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

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 865 15307-86-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diclofenac calcium
  • diclofenac diethylamine
  • diclofenac hydroxyethylpyrrolidine
  • diclofenac
  • diclofenamic acid
  • diclofenac sodium
  • diclofenac potassium
  • diclofenac epolamine
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
  • Molecular weight: 296.15
  • Formula: C14H11Cl2NO2
  • CLOGP: 4.58
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -4.82
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.85 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 54 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 28, 1988 FDA
March 23, 2021 PMDA Hisamitsu Pharmaceutical Co., Inc

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 2381.73 10.33 3623 302102 180103 63003194
Glossodynia 2254.49 10.33 3482 302243 175394 63007903
Systemic lupus erythematosus 2111.72 10.33 3681 302044 205237 62978060
Rheumatoid arthritis 2032.61 10.33 4046 301679 249773 62933524
Hand deformity 1975.04 10.33 3080 302645 156377 63026920
Wound 1775.56 10.33 2973 302752 160290 63023007
Pericarditis 1665.55 10.33 2568 303157 129011 63054286
Abdominal discomfort 1599.13 10.33 4242 301483 316643 62866654
Discomfort 1595.59 10.33 2876 302849 164498 63018799
Arthropathy 1521.51 10.33 3435 302290 231357 62951940
Anti-cyclic citrullinated peptide antibody positive 1492.82 10.33 2284 303441 113928 63069369
Alopecia 1256.95 10.33 4022 301703 333514 62849783
Swelling 1192.87 10.33 3461 302264 271917 62911380
Duodenal ulcer perforation 1146.27 10.33 1733 303992 85476 63097821
Synovitis 1145.01 10.33 2676 303049 184242 62999055
Contraindicated product administered 1144.39 10.33 2938 302787 214710 62968587
Helicobacter infection 1069.68 10.33 1736 303989 91049 63092248
Maternal exposure during pregnancy 958.05 10.33 2772 302953 217290 62966007
Hepatic enzyme increased 910.05 10.33 2579 303146 199749 62983548
Infusion related reaction 872.11 10.33 2881 302844 242640 62940657
Product use issue 848.70 10.33 2660 303065 217860 62965437
Rheumatoid factor positive 751.98 10.33 1410 304315 82996 63100301
Embolia cutis medicamentosa 713.04 10.33 199 305526 228 63183069
Death 690.48 10.33 480 305245 373901 62809396
Hypersensitivity 689.07 10.33 3012 302713 289673 62893624
Drug intolerance 674.60 10.33 3107 302618 305554 62877743
Joint swelling 644.87 10.33 3200 302525 324466 62858831
Treatment failure 605.71 10.33 2220 303505 196823 62986474
Blister 541.77 10.33 1612 304113 128202 63055095
Folliculitis 497.15 10.33 1067 304658 69250 63114047
Rheumatic fever 496.87 10.33 807 304918 42304 63140993
Muscle injury 495.06 10.33 1020 304705 64325 63118972
Pain 485.91 10.33 5569 300156 735059 62448238
Swollen joint count increased 436.15 10.33 690 305035 35364 63147933
Irritable bowel syndrome 435.59 10.33 1116 304609 81296 63102001
Therapeutic product effect decreased 403.85 10.33 1921 303804 191266 62992031
Sleep disorder due to general medical condition, insomnia type 402.46 10.33 821 304904 51396 63131901
Psoriatic arthropathy 385.92 10.33 1141 304584 90379 63092918
Rash 375.19 10.33 4236 301489 556635 62626662
Liver injury 361.51 10.33 859 304866 59661 63123636
Musculoskeletal stiffness 355.21 10.33 1793 303932 182825 63000472
Neutropenia 352.86 10.33 202 305523 174803 63008494
Toxicity to various agents 344.52 10.33 410 305315 246840 62936457
Hip arthroplasty 343.61 10.33 729 304996 46917 63136380
Febrile neutropenia 335.60 10.33 79 305646 118370 63064927
Diarrhoea 330.87 10.33 2056 303669 713310 62469987
Impaired healing 327.82 10.33 1163 304562 101379 63081918
Completed suicide 326.82 10.33 146 305579 145527 63037770
Blood cholesterol increased 322.77 10.33 1092 304633 92940 63090357
Type 2 diabetes mellitus 319.09 10.33 847 304878 63021 63120276
Knee arthroplasty 278.03 10.33 726 304999 53480 63129817
Cough 267.66 10.33 637 305088 292106 62891191
Gastrointestinal disorder 261.03 10.33 1287 304438 129952 63053345
Hypotension 254.14 10.33 587 305138 272017 62911280
Pneumonia 251.51 10.33 1238 304487 455529 62727768
Nausea 243.60 10.33 2790 302935 851681 62331616
Product dose omission issue 239.61 10.33 479 305246 233834 62949463
Deafness transitory 217.20 10.33 129 305596 1841 63181456
Fall 212.03 10.33 1070 304655 391264 62792033
General physical health deterioration 207.12 10.33 1668 304057 199734 62983563
Constipation 190.33 10.33 509 305216 224434 62958863
Cardiac failure congestive 187.20 10.33 106 305619 92327 63090970
Thrombocytopenia 181.67 10.33 279 305446 150878 63032419
Urinary tract infection 169.82 10.33 677 305048 264007 62919290
Seizure 168.99 10.33 235 305490 132399 63050898
Stomatitis 166.72 10.33 1192 304533 137533 63045764
Dehydration 165.71 10.33 368 305357 172986 63010311
Ill-defined disorder 159.79 10.33 798 304927 80957 63102340
Lower respiratory tract infection 159.08 10.33 1137 304588 131170 63052127
Ankylosing spondylitis 158.97 10.33 223 305502 10251 63173046
Electrocardiogram QT prolonged 158.43 10.33 45 305680 59485 63123812
Disease progression 153.91 10.33 220 305505 122538 63060759
Hypokalaemia 151.05 10.33 166 305559 103638 63079659
Anaemia 150.65 10.33 814 304911 292616 62890681
Atrial fibrillation 149.24 10.33 206 305519 116430 63066867
Fibromyalgia 146.72 10.33 770 304955 79650 63103647
Pancytopenia 146.66 10.33 150 305575 96783 63086514
White blood cell count decreased 143.26 10.33 283 305442 138821 63044476
Grip strength decreased 141.39 10.33 324 305401 21963 63161334
Sleep disorder 135.99 10.33 762 304963 80804 63102493
Infection 133.53 10.33 1688 304037 227485 62955812
Sepsis 132.86 10.33 342 305383 152781 63030516
Device expulsion 132.86 10.33 9 305716 34913 63148384
Neuropathy peripheral 128.84 10.33 218 305507 113449 63069848
Platelet count decreased 128.62 10.33 226 305499 115896 63067401
Cerebrovascular accident 127.27 10.33 202 305523 107822 63075475
COVID-19 125.38 10.33 220 305505 112883 63070414
Leukopenia 122.23 10.33 115 305610 77175 63106122
Prescribed overdose 121.85 10.33 402 305323 33751 63149546
Intentional product use issue 119.50 10.33 1037 304688 126855 63056442
Asthenia 118.87 10.33 1227 304498 382377 62800920
Cardiac arrest 113.88 10.33 168 305557 92377 63090920
Anxiety 113.51 10.33 600 305125 216941 62966356
Gastric ulcer perforation 113.45 10.33 72 305653 1164 63182133
Contusion 111.54 10.33 1159 304566 148885 63034412
Ear infection 105.80 10.33 414 305311 37799 63145498
Live birth 101.76 10.33 313 305412 25317 63157980
Heart rate increased 101.13 10.33 187 305538 94051 63089246
Neutrophil count decreased 100.16 10.33 75 305650 56331 63126966
Balance disorder 99.31 10.33 158 305567 84264 63099033
Hypoxia 99.29 10.33 85 305640 59707 63123590
Arthralgia 97.57 10.33 3503 302222 566207 62617090
Malignant neoplasm progression 97.26 10.33 153 305572 81968 63101329
Dyspnoea 96.46 10.33 2437 303288 658876 62524421
Pleural effusion 95.62 10.33 190 305535 93020 63090277
Cardiac failure 95.55 10.33 177 305548 88965 63094332
Injury 94.77 10.33 641 305084 72606 63110691
Pulmonary embolism 94.15 10.33 270 305455 116414 63066883
Cognitive disorder 93.10 10.33 79 305646 55736 63127561
Off label use 91.63 10.33 2511 303214 671951 62511346
Cardio-respiratory arrest 91.57 10.33 92 305633 59867 63123430
Gastrointestinal pain 91.56 10.33 167 305558 9609 63173688
Injection site pain 89.62 10.33 322 305403 129478 63053819
Hospitalisation 89.38 10.33 171 305554 84910 63098387
Oxygen saturation decreased 87.95 10.33 184 305541 88401 63094896
Gastric ulcer 86.70 10.33 284 305441 23753 63159544
Osteoarthritis 86.40 10.33 768 304957 94575 63088722
Blood glucose increased 85.68 10.33 171 305554 83585 63099712
Hypoglycaemia 85.23 10.33 98 305627 59967 63123330
Melaena 84.89 10.33 330 305395 30035 63153262
Pharyngitis 84.68 10.33 251 305474 19892 63163405
Respiratory failure 84.16 10.33 233 305492 101625 63081672
Adverse event 83.12 10.33 584 305141 66975 63116322
Bradycardia 82.45 10.33 141 305584 73086 63110211
Myocardial infarction 82.17 10.33 229 305496 99664 63083633
Epistaxis 81.91 10.33 140 305585 72585 63110712
Fatigue 81.65 10.33 5132 300593 882896 62300401
Chest discomfort 80.51 10.33 266 305459 109703 63073594
Plasma cell myeloma 80.44 10.33 36 305689 35869 63147428
Tachycardia 80.32 10.33 295 305430 117861 63065436
Coma 79.02 10.33 117 305608 64247 63119050
Deep vein thrombosis postoperative 77.39 10.33 170 305555 11199 63172098
Neoplasm progression 76.31 10.33 40 305685 36388 63146909
Multiple sclerosis relapse 75.62 10.33 73 305652 48405 63134892
Pulmonary oedema 74.17 10.33 93 305632 54780 63128517
Wrong technique in product usage process 73.95 10.33 116 305609 62224 63121073
Mucosal inflammation 72.82 10.33 71 305654 46857 63136440
Chills 72.60 10.33 290 305435 113088 63070209
Mental status changes 72.46 10.33 51 305674 39548 63143749
Blood pressure increased 71.72 10.33 471 305254 161591 63021706
Shoulder arthroplasty 71.09 10.33 92 305633 3910 63179387
Adjustment disorder with depressed mood 71.08 10.33 154 305571 10050 63173247
Clostridium difficile infection 70.24 10.33 28 305697 29894 63153403
Joint range of motion decreased 69.42 10.33 325 305400 32103 63151194
Abdominal pain 68.64 10.33 997 304728 292459 62890838
Injection site erythema 68.16 10.33 191 305534 82983 63100314
Dislocation of vertebra 67.95 10.33 137 305588 8498 63174799
Influenza 67.16 10.33 282 305443 108440 63074857
No adverse event 66.17 10.33 61 305664 41344 63141953
Mobility decreased 66.08 10.33 882 304843 120277 63063020
Pulmonary arterial hypertension 66.04 10.33 14 305711 22563 63160734
Facet joint syndrome 65.74 10.33 166 305559 11972 63171325
Syncope 65.59 10.33 316 305409 117069 63066228
Hyperglycaemia 65.36 10.33 63 305662 41804 63141493
Sedation 64.64 10.33 55 305670 38754 63144543
Dry skin 64.53 10.33 109 305616 56778 63126519
Bronchitis 64.32 10.33 346 305379 124589 63058708
Insomnia 64.31 10.33 694 305031 214558 62968739
Pneumonia aspiration 63.84 10.33 44 305681 34496 63148801
Drug abuse 63.61 10.33 161 305564 72357 63110940
Retinitis 63.37 10.33 110 305615 6086 63177211
Depression 62.59 10.33 624 305101 195868 62987429
Chronic obstructive pulmonary disease 61.55 10.33 131 305594 62555 63120742
Hyponatraemia 60.93 10.33 304 305421 111596 63071701
Lip dry 60.55 10.33 188 305537 15282 63168015
Red blood cell sedimentation rate abnormal 60.52 10.33 11 305714 19771 63163526
Full blood count abnormal 60.51 10.33 39 305686 31678 63151619
Unevaluable event 59.64 10.33 97 305628 51289 63132008
Myelosuppression 59.32 10.33 20 305705 23683 63159614
Lethargy 59.31 10.33 112 305613 55895 63127402
Posterior reversible encephalopathy syndrome 59.18 10.33 7 305718 17338 63165959
Tonsillar ulcer 59.16 10.33 29 305696 274 63183023
Anti-cyclic citrullinated peptide antibody 58.98 10.33 112 305613 6646 63176651
Device dislocation 58.81 10.33 25 305700 25680 63157617
Pancreatitis 58.45 10.33 91 305634 48964 63134333
Septic shock 58.38 10.33 148 305577 66481 63116816
Palpitations 58.22 10.33 312 305413 112458 63070839
Feeling abnormal 57.52 10.33 448 305277 147944 63035353
Deep vein thrombosis 57.09 10.33 209 305516 83591 63099706
Vomiting 57.00 10.33 2162 303563 557455 62625842
Intestinal diaphragm disease 56.81 10.33 21 305704 89 63183208
Autoimmune disorder 55.83 10.33 196 305529 16981 63166316
Flushing 55.38 10.33 181 305544 74906 63108391
Hypomagnesaemia 55.29 10.33 35 305690 28702 63154595
Renal failure 55.09 10.33 336 305389 117316 63065981
Blood potassium decreased 54.97 10.33 73 305652 41953 63141344
Oligohydramnios 54.94 10.33 105 305620 6261 63177036
Drug tolerance decreased 54.75 10.33 197 305528 17276 63166021
Somnolence 54.21 10.33 574 305151 178111 63005186
Lupus vulgaris 53.13 10.33 100 305625 5894 63177403
Respiratory distress 53.10 10.33 51 305674 33900 63149397
Duodenal ulcer 52.82 10.33 116 305609 7640 63175657
Dysphagia 52.73 10.33 233 305492 88352 63094945
Incorrect dose administered 52.70 10.33 133 305592 59835 63123462
Dyspnoea exertional 52.02 10.33 135 305590 60167 63123130
Cellulitis 51.59 10.33 211 305514 81747 63101550
Premature delivery 51.56 10.33 42 305683 30239 63153058
Nasal congestion 51.44 10.33 154 305571 65506 63117791
Drug ineffective 51.19 10.33 5759 299966 1039006 62144291
Complication associated with device 50.75 10.33 10 305715 16968 63166329
Macular degeneration 50.72 10.33 27 305698 24349 63158948
Injection site bruising 50.65 10.33 77 305648 41833 63141464
Vision blurred 50.46 10.33 249 305476 91675 63091622
X-ray abnormal 50.44 10.33 117 305608 7993 63175304
Cytomegalovirus infection 50.18 10.33 19 305706 20933 63162364
Joint dislocation 49.87 10.33 201 305524 18599 63164698
Acute myeloid leukaemia 49.41 10.33 11 305714 17136 63166161
Confusional state 49.14 10.33 1488 304237 234892 62948405
Sedation complication 48.62 10.33 5 305720 13817 63169480
Agitation 48.38 10.33 138 305587 59619 63123678
Orthostatic hypotension 48.12 10.33 62 305663 36098 63147199
Functional gastrointestinal disorder 48.05 10.33 79 305646 4180 63179117
Anaphylactic shock 47.79 10.33 233 305492 23400 63159897
Exposure during pregnancy 46.94 10.33 1029 304696 154518 63028779
Metastases to liver 46.57 10.33 28 305697 23611 63159686
Nasopharyngitis 46.46 10.33 1576 304149 252681 62930616
Hypervolaemia 46.43 10.33 41 305684 28372 63154925
Small intestine ulcer 46.34 10.33 26 305699 331 63182966
Haemoglobin decreased 46.32 10.33 462 305263 145023 63038274
Ductus arteriosus stenosis foetal 46.25 10.33 21 305704 164 63183133
Ascites 46.23 10.33 78 305647 40650 63142647
Liver function test abnormal 46.21 10.33 102 305623 48079 63135218
Inappropriate schedule of product administration 46.05 10.33 302 305423 103663 63079634
Diabetes mellitus 45.84 10.33 128 305597 55682 63127615
Renal failure neonatal 45.82 10.33 21 305704 168 63183129
Tremor 45.48 10.33 412 305313 131827 63051470
Weight decreased 44.86 10.33 1003 304722 275795 62907502
Depressed level of consciousness 44.84 10.33 151 305574 61927 63121370
Cardiac disorder 44.42 10.33 113 305612 50703 63132594
Productive cough 44.14 10.33 156 305569 63052 63120245
Hallucination 44.08 10.33 127 305598 54690 63128607
Urosepsis 44.03 10.33 17 305708 18507 63164790
Drug resistance 44.02 10.33 28 305697 22905 63160392
Unresponsive to stimuli 43.96 10.33 59 305666 33757 63149540
Type I hypersensitivity 43.70 10.33 62 305663 2880 63180417
Drug interaction 43.46 10.33 809 304916 228322 62954975
Neoplasm malignant 43.14 10.33 48 305677 29813 63153484
Neurotoxicity 43.11 10.33 14 305711 16976 63166321
Prescribed underdose 42.77 10.33 267 305458 29422 63153875
Bone marrow failure 42.41 10.33 47 305678 29243 63154054
Suicidal ideation 42.30 10.33 156 305569 62265 63121032
Condition aggravated 42.30 10.33 2354 303371 399863 62783434
Peripheral venous disease 42.28 10.33 167 305558 15310 63167987
Stress 42.23 10.33 173 305552 66994 63116303
Abortion spontaneous 41.99 10.33 104 305621 47091 63136206
Peripheral swelling 41.88 10.33 1621 304104 264321 62918976
Torsade de pointes 41.77 10.33 7 305718 13344 63169953
Hypocalcaemia 41.56 10.33 55 305670 31658 63151639
Hypercalcaemia 41.50 10.33 45 305680 28277 63155020
Transfusion 41.42 10.33 11 305714 15206 63168091
Fluid retention 41.22 10.33 148 305577 59538 63123759
Large intestinal stenosis 41.09 10.33 49 305676 1914 63181383
Headache 41.06 10.33 2565 303160 630676 62552621
Fat necrosis 40.53 10.33 30 305695 630 63182667
Device issue 40.47 10.33 33 305692 23748 63159549
Transplant rejection 40.36 10.33 3 305722 10777 63172520
Palmar-plantar erythrodysaesthesia syndrome 40.34 10.33 31 305694 22984 63160313
Laboratory test abnormal 40.28 10.33 42 305683 26870 63156427
