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

Stem definitionDrug idCAS RN
463 58-08-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • anhydrous caffeine
  • peyona
  • caffeine
  • 1,3,7-trimethyl-2,6-dioxopurine
  • 7-methyltheophylline
  • cafalgine
  • cafeina
  • durvitan
  • guaranine
  • thein
  • caffeine citrate
  • caffeine, citrated
  • nymusa
A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
  • Molecular weight: 194.19
  • Formula: C8H10N4O2
  • CLOGP: -0.04
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 0
  • TPSA: 58.44
  • ALOGS: -1.25
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 21.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 51.77 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 98 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.63 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.64 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 26, 1948 FDA NOVARTIS

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
Completed suicide 2406.36 9.83 3633 334399 128256 50138836
Toxicity to various agents 2015.12 9.83 4404 333628 208095 50058997
Infusion related reaction 833.11 9.83 2758 335274 166799 50100293
Sinusitis 623.43 9.83 2521 335511 168037 50099055
Muscle injury 545.57 9.83 928 337104 36183 50230909
Folliculitis 540.25 9.83 953 337079 38272 50228820
Exposure to toxic agent 517.44 9.83 316 337716 3342 50263750
Acute hepatic failure 483.95 9.83 560 337472 15117 50251975
Irritable bowel syndrome 462.76 9.83 1046 336986 50395 50216697
Lower respiratory tract infection 457.43 9.83 1538 336494 93663 50173429
Overdose 452.84 9.83 1581 336451 98146 50168946
Blister 363.61 9.83 1326 336706 84092 50183000
Sleep disorder due to general medical condition, insomnia type 361.47 9.83 707 337325 30740 50236352
Ill-defined disorder 352.34 9.83 979 337053 53675 50213417
Intentional product misuse 342.58 9.83 878 337154 45856 50221236
Metabolic acidosis 338.64 9.83 780 337252 38045 50229047
Blood pressure fluctuation 335.10 9.83 740 337292 35083 50232009
Product dose omission issue 321.15 9.83 456 337576 183382 50083710
Duodenal ulcer perforation 307.90 9.83 831 337201 44780 50222312
Impaired healing 300.89 9.83 1088 336944 68698 50198394
Helicobacter infection 299.59 9.83 869 337163 48833 50218259
Anti-cyclic citrullinated peptide antibody positive 297.18 9.83 1092 336940 69495 50197597
Pericarditis 276.57 9.83 1150 336882 77539 50189553
Joint swelling 265.56 9.83 2653 335379 242633 50024459
Injection site pain 264.56 9.83 212 337820 110812 50156280
Hepatic enzyme increased 259.93 9.83 1689 336343 135691 50131401
Rheumatoid arthritis 238.43 9.83 2230 335802 200320 50066772
Nasopharyngitis 234.61 9.83 2139 335893 190788 50076304
Therapeutic product effect decreased 224.85 9.83 1618 336414 134432 50132660
Hepatotoxicity 217.87 9.83 529 337503 26697 50240395
Diarrhoea 210.75 9.83 2722 335310 585754 49681338
Gastrointestinal disorder 206.74 9.83 1206 336826 93250 50173842
Anion gap 197.01 9.83 112 337920 1025 50266067
Stomatitis 189.77 9.83 1243 336789 100101 50166991
Body temperature increased 179.30 9.83 538 337494 30803 50236289
Intentional overdose 174.93 9.83 854 337178 61650 50205442
Hypersensitivity 171.31 9.83 2192 335840 212969 50054123
Hand deformity 169.74 9.83 1199 336833 99000 50168092
Synovitis 167.39 9.83 1406 336626 122459 50144633
Medication error 165.94 9.83 575 337457 35529 50231563
Discomfort 164.82 9.83 1264 336768 107116 50159976
Intentional product use issue 164.35 9.83 976 337056 75942 50191150
Weight increased 161.63 9.83 2059 335973 199832 50067260
Psoriasis 159.07 9.83 136 337896 68864 50198228
Swelling 156.75 9.83 2039 335993 198833 50068259
Device expulsion 156.01 9.83 9 338023 28813 50238279
Depressed level of consciousness 152.72 9.83 720 337312 51233 50215859
Injection site erythema 146.05 9.83 171 337861 74765 50192327
Wound 138.74 9.83 1193 336839 104601 50162491
Wrong technique in product usage process 135.97 9.83 103 337929 55407 50211685
Respiratory arrest 131.93 9.83 471 337561 29538 50237554
Peripheral swelling 129.62 9.83 2013 336019 203923 50063169
Coagulopathy 127.19 9.83 333 337699 17611 50249481
Sedation complication 127.16 9.83 218 337814 8548 50258544
Injection site reaction 124.91 9.83 91 337941 49941 50217151
Hepatic cytolysis 124.83 9.83 207 337825 7896 50259196
Heart rate decreased 120.86 9.83 524 337508 35973 50231119
Ear pain 120.16 9.83 439 337593 27844 50239248
Drug hypersensitivity 115.65 9.83 1095 336937 249915 50017177
Cardio-respiratory arrest 112.64 9.83 680 337352 53212 50213880
Analgesic drug level increased 112.46 9.83 93 337939 1638 50265454
Hepatic failure 107.28 9.83 464 337568 31819 50235273
Creatinine renal clearance decreased 107.21 9.83 242 337790 11639 50255453
Confusional state 106.33 9.83 1789 336243 184139 50082953
Anaemia 106.03 9.83 1126 336906 251330 50015762
Blood pressure diastolic abnormal 103.36 9.83 207 337825 9154 50257938
Infusion site pain 103.19 9.83 244 337788 12102 50254990
Muscle spasticity 102.09 9.83 299 337733 16885 50250207
Injection site pruritus 100.23 9.83 74 337958 40337 50226755
Rheumatoid factor positive 99.08 9.83 621 337411 49238 50217854
Infection 95.55 9.83 1655 336377 171299 50095793
Cardiac failure congestive 95.06 9.83 270 337762 84112 50182980
Poisoning 94.66 9.83 237 337795 12192 50254900
Infusion site swelling 94.44 9.83 171 337861 7005 50260087
Neutropenia 91.64 9.83 595 337437 147370 50119722
Pruritus 91.59 9.83 2511 335521 281057 49986035
Hospitalisation 90.85 9.83 199 337833 67738 50199354
Disease progression 90.41 9.83 332 337700 95534 50171558
Injection site bruising 90.32 9.83 68 337964 36700 50230392
Sopor 89.60 9.83 13 338019 19866 50247226
Blood calcium decreased 87.62 9.83 321 337711 20385 50246707
Acute lung injury 84.63 9.83 72 337960 1321 50265771
Myocardial infarction 83.51 9.83 309 337723 88718 50178374
Hepatic necrosis 83.45 9.83 136 337896 5112 50261980
Blood pressure systolic abnormal 83.40 9.83 169 337863 7537 50259555
Therapy cessation 82.70 9.83 35 337997 25976 50241116
Blood pressure diastolic decreased 82.14 9.83 273 337759 16508 50250584
Drug resistance 79.84 9.83 15 338017 18974 50248118
Respiratory depression 79.18 9.83 217 337815 11793 50255299
Osteonecrosis of jaw 78.82 9.83 61 337971 32465 50234627
Neuropathy peripheral 78.74 9.83 355 337677 96402 50170690
Oxygen saturation decreased 78.38 9.83 791 337241 72457 50194635
Glossodynia 78.15 9.83 1144 336888 114425 50152667
Blood pressure increased 77.52 9.83 1285 336747 131847 50135245
Cognitive disorder 77.00 9.83 532 337500 43591 50223501
Drug ineffective 75.68 9.83 4595 333437 814738 49452354
Infusion site extravasation 75.51 9.83 153 337879 6823 50260269
Injection site swelling 75.44 9.83 101 337931 41672 50225420
Suspected suicide 73.50 9.83 130 337902 5227 50261865
Therapeutic product effect incomplete 73.13 9.83 338 337694 91177 50175915
Arthropathy 70.33 9.83 1462 336570 156444 50110648
Decreased appetite 69.40 9.83 935 337097 199988 50067104
Infusion site erythema 69.20 9.83 169 337863 8558 50258534
Dizziness 67.87 9.83 1778 336254 344591 49922501
Product quality issue 67.30 9.83 64 337968 30794 50236298
Exposure via ingestion 66.92 9.83 88 337944 2715 50264377
Cardiac failure 66.77 9.83 271 337761 75769 50191323
Pyroglutamate increased 66.45 9.83 39 337993 381 50266711
Malignant neoplasm progression 66.16 9.83 233 337799 67891 50199201
Blood pressure systolic increased 65.79 9.83 434 337598 35015 50232077
Nausea 63.26 9.83 3966 334066 701432 49565660
Feeling abnormal 63.15 9.83 535 337497 124957 50142135
Contraindicated product administered 63.04 9.83 1369 336663 147589 50119503
Throat irritation 62.81 9.83 381 337651 29858 50237234
Orthostatic hypotension 61.59 9.83 372 337660 29109 50237983
Night sweats 61.08 9.83 409 337623 33165 50233927
No adverse event 60.83 9.83 81 337951 33497 50233595
Pemphigus 60.35 9.83 1133 336899 119033 50148059
Muscle spasms 57.60 9.83 548 337484 125005 50142087
Sedation 57.56 9.83 376 337656 30234 50236858
Coma 56.01 9.83 604 337428 56275 50210817
Infusion site pruritus 55.91 9.83 97 337935 3840 50263252
Rheumatic fever 55.70 9.83 242 337790 16625 50250467
Cerebrovascular accident 55.45 9.83 387 337645 94293 50172799
Interstitial lung disease 54.96 9.83 177 337855 52999 50214093
Bone marrow failure 54.93 9.83 62 337970 27562 50239530
Arthralgia 54.73 9.83 3512 334520 435190 49831902
Liver injury 54.38 9.83 317 337715 24489 50242603
Electric shock 54.16 9.83 49 337983 979 50266113
Pyrexia 53.25 9.83 3075 334957 377128 49889964
Product storage error 52.81 9.83 9 338023 12215 50254877
Surgery 52.57 9.83 75 337957 30130 50236962
Drug interaction 52.13 9.83 979 337053 198642 50068450
Respiratory disorder 52.05 9.83 372 337660 30815 50236277
Pyroglutamic acidosis 51.97 9.83 34 337998 409 50266683
Heart rate increased 51.92 9.83 764 337268 76486 50190606
Pancytopenia 51.43 9.83 339 337693 83691 50183401
Paraesthesia 51.32 9.83 534 337498 119709 50147383
Mucosal inflammation 50.89 9.83 121 337911 40021 50227071
Contusion 50.68 9.83 1041 336991 111142 50155950
Oedema peripheral 49.61 9.83 749 337283 157212 50109880
Product substitution issue 49.59 9.83 16 338016 14041 50253051
White blood cell count decreased 49.56 9.83 519 337513 116203 50150889
Unevaluable event 49.25 9.83 151 337881 45915 50221177
Epistaxis 48.87 9.83 240 337792 63714 50203378
Red blood cell sedimentation rate abnormal 48.82 9.83 24 338008 16319 50250773
Swollen joint count increased 48.81 9.83 213 337819 14660 50252432
Injection site warmth 48.54 9.83 16 338016 13850 50253242
Palmar-plantar erythrodysaesthesia syndrome 48.30 9.83 38 337994 20060 50247032
Rash 47.47 9.83 3462 334570 434009 49833083
Injection site rash 46.47 9.83 25 338007 16152 50250940
Psoriatic arthropathy 46.24 9.83 160 337872 46872 50220220
Memory impairment 46.16 9.83 325 337707 79035 50188057
Posterior reversible encephalopathy syndrome 46.01 9.83 21 338011 14907 50252185
Device malfunction 45.48 9.83 22 338010 15099 50251993
Body temperature decreased 45.11 9.83 223 337809 16172 50250920
Diabetes mellitus 44.78 9.83 172 337860 48861 50218231
Crystal urine present 44.39 9.83 52 337980 1422 50265670
Device dislocation 44.34 9.83 47 337985 21499 50245593
Dyspnoea exertional 44.09 9.83 184 337848 51049 50216043
Anion gap abnormal 43.94 9.83 28 338004 321 50266771
Malaise 43.87 9.83 1814 336218 333718 49933374
Neoplasm progression 43.60 9.83 80 337952 29077 50238015
Heart rate irregular 43.48 9.83 249 337783 19111 50247981
Renal impairment 42.96 9.83 312 337720 75349 50191743
Infusion site bruising 42.79 9.83 64 337968 2231 50264861
White blood cells urine positive 42.14 9.83 94 337938 4484 50262608
Accidental overdose 41.77 9.83 248 337784 19285 50247807
Hypotension 41.33 9.83 1946 336086 233523 50033569
Underdose 40.88 9.83 45 337987 20233 50246859
Device issue 40.62 9.83 44 337988 19928 50247164
Injection site haemorrhage 40.20 9.83 50 337982 21296 50245796
International normalised ratio increased 40.08 9.83 453 337579 42699 50224393
Product prescribing error 39.58 9.83 49 337983 20912 50246180
Suicide attempt 39.35 9.83 523 337509 51209 50215883
Alanine aminotransferase increased 39.27 9.83 818 337214 87541 50179551
Therapy interrupted 39.23 9.83 46 337986 20106 50246986
Drug abuse 38.70 9.83 588 337444 59258 50207834
Soft tissue disorder 38.20 9.83 86 337946 4128 50262964
Systemic lupus erythematosus 38.14 9.83 1219 336813 139403 50127689
Injection site urticaria 37.95 9.83 17 338015 12200 50254892
Pneumonia 37.75 9.83 2105 335927 376296 49890796
Acute kidney injury 37.44 9.83 1199 336833 226859 50040233
Drug intolerance 37.43 9.83 1806 336226 217298 50049794
Respiratory rate increased 37.33 9.83 163 337869 11222 50255870
Injection site mass 37.24 9.83 30 338002 15650 50251442
Substance abuse 37.20 9.83 84 337948 4040 50263052
Mobility decreased 36.80 9.83 744 337288 79204 50187888
Administration site swelling 36.75 9.83 40 337992 1007 50266085
Urine abnormality 36.53 9.83 108 337924 6130 50260962
Rash pruritic 36.29 9.83 180 337852 47666 50219426
Blood parathyroid hormone decreased 36.24 9.83 3 338029 7111 50259981
