diphenhydramine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
916 58-73-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • benadryl
  • diphenhydramine salicylate
  • diphenhydramine laurylsulfate
  • diphenhydramine
  • benzhydramine
  • probedryl
  • diphenhydramine hydrochloride
  • diphenhydramine citrate
  • diphenhydramine HCl
A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
  • Molecular weight: 255.36
  • Formula: C17H21NO
  • CLOGP: 3.45
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -3.53
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O
0.30 g O
0.20 g R
0.30 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.26 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.19 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 4, 1946 FDA MCNEIL CONS

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
Toxicity to various agents 17069.13 24.84 4691 21589 28063 2303742
Completed suicide 16740.09 24.84 4223 22057 16811 2314994
Overdose 5465.21 24.84 1761 24519 18146 2313659
Drug hypersensitivity 4554.87 24.84 1927 24353 44716 2287089
Intentional overdose 4440.33 24.84 1319 24961 10002 2321803
Drug abuse 3723.18 24.84 1169 25111 10857 2320948
Intentional product misuse 2600.95 24.84 842 25438 8647 2323158
Death 2525.13 24.84 1554 24726 79914 2251891
Cardio-respiratory arrest 2483.75 24.84 806 25474 8340 2323465
Cardiac arrest 2315.00 24.84 866 25414 14064 2317741
Suicide attempt 2171.65 24.84 768 25512 10514 2321291
Respiratory arrest 2106.02 24.84 648 25632 5530 2326275
Acute kidney injury 2016.78 24.84 941 25339 27181 2304624
Metabolic acidosis 1800.42 24.84 571 25709 5427 2326378
Acute hepatic failure 1662.35 24.84 447 25833 2195 2329610
Vomiting 1507.99 24.84 1077 25203 70525 2261280
Hypotension 1318.09 24.84 741 25539 31695 2300110
Somnolence 1295.85 24.84 658 25622 22827 2308978
Coma 1294.85 24.84 496 25784 8560 2323245
Poisoning 1286.81 24.84 371 25909 2449 2329356
Angioedema 1186.37 24.84 456 25824 7940 2323865
Tachycardia 1047.23 24.84 508 25772 15901 2315904
Urticaria 959.09 24.84 545 25735 23716 2308089
Nausea 940.05 24.84 998 25282 111191 2220614
Hepatic failure 886.23 24.84 332 25948 5357 2326448
Pruritus 771.12 24.84 591 25689 42749 2289056
Drug interaction 759.70 24.84 502 25778 28661 2303144
Alanine aminotransferase increased 731.45 24.84 379 25901 13653 2318152
Hepatotoxicity 729.21 24.84 253 26027 3228 2328577
Depressed level of consciousness 719.66 24.84 310 25970 7294 2324511
Accidental overdose 704.05 24.84 255 26025 3717 2328088
Drug ineffective 652.98 24.84 789 25491 100835 2230970
Rash 634.24 24.84 605 25675 58953 2272852
Gastrointestinal haemorrhage 622.55 24.84 327 25953 12108 2319697
Aspartate aminotransferase increased 615.36 24.84 326 25954 12286 2319519
Medication error 596.64 24.84 255 26025 5876 2325929
Tubulointerstitial nephritis 592.03 24.84 198 26082 2240 2329565
Abdominal pain 580.72 24.84 455 25825 33919 2297886
Coagulopathy 576.83 24.84 203 26077 2706 2329099
Haematemesis 562.66 24.84 218 26062 3864 2327941
Abdominal pain upper 552.21 24.84 371 25909 21729 2310076
Exposure during pregnancy 530.81 24.84 381 25899 24838 2306967
International normalised ratio increased 503.19 24.84 239 26041 7097 2324708
Dyspnoea 499.17 24.84 608 25672 78125 2253680
Toxic epidermal necrolysis 487.53 24.84 183 26097 2961 2328844
Liver injury 479.92 24.84 167 26113 2147 2329658
Gastric ulcer 476.60 24.84 178 26102 2838 2328967
Exposure via ingestion 474.76 24.84 129 26151 659 2331146
Confusional state 465.16 24.84 347 25933 23997 2307808
Stevens-Johnson syndrome 457.18 24.84 190 26090 4069 2327736
Pyrexia 450.66 24.84 480 25800 53228 2278577
Melaena 450.29 24.84 186 26094 3920 2327885
Drug-induced liver injury 437.86 24.84 177 26103 3522 2328283
Hepatic necrosis 431.05 24.84 129 26151 981 2330824
Loss of consciousness 428.17 24.84 298 25982 18469 2313336
Agitation 416.24 24.84 241 26039 10810 2320995
Renal failure 415.82 24.84 284 25996 17065 2314740
Pain 408.33 24.84 488 25792 61369 2270436
Seizure 395.80 24.84 316 25964 24150 2307655
Anaphylactic reaction 393.23 24.84 222 26058 9483 2322322
Condition aggravated 391.97 24.84 352 25928 31627 2300178
Headache 386.00 24.84 541 25739 79638 2252167
Unresponsive to stimuli 381.28 24.84 174 26106 4702 2327103
Hypersensitivity 377.94 24.84 303 25977 23290 2308515
Erythema 373.32 24.84 309 25971 24850 2306955
Electrocardiogram QT prolonged 361.21 24.84 195 26085 7619 2324186
Brain oedema 360.07 24.84 135 26145 2175 2329630
Hypertension 356.78 24.84 312 25968 27049 2304756
Fatigue 350.88 24.84 533 25747 84340 2247465
Aspirin-exacerbated respiratory disease 344.75 24.84 76 26204 120 2331685
Hepatitis 343.69 24.84 176 26104 6161 2325644
Hypothermia 329.22 24.84 124 26156 2024 2329781
Jaundice 328.07 24.84 163 26117 5345 2326460
Lethargy 327.64 24.84 190 26090 8540 2323265
Product use issue 322.17 24.84 212 26068 11957 2319848
Sinus tachycardia 319.02 24.84 137 26143 3188 2328617
Upper gastrointestinal haemorrhage 304.39 24.84 116 26164 1958 2329847
Poisoning deliberate 302.09 24.84 100 26180 1091 2330714
Anaemia 302.03 24.84 317 25963 34475 2297330
Mydriasis 300.31 24.84 117 26163 2102 2329703
Anion gap 297.39 24.84 63 26217 72 2331733
Blood creatinine increased 294.72 24.84 190 26090 10343 2321462
Dizziness 292.51 24.84 403 25877 58262 2273543
Electrocardiogram QRS complex prolonged 289.44 24.84 95 26185 1007 2330798
Acidosis 283.74 24.84 103 26177 1507 2330298
Asthma 282.32 24.84 190 26090 11124 2320681
Product administration error 281.09 24.84 132 26148 3811 2327994
Mental status changes 276.77 24.84 146 26134 5436 2326369
Infusion related reaction 272.32 24.84 176 26104 9620 2322185
Rhabdomyolysis 270.51 24.84 153 26127 6551 2325254
Acute respiratory distress syndrome 268.45 24.84 121 26159 3171 2328634
Gastritis 265.21 24.84 133 26147 4448 2327357
Heart rate increased 264.01 24.84 181 26099 10924 2320881
Intentional self-injury 260.24 24.84 127 26153 4000 2327805
Transaminases increased 253.33 24.84 129 26151 4458 2327347
Abortion spontaneous 252.78 24.84 190 26090 13255 2318550
Haematochezia 252.65 24.84 135 26145 5160 2326645
Face oedema 250.47 24.84 122 26158 3826 2327979
Rheumatoid arthritis 242.76 24.84 215 26065 18925 2312880
Off label use 242.00 24.84 417 25863 73181 2258624
Product use in unapproved indication 239.30 24.84 171 26109 11029 2320776
Respiratory depression 236.81 24.84 98 26182 2072 2329733
Prothrombin time prolonged 236.07 24.84 91 26189 1586 2330219
Hepatic enzyme increased 235.91 24.84 161 26119 9641 2322164
Lip swelling 233.06 24.84 124 26156 4697 2327108
Duodenal ulcer 231.90 24.84 81 26199 1052 2330753
Drug reaction with eosinophilia and systemic symptoms 230.92 24.84 129 26151 5389 2326416
Tachypnoea 230.92 24.84 97 26183 2132 2329673
Asthenia 225.65 24.84 317 25963 46609 2285196
Brain death 224.55 24.84 67 26213 503 2331302
Hyperhidrosis 219.36 24.84 185 26095 15237 2316568
Blood bilirubin increased 218.36 24.84 123 26157 5222 2326583
Drug dependence 217.21 24.84 102 26178 2943 2328862
Drug screen positive 208.58 24.84 71 26209 849 2330956
Haemoglobin decreased 206.81 24.84 192 26088 17959 2313846
Liver function test abnormal 204.27 24.84 133 26147 7357 2324448
Substance abuse 201.05 24.84 61 26219 488 2331317
Accidental death 200.45 24.84 54 26226 265 2331540
Drug intolerance 200.13 24.84 167 26113 13550 2318255
Generalised tonic-clonic seizure 199.04 24.84 116 26164 5256 2326549
Blood pH decreased 199.02 24.84 59 26221 432 2331373
Gastrointestinal sounds abnormal 198.27 24.84 61 26219 514 2331291
Encephalopathy 197.33 24.84 109 26171 4452 2327353
Swelling face 196.04 24.84 142 26138 9351 2322454