Ductus arteriosus premature closure 39.67 10.33 23 305702 313 63182984
Malaise 39.66 10.33 1619 304106 414335 62768962
Accidental exposure to product 39.65 10.33 44 305681 27361 63155936
Status epilepticus 39.64 10.33 12 305713 15221 63168076
Influenza like illness 39.62 10.33 176 305549 66648 63116649
Rhinorrhoea 39.32 10.33 172 305553 65405 63117892
Intestinal obstruction 39.07 10.33 55 305670 30844 63152453
Ileal ulcer 38.85 10.33 26 305699 462 63182835
Blood calcium decreased 38.79 10.33 42 305683 26409 63156888
Abnormal behaviour 38.67 10.33 28 305697 21398 63161899
Maternal exposure timing unspecified 38.46 10.33 97 305628 6990 63176307
Neuroleptic malignant syndrome 38.44 10.33 6 305719 12050 63171247
Generalised tonic-clonic seizure 38.36 10.33 50 305675 28966 63154331
Diabetic ketoacidosis 38.05 10.33 26 305699 20479 63162818
Gastrointestinal erosion 37.99 10.33 29 305696 639 63182658
Dysgeusia 37.72 10.33 108 305617 46602 63136695
Large intestinal ulcer 37.67 10.33 63 305662 3381 63179916
Sacroiliitis 37.54 10.33 61 305664 3196 63180101
Ventricular tachycardia 37.53 10.33 25 305700 19954 63163343
Blood pressure fluctuation 37.47 10.33 107 305618 46210 63137087
Back pain 37.34 10.33 977 304748 263168 62920129
Therapeutic product effect incomplete 37.00 10.33 404 305321 124652 63058645
Adverse drug reaction 36.93 10.33 564 305161 79150 63104147
Hepatotoxicity 36.70 10.33 77 305648 36964 63146333
Throat irritation 36.68 10.33 79 305646 37568 63145729
Procedural pain 36.62 10.33 30 305695 21539 63161758
Progressive multifocal leukoencephalopathy 36.03 10.33 9 305716 12962 63170335
Cytokine release syndrome 35.96 10.33 12 305713 14302 63168995
Injection site pruritus 35.93 10.33 105 305620 45011 63138286
Erythema 35.69 10.33 613 305112 175138 63008159
Extrapyramidal disorder 35.42 10.33 10 305715 13274 63170023
Psychotic disorder 35.35 10.33 43 305682 25669 63157628
Duodenal ulcer haemorrhage 35.19 10.33 51 305674 2416 63180881
Atelectasis 35.10 10.33 31 305694 21452 63161845
Seronegative arthritis 35.03 10.33 66 305659 3893 63179404
Bacteraemia 34.95 10.33 20 305705 17328 63165969
Aggression 34.80 10.33 37 305688 23461 63159836
Pericardial effusion 34.64 10.33 57 305668 30001 63153296
Encephalopathy 34.44 10.33 85 305640 38535 63144762
Ejection fraction decreased 34.40 10.33 34 305691 22298 63160999
Frequent bowel movements 34.38 10.33 36 305689 22986 63160311
Lymphocyte count decreased 34.29 10.33 58 305667 30199 63153098
Laryngitis 34.10 10.33 167 305558 16800 63166497
Injection site necrosis 33.98 10.33 37 305688 1307 63181990
Therapy cessation 33.95 10.33 59 305666 30398 63152899
Sinus disorder 33.82 10.33 41 305684 24512 63158785
Thrombosis 33.50 10.33 179 305546 64576 63118721
Blood glucose decreased 33.32 10.33 31 305694 20921 63162376
Depressed mood 33.14 10.33 92 305633 40099 63143198
Neutropenic sepsis 33.05 10.33 19 305706 16419 63166878
Right ventricular failure 32.97 10.33 21 305704 17167 63166130
Hepatic failure 32.96 10.33 77 305648 35579 63147718
Feeling cold 32.79 10.33 40 305685 23848 63159449
Porphyria acute 32.58 10.33 34 305691 1143 63182154
Angioedema 32.57 10.33 364 305361 47601 63135696
Obstructive airways disorder 32.48 10.33 31 305694 20668 63162629
Endoscopy abnormal 32.39 10.33 9 305716 10 63183287
Rhabdomyolysis 31.68 10.33 107 305618 43844 63139453
Jejunal ulcer 31.66 10.33 14 305711 102 63183195
Blood test abnormal 31.52 10.33 18 305707 15611 63167686
Injection site swelling 31.51 10.33 120 305605 47452 63135845
Fungal infection 31.46 10.33 83 305642 36791 63146506
Haematotoxicity 31.46 10.33 4 305721 9372 63173925
Oropharyngeal pain 31.35 10.33 297 305428 94190 63089107
Respiratory tract congestion 31.28 10.33 24 305701 17808 63165489
Upper respiratory tract infection 31.17 10.33 249 305476 81798 63101499
Bone disorder 31.12 10.33 34 305691 21292 63162005
Bursitis 30.81 10.33 293 305432 36748 63146549
Sopor 30.54 10.33 37 305688 22127 63161170
Wound infection 30.50 10.33 192 305533 21218 63162079
Foetal methotrexate syndrome 30.44 10.33 14 305711 113 63183184
Cytopenia 30.44 10.33 9 305716 11592 63171705
Full blood count decreased 30.31 10.33 49 305676 25975 63157322
Hyperhidrosis 30.07 10.33 353 305372 107483 63075814
Gastritis erosive 30.04 10.33 80 305645 5959 63177338
Thrombotic microangiopathy 29.98 10.33 7 305718 10554 63172743
Lower respiratory tract infection viral 29.89 10.33 29 305696 892 63182405
Oral pain 29.87 10.33 57 305668 28337 63154960
Pulmonary hypertension 29.85 10.33 86 305639 37037 63146260
Heavy menstrual bleeding 29.83 10.33 25 305700 17748 63165549
Injection site reaction 29.60 10.33 163 305562 58361 63124936
Cerebral haemorrhage 29.51 10.33 65 305660 30664 63152633
Oral candidiasis 29.41 10.33 40 305685 22758 63160539
Chest pain 29.40 10.33 803 304922 215156 62968141
Spinal stenosis 29.36 10.33 146 305579 14779 63168518
Device related infection 29.22 10.33 42 305683 23350 63159947
Cardiac murmur 29.00 10.33 17 305708 14535 63168762
Overdose 28.98 10.33 385 305340 114693 63068604
Aspirin-exacerbated respiratory disease 28.71 10.33 28 305697 867 63182430
Herpes zoster 28.30 10.33 257 305468 82205 63101092
Paraesthesia 28.27 10.33 559 305166 156407 63026890
Breast cancer female 28.23 10.33 15 305710 13544 63169753
Haemoptysis 28.22 10.33 60 305665 28666 63154631
Haemorrhage 28.17 10.33 175 305550 60847 63122450
Akathisia 28.17 10.33 5 305720 9141 63174156
Loss of consciousness 28.02 10.33 400 305325 117721 63065576
Lung neoplasm malignant 27.88 10.33 32 305693 19601 63163696
Osteonecrosis of jaw 27.78 10.33 82 305643 35041 63148256
Second primary malignancy 27.66 10.33 3 305722 7950 63175347
Acute respiratory failure 27.65 10.33 80 305645 34405 63148892
Foot operation 27.49 10.33 87 305638 7144 63176153
Ataxia 27.23 10.33 20 305705 15175 63168122
Feeding disorder 27.20 10.33 132 305593 13230 63170067
Injection site haemorrhage 27.19 10.33 47 305678 24267 63159030
Small intestinal obstruction 27.02 10.33 29 305696 18308 63164989
Periorbital oedema 26.97 10.33 74 305651 5610 63177687
Injection site mass 26.94 10.33 30 305695 18626 63164671
Infective pulmonary exacerbation of cystic fibrosis 26.76 10.33 5 305720 8812 63174485
Fear 26.67 10.33 22 305703 15744 63167553
Myalgia 26.64 10.33 521 305204 146008 63037289
Metabolic acidosis 26.54 10.33 119 305606 44950 63138347
Renal impairment 26.30 10.33 285 305440 88070 63095227
Blood creatinine increased 26.29 10.33 283 305442 87561 63095736
Abnormal loss of weight 26.18 10.33 74 305651 5708 63177589
Sleep disorder due to a general medical condition 26.10 10.33 13 305712 12175 63171122
Creatinine renal clearance decreased 26.08 10.33 24 305701 16284 63167013
Product quality issue 26.06 10.33 87 305638 35778 63147519
Arrhythmia 26.05 10.33 95 305630 38045 63145252
Rotator cuff repair 26.01 10.33 41 305684 2093 63181204
Respiratory arrest 25.97 10.33 76 305649 32569 63150728
Complication of device insertion 25.94 10.33 3 305722 7561 63175736
Pyrexia 25.88 10.33 1933 303792 468545 62714752
Lacrimation increased 25.81 10.33 37 305688 20594 63162703
Diabetes mellitus inadequate control 25.72 10.33 21 305704 15105 63168192
Serotonin syndrome 25.67 10.33 63 305662 28619 63154678
C-reactive protein 25.64 10.33 66 305659 4816 63178481
Therapy interrupted 25.50 10.33 76 305649 32379 63150918
Cholelithiasis 25.25 10.33 117 305608 43808 63139489
Anaphylactic reaction 25.19 10.33 453 305272 65647 63117650
Breast cancer stage III 25.16 10.33 108 305617 10278 63173019
Burning sensation 25.13 10.33 156 305569 54251 63129046
Hot flush 25.05 10.33 144 305581 51015 63132282
Drug dependence 25.01 10.33 50 305675 24433 63158864
Blood calcium increased 25.00 10.33 7 305718 9343 63173954
Psychomotor hyperactivity 24.99 10.33 10 305715 10653 63172644
Gestational diabetes 24.98 10.33 5 305720 8391 63174906
Haematocrit decreased 24.93 10.33 101 305624 39239 63144058
Lymphopenia 24.83 10.33 31 305694 18296 63165001
Disease recurrence 24.75 10.33 62 305663 27968 63155329
Sinusitis 24.65 10.33 1331 304394 225322 62957975
Clostridium difficile colitis 24.65 10.33 38 305687 20531 63162766
Intentional overdose 24.63 10.33 233 305492 73919 63109378
Panniculitis 24.60 10.33 12 305713 11373 63171924
Mood swings 24.58 10.33 31 305694 18217 63165080
Abdominal distension 24.36 10.33 283 305442 86332 63096965
Neonatal intestinal perforation 24.26 10.33 8 305717 22 63183275
Hypercholesterolaemia 24.26 10.33 181 305544 21153 63162144
Subdural haematoma 24.23 10.33 20 305705 14308 63168989
Paranoia 24.20 10.33 13 305712 11666 63171631
Red blood cell count decreased 24.12 10.33 107 305618 40538 63142759
Aspiration 24.12 10.33 11 305714 10840 63172457
Product storage error 23.93 10.33 22 305703 14934 63168363
Metastases to central nervous system 23.81 10.33 17 305708 13088 63170209
Application site rash 23.81 10.33 43 305682 2455 63180842
Ischaemic stroke 23.68 10.33 31 305694 17926 63165371
Haemorrhage intracranial 23.62 10.33 18 305707 13401 63169896
Crying 23.57 10.33 48 305677 23295 63160002
Bone pain 23.55 10.33 160 305565 54481 63128816
Skin ulcer 23.38 10.33 117 305608 42928 63140369
Rheumatoid lung 23.37 10.33 55 305670 3793 63179504
Walking aid user 23.37 10.33 108 305617 10609 63172688
Dyskinesia 23.00 10.33 78 305647 31924 63151373
Lupus-like syndrome 22.94 10.33 139 305586 15156 63168141
Transaminases increased 22.85 10.33 76 305649 31291 63152006
Skin discolouration 22.80 10.33 99 305626 37729 63145568
Breast cancer 22.73 10.33 138 305587 48245 63135052
Candida infection 22.56 10.33 66 305659 28285 63155012
Mania 22.53 10.33 16 305709 12351 63170946
Multiple allergies 22.45 10.33 20 305705 13782 63169515
Feeling hot 22.43 10.33 146 305579 50208 63133089
Pulmonary mass 22.36 10.33 47 305678 22549 63160748
Electrolyte imbalance 22.28 10.33 39 305686 20037 63163260
Acute kidney injury 22.22 10.33 1039 304686 262376 62920921
Synostosis 22.09 10.33 9 305716 52 63183245
Alanine aminotransferase increased 22.02 10.33 359 305366 103411 63079886
Dizziness 21.97 10.33 1777 303948 428148 62755149
Abdominal rebound tenderness 21.84 10.33 7 305718 17 63183280
Central nervous system lesion 21.80 10.33 12 305713 10623 63172674
Dysphonia 21.74 10.33 137 305588 47477 63135820
Congenital pulmonary hypertension 21.68 10.33 9 305716 55 63183242
Tachypnoea 21.67 10.33 31 305694 17271 63166026
Corneal epithelium defect 21.61 10.33 16 305709 336 63182961
Bacterial infection 21.53 10.33 38 305687 19461 63163836
Gallbladder disorder 21.46 10.33 36 305689 18806 63164491
Nodule 21.43 10.33 43 305682 20983 63162314
Blood pressure abnormal 21.34 10.33 25 305700 15173 63168124
Urine abnormality 21.26 10.33 4 305721 7015 63176282
Thyroid disorder 21.22 10.33 25 305700 15137 63168160
Multiple organ dysfunction syndrome 21.20 10.33 173 305552 56579 63126718
Exostosis 21.14 10.33 153 305572 17709 63165588
Drug withdrawal syndrome 21.14 10.33 64 305661 27130 63156167
Keratopathy 21.14 10.33 20 305705 596 63182701
Hepatitis 21.13 10.33 109 305616 39679 63143618
Cholestasis 20.98 10.33 72 305653 29362 63153935
Device breakage 20.94 10.33 15 305710 11527 63171770
Upper limb fracture 20.91 10.33 37 305688 18931 63164366
Device occlusion 20.76 10.33 5 305720 7382 63175915
Schizophrenia 20.74 10.33 11 305714 9941 63173356
Wrist deformity 20.73 10.33 37 305688 2093 63181204
Blood bilirubin increased 20.72 10.33 100 305625 37040 63146257
Nephrolithiasis 20.65 10.33 118 305607 41866 63141431
Bedridden 20.52 10.33 14 305711 11037 63172260
Lymphatic fistula 20.51 10.33 22 305703 764 63182533
Soft tissue injury 20.50 10.33 32 305693 1620 63181677
International normalised ratio increased 20.48 10.33 135 305590 46290 63137007
Vascular device infection 20.45 10.33 5 305720 7307 63175990
Hip fracture 20.40 10.33 73 305652 29401 63153896
Emotional distress 20.35 10.33 84 305641 32465 63150832
Haematemesis 20.29 10.33 230 305495 30182 63153115
Device difficult to use 20.27 10.33 19 305706 12777 63170520
Heart rate irregular 20.26 10.33 49 305676 22372 63160925
Meralgia paraesthetica 20.15 10.33 17 305708 434 63182863
Aphasia 20.12 10.33 86 305639 32914 63150383
Coagulopathy 20.11 10.33 43 305682 20501 63162796
Bladder disorder 19.99 10.33 9 305716 8937 63174360
Failure to thrive 19.98 10.33 5 305720 7193 63176104
Treatment noncompliance 19.96 10.33 102 305623 37223 63146074
Aspergillus infection 19.95 10.33 7 305718 8086 63175211
Hepatic cytolysis 19.90 10.33 27 305698 15380 63167917
Ulcer 19.90 10.33 62 305663 26045 63157252
Urinary incontinence 19.78 10.33 83 305642 31931 63151366
Synovial cyst 19.77 10.33 101 305624 10332 63172965
Metastases to bone 19.74 10.33 45 305680 20974 63162323
Adrenal insufficiency 19.70 10.33 35 305690 17880 63165417
Respiratory disorder 19.68 10.33 109 305616 38973 63144324
Pancreatitis acute 19.67 10.33 66 305659 27100 63156197
Femur fracture 19.66 10.33 119 305606 41637 63141660
Ovulation disorder 19.66 10.33 7 305718 26 63183271
Cardiomyopathy 19.66 10.33 34 305691 17550 63165747
Aspartate aminotransferase increased 19.59 10.33 311 305414 89966 63093331
Device malfunction 19.53 10.33 35 305690 17822 63165475
Hypertransaminasaemia 19.53 10.33 4 305721 6605 63176692
Therapy change 19.45 10.33 3 305722 6078 63177219
Dysarthria 19.45 10.33 123 305602 42588 63140709
Vaginal discharge 19.41 10.33 10 305715 9188 63174109
Femoral hernia incarcerated 19.28 10.33 22 305703 819 63182478
Chronic sinusitis 19.27 10.33 20 305705 12823 63170474
Nasal polyps 19.27 10.33 3 305722 6036 63177261
Upper-airway cough syndrome 19.23 10.33 16 305709 11402 63171895
Neonatal respiratory acidosis 19.18 10.33 12 305713 189 63183108
Amenorrhoea 19.17 10.33 12 305713 9902 63173395
Pre-eclampsia 19.17 10.33 10 305715 9123 63174174
Gallbladder adenocarcinoma 19.17 10.33 10 305715 109 63183188
Kidney infection 19.14 10.33 53 305672 23123 63160174
Vertigo 19.12 10.33 190 305535 59697 63123600
Dystonia 19.11 10.33 23 305702 13796 63169501
Mental impairment 19.10 10.33 24 305701 14127 63169170
Rhinitis allergic 19.06 10.33 17 305708 11710 63171587
Uterine perforation 19.02 10.33 5 305720 6958 63176339
Enterococcal infection 18.99 10.33 7 305718 7841 63175456
Caesarean section 18.98 10.33 33 305692 16999 63166298
Disturbance in attention 18.96 10.33 107 305618 38082 63145215
Pulmonary fibrosis 18.95 10.33 283 305442 39526 63143771
Basal cell carcinoma 18.93 10.33 70 305655 27921 63155376
Tongue disorder 18.87 10.33 14 305711 10566 63172731
Blood pressure systolic increased 18.86 10.33 142 305583 47255 63136042
Bronchopulmonary aspergillosis 18.81 10.33 9 305716 8626 63174671
Drug level increased 18.77 10.33 52 305673 22684 63160613
Injection site hyperaesthesia 18.73 10.33 8 305717 53 63183244
Injection site rash 18.72 10.33 39 305686 18770 63164527
Breast cancer stage I 18.71 10.33 5 305720 6884 63176413
Dementia 18.68 10.33 39 305686 18755 63164542
Genital haemorrhage 18.67 10.33 6 305719 7326 63175971
Tooth disorder 18.66 10.33 71 305654 28086 63155211
Gastric ulcer haemorrhage 18.61 10.33 59 305666 4849 63178448
Nervous system disorder 18.60 10.33 39 305686 18727 63164570
Anosmia 18.59 10.33 5 305720 6855 63176442
Intestinal ulcer 18.45 10.33 28 305697 1383 63181914
Arteriovenous fistula occlusion 18.42 10.33 15 305710 364 63182933
Femur-fibula-ulna complex 18.26 10.33 5 305720 5 63183292
Encephalitis 18.23 10.33 10 305715 8870 63174427
Transient ischaemic attack 18.09 10.33 107 305618 37646 63145651
Acute respiratory distress syndrome 17.86 10.33 56 305669 23478 63159819
Multiple sclerosis 17.79 10.33 59 305666 24313 63158984
Haemophagocytic lymphohistiocytosis 17.77 10.33 15 305710 10612 63172685
Sebaceous gland infection 17.65 10.33 11 305714 172 63183125