Lymphocyte count decreased 36.21 9.83 300 337732 26007 50241085
Depression 35.89 9.83 836 337196 164587 50102505
Myelodysplastic syndrome 35.88 9.83 29 338003 15103 50251989
Hyperkalaemia 35.85 9.83 182 337850 47907 50219185
Full blood count decreased 35.52 9.83 59 337973 22287 50244805
Administration site pain 35.51 9.83 32 338000 636 50266456
Device difficult to use 35.33 9.83 11 338021 9875 50257217
Cardiac arrest 35.10 9.83 768 337264 82883 50184209
Bone pain 35.07 9.83 179 337853 47050 50220042
Drug ineffective for unapproved indication 34.94 9.83 55 337977 21226 50245866
Product use in unapproved indication 34.38 9.83 555 337477 115264 50151828
Jaundice cholestatic 34.34 9.83 93 337939 5018 50262074
Abortion spontaneous 34.12 9.83 153 337879 41619 50225473
Gastrooesophageal reflux disease 33.59 9.83 337 337695 76091 50191001
Seizure 33.30 9.83 570 337462 117304 50149788
Fall 33.24 9.83 1864 336168 333068 49934024
Myelosuppression 33.19 9.83 25 338007 13492 50253600
Poor venous access 33.11 9.83 147 337885 10193 50256899
Blood pressure diastolic increased 32.85 9.83 117 337915 7326 50259766
Infusion site nodule 32.68 9.83 39 337993 1088 50266004
Off label use 32.37 9.83 2729 335303 471697 49795395
Urinary sediment present 32.21 9.83 52 337980 1939 50265153
Thrombocytopenia 31.81 9.83 631 337401 127042 50140050
Urticaria 30.79 9.83 1106 336926 128455 50138637
Blood pH decreased 30.41 9.83 57 337975 2398 50264694
Red blood cells urine positive 30.20 9.83 61 337971 2714 50264378
Dysgeusia 29.75 9.83 146 337886 38770 50228322
Red cell distribution width increased 29.18 9.83 124 337908 8435 50258657
Injection site induration 28.85 9.83 10 338022 8387 50258705
Visual acuity reduced 28.59 9.83 57 337975 20082 50247010
Neutrophil percentage increased 28.56 9.83 59 337973 2668 50264424
Musculoskeletal disorder 28.33 9.83 45 337987 17304 50249788
Hypomania 28.32 9.83 80 337952 4425 50262667
Anion gap increased 28.23 9.83 42 337990 1457 50265635
Pain 28.16 9.83 4340 333692 574563 49692529
Suicidal ideation 27.89 9.83 236 337796 55149 50211943
Dehydration 27.84 9.83 790 337242 151659 50115433
Brain death 27.73 9.83 59 337973 2724 50264368
Neonatal hypoxia 27.39 9.83 24 338008 459 50266633
Coronary artery disease 27.32 9.83 104 337928 29622 50237470
Accidental exposure to product 27.28 9.83 72 337960 22985 50244107
Intervertebral discitis 27.27 9.83 57 337975 2599 50264493
Body temperature fluctuation 27.22 9.83 48 337984 1925 50265167
Vision blurred 27.10 9.83 366 337666 78281 50188811
Dry skin 27.05 9.83 173 337859 43018 50224074
Gait disturbance 26.97 9.83 779 337253 149226 50117866
Full blood count abnormal 26.94 9.83 74 337958 23314 50243778
Lymphocyte percentage decreased 26.91 9.83 58 337974 2702 50264390
Transient ischaemic attack 26.90 9.83 117 337915 32093 50234999
Multiple drug therapy 26.57 9.83 47 337985 1890 50265202
Ageusia 26.47 9.83 23 338009 11560 50255532
Brain oedema 26.41 9.83 157 337875 12213 50254879
Urine leukocyte esterase positive 26.32 9.83 59 337973 2824 50264268
Therapeutic response unexpected 26.25 9.83 41 337991 15874 50251218
Fracture 26.24 9.83 45 337987 16788 50250304
Myalgia 26.19 9.83 631 337401 123688 50143404
Burning sensation 25.99 9.83 187 337845 45259 50221833
Acidosis 25.96 9.83 136 337896 10091 50257001
Ear pruritus 25.69 9.83 54 337978 2472 50264620
Hypertensive crisis 25.63 9.83 30 338002 13124 50253968
Multiple sclerosis relapse 25.44 9.83 175 337857 42789 50224303
Hypercalcaemia 25.35 9.83 76 337956 23276 50243816
Hyperlipidaemia 25.26 9.83 49 337983 17441 50249651
Hyponatraemia 25.21 9.83 471 337561 95668 50171424
Septic shock 25.17 9.83 252 337780 56923 50210169
Platelet count decreased 25.03 9.83 498 337534 100228 50166864
Diabetic ketoacidosis 25.01 9.83 51 337981 17821 50249271
Sepsis 24.73 9.83 687 337345 132238 50134854
Infusion site haemorrhage 24.70 9.83 59 337973 2945 50264147
Liver transplant 24.57 9.83 48 337984 2084 50265008
Incorrect drug administration rate 24.54 9.83 54 337978 2552 50264540
Renal failure 24.21 9.83 535 337497 106098 50160994
Analgesic drug level above therapeutic 24.14 9.83 15 338017 164 50266928
Pneumocystis jirovecii pneumonia 23.97 9.83 38 337994 14625 50252467
Drug-induced liver injury 23.89 9.83 290 337742 27805 50239287
Breast cancer 23.80 9.83 178 337854 42712 50224380
Pain in extremity 23.78 9.83 1537 336495 271328 49995764
Leukopenia 23.72 9.83 313 337719 67215 50199877
Foetal exposure during pregnancy 23.69 9.83 98 337934 27261 50239831
Specific gravity urine decreased 23.69 9.83 26 338006 661 50266431
Cytomegalovirus infection 23.69 9.83 53 337979 17909 50249183
Joint stiffness 23.57 9.83 113 337919 30195 50236897
Cytokine release syndrome 23.44 9.83 117 337915 8517 50258575
Hepatic cirrhosis 23.07 9.83 52 337980 17525 50249567
Haematotoxicity 22.98 9.83 12 338020 7883 50259209
Dysphonia 22.74 9.83 159 337873 38733 50228359
Lupus-like syndrome 22.74 9.83 18 338014 9473 50257619
Disturbance in attention 22.70 9.83 119 337913 31067 50236025
Blood cholesterol increased 22.54 9.83 505 337527 54710 50212382
Bone erosion 22.40 9.83 27 338005 11660 50255432
Genital haemorrhage 22.29 9.83 8 338024 6566 50260526
Gastrointestinal haemorrhage 22.20 9.83 350 337682 72971 50194121
Carpal tunnel syndrome 22.15 9.83 50 337982 16843 50250249
Therapeutic response decreased 22.13 9.83 205 337827 47026 50220066
Tremor 22.11 9.83 591 337441 114312 50152780
Atrial fibrillation 22.10 9.83 514 337518 101231 50165861
Prothrombin time prolonged 22.07 9.83 117 337915 8721 50258371
Basal cell carcinoma 21.93 9.83 81 337951 23275 50243817
Infusion site mass 21.88 9.83 33 337999 1159 50265933
Aspartate aminotransferase increased 21.88 9.83 679 337353 77319 50189773
Hypokalaemia 21.87 9.83 435 337597 87557 50179535
Blood creatine increased 21.72 9.83 77 337955 4810 50262282
Administration site erythema 21.56 9.83 22 338010 513 50266579
Femur fracture 21.50 9.83 154 337878 37310 50229782
Metastases to bone 21.44 9.83 56 337976 17939 50249153
Metastases to liver 21.41 9.83 66 337966 20038 50247054
Pulmonary hypertension 21.36 9.83 133 337899 33284 50233808
Renal failure neonatal 21.22 9.83 14 338018 171 50266921
Pathogen resistance 20.93 9.83 6 338026 5683 50261409
Second primary malignancy 20.89 9.83 10 338022 6904 50260188
Macular degeneration 20.84 9.83 166 337866 14222 50252870
Respiratory failure 20.83 9.83 457 337575 90724 50176368
Gestational diabetes 20.77 9.83 12 338020 7453 50259639
Extrapyramidal disorder 20.70 9.83 29 338003 11741 50255351
Disease recurrence 20.63 9.83 67 337965 20014 50247078
Hypothermia 20.44 9.83 144 337888 11872 50255220
Complication associated with device 20.36 9.83 42 337990 14613 50252479
Syncope 20.29 9.83 528 337504 102474 50164618
Polyneuropathy 20.25 9.83 31 338001 12100 50254992
Ductus arteriosus premature closure 20.11 9.83 17 338015 309 50266783
Epilepsy 20.11 9.83 75 337957 21492 50245600
Infusion site urticaria 20.06 9.83 29 338003 980 50266112
Aphasia 20.03 9.83 110 337922 28384 50238708
Drug screen positive 20.02 9.83 59 337973 3343 50263749
Body height decreased 19.98 9.83 18 338014 8890 50258202
Haemorrhage 19.77 9.83 245 337787 53196 50213896
C-reactive protein abnormal 19.74 9.83 107 337925 27702 50239390
Angioedema 19.67 9.83 159 337873 37517 50229575
Precancerous cells present 19.59 9.83 32 338000 1205 50265887
Iron deficiency anaemia 19.59 9.83 53 337979 16781 50250311
Laboratory test abnormal 19.56 9.83 84 337948 23124 50243968
Respiratory tract congestion 19.47 9.83 41 337991 14158 50252934
Panniculitis 19.29 9.83 17 338015 8486 50258606
Osteonecrosis 19.28 9.83 81 337951 22436 50244656
Palpitations 19.27 9.83 482 337550 94024 50173068
Neurotoxicity 19.02 9.83 44 337988 14696 50252396
Cardiomyopathy 18.95 9.83 48 337984 15538 50251554
Skin necrosis 18.89 9.83 27 338005 10840 50256252
Fluid retention 18.82 9.83 232 337800 50417 50216675
Pulmonary arterial hypertension 18.73 9.83 71 337961 20248 50246844
Spinal stenosis 18.68 9.83 39 337993 13511 50253581
Cardiac disorder 18.68 9.83 190 337842 42789 50224303
Hypocalcaemia 18.59 9.83 104 337928 26712 50240380
Anxiety 18.58 9.83 983 337049 176623 50090469
PCO2 decreased 18.57 9.83 31 338001 1189 50265903
Blood urine present 18.55 9.83 148 337884 12685 50254407
Right ventricular failure 18.52 9.83 50 337982 15843 50251249
Loss of consciousness 18.47 9.83 543 337489 103810 50163282
Taste disorder 18.46 9.83 17 338015 8307 50258785
Dyspnoea 18.30 9.83 3300 334732 544308 49722784
Blood glucose increased 18.21 9.83 351 337681 70973 50196119
Intentional self-injury 18.07 9.83 86 337946 23026 50244066
Osteoarthritis 18.02 9.83 336 337696 68270 50198822
Inappropriate antidiuretic hormone secretion 17.98 9.83 38 337994 13105 50253987
Febrile bone marrow aplasia 17.77 9.83 10 338022 6301 50260791
Transplant rejection 17.58 9.83 23 338009 9586 50257506
Smear cervix abnormal 17.55 9.83 49 337983 2692 50264400
Temperature regulation disorder 17.44 9.83 65 337967 4162 50262930
Haemolysis 17.39 9.83 83 337949 5933 50261159
Product adhesion issue 17.37 9.83 4 338028 4388 50262704
Hallucination, auditory 17.35 9.83 28 338004 10700 50256392
Lactic acidosis 17.30 9.83 141 337891 33214 50233878
Osmolar gap 17.27 9.83 10 338022 95 50266997
Withdrawal syndrome 17.18 9.83 60 337972 17530 50249562
COVID-19 immunisation 17.16 9.83 23 338009 723 50266369
Infusion site irritation 17.10 9.83 21 338011 604 50266488
Lung neoplasm malignant 17.09 9.83 50 337982 15434 50251658
Bacterial test 17.08 9.83 29 338003 1128 50265964
Abdominal distension 17.05 9.83 364 337668 72539 50194553
Oral discomfort 17.05 9.83 17 338015 8000 50259092
Post procedural pulmonary embolism 17.00 9.83 14 338018 245 50266847
Injection site discolouration 16.99 9.83 13 338019 6961 50260131
Bursitis 16.92 9.83 224 337808 21911 50245181
Blood creatinine decreased 16.89 9.83 72 337960 4904 50262188
Mean cell haemoglobin concentration increased 16.64 9.83 18 338014 450 50266642
Tinnitus 16.45 9.83 115 337917 28017 50239075
Thrombosis 16.41 9.83 268 337764 55565 50211527
Chronic kidney disease 16.40 9.83 178 337854 39593 50227499
Anaphylactic shock 16.35 9.83 74 337958 20081 50247011
Meniscus injury 16.34 9.83 11 338021 6291 50260801
Pericardial effusion 16.28 9.83 102 337930 25487 50241605
Swollen tongue 16.27 9.83 118 337914 28512 50238580
Renal papillary necrosis 16.25 9.83 13 338019 218 50266874
Pain in jaw 16.24 9.83 171 337861 38257 50228835
Hyperglycaemia 16.21 9.83 160 337872 36245 50230847
Sensitivity to weather change 16.20 9.83 10 338022 5991 50261101
Chest pain 16.14 9.83 992 337040 175890 50091202
Complication of device removal 16.06 9.83 4 338028 4160 50262932
Acute myocardial infarction 15.99 9.83 122 337910 29151 50237941
Bradypnoea 15.93 9.83 51 337981 3023 50264069
Heavy menstrual bleeding 15.85 9.83 52 337980 15485 50251607
Gout 15.82 9.83 33 337999 11437 50255655
Akathisia 15.79 9.83 19 338013 8210 50258882
Skin exfoliation 15.70 9.83 146 337886 33466 50233626
Infusion site discomfort 15.68 9.83 24 338008 854 50266238
Rhinitis allergic 15.62 9.83 15 338017 7185 50259907
Haemophagocytic lymphohistiocytosis 15.46 9.83 21 338011 8612 50258480
Hepatitis cholestatic 15.29 9.83 81 337951 6036 50261056
Asthma 15.28 9.83 467 337565 88870 50178222
Band neutrophil count increased 15.18 9.83 15 338017 336 50266756
Electrolyte imbalance 15.18 9.83 61 337971 17108 50249984
Immune reconstitution inflammatory syndrome 15.16 9.83 9 338023 5507 50261585
Pre-existing condition improved 15.15 9.83 15 338017 7082 50260010
Cerebral haemorrhage 15.13 9.83 112 337920 26940 50240152
Macular oedema 15.12 9.83 3 338029 3651 50263441
Hepatic encephalopathy 14.97 9.83 113 337919 9523 50257569
Metastases to lung 14.96 9.83 32 338000 10988 50256104
Acute graft versus host disease 14.89 9.83 4 338028 3954 50263138
Weight decreased 14.82 9.83 1274 336758 219971 50047121
Cholecystitis chronic 14.80 9.83 113 337919 9556 50257536
Schizoaffective disorder 14.68 9.83 40 337992 2166 50264926
Therapeutic response shortened 14.65 9.83 92 337940 7297 50259795
Schizophrenia 14.60 9.83 92 337940 7305 50259787