Analgesic drug level increased 195.64 24.84 52 26228 240 2331565
Acute generalised exanthematous pustulosis 194.96 24.84 79 26201 1579 2330226
Drug level increased 194.61 24.84 92 26188 2695 2329110
Hepatic encephalopathy 193.89 24.84 78 26202 1529 2330276
Hepatic function abnormal 193.15 24.84 119 26161 5973 2325832
Kounis syndrome 191.54 24.84 50 26230 212 2331593
Contraindicated product administered 190.55 24.84 93 26187 2928 2328877
Cholestasis 189.19 24.84 99 26181 3622 2328183
Ulcer 188.70 24.84 80 26200 1800 2330005
Malaise 186.47 24.84 318 25962 55267 2276538
Bradycardia 185.22 24.84 140 26140 9841 2321964
Lip oedema 182.50 24.84 63 26217 788 2331017
Renal tubular necrosis 180.94 24.84 74 26206 1516 2330289
Anticholinergic syndrome 180.80 24.84 49 26231 247 2331558
Product prescribing error 180.36 24.84 89 26191 2871 2328934
Hepatitis cholestatic 178.02 24.84 67 26213 1090 2330715
Multiple organ dysfunction syndrome 177.91 24.84 123 26157 7518 2324287
Arthralgia 177.40 24.84 307 25973 53978 2277827
Pulmonary oedema 177.28 24.84 121 26159 7242 2324563
Coma scale abnormal 177.14 24.84 61 26219 757 2331048
Abdominal discomfort 176.71 24.84 173 26107 17283 2314522
C-reactive protein abnormal 174.64 24.84 60 26220 739 2331066
Serotonin syndrome 173.76 24.84 92 26188 3448 2328357
Dysphagia 172.65 24.84 149 26131 12656 2319149
Pyroglutamate increased 171.84 24.84 35 26245 27 2331778
Self-medication 170.94 24.84 55 26225 544 2331261
Dry mouth 169.37 24.84 123 26157 8130 2323675
Hepatocellular injury 167.47 24.84 94 26186 3961 2327844
Cough 166.93 24.84 229 26051 32888 2298917
Circulatory collapse 166.70 24.84 91 26189 3629 2328176
Hepatitis acute 166.39 24.84 69 26211 1466 2330339
Blood pressure decreased 165.75 24.84 127 26153 9109 2322696
Diarrhoea 164.10 24.84 382 25898 83182 2248623
Thrombocytopenia 163.41 24.84 173 26107 18958 2312847
Acute lung injury 161.63 24.84 41 26239 151 2331654
Hypoglycaemia 158.37 24.84 119 26161 8288 2323517
Agranulocytosis 158.31 24.84 86 26194 3396 2328409
General physical health deterioration 158.00 24.84 148 26132 13991 2317814
Insomnia 157.43 24.84 196 26084 25591 2306214
Pancreatitis acute 152.86 24.84 87 26193 3766 2328039
Respiratory distress 152.01 24.84 96 26184 5033 2326772
Eyelid oedema 151.25 24.84 76 26204 2550 2329255
Dehydration 149.97 24.84 178 26102 22117 2309688
Renal impairment 149.52 24.84 124 26156 9968 2321837
Lactic acidosis 148.63 24.84 96 26184 5234 2326571
Syncope 148.39 24.84 155 26125 16720 2315085
Musculoskeletal stiffness 148.11 24.84 134 26146 12113 2319692
Blood urea increased 147.33 24.84 83 26197 3522 2328283
Respiratory failure 146.17 24.84 139 26141 13389 2318416
Eye disorder 144.94 24.84 79 26201 3140 2328665
Arteriosclerosis coronary artery 141.73 24.84 57 26223 1116 2330689
Synovitis 139.92 24.84 73 26207 2653 2329152
Rash maculo-papular 139.73 24.84 85 26195 4167 2327638
Duodenal ulcer perforation 139.03 24.84 41 26239 294 2331511
Tremor 139.02 24.84 165 26115 20496 2311309
Rash erythematous 138.64 24.84 96 26184 5880 2325925
Temperature regulation disorder 138.59 24.84 35 26245 126 2331679
Bezoar 138.28 24.84 37 26243 176 2331629
Delirium 135.70 24.84 90 26190 5133 2326672
Blood lactic acid increased 133.54 24.84 50 26230 801 2331004
Incorrect dose administered 133.07 24.84 114 26166 9581 2322224
White blood cell count increased 132.89 24.84 100 26180 6978 2324827
Hyperkalaemia 132.81 24.84 93 26187 5800 2326005
Blood pressure increased 131.73 24.84 146 26134 16840 2314965
Hypokalaemia 131.64 24.84 118 26162 10536 2321269
Inflammation 130.67 24.84 94 26186 6119 2325686
Wheezing 130.64 24.84 95 26185 6289 2325516
Gamma-glutamyltransferase increased 130.56 24.84 90 26190 5472 2326333
Pharyngitis 129.64 24.84 65 26215 2170 2329635
Renal tubular acidosis 129.64 24.84 39 26241 302 2331503
Suicidal ideation 129.54 24.84 119 26161 10968 2320837
Food allergy 128.69 24.84 45 26235 586 2331219
Rectal haemorrhage 128.68 24.84 91 26189 5765 2326040
Liver transplant 127.98 24.84 44 26236 543 2331262
Hallucination 126.73 24.84 103 26177 8045 2323760
Shock 126.36 24.84 78 26202 3926 2327879
Blood creatine phosphokinase increased 125.03 24.84 85 26195 5051 2326754
Gastritis erosive 123.67 24.84 47 26233 786 2331019
Peripheral swelling 122.47 24.84 143 26137 17454 2314351
Dyspepsia 119.58 24.84 108 26172 9736 2322069
Hypoxia 119.17 24.84 89 26191 6138 2325667
Blood bicarbonate decreased 118.66 24.84 40 26240 463 2331342
Haematocrit decreased 118.49 24.84 77 26203 4241 2327564
Aggression 118.39 24.84 80 26200 4706 2327099
Dysarthria 118.22 24.84 89 26191 6213 2325592
Nasal disorder 116.82 24.84 36 26244 305 2331500
Leukocytosis 116.25 24.84 71 26209 3505 2328300
Back pain 115.16 24.84 188 26092 31471 2300334
Sedation 115.09 24.84 69 26211 3293 2328512
Anxiety 114.54 24.84 180 26100 29179 2302626
Pupil fixed 114.31 24.84 38 26242 420 2331385
Decreased appetite 113.92 24.84 178 26102 28713 2303092
Pneumonia 113.03 24.84 240 26040 49056 2282749
Fall 112.29 24.84 233 26047 46866 2284939
Maternal exposure during pregnancy 112.23 24.84 126 26154 14737 2317068
Drug eruption 111.86 24.84 67 26213 3192 2328613
Anaphylactic shock 111.69 24.84 74 26206 4212 2327593
Pulseless electrical activity 111.27 24.84 46 26234 969 2330836
Toxicologic test abnormal 111.26 24.84 29 26251 122 2331683
Flank pain 110.93 24.84 52 26228 1493 2330312
Sepsis 110.34 24.84 139 26141 18349 2313456
Joint swelling 109.31 24.84 132 26148 16687 2315118
Depression 109.08 24.84 172 26108 27960 2303845
Asphyxia 108.37 24.84 45 26235 959 2330846
Eosinophilia 107.00 24.84 63 26217 2907 2328898
Flushing 106.05 24.84 110 26170 11761 2320044
Swelling 105.74 24.84 128 26152 16222 2315583
Gastrointestinal disorder 104.72 24.84 96 26184 8821 2322984
Meningitis aseptic 103.63 24.84 39 26241 634 2331171
C-reactive protein increased 103.50 24.84 82 26198 6173 2325632
Bursitis 103.40 24.84 53 26227 1855 2329950
Postmortem blood drug level increased 103.30 24.84 23 26257 39 2331766
Foetal death 103.29 24.84 53 26227 1859 2329946
Ventricular arrhythmia 103.23 24.84 38 26242 579 2331226
Body temperature increased 103.19 24.84 63 26217 3108 2328697
Respiratory rate increased 102.51 24.84 49 26231 1471 2330334
Throat tightness 102.27 24.84 71 26209 4365 2327440
Loss of personal independence in daily activities 101.83 24.84 76 26204 5235 2326570
Anion gap increased 101.72 24.84 31 26249 252 2331553
Compartment syndrome 101.45 24.84 34 26246 386 2331419
Laryngeal oedema 100.73 24.84 46 26234 1242 2330563
Blood alkaline phosphatase increased 100.23 24.84 82 26198 6463 2325342
Chest pain 99.50 24.84 165 26115 27972 2303833
Lower respiratory tract infection 98.20 24.84 75 26205 5349 2326456
Disorientation 97.93 24.84 80 26200 6292 2325513
Vanishing bile duct syndrome 97.88 24.84 27 26253 147 2331658
Oxygen saturation decreased 97.63 24.84 86 26194 7500 2324305
Mucosal dryness 97.14 24.84 32 26248 343 2331462
Visual impairment 96.26 24.84 104 26176 11651 2320154
Oedema 93.76 24.84 96 26184 10107 2321698
Miosis 93.48 24.84 43 26237 1181 2330624
Hypertensive emergency 92.82 24.84 28 26252 219 2331586
Electric shock 92.82 24.84 23 26257 75 2331730
Urinary retention 92.38 24.84 62 26218 3605 2328200
Hyponatraemia 92.21 24.84 108 26172 13217 2318588
Gastric ulcer haemorrhage 91.85 24.84 38 26242 802 2331003
Blood sodium decreased 91.79 24.84 58 26222 3042 2328763
Abnormal behaviour 91.00 24.84 68 26212 4692 2327113
Labelled drug-drug interaction medication error 90.76 24.84 43 26237 1265 2330540
Status epilepticus 90.42 24.84 53 26227 2425 2329380
Cognitive disorder 90.01 24.84 71 26209 5310 2326495
Anuria 88.36 24.84 47 26233 1777 2330028
Arthropathy 88.32 24.84 80 26200 7236 2324569