Drug level decreased 17.64 10.33 8 305717 7911 63175386
Visual impairment 17.63 10.33 293 305432 84153 63099144
Retching 17.60 10.33 27 305698 14618 63168679
Gastroenteritis viral 17.56 10.33 57 305668 23643 63159654
Eye pruritus 17.52 10.33 40 305685 18631 63164666
C-reactive protein increased 17.50 10.33 588 305137 94119 63089178
Pancreatic steatosis 17.49 10.33 23 305702 993 63182304
Blue toe syndrome 17.49 10.33 15 305710 392 63182905
Peripheral sensory neuropathy 17.44 10.33 7 305718 7444 63175853
Muscle tone disorder 17.38 10.33 10 305715 134 63183163
Urine porphobilinogen increased 17.36 10.33 4 305721 0 63183297
Foetal exposure during pregnancy 17.29 10.33 87 305638 31875 63151422
Spinal fracture 17.26 10.33 39 305686 18232 63165065
Urinoma 17.25 10.33 7 305718 40 63183257
Renal cancer 17.22 10.33 3 305722 5559 63177738
Metabolic disorder 17.14 10.33 5 305720 6498 63176799
Renal disorder 17.13 10.33 91 305634 32883 63150414
Staphylococcal bacteraemia 17.08 10.33 3 305722 5527 63177770
Fistula 16.98 10.33 15 305710 10378 63172919
Gastrointestinal toxicity 16.97 10.33 8 305717 7733 63175564
Mood altered 16.95 10.33 28 305697 14715 63168582
Swelling face 16.85 10.33 210 305515 63265 63120032
Central pain syndrome 16.80 10.33 12 305713 238 63183059
Pneumothorax 16.79 10.33 33 305692 16228 63167069
Cushingoid 16.79 10.33 10 305715 8475 63174822
Fracture 16.77 10.33 44 305681 19540 63163757
Onychomadesis 16.75 10.33 64 305661 5776 63177521
Myocarditis 16.75 10.33 15 305710 10310 63172987
Hypovolaemia 16.73 10.33 16 305709 10657 63172640
Adactyly 16.70 10.33 7 305718 44 63183253
Salivary hypersecretion 16.68 10.33 8 305717 7658 63175639
Orbital oedema 16.67 10.33 13 305712 296 63183001
Epstein-Barr virus infection 16.62 10.33 9 305716 8041 63175256
Libido increased 16.61 10.33 26 305699 1319 63181978
Complications of intestinal transplant 16.60 10.33 5 305720 9 63183288
Cataract 16.59 10.33 185 305540 56868 63126429
Muscle spasms 16.54 10.33 600 305125 155550 63027747
Lower limb fracture 16.53 10.33 184 305541 24037 63159260
Dysuria 16.50 10.33 95 305630 33643 63149654
Spinal pain 16.40 10.33 114 305611 13025 63170272
Hypogammaglobulinaemia 16.30 10.33 7 305718 7148 63176149
Pharyngo-oesophageal diverticulum 16.26 10.33 5 305720 10 63183287
Lymphocyte stimulation test positive 16.21 10.33 16 305709 503 63182794
Pulseless electrical activity 16.14 10.33 8 305717 7513 63175784
Cystitis 16.11 10.33 178 305547 54813 63128484
Oedema peripheral 16.07 10.33 747 304978 188764 62994533
Heart rate decreased 16.07 10.33 141 305584 45419 63137878
Product substitution issue 16.06 10.33 33 305692 15963 63167334
Skin cancer 16.04 10.33 19 305706 11476 63171821
Large intestine perforation 16.00 10.33 82 305643 8400 63174897
Granuloma 16.00 10.33 4 305721 5757 63177540
Diverticulitis 15.98 10.33 118 305607 39439 63143858
Coordination abnormal 15.98 10.33 26 305699 13747 63169550
Sciatica 15.95 10.33 243 305482 34081 63149216
Injection site urticaria 15.92 10.33 27 305698 14046 63169251
Tumour lysis syndrome 15.90 10.33 12 305713 8978 63174319
Gait inability 15.84 10.33 350 305375 52609 63130688
Unintended pregnancy 15.84 10.33 5 305720 6174 63177123
Muscle spasticity 15.74 10.33 53 305672 21741 63161556
Glycosylated haemoglobin increased 15.74 10.33 22 305703 12376 63170921
Menstruation irregular 15.72 10.33 7 305718 6997 63176300
Myoclonus 15.71 10.33 33 305692 15835 63167462
Joint injury 15.71 10.33 81 305644 29491 63153806
Respiratory tract infection 15.70 10.33 126 305599 41357 63141940
Vaccination site reaction 15.68 10.33 9 305716 120 63183177
Granulocytopenia 15.63 10.33 4 305721 5668 63177629
Irritability 15.63 10.33 89 305636 31605 63151692
Bronchiectasis 15.62 10.33 34 305691 16108 63167189
Libido disorder 15.60 10.33 7 305718 53 63183244
Breast cancer metastatic 15.59 10.33 21 305704 11997 63171300
Cardiogenic shock 15.57 10.33 40 305685 17892 63165405
Drug ineffective for unapproved indication 15.56 10.33 98 305627 33965 63149332
Punctate keratitis 15.53 10.33 17 305708 604 63182693
Lip ulceration 15.51 10.33 32 305693 2018 63181279
Hypochromic anaemia 15.50 10.33 31 305694 1911 63181386
Sinus bradycardia 15.49 10.33 29 305696 14522 63168775
Tardive dyskinesia 15.49 10.33 11 305714 8491 63174806
Eye irritation 15.49 10.33 54 305671 21917 63161380
Complication of device removal 15.43 10.33 3 305722 5139 63178158
Chronic kidney disease 15.35 10.33 142 305583 45256 63138041
Gastrooesophageal reflux disease 15.33 10.33 347 305378 95292 63088005
Spondylitis 15.30 10.33 51 305674 4303 63178994
Immunosuppression 15.29 10.33 12 305713 8802 63174495
Acne 15.27 10.33 59 305666 23234 63160063
Liver function test increased 15.19 10.33 94 305631 32717 63150580
Creutzfeldt-Jakob disease 15.17 10.33 10 305715 173 63183124
Nail operation 15.10 10.33 20 305705 870 63182427
Glaucoma 15.05 10.33 44 305681 18861 63164436
Agranulocytosis 15.01 10.33 66 305659 25068 63158229
Skin exfoliation 14.93 10.33 134 305591 42968 63140329
Normal newborn 14.92 10.33 11 305714 8330 63174967
Exercise tolerance decreased 14.91 10.33 4 305721 5493 63177804
Staphylococcal infection 14.85 10.33 127 305598 41129 63142168
Erythematotelangiectatic rosacea 14.85 10.33 5 305720 15 63183282
Anal erosion 14.83 10.33 6 305719 34 63183263
Haemolysis 14.83 10.33 7 305718 6761 63176536
Female genital tract fistula 14.83 10.33 9 305716 7550 63175747
Pneumonia viral 14.76 10.33 10 305715 7912 63175385
Pneumonitis 14.75 10.33 104 305621 35118 63148179
Tenderness 14.72 10.33 170 305555 22408 63160889
Proctitis 14.68 10.33 4 305721 5437 63177860
Respiratory acidosis 14.63 10.33 7 305718 6708 63176589
Diffuse large B-cell lymphoma 14.61 10.33 7 305718 6705 63176592
Soft tissue infection 14.60 10.33 32 305693 2105 63181192
Joint stiffness 14.59 10.33 283 305442 41586 63141711
Haemorrhoids 14.58 10.33 56 305669 22094 63161203
Hemiplegia 14.58 10.33 14 305711 9309 63173988
Hypothyroidism 14.57 10.33 133 305592 42499 63140798
Hypothermia 14.52 10.33 27 305698 13554 63169743
Pharyngitis streptococcal 14.51 10.33 18 305707 10654 63172643
Partial seizures 14.50 10.33 5 305720 5837 63177460
Brain oedema 14.49 10.33 29 305696 14166 63169131
Catheter site infection 14.47 10.33 3 305722 4911 63178386
Intestinal haemorrhage 14.36 10.33 46 305679 3801 63179496
Vasoconstriction 14.36 10.33 16 305709 580 63182717
Basal ganglion degeneration 14.34 10.33 14 305711 434 63182863
Obesity 14.28 10.33 213 305512 29739 63153558
Respiratory syncytial virus infection 14.27 10.33 8 305717 7010 63176287
Adverse reaction 14.22 10.33 91 305634 10112 63173185
Proteinuria 14.21 10.33 46 305679 19099 63164198
Sensory loss 14.20 10.33 17 305708 10221 63173076
Homicide 14.17 10.33 13 305712 372 63182925
Parotid gland enlargement 14.12 10.33 19 305706 839 63182458
Viral infection 14.12 10.33 107 305618 35556 63147741
Colitis erosive 14.11 10.33 8 305717 104 63183193
Muscle twitching 14.09 10.33 48 305677 19620 63163677
Suspected suicide 14.07 10.33 7 305718 6561 63176736
Myopathy 14.07 10.33 20 305705 11171 63172126
Accidental overdose 14.05 10.33 61 305664 23248 63160049
Pollakiuria 14.02 10.33 78 305647 27859 63155438
Hemiparesis 13.99 10.33 61 305664 23221 63160076
Skin disorder 13.94 10.33 84 305641 29423 63153874
Hyperammonaemia 13.83 10.33 4 305721 5228 63178069
Limb discomfort 13.83 10.33 85 305640 29631 63153666
Bone marrow oedema 13.83 10.33 23 305702 1229 63182068
Anterior chamber cell 13.80 10.33 15 305710 529 63182768
Immune reconstitution inflammatory syndrome 13.78 10.33 6 305719 6078 63177219
Nervousness 13.70 10.33 90 305635 30889 63152408
Rash pruritic 13.65 10.33 204 305521 59595 63123702
Road traffic accident 13.59 10.33 250 305475 36382 63146915
pH body fluid decreased 13.56 10.33 5 305720 21 63183276
Cyanosis neonatal 13.50 10.33 13 305712 396 63182901
Therapy partial responder 13.44 10.33 19 305706 10639 63172658
Restless legs syndrome 13.43 10.33 45 305680 18486 63164811
Breath sounds abnormal 13.41 10.33 20 305705 10953 63172344
Papulopustular rosacea 13.38 10.33 5 305720 22 63183275
Blood glucose abnormal 13.37 10.33 11 305714 7881 63175416
Pyoderma streptococcal 13.35 10.33 4 305721 7 63183290
Stillbirth 13.29 10.33 8 305717 6742 63176555
Electrocardiogram QRS complex prolonged 13.23 10.33 6 305719 5932 63177365
Arterial haemorrhage 13.22 10.33 27 305698 1690 63181607
Injection site abscess 13.22 10.33 22 305703 1176 63182121
Porphyria 13.21 10.33 9 305716 165 63183132
Acquired porphyria 13.20 10.33 5 305720 23 63183274
Porphyrins urine increased 13.20 10.33 5 305720 23 63183274
Abortion induced 13.18 10.33 18 305707 10224 63173073
Pseudomonas infection 13.17 10.33 21 305704 11192 63172105
Gastrointestinal ulcer 13.11 10.33 31 305694 2144 63181153
Application site eczema 13.02 10.33 3 305722 0 63183297
Pseudodiverticular disease 13.02 10.33 3 305722 0 63183297
Bone lesion 13.01 10.33 6 305719 5875 63177422
Toothache 12.99 10.33 48 305677 19151 63164146
Deafness 12.98 10.33 138 305587 17819 63165478
Aortic stenosis 12.98 10.33 4 305721 5016 63178281
Head injury 12.94 10.33 78 305647 27318 63155979
Palatal oedema 12.90 10.33 15 305710 570 63182727
Infusion site pain 12.90 10.33 40 305685 16829 63166468
Coronary artery disease 12.88 10.33 97 305628 32280 63151017
COVID-19 pneumonia 12.88 10.33 31 305694 14178 63169119
White blood cell count abnormal 12.86 10.33 7 305718 6235 63177062
Rhinovirus infection 12.86 10.33 3 305722 4526 63178771
Wound infection pseudomonas 12.84 10.33 23 305702 1305 63181992
Epilepsy 12.81 10.33 77 305648 26988 63156309
Motor dysfunction 12.78 10.33 20 305705 10741 63172556
Alanine aminotransferase abnormal 12.76 10.33 3 305722 4501 63178796
Body temperature increased 12.72 10.33 116 305609 37076 63146221
Application site injury 12.71 10.33 5 305720 26 63183271
Appetite disorder 12.66 10.33 10 305715 7311 63175986
Congestive cardiomyopathy 12.64 10.33 7 305718 6175 63177122
Erythema induratum 12.58 10.33 9 305716 179 63183118
Hernia 12.57 10.33 26 305699 12548 63170749
Pulmonary thrombosis 12.56 10.33 14 305711 8688 63174609
Hyperlipidaemia 12.55 10.33 50 305675 19521 63163776
Cholecystitis chronic 12.55 10.33 19 305706 10342 63172955
Atrioventricular block 12.53 10.33 11 305714 7636 63175661
Peritonitis 12.48 10.33 132 305593 17022 63166275
Foot deformity 12.48 10.33 196 305529 27657 63155640
Onychomycosis 12.48 10.33 73 305652 7859 63175438
Spinal fusion surgery 12.48 10.33 57 305668 5571 63177726
Hepatic encephalopathy 12.44 10.33 22 305703 11260 63172037
Acute graft versus host disease 12.44 10.33 3 305722 4425 63178872
Thinking abnormal 12.43 10.33 20 305705 10623 63172674
Insurance issue 12.41 10.33 7 305718 6114 63177183
Oesophageal carcinoma recurrent 12.40 10.33 5 305720 28 63183269
Polyneuropathy 12.32 10.33 33 305692 14556 63168741
Localised infection 12.26 10.33 90 305635 30120 63153177
Reticulocytosis 12.26 10.33 8 305717 136 63183161
Eye infection 12.24 10.33 25 305700 12120 63171177
Atrioventricular block complete 12.21 10.33 13 305712 8238 63175059
Oedema 12.18 10.33 581 305144 97041 63086256
Blood pressure diastolic decreased 12.17 10.33 62 305663 22644 63160653
Presyncope 12.15 10.33 81 305644 27704 63155593
Porphyrins stool increased 12.12 10.33 5 305720 30 63183267
Vaginal haemorrhage 12.09 10.33 80 305645 27407 63155890
Tissue infiltration 12.03 10.33 15 305710 614 63182683
Sinus headache 12.01 10.33 6 305719 5610 63177687
Gout 11.99 10.33 29 305696 13242 63170055
Mitral valve incompetence 11.98 10.33 51 305674 19543 63163754
Colitis 11.98 10.33 163 305562 48365 63134932
Iris transillumination defect 11.96 10.33 7 305718 97 63183200
Panic attack 11.95 10.33 61 305664 22270 63161027
Immune system disorder 11.95 10.33 18 305707 9816 63173481
Cardiomegaly 11.94 10.33 44 305681 17570 63165727
Myelodysplastic syndrome 11.93 10.33 41 305684 16713 63166584
Movement disorder 11.92 10.33 158 305567 21503 63161794
Application site ulcer 11.90 10.33 7 305718 98 63183199
Device leakage 11.88 10.33 10 305715 7086 63176211
Meteoropathy 11.88 10.33 4 305721 12 63183285
Neurological procedural complication 11.88 10.33 4 305721 12 63183285
Skin fissures 11.86 10.33 23 305702 11365 63171932
Parkinsonism 11.84 10.33 20 305705 10419 63172878
Hypoacusis 11.81 10.33 68 305657 24083 63159214
Tinnitus 11.81 10.33 112 305613 35516 63147781
Skin mass 11.81 10.33 7 305718 5948 63177349
Blood magnesium decreased 11.80 10.33 29 305696 13169 63170128
Gastrointestinal procedural complication 11.80 10.33 9 305716 198 63183099
Stress cardiomyopathy 11.77 10.33 17 305708 9433 63173864
Body temperature decreased 11.75 10.33 54 305671 20265 63163032
Pruritus 11.75 10.33 1946 303779 359507 62823790
Alpha tumour necrosis factor increased 11.72 10.33 5 305720 33 63183264
Needle issue 11.65 10.33 20 305705 10356 63172941
Injection site warmth 11.64 10.33 36 305689 15159 63168138
Cardiac massage 11.64 10.33 4 305721 13 63183284
Feeling jittery 11.56 10.33 30 305695 13373 63169924
Ventricular hypokinesia 11.48 10.33 4 305721 4640 63178657
Anger 11.43 10.33 27 305698 12429 63170868
Oral herpes 11.41 10.33 76 305649 25998 63157299
Asthma 11.38 10.33 500 305225 127061 63056236
Ovarian cyst 11.37 10.33 39 305686 15906 63167391
Conjunctival hyperaemia 11.32 10.33 31 305694 2348 63180949
Paradoxical drug reaction 11.30 10.33 3 305722 4149 63179148
Atrioventricular block first degree 11.28 10.33 11 305714 7262 63176035
Wrist fracture 11.27 10.33 31 305694 13556 63169741
Perforation bile duct 11.20 10.33 4 305721 15 63183282
Premature rupture of membranes 11.19 10.33 5 305720 4988 63178309
Flatulence 11.11 10.33 110 305615 34592 63148705
Mental disorder 11.11 10.33 76 305649 25843 63157454
Pelvic pain 11.10 10.33 31 305694 13488 63169809
Hypoproteinaemia 11.07 10.33 28 305697 2021 63181276
Hypersomnia 11.04 10.33 47 305678 18008 63165289
Hypoaesthesia 11.02 10.33 948 304777 167445 63015852
Spinal cord infection 11.02 10.33 15 305710 670 63182627
Pulmonary haemorrhage 10.98 10.33 11 305714 7170 63176127
Sputum discoloured 10.98 10.33 41 305684 16306 63166991
Venous valve ruptured 10.96 10.33 3 305722 3 63183294
Rhinitis 10.95 10.33 24 305701 11342 63171955
Colitis ulcerative 10.94 10.33 77 305648 26014 63157283
Product preparation error 10.94 10.33 8 305717 6084 63177213
Tumour marker increased 10.90 10.33 5 305720 4910 63178387
Menstrual disorder 10.88 10.33 6 305719 5307 63177990
Mass 10.84 10.33 33 305692 13967 63169330
Metastases to lymph nodes 10.84 10.33 14 305711 8144 63175153
Viral upper respiratory tract infection 10.84 10.33 69 305656 7655 63175642
Atrial flutter 10.83 10.33 19 305706 9753 63173544
Subarachnoid haemorrhage 10.83 10.33 34 305691 14249 63169048
Infusion site swelling 10.82 10.33 19 305706 9751 63173546
Catatonia 10.82 10.33 4 305721 4473 63178824
Hyperbilirubinaemia 10.81 10.33 24 305701 11290 63172007
Kounis syndrome 10.80 10.33 25 305700 1705 63181592
Polycystic ovaries 10.80 10.33 4 305721 4467 63178830
Thyroid neoplasm 10.76 10.33 3 305722 4016 63179281
Lymphoma 10.73 10.33 27 305698 12160 63171137
Diverticulum intestinal 10.71 10.33 62 305663 6651 63176646
Anal fissure 10.69 10.33 4 305721 4439 63178858
Acute myocardial infarction 10.64 10.33 101 305624 32023 63151274
Hypoaesthesia oral 10.62 10.33 30 305695 13003 63170294
Systemic mastocytosis 10.61 10.33 8 305717 173 63183124
Soft tissue disorder 10.61 10.33 4 305721 4418 63178879
Eosinophil count increased 10.59 10.33 23 305702 10905 63172392
Peptic ulcer 10.58 10.33 47 305678 4540 63178757
Nephropathy 10.54 10.33 9 305716 6332 63176965
Malnutrition 10.51 10.33 38 305687 15260 63168037
Hypomania 10.50 10.33 9 305716 6321 63176976
Vitreous floaters 10.50 10.33 8 305717 5958 63177339