Ventricular arrhythmia 14.59 9.83 52 337980 3257 50263835
Transfusion-related acute lung injury 14.59 9.83 9 338023 97 50266995
Skin ulcer 14.59 9.83 158 337874 35160 50231932
Thinking abnormal 14.53 9.83 26 338006 9541 50257551
Angina unstable 14.51 9.83 14 338018 6692 50260400
Post transplant lymphoproliferative disorder 14.45 9.83 5 338027 4199 50262893
Hypomagnesaemia 14.37 9.83 93 337939 23063 50244029
Hypothyroidism 14.36 9.83 152 337880 33973 50233119
Haemoglobin urine present 14.35 9.83 22 338010 784 50266308
Speech disorder 14.30 9.83 160 337872 35388 50231704
Glycosylated haemoglobin increased 14.23 9.83 31 338001 10575 50256517
Ascites 14.19 9.83 162 337870 35699 50231393
Coma hepatic 14.18 9.83 19 338013 597 50266495
Eye pruritus 14.18 9.83 40 337992 12494 50254598
Culture urine positive 14.18 9.83 53 337979 3398 50263694
Neutrophil count decreased 14.17 9.83 219 337813 45807 50221285
Fear of injection 14.09 9.83 12 338020 6091 50261001
Administration site pruritus 14.08 9.83 13 338019 267 50266825
Parosmia 14.05 9.83 6 338026 4430 50262662
Toxicologic test abnormal 14.01 9.83 19 338013 604 50266488
Vitamin D deficiency 13.95 9.83 35 337997 11367 50255725
Shoulder arthroplasty 13.92 9.83 3 338029 3445 50263647
Cells in urine 13.87 9.83 11 338021 182 50266910
Transplant dysfunction 13.81 9.83 7 338025 4677 50262415
Nail bed inflammation 13.80 9.83 15 338017 377 50266715
Oedema 13.75 9.83 360 337672 69821 50197271
Labelled drug-drug interaction medication error 13.74 9.83 31 338001 10446 50256646
Flatulence 13.74 9.83 128 337904 29330 50237762
Cardiotoxicity 13.72 9.83 16 338016 7011 50260081
Premature delivery 13.71 9.83 97 337935 23566 50243526
Derailment 13.65 9.83 7 338025 51 50267041
Treatment noncompliance 13.64 9.83 132 337900 30018 50237074
Device breakage 13.57 9.83 27 338005 9520 50257572
Galactorrhoea 13.56 9.83 4 338028 3719 50263373
Lip swelling 13.56 9.83 103 337929 24633 50242459
Loss of personal independence in daily activities 13.55 9.83 360 337672 69690 50197402
Product physical issue 13.50 9.83 6 338026 4326 50262766
Pneumonia viral 13.49 9.83 85 337947 6749 50260343
Unresponsive to stimuli 13.46 9.83 283 337749 30326 50236766
Blood lactic acid increased 13.31 9.83 73 337959 5512 50261580
Administration site extravasation 13.29 9.83 20 338012 701 50266391
Ejection fraction decreased 13.29 9.83 71 337961 18449 50248643
Thrombotic microangiopathy 13.25 9.83 24 338008 8767 50258325
Invasive ductal breast carcinoma 13.24 9.83 12 338020 5909 50261183
Balance disorder 13.13 9.83 587 337445 70003 50197089
Blood bilirubin increased 13.07 9.83 293 337739 31745 50235347
Gastrointestinal pain 13.05 9.83 21 338011 8035 50259057
Asphyxia 12.98 9.83 71 337961 5356 50261736
Sputum culture positive 12.98 9.83 29 338003 1385 50265707
Caesarean section 12.94 9.83 57 337975 15582 50251510
Amenorrhoea 12.93 9.83 23 338009 8461 50258631
Abnormal dreams 12.92 9.83 27 338005 9350 50257742
Cardiac failure acute 12.91 9.83 22 338010 8228 50258864
Vitamin K deficiency 12.87 9.83 15 338017 408 50266684
Infusion site rash 12.86 9.83 28 338004 1314 50265778
Eating disorder 12.85 9.83 56 337976 15353 50251739
Ductus arteriosus stenosis foetal 12.84 9.83 10 338022 161 50266931
Eosinophil percentage increased 12.82 9.83 23 338009 935 50266157
Dysphagia 12.82 9.83 407 337625 77111 50189981
Swelling face 12.77 9.83 261 337771 52334 50214758
Tardive dyskinesia 12.74 9.83 18 338014 7261 50259831
Impaired quality of life 12.70 9.83 13 338019 6043 50261049
Blood uric acid decreased 12.69 9.83 19 338013 663 50266429
Mood swings 12.69 9.83 59 337973 15895 50251197
Metastases to lymph nodes 12.66 9.83 17 338015 7007 50260085
Alpha 1 microglobulin increased 12.60 9.83 7 338025 61 50267031
Epstein-Barr virus infection 12.55 9.83 17 338015 6980 50260112
Death 12.51 9.83 2410 335622 322969 49944123
Blindness 12.51 9.83 66 337966 17203 50249889
Coagulation factor X level decreased 12.50 9.83 7 338025 62 50267030
Infective pulmonary exacerbation of cystic fibrosis 12.46 9.83 21 338011 7888 50259204
Encephalopathy 12.43 9.83 304 337728 33407 50233685
Intestinal haemorrhage 12.37 9.83 3 338029 3177 50263915
Antidepressant drug level above therapeutic 12.35 9.83 14 338018 369 50266723
Sleep apnoea syndrome 12.33 9.83 101 337931 23767 50243325
Administration site bruise 12.21 9.83 12 338020 267 50266825
Product preparation error 12.21 9.83 7 338025 4365 50262727
Injury 12.19 9.83 420 337612 48505 50218587
Atypical femur fracture 12.19 9.83 9 338023 4907 50262185
Hemiplegia 12.19 9.83 19 338013 7362 50259730
Traumatic liver injury 12.18 9.83 12 338020 268 50266824
Pregnancy with contraceptive device 12.17 9.83 6 338026 4073 50263019
Therapy non-responder 12.15 9.83 254 337778 50768 50216324
Drug withdrawal syndrome 12.12 9.83 108 337924 24973 50242119
Uterine perforation 12.11 9.83 15 338017 6400 50260692
Anoxia 12.07 9.83 11 338021 222 50266870
Rheumatoid nodule 12.06 9.83 44 337988 12691 50254401
Low density lipoprotein increased 11.97 9.83 12 338020 5634 50261458
Coagulation factor VII level decreased 11.88 9.83 7 338025 69 50267023
Urine analysis abnormal 11.85 9.83 59 337973 4291 50262801
Hallucination 11.79 9.83 230 337802 46427 50220665
Renal disorder 11.78 9.83 122 337910 27383 50239709
Intermenstrual bleeding 11.78 9.83 17 338015 6797 50260295
Vertigo 11.77 9.83 260 337772 51572 50215520
Pleural effusion 11.77 9.83 435 337597 81019 50186073
Low turnover osteopathy 11.73 9.83 6 338026 3988 50263104
Pulmonary mass 11.67 9.83 75 337957 18630 50248462
Cardiogenic shock 11.65 9.83 59 337973 15540 50251552
Status epilepticus 11.62 9.83 48 337984 13358 50253734
Myelocyte count increased 11.55 9.83 13 338019 340 50266752
Complication of device insertion 11.53 9.83 14 338018 6027 50261065
Asthenia 11.53 9.83 1914 336118 317128 49949964
Urine ketone body present 11.46 9.83 38 337994 2295 50264797
Base excess 11.38 9.83 7 338025 75 50267017
Nightmare 11.36 9.83 62 337970 16024 50251068
Metastases to central nervous system 11.35 9.83 38 337994 11244 50255848
Skin toxicity 11.31 9.83 6 338026 3907 50263185
Eczema 11.31 9.83 97 337935 22605 50244487
Priapism 11.23 9.83 7 338025 77 50267015
Therapy change 11.20 9.83 11 338021 5214 50261878
Continuous haemodiafiltration 11.18 9.83 22 338010 960 50266132
Skin burning sensation 11.16 9.83 33 337999 10152 50256940
Diaphragmatic rupture 11.08 9.83 11 338021 248 50266844
Hepatitis acute 11.07 9.83 91 337941 7870 50259222
Delusion 11.04 9.83 35 337997 10534 50256558
Hypoaesthesia 11.03 9.83 717 337315 126540 50140552
Monocyte count increased 11.00 9.83 69 337963 5470 50261622
Diffuse large B-cell lymphoma 10.94 9.83 13 338019 5649 50261443
Type 2 diabetes mellitus 10.93 9.83 304 337728 34071 50233021
Gastroenteritis 10.93 9.83 101 337931 23180 50243912
Erysipelas 10.92 9.83 17 338015 6591 50260501
Flushing 10.92 9.83 550 337482 66465 50200627
Endophthalmitis 10.87 9.83 3 338029 2913 50264179
Medication overuse headache 10.84 9.83 17 338015 618 50266474
Uterine cancer 10.83 9.83 6 338026 3814 50263278
Device leakage 10.83 9.83 14 338018 5864 50261228
Administration site reaction 10.80 9.83 10 338022 206 50266886
Gait inability 10.79 9.83 178 337854 36849 50230243
Application site pain 10.72 9.83 6 338026 3792 50263300
Acute myeloid leukaemia 10.70 9.83 58 337974 15016 50252076
Cardiovascular disorder 10.66 9.83 35 337997 10419 50256673
Device deployment issue 10.65 9.83 5 338027 3491 50263601
Band neutrophil percentage increased 10.61 9.83 10 338022 211 50266881
Chronic graft versus host disease 10.59 9.83 3 338029 2864 50264228
Dyskinesia 10.58 9.83 127 337905 27734 50239358
Intervertebral disc degeneration 10.58 9.83 50 337982 13411 50253681
Mental impairment 10.52 9.83 43 337989 12001 50255091
Autonomic dysreflexia 10.51 9.83 12 338020 319 50266773
Skin infection 10.51 9.83 127 337905 12164 50254928
Accident at home 10.49 9.83 9 338023 167 50266925
Vaginal haemorrhage 10.48 9.83 109 337923 24442 50242650
Skin lesion 10.47 9.83 121 337911 26606 50240486
Drug abuser 10.45 9.83 42 337990 2786 50264306
Ischaemic stroke 10.44 9.83 63 337969 15885 50251207
Ocular hyperaemia 10.42 9.83 86 337946 20206 50246886
Drug eruption 10.40 9.83 104 337928 23502 50243590
Metastases to peritoneum 10.40 9.83 3 338029 2830 50264262
Vital capacity decreased 10.39 9.83 21 338011 935 50266157
Hunger 10.32 9.83 8 338024 4255 50262837
Congestive cardiomyopathy 10.31 9.83 13 338019 5505 50261587
Urinary casts 10.30 9.83 17 338015 646 50266446
Dysphoria 10.29 9.83 10 338022 4764 50262328
Dyslipidaemia 10.29 9.83 15 338017 5973 50261119
Deafness 10.26 9.83 62 337970 15629 50251463
Abdominal pain upper 10.25 9.83 1215 336817 158094 50108998
Eructation 10.24 9.83 20 338012 7101 50259991
Eye haemorrhage 10.21 9.83 21 338011 7314 50259778
Mean cell haemoglobin concentration decreased 10.20 9.83 42 337990 2817 50264275
Large intestine polyp 10.19 9.83 21 338011 7311 50259781
Frequent bowel movements 10.19 9.83 53 337979 13865 50253227
Obstructive airways disorder 10.16 9.83 62 337970 15590 50251502
Left ventricular dysfunction 10.15 9.83 36 337996 10470 50256622
Pharyngeal paraesthesia 10.14 9.83 27 338005 1442 50265650
Corneal reflex decreased 10.11 9.83 8 338024 132 50266960
Head injury 10.10 9.83 107 337925 23913 50243179
Aplasia pure red cell 10.09 9.83 8 338024 4207 50262885
Drug use disorder 10.08 9.83 44 337988 3028 50264064
Drug tolerance 10.08 9.83 11 338021 4965 50262127
Device related thrombosis 10.03 9.83 25 338007 1282 50265810
Accidental death 10.03 9.83 30 338002 1714 50265378
Urine oxalate increased 10.02 9.83 10 338022 227 50266865
Infusion site reaction 10.01 9.83 35 337997 2171 50264921
Congestive hepatopathy 10.00 9.83 38 337994 2456 50264636
Plasma cell myeloma 9.99 9.83 148 337884 31174 50235918
Femoral neck fracture 9.96 9.83 22 338010 7468 50259624
Brain stem glioma 9.96 9.83 8 338024 135 50266957
Impaired work ability 9.95 9.83 52 337980 13588 50253504
Peripheral sensory neuropathy 9.93 9.83 18 338014 6573 50260519
Hip fracture 9.93 9.83 118 337914 25813 50241279
Deep vein thrombosis postoperative 9.92 9.83 29 338003 1636 50265456
Irritability 9.89 9.83 132 337900 28294 50238798
Excessive skin 9.86 9.83 8 338024 137 50266955
Adverse drug reaction 9.85 9.83 287 337745 54935 50212157

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
Completed suicide 1284.93 9.87 1833 136797 88413 29347484
Toxicity to various agents 1115.92 9.87 2488 136142 171173 29264724
Infusion related reaction 437.40 9.87 758 137872 43128 29392769
Overdose 374.60 9.87 1016 137614 78803 29357094
Blood pressure fluctuation 345.70 9.87 446 138184 19448 29416449
Exposure to toxic agent 291.82 9.87 170 138460 2405 29433492
Acute hepatic failure 269.78 9.87 306 138324 11646 29424251
Intentional product misuse 259.62 9.87 530 138100 34131 29401766
Drug ineffective 197.93 9.87 954 137676 362216 29073681
Intentional overdose 182.03 9.87 492 138138 38036 29397861
Heart rate decreased 150.06 9.87 349 138281 24563 29411334
Blood pressure increased 119.19 9.87 670 137960 73133 29362764
Metabolic acidosis 119.04 9.87 418 138212 37244 29398653
Product dose omission issue 95.74 9.87 192 138438 96191 29339706
Oxygen saturation decreased 92.74 9.87 437 138193 44500 29391397
Cardio-respiratory arrest 92.26 9.87 475 138155 50126 29385771
Hepatic cytolysis 92.09 9.87 151 138479 8196 29427701
Respiratory arrest 89.77 9.87 296 138334 25537 29410360
Hepatotoxicity 86.18 9.87 230 138400 17637 29418260
Anion gap 84.48 9.87 49 138581 687 29435210
Coagulopathy 82.85 9.87 227 138403 17680 29418217
Diarrhoea 77.38 9.87 1097 137533 331601 29104296
Myocardial infarction 76.48 9.87 263 138367 110033 29325864
Accidental overdose 72.60 9.87 214 138416 17379 29418518
Substance abuse 71.15 9.87 120 138510 6667 29429230
Cardiac failure congestive 66.64 9.87 164 138466 76417 29359480
Hepatic necrosis 63.99 9.87 81 138549 3461 29432436
Intentional product use issue 62.81 9.87 377 138253 42121 29393776
Drug resistance 61.35 9.87 13 138617 21527 29414370
Sinusitis 60.20 9.87 319 138311 34031 29401866
Heart rate irregular 59.40 9.87 165 138465 12952 29422945