Haemodialysis 88.24 24.84 49 26231 2020 2329785
Weight decreased 86.72 24.84 156 26124 28215 2303590
Oliguria 86.23 24.84 42 26238 1315 2330490
Erythema multiforme 85.96 24.84 49 26231 2126 2329679
Immunodeficiency 85.95 24.84 39 26241 1037 2330768
Haematuria 85.49 24.84 63 26217 4255 2327550
Clonus 85.48 24.84 33 26247 577 2331228
Accidental exposure to product by child 85.42 24.84 33 26247 578 2331227
Nephropathy toxic 85.33 24.84 40 26240 1148 2330657
Ataxia 84.92 24.84 51 26229 2441 2329364
Faeces discoloured 84.88 24.84 50 26230 2309 2329496
Constipation 84.86 24.84 133 26147 21496 2310309
Haemodynamic instability 82.54 24.84 39 26241 1140 2330665
Coeliac disease 82.14 24.84 35 26245 797 2331008
Brain injury 82.02 24.84 36 26244 883 2330922
Accidental exposure to product 81.82 24.84 82 26198 8415 2323390
Conjunctivitis 81.61 24.84 49 26231 2344 2329461
Tinnitus 80.02 24.84 65 26215 5070 2326735
Swollen tongue 79.84 24.84 66 26214 5277 2326528
Sinusitis 79.74 24.84 112 26168 16414 2315391
Premature labour 79.37 24.84 46 26234 2060 2329745
Liver disorder 79.12 24.84 71 26209 6343 2325462
Blood potassium decreased 78.16 24.84 65 26215 5240 2326565
Chest discomfort 78.10 24.84 104 26176 14491 2317314
Drug abuser 77.29 24.84 35 26245 926 2330879
Palpitations 77.15 24.84 110 26170 16346 2315459
Activated partial thromboplastin time prolonged 76.37 24.84 38 26242 1247 2330558
Feeling abnormal 76.36 24.84 133 26147 23448 2308357
Hypophagia 76.14 24.84 57 26223 3943 2327862
Oesophagitis 76.09 24.84 44 26236 1962 2329843
Chills 75.93 24.84 106 26174 15446 2316359
Bronchospasm 75.87 24.84 51 26229 2973 2328832
Photophobia 75.81 24.84 46 26234 2243 2329562
Hepatic steatosis 75.41 24.84 52 26228 3161 2328644
Periorbital oedema 75.36 24.84 35 26245 983 2330822
Body temperature decreased 75.33 24.84 38 26242 1285 2330520
Arrhythmia 74.90 24.84 67 26213 5961 2325844
Intervertebral discitis 74.58 24.84 25 26255 284 2331521
Alcohol use 74.46 24.84 28 26252 454 2331351
Fixed eruption 73.62 24.84 22 26258 166 2331639
Renal papillary necrosis 73.57 24.84 17 26263 37 2331768
Gastric disorder 73.16 24.84 54 26226 3656 2328149
Pancytopenia 72.95 24.84 89 26191 11363 2320442
Chromaturia 72.85 24.84 48 26232 2705 2329100
Throat irritation 72.80 24.84 61 26219 4969 2326836
Drug level above therapeutic 72.34 24.84 28 26252 493 2331312
Blood lactate dehydrogenase increased 71.62 24.84 52 26228 3432 2328373
Duodenal ulcer haemorrhage 71.12 24.84 26 26254 388 2331417
Haemolysis 71.02 24.84 34 26246 1024 2330781
Blood pressure systolic increased 69.84 24.84 44 26236 2295 2329510
Drug ineffective for unapproved indication 69.60 24.84 48 26232 2918 2328887
Breast cancer 69.11 24.84 79 26201 9416 2322389
Muscular weakness 68.97 24.84 99 26181 14798 2317007
Ammonia increased 68.60 24.84 30 26250 729 2331076
Disturbance in attention 68.29 24.84 62 26218 5623 2326182
Blister 68.25 24.84 67 26213 6704 2325101
Restlessness 67.41 24.84 56 26224 4507 2327298
Cardiogenic shock 67.30 24.84 44 26236 2447 2329358
Hypersensitivity vasculitis 67.19 24.84 35 26245 1267 2330538
Hyperbilirubinaemia 66.92 24.84 37 26243 1512 2330293
Proteinuria 66.59 24.84 46 26234 2804 2329001
Analgesic drug level above therapeutic 66.45 24.84 15 26265 28 2331777
Pulmonary congestion 66.40 24.84 40 26240 1925 2329880
Hyperthermia 66.00 24.84 36 26244 1432 2330373
Blood pressure systolic decreased 65.52 24.84 29 26251 726 2331079
Oedema peripheral 65.49 24.84 125 26155 23638 2308167
Pancreatitis 65.29 24.84 71 26209 8008 2323797
Jejunal ulcer 65.12 24.84 15 26265 32 2331773
Pharyngeal oedema 64.77 24.84 49 26231 3444 2328361
Gastric haemorrhage 64.57 24.84 32 26248 1041 2330764
Nasopharyngitis 64.49 24.84 119 26161 21937 2309868
Premature baby 64.00 24.84 47 26233 3157 2328648
Iron deficiency anaemia 63.96 24.84 40 26240 2059 2329746
Pneumonia aspiration 63.93 24.84 50 26230 3692 2328113
Gait disturbance 63.87 24.84 120 26160 22425 2309380
Haematoma 63.78 24.84 57 26223 5064 2326741
Discomfort 63.42 24.84 57 26223 5102 2326703
Respiratory disorder 63.05 24.84 51 26229 3953 2327852
Enthesopathy 63.05 24.84 19 26261 148 2331657
Gastric perforation 62.94 24.84 22 26258 286 2331519
Hepatitis fulminant 62.75 24.84 27 26253 630 2331175
Pain in extremity 61.94 24.84 174 26106 42366 2289439
Oligohydramnios 61.86 24.84 30 26250 930 2330875
Purpura 61.56 24.84 37 26243 1773 2330032
Feeling hot 61.50 24.84 64 26216 6864 2324941
Post-traumatic stress disorder 60.37 24.84 24 26256 455 2331350
Night sweats 60.30 24.84 47 26233 3453 2328352
Tongue oedema 59.14 24.84 28 26252 822 2330983
Weight increased 58.49 24.84 115 26165 22222 2309583
Gastrooesophageal reflux disease 58.44 24.84 71 26209 9024 2322781
Coordination abnormal 58.36 24.84 37 26243 1951 2329854
Red blood cell sedimentation rate abnormal 58.33 24.84 24 26256 499 2331306
Dactylitis 58.02 24.84 16 26264 87 2331718
Osteoarthritis 57.80 24.84 62 26218 6884 2324921
Hyperventilation 57.65 24.84 31 26249 1198 2330607
Ventricular tachycardia 57.52 24.84 43 26237 2968 2328837
Dermatitis exfoliative 57.37 24.84 31 26249 1210 2330595
Deep vein thrombosis 57.04 24.84 84 26196 12848 2318957
Alcohol poisoning 56.86 24.84 21 26259 323 2331482
Hepatomegaly 56.45 24.84 35 26245 1774 2330031
Blood glucose increased 55.90 24.84 81 26199 12209 2319596
Stillbirth 55.70 24.84 32 26248 1409 2330396
Rash macular 55.65 24.84 45 26235 3486 2328319
Urinary tract infection 55.40 24.84 134 26146 29808 2301997
Red blood cells urine positive 55.36 24.84 19 26261 233 2331572
Septic shock 55.28 24.84 61 26219 6993 2324812
Hyperreflexia 54.60 24.84 27 26253 874 2330931
Areflexia 54.29 24.84 24 26256 599 2331206
Urine output decreased 54.13 24.84 32 26248 1487 2330318
Migraine 54.07 24.84 74 26206 10579 2321226
Abdominal pain lower 54.06 24.84 41 26239 2892 2328913
Respiratory alkalosis 52.92 24.84 20 26260 329 2331476
Blood pressure fluctuation 52.82 24.84 34 26246 1841 2329964
PO2 increased 52.50 24.84 16 26264 130 2331675
Blood pressure diastolic decreased 52.43 24.84 28 26252 1067 2330738
Brain herniation 52.40 24.84 23 26257 564 2331241
Allergy test positive 52.32 24.84 13 26267 43 2331762
Bacterial test 52.29 24.84 16 26264 132 2331673
Bradypnoea 52.12 24.84 21 26259 413 2331392
Fibromyalgia 51.89 24.84 42 26238 3258 2328547
Coma hepatic 51.79 24.84 17 26263 180 2331625
Drug withdrawal syndrome 51.75 24.84 58 26222 6763 2325042
Myocardial ischaemia 51.65 24.84 36 26244 2226 2329579
Neutrophilia 51.46 24.84 22 26258 505 2331300
Adrenal insufficiency 51.22 24.84 30 26250 1370 2330435
Red blood cell sedimentation rate increased 51.13 24.84 35 26245 2102 2329703
Joint effusion 51.10 24.84 29 26251 1247 2330558
Dilatation intrahepatic duct acquired 51.10 24.84 14 26266 74 2331731
Intentional product use issue 50.72 24.84 43 26237 3559 2328246
Myalgia 50.40 24.84 111 26169 23222 2308583
Balance disorder 49.91 24.84 68 26212 9679 2322126
Infection 49.86 24.84 95 26185 17934 2313871
Hyperlactacidaemia 49.84 24.84 20 26260 389 2331416
Intestinal ischaemia 49.73 24.84 27 26253 1064 2330741
Toxic skin eruption 49.36 24.84 35 26245 2225 2329580
Synovial fluid analysis 48.91 24.84 11 26269 20 2331785
Myoclonus 48.64 24.84 36 26244 2447 2329358
Acute respiratory failure 48.48 24.84 39 26241 2999 2328806
Rheumatoid nodule 48.10 24.84 22 26258 596 2331209
Respiratory acidosis 47.97 24.84 24 26256 797 2331008
Gastric ulcer perforation 47.95 24.84 17 26263 231 2331574
Haemolytic anaemia 47.85 24.84 32 26248 1849 2329956
Ear pain 47.54 24.84 37 26243 2712 2329093
Foetal exposure during pregnancy 47.48 24.84 49 26231 5203 2326602
Vitamin K deficiency 47.40 24.84 13 26267 69 2331736
