivity reaction 13.32 9.88 5 544396 3473 70380570
Oxalosis 13.29 9.88 9 544392 99 70383944
Cervical incompetence 13.27 9.88 18 544383 496 70383547
Catheter management 13.20 9.88 5 544396 3454 70380589
Nervous system disorder 13.18 9.88 120 544281 24026 70360017
Alanine aminotransferase increased 13.15 9.88 964 543437 146516 70237527
Rheumatoid lung 13.10 9.88 57 544344 3402 70380641
Dyspnoea at rest 13.10 9.88 20 544381 6799 70377244
Body height below normal 13.04 9.88 38 544363 1857 70382186
Placental disorder 12.99 9.88 24 544377 866 70383177
Device leakage 12.96 9.88 33 544368 9275 70374768
Joint lock 12.89 9.88 51 544350 2916 70381127
Metastases to meninges 12.89 9.88 4 544397 3132 70380911
Finger deformity 12.88 9.88 86 544315 6050 70377993
Human herpesvirus 6 infection 12.87 9.88 11 544390 4848 70379195
Hypercapnia 12.81 9.88 28 544373 8301 70375742
Complications of transplanted kidney 12.81 9.88 16 544385 5918 70378125
Immune-mediated myositis 12.76 9.88 4 544397 3112 70380931
Laryngospasm 12.73 9.88 6 544395 3637 70380406
Troponin increased 12.71 9.88 75 544326 16539 70367504
Bone density abnormal 12.70 9.88 50 544351 2853 70381190
Injection site urticaria 12.69 9.88 141 544260 11497 70372546
Tuberculin test positive 12.69 9.88 54 544347 3192 70380851
Metastasis 12.67 9.88 17 544384 6097 70377946
Hypoglycaemic coma 12.65 9.88 9 544392 4352 70379691
Acute lung injury 12.64 9.88 3 544398 2806 70381237
Inadequate analgesia 12.64 9.88 8 544393 4114 70379929
Anhedonia 12.63 9.88 61 544340 14152 70369891
Pneumothorax 12.61 9.88 132 544269 25714 70358329
Lower respiratory tract congestion 12.59 9.88 55 544346 3289 70380754
Coordination abnormal 12.58 9.88 72 544329 15994 70368049
Drug-induced liver injury 12.56 9.88 331 544070 55782 70328261
Haemorrhage in pregnancy 12.53 9.88 30 544371 1301 70382742
Ankle arthroplasty 12.50 9.88 28 544373 1162 70382881
Blood lactate dehydrogenase increased 12.44 9.88 192 544209 34935 70349108
Abortion incomplete 12.42 9.88 4 544397 3058 70380985
Labyrinthitis 12.41 9.88 48 544353 2716 70381327
Respiration abnormal 12.37 9.88 21 544380 6843 70377200
Intervertebral disc degeneration 12.36 9.88 162 544239 13738 70370305
Aphthous ulcer 12.28 9.88 169 544232 14487 70369556
Vascular purpura 12.23 9.88 3 544398 2743 70381300
Psychomotor skills impaired 12.22 9.88 9 544392 4275 70379768
Lymphatic fistula 12.22 9.88 22 544379 778 70383265
Dyslipidaemia 12.20 9.88 37 544364 9823 70374220
Vision blurred 12.18 9.88 600 543801 94384 70289659
Skin laceration 12.14 9.88 272 544129 25606 70358437
Liver transplant 12.12 9.88 9 544392 4257 70379786
Wrong product administered 12.10 9.88 29 544372 8322 70375721
Femoral hernia incarcerated 12.08 9.88 22 544379 785 70383258
Dermatitis exfoliative 12.08 9.88 41 544360 10510 70373533
Palpitations 12.07 9.88 711 543690 110042 70274001
Skin texture abnormal 12.07 9.88 16 544385 431 70383612
Small for dates baby 12.01 9.88 16 544385 433 70383610
Drug hypersensitivity 12 9.88 1799 542602 260660 70123383
Hepatic siderosis 11.98 9.88 10 544391 154 70383889
Iodine allergy 11.98 9.88 18 544383 546 70383497
Swollen tongue 11.95 9.88 206 544195 36840 70347203
Plantar fasciitis 11.93 9.88 52 544349 3106 70380937
Areflexia 11.93 9.88 13 544388 5109 70378934
Mental disorder 11.91 9.88 149 544252 28091 70355952
Complication of device insertion 11.91 9.88 14 544387 5318 70378725
Neutropenic colitis 11.89 9.88 13 544388 5101 70378942