Respiratory depression 59.17 9.87 168 138462 13355 29422542
Neonatal hypoxia 59.11 9.87 31 138599 352 29435545
Suspected suicide 57.44 9.87 82 138548 3938 29431959
Hypotension 56.53 9.87 1249 137381 193105 29242792
Blood pressure diastolic abnormal 55.33 9.87 64 138566 2487 29433410
Alanine aminotransferase increased 54.97 9.87 541 138089 70403 29365494
Chills 54.90 9.87 543 138087 70757 29365140
Blood pressure systolic increased 54.09 9.87 188 138442 16657 29419240
Liver injury 53.93 9.87 156 138474 12534 29423363
Treatment failure 52.87 9.87 57 138573 36882 29399015
Medication error 49.52 9.87 214 138416 20997 29414900
Poisoning 45.54 9.87 126 138504 9867 29426030
Aspartate aminotransferase increased 44.59 9.87 452 138178 59273 29376624
Heart rate increased 43.39 9.87 322 138308 38616 29397281
Infusion site extravasation 42.08 9.87 62 138568 3065 29432832
Analgesic drug level increased 41.83 9.87 29 138601 563 29435334
Blood pressure diastolic increased 39.74 9.87 66 138564 3620 29432277
Cardiac failure 39.62 9.87 214 138416 79073 29356824
Exposure via ingestion 37.81 9.87 47 138583 1971 29433926
Toxic epidermal necrolysis 37.76 9.87 177 138453 17976 29417921
Drug abuse 37.57 9.87 554 138076 79329 29356568
Body temperature decreased 36.86 9.87 122 138508 10542 29425355
Blood pressure systolic abnormal 36.81 9.87 48 138582 2113 29433784
Neuropathy peripheral 36.44 9.87 190 138440 70837 29365060
Pyroglutamic acidosis 35.86 9.87 20 138610 259 29435638
Blood pressure diastolic decreased 35.49 9.87 92 138538 6930 29428967
Infusion site pain 35.12 9.87 55 138575 2870 29433027
Cardiac arrest 35.08 9.87 580 138050 85011 29350886
Depressed level of consciousness 34.84 9.87 294 138336 36648 29399249
Therapeutic response shortened 34.35 9.87 72 138558 4719 29431178
Therapeutic product effect incomplete 34.30 9.87 84 138546 39221 29396676
Cytokine release syndrome 34.26 9.87 137 138493 12982 29422915
Psoriasis 33.88 9.87 62 138568 32165 29403732
Renal cortical necrosis 32.61 9.87 16 138614 156 29435741
Stevens-Johnson syndrome 32.25 9.87 158 138472 16339 29419558
Contraindicated product administered 31.11 9.87 24 138606 18242 29417655
Neutrophil percentage increased 31.02 9.87 40 138590 1741 29434156
Appendicolith 30.63 9.87 57 138573 3423 29432474
Rheumatoid arthritis 30.38 9.87 256 138374 31896 29404001
Suicide attempt 30.35 9.87 268 138362 33842 29402055
Coronary artery disease 30.16 9.87 106 138524 44084 29391813
Product use in unapproved indication 29.75 9.87 262 138368 86613 29349284
Infusion site swelling 29.49 9.87 40 138590 1830 29434067
International normalised ratio increased 29.00 9.87 327 138303 44045 29391852
Injection site pain 28.58 9.87 69 138561 32377 29403520
Pyrexia 28.45 9.87 1633 136997 285989 29149908
Sopor 28.40 9.87 8 138622 10926 29424971
Anaemia 28.40 9.87 721 137909 200230 29235667
Blood pH decreased 28.28 9.87 42 138588 2091 29433806
Hepatic failure 28.25 9.87 248 138382 31264 29404633
Tachycardia 27.96 9.87 486 138144 71924 29363973
Aplastic anaemia 27.84 9.87 88 138542 7422 29428475
Product prescribing error 27.70 9.87 26 138604 17950 29417947
Unresponsive to stimuli 27.54 9.87 207 138423 24919 29410978
Body temperature increased 27.18 9.87 137 138493 14328 29421569
Myocardial fibrosis 26.95 9.87 29 138601 1039 29434858
Wrong technique in product usage process 26.77 9.87 68 138562 31360 29404537
Dizziness 26.68 9.87 681 137949 189003 29246894
Memory impairment 26.59 9.87 85 138545 36385 29399512
Methaemoglobinaemia 26.38 9.87 46 138584 2625 29433272
Hospitalisation 25.90 9.87 119 138511 45869 29390028
Disease progression 25.49 9.87 253 138377 81663 29354234
Asthenia 25.38 9.87 792 137838 214458 29221439
Abdominal pain 25.19 9.87 821 137809 134536 29301361
Pulmonary oedema 24.86 9.87 308 138322 42427 29393470
Depression 24.85 9.87 267 138363 84880 29351017
Body temperature fluctuation 24.38 9.87 32 138598 1418 29434479
Lymphocyte percentage decreased 24.32 9.87 38 138592 1979 29433918
Urticaria 24.11 9.87 375 138255 54285 29381612
Urine sodium decreased 23.81 9.87 13 138617 161 29435736
Fatigue 23.71 9.87 1229 137401 315592 29120305
Bone marrow failure 23.68 9.87 59 138571 27390 29408507
Respiratory rate increased 22.78 9.87 91 138539 8617 29427280
Malignant neoplasm progression 22.61 9.87 229 138401 73630 29362267
Glycosylated haemoglobin increased 22.52 9.87 8 138622 9418 29426479
Prothrombin time prolonged 22.08 9.87 91 138539 8741 29427156
Poor venous access 22.08 9.87 47 138583 3114 29432783
Interstitial lung disease 22.06 9.87 169 138461 57549 29378348
Febrile neutropenia 21.98 9.87 685 137945 111555 29324342
Acute lung injury 21.76 9.87 29 138601 1304 29434593
Coma 21.53 9.87 281 138349 39169 29396728
Progressive multifocal leukoencephalopathy 21.52 9.87 7 138623 8712 29427185
Diabetes mellitus 21.30 9.87 105 138525 39726 29396171
Ear infection 20.68 9.87 84 138546 8016 29427881
Ductus arteriosus premature closure 20.50 9.87 13 138617 216 29435681
Infusion site pruritus 20.40 9.87 18 138612 503 29435394
Inappropriate schedule of product administration 20.33 9.87 307 138323 44165 29391732
Cerebral artery thrombosis 20.24 9.87 21 138609 721 29435176
Visual acuity reduced 20.14 9.87 24 138606 14852 29421045
Granulomatosis with polyangiitis 20.10 9.87 23 138607 883 29435014
Feeling abnormal 20.07 9.87 161 138469 54284 29381613
Drug interaction 19.60 9.87 742 137888 196643 29239254
Brain scan abnormal 19.58 9.87 22 138608 828 29435069
Renal impairment 19.55 9.87 266 138364 81067 29354830
Balance disorder 19.54 9.87 95 138535 36075 29399822
Full blood count abnormal 19.51 9.87 25 138605 14988 29420909
Cerebrovascular accident 19.41 9.87 249 138381 76662 29359235
Haemolysis 19.26 9.87 74 138556 6882 29429015
Cerebral haemorrhage 19.10 9.87 79 138551 31347 29404550
Brain death 18.63 9.87 37 138593 2333 29433564
Dyspnoea 18.49 9.87 1301 137329 325431 29110466
Throat tightness 18.47 9.87 74 138556 7017 29428880
Transaminases increased 18.11 9.87 174 138456 22488 29413409
Oxygen saturation abnormal 18.05 9.87 25 138605 1167 29434730
Osteonecrosis of jaw 18.04 9.87 31 138599 16479 29419418
Immune reconstitution inflammatory syndrome 18.00 9.87 7 138623 7795 29428102
Chronic gastrointestinal bleeding 17.92 9.87 13 138617 272 29435625
Cerebral infarction 17.64 9.87 58 138572 24617 29411280
Anion gap abnormal 17.44 9.87 10 138620 137 29435760
Graft versus host disease 17.24 9.87 12 138618 9616 29426281
Haematotoxicity 17.22 9.87 5 138625 6694 29429203
Infusion site rash 17.17 9.87 14 138616 350 29435547
Drug ineffective for unapproved indication 17.13 9.87 25 138605 14189 29421708
Blood triglycerides increased 17.06 9.87 21 138609 12813 29423084
Pemphigus 16.95 9.87 24 138606 1144 29434753
Acidosis 16.90 9.87 90 138540 9615 29426282
Pulmonary congestion 16.90 9.87 108 138522 12328 29423569
Flushing 16.88 9.87 209 138421 28783 29407114
Nasopharyngitis 16.82 9.87 382 138248 59283 29376614
Renal papillary necrosis 16.60 9.87 10 138620 151 29435746
Psoriatic arthropathy 16.59 9.87 27 138603 14664 29421233
Fluid retention 16.42 9.87 56 138574 23504 29412393
Decreased appetite 16.33 9.87 538 138092 144804 29291093
Oedema peripheral 15.84 9.87 367 138263 103190 29332707
Inadequate analgesia 15.77 9.87 37 138593 2617 29433280
Urethral valves 15.76 9.87 12 138618 271 29435626
Lung neoplasm malignant 15.65 9.87 27 138603 14330 29421567
Dependent personality disorder 15.40 9.87 8 138622 89 29435808
Accidental death 15.38 9.87 32 138598 2086 29433811
Myopathy 15.35 9.87 16 138614 10517 29425380
Angina pectoris 15.13 9.87 73 138557 27777 29408120
Administration site pain 15.12 9.87 10 138620 179 29435718
Therapeutic response decreased 15.09 9.87 62 138568 24649 29411248
Appendicitis 15.01 9.87 81 138549 8698 29427199
Foetal exposure during pregnancy 14.99 9.87 95 138535 33772 29402125
Visual impairment 14.93 9.87 80 138550 29628 29406269
Mucosal inflammation 14.83 9.87 87 138543 31508 29404389
Mental status changes 14.78 9.87 238 138392 34689 29401208
Venoocclusive liver disease 14.70 9.87 7 138623 6910 29428987
Pallor 14.68 9.87 157 138473 20867 29415030
Leukopenia 14.57 9.87 177 138453 55026 29380871
Acute myocardial infarction 14.48 9.87 151 138479 48287 29387610
Asthma 14.45 9.87 96 138534 33753 29402144
Infusion site erythema 14.33 9.87 27 138603 1637 29434260
Bilirubin urine present 14.32 9.87 9 138621 147 29435750
Post transplant lymphoproliferative disorder 14.30 9.87 4 138626 5489 29430408
Cardiac disorder 14.29 9.87 109 138521 37154 29398743
Failure to suspend medication 14.27 9.87 13 138617 379 29435518
Environmental exposure 14.16 9.87 11 138619 256 29435641
Labelled drug-drug interaction medication error 14.06 9.87 22 138608 12137 29423760
No adverse event 13.99 9.87 39 138591 17439 29418458
Administration site erythema 13.95 9.87 7 138623 72 29435825
Therapeutic product effect decreased 13.88 9.87 81 138549 29370 29406527
Product quality issue 13.84 9.87 34 138596 15861 29420036
Maternal exposure before pregnancy 13.75 9.87 14 138616 470 29435427
Throat irritation 13.65 9.87 79 138551 8706 29427191
Loss of personal independence in daily activities 13.63 9.87 67 138563 25373 29410524
Monocyte percentage increased 13.60 9.87 19 138611 894 29435003
Brain oedema 13.57 9.87 101 138529 12119 29423778
Pathogen resistance 13.40 9.87 11 138619 8105 29427792
Anti-erythrocyte antibody positive 13.36 9.87 6 138624 47 29435850
Myelosuppression 13.32 9.87 23 138607 12204 29423693
Cardiac failure chronic 13.06 9.87 7 138623 6460 29429437
Infusion site nodule 13.01 9.87 7 138623 84 29435813
Injection site swelling 12.96 9.87 15 138615 9402 29426495
Tendonitis 12.88 9.87 11 138619 7950 29427947
Prescribed overdose 12.87 9.87 13 138617 8670 29427227
Anion gap increased 12.82 9.87 25 138605 1555 29434342
Hyperlipidaemia 12.55 9.87 25 138605 12565 29423332
Cytomegalovirus infection 12.52 9.87 61 138569 23154 29412743
Prostatic specific antigen increased 12.48 9.87 25 138605 12539 29423358
COVID-19 immunisation 12.46 9.87 8 138622 136 29435761
Infusion site bruising 12.43 9.87 12 138618 377 29435520
Acid-base balance disorder mixed 12.36 9.87 6 138624 57 29435840
Drug level below therapeutic 12.29 9.87 46 138584 4225 29431672
Infusion site haemorrhage 12.28 9.87 16 138614 704 29435193
Endocardial fibrosis 12.25 9.87 5 138625 30 29435867
Pyroglutamate increased 12.10 9.87 10 138620 255 29435642
Peripheral swelling 12.09 9.87 218 138412 63521 29372376
Bladder cancer 12.02 9.87 18 138612 10109 29425788
Injection site haemorrhage 11.93 9.87 13 138617 8373 29427524
C-reactive protein abnormal 11.90 9.87 8 138622 6528 29429369
Parkinsonism 11.85 9.87 10 138620 7268 29428629
Urine abnormality 11.61 9.87 25 138605 1669 29434228
Apnoea 11.61 9.87 58 138572 6044 29429853
Hepatitis fulminant 11.59 9.87 40 138590 3531 29432366
Sleep disorder 11.53 9.87 67 138563 24319 29411578
Bacterial test 11.51 9.87 8 138622 156 29435741
Gait disturbance 11.47 9.87 259 138371 73090 29362807
Crystal urine present 11.45 9.87 12 138618 417 29435480
Adrenergic syndrome 11.37 9.87 6 138624 69 29435828
Liver transplant 11.35 9.87 30 138600 2286 29433611
Diabetic ketoacidosis 11.34 9.87 38 138592 16035 29419862
Vital functions abnormal 11.33 9.87 8 138622 160 29435737
Myalgia 11.12 9.87 263 138367 73756 29362141
Prostate cancer 11.09 9.87 72 138558 25455 29410442
Urobilinogen urine increased 11.01 9.87 11 138619 361 29435536
Osteonecrosis 10.94 9.87 30 138600 13489 29422408
Bronchial dysplasia 10.93 9.87 5 138625 41 29435856
Protein urine 10.93 9.87 16 138614 786 29435111
Chronic obstructive pulmonary disease 10.93 9.87 131 138499 40824 29395073
Crohn's disease 10.92 9.87 35 138595 2974 29432923
Areflexia 10.88 9.87 33 138597 2721 29433176
Tooth infection 10.79 9.87 53 138577 5486 29430411
General physical health deterioration 10.78 9.87 384 138246 102473 29333424
Pharyngeal paraesthesia 10.76 9.87 12 138618 448 29435449
Ultrasound liver abnormal 10.75 9.87 7 138623 122 29435775
Sexual dysfunction 10.74 9.87 7 138623 5807 29430090
Vessel puncture site bruise 10.73 9.87 5 138625 43 29435854
Injection site reaction 10.49 9.87 23 138607 11165 29424732