Speech disorder 47.40 24.84 54 26226 6410 2325395
Adverse drug reaction 47.36 24.84 61 26219 8222 2323583
Pallor 47.29 24.84 42 26238 3700 2328105
Upper respiratory tract infection 47.23 24.84 63 26217 8788 2323017
Disseminated intravascular coagulation 47.18 24.84 40 26240 3310 2328495
Emphysema 47.10 24.84 26 26254 1059 2330746
Hypoaesthesia 46.90 24.84 99 26181 20116 2311689
Multiple fractures 46.88 24.84 22 26258 633 2331172
Eye pain 46.70 24.84 47 26233 4844 2326961
Muscle spasticity 46.62 24.84 30 26250 1623 2330182
Demyelination 46.61 24.84 25 26255 961 2330844
Contusion 46.41 24.84 76 26204 12734 2319071
Temperature intolerance 46.35 24.84 25 26255 972 2330833
Altered state of consciousness 46.17 24.84 42 26238 3818 2327987
Aspiration 46.16 24.84 29 26251 1505 2330300
Gastrointestinal ulcer 45.88 24.84 18 26262 329 2331476
Amylase increased 45.71 24.84 26 26254 1123 2330682
Shock haemorrhagic 45.64 24.84 27 26253 1256 2330549
Blood potassium increased 45.64 24.84 33 26247 2163 2329642
PCO2 decreased 45.59 24.84 17 26263 269 2331536
Anion gap abnormal 45.57 24.84 12 26268 53 2331752
Biliary sepsis 45.51 24.84 13 26267 82 2331723
Abdominal tenderness 45.20 24.84 25 26255 1022 2330783
Sopor 44.93 24.84 42 26238 3953 2327852
Urinary incontinence 44.74 24.84 43 26237 4190 2327615
Lacrimation increased 44.46 24.84 36 26244 2794 2329011
Depressed mood 44.31 24.84 47 26233 5151 2326654
Anal haemorrhage 44.31 24.84 17 26263 292 2331513
Oesophageal ulcer 44.24 24.84 22 26258 721 2331084
Blood creatine increased 44.03 24.84 21 26259 627 2331178
Gastrointestinal pain 43.92 24.84 25 26255 1081 2330724
Wrong product administered 43.79 24.84 27 26253 1355 2330450
Urine abnormality 43.65 24.84 20 26260 544 2331261
Eye swelling 43.42 24.84 43 26237 4347 2327458
Dry eye 43.36 24.84 41 26239 3915 2327890
Gastritis haemorrhagic 42.86 24.84 16 26264 254 2331551
Psychomotor hyperactivity 42.51 24.84 30 26250 1892 2329913
Polyuria 42.38 24.84 25 26255 1157 2330648
Therapy non-responder 42.19 24.84 57 26223 8047 2323758
Opiates positive 42.06 24.84 11 26269 47 2331758
Haemorrhage 42.05 24.84 67 26213 10972 2320833
Product communication issue 42.03 24.84 10 26270 26 2331779
Necrotising fasciitis 42.01 24.84 19 26261 501 2331304
Product monitoring error 41.58 24.84 13 26267 116 2331689
Dialysis 41.51 24.84 31 26249 2136 2329669
Hepatic cirrhosis 41.41 24.84 32 26248 2321 2329484
Osteoporosis 41.38 24.84 42 26238 4372 2327433
Pupillary reflex impaired 41.02 24.84 18 26262 441 2331364
Cardiomegaly 40.89 24.84 32 26248 2364 2329441
Hypotonia 40.60 24.84 28 26252 1702 2330103
Blood loss anaemia 40.48 24.84 24 26256 1121 2330684
Fluid retention 40.46 24.84 52 26228 6994 2324811
Caesarean section 40.41 24.84 40 26240 4041 2327764
Antidepressant drug level above therapeutic 40.33 24.84 11 26269 57 2331748
Respiratory rate decreased 40.22 24.84 19 26261 555 2331250
Dermo-hypodermitis 40.17 24.84 11 26269 58 2331747
Hepatitis toxic 39.84 24.84 20 26260 669 2331136
Dysphonia 39.78 24.84 49 26231 6315 2325490
Localised oedema 39.66 24.84 21 26259 786 2331019
Hypoaldosteronism 39.59 24.84 10 26270 36 2331769
Renal ischaemia 39.26 24.84 11 26269 64 2331741
Muscle rigidity 39.16 24.84 28 26252 1803 2330002
Lymphadenopathy 39.09 24.84 46 26234 5652 2326153
Ductus arteriosus premature closure 38.97 24.84 10 26270 39 2331766
Obstructive airways disorder 38.93 24.84 25 26255 1348 2330457
Therapeutic product effect incomplete 38.85 24.84 63 26217 10468 2321337
Arthritis 38.65 24.84 61 26219 9907 2321898
Red blood cell sedimentation rate 38.52 24.84 9 26271 21 2331784
Skin abrasion 38.26 24.84 23 26257 1102 2330703
Rhinitis 38.19 24.84 23 26257 1106 2330699
Incorrect route of product administration 38.15 24.84 44 26236 5292 2326513
Rash papular 38.12 24.84 32 26248 2612 2329193
Gastroenteritis 37.98 24.84 34 26246 3026 2328779
Therapeutic product effect decreased 37.73 24.84 63 26217 10726 2321079
Anhidrosis 37.12 24.84 10 26270 49 2331756
Deafness transitory 37.12 24.84 13 26267 170 2331635
Cerebral haemorrhage 37.04 24.84 44 26236 5460 2326345
Tenosynovitis stenosans 36.90 24.84 12 26268 123 2331682
Muscle twitching 36.87 24.84 32 26248 2733 2329072
Dermatitis bullous 36.85 24.84 25 26255 1479 2330326
Paraesthesia 36.79 24.84 95 26185 21993 2309812
Small intestinal haemorrhage 36.76 24.84 15 26265 305 2331500
Premature delivery 36.68 24.84 34 26246 3166 2328639
Palatal oedema 36.64 24.84 13 26267 177 2331628
Joint laxity 36.63 24.84 10 26270 52 2331753
Platelet count increased 36.29 24.84 29 26251 2208 2329597
Atrial fibrillation 36.17 24.84 71 26209 13697 2318108
Dysuria 36.04 24.84 37 26243 3904 2327901
Hepatic congestion 36.01 24.84 15 26265 322 2331483
Intestinal diaphragm disease 35.94 24.84 9 26271 31 2331774
Embolism venous 35.84 24.84 15 26265 326 2331479
Gastrointestinal inflammation 35.79 24.84 19 26261 715 2331090
Tenderness 35.76 24.84 27 26253 1891 2329914
Feeling jittery 35.59 24.84 27 26253 1905 2329900
Vaginal haemorrhage 35.49 24.84 41 26239 4939 2326866
Kidney enlargement 35.35 24.84 12 26268 142 2331663
Treatment noncompliance 35.22 24.84 43 26237 5491 2326314
Anti-thyroid antibody positive 35.20 24.84 11 26269 98 2331707
Adrenergic syndrome 35.20 24.84 7 26273 4 2331801
Oesophageal discomfort 35.15 24.84 10 26270 62 2331743
Intestinal perforation 35.15 24.84 26 26254 1765 2330040
Lipase increased 35.10 24.84 24 26256 1438 2330367
Haemophilus infection 35.05 24.84 12 26268 146 2331659
Post procedural complication 35.05 24.84 32 26248 2922 2328883
Lower gastrointestinal haemorrhage 35.00 24.84 21 26259 1003 2330802
Oropharyngeal pain 34.72 24.84 63 26217 11455 2320350
Dystonia 34.66 24.84 28 26252 2166 2329639
Heart rate decreased 34.50 24.84 35 26245 3641 2328164
Mouth ulceration 34.46 24.84 36 26244 3876 2327929
Multiple drug therapy 34.31 24.84 9 26271 39 2331766
Erythema nodosum 34.26 24.84 19 26261 781 2331024
Autoimmune hepatitis 34.15 24.84 25 26255 1670 2330135
Type IV hypersensitivity reaction 34.10 24.84 17 26263 560 2331245
Colitis microscopic 34.09 24.84 20 26260 916 2330889
Thyroid stimulating immunoglobulin increased 34.03 24.84 7 26273 6 2331799
Petechiae 33.91 24.84 27 26253 2045 2329760
Scleritis 33.90 24.84 14 26266 294 2331511
Colitis 33.89 24.84 41 26239 5185 2326620
Autoimmune thyroiditis 33.55 24.84 17 26263 580 2331225
Obstruction gastric 33.52 24.84 12 26268 168 2331637
Deafness 33.50 24.84 30 26250 2671 2329134
Peptic ulcer 33.50 24.84 17 26263 582 2331223
Rash pruritic 33.30 24.84 49 26231 7486 2324319
Pharyngeal paraesthesia 33.05 24.84 11 26269 122 2331683
Blood calcium decreased 32.95 24.84 27 26253 2131 2329674
Hepatorenal failure 32.89 24.84 11 26269 124 2331681
Toxic shock syndrome streptococcal 32.79 24.84 8 26272 24 2331781
Epistaxis 32.73 24.84 56 26224 9723 2322082
Prothrombin level increased 32.63 24.84 10 26270 83 2331722
Abscess rupture 32.63 24.84 9 26271 49 2331756
White blood cells urine positive 32.57 24.84 15 26265 413 2331392
Mucous stools 32.40 24.84 14 26266 330 2331475
Glomerular filtration rate decreased 32.32 24.84 23 26257 1470 2330335
Blood alcohol increased 32.27 24.84 11 26269 132 2331673
Hypoxic-ischaemic encephalopathy 32.14 24.84 18 26262 754 2331051
Stress 31.94 24.84 46 26234 6892 2324913
Skin laceration 31.72 24.84 29 26251 2653 2329152
Ischaemic hepatitis 31.70 24.84 13 26267 268 2331537
Hiatus hernia 31.66 24.84 26 26254 2058 2329747
Duodenal stenosis 31.62 24.84 10 26270 93 2331712
Myocarditis 31.57 24.84 21 26259 1202 2330603
Thrombotic thrombocytopenic purpura 31.57 24.84 18 26262 781 2331024
Mucosal disorder 31.54 24.84 15 26265 445 2331360
Corneal leukoma 31.39 24.84 7 26273 12 2331793