Lip scab 10.50 10.33 3 305722 4 63183293
Naevus haemorrhage 10.48 10.33 7 305718 124 63183173
Tubulointerstitial nephritis 10.47 10.33 144 305581 19759 63163538
Pulmonary function test decreased 10.47 10.33 3 305722 3944 63179353
Axial spondyloarthritis 10.46 10.33 11 305714 373 63182924
Drug dose omission by device 10.46 10.33 5 305720 4796 63178501
Diplopia 10.46 10.33 69 305656 23659 63159638
Joint arthroplasty 10.44 10.33 33 305692 2708 63180589
Pain in jaw 10.41 10.33 147 305578 43349 63139948
Cardiac tamponade 10.37 10.33 5 305720 4770 63178527
Allodynia 10.35 10.33 16 305709 803 63182494
Atrioventricular block second degree 10.34 10.33 3 305722 3911 63179386

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
Embolia cutis medicamentosa 277.83 10.36 72 82325 167 34874367
Ankylosing spondylitis 264.98 10.36 165 82232 5439 34869095
Death 252.26 10.36 343 82054 397706 34476828
Melaena 225.86 10.36 343 82054 35037 34839497
Gastric ulcer 208.17 10.36 219 82178 15431 34859103
Duodenal ulcer 165.67 10.36 160 82237 10172 34864362
Off label use 150.73 10.36 498 81899 419026 34455508
Kounis syndrome 131.46 10.36 79 82318 2439 34872095
Onychoclasis 129.71 10.36 71 82326 1829 34872705
Febrile neutropenia 124.55 10.36 85 82312 136764 34737770
Angioedema 105.36 10.36 256 82141 37118 34837416
Anaphylactic shock 105.16 10.36 157 82240 15784 34858750
Neutropenia 104.08 10.36 130 82267 156648 34717886
Inflammation 99.99 10.36 212 82185 28083 34846451
Gastritis erosive 97.24 10.36 93 82304 5839 34868695
Psoriatic arthropathy 95.24 10.36 169 82228 19629 34854905
Large intestinal stenosis 89.23 10.36 52 82345 1515 34873019
Gastric ulcer haemorrhage 84.53 10.36 83 82314 5383 34869151
Fractional exhaled nitric oxide increased 83.87 10.36 44 82353 1038 34873496
Large intestinal ulcer 83.17 10.36 54 82343 1915 34872619
Neck pain 81.68 10.36 183 82214 25166 34849368
Joint swelling 80.80 10.36 317 82080 59573 34814961
Tooth loss 79.95 10.36 69 82328 3789 34870745
Upper gastrointestinal haemorrhage 76.45 10.36 179 82218 25339 34849195
Musculoskeletal stiffness 75.48 10.36 262 82135 46418 34828116
Pruritus 73.97 10.36 580 81817 141401 34733133
Arthralgia 73.95 10.36 667 81730 169374 34705160
Duodenal ulcer perforation 72.00 10.36 46 82351 1586 34872948
Lymphoma 69.71 10.36 114 82283 12393 34862141
Intestinal diaphragm disease 69.38 10.36 25 82372 224 34874310
Haematemesis 68.88 10.36 181 82216 27530 34847004
Myoglobin blood increased 68.67 10.36 57 82340 2966 34871568
Sensation of foreign body 68.52 10.36 55 82342 2728 34871806
Ductus arteriosus premature closure 68.24 10.36 25 82372 236 34874298
Psoriasis 67.28 10.36 223 82174 38589 34835945
Urticaria 66.94 10.36 308 82089 62069 34812465
Gastric haemorrhage 64.75 10.36 99 82298 10162 34864372
Plantar fasciitis 63.43 10.36 47 82350 2069 34872465
Thrombocytopenia 63.30 10.36 175 82222 156072 34718462
Sacroiliitis 63.07 10.36 41 82356 1457 34873077
Cardiac failure congestive 62.94 10.36 62 82335 83208 34791326
Anaphylactic reaction 62.74 10.36 193 82204 32108 34842426
Pain 62.46 10.36 747 81650 203928 34670606
Abdominal pain upper 61.14 10.36 331 82066 71159 34803375
Exostosis 60.84 10.36 65 82332 4658 34869876
Periorbital oedema 59.81 10.36 58 82339 3704 34870830
Type I hypersensitivity 59.72 10.36 38 82359 1301 34873233
Disease progression 57.72 10.36 104 82293 107973 34766561
Macrocephaly 55.23 10.36 26 82371 482 34874052
Pyloric stenosis 55.11 10.36 31 82366 843 34873691
C-reactive protein increased 55.02 10.36 263 82134 53835 34820699
Toxicity to various agents 54.41 10.36 265 82132 200097 34674437
Tubulointerstitial nephritis and uveitis syndrome 53.21 10.36 16 82381 75 34874459
Arthritis 52.46 10.36 178 82219 31168 34843366
Antidepressant drug level above therapeutic 51.40 10.36 20 82377 226 34874308
Spinal pain 50.80 10.36 66 82331 5823 34868711
Analgesic drug level above therapeutic 50.06 10.36 21 82376 292 34874242
Gastric ulcer perforation 49.36 10.36 31 82366 1037 34873497
Metastases to stomach 48.45 10.36 15 82382 79 34874455
Application site rash 47.64 10.36 28 82369 829 34873705
Acute kidney injury 46.79 10.36 992 81405 303996 34570538
Head discomfort 46.71 10.36 53 82344 4063 34870471
Nephrotic syndrome 45.43 10.36 70 82327 7233 34867301
Secretion discharge 43.07 10.36 61 82336 5844 34868690
Mucosal erosion 42.82 10.36 26 82371 818 34873716
Product dose omission issue 42.78 10.36 142 82255 119569 34754965
Back pain 42.27 10.36 456 81941 121333 34753201
Erythema 42.02 10.36 355 82042 88425 34786109
Hospitalisation 41.13 10.36 44 82353 56858 34817676
Seronegative arthritis 40.26 10.36 27 82370 1012 34873522
Peritonitis 39.75 10.36 106 82291 16259 34858275
Aspirin-exacerbated respiratory disease 39.61 10.36 19 82378 368 34874166
Muscle swelling 39.47 10.36 19 82378 371 34874163
Ligament calcification 39.39 10.36 16 82381 204 34874330
Product used for unknown indication 39.18 10.36 26 82371 957 34873577
Nephrolithiasis 38.83 10.36 158 82239 30175 34844359
Neoplasm malignant 37.78 10.36 118 82279 19787 34854747
Sepsis 37.67 10.36 234 82163 166327 34708207
Nightmare 36.78 10.36 95 82302 14296 34860238
Ulcerative keratitis 35.98 10.36 31 82366 1698 34872836
Plasma cell myeloma 35.73 10.36 28 82369 42009 34832525
Bronchospasm 35.15 10.36 78 82319 10653 34863881
Aminoaciduria 35.13 10.36 16 82381 274 34874260
Gastrointestinal erosion 35.08 10.36 18 82379 405 34874129
Hypomagnesaemia 34.86 10.36 5 82392 21846 34852688
Conjunctival hyperaemia 34.42 10.36 35 82362 2367 34872167
Injection site necrosis 34.37 10.36 18 82379 423 34874111
Erythema multiforme 34.32 10.36 68 82329 8581 34865953
Ductus arteriosus stenosis foetal 34.08 10.36 14 82383 184 34874350
Gastrointestinal haemorrhage 32.90 10.36 336 82061 88141 34786393
Cerebrovascular accident 32.83 10.36 97 82300 84714 34789820
Cytokine release syndrome 32.65 10.36 7 82390 22870 34851664
Glomerulonephritis minimal lesion 32.56 10.36 18 82379 473 34874061
Duodenal ulcer haemorrhage 32.52 10.36 49 82348 4964 34869570
Blood pressure measurement 31.92 10.36 13 82384 167 34874367
Corneal thinning 30.89 10.36 12 82385 135 34874399
Uveitis 30.81 10.36 60 82337 7475 34867059
Drug tolerance decreased 30.66 10.36 30 82367 1937 34872597
Toxic epidermal necrolysis 30.32 10.36 116 82281 21530 34853004
Mastoid abscess 30.32 10.36 6 82391 0 34874534
Cerebral atrophy congenital 30.15 10.36 10 82387 68 34874466
Blister 30.00 10.36 120 82277 22738 34851796
Pancytopenia 29.94 10.36 119 82278 95038 34779496
Pneumonia 29.85 10.36 640 81757 361987 34512547
Faeces discoloured 28.97 10.36 89 82308 14789 34859745
Fibromyalgia 28.72 10.36 36 82361 3064 34871470
Lymphocyte stimulation test positive 28.59 10.36 19 82378 701 34873833
Peptic ulcer 28.51 10.36 34 82363 2749 34871785
Intestinal atony 28.46 10.36 8 82389 28 34874506
Gastritis 28.04 10.36 114 82283 21759 34852775
Drug interaction 27.50 10.36 712 81685 225234 34649300
Hyperhidrosis 27.44 10.36 286 82111 75406 34799128
Brain natriuretic peptide increased 26.81 10.36 48 82349 5611 34868923
Neurotoxicity 26.77 10.36 5 82392 18005 34856529
Application site reaction 26.60 10.36 15 82382 410 34874124
Blood urea increased 26.21 10.36 141 82256 30223 34844311
Neuropathy peripheral 25.64 10.36 105 82292 83158 34791376
Atrial fibrillation 25.59 10.36 176 82221 122217 34752317
Malignant mesenteric neoplasm 25.55 10.36 8 82389 44 34874490
Nerve stimulation test abnormal 25.26 10.36 5 82392 0 34874534
Sedation 24.99 10.36 107 82290 20899 34853635
Leukopenia 24.97 10.36 71 82326 62785 34811749
Anuria 24.95 10.36 67 82330 10318 34864216
Tubulointerstitial nephritis 24.94 10.36 107 82290 20917 34853617
Oral pruritus 24.84 10.36 13 82384 305 34874229
Gingivitis ulcerative 24.69 10.36 8 82389 50 34874484
Stevens-Johnson syndrome 24.58 10.36 98 82299 18541 34855993
Erosive duodenitis 24.49 10.36 25 82372 1699 34872835
Microcytic anaemia 24.06 10.36 29 82368 2371 34872163
Angiocardiogram 24.02 10.36 11 82386 191 34874343
Corneal perforation 23.91 10.36 11 82386 193 34874341
Haematochezia 23.56 10.36 189 82208 46345 34828189
Laryngeal discomfort 23.56 10.36 11 82386 200 34874334
Cardiogenic shock 23.56 10.36 17 82380 26601 34847933
Application site swelling 23.47 10.36 12 82385 268 34874266
Intentional product use issue 23.44 10.36 68 82329 59748 34814786
Anorgasmia 23.39 10.36 18 82379 839 34873695
Platelet dysfunction 23.39 10.36 12 82385 270 34874264
Disability 23.33 10.36 41 82356 4724 34869810
Electrocardiogram QT prolonged 23.12 10.36 38 82359 40914 34833620
Gastric perforation 22.93 10.36 29 82368 2491 34872043
Deep vein thrombosis 22.88 10.36 78 82319 65170 34809364
Mental status changes 22.78 10.36 34 82363 38049 34836485
Corneal epithelium defect 22.71 10.36 13 82384 366 34874168
Renal failure neonatal 22.57 10.36 9 82388 109 34874425
Terminal insomnia 22.11 10.36 15 82382 573 34873961
Palmoplantar pustulosis 22.07 10.36 9 82388 116 34874418
Cardiac septal defect 21.99 10.36 12 82385 307 34874227
Medium-chain acyl-coenzyme A dehydrogenase deficiency 21.99 10.36 7 82390 41 34874493
Nasopharyngitis 21.98 10.36 257 82140 69711 34804823
Pulmonary embolism 21.89 10.36 123 82274 89623 34784911
Leptotrichia infection 21.88 10.36 8 82389 75 34874459
Platelet function test abnormal 21.86 10.36 9 82388 119 34874415
Fragile X syndrome 21.85 10.36 7 82390 42 34874492
Iris hypopigmentation 21.85 10.36 7 82390 42 34874492
Cryopyrin associated periodic syndrome 21.79 10.36 8 82389 76 34874458
Mast cell activation syndrome 21.78 10.36 11 82386 239 34874295
Alopecia 21.63 10.36 114 82283 24241 34850293
Completed suicide 21.60 10.36 139 82258 98029 34776505
Face oedema 21.60 10.36 68 82329 11448 34863086
Secondary amyloidosis 21.43 10.36 8 82389 80 34874454
Shock 21.36 10.36 113 82284 24066 34850468
Hypoaldosteronism 21.11 10.36 10 82387 188 34874346
Jejunal ulcer perforation 20.91 10.36 8 82389 86 34874448
COVID-19 20.75 10.36 103 82294 77447 34797087
Hypoxia 20.60 10.36 64 82333 55031 34819503
Factor VIII deficiency 20.49 10.36 9 82388 141 34874393
Hypotension 20.34 10.36 384 82013 221265 34653269
Cytomegalovirus infection 20.27 10.36 19 82378 26116 34848418
Cytopenia 20.09 10.36 3 82394 12720 34861814
Right-to-left cardiac shunt 20.05 10.36 8 82389 97 34874437
Blood lactate dehydrogenase increased 20.00 10.36 107 82290 22883 34851651
Discomfort 19.92 10.36 93 82304 18845 34855689
Sciatic nerve injury 19.91 10.36 8 82389 99 34874435
Fatigue 19.86 10.36 695 81702 369958 34504576
Gastric mucosal lesion 19.83 10.36 14 82383 571 34873963
Synovial cyst 19.80 10.36 26 82371 2318 34872216
Body mass index abnormal 19.77 10.36 9 82388 154 34874380
Intervertebral disc compression 19.76 10.36 11 82386 293 34874241
Musculoskeletal pain 19.69 10.36 136 82261 31827 34842707
Mobility decreased 19.64 10.36 130 82267 29998 34844536
Omental necrosis 19.64 10.36 6 82391 30 34874504
Inflammatory bowel disease 19.60 10.36 29 82368 2891 34871643
Weight bearing difficulty 19.54 10.36 18 82379 1077 34873457
Eschar 19.53 10.36 15 82382 697 34873837
Application site eczema 19.47 10.36 5 82392 11 34874523
Gastrointestinal ulcer 19.36 10.36 22 82375 1689 34872845
Neuroleptic malignant syndrome 19.36 10.36 9 82388 17925 34856609
Mesenteric neoplasm 19.32 10.36 6 82391 32 34874502
Kidney duplex 19.25 10.36 12 82385 396 34874138
Subacute endocarditis 19.21 10.36 7 82390 65 34874469
Product administered at inappropriate site 19.19 10.36 25 82372 2211 34872323
Grip strength decreased 19.18 10.36 30 82367 3139 34871395
Intestinal congestion 19.17 10.36 5 82392 12 34874522
Tongue oedema 19.02 10.36 29 82368 2968 34871566
Duodenal stenosis 18.87 10.36 10 82387 241 34874293
Trisomy 8 18.84 10.36 7 82390 69 34874465
Drug resistance 18.78 10.36 20 82377 25907 34848627
Swelling 18.76 10.36 167 82230 42199 34832335
Drug abuse 18.55 10.36 147 82250 98949 34775585
Pseudarthrosis 18.40 10.36 7 82390 74 34874460
Application site erythema 18.33 10.36 25 82372 2311 34872223
Eastern Cooperative Oncology Group performance status 18.32 10.36 6 82391 39 34874495
Hypervolaemia 18.22 10.36 12 82385 19697 34854837
Necrotising fasciitis 18.19 10.36 32 82365 3690 34870844
Dactylitis 18.12 10.36 16 82381 906 34873628
Twin pregnancy 17.98 10.36 4 82393 3 34874531
Cold sweat 17.85 10.36 58 82339 9929 34864605
Tissue infiltration 17.84 10.36 7 82390 81 34874453
Arthritis bacterial 17.73 10.36 38 82359 5068 34869466
Contraindicated product administered 17.36 10.36 98 82299 21383 34853151
Gastroduodenal ulcer 17.28 10.36 11 82386 377 34874157
Duodenal perforation 17.19 10.36 18 82379 1260 34873274
Abdominal lymphadenopathy 17.14 10.36 15 82382 839 34873695
Tendon disorder 17.10 10.36 27 82370 2848 34871686
Atrial septal defect 17.07 10.36 47 82350 7345 34867189
Gastritis haemorrhagic 17.00 10.36 19 82378 1432 34873102
Diarrhoea 16.98 10.36 749 81648 389163 34485371
Cardio-respiratory arrest 16.82 10.36 70 82327 55203 34819331
Seizure 16.77 10.36 162 82235 104695 34769839
Full blood count decreased 16.74 10.36 11 82386 18077 34856457
Hyperaesthesia 16.70 10.36 35 82362 4595 34869939
Oral herpes 16.70 10.36 39 82358 5508 34869026
Diabetes mellitus 16.45 10.36 56 82341 46817 34827717
Hyperkalaemia 16.40 10.36 242 82155 69147 34805387
Polyneuropathy in malignant disease 16.30 10.36 9 82388 236 34874298
Intestinal ulcer 16.21 10.36 15 82382 903 34873631
Drug intolerance 16.20 10.36 213 82184 59357 34815177
Myelosuppression 16.16 10.36 13 82384 19252 34855282
Red blood cell sedimentation rate decreased 16.07 10.36 6 82391 60 34874474
Mallory-Weiss syndrome 16.01 10.36 18 82379 1366 34873168
Oculomucocutaneous syndrome 15.96 10.36 8 82389 171 34874363
Lipoma 15.92 10.36 20 82377 1706 34872828
Platelet count decreased 15.92 10.36 193 82204 119524 34755010
Osteoarthritis 15.92 10.36 93 82304 20549 34853985
White blood cell count decreased 15.89 10.36 146 82251 95299 34779235
Cognitive disorder 15.85 10.36 27 82370 28666 34845868
Incorrect product administration duration 15.79 10.36 35 82362 4776 34869758
Renal tubular necrosis 15.76 10.36 76 82321 15604 34858930
Acute myeloid leukaemia 15.74 10.36 12 82385 18258 34856276
Ocular hyperaemia 15.73 10.36 61 82336 11391 34863143
Gastric mucosa erythema 15.70 10.36 9 82388 254 34874280
Metastases to lung 15.65 10.36 53 82344 9267 34865267
Skull fractured base 15.59 10.36 8 82389 180 34874354
Self-medication 15.55 10.36 25 82372 2678 34871856
Ureteral disorder 15.51 10.36 8 82389 182 34874352
Oral mucosa erosion 15.48 10.36 15 82382 957 34873577
Gastrointestinal mucosal exfoliation 15.47 10.36 7 82390 118 34874416
Application site oedema 15.47 10.36 5 82392 31 34874503
Ciliary hyperaemia 15.47 10.36 5 82392 31 34874503
Upper gastrointestinal perforation 15.22 10.36 4 82393 10 34874524
Undifferentiated connective tissue disease 15.20 10.36 5 82392 33 34874501
Internal limiting membrane peeling 15.16 10.36 3 82394 0 34874534
Leucine aminopeptidase increased 15.16 10.36 3 82394 0 34874534
Hypoosmolar state 15.11 10.36 7 82390 125 34874409
Joint space narrowing 15.09 10.36 8 82389 193 34874341
Nikolsky's sign 15.09 10.36 8 82389 193 34874341
Intestinal metaplasia 15.07 10.36 5 82392 34 34874500
Application site hypersensitivity 15.06 10.36 7 82390 126 34874408
Transplant rejection 15.03 10.36 3 82394 10308 34864226
Oropharyngeal discomfort 15.00 10.36 27 82370 3169 34871365
Bradycardia 15.00 10.36 110 82287 75308 34799226
Migraine 14.97 10.36 81 82316 17397 34857137
Persistent corneal epithelial defect 14.95 10.36 5 82392 35 34874499
Bladder cancer 14.93 10.36 10 82387 16268 34858266
Anxiety 14.91 10.36 156 82241 99272 34775262
Visual evoked potentials abnormal 14.81 10.36 6 82391 76 34874458
Jaundice 14.80 10.36 127 82270 31755 34842779