Ammonia increased 10.45 9.87 42 138588 3989 29431908
Hallucinations, mixed 10.42 9.87 30 138600 2403 29433494
Blood pressure decreased 10.38 9.87 283 138347 45194 29390703
Alopecia 10.38 9.87 50 138580 19034 29416863
Deep vein thrombosis 10.36 9.87 198 138432 57201 29378696
Hypoxia 10.30 9.87 293 138337 47086 29388811
Analgesic drug level above therapeutic 10.27 9.87 9 138621 249 29435648
Product substitution issue 10.22 9.87 17 138613 9155 29426742
Adverse event 10.22 9.87 37 138593 15254 29420643
Haematocrit decreased 10.20 9.87 192 138438 28830 29407067
Hypertriglyceridaemia 10.18 9.87 12 138618 7463 29428434
Drug screen positive 10.17 9.87 40 138590 3761 29432136
Hypoaesthesia 10.09 9.87 183 138447 53284 29382613
Fall 10.06 9.87 705 137925 176473 29259424
Specific gravity urine decreased 9.99 9.87 6 138624 90 29435807
Enterocolitis infectious 9.98 9.87 20 138610 1269 29434628
Intraocular pressure increased 9.94 9.87 5 138625 4784 29431113
Hepatocellular carcinoma 9.91 9.87 11 138619 7027 29428870

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 3931.74 9.93 5722 380953 218692 63893365
Toxicity to various agents 2962.98 9.93 6640 380035 356873 63755184
Infusion related reaction 1075.19 9.93 2764 383911 161703 63950354
Exposure to toxic agent 793.48 9.93 482 386193 5677 64106380
Overdose 754.93 9.93 2387 384288 157179 63954878
Acute hepatic failure 721.69 9.93 836 385839 25276 64086781
Intentional product misuse 691.51 9.93 1413 385262 70882 64041175
Blood pressure fluctuation 672.43 9.93 1155 385520 50716 64061341
Intentional overdose 395.49 9.93 1313 385362 88631 64023426
Metabolic acidosis 389.28 9.93 1119 385556 69839 64042218
Rheumatoid arthritis 362.52 9.93 1942 384733 162352 63949705
Product dose omission issue 322.96 9.93 416 386259 194331 63917726
Hepatotoxicity 305.57 9.93 714 385961 39248 64072809
Muscle injury 289.28 9.93 547 386128 25890 64086167
Heart rate decreased 283.42 9.93 849 385826 54218 64057839
Sinusitis 276.35 9.93 1656 385019 144272 63967785
Folliculitis 266.54 9.93 570 386105 29507 64082550
Anion gap 263.58 9.93 155 386520 1712 64110345
Duodenal ulcer perforation 260.75 9.93 615 386060 34010 64078047
Anti-cyclic citrullinated peptide antibody positive 260.63 9.93 770 385905 48792 64063265
Irritable bowel syndrome 255.00 9.93 639 386036 36730 64075327
Sleep disorder due to general medical condition, insomnia type 252.83 9.93 515 386160 25755 64086302
Helicobacter infection 245.22 9.93 640 386035 37722 64074335
Injection site pain 229.44 9.93 198 386477 111210 64000847
Hepatic enzyme increased 229.22 9.93 1448 385227 128495 63983562
Blood pressure increased 225.07 9.93 1787 384888 170765 63941292
Respiratory arrest 214.82 9.93 753 385922 52232 64059825
Hand deformity 212.70 9.93 842 385833 61929 64050128
Lower respiratory tract infection 212.33 9.93 1124 385551 93490 64018567
Cardio-respiratory arrest 210.71 9.93 1154 385521 97239 64014818
Diarrhoea 207.81 9.93 3068 383607 719636 63392421
Medication error 205.09 9.93 713 385962 49253 64062804
Pemphigus 199.08 9.93 806 385869 59895 64052162
Pericarditis 197.84 9.93 821 385854 61695 64050362
Coagulopathy 195.34 9.93 524 386151 31396 64080661
Intentional product use issue 188.68 9.93 1095 385580 94269 64017788
Depressed level of consciousness 178.99 9.93 962 385713 80474 64031583
Myocardial infarction 176.16 9.93 465 386210 165356 63946701
Hepatic cytolysis 175.65 9.93 308 386367 13741 64098316
Ill-defined disorder 173.37 9.93 620 386055 43432 64068625
Nasopharyngitis 171.03 9.93 1863 384812 194210 63917847
Hepatic necrosis 169.71 9.93 231 386444 8242 64103815
Wound 166.43 9.93 901 385774 75576 64036481
Glossodynia 165.81 9.93 798 385877 63898 64048159
Anaemia 164.36 9.93 1465 385210 377215 63734842
Oxygen saturation decreased 158.80 9.93 1144 385531 106032 64006025
Blood pressure diastolic abnormal 157.81 9.93 268 386407 11649 64100408
Blister 155.82 9.93 923 385752 80044 64032013
Discomfort 155.65 9.93 922 385753 79956 64032101
Cardiac failure congestive 150.53 9.93 351 386324 130229 63981828
Analgesic drug level increased 146.20 9.93 116 386559 2154 64109903
Injection site erythema 143.12 9.93 128 386547 70672 64041385
Systemic lupus erythematosus 142.49 9.93 874 385801 76738 64035319
Poisoning 140.82 9.93 366 386309 21513 64090544
Joint swelling 140.31 9.93 1937 384738 213445 63898612
Impaired healing 137.40 9.93 721 385954 59752 64052305
Body temperature increased 133.30 9.93 503 386172 36163 64075894
Liver injury 133.28 9.93 439 386236 29493 64082564
Respiratory depression 132.66 9.93 374 386301 23069 64088988
Drug resistance 132.23 9.93 25 386650 35077 64076980
Sedation complication 132.05 9.93 229 386446 10125 64101932
Synovitis 130.06 9.93 1028 385647 98062 64013995
Blood pressure diastolic decreased 126.41 9.93 356 386319 21945 64090112
Weight increased 125.94 9.93 1886 384789 211462 63900595
Sopor 125.76 9.93 15 386660 29646 64082411
Suspected suicide 124.49 9.93 202 386473 8452 64103605
Blood pressure systolic increased 123.12 9.93 605 386070 48848 64063209
Psoriasis 122.04 9.93 150 386525 71553 64040504
Blood pressure systolic abnormal 121.75 9.93 216 386459 9726 64102331
Drug interaction 119.53 9.93 1493 385182 360590 63751467
Cardiac failure 117.70 9.93 403 386272 131970 63980087
Wrong technique in product usage process 113.69 9.93 133 386542 64841 64047216
Drug ineffective 112.03 9.93 4019 382656 836228 63275829
Creatinine renal clearance decreased 110.57 9.93 258 386417 14163 64097894
Heart rate increased 110.53 9.93 988 385687 97687 64014370
Therapeutic product effect decreased 108.92 9.93 1114 385561 114237 63997820
Death 108.46 9.93 3718 382957 478987 63633070
Hepatic failure 108.18 9.93 634 386041 54760 64057297
Accidental overdose 104.81 9.93 439 386236 33118 64078939
Heart rate irregular 104.61 9.93 382 386293 27031 64085026
Blood calcium decreased 104.27 9.93 364 386311 25190 64086867
Substance abuse 102.55 9.93 193 386482 9099 64102958
Arthropathy 100.18 9.93 1138 385537 119829 63992228
Device expulsion 99.46 9.93 7 386668 21129 64090928
Exposure via ingestion 98.72 9.93 134 386541 4768 64107289
Throat irritation 97.57 9.93 422 386253 32289 64079768
Bone marrow failure 96.54 9.93 87 386588 47865 64064192
Injection site pruritus 95.32 9.93 54 386621 37772 64074285
Osteonecrosis of jaw 94.56 9.93 61 386614 39764 64072293
Acute lung injury 93.74 9.93 98 386577 2633 64109424
Injection site reaction 92.36 9.93 86 386589 46578 64065479
Neutropenia 91.53 9.93 956 385719 238668 63873389
Swelling 90.51 9.93 1406 385269 158812 63953245
Interstitial lung disease 89.28 9.93 294 386381 97438 64014619
Injection site swelling 85.70 9.93 73 386602 41280 64070777
Pyroglutamic acidosis 85.66 9.93 54 386621 682 64111375
Hypotension 85.60 9.93 2935 383740 378039 63734018
Disease progression 83.01 9.93 503 386172 141177 63970880
Product use in unapproved indication 81.95 9.93 671 386004 175947 63936110
Gastrointestinal disorder 80.25 9.93 857 385818 88852 64023205
Injection site bruising 76.87 9.93 63 386612 36310 64075747
Coma 75.59 9.93 831 385844 86784 64025273
Body temperature decreased 75.43 9.93 332 386343 25596 64086461
Cognitive disorder 74.18 9.93 575 386100 54512 64057545
Hospitalisation 73.80 9.93 219 386456 74988 64037069
Alanine aminotransferase increased 73.21 9.93 1206 385469 137825 63974232
Product prescribing error 72.19 9.93 63 386612 35206 64076851
Malignant neoplasm progression 70.23 9.93 393 386282 112478 63999579
Renal impairment 70.15 9.93 497 386178 134520 63977537
Neuropathy peripheral 70.02 9.93 415 386260 117110 63994947
Decreased appetite 69.77 9.93 1226 385449 280063 63831994
Pancytopenia 68.99 9.93 539 386136 142770 63969287
Therapeutic product effect incomplete 68.43 9.93 353 386322 103129 64008928
Blood pressure diastolic increased 68.30 9.93 179 386496 10573 64101484
Coronary artery disease 66.79 9.93 166 386509 60267 64051790
Pneumonia 66.68 9.93 2711 383964 556865 63555192
Ear pain 65.06 9.93 311 386364 24825 64087232
Hypersensitivity 63.38 9.93 1584 385091 194868 63917189
Mucosal inflammation 63.04 9.93 180 386495 62404 64049653
Therapy cessation 62.98 9.93 61 386614 32428 64079629
Neutrophil percentage increased 62.91 9.93 103 386572 4342 64107715
Pyroglutamate increased 61.87 9.93 42 386633 606 64111451
Cerebrovascular accident 61.86 9.93 527 386148 137056 63975001
Dyspnoea 61.13 9.93 3607 383068 715067 63396990
Acute kidney injury 60.19 9.93 2146 384529 447094 63664963
Sedation 59.31 9.93 439 386236 41023 64071034
Contraindicated product administered 59.24 9.93 942 385733 106887 64005170
Respiratory rate increased 58.95 9.93 242 386433 18089 64093968
Anion gap abnormal 58.83 9.93 38 386637 502 64111555
Oedema peripheral 58.27 9.93 898 385777 209419 63902638
Crystal urine present 57.07 9.93 64 386611 1865 64110192
Rheumatoid factor positive 57.04 9.93 382 386293 34556 64077501
White blood cells urine positive 56.96 9.93 110 386565 5288 64106769
Injection site warmth 56.60 9.93 7 386668 13455 64098602
Drug abuse 55.84 9.93 1109 385566 131265 63980792
Electric shock 54.77 9.93 49 386626 1080 64110977
Urine abnormality 54.58 9.93 130 386545 7232 64104825
Lymphocyte percentage decreased 54.36 9.93 99 386576 4550 64107507
Suicide attempt 54.31 9.93 658 386017 70349 64041708
Aspartate aminotransferase increased 52.70 9.93 1010 385665 118778 63993279
Blood pH decreased 51.80 9.93 94 386581 4308 64107749
Diabetes mellitus 51.50 9.93 214 386461 66260 64045797
Cardiac arrest 51.10 9.93 1247 385428 152817 63959240
Drug ineffective for unapproved indication 51.02 9.93 67 386608 31066 64080991
Dizziness 50.74 9.93 2086 384589 428077 63683980
Therapeutic response shortened 50.60 9.93 155 386520 10015 64102042
International normalised ratio increased 50.25 9.93 709 385966 78458 64033599
Leukopenia 49.54 9.93 379 386296 100863 64011194
Septic shock 49.14 9.93 400 386275 105037 64007020
Body temperature fluctuation 48.83 9.93 78 386597 3220 64108837
Hyperkalaemia 48.35 9.93 381 386294 100748 64011309
Poor venous access 48.19 9.93 174 386501 12243 64099814
Arthralgia 47.16 9.93 3165 383510 439095 63672962
Cerebral haemorrhage 47.12 9.93 153 386522 50937 64061120
Cytokine release syndrome 47.06 9.93 248 386427 20581 64091476
Posterior reversible encephalopathy syndrome 46.94 9.93 41 386634 22905 64089152
Neoplasm progression 46.46 9.93 111 386564 40853 64071204
Product quality issue 45.96 9.93 67 386608 29732 64082325
Myelosuppression 45.89 9.93 45 386630 23785 64088272
Feeling abnormal 45.44 9.93 547 386128 133055 63979002
Palmar-plantar erythrodysaesthesia syndrome 45.23 9.93 64 386611 28755 64083302
Epistaxis 44.04 9.93 376 386299 97755 64014302
Drug hypersensitivity 43.74 9.93 1088 385587 236727 63875330
Cytomegalovirus infection 43.63 9.93 99 386576 37100 64074957
Stomatitis 43.16 9.93 909 385766 108696 64003361
Injection site mass 43.02 9.93 25 386650 17245 64094812
Dyspnoea exertional 42.51 9.93 263 386412 73467 64038590
Muscle spasticity 42.24 9.93 205 386470 16464 64095593
Prothrombin time prolonged 41.64 9.93 196 386479 15545 64096512
Hyperlipidaemia 41.30 9.93 46 386629 22930 64089127
Haematotoxicity 41.14 9.93 13 386662 12883 64099174
Acute myocardial infarction 41.08 9.93 247 386428 69471 64042586
Underdose 40.89 9.93 57 386618 25772 64086285
Brain death 40.63 9.93 90 386585 4771 64107286
Gait disturbance 40.53 9.93 757 385918 171398 63940659
Product substitution issue 40.20 9.93 29 386646 17832 64094225
Muscle spasms 39.76 9.93 600 386075 140423 63971634
Infusion site extravasation 39.59 9.93 110 386565 6727 64105330
Dehydration 39.50 9.93 993 385682 215770 63896287
Memory impairment 39.49 9.93 326 386349 85356 64026701
Atrial fibrillation 39.45 9.93 755 385920 170334 63941723
Lymphocyte count decreased 39.31 9.93 395 386280 40304 64071753
Surgery 39.19 9.93 68 386607 28145 64083912
Pain 39.07 9.93 3838 382837 549673 63562384
Immune reconstitution inflammatory syndrome 39.02 9.93 13 386662 12457 64099600
Visual acuity reduced 39.01 9.93 64 386611 27077 64084980
Urinary sediment present 38.95 9.93 57 386618 2177 64109880
Injection site rash 38.91 9.93 23 386652 15719 64096338