Impaired healing 31.17 24.84 40 26240 5371 2326434
Musculoskeletal pain 31.09 24.84 58 26222 10772 2321033
Infected dermal cyst 30.95 24.84 9 26271 61 2331744
Evans syndrome 30.95 24.84 9 26271 61 2331744
Blood glucose decreased 30.59 24.84 31 26249 3221 2328584
Skin exfoliation 30.56 24.84 41 26239 5749 2326056
Cholelithiasis 30.49 24.84 41 26239 5762 2326043
Protein-losing gastroenteropathy 30.46 24.84 9 26271 65 2331740
Milk-alkali syndrome 30.45 24.84 10 26270 106 2331699
Acute haemorrhagic oedema of infancy 30.45 24.84 6 26274 3 2331802
Vertigo 30.44 24.84 53 26227 9331 2322474
Duodenitis haemorrhagic 30.37 24.84 7 26273 15 2331790
Cheilitis 30.36 24.84 18 26262 841 2330964
Bilirubin conjugated increased 30.35 24.84 15 26265 485 2331320
Streptococcal infection 30.20 24.84 18 26262 849 2330956
Abscess 30.15 24.84 27 26253 2404 2329401
Large intestinal ulcer 30.15 24.84 15 26265 492 2331313
Electrolyte imbalance 30.08 24.84 25 26255 2012 2329793
Torsade de pointes 29.96 24.84 26 26254 2220 2329585
Tenosynovitis 29.90 24.84 15 26265 501 2331304
Granuloma skin 29.88 24.84 10 26270 113 2331692
Lung infiltration 29.78 24.84 26 26254 2238 2329567
Urinary sediment present 29.73 24.84 11 26269 170 2331635
Staphylococcal scalded skin syndrome 29.73 24.84 8 26272 39 2331766
Anoxia 29.55 24.84 9 26271 73 2331732
Haemarthrosis 29.54 24.84 14 26266 412 2331393
Obesity 29.48 24.84 22 26258 1514 2330291
International normalised ratio decreased 29.11 24.84 17 26263 772 2331033
Crepitations 29.02 24.84 16 26264 650 2331155
Nasal congestion 28.92 24.84 44 26236 6922 2324883
Still's disease 28.89 24.84 10 26270 126 2331679
Ecchymosis 28.89 24.84 22 26258 1561 2330244
Atelectasis 28.78 24.84 24 26256 1941 2329864
Allergic respiratory disease 28.69 24.84 7 26273 21 2331784
Interleukin level increased 28.49 24.84 8 26272 47 2331758
Ventricular fibrillation 28.40 24.84 25 26255 2176 2329629
Drug use disorder 28.36 24.84 13 26267 354 2331451
Neutrophil count increased 28.36 24.84 24 26256 1981 2329824
Distributive shock 28.33 24.84 9 26271 85 2331720
Lung disorder 28.32 24.84 41 26239 6171 2325634
Tongue disorder 28.31 24.84 19 26261 1104 2330701
Neonatal cardiac failure 28.25 24.84 6 26274 7 2331798
Ulcer haemorrhage 28.12 24.84 15 26265 570 2331235
Muscle injury 28.05 24.84 12 26268 276 2331529
Irritable bowel syndrome 28.04 24.84 23 26257 1818 2329987
Ductus arteriosus stenosis foetal 27.98 24.84 7 26273 24 2331781
Myocardial infarction 27.86 24.84 78 26202 18935 2312870
Infusion site streaking 27.81 24.84 6 26274 8 2331797
Vulvovaginal candidiasis 27.70 24.84 13 26267 374 2331431
Conjunctival hyperaemia 27.69 24.84 15 26265 588 2331217
Immune thrombocytopenic purpura 27.66 24.84 21 26259 1483 2330322
Dry skin 27.59 24.84 42 26238 6610 2325195
Mobility decreased 27.59 24.84 49 26231 8761 2323044
Hypertensive crisis 27.45 24.84 26 26254 2487 2329318
Glomerulonephritis chronic 27.34 24.84 7 26273 27 2331778
Patient uncooperative 27.34 24.84 7 26273 27 2331778
Leukopenia 27.29 24.84 53 26227 10143 2321662
Vasculitis 27.29 24.84 25 26255 2293 2329512
Hypovolaemia 27.12 24.84 19 26261 1184 2330621
Body height below normal 27.03 24.84 9 26271 100 2331705
Alanine aminotransferase abnormal 26.99 24.84 11 26269 223 2331582
Hypercalcaemia 26.77 24.84 26 26254 2566 2329239
Haemoptysis 26.77 24.84 30 26250 3497 2328308
Concussion 26.75 24.84 17 26263 900 2330905
Urinary hesitation 26.72 24.84 11 26269 229 2331576
Systemic inflammatory response syndrome 26.65 24.84 16 26264 765 2331040
Acute left ventricular failure 26.63 24.84 9 26271 105 2331700
Psychomotor skills impaired 26.63 24.84 13 26267 409 2331396
Pleuritic pain 26.62 24.84 15 26265 636 2331169
Continuous haemodiafiltration 26.62 24.84 12 26268 314 2331491
Apnoea 26.61 24.84 20 26260 1391 2330414
Skin ulcer 26.58 24.84 32 26248 4027 2327778
Panniculitis 26.51 24.84 14 26266 521 2331284
Genital odour 26.49 24.84 5 26275 1 2331804
Muscle spasms 26.39 24.84 83 26197 21483 2310322
Haemorrhagic diathesis 26.34 24.84 14 26266 528 2331277
Progressive multifocal leukoencephalopathy 26.32 24.84 24 26256 2188 2329617
Orthostatic hypotension 26.27 24.84 27 26253 2852 2328953
Bone loss 26.27 24.84 14 26266 531 2331274
Psychotic disorder 26.03 24.84 34 26246 4645 2327160
Optic neuritis 25.98 24.84 21 26259 1625 2330180
Accidental poisoning 25.82 24.84 9 26271 116 2331689
Restless legs syndrome 25.78 24.84 24 26256 2247 2329558
Abdominal compartment syndrome 25.75 24.84 9 26271 117 2331688
Hyperammonaemia 25.71 24.84 16 26264 816 2330989
Thyroxine free increased 25.68 24.84 9 26271 118 2331687
Paraesthesia oral 25.57 24.84 24 26256 2270 2329535
Perforated ulcer 25.54 24.84 9 26271 120 2331685
Acute myocardial infarction 25.47 24.84 35 26245 5020 2326785
Electrocardiogram abnormal 25.19 24.84 19 26261 1329 2330476
Skin lesion 25.16 24.84 31 26249 3994 2327811
Sleep apnoea syndrome 25.16 24.84 23 26257 2103 2329702
Hepatosplenomegaly 25.12 24.84 13 26267 464 2331341
Enanthema 25.08 24.84 9 26271 127 2331678
Skin discolouration 25.04 24.84 36 26244 5384 2326421
Abnormal clotting factor 24.94 24.84 7 26273 41 2331764

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
Toxicity to various agents 9439.35 32.34 2958 14652 26183 1702988
Completed suicide 8048.80 32.34 2302 15308 14010 1715161
Drug abuse 3196.77 32.34 1100 16510 12589 1716582
Overdose 2798.13 32.34 1050 16560 15651 1713520
Intentional overdose 2125.88 32.34 703 16907 6967 1722204
Acute kidney injury 1855.45 32.34 982 16628 33962 1695209
Intentional product misuse 1802.61 32.34 615 16995 6743 1722428
Drug hypersensitivity 1317.58 32.34 598 17012 14537 1714634
Cardio-respiratory arrest 1214.46 32.34 490 17120 8803 1720368
Suicide attempt 1203.54 32.34 457 17153 6924 1722247
Angioedema 1114.40 32.34 466 17144 9198 1719973
Respiratory arrest 1095.94 32.34 401 17209 5438 1723733
Cardiac arrest 1049.93 32.34 520 17090 15410 1713761
Death 903.13 32.34 910 16700 86533 1642638
Metabolic acidosis 852.83 32.34 327 17283 5075 1724096
Poisoning 832.68 32.34 265 17345 2267 1726904
Acute hepatic failure 772.78 32.34 238 17372 1805 1727366
Hypotension 758.98 32.34 524 17086 29130 1700041
Accidental overdose 751.18 32.34 278 17332 3886 1725285
Haematemesis 734.03 32.34 277 17333 4100 1725071
Gastrointestinal haemorrhage 709.63 32.34 386 17224 13881 1715290
Coma 706.90 32.34 311 17299 6951 1722220
Vomiting 636.95 32.34 523 17087 37792 1691379
Melaena 612.04 32.34 255 17355 4955 1724216
Urticaria 542.00 32.34 307 17303 11934 1717237
Drug interaction 502.62 32.34 400 17210 27558 1701613
Gastric ulcer 460.98 32.34 173 17437 2512 1726659
Somnolence 453.46 32.34 307 17303 16432 1712739
Gastric haemorrhage 443.55 32.34 173 17437 2805 1726366
Toxic epidermal necrolysis 407.83 32.34 153 17457 2218 1726953
Upper gastrointestinal haemorrhage 400.41 32.34 161 17449 2838 1726333
Nausea 368.03 32.34 443 17167 50753 1678418
Agitation 363.85 32.34 229 17381 10797 1718374
Hepatotoxicity 358.69 32.34 150 17460 2934 1726237
Duodenal ulcer 341.05 32.34 124 17486 1636 1727535
Tachycardia 337.85 32.34 230 17380 12398 1716773
Depressed level of consciousness 337.12 32.34 182 17428 6410 1722761
Gastritis 330.57 32.34 142 17468 2975 1726196
Abdominal pain 328.11 32.34 280 17330 21210 1707961
Alanine aminotransferase increased 319.85 32.34 220 17390 12058 1717113
Medication error 314.63 32.34 156 17454 4587 1724584
Stevens-Johnson syndrome 310.82 32.34 139 17471 3218 1725953
Renal failure 297.74 32.34 257 17353 19760 1709411
Aspartate aminotransferase increased 297.40 32.34 200 17410 10556 1718615
Anaphylactic reaction 291.01 32.34 161 17449 5952 1723219
Tubulointerstitial nephritis 288.36 32.34 127 17483 2831 1726340