Radiation inflammation 11.88 9.88 18 544383 550 70383493
Bacteraemia 11.86 9.88 156 544245 29153 70354890
Deep vein thrombosis postoperative 11.85 9.88 57 544344 3550 70380493
Cogwheel rigidity 11.82 9.88 4 544397 2964 70381079
Hypophosphataemia 11.81 9.88 75 544326 16251 70367792
Retinal haemorrhage 11.80 9.88 26 544375 7684 70376359
Toothache 11.79 9.88 203 544198 18227 70365816
Foetal exposure during pregnancy 11.78 9.88 79 544322 5566 70378477
Hydrocephalus 11.77 9.88 28 544373 8057 70375986
Granulocytopenia 11.77 9.88 42 544359 10605 70373438
Salivary hypersecretion 11.76 9.88 55 544346 12870 70371173
Cushingoid 11.74 9.88 107 544294 8281 70375762
Magnesium deficiency 11.67 9.88 18 544383 559 70383484
Renal tubular disorder 11.66 9.88 18 544383 6092 70377951
Lung hernia 11.60 9.88 7 544394 62 70383981
Metabolic disorder 11.58 9.88 28 544373 8012 70376031
Skin abrasion 11.56 9.88 145 544256 12172 70371871
Lupus nephritis 11.56 9.88 48 544353 2806 70381237
Faecal calprotectin increased 11.53 9.88 66 544335 4399 70379644
Bacterial sepsis 11.52 9.88 26 544375 7621 70376422
Hepatic cancer 11.52 9.88 37 544364 9646 70374397
Congestive cardiomyopathy 11.48 9.88 44 544357 10882 70373161
Mitochondrial toxicity 11.46 9.88 4 544397 2906 70381137
Injection site extravasation 11.46 9.88 110 544291 8636 70375407
Gestational hypertension 11.35 9.88 35 544366 1765 70382278
Systemic inflammatory response syndrome 11.35 9.88 43 544358 10669 70373374
Abortion threatened 11.34 9.88 15 544386 403 70383640
Bone density increased 11.33 9.88 19 544382 634 70383409
Human anti-human antibody test 11.29 9.88 15 544386 405 70383638
Peritoneal dialysis complication 11.24 9.88 41 544360 2255 70381788
Onychomycosis 11.22 9.88 91 544310 6810 70377233
Type 1 diabetes mellitus 11.21 9.88 19 544382 6195 70377848
Metastases to lymph nodes 11.20 9.88 35 544366 9203 70374840
Cerebral haematoma 11.19 9.88 25 544376 7353 70376690
Medication error 11.14 9.88 342 544059 56570 70327473
Arthropod bite 11.11 9.88 95 544306 7220 70376823
Product monitoring error 11.08 9.88 22 544379 6754 70377289
Gonorrhoea 11.08 9.88 10 544391 172 70383871
Hyperpyrexia 11.08 9.88 15 544386 5359 70378684
Catheter site erythema 11.04 9.88 13 544388 4935 70379108
Placental insufficiency 11.03 9.88 25 544376 1046 70382997
Nephrolithiasis 10.96 9.88 456 543945 46867 70337176
Limb injury 10.95 9.88 267 544134 25485 70358558
Dyspnoea exertional 10.94 9.88 491 543910 77939 70306104
Personality disorder 10.92 9.88 16 544385 5532 70378511
Musculoskeletal discomfort 10.90 9.88 195 544206 17637 70366406
Oesophageal fibrosis 10.89 9.88 10 544391 176 70383867
Ejection fraction abnormal 10.86 9.88 34 544367 1729 70382314
Long QT syndrome 10.85 9.88 15 544386 5312 70378731
Drug specific antibody 10.81 9.88 41 544360 2298 70381745
Cryptococcosis 10.75 9.88 6 544395 3304 70380739
Hernia 10.74 9.88 167 544234 14693 70369350
Pleuritic pain 10.73 9.88 110 544291 8787 70375256
Joint warmth 10.69 9.88 31 544370 1511 70382532
Hypervolaemia 10.60 9.88 228 544173 39478 70344565
Loss of libido 10.60 9.88 3 544398 2494 70381549
Defaecation disorder 10.56 9.88 18 544383 609 70383434
Stress 10.55 9.88 630 543771 67336 70316707
Gastrointestinal pain 10.55 9.88 104 544297 8223 70375820
Cell death 10.53 9.88 10 544391 4190 70379853
Neutrophilia 10.52 9.88 25 544376 7196 70376847
Product administered to patient of inappropriate age 10.51 9.88 13 544388 4830 70379213