Ascites 14.79 10.36 58 82339 46513 34828021
Oropharyngeal pain 14.76 10.36 138 82259 35347 34839187
Muscle abscess 14.73 10.36 12 82385 608 34873926
Application site vesicles 14.69 10.36 12 82385 610 34873924
Ventricular tachycardia 14.69 10.36 25 82372 26554 34847980
Wound secretion 14.45 10.36 24 82373 2641 34871893
Respiratory failure 14.44 10.36 175 82222 108397 34766137
Skin erosion 14.42 10.36 21 82376 2064 34872470
Hypoglycaemia 14.37 10.36 73 82324 54567 34819967
Pelvic pain 14.35 10.36 23 82374 2457 34872077
Generalised bullous fixed drug eruption 14.33 10.36 6 82391 83 34874451
Suicide attempt 14.26 10.36 148 82249 38968 34835566
Bacteroides infection 14.25 10.36 7 82390 143 34874391
Chronic obstructive pulmonary disease 14.24 10.36 63 82334 48855 34825679
Dehydration 14.23 10.36 218 82179 129751 34744783
Discoloured vomit 14.22 10.36 11 82386 517 34874017
No adverse event 14.17 10.36 20 82377 22907 34851627
Stomatitis 14.11 10.36 52 82345 42462 34832072
Large intestine perforation 13.97 10.36 48 82349 8455 34866079
Encephalopathy 13.94 10.36 40 82357 35279 34839255
Sciatic nerve palsy 13.86 10.36 5 82392 45 34874489
Microcephaly 13.83 10.36 13 82384 798 34873736
Gastric disorder 13.75 10.36 62 82335 12379 34862155
Myelodysplastic syndrome 13.71 10.36 15 82382 19193 34855341
Retinal toxicity 13.70 10.36 10 82387 430 34874104
Xanthelasma 13.60 10.36 6 82391 95 34874439
Costovertebral angle tenderness 13.60 10.36 6 82391 95 34874439
Energy increased 13.51 10.36 16 82381 1284 34873250
Tonsil cancer 13.50 10.36 15 82382 1123 34873411
Rash erythematous 13.50 10.36 103 82294 24874 34849660
Pain in extremity 13.46 10.36 392 82005 126121 34748413
Urinary tract infection 13.40 10.36 130 82267 83951 34790583
Skin ulcer 13.37 10.36 94 82303 22122 34852412
Craniocerebral injury 13.36 10.36 26 82371 3237 34871297
Deafness congenital 13.32 10.36 6 82391 100 34874434
Corneal opacity 13.21 10.36 11 82386 575 34873959
Delirium 13.21 10.36 56 82341 43935 34830599
Lipid metabolism disorder 13.19 10.36 9 82388 347 34874187
Duodenal obstruction 13.12 10.36 7 82390 171 34874363
Fixed eruption 13.05 10.36 18 82379 1682 34872852
Neutrophil count decreased 13.03 10.36 69 82328 51035 34823499
Lentigo maligna 12.92 10.36 9 82388 359 34874175
Oligohydramnios 12.92 10.36 9 82388 359 34874175
Shock haemorrhagic 12.86 10.36 57 82340 11297 34863237
Endoscopy abnormal 12.78 10.36 4 82393 22 34874512
Eye swelling 12.73 10.36 52 82345 9943 34864591
Aggression 12.71 10.36 48 82349 38916 34835618
CADASIL 12.71 10.36 6 82391 112 34874422
Drug ineffective 12.71 10.36 1245 81152 455506 34419028
Remission not achieved 12.66 10.36 6 82391 113 34874421
Pallor 12.63 10.36 103 82294 25377 34849157
Ileal perforation 12.54 10.36 12 82385 754 34873780
Sciatic nerve neuropathy 12.51 10.36 5 82392 61 34874473
Duodenitis 12.47 10.36 32 82365 4796 34869738
Appendicitis 12.41 10.36 10 82387 14797 34859737
Dysphonia 12.40 10.36 96 82301 23287 34851247
Pyoderma gangrenosum 12.28 10.36 16 82381 1415 34873119
Intentional overdose 12.23 10.36 157 82240 43517 34831017
Retroperitoneal fibrosis 12.21 10.36 9 82388 393 34874141
Gastric bypass 12.19 10.36 8 82389 289 34874245
Megacolon 12.18 10.36 18 82379 1792 34872742
Linear IgA disease 12.16 10.36 17 82380 1609 34872925
Spondyloarthropathy 12.14 10.36 11 82386 644 34873890
Prurigo 12.14 10.36 11 82386 644 34873890
Shock symptom 12.07 10.36 6 82391 126 34874408
Laryngeal oedema 12.06 10.36 26 82371 3482 34871052
Blood glucose increased 12.01 10.36 100 82297 66618 34807916
Pancreatitis 11.99 10.36 49 82348 38842 34835692
Hepatic mass 11.93 10.36 14 82383 1113 34873421
Oligoarthritis 11.90 10.36 6 82391 130 34874404
Pyrexia 11.88 10.36 653 81744 332360 34542174
Peritonsillitis 11.88 10.36 3 82394 6 34874528
Skin graft 11.87 10.36 10 82387 531 34874003
Tumour invasion 11.83 10.36 8 82389 304 34874230
Double stranded DNA antibody positive 11.77 10.36 7 82390 212 34874322
Muscle spasms 11.76 10.36 245 82152 74756 34799778
Physical examination abnormal 11.65 10.36 8 82389 312 34874222
Pulmonary contusion 11.64 10.36 5 82392 74 34874460
Thrombosis mesenteric vessel 11.64 10.36 5 82392 74 34874460
Drug reaction with eosinophilia and systemic symptoms 11.61 10.36 124 82273 32888 34841646
Intestinal transit time decreased 11.56 10.36 3 82394 7 34874527
Frequent bowel movements 11.53 10.36 8 82389 12779 34861755
Dermatosis 11.47 10.36 8 82389 320 34874214
Rhabdomyolysis 11.47 10.36 225 82172 67938 34806596
Post infection glomerulonephritis 11.46 10.36 5 82392 77 34874457
Magnetic resonance imaging spinal abnormal 11.46 10.36 6 82391 141 34874393
Acquired haemophilia 11.45 10.36 13 82384 997 34873537
Skin necrosis 11.38 10.36 35 82362 5818 34868716
Ventricular hypertrophy 11.35 10.36 30 82367 4577 34869957
Small intestine ulcer 11.32 10.36 9 82388 440 34874094
Weight increased 11.24 10.36 153 82244 92880 34781654
Intervertebral disc degeneration 11.23 10.36 37 82360 6380 34868154
Metastases to heart 11.16 10.36 6 82391 149 34874385
Sudden cardiac death 11.12 10.36 26 82371 3675 34870859
Exposure to communicable disease 11.09 10.36 6 82391 151 34874383
N-terminal prohormone brain natriuretic peptide decreased 11.02 10.36 3 82394 9 34874525
Metatarsalgia 10.96 10.36 5 82392 86 34874448
Corneal infiltrates 10.94 10.36 6 82391 155 34874379
Ecthyma 10.93 10.36 9 82388 463 34874071
Pneumonitis 10.88 10.36 42 82355 33836 34840698
Diabetic ketoacidosis 10.88 10.36 16 82381 18016 34856518
Full blood count abnormal 10.84 10.36 17 82380 18651 34855883
Hypoproteinaemia 10.83 10.36 19 82378 2185 34872349
Duodenal ulcer repair 10.78 10.36 3 82394 10 34874524
Application site exfoliation 10.77 10.36 6 82391 160 34874374
Intestinal metastasis 10.76 10.36 7 82390 249 34874285
Febrile bone marrow aplasia 10.76 10.36 3 82394 8206 34866328
Abdominal pain 10.75 10.36 480 81917 163138 34711396
Loss of personal independence in daily activities 10.74 10.36 41 82356 33138 34841396
Dermatitis allergic 10.74 10.36 38 82359 6792 34867742
Infusion related reaction 10.73 10.36 77 82320 52980 34821554
Portal vein thrombosis 10.72 10.36 26 82371 3762 34870772
Disseminated intravascular coagulation 10.71 10.36 88 82309 21728 34852806
Defaecation disorder 10.70 10.36 5 82392 91 34874443
Inflammatory marker increased 10.66 10.36 31 82366 4997 34869537
Aspergillus infection 10.62 10.36 8 82389 12246 34862288
Soft tissue infection 10.61 10.36 19 82378 2221 34872313
Eye pain 10.60 10.36 61 82336 13401 34861133
Ventricular fibrillation 10.60 10.36 24 82373 22930 34851604
Postictal paralysis 10.57 10.36 7 82390 257 34874277
Spondylolisthesis 10.55 10.36 11 82386 766 34873768
Laboratory test abnormal 10.53 10.36 20 82377 20371 34854163
Noninfective gingivitis 10.53 10.36 8 82389 366 34874168
Bacteraemia 10.49 10.36 19 82378 19698 34854836
Product prescribing error 10.47 10.36 91 82306 22836 34851698
Papillary renal cell carcinoma 10.47 10.36 7 82390 261 34874273
Myofascial pain syndrome 10.47 10.36 8 82389 369 34874165
Skin lesion 10.47 10.36 88 82309 21873 34852661
Intracranial infection 10.46 10.36 4 82393 43 34874491
Application site dermatitis 10.46 10.36 4 82393 43 34874491
Bronchiectasis 10.45 10.36 5 82392 9796 34864738
Small intestine carcinoma 10.45 10.36 10 82387 628 34873906
Nail bed inflammation 10.38 10.36 6 82391 172 34874362
Hypothyroidism 10.37 10.36 21 82376 20881 34853653
Hyponatriuria 10.36 10.36 3 82394 12 34874522
Keratopathy 10.36 10.36 10 82387 635 34873899
Axillary pain 10.36 10.36 8 82389 375 34874159

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
Pemphigus 1666.89 9.92 1928 287244 97654 79357562
Systemic lupus erythematosus 1473.39 9.92 1999 287173 119150 79336066
Glossodynia 1461.71 9.92 1837 287335 101500 79353716
Hand deformity 1436.04 9.92 1826 287346 102093 79353123
Pericarditis 1345.57 9.92 1771 287401 102465 79352751
Anti-cyclic citrullinated peptide antibody positive 1254.36 9.92 1527 287645 81616 79373600
Wound 1222.58 9.92 1789 287383 114390 79340826
Discomfort 1148.63 9.92 1812 287360 123805 79331411
Duodenal ulcer perforation 1114.22 9.92 1286 287886 64925 79390291
Rheumatoid arthritis 1106.63 9.92 2377 286795 206093 79249123
Embolia cutis medicamentosa 1008.86 9.92 268 288904 368 79454848
Arthropathy 998.37 9.92 2070 287102 175041 79280175
Synovitis 964.93 9.92 1858 287314 148876 79306340
Helicobacter infection 961.17 9.92 1224 287948 68480 79386736
Swelling 875.94 9.92 2221 286951 214490 79240726
Abdominal discomfort 864.22 9.92 2422 286750 248305 79206911
Alopecia 836.04 9.92 2274 286898 229081 79226135
Joint swelling 771.28 9.92 2550 286622 286096 79169120
Hepatic enzyme increased 700.93 9.92 1836 287336 180774 79274442
Death 699.97 9.92 616 288556 565898 78889318
Contraindicated product administered 693.73 9.92 1669 287503 155869 79299347
Blister 668.74 9.92 1393 287779 118083 79337133
Hypersensitivity 655.56 9.92 2266 286906 259973 79195243
Maternal exposure during pregnancy 612.32 9.92 1457 287715 135081 79320135
Muscle injury 612.06 9.92 816 288356 47745 79407471
Drug intolerance 604.28 9.92 2217 286955 261902 79193314
Folliculitis 593.92 9.92 861 288311 54519 79400697
Rheumatoid factor positive 586.72 9.92 892 288280 58947 79396269
Irritable bowel syndrome 571.36 9.92 900 288272 61341 79393875
Infusion related reaction 513.36 9.92 1917 287255 228320 79226896
Sleep disorder due to general medical condition, insomnia type 500.64 9.92 700 288472 42856 79412360
Febrile neutropenia 442.70 9.92 143 289029 230856 79224360
Therapeutic product effect decreased 439.01 9.92 1450 287722 162413 79292803
Impaired healing 433.05 9.92 972 288200 86683 79368533
Neutropenia 406.67 9.92 272 288900 287438 79167778
Pain 382.84 9.92 4064 285108 699738 78755478
Rheumatic fever 366.55 9.92 484 288688 28041 79427175
Psoriatic arthropathy 352.29 9.92 835 288337 77164 79378052
Gastrointestinal disorder 343.98 9.92 1100 288072 121105 79334111
Musculoskeletal stiffness 343.32 9.92 1400 287772 173608 79281608
Toxicity to various agents 325.82 9.92 648 288524 420892 79034324
Swollen joint count increased 299.20 9.92 392 288780 22535 79432681
Ankylosing spondylitis 292.02 9.92 286 288886 11919 79443297
Hip arthroplasty 286.03 9.92 486 288686 35270 79419946
Completed suicide 284.21 9.92 283 288889 245484 79209732
Off label use 265.28 9.92 2066 287106 905149 78550067
Treatment failure 254.65 9.92 1258 287914 169228 79285988
Product use issue 239.66 9.92 1439 287733 208383 79246833
Pneumonia 234.06 9.92 1420 287752 658826 78796390
Arthralgia 230.64 9.92 3121 286051 568682 78886534
Knee arthroplasty 229.84 9.92 494 288678 42754 79412462
Gastric ulcer 224.01 9.92 424 288748 33481 79421735
Melaena 221.85 9.92 601 288571 60289 79394927
Disease progression 219.23 9.92 207 288965 184155 79271061
Thrombocytopenia 217.68 9.92 393 288779 264866 79190350
Blood cholesterol increased 217.03 9.92 733 288439 82987 79372229
Hypotension 216.88 9.92 842 288330 439475 79015741
Stomatitis 208.61 9.92 1068 288104 145689 79309527
Rash 208.43 9.92 3095 286077 575263 78879953
Fibromyalgia 207.90 9.92 608 288564 63732 79391484
Ill-defined disorder 199.12 9.92 608 288564 65267 79389949
Lower respiratory tract infection 198.97 9.92 962 288210 128258 79326958
Grip strength decreased 196.13 9.92 313 288859 21556 79433660
Type 2 diabetes mellitus 195.41 9.92 551 288621 56571 79398645
Cardiac failure congestive 195.21 9.92 139 289033 142263 79312953
Atrial fibrillation 192.98 9.92 261 288911 197625 79257591
Sepsis 179.41 9.92 449 288723 268979 79186237
Cough 176.95 9.92 707 288465 366082 79089134
Liver injury 172.48 9.92 524 288648 56090 79399126
Duodenal ulcer 163.17 9.92 246 288926 16123 79439093
Pancytopenia 159.17 9.92 221 288951 165524 79289692
Osteoarthritis 158.96 9.92 683 288489 86626 79368590
Diarrhoea 152.04 9.92 2264 286908 878225 78576991
Product dose omission issue 149.34 9.92 433 288739 247104 79208112
Electrocardiogram QT prolonged 140.79 9.92 76 289096 90310 79364906
Contusion 140.06 9.92 972 288200 147804 79307412
Platelet count decreased 134.58 9.92 318 288854 194346 79260870
Gastric ulcer perforation 133.65 9.92 88 289084 2047 79453169
Large intestinal stenosis 128.14 9.92 96 289076 2760 79452456
Constipation 122.09 9.92 569 288603 282481 79172735
Intestinal diaphragm disease 120.43 9.92 46 289126 304 79454912
COVID-19 120.17 9.92 244 288928 157430 79297786
Dehydration 119.83 9.92 478 288694 247709 79207507
Cerebrovascular accident 116.92 9.92 242 288930 155050 79300166
Seizure 115.55 9.92 328 288844 188506 79266710
Pruritus 114.59 9.92 2039 287133 392609 79062607
Drug abuse 113.86 9.92 264 288908 162427 79292789
Anaphylactic shock 112.29 9.92 336 288836 35660 79419556
Leukopenia 112.20 9.92 155 289017 116358 79338858
Nasopharyngitis 110.40 9.92 1406 287766 252475 79202741
White blood cell count decreased 109.45 9.92 335 288837 187953 79267263
Hypokalaemia 107.98 9.92 225 288947 143815 79311401
Sinusitis 105.13 9.92 1128 288044 194373 79260843
Prescribed overdose 104.66 9.92 339 288833 37544 79417672
Infection 103.56 9.92 1335 287837 240377 79214839
Deep vein thrombosis postoperative 103.51 9.92 159 289013 10593 79444623
Large intestinal ulcer 102.98 9.92 106 289066 4691 79450525
Cardio-respiratory arrest 102.84 9.92 146 289026 108364 79346852
Hypoxia 102.81 9.92 134 289038 103109 79352107
Peripheral swelling 102.35 9.92 1457 287715 268160 79187056
Malignant neoplasm progression 102.30 9.92 212 288960 135778 79319438
Cardiac arrest 100.16 9.92 306 288866 171790 79283426
Neutrophil count decreased 98.75 9.92 117 289055 93842 79361374
Adjustment disorder with depressed mood 95.51 9.92 140 289032 8946 79446270
Respiratory failure 95.39 9.92 336 288836 180575 79274641
Neuropathy peripheral 94.35 9.92 235 288937 141070 79314146
Fall 94.13 9.92 1225 287947 486404 78968812
Gastritis erosive 92.83 9.92 152 289020 10695 79444521
Kounis syndrome 92.61 9.92 95 289077 4187 79451029
Bradycardia 92.42 9.92 223 288949 135334 79319882
Facet joint syndrome 92.20 9.92 155 289017 11147 79444069
Pulmonary embolism 91.72 9.92 317 288855 171337 79283879
Cardiac failure 91.05 9.92 274 288898 154568 79300648
Plasma cell myeloma 90.19 9.92 40 289132 53219 79401997
Joint range of motion decreased 89.40 9.92 295 288877 32987 79422229
Angioedema 88.93 9.92 525 288647 75510 79379706
Injury 88.02 9.92 531 288641 76965 79378251
Mobility decreased 88.02 9.92 750 288422 121425 79333791
Adverse event 85.33 9.92 438 288734 59776 79395440
Lip dry 82.91 9.92 177 288995 15241 79439975
Nausea 82.78 9.92 2745 286427 954451 78500765
General physical health deterioration 82.27 9.92 1429 287743 273809 79181407
Hypoglycaemia 81.92 9.92 152 289020 101442 79353774
Cognitive disorder 81.33 9.92 80 289092 69846 79385370
Live birth 80.63 9.92 197 288975 18547 79436669
Cytomegalovirus infection 80.54 9.92 27 289145 42617 79412599
Joint dislocation 80.42 9.92 185 288987 16754 79438462
Deafness transitory 79.84 9.92 48 289124 947 79454269
Hypomagnesaemia 79.80 9.92 35 289137 46876 79408340
Dislocation of vertebra 79.35 9.92 119 289053 7761 79447455
Periorbital oedema 79.13 9.92 123 289049 8279 79446937
Urinary tract infection 77.47 9.92 630 288542 273882 79181334
Anaphylactic reaction 76.93 9.92 544 288628 83199 79372017
Mental status changes 76.28 9.92 78 289094 66881 79388335
Anti-cyclic citrullinated peptide antibody 76.25 9.92 100 289072 5752 79449464
Pleural effusion 75.76 9.92 271 288901 144991 79310225
Cytokine release syndrome 74.94 9.92 19 289153 35979 79419237
Myocardial infarction 74.21 9.92 379 288793 183750 79271466
Sacroiliitis 73.54 9.92 79 289093 3675 79451541
Retinitis 72.86 9.92 96 289076 5547 79449669
Autoimmune disorder 71.89 9.92 175 288997 16437 79438779