Hepatic failure 287.97 32.34 158 17452 5745 1723426
Dizziness 284.23 32.34 320 17290 34041 1695130
Coagulopathy 282.78 32.34 123 17487 2658 1726513
International normalised ratio increased 280.26 32.34 175 17435 8124 1721047
Aspirin-exacerbated respiratory disease 277.40 32.34 60 17550 68 1729103
Abdominal pain upper 276.79 32.34 193 17417 10808 1718363
Blood creatinine increased 265.94 32.34 207 17403 13739 1715432
Pruritus 264.96 32.34 257 17353 22965 1706206
Liver injury 264.90 32.34 105 17505 1777 1727394
Dyspnoea 262.76 32.34 379 17231 51680 1677491
Faeces discoloured 259.75 32.34 111 17499 2293 1726878
Anaemia 254.93 32.34 281 17329 29176 1699995
Rhabdomyolysis 252.30 32.34 183 17427 10907 1718264
Hyperkalaemia 250.86 32.34 165 17445 8382 1720789
Unresponsive to stimuli 242.71 32.34 130 17480 4499 1724672
Rash 242.42 32.34 313 17297 38380 1690791
Pyrexia 237.19 32.34 340 17270 46060 1683111
Substance abuse 233.49 32.34 81 17529 922 1728249
Drug-induced liver injury 231.15 32.34 112 17498 3125 1726046
Loss of consciousness 227.13 32.34 194 17416 14681 1714490
Brain oedema 222.82 32.34 97 17513 2099 1727072
Exposure via ingestion 222.55 32.34 71 17539 609 1728562
Lip oedema 213.02 32.34 67 17543 546 1728625
Duodenal ulcer haemorrhage 209.27 32.34 70 17540 707 1728464
Transaminases increased 208.12 32.34 111 17499 3806 1725365
Product use issue 207.65 32.34 147 17463 8424 1720747
Hypersensitivity 196.77 32.34 154 17456 10290 1718881
Respiratory depression 195.11 32.34 89 17521 2158 1727013
Mental status changes 189.76 32.34 122 17488 5953 1723218
Hepatic necrosis 188.67 32.34 64 17546 677 1728494
Renal tubular necrosis 187.36 32.34 85 17525 2034 1727137
Pulmonary oedema 185.58 32.34 124 17486 6462 1722709
Product use in unapproved indication 184.15 32.34 142 17468 9280 1719891
Hypothermia 183.17 32.34 79 17531 1669 1727502
Headache 181.42 32.34 256 17354 34120 1695051
Haemoglobin decreased 179.39 32.34 181 17429 16933 1712238
Duodenal ulcer perforation 178.15 32.34 50 17560 260 1728911
Condition aggravated 177.97 32.34 199 17411 20951 1708220
Off label use 177.17 32.34 269 17341 38302 1690869
Electrocardiogram QT prolonged 174.77 32.34 112 17498 5433 1723738
Asthma 172.00 32.34 106 17504 4798 1724373
Confusional state 171.87 32.34 196 17414 21082 1708089
Pulmonary congestion 171.04 32.34 76 17534 1729 1727442
Haematochezia 168.90 32.34 105 17505 4827 1724344
Renal impairment 168.59 32.34 151 17459 12163 1717008
Gastritis erosive 168.36 32.34 63 17547 904 1728267
Hyperhidrosis 166.76 32.34 151 17459 12337 1716834
Peptic ulcer 165.75 32.34 53 17557 458 1728713
Lip swelling 164.97 32.34 85 17525 2710 1726461
Jaundice 160.90 32.34 110 17500 5952 1723219
Prothrombin time prolonged 155.99 32.34 69 17541 1552 1727619
Renal papillary necrosis 154.81 32.34 32 17578 23 1729148
Multiple organ dysfunction syndrome 154.30 32.34 127 17483 9115 1720056
Pain 153.27 32.34 207 17403 26450 1702721
Erythema 152.21 32.34 152 17458 14036 1715135
Anion gap 150.62 32.34 34 17576 54 1729117
Heart rate increased 149.23 32.34 108 17502 6402 1722769
Leukocytosis 148.97 32.34 86 17524 3447 1725724
Delirium 146.87 32.34 106 17504 6256 1722915
Lethargy 146.33 32.34 111 17499 7073 1722098
Anuria 145.93 32.34 69 17541 1819 1727352
Gastric ulcer haemorrhage 144.97 32.34 57 17553 942 1728229
Gastric ulcer perforation 141.55 32.34 38 17572 162 1729009
Seizure 141.39 32.34 174 17436 20267 1708904
Poisoning deliberate 139.85 32.34 53 17557 789 1728382
Accident 136.91 32.34 52 17558 779 1728392
Bradycardia 135.96 32.34 125 17485 10409 1718762
Alcohol use 135.71 32.34 52 17558 799 1728372
Hepatitis 134.06 32.34 91 17519 4864 1724307
Acute respiratory distress syndrome 130.24 32.34 79 17531 3472 1725699
Hepatitis acute 129.04 32.34 56 17554 1201 1727970
Blood urea increased 126.22 32.34 86 17524 4625 1724546
Acute generalised exanthematous pustulosis 125.11 32.34 53 17557 1069 1728102
Self-medication 124.46 32.34 46 17564 636 1728535
Incorrect dose administered 124.04 32.34 102 17508 7307 1721864
Sinus tachycardia 124.00 32.34 68 17542 2464 1726707
Shock 123.60 32.34 81 17529 4080 1725091
Rectal haemorrhage 122.60 32.34 90 17520 5452 1723719
Drug ineffective 120.67 32.34 306 17304 63495 1665676
Intentional self-injury 120.55 32.34 68 17542 2605 1726566
Thrombocytopenia 119.01 32.34 163 17447 21086 1708085
Environmental exposure 118.58 32.34 26 17584 33 1729138
Acidosis 116.57 32.34 55 17555 1442 1727729
Intestinal diaphragm disease 116.07 32.34 26 17584 39 1729132
Face oedema 115.12 32.34 63 17547 2273 1726898
Blood pH decreased 112.14 32.34 39 17571 447 1728724
Duodenitis 111.94 32.34 42 17568 607 1728564
Wheezing 111.69 32.34 76 17534 4077 1725094
Liver function test abnormal 111.16 32.34 86 17524 5640 1723531
Rash maculo-papular 109.78 32.34 72 17538 3631 1725540
Hypertension 108.60 32.34 149 17461 19299 1709872
Drug screen positive 108.20 32.34 47 17563 1010 1728161
Drug level increased 107.57 32.34 64 17546 2713 1726458
Meningitis aseptic 107.39 32.34 38 17572 460 1728711
Drug reaction with eosinophilia and systemic symptoms 106.90 32.34 80 17530 4990 1724181
Dehydration 105.78 32.34 140 17470 17518 1711653
Erythema multiforme 105.62 32.34 54 17556 1692 1727479
Agranulocytosis 104.72 32.34 69 17541 3507 1725664
General physical health deterioration 102.69 32.34 119 17491 12999 1716172
Product prescribing error 102.47 32.34 59 17551 2351 1726820
Diarrhoea 102.45 32.34 259 17351 53593 1675578
Apnoea 99.98 32.34 49 17561 1400 1727771
Malaise 98.90 32.34 179 17431 29386 1699785
Cholestasis 93.66 32.34 65 17545 3600 1725571
Pneumonia aspiration 93.40 32.34 75 17535 5191 1723980
Respiratory failure 93.08 32.34 119 17491 14386 1714785
Tongue oedema 92.49 32.34 36 17574 578 1728593
Hepatic enzyme increased 92.13 32.34 82 17528 6539 1722632
Syncope 92.11 32.34 117 17493 14052 1715119
Nasal disorder 91.17 32.34 27 17583 175 1728996
Fixed eruption 91.14 32.34 28 17582 209 1728962
Electrocardiogram QRS complex prolonged 91.05 32.34 38 17572 737 1728434
Chest discomfort 90.70 32.34 85 17525 7246 1721925
Enthesopathy 89.57 32.34 23 17587 79 1729092
Erosive oesophagitis 89.44 32.34 29 17581 263 1728908
Eyelid oedema 89.40 32.34 44 17566 1269 1727902
Mydriasis 89.05 32.34 44 17566 1280 1727891
Blood ethanol increased 87.44 32.34 21 17589 50 1729121
Miosis 87.34 32.34 45 17565 1433 1727738
Macrocephaly 84.68 32.34 20 17590 43 1729128
Drug eruption 84.55 32.34 56 17554 2870 1726301
Hepatic encephalopathy 84.05 32.34 51 17559 2241 1726930
Foetal exposure during pregnancy 83.05 32.34 76 17534 6283 1722888
Iron deficiency anaemia 81.76 32.34 40 17570 1138 1728033
Disorientation 80.63 32.34 70 17540 5399 1723772
Conjunctivitis 80.44 32.34 44 17566 1585 1727586
Dysphagia 79.15 32.34 92 17518 10076 1719095
Hypokalaemia 79.03 32.34 74 17536 6300 1722871
Blood bilirubin increased 78.73 32.34 73 17537 6137 1723034
Haemorrhage 78.30 32.34 90 17520 9739 1719432
Haematocrit decreased 78.21 32.34 62 17548 4211 1724960
Jejunal ulcer perforation 77.94 32.34 15 17595 3 1729168
Asthenia 76.80 32.34 177 17433 34493 1694678
Oesophagitis 75.95 32.34 43 17567 1658 1727513
Cardiomegaly 75.62 32.34 48 17562 2286 1726885
Methaemoglobinaemia 75.55 32.34 27 17583 337 1728834
Nephropathy toxic 75.23 32.34 43 17567 1689 1727482
Hepatocellular injury 74.91 32.34 54 17556 3177 1725994
Analgesic drug level increased 74.54 32.34 20 17590 85 1729086
Lactic acidosis 74.30 32.34 65 17545 5064 1724107
Milk-alkali syndrome 74.28 32.34 19 17591 64 1729107
Drug abuser 73.74 32.34 40 17570 1417 1727754
Haematuria 73.73 32.34 77 17533 7483 1721688
Fatigue 73.39 32.34 221 17389 50560 1678611