Haemodialysis 10.51 9.88 84 544317 17282 70366761
Blood urea increased 10.49 9.88 270 544131 45639 70338404
Rash morbilliform 10.48 9.88 16 544385 5439 70378604
Mixed liver injury 10.47 9.88 20 544381 6229 70377814
Type I hypersensitivity 10.44 9.88 8 544393 3724 70380319
Nasal congestion 10.44 9.88 610 543791 65062 70318981
Appendicolith 10.40 9.88 77 544324 5603 70378440
Wrist fracture 10.39 9.88 125 544276 10391 70373652
Hypertensive emergency 10.38 9.88 3 544398 2460 70381583
Breast abscess 10.37 9.88 27 544374 1235 70382808
Corneal oedema 10.36 9.88 3 544398 2457 70381586
Upper respiratory tract inflammation 10.34 9.88 9 544392 3933 70380110
Infective pulmonary exacerbation of cystic fibrosis 10.34 9.88 53 544348 12105 70371938
Psychiatric decompensation 10.31 9.88 5 544396 2982 70381061
Hepatic necrosis 10.31 9.88 33 544368 8613 70375430
Vascular rupture 10.29 9.88 30 544371 1466 70382577
Sinus congestion 10.27 9.88 189 544212 17184 70366859
Respiratory tract infection viral 10.25 9.88 54 544347 3487 70380556
Ligament rupture 10.24 9.88 47 544354 2870 70381173
Lip and/or oral cavity cancer 10.24 9.88 22 544379 887 70383156
Illness 10.24 9.88 318 544083 31473 70352570
Threatened labour 10.23 9.88 17 544384 563 70383480
Extradural haematoma 10.18 9.88 4 544397 2701 70381342
Skin infection 10.14 9.88 177 544224 15935 70368108
Gastric cancer 10.11 9.88 35 544366 8920 70375123
Pancreatic steatosis 10.10 9.88 24 544377 1036 70383007
Congenital neuropathy 10.06 9.88 4 544397 12 70384031
Leukoencephalopathy 10.04 9.88 26 544375 7268 70376775
Apraxia 10.04 9.88 4 544397 2679 70381364
Partial seizures 10.01 9.88 31 544370 8174 70375869
Blood iron increased 9.98 9.88 29 544372 1415 70382628
Delivery 9.95 9.88 17 544384 576 70383467
Chondropathy 9.95 9.88 41 544360 2389 70381654
Stress at work 9.91 9.88 24 544377 1049 70382994
Haemorrhage subcutaneous 9.90 9.88 12 544389 4497 70379546
Nodal osteoarthritis 9.89 9.88 17 544384 579 70383464

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11GA01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), plain
ATC A11GB01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), combinations
ATC G01AD03 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Organic acids
ATC S01XA15 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA CS M0001797 Ascorbic Acid
MeSH PA D000975 Antioxidants
MeSH PA D018977 Micronutrients
MeSH PA D020011 Protective Agents
MeSH PA D014815 Vitamins
FDA EPC N0000193618 Vitamin C
CHEBI has role CHEBI:23354 coenzymes
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:64577 dough improvers
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:77962 food antioxidants
CHEBI has role CHEBI:85046 skin lightening agents
CHEBI has role CHEBI:176497 geroprotectors
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:83056 Daphnia magna metabolites
CHEBI has role CHEBI:63247 reducer
CHEBI has role CHEBI:27314 water-soluble vitamins

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

DiseaseRelationSNOMED_IDDOID
Ascorbic acid deficiency indication 76169001
Breastfeeding (mother) indication 413712001
Coronavirus infection off-label use 186747009
Anuria contraindication 2472002 DOID:2983
Hypocalcemia contraindication 5291005
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Operation on stomach contraindication 16453004
Primary hyperoxaluria contraindication 17901006 DOID:2977
Hypocupremia contraindication 19577007