Device expulsion 71.30 9.92 6 289166 25855 79429361
Ascites 71.26 9.92 102 289070 75460 79379756
Abdominal pain upper 70.85 9.92 1173 287999 222646 79232570
Urticaria 70.69 9.92 1002 288170 184199 79271017
Anaemia 69.49 9.92 1165 288007 443850 79011366
Hospitalisation 69.11 9.92 149 289023 94087 79361129
Sleep disorder 68.18 9.92 538 288634 85139 79370077
Blood glucose increased 67.91 9.92 203 288969 114772 79340444
Mucosal inflammation 67.43 9.92 106 289066 75474 79379742
Seronegative arthritis 67.15 9.92 84 289088 4608 79450608
Oxygen saturation decreased 67.12 9.92 241 288931 128806 79326410
Myelosuppression 67.08 9.92 31 289141 40265 79414951
Neurotoxicity 66.10 9.92 18 289154 32500 79422716
Tachycardia 66.06 9.92 376 288796 177392 79277824
Exposure during pregnancy 65.20 9.92 606 288566 100526 79354690
Maternal exposure timing unspecified 64.91 9.92 92 289080 5700 79449516
Epistaxis 64.35 9.92 199 288973 111316 79343900
Ear infection 63.13 9.92 270 288902 34162 79421054
Bursitis 62.61 9.92 277 288895 35567 79419649
Gastric ulcer haemorrhage 60.99 9.92 114 289058 8913 79446303
Anxiety 60.58 9.92 592 288580 247920 79207296
Aspirin-exacerbated respiratory disease 59.63 9.92 43 289129 1164 79454052
Septic shock 59.54 9.92 236 288936 122565 79332651
Deep vein thrombosis 58.87 9.92 232 288940 120687 79334529
Type I hypersensitivity 58.62 9.92 76 289096 4322 79450894
Neuroleptic malignant syndrome 58.43 9.92 14 289158 27545 79427671
Injection site necrosis 58.25 9.92 46 289126 1432 79453784
Bacteraemia 58.24 9.92 23 289149 32801 79422415
Hypoaesthesia 57.49 9.92 942 288230 178410 79276806
Ventricular tachycardia 57.35 9.92 41 289131 41894 79413322
Peripheral venous disease 56.89 9.92 156 289016 15753 79439463
Clostridium difficile infection 56.73 9.92 43 289129 42642 79412574
Agitation 56.09 9.92 180 288992 99535 79355681
Chronic obstructive pulmonary disease 55.50 9.92 144 289028 85275 79369941
Spinal pain 55.11 9.92 151 289021 15241 79439975
Gastrointestinal erosion 54.62 9.92 39 289133 1039 79454177
Drug resistance 54.24 9.92 44 289128 42169 79413047
Acute myeloid leukaemia 54.21 9.92 22 289150 30863 79424353
Balance disorder 53.16 9.92 182 288990 98675 79356541
Posterior reversible encephalopathy syndrome 52.58 9.92 15 289157 26266 79428950
Neoplasm progression 52.56 9.92 66 289106 51616 79403600
Pancreatitis 52.32 9.92 106 289066 68469 79386747
Full blood count abnormal 52.24 9.92 42 289130 40432 79414784
Hypervolaemia 51.80 9.92 47 289125 42643 79412573
Aggression 50.86 9.92 66 289106 50892 79404324
Bone marrow failure 50.18 9.92 67 289105 51040 79404176
Encephalopathy 49.88 9.92 106 289066 67291 79387925
Thrombotic microangiopathy 49.72 9.92 7 289165 20162 79435054
Transplant rejection 49.71 9.92 6 289166 19431 79435785
Heart rate increased 49.48 9.92 247 288925 120477 79334739
Hyperglycaemia 49.29 9.92 114 289058 70221 79384995
Pulmonary arterial hypertension 46.94 9.92 22 289150 28344 79426872
Laryngitis 46.55 9.92 146 289026 15893 79439323
Haematemesis 46.53 9.92 337 288835 51927 79403289
Hallucination 46.01 9.92 158 289014 85587 79369629
Cytopenia 45.97 9.92 9 289163 20374 79434842
Respiratory distress 45.52 9.92 89 289083 58250 79396966
Dry skin 45.43 9.92 113 289059 67882 79387334
Cardiogenic shock 45.32 9.92 51 289121 41863 79413353
Asthenia 44.59 9.92 1465 287707 510224 78944992
Haematotoxicity 44.49 9.92 3 289169 15516 79439700
Drug hypersensitivity 44.41 9.92 1408 287764 297508 79157708
Multiple organ dysfunction syndrome 44.30 9.92 255 288917 119991 79335225
Exostosis 44.01 9.92 148 289024 16710 79438506
Diabetes mellitus 43.74 9.92 142 289030 78248 79376968
Dyspnoea 43.50 9.92 2605 286567 854420 78600796
Corneal epithelium defect 43.47 9.92 29 289143 690 79454526
Upper gastrointestinal haemorrhage 42.89 9.92 277 288895 41103 79414113
Foot deformity 42.77 9.92 187 288985 23887 79431329
Syncope 42.66 9.92 430 288742 179019 79276197
Right ventricular failure 42.45 9.92 16 289156 23481 79431735
Oligohydramnios 42.45 9.92 57 289115 3355 79451861
Dyspnoea exertional 42.42 9.92 167 289005 86906 79368310
Hyponatraemia 42.35 9.92 426 288746 177422 79277794
Pericardial effusion 42.05 9.92 64 289108 46173 79409043
Gastric haemorrhage 41.86 9.92 135 289037 14915 79440301
Wrong technique in product usage process 41.79 9.92 133 289039 73742 79381474
Wound infection 41.59 9.92 185 288987 23806 79431410
Spinal stenosis 41.54 9.92 139 289033 15652 79439564
Unevaluable event 41.49 9.92 87 289085 55498 79399718
C-reactive protein increased 41.45 9.92 678 288494 128349 79326867
Hypercalcaemia 41.29 9.92 47 289125 38383 79416833
Pneumonia aspiration 41.17 9.92 116 289056 66851 79388365
Small intestine ulcer 41.08 9.92 28 289144 691 79454525
Hypocalcaemia 40.85 9.92 74 289098 49850 79405366
Weight increased 40.78 9.92 1305 287867 276081 79179135
Torsade de pointes 40.57 9.92 10 289162 19302 79435914
Orthostatic hypotension 40.19 9.92 90 289082 56074 79399142
Red blood cell sedimentation rate abnormal 40.07 9.92 13 289159 20950 79434266
Neck pain 39.95 9.92 434 288738 74983 79380233
Adverse drug reaction 39.89 9.92 392 288780 66000 79389216
Transfusion 39.43 9.92 14 289158 21316 79433900
Neutropenic sepsis 38.96 9.92 25 289147 27039 79428177
Bronchopulmonary aspergillosis 38.93 9.92 16 289156 22278 79432938
Breast cancer stage III 38.83 9.92 100 289072 9726 79445490
Fat necrosis 38.70 9.92 29 289143 834 79454382
Porphyria acute 38.65 9.92 37 289135 1498 79453718
Endoscopy abnormal 38.42 9.92 13 289159 57 79455159
Pulmonary oedema 38.23 9.92 177 288995 88077 79367139
Shoulder arthroplasty 38.07 9.92 53 289119 3229 79451987
Lymphocyte count decreased 37.89 9.92 71 289101 47218 79407998
Ileal ulcer 37.87 9.92 32 289140 1098 79454118
Tonsillar ulcer 37.74 9.92 22 289150 409 79454807
Bladder cancer 37.51 9.92 12 289160 19514 79435702
Ejection fraction decreased 37.46 9.92 42 289130 34535 79420681
Diabetic ketoacidosis 37.46 9.92 41 289131 34081 79421135
Sedation complication 37.34 9.92 6 289166 15663 79439553
Progressive multifocal leukoencephalopathy 37.27 9.92 14 289158 20586 79434630
Duodenal ulcer haemorrhage 37.10 9.92 81 289091 7082 79448134
Drug ineffective 37.08 9.92 4467 284705 1076446 78378770
Pregnancy 36.43 9.92 193 288979 26658 79428558
Aspergillus infection 36.41 9.92 12 289160 19149 79436067
C-reactive protein 36.32 9.92 65 289107 4914 79450302
X-ray abnormal 36.31 9.92 71 289101 5742 79449474
Coma 36.24 9.92 215 288957 100434 79354782
Febrile bone marrow aplasia 35.95 9.92 3 289169 13017 79442199
Confusional state 35.45 9.92 1450 287722 316547 79138669
Sciatica 35.42 9.92 224 288948 32998 79422218
Analgesic drug level above therapeutic 35.18 9.92 22 289150 467 79454749
Cellulitis 35.15 9.92 241 288931 108819 79346397
Atelectasis 35.15 9.92 39 289133 32218 79422998
Enterococcal infection 35.14 9.92 7 289165 15653 79439563
Functional gastrointestinal disorder 34.95 9.92 64 289108 4926 79450290
Intestinal ulcer 34.94 9.92 40 289132 1998 79453218
Status epilepticus 34.88 9.92 24 289148 25017 79430199
Device dislocation 34.72 9.92 26 289146 25944 79429272
Device related infection 34.65 9.92 44 289128 34250 79420966
Respiratory arrest 34.41 9.92 101 289071 57449 79397767
Lower limb fracture 34.38 9.92 171 289001 23044 79432172
Peritonitis 34.34 9.92 196 288976 27840 79427376
Obstructive airways disorder 34.32 9.92 38 289134 31421 79423795
Incorrect dose administered 34.20 9.92 152 289020 76478 79378738
Peptic ulcer 34.11 9.92 72 289100 6151 79449065
Lupus-like syndrome 33.85 9.92 119 289053 13738 79441478
Suicidal ideation 33.73 9.92 152 289020 76188 79379028
Ulcerative keratitis 33.35 9.92 53 289119 3636 79451580
Synovial cyst 33.35 9.92 96 289076 9969 79445247
Dysphagia 33.19 9.92 283 288889 121853 79333363
Chest discomfort 33.13 9.92 330 288842 137714 79317502
Lupus vulgaris 32.94 9.92 50 289122 3296 79451920
Ligament calcification 32.71 9.92 16 289156 205 79455011
Renal failure neonatal 32.53 9.92 12 289160 71 79455145
Mucosal erosion 32.38 9.92 41 289131 2277 79452939
Blood pressure increased 32.37 9.92 555 288617 210805 79244411
Multiple sclerosis relapse 32.14 9.92 76 289096 46457 79408759
Wrist deformity 32.07 9.92 39 289133 2078 79453138
Application site rash 31.85 9.92 39 289133 2093 79453123
Psychotic disorder 31.58 9.92 64 289108 41338 79413878
Pneumocystis jirovecii pneumonia 31.53 9.92 43 289129 32465 79422751
Ductus arteriosus stenosis foetal 31.45 9.92 12 289160 79 79455137
Immune reconstitution inflammatory syndrome 31.45 9.92 6 289166 13835 79441381
Urosepsis 31.17 9.92 30 289142 26465 79428751
Renal failure 31.01 9.92 527 288645 200441 79254775
Generalised tonic-clonic seizure 30.90 9.92 71 289101 43839 79411377
Rotator cuff repair 30.88 9.92 36 289136 1834 79453382
Fluid retention 30.84 9.92 139 289033 69670 79385546
Frequent bowel movements 30.79 9.92 37 289135 29502 79425714
Weight decreased 30.65 9.92 1018 288154 354180 79101036
Inflammation 30.61 9.92 494 288678 93259 79361957
Keratopathy 30.48 9.92 29 289143 1165 79454051
Unresponsive to stimuli 30.47 9.92 102 289070 55686 79399530
Infective pulmonary exacerbation of cystic fibrosis 30.44 9.92 5 289167 12846 79442370
Conjunctival hyperaemia 30.15 9.92 56 289116 4357 79450859
Glomerulonephritis minimal lesion 29.96 9.92 24 289148 763 79454453
Gastrointestinal pain 29.80 9.92 91 289081 9764 79445452
Stress 29.76 9.92 168 289004 79444 79375772
Akathisia 29.60 9.92 6 289166 13253 79441963
Lymphopenia 29.05 9.92 41 289131 30516 79424700
Flushing 28.97 9.92 194 288978 88074 79367142
Blood pressure fluctuation 28.88 9.92 135 289037 67010 79388206
Hepatic failure 28.80 9.92 119 289053 61093 79394123
Corneal thinning 28.64 9.92 14 289158 179 79455037
Application site eczema 28.61 9.92 7 289165 5 79455211
Cardiac disorder 28.41 9.92 132 289040 65625 79389591
Inflammatory bowel disease 28.25 9.92 63 289109 5588 79449628
Device issue 28.21 9.92 34 289138 27074 79428142
Lymphocyte stimulation test positive 27.94 9.92 27 289145 1106 79454110
No adverse event 27.93 9.92 58 289114 37134 79418082
Neonatal respiratory acidosis 27.71 9.92 10 289162 55 79455161
Gait inability 27.58 9.92 331 288841 58586 79396630
Hypernatraemia 27.55 9.92 9 289163 14442 79440774
Extrapyramidal disorder 27.48 9.92 25 289147 22654 79432562
Hepatotoxicity 27.29 9.92 95 289077 51257 79403959
Intestinal atony 27.25 9.92 9 289163 36 79455180
Palmar-plantar erythrodysaesthesia syndrome 27.21 9.92 49 289123 33085 79422131
Cerebral haemorrhage 27.21 9.92 112 289060 57561 79397655
Abnormal behaviour 27.18 9.92 57 289115 36364 79418852
Schizophrenia 27.09 9.92 11 289161 15429 79439787
Haemoptysis 26.89 9.92 108 289064 55891 79399325
Tenderness 26.83 9.92 162 289010 23480 79431736
Gastritis 26.73 9.92 279 288893 47714 79407502
Productive cough 26.61 9.92 199 288973 88132 79367084
Large intestine perforation 26.52 9.92 114 289058 14453 79440763
Fatigue 26.48 9.92 3800 285372 925927 78529289
Gastrointestinal ulcer 26.45 9.92 46 289126 3400 79451816
Chills 26.43 9.92 415 288757 159819 79295397
Ventricular fibrillation 26.41 9.92 47 289125 31879 79423337
Walking aid user 26.41 9.92 89 289083 10059 79445157
Road traffic accident 26.32 9.92 258 288914 43406 79411810
Staphylococcal bacteraemia 26.31 9.92 6 289166 12212 79443004
Premature delivery 25.98 9.92 28 289144 23439 79431777
Bacterial infection 25.92 9.92 46 289126 31234 79423982
Throat irritation 25.85 9.92 70 289102 40876 79414340
Onychomadesis 25.71 9.92 58 289114 5184 79450032
Diabetes mellitus inadequate control 25.71 9.92 30 289142 24234 79430982
Soft tissue injury 25.67 9.92 32 289140 1749 79453467
Tubulointerstitial nephritis 25.58 9.92 231 288941 38004 79417212
Second primary malignancy 25.55 9.92 10 289162 14340 79440876
Rheumatoid lung 25.49 9.92 51 289121 4194 79451022
Hepatic encephalopathy 25.48 9.92 30 289142 24136 79431080
Lymphatic fistula 25.40 9.92 22 289150 781 79454435
Respiratory tract congestion 25.38 9.92 21 289151 19933 79435283
Oedema 25.35 9.92 590 288582 118990 79336226
Mastoid abscess 25.32 9.92 6 289166 3 79455213
Psoriasis 25.24 9.92 461 288711 89126 79366090
Bradycardia neonatal 25.22 9.92 10 289162 74 79455142
Failure to thrive 25.14 9.92 6 289166 11838 79443378
International normalised ratio increased 24.99 9.92 192 288980 84529 79370687
Tumour lysis syndrome 24.94 9.92 30 289142 23909 79431307
Oesophageal carcinoma 24.77 9.92 5 289167 11079 79444137
Pharyngitis 24.56 9.92 152 289020 22223 79432993
Femoral hernia incarcerated 24.50 9.92 22 289150 820 79454396
Antidepressant drug level above therapeutic 24.43 9.92 20 289152 656 79454560
Acute respiratory failure 24.28 9.92 122 289050 59419 79395797
Aminoaciduria 24.08 9.92 16 289156 378 79454838
Complication associated with device 24.06 9.92 17 289155 17479 79437737
Tissue infiltration 24.05 9.92 20 289152 671 79454545
Jejunal ulcer perforation 24.04 9.92 11 289161 120 79455096
Acute graft versus host disease 23.99 9.92 4 289168 10163 79445053
Cyanosis neonatal 23.75 9.92 9 289163 58 79455158
Candida infection 23.63 9.92 66 289106 38148 79417068
Blood calcium decreased 23.58 9.92 50 289122 31769 79423447
Spinal fusion surgery 23.55 9.92 56 289116 5182 79450034
Dysarthria 23.53 9.92 146 289026 67476 79387740
Iris hypopigmentation 23.49 9.92 9 289163 60 79455156
Blood potassium decreased 23.43 9.92 88 289084 46424 79408792
Hepatic cytolysis 23.35 9.92 39 289133 27112 79428104
Peripheral sensory neuropathy 23.34 9.92 9 289163 13024 79442192
Influenza like illness 23.33 9.92 158 289014 71549 79383667
Intentional product use issue 23.21 9.92 719 288453 151393 79303823
Metastases to stomach 23.21 9.92 14 289158 278 79454938
Drug tolerance decreased 23.20 9.92 101 289071 12877 79442339
Clostridium difficile colitis 22.88 9.92 52 289120 32231 79422985
Paranoia 22.86 9.92 22 289150 19410 79435806
Spondylitis 22.82 9.92 52 289120 4679 79450537
Hyperammonaemia 22.81 9.92 6 289166 11087 79444129
Night sweats 22.80 9.92 289 288883 51806 79403410
Neutrophil count increased 22.80 9.92 45 289127 29351 79425865
Renal cancer 22.64 9.92 8 289164 12218 79442998
Musculoskeletal pain 22.63 9.92 508 288664 101846 79353370
Immunosuppressant drug level increased 22.57 9.92 3 289169 9024 79446192
Disability 22.51 9.92 122 289050 16998 79438218
Depressed level of consciousness 22.38 9.92 233 288939 96419 79358797
Pulmonary hypertension 22.29 9.92 94 289078 47986 79407230
Haemoglobin decreased 22.23 9.92 624 288548 221495 79233721
Sleep disorder due to a general medical condition 22.23 9.92 12 289160 14265 79440951
Vascular device infection 22.22 9.92 5 289167 10271 79444945
Depression 22.22 9.92 607 288565 216183 79239033
Movement disorder 22.13 9.92 172 289000 27087 79428129
Pyrexia 22.11 9.92 2140 287032 676569 78778647
Electrocardiogram QRS complex prolonged 22.01 9.92 6 289166 10827 79444389
Granulocytopenia 22.00 9.92 7 289165 11424 79443792
Subdural haematoma 21.98 9.92 51 289121 31383 79423833
Drug dependence 21.95 9.92 75 289097 40694 79414522
Tongue oedema 21.78 9.92 66 289106 7051 79448165
Adrenal insufficiency 21.76 9.92 44 289128 28443 79426773
Depressed mood 21.73 9.92 96 289076 48384 79406832
Injection site bruising 21.69 9.92 76 289096 40926 79414290
Fungal infection 21.67 9.92 78 289094 41670 79413546
Atrioventricular block 21.58 9.92 12 289160 14029 79441187
Hypogammaglobulinaemia 21.50 9.92 10 289162 12941 79442275
Tubulointerstitial nephritis and uveitis syndrome 21.44 9.92 14 289158 321 79454895
Coronary artery disease 21.43 9.92 144 289028 65330 79389886
Arteriovenous fistula occlusion 21.37 9.92 17 289155 535 79454681
Blood glucose decreased 21.36 9.92 39 289133 26195 79429021
Haemorrhage intracranial 21.27 9.92 39 289133 26154 79429062