Peripheral swelling 38.82 9.93 1578 385097 207575 63904482
Red cell distribution width increased 38.41 9.93 161 386514 12148 64099909
Flushing 38.38 9.93 674 386001 77974 64034083
Product storage error 38.13 9.93 16 386659 13302 64098755
Orthostatic hypotension 37.90 9.93 438 386237 46300 64065757
Asthenia 37.58 9.93 2141 384534 425903 63686154
Renal failure 37.08 9.93 818 385857 180870 63931187
Injection site haemorrhage 37.03 9.93 55 386620 24223 64087834
Diabetic ketoacidosis 37.01 9.93 77 386598 29768 64082289
Device issue 36.85 9.93 49 386626 22599 64089458
Contusion 36.74 9.93 919 385756 113046 63999011
Rheumatic fever 36.72 9.93 131 386544 9163 64102894
Infusion site pain 36.44 9.93 141 386534 10256 64101801
Red blood cell sedimentation rate abnormal 36.02 9.93 27 386648 16279 64095778
Pathogen resistance 36.02 9.93 15 386660 12528 64099529
Anion gap increased 35.82 9.93 65 386610 2979 64109078
Cerebral infarction 35.75 9.93 126 386549 40918 64071139
Urine leukocyte esterase positive 35.48 9.93 69 386606 3334 64108723
Therapy interrupted 35.06 9.93 41 386634 19995 64092062
Malaise 34.58 9.93 1983 384692 394264 63717793
Injection site induration 34.42 9.93 6 386669 8926 64103131
Extrapyramidal disorder 34.22 9.93 40 386635 19512 64092545
Haemolysis 34.14 9.93 144 386531 10895 64101162
Jaundice cholestatic 34.08 9.93 122 386553 8548 64103509
Myelodysplastic syndrome 33.49 9.93 72 386603 27507 64084550
Fall 33.19 9.93 2104 384571 414722 63697335
Thrombocytopenia 33.19 9.93 1055 385620 222746 63889311
Device malfunction 33.15 9.93 34 386641 17599 64094458
Acidosis 33.02 9.93 201 386474 17594 64094463
Device difficult to use 32.86 9.93 9 386666 9789 64102268
Loss of personal independence in daily activities 32.79 9.93 277 386398 72177 64039880
Labelled drug-drug interaction medication error 32.67 9.93 51 386624 22011 64090046
Urticaria 32.49 9.93 1133 385542 146184 63965873
Unresponsive to stimuli 32.25 9.93 452 386223 49941 64062116
Specific gravity urine decreased 32.21 9.93 31 386644 752 64111305
Analgesic drug level above therapeutic 31.93 9.93 24 386651 410 64111647
Full blood count abnormal 31.90 9.93 83 386592 29674 64082383
Post transplant lymphoproliferative disorder 31.57 9.93 9 386666 9535 64102522
Electrocardiogram QT prolonged 31.50 9.93 314 386361 79134 64032923
General physical health deterioration 31.44 9.93 959 385716 203466 63908591
Infusion site pruritus 31.12 9.93 56 386619 2550 64109507
Renal papillary necrosis 31.02 9.93 22 386653 342 64111715
Red blood cells urine positive 30.98 9.93 77 386598 4401 64107656
Infusion site swelling 30.73 9.93 87 386588 5378 64106679
Night sweats 30.67 9.93 341 386334 35705 64076352
Paraesthesia 30.59 9.93 595 386080 133927 63978130
Blood parathyroid hormone decreased 30.56 9.93 4 386671 7362 64104695
Second primary malignancy 30.53 9.93 18 386657 12319 64099738
No adverse event 30.36 9.93 80 386595 28481 64083576
Unevaluable event 30.20 9.93 178 386497 50311 64061746
Syncope 30.11 9.93 717 385958 156918 63955139
Drug screen positive 30.09 9.93 89 386586 5640 64106417
Glycosylated haemoglobin increased 29.99 9.93 31 386644 15988 64096069
Haematuria 29.75 9.93 226 386449 60245 64051812
Unintentional medical device removal 29.57 9.93 3 386672 6731 64105326
Brain oedema 29.47 9.93 230 386445 21845 64090212
Gastrointestinal haemorrhage 29.24 9.93 588 386087 131724 63980333
Ear pruritus 29.04 9.93 55 386620 2605 64109452
Lactic acidosis 28.59 9.93 233 386442 61177 64050880
Hypertensive crisis 28.17 9.93 41 386634 18207 64093850
Sexual dysfunction 28.12 9.93 3 386672 6468 64105589
Precancerous cells present 27.56 9.93 32 386643 969 64111088
C-reactive protein abnormal 27.48 9.93 86 386589 28961 64083096
Bacterial test 27.41 9.93 35 386640 1172 64110885
Transient ischaemic attack 27.38 9.93 154 386521 44028 64068029
Drug intolerance 27.17 9.93 1383 385292 186609 63925448
Urine analysis abnormal 27.04 9.93 86 386589 5670 64106387
Liver transplant 26.89 9.93 69 386606 4023 64108034
Lung neoplasm malignant 26.88 9.93 55 386620 21393 64090664
Device dislocation 26.81 9.93 54 386621 21124 64090933
Injection site urticaria 26.71 9.93 17 386658 11164 64100893
Infusion site erythema 26.41 9.93 96 386579 6777 64105280
Aplastic anaemia 26.32 9.93 158 386517 13762 64098295
Psoriatic arthropathy 26.20 9.93 152 386523 43129 64068928
Hypocalcaemia 26.16 9.93 145 386530 41608 64070449
Bilirubin urine present 25.96 9.93 19 386656 311 64111746
Epilepsy 25.93 9.93 108 386567 33423 64078634
Swollen joint count increased 25.91 9.93 103 386572 7586 64104471
Abdominal discomfort 25.88 9.93 1339 385336 180983 63931074
Acute graft versus host disease 25.87 9.93 11 386664 9073 64102984
Forced expiratory volume decreased 25.63 9.93 5 386670 6862 64105195
Graft versus host disease 25.56 9.93 27 386648 13786 64098271
Soft tissue disorder 25.54 9.93 59 386616 3217 64108840
Myalgia 25.40 9.93 740 385935 157877 63954180
Iron deficiency anaemia 25.07 9.93 59 386616 21830 64090227
Nausea 24.98 9.93 4237 382438 781563 63330494
Full blood count decreased 24.97 9.93 62 386613 22520 64089537
Inappropriate antidiuretic hormone secretion 24.80 9.93 61 386614 22228 64089829
Confusional state 24.67 9.93 1851 384824 259293 63852764
Cardiac failure chronic 24.11 9.93 12 386663 9029 64103028
Bursitis 23.97 9.93 215 386460 21270 64090787
Pneumocystis jirovecii pneumonia 23.95 9.93 85 386590 27549 64084508
Pruritus 23.88 9.93 2179 384496 310221 63801836
Multiple drug therapy 23.86 9.93 46 386629 2208 64109849
Drug-induced liver injury 23.85 9.93 410 386265 47233 64064824
Coronary arterial stent insertion 23.83 9.93 3 386672 5689 64106368
Prostate cancer 23.77 9.93 52 386623 19743 64092314
Multiple-drug resistance 23.71 9.93 5 386670 6497 64105560
Osteonecrosis 23.70 9.93 88 386587 28141 64083916
Angina unstable 23.63 9.93 35 386640 15432 64096625
Granuloma skin 23.58 9.93 4 386671 6070 64105987
Hepatic cirrhosis 23.39 9.93 80 386595 26218 64085839
Smear cervix abnormal 23.38 9.93 47 386628 2327 64109730
Cardiomyopathy 23.33 9.93 76 386599 25280 64086777
Hypomagnesaemia 23.31 9.93 130 386545 37246 64074811
Renal cortical necrosis 23.24 9.93 17 386658 278 64111779
Rash pruritic 23.12 9.93 226 386449 57178 64054879
Angina pectoris 22.88 9.93 167 386508 44914 64067143
Mobility decreased 22.50 9.93 674 386001 85166 64026891
Depression 22.37 9.93 885 385790 182406 63929651
Culture urine positive 22.29 9.93 65 386610 4086 64107971
Hyponatraemia 22.28 9.93 698 385977 147641 63964416
Acute myeloid leukaemia 22.16 9.93 87 386588 27376 64084681
Cardiac failure acute 22.15 9.93 40 386635 16304 64095753
Endophthalmitis 22.05 9.93 3 386672 5362 64106695
Disturbance in attention 21.90 9.93 150 386525 40924 64071133
Hypomania 21.74 9.93 79 386596 5575 64106482
Blood urine present 21.74 9.93 186 386489 18154 64093903
Polyneuropathy 21.70 9.93 55 386620 19839 64092218
Transaminases increased 21.69 9.93 382 386293 44212 64067845
Hepatic encephalopathy 21.58 9.93 207 386468 20859 64091198
Infusion site mass 21.57 9.93 28 386647 953 64111104
Haemorrhage 21.54 9.93 340 386335 79011 64033046
Hypercalcaemia 21.42 9.93 106 386569 31310 64080747
Monocyte percentage increased 21.40 9.93 41 386634 1959 64110098
Aspergillus infection 21.39 9.93 41 386634 16338 64095719
Haematochezia 21.33 9.93 275 386400 66098 64045959
Status epilepticus 21.30 9.93 63 386612 21600 64090457
Drug level below therapeutic 21.06 9.93 94 386581 7290 64104767
Angioedema 21.05 9.93 253 386422 61568 64050489
Febrile bone marrow aplasia 20.82 9.93 22 386653 11233 64100824
Temperature regulation disorder 20.78 9.93 64 386611 4147 64107910
Seizure 20.76 9.93 804 385871 166088 63945969
Thrombotic microangiopathy 20.63 9.93 43 386632 16612 64095445
Sepsis 20.55 9.93 1150 385525 229191 63882866
Basal cell carcinoma 20.48 9.93 105 386570 30733 64081324
Ageusia 20.39 9.93 32 386643 13781 64098276
Dry skin 20.36 9.93 202 386473 50959 64061098
Intervertebral discitis 20.34 9.93 60 386615 3797 64108260
Environmental exposure 20.33 9.93 17 386658 341 64111716
Appendicolith 20.27 9.93 56 386619 3413 64108644
Platelet count decreased 20.20 9.93 811 385864 166900 63945157
Oedema 20.18 9.93 409 386266 91526 64020531
Cytopenia 19.97 9.93 39 386636 15432 64096625
Asthma 19.91 9.93 427 386248 94798 64017259
Spinal stenosis 19.88 9.93 33 386642 13898 64098159
Granulomatosis with polyangiitis 19.73 9.93 41 386634 2079 64109978
Maternal exposure during pregnancy 19.55 9.93 731 385944 95153 64016904
Blood creatinine decreased 19.54 9.93 89 386586 6961 64105096
Transplant dysfunction 19.30 9.93 8 386667 6700 64105357
Myopathy 19.19 9.93 49 386626 17631 64094426
Vision blurred 19.17 9.93 404 386271 89912 64022145
Transplant rejection 19.06 9.93 48 386627 17353 64094704
Loss of consciousness 19.06 9.93 712 385963 147653 63964404
Bone erosion 18.95 9.93 25 386650 11570 64100487
Pharyngeal paraesthesia 18.94 9.93 38 386637 1879 64110178
Subdural haematoma 18.93 9.93 95 386580 27959 64084098
Chills 18.85 9.93 1005 385670 136259 63975798
Hypothermia 18.83 9.93 192 386483 19664 64092393
Cardiac disorder 18.78 9.93 229 386446 55587 64056470
Pain in extremity 18.73 9.93 1563 385112 301522 63810535
Neurotoxicity 18.38 9.93 93 386582 27311 64084746
Coronary artery bypass 18.31 9.93 6 386669 5809 64106248
Toxic epidermal necrolysis 18.30 9.93 319 386356 36847 64075210
Bacterial test positive 18.21 9.93 84 386591 6606 64105451
PCO2 decreased 18.11 9.93 48 386627 2854 64109203
Right ventricular failure 17.98 9.93 67 386608 21404 64090653
Methaemoglobinaemia 17.79 9.93 62 386613 4286 64107771
Urine bilirubin decreased 17.72 9.93 11 386664 135 64111922
Akathisia 17.63 9.93 26 386649 11484 64100573
Osmolar gap 17.51 9.93 11 386664 138 64111919
Prostatic specific antigen increased 17.50 9.93 16 386659 8744 64103313
Fracture 17.41 9.93 56 386619 18699 64093358
Burning sensation 17.39 9.93 202 386473 49462 64062595
Agranulocytosis 17.36 9.93 146 386529 38083 64073974
Metastases to lymph nodes 17.32 9.93 16 386659 8701 64103356
Chronic graft versus host disease 17.24 9.93 8 386667 6268 64105789
Infusion site bruising 17.13 9.93 32 386643 1500 64110557
Maternal exposure timing unspecified 17.12 9.93 45 386630 2662 64109395
Fluid retention 16.99 9.93 253 386422 59353 64052704
Cells in urine 16.89 9.93 12 386663 187 64111870
Sputum culture positive 16.85 9.93 48 386627 2978 64109079
Panniculitis 16.83 9.93 17 386658 8862 64103195
Thrombosis 16.80 9.93 310 386365 70332 64041725
Inappropriate schedule of product administration 16.80 9.93 695 385980 91591 64020466
Rhabdomyolysis 16.74 9.93 420 386255 91306 64020751
COVID-19 immunisation 16.72 9.93 19 386656 562 64111495
Mean cell haemoglobin concentration increased 16.59 9.93 22 386653 765 64111292
Chronic obstructive pulmonary disease 16.52 9.93 313 386362 70735 64041322
Deep vein thrombosis 16.51 9.93 492 386183 104690 64007367
Pulmonary arterial hypertension 16.50 9.93 87 386588 25280 64086777
Band neutrophil count increased 16.49 9.93 20 386655 635 64111422
Brain scan abnormal 16.44 9.93 27 386648 1141 64110916
Blood triglycerides increased 16.37 9.93 58 386617 18808 64093249
Mean cell haemoglobin concentration decreased 16.37 9.93 54 386621 3630 64108427
White blood cell count decreased 16.36 9.93 776 385899 157061 63954996
Therapeutic response unexpected 16.32 9.93 50 386625 16951 64095106
Speech disorder 16.20 9.93 199 386476 48242 64063815
Tachycardia 16.15 9.93 1072 385603 148507 63963550
Chronic kidney disease 16.12 9.93 247 386428 57672 64054385
Pulmonary hypertension 16.07 9.93 173 386502 42966 64069091
Hepatocellular carcinoma 16.03 9.93 16 386659 8387 64103670
Abortion spontaneous 15.92 9.93 87 386588 25056 64087001
Tremor 15.92 9.93 726 385949 147504 63964553
Suicidal ideation 15.83 9.93 292 386383 66250 64045807
Pulmonary mass 15.82 9.93 82 386593 23934 64088123
Pain in jaw 15.77 9.93 162 386513 40593 64071464
Alopecia 15.73 9.93 1175 385500 164515 63947542
Aphasia 15.66 9.93 163 386512 40743 64071314
Haematocrit decreased 15.66 9.93 434 386241 54221 64057836
Withdrawal syndrome 15.60 9.93 80 386595 23412 64088645
Anaphylactic shock 15.56 9.93 112 386563 30216 64081841