Hyperphosphatemia contraindication 20165001 DOID:0050459
Sunburn contraindication 23346002
Acute vomiting contraindication 23971007
Multiple sclerosis contraindication 24700007 DOID:2377
Gastroenteritis contraindication 25374005 DOID:2326
Acute tuberculosis contraindication 25629007
Hypervitaminosis D contraindication 27712000 DOID:9971
Complete atrioventricular block contraindication 27885002
Toxic megacolon contraindication 28536002 DOID:1770
Dental fluorosis contraindication 30265004
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Hemosiderosis contraindication 39011001 DOID:12119
Gastrointestinal ulcer contraindication 40845000
Toxic colitis contraindication 42359007
Hypokalemia contraindication 43339004
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Congenital myotonia, autosomal dominant form contraindication 57938005
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Hemolytic anemia contraindication 61261009 DOID:583
Allergic rhinitis contraindication 61582004
Hypervitaminosis A contraindication 64559002 DOID:9972
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Rheumatoid arthritis contraindication 69896004 DOID:7148
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperchloremia contraindication 74450001
Third degree burn injury contraindication 80247002
Intestinal obstruction contraindication 81060008 DOID:8437
Atrophic gastritis contraindication 84568007 DOID:8929
Human immunodeficiency virus infection contraindication 86406008 DOID:526
Wilson's disease contraindication 88518009
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Leukemia, disease contraindication 93143009 DOID:1240
Kidney stone contraindication 95570007
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Hb SS disease contraindication 127040003 DOID:10923
Seizure disorder contraindication 128613002
Osteolysis contraindication 203522001
Disease of liver contraindication 235856003 DOID:409
Hyporeninemic hypoaldosteronism contraindication 236464008
Esophageal dysmotility contraindication 266434009 DOID:9192
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Gastric retention contraindication 307227006
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
At risk for aspiration contraindication 371736008
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Denuded skin contraindication 418242004
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Vitamin K Deficiency Induced Hypoprothrombinemia contraindication
Malabsorption States contraindication
Repeated Blood Transfusions contraindication




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 4.02 acidic
pKa2 9.62 acidic
pKa3 11.85 acidic
pKa4 12.53 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10792306 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9592252 Aug. 11, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10918723 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25,000MG/50ML (500MG/ML) ASCOR MCGUFF N209112 Oct. 2, 2017 RX SOLUTION INTRAVENOUS Oct. 2, 2024 FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tyrosinase Enzyme IC50 4.49 CHEMBL
Prolyl 4-hydroxylase subunit alpha-1 Enzyme WOMBAT-PK
Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1 Enzyme WOMBAT-PK
Solute carrier family 23 member 2 Transporter WOMBAT-PK
Solute carrier family 23 member 1 Transporter WOMBAT-PK
Pancreatic alpha-amylase Enzyme IC50 4.58 CHEMBL

External reference:

IDSource
4017646 VUID
N0000146025 NUI
D00018 KEGG_DRUG