Pyloric stenosis 73.33 32.34 22 17588 150 1729021
Cough 72.93 32.34 123 17487 19074 1710097
Synovitis 72.59 32.34 32 17578 713 1728458
Tremor 72.34 32.34 100 17510 13031 1716140
Back pain 72.00 32.34 113 17497 16500 1712671
Blood bicarbonate decreased 71.53 32.34 27 17583 397 1728774
Eosinophilia 70.68 32.34 54 17556 3473 1725698
Generalised tonic-clonic seizure 70.41 32.34 57 17553 3989 1725182
Ulcer 70.19 32.34 36 17574 1135 1728036
Brain herniation 70.17 32.34 30 17580 619 1728552
Alcohol poisoning 70.04 32.34 28 17582 484 1728687
Palatal oedema 69.02 32.34 23 17587 229 1728942
Drug withdrawal syndrome 68.89 32.34 59 17551 4466 1724705
Hepatic function abnormal 68.89 32.34 72 17538 7002 1722169
Hepatic steatosis 68.78 32.34 47 17563 2537 1726634
Eye swelling 67.97 32.34 42 17568 1907 1727264
C-reactive protein abnormal 67.72 32.34 23 17587 244 1728927
Wrong product administered 67.65 32.34 35 17575 1124 1728047
Anion gap increased 67.55 32.34 23 17587 246 1728925
Chest pain 67.06 32.34 121 17489 19793 1709378
Vanishing bile duct syndrome 66.33 32.34 20 17590 139 1729032
Blister 65.67 32.34 55 17555 4037 1725134
Erosive duodenitis 65.49 32.34 22 17588 225 1728946
Liver transplant 65.48 32.34 28 17582 578 1728593
Tenosynovitis 65.40 32.34 23 17587 273 1728898
Sopor 64.45 32.34 41 17569 1960 1727211
Hypoxic-ischaemic encephalopathy 64.04 32.34 31 17579 861 1728310
Brain death 64.02 32.34 26 17584 469 1728702
Palpitations 63.94 32.34 68 17542 6746 1722425
Blood alkaline phosphatase increased 63.79 32.34 60 17550 5135 1724036
Kounis syndrome 63.63 32.34 25 17585 412 1728759
Tropical infectious disease 63.57 32.34 12 17598 1 1729170
Gastritis haemorrhagic 63.26 32.34 22 17588 252 1728919
Circulatory collapse 62.79 32.34 50 17560 3417 1725754
Aggression 62.43 32.34 73 17537 8042 1721129
Aspiration 61.94 32.34 39 17571 1831 1727340
Chills 61.38 32.34 87 17523 11600 1717571
Haemodialysis 61.28 32.34 44 17566 2572 1726599
Tongue disorder 61.19 32.34 26 17584 528 1728643
Hiatus hernia 59.96 32.34 31 17579 994 1728177
Encephalopathy 59.67 32.34 54 17556 4398 1724773
Pallor 59.24 32.34 48 17562 3363 1725808
Restlessness 59.08 32.34 53 17557 4268 1724903
Hypoglycaemia 58.51 32.34 72 17538 8366 1720805
Sepsis 57.82 32.34 112 17498 19326 1709845
Oesophageal ulcer 57.59 32.34 26 17584 614 1728557
Hallucination 57.11 32.34 70 17540 8100 1721071
Fall 57.01 32.34 136 17474 27078 1702093
Respiratory distress 56.61 32.34 56 17554 5101 1724070
Shock haemorrhagic 55.78 32.34 33 17577 1383 1727788
Accidental exposure to product 55.47 32.34 50 17560 4051 1725120
Loss of personal independence in daily activities 55.39 32.34 40 17570 2359 1726812
Contraindicated product administered 55.19 32.34 33 17577 1411 1727760
Periorbital oedema 54.18 32.34 26 17584 708 1728463
Dysarthria 53.85 32.34 55 17555 5204 1723967
Lower gastrointestinal haemorrhage 53.69 32.34 30 17580 1127 1728044
Ureteric obstruction 53.39 32.34 19 17591 234 1728937
Respiratory rate increased 53.20 32.34 31 17579 1263 1727908
Accidental exposure to product by child 52.94 32.34 26 17584 746 1728425
Blood pressure decreased 52.62 32.34 65 17545 7581 1721590
Pupil fixed 52.42 32.34 21 17589 365 1728806
Compartment syndrome 51.62 32.34 23 17587 526 1728645
Brain injury 51.32 32.34 28 17582 1003 1728168
Haematoma 51.21 32.34 47 17563 3898 1725273
Blood creatine phosphokinase increased 51.10 32.34 69 17541 8787 1720384
Flushing 50.84 32.34 58 17552 6221 1722950
Accidental death 50.71 32.34 21 17589 399 1728772
Intracranial pressure increased 50.56 32.34 25 17585 728 1728443
Ammonia increased 50.45 32.34 26 17584 828 1728343
Alanine aminotransferase abnormal 50.19 32.34 18 17592 227 1728944
Hepatitis cholestatic 49.99 32.34 30 17580 1291 1727880
Hypoxia 49.84 32.34 56 17554 5907 1723264
Abdominal pain lower 49.84 32.34 29 17581 1178 1727993
Swelling face 49.79 32.34 49 17561 4434 1724737
Pain in extremity 49.61 32.34 102 17508 18370 1710801
Septic shock 49.59 32.34 65 17545 8044 1721127
Inappropriate antidiuretic hormone secretion 49.40 32.34 33 17577 1715 1727456
Blood pressure increased 49.16 32.34 75 17535 10678 1718493
Insomnia 48.66 32.34 94 17516 16182 1712989
Oropharyngeal pain 48.63 32.34 50 17560 4768 1724403
Abdominal discomfort 48.26 32.34 68 17542 9013 1720158
Blood lactate dehydrogenase increased 48.12 32.34 44 17566 3631 1725540
Product administration error 48.02 32.34 40 17570 2913 1726258
Pneumonia 48.01 32.34 180 17430 46002 1683169
Pancreatitis acute 47.88 32.34 46 17564 4041 1725130
Lip erosion 47.27 32.34 15 17595 126 1729045
Pupils unequal 47.08 32.34 17 17593 219 1728952
Sedation 46.88 32.34 42 17568 3375 1725796
Disseminated intravascular coagulation 46.80 32.34 43 17567 3571 1725600
Cold sweat 46.71 32.34 32 17578 1734 1727437
Infection 46.65 32.34 79 17531 12281 1716890
Rash macular 46.56 32.34 33 17577 1889 1727282
Bronchospasm 46.44 32.34 34 17576 2048 1727123
Irritability 46.32 32.34 52 17558 5480 1723691
Hallucination, visual 46.12 32.34 37 17573 2555 1726616
Anion gap abnormal 45.86 32.34 11 17599 26 1729145
Onychomycosis 45.51 32.34 18 17592 302 1728869
Pyroglutamate increased 45.47 32.34 10 17600 13 1729158
Haemolytic anaemia 45.18 32.34 32 17578 1830 1727341
Body temperature increased 45.07 32.34 37 17573 2640 1726531
Dermatomyositis 44.97 32.34 17 17593 251 1728920
Hypercalcaemia 44.81 32.34 32 17578 1854 1727317
Arthralgia 44.66 32.34 113 17497 23331 1705840
Conjunctival hyperaemia 44.62 32.34 21 17589 547 1728624
Anaphylactic shock 44.53 32.34 38 17572 2861 1726310
Peritonitis 44.33 32.34 37 17573 2702 1726469
Gastric perforation 44.13 32.34 19 17591 399 1728772
Mast cell activation syndrome 43.81 32.34 9 17601 6 1729165
Streptococcal infection 43.77 32.34 22 17588 664 1728507
Weight decreased 43.69 32.34 110 17500 22643 1706528
Infusion related reaction 43.69 32.34 55 17555 6538 1722633
Dysphonia 43.52 32.34 41 17569 3514 1725657
Decreased appetite 43.35 32.34 113 17497 23758 1705413
Hepatomegaly 43.31 32.34 30 17580 1655 1727516
Anticholinergic syndrome 43.19 32.34 15 17595 171 1729000
Eye disorder 42.85 32.34 29 17581 1540 1727631
Peptic ulcer perforation 42.57 32.34 11 17599 39 1729132
Pseudomonal sepsis 42.29 32.34 18 17592 367 1728804
Macrophages increased 42.18 32.34 9 17601 9 1729162
Therapeutic product cross-reactivity 41.73 32.34 16 17594 246 1728925
Vision blurred 41.72 32.34 61 17549 8362 1720809
Gastrointestinal ulcer 41.54 32.34 17 17593 313 1728858
Swollen tongue 41.49 32.34 36 17574 2772 1726399
Peritonsillar abscess 40.78 32.34 13 17597 111 1729060
Presyncope 40.70 32.34 35 17575 2663 1726508
Drug level above therapeutic 40.51 32.34 19 17591 491 1728680
Rhinitis 40.48 32.34 21 17589 678 1728493
Hypophagia 40.29 32.34 39 17571 3458 1725713
Dry mouth 40.20 32.34 41 17569 3872 1725299
Retching 40.17 32.34 25 17585 1149 1728022
Rhinorrhoea 40.16 32.34 41 17569 3876 1725295
Ocular icterus 40.08 32.34 20 17590 594 1728577
Urine output decreased 39.91 32.34 27 17583 1433 1727738
Oedema 39.87 32.34 54 17556 6894 1722277
Gastrointestinal necrosis 39.81 32.34 20 17590 603 1728568
Arrhythmia 39.56 32.34 50 17560 5966 1723205
Oedema peripheral 39.56 32.34 84 17526 15466 1713705
Nystagmus 39.49 32.34 23 17587 936 1728235
Superinfection 39.47 32.34 16 17594 287 1728884
Haemoptysis 39.40 32.34 45 17565 4831 1724340
Ventricular tachycardia 39.39 32.34 40 17570 3758 1725413
Atrial septal defect 39.25 32.34 26 17584 1332 1727839
Oral pruritus 39.24 32.34 12 17598 88 1729083
C-reactive protein increased 38.84 32.34 49 17561 5836 1723335
Oxygen saturation decreased 38.65 32.34 48 17562 5627 1723544
Obstruction gastric 38.58 32.34 14 17596 183 1728988
Hypoaldosteronism 38.58 32.34 10 17600 36 1729135