Toxicologic test abnormal 15.50 9.93 27 386648 1198 64110859
Sinus node dysfunction 15.48 9.93 11 386664 6817 64105240
Device leakage 15.47 9.93 16 386659 8250 64103807
Hepatocellular injury 15.44 9.93 185 386490 45050 64067007
Cholecystitis chronic 15.43 9.93 102 386573 9185 64102872
Food allergy 15.41 9.93 90 386585 7761 64104296
Serum sickness 15.31 9.93 48 386627 3141 64108916
Diffuse large B-cell lymphoma 15.29 9.93 24 386651 10337 64101720
Abnormal dreams 15.28 9.93 24 386651 10332 64101725
Fibromyalgia 15.27 9.93 300 386375 35431 64076626
Congestive cardiomyopathy 15.23 9.93 24 386651 10320 64101737
Prescribed underdose 15.22 9.93 56 386619 17959 64094098
Candida infection 15.18 9.93 118 386557 31301 64080756
Accidental death 15.14 9.93 53 386622 3672 64108385
Cytomegalovirus viraemia 15.13 9.93 26 386649 10802 64101255
Actinic keratosis 15.12 9.93 6 386669 5159 64106898
Metastases to liver 15.08 9.93 83 386592 23858 64088199
Hallucination 15.04 9.93 327 386348 72461 64039596
Thinking abnormal 15.03 9.93 29 386646 11527 64100530
Haemoglobin urine present 15.02 9.93 22 386653 841 64111216
Eosinophil percentage increased 15.00 9.93 29 386646 1395 64110662
Product monitoring error 14.91 9.93 7 386668 5447 64106610
Lipodystrophy acquired 14.89 9.93 3 386672 4024 64108033
Nocardiosis 14.86 9.93 5 386670 4762 64107295
Epstein-Barr virus infection 14.84 9.93 33 386642 12455 64099602
Lymphoproliferative disorder 14.82 9.93 6 386669 5097 64106960
Skin exfoliation 14.78 9.93 185 386490 44700 64067357
Oesophageal carcinoma 14.75 9.93 5 386670 4738 64107319
Oxygen saturation abnormal 14.68 9.93 51 386624 3520 64108537
Hypertriglyceridaemia 14.67 9.93 28 386647 11177 64100880
Dyspnoea at rest 14.61 9.93 10 386665 6319 64105738
Enthesopathy 14.54 9.93 22 386653 9616 64102441
Anti-erythrocyte antibody positive 14.54 9.93 8 386667 77 64111980
Altered state of consciousness 14.53 9.93 151 386524 37751 64074306
Skin toxicity 14.50 9.93 11 386664 6591 64105466
Neuroleptic malignant syndrome 14.49 9.93 89 386586 24907 64087150
Treatment noncompliance 14.40 9.93 179 386496 43303 64068754
Respiratory disorder 14.37 9.93 300 386375 35811 64076246
Fungal rhinitis 14.36 9.93 7 386668 51 64112006
Lupus vulgaris 14.28 9.93 8 386667 80 64111977
Chest pain 14.26 9.93 1219 385456 234761 63877296
Ejection fraction decreased 14.25 9.93 107 386568 28600 64083457
Blood lactic acid increased 14.24 9.93 109 386566 10292 64101765
Abnormal loss of weight 14.22 9.93 14 386661 7386 64104671
Skin ulcer 14.20 9.93 182 386493 43792 64068265
Injection site extravasation 14.17 9.93 90 386585 7996 64104061
Carotid artery stenosis 14.16 9.93 16 386659 7925 64104132
Disturbance in social behaviour 14.15 9.93 3 386672 3884 64108173
Pyrexia 14.13 9.93 3660 383015 554984 63557073
Skin lesion 14.12 9.93 145 386530 36337 64075720
Visual impairment 14.11 9.93 337 386338 73740 64038317
Tendonitis 14.08 9.93 68 386607 20214 64091843
Incorrect drug administration rate 14.05 9.93 42 386633 2677 64109380
Venoocclusive liver disease 14.04 9.93 24 386651 9991 64102066
Dyslipidaemia 14.03 9.93 21 386654 9221 64102836
Rebound effect 13.93 9.93 6 386669 4911 64107146
Post-traumatic stress disorder 13.91 9.93 56 386619 4149 64107908
Urinary casts 13.89 9.93 24 386651 1058 64110999
Metastases to lung 13.87 9.93 46 386629 15218 64096839
Bronchopulmonary aspergillosis 13.83 9.93 63 386612 19022 64093035
Hepatitis B reactivation 13.79 9.93 6 386669 4883 64107174
Dependent personality disorder 13.74 9.93 9 386666 122 64111935
Obstructive airways disorder 13.73 9.93 82 386593 23103 64088954
Infection 13.72 9.93 1287 385388 183593 63928464
Macular oedema 13.69 9.93 6 386669 4861 64107196
Poisoning deliberate 13.67 9.93 132 386543 13326 64098731
Rhinitis allergic 13.63 9.93 17 386658 8061 64103996
Specific gravity urine increased 13.54 9.93 15 386660 431 64111626
Pulmonary embolism 13.54 9.93 728 385947 145628 63966429
Hemiparesis 13.50 9.93 114 386561 29713 64082344
Left ventricular dysfunction 13.49 9.93 54 386621 16900 64095157
Erysipelas 13.44 9.93 21 386654 9060 64102997
Nasal necrosis 13.31 9.93 9 386666 129 64111928
Mitral valve incompetence 13.25 9.93 94 386581 25444 64086613
Gynaecomastia 13.24 9.93 10 386665 6006 64106051
Injection site discolouration 13.22 9.93 13 386662 6862 64105195
Skin necrosis 13.15 9.93 43 386632 14286 64097771
Rash 13.13 9.93 3021 383654 455528 63656529
Ischaemic cardiomyopathy 13.07 9.93 13 386662 6825 64105232
Bladder cancer 13.04 9.93 29 386646 10945 64101112
Shock haemorrhagic 13.04 9.93 54 386621 16737 64095320
Decerebrate posture 13.00 9.93 10 386665 177 64111880
Traumatic liver injury 12.87 9.93 16 386659 521 64111536
Carpal tunnel syndrome 12.86 9.93 50 386625 15778 64096279
Dysphonia 12.84 9.93 198 386477 46184 64065873
Graft versus host disease in gastrointestinal tract 12.78 9.93 9 386666 5603 64106454
Alpha 1 microglobulin increased 12.75 9.93 7 386668 67 64111990
Blood glucose increased 12.73 9.93 470 386205 97603 64014454
Partial seizures 12.73 9.93 15 386660 7292 64104765
Therapeutic response decreased 12.73 9.93 228 386447 51960 64060097
Ischaemic stroke 12.69 9.93 112 386563 28923 64083134
Acute coronary syndrome 12.68 9.93 66 386609 19244 64092813
Gestational diabetes 12.68 9.93 9 386666 5581 64106476
Dysgeusia 12.63 9.93 202 386473 46845 64065212
Rash maculo-papular 12.59 9.93 202 386473 46824 64065233
Derailment 12.58 9.93 7 386668 69 64111988
Immunodeficiency 12.58 9.93 150 386525 15974 64096083
Obesity 12.56 9.93 72 386603 20490 64091567
Infusion site urticaria 12.54 9.93 17 386658 604 64111453
Ventricular tachycardia 12.53 9.93 138 386537 34127 64077930
Hypoglycaemic coma 12.45 9.93 5 386670 4269 64107788
Paradoxical drug reaction 12.44 9.93 11 386664 6109 64105948
Monocyte count increased 12.39 9.93 87 386588 7992 64104065
Genital haemorrhage 12.38 9.93 9 386666 5513 64106544
Lupus-like syndrome 12.38 9.93 21 386654 8770 64103287
Sudden cardiac death 12.37 9.93 6 386669 4581 64107476
Frequent bowel movements 12.34 9.93 62 386613 18243 64093814
Drug abuser 12.34 9.93 68 386607 5740 64106317
Renal disorder 12.32 9.93 144 386531 35221 64076836
Brain stem glioma 12.31 9.93 9 386666 147 64111910
Urobilinogen urine increased 12.31 9.93 17 386658 615 64111442
Eyelid ptosis 12.30 9.93 24 386651 9501 64102556
Accidental poisoning 12.26 9.93 27 386648 1426 64110631
Kidney transplant rejection 12.25 9.93 24 386651 9487 64102570
Blood uric acid decreased 12.24 9.93 23 386652 1083 64110974
Dysarthria 12.24 9.93 267 386408 59139 64052918
Transferrin decreased 12.18 9.93 12 386663 300 64111757
Ascites 12.11 9.93 281 386394 61720 64050337
Cerebral ischaemia 12.10 9.93 26 386649 9936 64102121
Nocturia 12.08 9.93 31 386644 11134 64100923
Disorientation 12.06 9.93 249 386426 55579 64056478
Blood bilirubin increased 12.02 9.93 440 386235 57113 64054944
Acute graft versus host disease in skin 12.02 9.93 14 386661 6841 64105216
Blood bicarbonate decreased 11.96 9.93 59 386616 4770 64107287
Metastases to central nervous system 11.92 9.93 43 386632 13869 64098188
Musculoskeletal stiffness 11.90 9.93 875 385800 122331 63989726
Encephalopathy 11.88 9.93 448 386227 58371 64053686
Pneumonia viral 11.86 9.93 84 386591 7738 64104319
Pancreatic carcinoma 11.85 9.93 28 386647 10345 64101712
Adrenergic syndrome 11.81 9.93 8 386667 115 64111942
Metastases to bone 11.72 9.93 73 386602 20362 64091695
Urine ketone body present 11.71 9.93 45 386630 3262 64108795
Electrolyte imbalance 11.64 9.93 96 386579 25147 64086910
Aplasia pure red cell 11.59 9.93 15 386660 6999 64105058
Stevens-Johnson syndrome 11.57 9.93 278 386397 33971 64078086
Base excess 11.55 9.93 7 386668 82 64111975
Anticipatory anxiety 11.53 9.93 11 386664 264 64111793
Nephrogenic systemic fibrosis 11.49 9.93 11 386664 5881 64106176
Sensitivity to weather change 11.47 9.93 14 386661 6700 64105357
Balance disorder 11.42 9.93 614 386061 83312 64028745
Leukoencephalopathy 11.41 9.93 15 386660 6952 64105105
JC virus infection 11.41 9.93 3 386672 3352 64108705
Angiokeratoma 11.38 9.93 10 386665 215 64111842
Respiratory failure 11.38 9.93 822 385853 160361 63951696
Vitamin K deficiency 11.37 9.93 17 386658 662 64111395
Low density lipoprotein increased 11.36 9.93 18 386657 7722 64104335
Pulmonary alveolar haemorrhage 11.35 9.93 26 386649 9712 64102345
Hypokalaemia 11.34 9.93 606 386069 121297 63990760
Stent placement 11.34 9.93 10 386665 5561 64106496
Laboratory test abnormal 11.34 9.93 91 386584 23972 64088085
Mydriasis 11.32 9.93 141 386534 15171 64096886
Bone pain 11.24 9.93 209 386466 47363 64064694
Human herpesvirus 6 infection 11.22 9.93 7 386668 4647 64107410
Cystitis haemorrhagic 11.21 9.93 19 386656 7937 64104120
Red cell distribution width decreased 11.20 9.93 22 386653 1071 64110986
Activated partial thromboplastin time prolonged 11.19 9.93 122 386553 12709 64099348
Urine oxalate increased 11.19 9.93 10 386665 220 64111837
Infusion site discomfort 11.18 9.93 18 386657 748 64111309
Cardiovascular disorder 11.16 9.93 53 386622 15828 64096229
Swollen tongue 11.16 9.93 145 386530 34809 64077248
Therapy non-responder 11.16 9.93 305 386370 65594 64046463
Diaphragmatic rupture 11.16 9.93 10 386665 221 64111836
Gastrooesophageal reflux disease 11.12 9.93 397 386278 82746 64029311
Tardive dyskinesia 11.11 9.93 24 386651 9154 64102903
BK virus infection 11.10 9.93 17 386658 7395 64104662
Vertigo 11.09 9.93 269 386406 58742 64053315
Retinal deposits 11.08 9.93 8 386667 128 64111929
Eosinophilia 11.07 9.93 161 386514 37915 64074142
Retinal haemorrhage 11.05 9.93 17 386658 7381 64104676
Autonomic dysreflexia 11.03 9.93 13 386662 400 64111657
Adenocarcinoma of colon 11.01 9.93 8 386667 4900 64107157
Coagulation factor X level decreased 11.00 9.93 7 386668 90 64111967
Skin burning sensation 10.98 9.93 30 386645 10553 64101504
Dyskinesia 10.95 9.93 168 386507 39220 64072837
Diplopia 10.94 9.93 105 386570 26660 64085397
Aortic valve stenosis 10.89 9.93 7 386668 4573 64107484
Medication overuse headache 10.80 9.93 17 386658 693 64111364
Drug eruption 10.78 9.93 152 386523 35984 64076073
Injection site nodule 10.77 9.93 3 386672 3227 64108830
Vessel puncture site bruise 10.76 9.93 13 386662 411 64111646
Respiratory tract congestion 10.76 9.93 55 386620 16110 64095947
Eczema 10.75 9.93 120 386555 29600 64082457
Blood creatine increased 10.74 9.93 85 386590 8107 64103950
Acid-base balance disorder mixed 10.74 9.93 7 386668 94 64111963
Endocardial fibrosis 10.71 9.93 6 386669 60 64111997
Tricuspid valve incompetence 10.68 9.93 59 386616 16944 64095113
Hernia 10.65 9.93 126 386549 13392 64098665
Post procedural pulmonary embolism 10.65 9.93 10 386665 235 64111822
Anal fissure 10.62 9.93 58 386617 4878 64107179
Hypersensitivity vasculitis 10.62 9.93 15 386660 6746 64105311
Blood loss anaemia 10.58 9.93 45 386630 13847 64098210
Pleural effusion 10.53 9.93 636 386039 125923 63986134
Impaired quality of life 10.53 9.93 14 386661 6457 64105600
Hallucination, auditory 10.52 9.93 59 386616 16880 64095177
pH urine increased 10.52 9.93 13 386662 421 64111636
Mania 10.51 9.93 56 386619 16230 64095827
Toxic skin eruption 10.49 9.93 70 386605 19214 64092843
Dermatitis exfoliative generalised 10.46 9.93 12 386663 5904 64106153
Gallbladder injury 10.45 9.93 22 386653 1126 64110931
Myelocyte percentage increased 10.44 9.93 10 386665 241 64111816
Oral pruritus 10.41 9.93 29 386646 1776 64110281
Graft versus host disease in skin 10.41 9.93 10 386665 5337 64106720
Atrioventricular block 10.38 9.93 37 386638 11978 64100079
Drug use disorder 10.37 9.93 67 386608 5987 64106070
Diffuse large B-cell lymphoma recurrent 10.35 9.93 3 386672 3143 64108914
Hepatic cancer 10.30 9.93 18 386657 7430 64104627
Vital capacity decreased 10.29 9.93 21 386654 1051 64111006
Dermatitis acneiform 10.29 9.93 22 386653 8421 64103636
Pulmonary fibrosis 10.27 9.93 122 386553 29756 64082301
Spinal operation 10.25 9.93 13 386662 6120 64105937
Oral discomfort 10.16 9.93 22 386653 8384 64103673
Red blood cell elliptocytes present 10.11 9.93 8 386667 148 64111909
Gastritis erosive 10.10 9.93 27 386648 9568 64102489