Influenza 21.26 9.92 336 288836 129270 79325946
Acute respiratory distress syndrome 21.15 9.92 85 289087 43982 79411234
Drug level decreased 21.15 9.92 13 289159 14389 79440827
Psychomotor hyperactivity 21.10 9.92 18 289154 16831 79438385
Therapy cessation 20.98 9.92 68 289104 37494 79417722
Procedural pain 20.94 9.92 32 289140 23052 79432164
Malignant mesenteric neoplasm 20.93 9.92 8 289164 53 79455163
Lethargy 20.91 9.92 191 288981 81101 79374115
Blood test abnormal 20.89 9.92 20 289152 17690 79437526
Gallbladder adenocarcinoma 20.80 9.92 10 289162 123 79455093
Nephrotic syndrome 20.77 9.92 88 289084 11086 79444130
Exposure to toxic agent 20.74 9.92 4 289168 9154 79446062
Acute myocardial infarction 20.70 9.92 179 288993 76857 79378359
Salivary hypersecretion 20.67 9.92 13 289159 14211 79441005
Sebaceous gland infection 20.61 9.92 11 289161 171 79455045
Disease recurrence 20.60 9.92 86 289086 44023 79411193
Ataxia 20.59 9.92 37 289135 25002 79430214
Muscle swelling 20.58 9.92 20 289152 825 79454391
Sinus disorder 20.51 9.92 31 289141 22433 79432783
Pulseless electrical activity 20.49 9.92 13 289159 14147 79441069
Injection site erythema 20.44 9.92 183 288989 78014 79377202
Anterior chamber cell 20.42 9.92 21 289151 928 79454288
Blue toe syndrome 20.35 9.92 17 289155 574 79454642
Necrotising fasciitis 20.33 9.92 58 289114 5992 79449224
Microcytic anaemia 20.15 9.92 53 289119 5221 79449995
Application site reaction 20.10 9.92 19 289153 757 79454459
Haemophagocytic lymphohistiocytosis 20.07 9.92 30 289142 21807 79433409
Cholestasis 20 9.92 109 289063 52000 79403216
Injection site hyperaesthesia 19.97 9.92 8 289164 61 79455155
Acquired porphyria 19.95 9.92 7 289165 35 79455181
Rhinorrhoea 19.89 9.92 178 288994 75896 79379320
Myocarditis 19.84 9.92 30 289142 21703 79433513
Dementia 19.78 9.92 37 289135 24622 79430594
Punctate keratitis 19.76 9.92 21 289151 965 79454251
Nasal congestion 19.64 9.92 180 288992 76372 79378844
Multiple-drug resistance 19.63 9.92 4 289168 8804 79446412
Injection site pain 19.52 9.92 342 288830 129496 79325720
Product used for unknown indication 19.52 9.92 26 289146 1518 79453698
Therapy interrupted 19.47 9.92 54 289118 31287 79423929
Terminal insomnia 19.39 9.92 23 289149 1194 79454022
Thrombosis 19.36 9.92 203 288969 83897 79371319
Small intestinal obstruction 19.27 9.92 44 289128 27228 79427988
Full blood count decreased 19.17 9.92 43 289129 26776 79428440
Myelodysplastic syndrome 18.98 9.92 52 289120 30249 79424967
Blood calcium increased 18.93 9.92 7 289165 10393 79444823
Pancreatic steatosis 18.84 9.92 22 289150 1123 79454093
Pulmonary mass 18.81 9.92 49 289123 28985 79426231
Sciatic nerve injury 18.79 9.92 16 289156 555 79454661
Bronchitis 18.74 9.92 347 288825 130297 79324919
Tongue disorder 18.67 9.92 14 289158 13961 79441255
Aplasia 18.62 9.92 3 289169 7817 79447399
Electrolyte imbalance 18.60 9.92 54 289118 30827 79424389
Aplasia pure red cell 18.59 9.92 3 289169 7807 79447409
Palpitations 18.56 9.92 335 288837 126275 79328941
Subarachnoid haemorrhage 18.50 9.92 38 289134 24427 79430789
Aplasia cutis congenita 18.49 9.92 4 289168 0 79455216
Urine porphobilinogen increased 18.49 9.92 4 289168 0 79455216
Ischaemic stroke 18.49 9.92 60 289112 33071 79422145
Sinus bradycardia 18.44 9.92 40 289132 25207 79430009
Jejunal ulcer 18.43 9.92 11 289161 214 79455002
Laboratory test abnormal 18.43 9.92 47 289125 28001 79427215
Panniculitis 18.40 9.92 11 289161 12360 79442856
Orbital oedema 18.37 9.92 14 289158 413 79454803
Face oedema 18.32 9.92 169 289003 27967 79427249
Cardiomyopathy 18.31 9.92 49 289123 28725 79426491
Overdose 18.30 9.92 518 288654 183688 79271528
Unintentional medical device removal 18.27 9.92 3 289169 7709 79447507
Aspiration 18.23 9.92 28 289144 20130 79435086
Partial seizures 18.19 9.92 5 289167 8973 79446243
Peritonitis bacterial 18.17 9.92 6 289166 9561 79445655
Toxic epidermal necrolysis 18.12 9.92 244 288928 44337 79410879
Vaccination site reaction 18.08 9.92 9 289163 120 79455096
Linear IgA disease 18.06 9.92 37 289135 3095 79452121
Intestinal congestion 18.00 9.92 5 289167 9 79455207
Pseudomonas infection 18.00 9.92 30 289142 20873 79434343
Basal cell carcinoma 18.00 9.92 72 289100 37303 79417913
Application site ulcer 17.95 9.92 9 289163 122 79455094
Eschar 17.92 9.92 23 289149 1295 79453921
Hypoproteinaemia 17.91 9.92 43 289129 4003 79451213
Meralgia paraesthetica 17.84 9.92 15 289157 511 79454705
Diffuse large B-cell lymphoma 17.79 9.92 11 289161 12138 79443078
Lower respiratory tract infection viral 17.71 9.92 22 289150 1198 79454018
COVID-19 pneumonia 17.71 9.92 50 289122 28799 79426417
Hypochromic anaemia 17.67 9.92 34 289138 2717 79452499
Complications of intestinal transplant 17.66 9.92 5 289167 10 79455206
Angiocardiogram 17.57 9.92 11 289161 234 79454982
Catatonia 17.51 9.92 5 289167 8751 79446465
Oral pain 17.46 9.92 58 289114 31740 79423476
Pneumonitis 17.45 9.92 139 289033 60721 79394495
Renal impairment 17.43 9.92 437 288735 157346 79297870
Undifferentiated connective tissue disease 17.43 9.92 8 289164 88 79455128
Somnolence 17.42 9.92 699 288473 238282 79216934
Osteonecrosis of jaw 17.38 9.92 89 289083 43137 79412079
Hypoaldosteronism 17.37 9.92 13 289159 373 79454843
Body mass index abnormal 17.36 9.92 11 289161 239 79454977
Breast cancer female 17.32 9.92 10 289162 11451 79443765
Accidental exposure to product 17.29 9.92 57 289115 31265 79423951
Hypercholesterolaemia 17.26 9.92 143 289029 22952 79432264
Drug use disorder 17.19 9.92 5 289167 8646 79446570
Abnormal loss of weight 17.18 9.92 68 289104 8308 79446908
Obesity 17.17 9.92 199 288973 34926 79420290
Haematocrit decreased 17.13 9.92 141 289031 61171 79394045
Haemorrhage 17.11 9.92 230 288942 90888 79364328
Atrioventricular block complete 17.11 9.92 21 289151 16589 79438627
Device leakage 17.09 9.92 9 289163 10847 79444369
Neonatal respiratory distress syndrome 17.08 9.92 11 289161 246 79454970
Encephalitis 17.03 9.92 17 289155 14743 79440473
Device occlusion 17.03 9.92 11 289161 11855 79443361
Faeces discoloured 17.02 9.92 171 289001 28956 79426260
Heart rate irregular 17 9.92 61 289111 32618 79422598
Cystitis haemorrhagic 16.99 9.92 6 289166 9166 79446050
Rhinovirus infection 16.94 9.92 4 289168 7949 79447267
Myoclonus 16.93 9.92 48 289124 27612 79427604
Gastric mucosal lesion 16.84 9.92 19 289153 934 79454282
Transaminases increased 16.84 9.92 114 289058 51629 79403587
Allodynia 16.76 9.92 25 289147 1623 79453593
Fear 16.75 9.92 34 289138 21952 79433264
Bronchiectasis 16.74 9.92 35 289137 22351 79432865
Viral upper respiratory tract infection 16.71 9.92 71 289101 8955 79446261
Tremor 16.71 9.92 479 288693 169604 79285612
Cardiomegaly 16.68 9.92 45 289127 26307 79428909
Abdominal rebound tenderness 16.67 9.92 7 289165 61 79455155
Dysgeusia 16.66 9.92 130 289042 57047 79398169
Hypothermia 16.64 9.92 36 289136 22710 79432506
Drug ineffective for unapproved indication 16.62 9.92 113 289059 51125 79404091
Porphyria 16.60 9.92 10 289162 198 79455018
Oculomucocutaneous syndrome 16.57 9.92 12 289160 327 79454889
Lip ulceration 16.51 9.92 30 289142 2295 79452921
Intestinal obstruction 16.50 9.92 90 289082 42930 79412286
Nerve stimulation test abnormal 16.49 9.92 5 289167 14 79455202
Axial spondyloarthritis 16.44 9.92 15 289157 571 79454645
Insomnia 16.41 9.92 724 288448 244446 79210770
Intestinal haemorrhage 16.41 9.92 56 289116 6370 79448846
Sexual dysfunction 16.35 9.92 4 289168 7759 79447457
Nodule 16.32 9.92 37 289135 22957 79432259
Creutzfeldt-Jakob disease 16.30 9.92 10 289162 205 79455011
Mesenteric neoplasm 16.28 9.92 7 289165 65 79455151
Foetal death 16.25 9.92 65 289107 7979 79447237
Erythematotelangiectatic rosacea 16.24 9.92 5 289167 15 79455201
Application site erythema 16.22 9.92 48 289124 5062 79450154
Muscle tone disorder 16.20 9.92 9 289163 152 79455064
Skin toxicity 16.17 9.92 5 289167 8309 79446907
Onychomycosis 16.09 9.92 66 289106 8195 79447021
Self-medication 16.09 9.92 48 289124 5084 79450132
Alanine aminotransferase abnormal 16.08 9.92 6 289166 8861 79446355
Herpes zoster 16.05 9.92 239 288933 92844 79362372
Respiratory syncytial virus infection 16.01 9.92 7 289165 9395 79445821
Atrial flutter 16.01 9.92 34 289138 21591 79433625
Ventricular arrhythmia 16.00 9.92 6 289166 8834 79446382
Appendicitis 15.98 9.92 32 289140 20762 79434454
Respiratory tract infection 15.98 9.92 107 289065 48582 79406634
Central nervous system lesion 15.88 9.92 15 289157 13353 79441863
Urine abnormality 15.88 9.92 5 289167 8214 79447002
Staphylococcal infection 15.86 9.92 135 289037 58160 79397056
Hypertransaminasaemia 15.86 9.92 12 289160 11912 79443304
Myasthenia gravis 15.82 9.92 9 289163 10390 79444826
Pulmonary haemorrhage 15.81 9.92 18 289154 14699 79440517
Pancreatitis acute 15.79 9.92 110 289062 49494 79405722
Cholelithiasis 15.69 9.92 119 289053 52545 79402671
Soft tissue infection 15.65 9.92 40 289132 3872 79451344
Sopor 15.64 9.92 64 289108 32946 79422270
Small intestine carcinoma 15.55 9.92 19 289153 1017 79454199
Blood pressure measurement 15.54 9.92 13 289159 440 79454776
Aortic stenosis 15.52 9.92 4 289168 7491 79447725
Pneumonia bacterial 15.51 9.92 29 289143 19302 79435914
Pyloric stenosis 15.48 9.92 14 289158 527 79454689
Hypermobility syndrome 15.45 9.92 14 289158 528 79454688
Spondyloarthropathy 15.42 9.92 19 289153 1026 79454190
Postictal paralysis 15.35 9.92 12 289160 368 79454848
Cardiac massage 15.34 9.92 5 289167 19 79455197
Central pain syndrome 15.34 9.92 11 289161 295 79454921
Nail disorder 15.27 9.92 84 289088 11768 79443448
Anuria 15.24 9.92 129 289043 20834 79434382
Aphasia 15.19 9.92 103 289069 46629 79408587
Fibrosis 15.11 9.92 48 289124 5261 79449955
Sciatic nerve palsy 15.09 9.92 7 289165 79 79455137
Omental necrosis 15.06 9.92 6 289166 45 79455171
Breast cancer stage I 15.02 9.92 3 289169 6697 79448519
Application site swelling 15.02 9.92 16 289156 737 79454479
Oral mucosa erosion 14.96 9.92 26 289146 1921 79453295
Cushingoid 14.92 9.92 8 289164 9544 79445672
Tardive dyskinesia 14.90 9.92 10 289162 10561 79444655
Blood triglycerides increased 14.82 9.92 34 289138 21006 79434210
Application site oedema 14.79 9.92 7 289165 83 79455133
Papulopustular rosacea 14.76 9.92 5 289167 22 79455194
Bone marrow oedema 14.67 9.92 24 289148 1687 79453529
Foot operation 14.67 9.92 50 289122 5683 79449533
Pulmonary alveolar haemorrhage 14.65 9.92 12 289160 11445 79443771
Erosive duodenitis 14.63 9.92 27 289145 2090 79453126
Metastases to liver 14.63 9.92 53 289119 28261 79426955
Nail operation 14.59 9.92 15 289157 663 79454553
Feeding disorder 14.57 9.92 105 289067 16149 79439067
Musculoskeletal disorder 14.56 9.92 130 289042 21318 79433898
Eastern Cooperative Oncology Group performance status 14.52 9.92 6 289166 50 79455166
Injection site haemorrhage 14.51 9.92 52 289120 27818 79427398
Haemolysis 14.50 9.92 15 289157 12797 79442419
Parotid gland enlargement 14.50 9.92 18 289154 980 79454236
Troponin increased 14.48 9.92 30 289142 19225 79435991
Libido increased 14.44 9.92 26 289146 1975 79453241
Angina pectoris 14.44 9.92 119 289053 51613 79403603
Red blood cell count decreased 14.42 9.92 136 289036 57377 79397839
Joint stiffness 14.41 9.92 218 288954 40612 79414604
Rales 14.35 9.92 32 289140 19969 79435247
Anal fissure 14.33 9.92 5 289167 7698 79447518
Coeliac disease 14.33 9.92 80 289092 11271 79443945
Product administered at inappropriate site 14.30 9.92 39 289133 3926 79451290
Injection site swelling 14.28 9.92 106 289066 47026 79408190
Abdominal tenderness 14.27 9.92 76 289096 10518 79444698
Gynaecomastia 14.27 9.92 5 289167 7676 79447540
Wound infection pseudomonas 14.26 9.92 23 289149 1598 79453618
Application site injury 14.25 9.92 5 289167 25 79455191
Hemiplegia 14.25 9.92 20 289152 14919 79440297
Feeling abnormal 14.25 9.92 454 288718 158745 79296471
Pulmonary function test decreased 14.14 9.92 5 289167 7632 79447584
Lip scab 14.13 9.92 4 289168 8 79455208
Mania 14.12 9.92 28 289144 18232 79436984
Upper respiratory tract infection 14.07 9.92 239 288933 90929 79364287
Arrhythmia 14.06 9.92 148 289024 61124 79394092
Pneumatosis intestinalis 14.06 9.92 3 289169 6394 79448822
Pulmonary thrombosis 14.06 9.92 14 289158 12157 79443059
Emotional distress 14.06 9.92 86 289086 39883 79415333
Epstein-Barr virus infection 14.05 9.92 19 289153 14397 79440819
Upper-airway cough syndrome 14.03 9.92 13 289159 11680 79443536
Creatinine renal clearance decreased 13.96 9.92 30 289142 18972 79436244
Dystonia 13.95 9.92 36 289136 21363 79433853
Vaginal ulceration 13.92 9.92 10 289162 269 79454947
Complication of device insertion 13.91 9.92 3 289169 6347 79448869
Intentional product misuse 13.88 9.92 252 288920 94913 79360303
Internal limiting membrane peeling 13.87 9.92 3 289169 0 79455216
Injection site ulcer 13.85 9.92 15 289157 704 79454512
Eyelid oedema 13.80 9.92 91 289081 13596 79441620
Agranulocytosis 13.78 9.92 101 289071 44929 79410287
Platelet dysfunction 13.76 9.92 12 289160 430 79454786
Head titubation 13.76 9.92 17 289155 921 79454295
Fixed eruption 13.73 9.92 32 289140 2922 79452294
Atrioventricular block first degree 13.72 9.92 15 289157 12476 79442740
Porphyrins urine increased 13.64 9.92 5 289167 29 79455187
Basal ganglion degeneration 13.62 9.92 12 289160 436 79454780
Blood bilirubin increased 13.62 9.92 164 289008 66068 79389148
Iris transillumination defect 13.62 9.92 8 289164 151 79455065
Factor VIII deficiency 13.62 9.92 8 289164 151 79455065
Colitis erosive 13.62 9.92 8 289164 151 79455065
Musculoskeletal deformity 13.58 9.92 22 289150 1534 79453682
Secondary amyloidosis 13.53 9.92 9 289163 213 79455003
Joint abscess 13.53 9.92 13 289159 529 79454687
Pyoderma streptococcal 13.52 9.92 4 289168 10 79455206
Euglycaemic diabetic ketoacidosis 13.52 9.92 4 289168 6840 79448376
Upper limb fracture 13.51 9.92 28 289144 17939 79437277
Hepatitis C 13.46 9.92 14 289158 11911 79443305
Respiratory depression 13.45 9.92 53 289119 27577 79427639
Sickle cell anaemia with crisis 13.33 9.92 6 289166 7916 79447300
Oesophagitis ulcerative 13.32 9.92 19 289153 1184 79454032
Mood swings 13.31 9.92 33 289139 19847 79435369
pH body fluid decreased 13.23 9.92 5 289167 32 79455184
Nasal polyps 13.22 9.92 5 289167 7322 79447894
Interstitial lung disease 13.21 9.92 309 288863 112291 79342925
Renal tubular necrosis 13.21 9.92 144 289028 24895 79430321
Squamous cell carcinoma of skin 13.17 9.92 19 289153 14014 79441202
Hepatitis B reactivation 13.15 9.92 3 289169 6105 79449111
Dyspnoea at rest 13.15 9.92 5 289167 7297 79447919
Heavy menstrual bleeding 13.12 9.92 19 289153 13992 79441224
Systemic candida 13.10 9.92 4 289168 6702 79448514
Drug level increased 13.08 9.92 87 289085 39564 79415652
Angina unstable 13.08 9.92 25 289147 16502 79438714
Embolic stroke 13.06 9.92 6 289166 7820 79447396
Gastrointestinal mucosal exfoliation 13.03 9.92 9 289163 227 79454989
Vomiting 13.03 9.92 2169 287003 663659 78791557
Hyperventilation 13.01 9.92 60 289112 7839 79447377
Meteoropathy 12.99 9.92 4 289168 12 79455204
Pharyngo-oesophageal diverticulum 12.97 9.92 5 289167 34 79455182
Supraventricular tachycardia 12.95 9.92 37 289135 21233 79433983
Duodenal perforation 12.93 9.92 26 289146 2146 79453070
Coagulopathy 12.91 9.92 77 289095 35929 79419287
Chronic sinusitis 12.86 9.92 17 289155 13009 79442207
Rash erythematous 12.85 9.92 287 288885 57482 79397734
Liver function test abnormal 12.75 9.92 161 289011 64314 79390902
Hypertensive crisis 12.75 9.92 36 289136 20734 79434482
Acquired haemophilia 12.74 9.92 24 289148 1887 79453329
Lip oedema 12.73 9.92 51 289121 6265 79448951
Small intestinal ulcer haemorrhage 12.72 9.92 7 289165 116 79455100
Sinus node dysfunction 12.70 9.92 6 289166 7695 79447521