Occult blood positive 38.49 32.34 19 17591 551 1728620
Suicidal ideation 38.35 32.34 59 17551 8459 1720712
Pulseless electrical activity 38.17 32.34 23 17587 997 1728174
Haemolysis 38.02 32.34 24 17586 1131 1728040
Nasal obstruction 38.01 32.34 12 17598 99 1729072
Mallory-Weiss syndrome 37.97 32.34 16 17594 318 1728853
Ischaemic hepatitis 37.80 32.34 15 17595 254 1728917
Oral mucosa erosion 37.77 32.34 14 17596 195 1728976
Coma scale abnormal 37.60 32.34 19 17591 580 1728591
Anxiety 37.35 32.34 82 17528 15445 1713726
Tonsillitis 37.31 32.34 18 17592 496 1728675
Hepatitis fulminant 37.24 32.34 20 17590 694 1728477
Alveolitis 37.07 32.34 16 17594 338 1728833
Myalgia 36.88 32.34 82 17528 15576 1713595
Incorrect route of product administration 36.86 32.34 37 17573 3428 1725743
Necrosis 36.67 32.34 22 17588 946 1728225
Hyponatraemia 35.92 32.34 59 17551 8941 1720230
Dialysis 35.88 32.34 31 17579 2373 1726798
Musculoskeletal stiffness 35.76 32.34 47 17563 5829 1723342
Serotonin syndrome 35.76 32.34 33 17577 2755 1726416
Gastritis bacterial 35.62 32.34 10 17600 52 1729119
PO2 increased 35.61 32.34 12 17598 124 1729047
Blood lactic acid increased 35.54 32.34 21 17589 878 1728293
Polyuria 35.27 32.34 24 17586 1286 1727885
Purpura 35.18 32.34 27 17583 1747 1727424
Inflammation 35.17 32.34 36 17574 3414 1725757
Respiratory acidosis 35.12 32.34 19 17591 669 1728502
Accidental poisoning 35.02 32.34 12 17598 131 1729040
Labelled drug-drug interaction medication error 34.60 32.34 24 17586 1327 1727844
Blood loss anaemia 34.55 32.34 21 17589 925 1728246
Dermo-hypodermitis 34.42 32.34 10 17600 60 1729111
Muscle rigidity 34.20 32.34 27 17583 1821 1727350
Liver disorder 34.17 32.34 45 17565 5591 1723580
Hyperreflexia 34.09 32.34 18 17592 603 1728568
Feeling abnormal 33.98 32.34 65 17545 11101 1718070
Feeling hot 33.82 32.34 33 17577 2954 1726217
Chromaturia 33.28 32.34 31 17579 2619 1726552
Pancreatitis 32.66 32.34 50 17560 7137 1722034
Drug dependence 32.62 32.34 34 17576 3293 1725878
Abdominal distension 32.39 32.34 47 17563 6397 1722774
Implant site extravasation 32.39 32.34 12 17598 167 1729004

Pharmacologic Action:

SourceCodeDescription
ATC D04AA32 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AA02 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA52 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
MeSH PA D000777 Anesthetics
CHEBI has role CHEBI:37955 H1-receptor antagonist
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:50857 anti-allergic agent
CHEBI has role CHEBI:48876 muscarinic antagonist
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:59683 antipruritic drug
CHEBI has role CHEBI:36333 local anaesthetic
CHEBI has role CHEBI:66956 antidyskinesia agent
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:146270 oneirogen
MeSH PA D000779 Anesthetics, Local
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Insomnia indication 193462001
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG ADVIL PM GLAXOSMITHKLINE N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 7.81 WOMBAT-PK CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.66 SCIENTIFIC LITERATURE
Muscarinic acetylcholine receptor M4 GPCR Ki 6.95 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.92 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 7 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 6.59 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.43 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.15 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.29 DRUG MATRIX
Histamine H4 receptor GPCR Ki 4.37 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.59 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL
Cytochrome P450 2D6 Enzyme Ki 4.93 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 6.64 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Kd 6.02 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Kd 5.42 SCIENTIFIC LITERATURE
Solute carrier family 22 member 2 Transporter IC50 4.68 WOMBAT-PK
Histamine H1 receptor GPCR IC50 9 CHEMBL

External reference:

IDSource
D004155 MESH_DESCRIPTOR_UI
4019724 VUID
N0000147816 NUI
C0012522 UMLSCUI
D00300 KEGG_DRUG
3E2CN035LB UNII
103659-13-8 SECONDARY_CAS_RN
3498 RXNORM
372682005 SNOMEDCT_US
d00212 MMSL
26458009 SNOMEDCT_US
4019724 VANDF
004787 NDDF
1774 INN_ID
CHEBI:4636 CHEBI
CHEMBL657 ChEMBL_ID
DB01075 DRUGBANK_ID
CHEMBL1620 ChEMBL_ID
2PM PDB_CHEM_ID
1224 IUPHAR_LIGAND_ID
3100 PUBCHEM_CID
CHEMBL1201089 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION HUMAN OTC DRUG LABEL 2 0031-2247 LIQUID 6.25 mg ORAL OTC MONOGRAPH FINAL 9 sections
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 12.50 mg ORAL UNAPPROVED DRUG OTHER 9 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC MONOGRAPH FINAL 9 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 9 sections
THERAFLU HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 9 sections
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 6 0067-7919 KIT 25 mg None OTC monograph final 9 sections
TRIAMINIC HUMAN OTC DRUG LABEL 2 0067-8106 SYRUP 6.25 mg ORAL OTC monograph final 9 sections
Triaminic HUMAN OTC DRUG LABEL 4 0067-8112 KIT 6.25 mg None OTC monograph final 10 sections
Theraflu Nighttime Multi-Symptom Severe Cold Powder HUMAN OTC DRUG LABEL 3 0067-8124 POWDER 25 mg ORAL OTC monograph final 9 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 6 0067-8125 KIT 25 mg None OTC monograph final 10 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 9 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 3 0067-8131 SYRUP 25 mg ORAL OTC monograph final 9 sections
Theraflu ExpressMax HUMAN OTC DRUG LABEL 3 0067-8137 TABLET, FILM COATED 12.50 mg ORAL OTC monograph final 9 sections
Theraflu Expressmax Daytime Severe Cold and Cough and Theraflu Expressmax Nighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 6 0067-8138 KIT 12.50 mg None OTC monograph final 9 sections
Excedrin PM Triple Action Caplets and Excedrin Tension Headache HUMAN OTC DRUG LABEL 5 0067-8147 KIT 38 mg None OTC monograph not final 9 sections
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever HUMAN OTC DRUG LABEL 6 0067-8148 KIT 38 mg None OTC monograph not final 9 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 38 mg ORAL ANDA 9 sections
good sense sleep time HUMAN OTC DRUG LABEL 1 0113-0052 CAPSULE, LIQUID FILLED 25 mg ORAL OTC monograph final 8 sections
Good Sense Sleep Time HUMAN OTC DRUG LABEL 1 0113-0186 SOLUTION 50 mg ORAL OTC monograph final 9 sections
Good Sense headache pm HUMAN OTC DRUG LABEL 2 0113-0355 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 9 sections
good sense allergy HUMAN OTC DRUG LABEL 1 0113-0379 SOLUTION 12.50 mg ORAL OTC monograph final 9 sections
good sense nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-0431 TABLET, FILM COATED 25 mg ORAL OTC monograph final 9 sections
good sense pain relief pm HUMAN OTC DRUG LABEL 2 0113-0437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 8 sections
Good Sense Allergy Relief HUMAN OTC DRUG LABEL 1 0113-0462 CAPSULE 25 mg ORAL OTC monograph final 9 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0479 TABLET 25 mg ORAL OTC monograph final 9 sections
good sense itch relief HUMAN OTC DRUG LABEL 2 0113-0622 CREAM 2 g TOPICAL OTC monograph not final 9 sections
Good Sense Pain Relief PM HUMAN OTC DRUG LABEL 2 0113-0837 TABLET, COATED 25 mg ORAL OTC monograph not final 8 sections
good sense flu and severe cold and cough HUMAN OTC DRUG LABEL 3 0113-0964 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 9 sections
good sense sleep aid HUMAN OTC DRUG LABEL 1 0113-1909 CAPSULE, LIQUID FILLED 50 mg ORAL OTC monograph final 9 sections