Polydipsia 10.09 9.93 12 386663 5809 64106248
Laryngospasm 10.09 9.93 4 386671 3441 64108616
Leukocytosis 10.07 9.93 297 386378 37443 64074614
Cystic fibrosis 10.03 9.93 4 386671 3430 64108627
Dermatitis 10.03 9.93 65 386610 17964 64094093
Dystonia 10.00 9.93 69 386606 18796 64093261
Intestinal haemorrhage 9.95 9.93 11 386664 5503 64106554
Dysstasia 9.95 9.93 90 386585 23125 64088932
Deep vein thrombosis postoperative 9.94 9.93 24 386651 1347 64110710

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D11AX26 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC N06BC01 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Xanthine derivatives
ATC V04CG30 VARIOUS
DIAGNOSTIC AGENTS
OTHER DIAGNOSTIC AGENTS
Tests for gastric secretion
FDA CS M0023046 Xanthines
MeSH PA D002491 Central Nervous System Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D010726 Phosphodiesterase Inhibitors
MeSH PA D058914 Purinergic Antagonists
MeSH PA D058915 Purinergic P1 Receptor Antagonists
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175739 Central Nervous System Stimulant
FDA EPC N0000175790 Methylxanthine
CHEBI has role CHEBI:25435 mutagens
CHEBI has role CHEBI:35337 analeptic
CHEBI has role CHEBI:35471 psychotropic drugs
CHEBI has role CHEBI:35498 diuretics
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50218 phosphodiesterase inhibitors
CHEBI has role CHEBI:50925 serine/threonine protein kinase inhibitor
CHEBI has role CHEBI:53121 adenosine A2A receptor antagonists
CHEBI has role CHEBI:60809 adjuvants
CHEBI has role CHEBI:64047 food additives
CHEBI has role CHEBI:67114 ryanodine receptor activators
CHEBI has role CHEBI:71232 adenosine receptor antagonists
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:76946 fungal metabolites
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:85234 human blood serum metabolites
CHEBI has role CHEBI:176497 geroprotectors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Apnea in the newborn indication 13094009
Pain indication 22253000
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Common cold indication 82272006 DOID:10459
Vascular headache indication 128187005
Backache indication 161891005
Cluster headache syndrome indication 193031009
Spasticity indication 221360009
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Influenza-like symptoms indication 315642008
Tension-type headache indication 398057008
Cluster Headache Prevention indication
Fatigue off-label use 84229001
Urinary incontinence off-label use 165232002
Obesity off-label use 414916001 DOID:9970
Brain damage contraindication 2470005
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Ocular hypertension contraindication 4210003 DOID:9282
Gastritis contraindication 4556007 DOID:4029
Hypophosphatemia contraindication 4996001
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Chronic disease of respiratory system contraindication 17097001
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Ventricular tachycardia contraindication 25569003
Alcohol intoxication contraindication 25702006
Complete atrioventricular block contraindication 27885002
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Acute cerebrovascular insufficiency contraindication 29322000
Atony of colon contraindication 29479008
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Hyperactive behavior contraindication 44548000
Fecal impaction contraindication 44635007
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Retroperitoneal fibrosis contraindication 49120005
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acidosis contraindication 51387008
Fibrosis of lung contraindication 51615001 DOID:3770
Gastrointestinal perforation contraindication 51875005
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Gastrectomy contraindication 53442002
Paralytic ileus contraindication 55525008 DOID:8442
Peptic reflux disease contraindication 57643001
Congenital myotonia, autosomal dominant form contraindication 57938005
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Thrombophlebitis contraindication 64156001 DOID:3875
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Arterial thrombosis contraindication 65198009
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Hypermagnesemia contraindication 66978005
Benign intracranial hypertension contraindication 68267002 DOID:11459
Hemorrhoids contraindication 70153002 DOID:9746
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Arteriosclerotic vascular disease contraindication 72092001
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Atrophic gastritis contraindication 84568007 DOID:8929
Epilepsy contraindication 84757009 DOID:1826
Pulmonary emphysema contraindication 87433001
Gout contraindication 90560007 DOID:13189
Chronic renal failure syndrome contraindication 90688005
Kidney disease contraindication 90708001 DOID:557
Thyrotoxicosis contraindication 90739004 DOID:7997
Hemophilia contraindication 90935002
Myasthenia gravis contraindication 91637004 DOID:437
Obstruction of duodenum contraindication 95532008 DOID:3558
Disorder of biliary tract contraindication 105997008 DOID:9741
Anemia due to enzyme deficiency contraindication 111577008
Prolonged QT interval contraindication 111975006
Acute abdominal pain contraindication 116290004
Procedure on urinary system contraindication 118677009
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
von Willebrand disorder contraindication 128105004 DOID:12531
Seizure disorder contraindication 128613002
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Prolonged PR interval contraindication 164947007
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Partial atrioventricular block contraindication 195039008
Decompensated cardiac failure contraindication 195111005
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Coronary artery bypass graft contraindication 232717009
Myocardial dysfunction contraindication 233928007
Peripheral ischemia contraindication 233958001
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Gastroparesis contraindication 235675006
Disease of liver contraindication 235856003 DOID:409
Chronic diarrhea contraindication 236071009
Hyporeninemic hypoaldosteronism contraindication 236464008
Aluminum intoxication contraindication 236546003
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Sepsis syndrome contraindication 238150007
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Raynaud's phenomenon contraindication 266261006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Drowsy contraindication 271782001
Exacerbation of asthma contraindication 281239006
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Gastric ulcer contraindication 397825006 DOID:10808
Peripheral vascular disease contraindication 400047006
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004
Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant contraindication 422681000
Dysfunction of sphincter of Oddi contraindication 430887001
Fibrosis of pleura contraindication 442110002
Congenital long QT syndrome contraindication 442917000
Hypertensive urgency contraindication 443482000
Acute erosive gastritis contraindication 444926003
Smokes tobacco daily contraindication 449868002
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Ergot Alkaloid Toxicity contraindication
Acute Thromboembolic Stroke contraindication
Organic Cardiac Disease contraindication
Severe Pruritus contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 1.86 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Adenosine receptor A1 GPCR ANTAGONIST Ki 4.97 IUPHAR CHEMBL
Adenosine receptor A2b GPCR ANTAGONIST Ki 4.77 WOMBAT-PK CHEMBL
Adenosine receptor A2a GPCR ANTAGONIST Ki 5.61 CHEMBL CHEMBL
Acetylcholinesterase Enzyme IC50 5.14 CHEMBL
Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform Kinase IC50 4.12 CHEMBL
Guanine deaminase Enzyme Ki 4.99 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.31 CHEMBL
Adenosine receptor A3 GPCR ANTAGONIST Ki 4.33 WOMBAT-PK
Glycogen phosphorylase, muscle form Enzyme IC50 4.13 CHEMBL
Adenosine receptor A1 GPCR Ki 4.77 CHEMBL
Adenosine receptor A2a GPCR Ki 5.03 CHEMBL
Adenosine receptor A1 GPCR Ki 4.54 CHEMBL
Adenosine receptor A1 GPCR Ki 4 CHEMBL
Adenosine A2 receptor GPCR Ki 4.57 CHEMBL
Adenosine receptor GPCR Ki 4.22 CHEMBL
Adenosine A2a receptor GPCR Ki 4.10 CHEMBL
Adenosine receptor A2b GPCR ANTAGONIST Ki 4.89 IUPHAR

External reference:

IDSource
4017537 VUID
N0000145919 NUI
D00528 KEGG_DRUG
69-22-7 SECONDARY_CAS_RN
1886 RXNORM
C0006644 UMLSCUI
CHEBI:27732 CHEBI
CFF PDB_CHEM_ID
CHEMBL113 ChEMBL_ID
DB00201 DRUGBANK_ID
CHEMBL1200569 ChEMBL_ID
D002110 MESH_DESCRIPTOR_UI
2519 PUBCHEM_CID
C026189 MESH_SUPPLEMENTAL_RECORD_UI
407 IUPHAR_LIGAND_ID
3G6A5W338E UNII
11623 MMSL
17093 MMSL
4318 MMSL
4319 MMSL
46084 MMSL
4939 MMSL
d00801 MMSL
000600 NDDF
000601 NDDF
23068001 SNOMEDCT_US
255641001 SNOMEDCT_US
91107009 SNOMEDCT_US
4017537 VANDF
4018995 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fiorinal with Codeine HUMAN PRESCRIPTION DRUG LABEL 4 0023-6010 CAPSULE 40 mg ORAL NDA 36 sections
Fiorinal HUMAN PRESCRIPTION DRUG LABEL 3 0023-6146 CAPSULE 40 mg ORAL NDA 23 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-0650 CAPSULE 40 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-3000 CAPSULE 40 mg ORAL ANDA 33 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2000 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 13 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2001 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
ExcedrinExtra Strength Geltabs HUMAN OTC DRUG LABEL 3 0067-2021 TABLET, COATED 65 mg ORAL OTC monograph not final 14 sections
ExcedrinMigraine Geltabs HUMAN OTC DRUG LABEL 3 0067-2035 TABLET, COATED 65 mg ORAL NDA 14 sections
EXCEDRINMIGRAINE HUMAN OTC DRUG LABEL 3 0067-2039 TABLET, FILM COATED 65 mg ORAL NDA 15 sections
ExcedrinMigraine HUMAN OTC DRUG LABEL 3 0067-2040 TABLET, FILM COATED 65 mg ORAL NDA 16 sections
ExcedrinTension Headache HUMAN OTC DRUG LABEL 2 0067-8139 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
EXCEDRINMIGRAINE HUMAN OTC DRUG LABEL 3 0067-8201 TABLET, FILM COATED 65 mg ORAL NDA 15 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-8202 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-8203 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
good sense migraine formula HUMAN OTC DRUG LABEL 3 0113-0374 TABLET, FILM COATED 65 mg ORAL ANDA 15 sections
good sense stay awake HUMAN OTC DRUG LABEL 1 0113-0409 TABLET 200 mg ORAL OTC monograph final 14 sections
good sense headache relief HUMAN OTC DRUG LABEL 3 0113-1855 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
basic care migraine relief HUMAN OTC DRUG LABEL 3 0113-7374 TABLET, FILM COATED 65 mg ORAL ANDA 15 sections
PANADOLExtra HUMAN OTC DRUG LABEL 2 0135-0620 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 16 sections
Butalbital, Acetaminophen, and Caffeine HUMAN PRESCRIPTION DRUG LABEL 3 0143-0170 CAPSULE 40 mg ORAL ANDA 26 sections
ERGOTAMINE HUMAN PRESCRIPTION DRUG LABEL 2 0143-2120 TABLET, FILM COATED 100 mg ORAL ANDA 22 sections
Bayer Headache HUMAN OTC DRUG LABEL 2 0280-0064 TABLET 32.50 mg ORAL OTC monograph not final 14 sections
Alka-Seltzer Hangover Relief HUMAN OTC DRUG LABEL 2 0280-0084 TABLET, EFFERVESCENT 65 mg ORAL OTC monograph not final 17 sections
Alka-Seltzer Hangover Relief HUMAN OTC DRUG LABEL 2 0280-0084 TABLET, EFFERVESCENT 65 mg ORAL OTC monograph not final 17 sections
Bayer Back and BodyExtra Strength HUMAN OTC DRUG LABEL 2 0280-2150 TABLET 35.50 mg ORAL OTC monograph not final 15 sections
Midol Complete HUMAN OTC DRUG LABEL 3 0280-8005 TABLET 60 mg ORAL OTC monograph not final 17 sections
Midol CompleteGelcaps HUMAN OTC DRUG LABEL 3 0280-8015 TABLET, COATED 60 mg ORAL OTC monograph not final 16 sections
Extra Strength Headache Relief HUMAN OTC DRUG LABEL 3 0363-0021 CAPSULE 65 mg ORAL OTC monograph not final 16 sections
Headache ReliefExtra Strength HUMAN OTC DRUG LABEL 3 0363-0159 TABLET, FILM COATED 65 mg ORAL OTC monograph not final 15 sections
Stay AwakeMaximum Strength HUMAN OTC DRUG LABEL 1 0363-0226 TABLET 200 mg ORAL OTC monograph final 13 sections