Emphysema 12.60 9.92 25 289147 16275 79438941
Gastritis haemorrhagic 12.59 9.92 29 289143 2628 79452588
Device malfunction 12.56 9.92 38 289134 21410 79433806
Heparin-induced thrombocytopenia 12.55 9.92 10 289162 9672 79445544
Arthritis bacterial 12.51 9.92 66 289106 9100 79446116
Neoplasm malignant 12.51 9.92 66 289106 31744 79423472
Accidental overdose 12.49 9.92 88 289084 39493 79415723
Retching 12.49 9.92 28 289144 17439 79437777
Diverticulum intestinal 12.47 9.92 63 289109 8542 79446674
Cardiac murmur 12.46 9.92 24 289148 15800 79439416
Intestinal ischaemia 12.42 9.92 18 289154 13252 79441964
Laryngeal discomfort 12.41 9.92 13 289159 587 79454629
Post-traumatic neck syndrome 12.38 9.92 25 289147 2069 79453147
Injection site pruritus 12.38 9.92 96 289076 42187 79413029
Malnutrition 12.38 9.92 41 289131 22461 79432755
Disturbance in attention 12.37 9.92 121 289051 50680 79404536
Inflammatory pain 12.36 9.92 17 289155 1024 79454192
Parkinsonism 12.34 9.92 26 289146 16558 79438658
Clostridium test positive 12.34 9.92 4 289168 6450 79448766
Heart rate decreased 12.31 9.92 180 288992 70136 79385080
Naevus haemorrhage 12.31 9.92 7 289165 124 79455092
Intervertebral disc disorder 12.28 9.92 42 289130 4783 79450433
Haemorrhoids 12.27 9.92 59 289113 29069 79426147
Gastrointestinal haemorrhage 12.23 9.92 654 288518 147065 79308151
Hiccups 12.22 9.92 11 289161 10020 79445196
Feeling cold 12.21 9.92 58 289114 28671 79426545
Gastroduodenal ulcer 12.21 9.92 12 289160 502 79454714
Arterial haemorrhage 12.19 9.92 28 289144 2533 79452683
Palatal oedema 12.17 9.92 20 289152 1411 79453805
Jaundice 12.17 9.92 266 288906 53083 79402133
Alpha tumour necrosis factor increased 12.17 9.92 5 289167 41 79455175
Fibrous histiocytoma 12.14 9.92 14 289158 705 79454511
Mast cell activation syndrome 12.12 9.92 14 289158 706 79454510
Generalised bullous fixed drug eruption 12.12 9.92 8 289164 187 79455029
Hyperlipidaemia 12.10 9.92 51 289121 26042 79429174
Glycosylated haemoglobin increased 12.10 9.92 33 289139 19227 79435989
Intestinal metaplasia 12.07 9.92 5 289167 42 79455174
Iritis 12.03 9.92 36 289136 3819 79451397
Platelet function test abnormal 11.97 9.92 8 289164 191 79455025
Vasoconstriction 11.97 9.92 14 289158 716 79454500
Breath sounds abnormal 11.94 9.92 25 289147 15959 79439257
Herpes simplex 11.94 9.92 16 289156 12171 79443045
Oral pruritus 11.91 9.92 27 289145 2421 79452795
Seroma 11.90 9.92 26 289146 2274 79452942
Neutropenic colitis 11.90 9.92 3 289169 5704 79449512
Porphyrins stool increased 11.86 9.92 5 289167 44 79455172
Condition aggravated 11.86 9.92 2028 287144 499096 78956120
Gestational diabetes 11.86 9.92 4 289168 6289 79448927
Blood creatinine increased 11.84 9.92 451 288721 154606 79300610
Parainfluenzae virus infection 11.82 9.92 3 289169 5679 79449537
Transient ischaemic attack 11.80 9.92 128 289044 52567 79402649
Leucine aminopeptidase increased 11.80 9.92 3 289169 3 79455213
Tarsal tunnel syndrome 11.79 9.92 12 289160 524 79454692
Brain natriuretic peptide increased 11.78 9.92 9 289163 8891 79446325
Caesarean section 11.74 9.92 17 289155 12518 79442698
Pneumonia fungal 11.73 9.92 14 289158 11196 79444020
Sputum discoloured 11.70 9.92 40 289132 21703 79433513
Respiratory acidosis 11.70 9.92 14 289158 11186 79444030
Discoloured vomit 11.70 9.92 20 289152 1458 79453758
Left ventricular hypertrophy 11.68 9.92 14 289158 11177 79444039
Anosmia 11.64 9.92 9 289163 8835 79446381
Peptic ulcer haemorrhage 11.62 9.92 16 289156 965 79454251
Arteriosclerosis coronary artery 11.59 9.92 30 289142 17786 79437430
Hyperlactacidaemia 11.56 9.92 3 289169 5592 79449624
Cardiac failure acute 11.48 9.92 33 289139 18896 79436320
Polyneuropathy in malignant disease 11.43 9.92 9 289163 279 79454937
Acquired diaphragmatic eventration 11.43 9.92 13 289159 645 79454571
Faecal calprotectin increased 11.39 9.92 3 289169 5538 79449678
Colitis 11.37 9.92 192 288980 73115 79382101
Carcinoembryonic antigen 11.31 9.92 6 289166 92 79455124
Anorgasmia 11.31 9.92 18 289154 1236 79453980
Alanine aminotransferase increased 11.31 9.92 478 288694 162092 79293124
Immune system disorder 11.30 9.92 14 289158 11015 79444201
Gastrointestinal procedural complication 11.27 9.92 8 289164 211 79455005
Arthritis 11.25 9.92 517 288655 114363 79340853
Upper gastrointestinal perforation 11.24 9.92 4 289168 21 79455195
Hyperthyroidism 11.20 9.92 42 289130 22167 79433049
Death neonatal 11.16 9.92 13 289159 662 79454554
Carbohydrate antigen 15-3 11.14 9.92 6 289166 95 79455121
Corneal opacity 11.13 9.92 16 289156 1004 79454212
Colorectal cancer 11.12 9.92 9 289163 8638 79446578
Duodenal stenosis 11.12 9.92 14 289158 773 79454443
Lung infiltration 11.12 9.92 44 289128 22868 79432348
Coronary arterial stent insertion 11.11 9.92 4 289168 6040 79449176
Metastases to central nervous system 11.10 9.92 27 289145 16348 79438868
Atrial tachycardia 11.10 9.92 6 289166 7127 79448089
Iron deficiency anaemia 11.05 9.92 142 289030 25530 79429686
Drug withdrawal syndrome 11.04 9.92 77 289095 34641 79420575
End stage renal disease 11.03 9.92 17 289155 12203 79443013
Jejunal stenosis 10.98 9.92 6 289166 98 79455118
Gallbladder oedema 10.97 9.92 9 289163 296 79454920
Dactylitis 10.83 9.92 28 289144 2729 79452487
Subdural haemorrhage 10.83 9.92 4 289168 5944 79449272
Device difficult to use 10.81 9.92 20 289152 13365 79441851
Vascular malformation 10.80 9.92 10 289162 388 79454828
Drooling 10.79 9.92 4 289168 5930 79449286
Haemodynamic instability 10.76 9.92 30 289142 17352 79437864
Persistent corneal epithelial defect 10.73 9.92 5 289167 57 79455159
Dyslipidaemia 10.67 9.92 16 289156 11617 79443599
Serotonin syndrome 10.65 9.92 108 289064 44919 79410297
Inflammatory marker increased 10.58 9.92 71 289101 10669 79444547
Hydrocephalus 10.56 9.92 10 289162 8890 79446326
Immune effector cell-associated neurotoxicity syndrome 10.54 9.92 4 289168 5844 79449372
Bone erosion 10.53 9.92 105 289067 17742 79437474
Epilepsy 10.51 9.92 96 289076 40764 79414452
Abdominal lymphadenopathy 10.49 9.92 18 289154 1316 79453900
Hypophosphataemia 10.47 9.92 37 289135 19876 79435340
Catheter site erythema 10.46 9.92 3 289169 5237 79449979
Hallucinations, mixed 10.45 9.92 6 289166 6893 79448323
Oesophageal carcinoma recurrent 10.44 9.92 5 289167 61 79455155
Oligoarthritis 10.42 9.92 13 289159 711 79454505
Squamous cell carcinoma 10.40 9.92 26 289146 15596 79439620
Stupor 10.38 9.92 6 289166 6866 79448350
HLA-B*27 positive 10.37 9.92 6 289166 110 79455106
Product label confusion 10.33 9.92 20 289152 1606 79453610
Ketoacidosis 10.32 9.92 8 289164 7846 79447370
Gastrointestinal infection 10.29 9.92 16 289156 11445 79443771
Uterine perforation 10.26 9.92 5 289167 6298 79448918
Syringe issue 10.24 9.92 5 289167 6293 79448923
Blood glucose abnormal 10.22 9.92 14 289158 10552 79444664
Eosinophilia 10.22 9.92 110 289062 45235 79409981
Injection site abscess 10.20 9.92 20 289152 1620 79453596
Aspartate aminotransferase increased 10.20 9.92 405 288767 138236 79316980
Catheter site infection 10.17 9.92 6 289166 6789 79448427
Treatment noncompliance 10.15 9.92 131 289041 52137 79403079
Prurigo 10.15 9.92 18 289154 1351 79453865
Genital haemorrhage 10.12 9.92 5 289167 6250 79448966
Application site pain 10.11 9.92 39 289133 4708 79450508
Abortion spontaneous 10.11 9.92 64 289108 29443 79425773
Drug dose omission by device 10.11 9.92 5 289167 6245 79448971
Laparotomy 10.08 9.92 10 289162 423 79454793
Epidermal necrosis 10.05 9.92 19 289153 1498 79453718
Erythema multiforme 10.01 9.92 103 289069 17548 79437668
Multiple allergies 9.98 9.92 14 289158 10446 79444770
Vision blurred 9.96 9.92 300 288872 105598 79349618
Dry mouth 9.93 9.92 402 288770 87617 79367599

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Right ventricular hypertrophy 36.53 33.34 8 116 15 89653

Pharmacologic Action:

SourceCodeDescription
ATC D11AX18 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC M01AB05 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M01AB55 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA15 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC S01BC03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC S01CC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
FDA PE N0000008836 Decreased Prostaglandin Production
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35544 cyclooxygenase inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Tenosynovitis indication 67801009 DOID:970
Rheumatoid arthritis indication 69896004 DOID:7148
Actinic keratosis indication 201101007 DOID:8866
Dysmenorrhea indication 266599000
Lumbago indication 279039007
Osteoarthritis indication 396275006
Adhesive capsulitis of shoulder indication 399114005 DOID:14188
Post-Op Photophobia indication
Neckshoulderarm syndrome indication
Postoperative Ocular Pain indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Analgesia in various types of cancer indication
Sprains and Strains indication
Osteoarthritis in Patients at High Ulcer Risk indication
Osteoarthrosis of the Knee indication
Post-Op Ocular Inflammation indication
Renal colic off-label use 7093002
Tendinitis off-label use 34840004 DOID:971
Bursitis off-label use 84017003 DOID:2965
Cystoid macular edema off-label use 193387007 DOID:4447
Prevention of Ocular Surgery-Induced Miosis off-label use
Keratitis contraindication 5888003 DOID:4677
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Asthenia contraindication 13791008
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Skin ulcer contraindication 46742003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Perforation of cornea contraindication 74895004
Corneal ulcer contraindication 91514001 DOID:8463
Corneal degeneration contraindication 111521006 DOID:1237
Open wound contraindication 125643001
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Corneal Infiltrates contraindication
Gynecological Surgery contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Horses Pain and inflammation associated with osteoarthritis Indication

🐶 Veterinary products

ProductApplicantIngredients
Surpass Topical Anti-Inflammatory Cream Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.22 acidic
pKa2 0.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 7759394 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8097651 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8927604 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DYLOJECT JAVELIN PHARMS INC N022396 Dec. 23, 2014 DISCN SOLUTION INTRAVENOUS 8946292 March 22, 2027 MANAGEMENT OF PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8563613 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8871809 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9066913 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9101591 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9132110 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9168305 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9220784 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339551 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339552 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9539335 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8252838 April 21, 2028 USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7662858 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7884095 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7939518 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8110606 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8623920 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 9561200 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9370501 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9375412 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9415029 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 RX SYSTEM TOPICAL 11344520 Feb. 20, 2035 METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 RX SYSTEM TOPICAL 11351133 Feb. 20, 2035 METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL May 25, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 7.70 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.52 WOMBAT-PK CHEMBL
Transthyretin Secreted Kd 6 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 5.59 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor ANTAGONIST Ki 6.20 IUPHAR
Cytochrome c oxidase subunit 2 Enzyme IC50 5 CHEMBL
Interleukin-8 Cytokine IC50 8.10 CHEMBL
Transient receptor potential cation channel subfamily A member 1 Ion channel EC50 4.25 CHEMBL
Aldo-keto reductase family 1 member B10 Enzyme IC50 5.72 CHEMBL
Acid-sensing ion channel 3 Ion channel BLOCKER IC50 4 IUPHAR
C-X-C chemokine receptor type 1 GPCR IC50 7.92 CHEMBL
UDP-glucuronosyltransferase 1-1 Enzyme Ki 4.28 CHEMBL
UDP-glucuronosyltransferase 1-7 Enzyme Ki 4.72 CHEMBL
UDP-glucuronosyltransferase 1-6 Enzyme Ki 4.64 CHEMBL
UDP-glucuronosyltransferase 1-9 Enzyme Ki 4.96 CHEMBL
UDP-glucuronosyltransferase 1-10 Enzyme Ki 4.55 CHEMBL
Transient receptor potential cation channel subfamily M member 3 Ion channel BLOCKER IC50 5.20 IUPHAR
Fatty acid-binding protein, liver Unclassified Ki 5.49 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.66 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 7.17 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.52 CHEMBL

External reference:

IDSource
4019714 VUID
N0000147806 NUI
D00903 KEGG_DRUG
88170-10-9 SECONDARY_CAS_RN
78213-16-8 SECONDARY_CAS_RN
15307-79-6 SECONDARY_CAS_RN
15307-81-0 SECONDARY_CAS_RN
119623-66-4 SECONDARY_CAS_RN
203214 RXNORM
4019378 VANDF
4019714 VANDF
4020829 VANDF
4027248 VANDF
C0012091 UMLSCUI
CHEBI:47381 CHEBI
DIF PDB_CHEM_ID
CHEMBL139 ChEMBL_ID
CHEMBL1034 ChEMBL_ID
DB00586 DRUGBANK_ID
CHEMBL1200804 ChEMBL_ID
CHEMBL1201180 ChEMBL_ID
D004008 MESH_DESCRIPTOR_UI
C000614065 MESH_SUPPLEMENTAL_RECORD_UI
C064142 MESH_SUPPLEMENTAL_RECORD_UI
3033 PUBCHEM_CID
2714 IUPHAR_LIGAND_ID
3270 INN_ID
144O8QL0L1 UNII
11838 MMSL
23373 MMSL
3184 MMSL
340620 MMSL
37364 MMSL
4582 MMSL
4583 MMSL
4584 MMSL
d00848 MMSL
002391 NDDF
004409 NDDF
004410 NDDF
005170 NDDF
006237 NDDF
108515008 SNOMEDCT_US
363598004 SNOMEDCT_US
425650004 SNOMEDCT_US
426714006 SNOMEDCT_US
62039007 SNOMEDCT_US
7034005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
VoltarenArthritis Pain HUMAN OTC DRUG LABEL 1 0067-8152 GEL 10 mg TOPICAL NDA 18 sections
VoltarenArthritis Pain HUMAN OTC DRUG LABEL 1 0067-8152 GEL 10 mg TOPICAL NDA 18 sections
VOLTAREN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0478 SOLUTION 1 mg OPHTHALMIC NDA 16 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3225 PATCH 0.01 g TOPICAL NDA authorized generic 30 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA authorized generic 31 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA authorized generic 31 sections
good sense arthritis pain HUMAN OTC DRUG LABEL 1 0113-1189 GEL 10 mg TOPICAL ANDA 17 sections
good sense arthritis pain HUMAN OTC DRUG LABEL 1 0113-1189 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0803 GEL 30 mg TOPICAL NDA authorized generic 27 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0844 GEL 30 mg TOPICAL NDA authorized generic 27 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 26 sections
Aleve Arthritis Pain Gel HUMAN OTC DRUG LABEL 1 0280-0039 GEL 1 mg TOPICAL ANDA 17 sections
Aleve Arthritis Pain Gel HUMAN OTC DRUG LABEL 1 0280-0039 GEL 1 mg TOPICAL ANDA 17 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1210 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1210 GEL 10 mg TOPICAL ANDA 17 sections
diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1871 GEL 10 mg TOPICAL ANDA 17 sections
arthritis pain relieving HUMAN OTC DRUG LABEL 1 0363-5123 GEL 10 mg TOPICAL ANDA 17 sections