134-03-2 SECONDARY_CAS_RN
5743-28-2 SECONDARY_CAS_RN
4017471 VANDF
4017472 VANDF
4017646 VANDF
4021716 VANDF
4026966 VANDF
C0003968 UMLSCUI
CHEBI:29073 CHEBI
ASC PDB_CHEM_ID
CHEMBL196 ChEMBL_ID
CHEMBL591665 ChEMBL_ID
CHEMBL2146095 ChEMBL_ID
D001205 MESH_DESCRIPTOR_UI
DB00126 DRUGBANK_ID
C069207 MESH_SUPPLEMENTAL_RECORD_UI
4781 IUPHAR_LIGAND_ID
372 INN_ID
PQ6CK8PD0R UNII
54670067 PUBCHEM_CID
DB14482 DRUGBANK_ID
DB14483 DRUGBANK_ID
1151 RXNORM
1132 MMSL
32646 MMSL
4221 MMSL
5471 MMSL
5687 MMSL
6032 MMSL
72299 MMSL
NOCODE MMSL
d00426 MMSL
001010 NDDF
001011 NDDF
001012 NDDF
126230002 SNOMEDCT_US
126231003 SNOMEDCT_US
43706004 SNOMEDCT_US
46123006 SNOMEDCT_US
174 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 120 mg ORAL unapproved drug other 17 sections
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 120 mg ORAL unapproved drug other 17 sections
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 120 mg ORAL Unapproved drug other 12 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 15 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 15 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 120 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 120 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN OTC DRUG LABEL 14 0178-0829 TABLET 120 mg ORAL Unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 13 0178-0858 TABLET 120 mg ORAL Unapproved drug other 12 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 14 0178-0859 TABLET 120 mg ORAL Unapproved drug other 9 sections
CitraNatal DHA HUMAN OTC DRUG LABEL 14 0178-0898 TABLET 120 mg ORAL Unapproved drug other 11 sections
Antiflu Kids HUMAN OTC DRUG LABEL 3 0280-0046 POWDER, FOR SOLUTION 50 mg ORAL Export only 2 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 30 mg ORAL unapproved drug other 14 sections
Vitafol Caplet HUMAN PRESCRIPTION DRUG LABEL 12 0642-0072 CAPSULE 60 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 70 mg ORAL Unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 12 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 30 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 60 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Strovite Forte Caplet HUMAN PRESCRIPTION DRUG LABEL 19 0642-0204 TABLET, COATED 500 mg ORAL UNAPPROVED DRUG OTHER 15 sections
Strovite One Caplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 300 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Reaphirm Plant Source DHA HUMAN PRESCRIPTION DRUG LABEL 16 0642-3010 CAPSULE, GELATIN COATED 30 mg ORAL unapproved drug other 7 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Marnatal F HUMAN PRESCRIPTION DRUG LABEL 13 0682-1570 CAPSULE 100 mg ORAL UNAPPROVED DRUG OTHER 4 sections
BACMIN HUMAN PRESCRIPTION DRUG LABEL 19 0682-3001 TABLET, COATED 500 mg ORAL UNAPPROVED DRUG OTHER 10 sections
O-Cal Prenatal Vitamin HUMAN PRESCRIPTION DRUG LABEL 16 0813-0202 TABLET 70 mg ORAL UNAPPROVED DRUG OTHER 6 sections
Acetaminophen, Ascorbic acid, Chlorpheniramine Maleate HUMAN OTC DRUG LABEL 3 10267-2949 POWDER, FOR SOLUTION 50 mg ORAL Export only 1 sections
Dialyvite Supreme D HUMAN PRESCRIPTION DRUG LABEL 13 10542-009 TABLET, COATED 100 mg ORAL Unapproved drug other 7 sections
Dialyvite Supreme D HUMAN PRESCRIPTION DRUG LABEL 13 10542-009 TABLET, COATED 100 mg ORAL Unapproved drug other 7 sections
Dialyvite HUMAN PRESCRIPTION DRUG LABEL 9 10542-010 TABLET, COATED 100 mg ORAL Unapproved drug other 7 sections