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

Stem definitionDrug idCAS RN
gabamimetic agents 2255 148553-50-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pregabalin
  • (S)-Pregabalin
  • gabanext
  • maxgalin
  • lyrica
  • pregabalin hydrochloride
  • pregabalin HCl
A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.
  • Molecular weight: 159.23
  • Formula: C8H17NO2
  • CLOGP: -0.92
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -1.15
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 33 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 90 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 53.83 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
July 6, 2004 EMA
Dec. 30, 2004 FDA PF PRISM CV

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
Pain 6842.63 23.91 2725 21814 59132 2274414
Weight increased 4225.01 23.91 1469 23070 20868 2312678
Somnolence 4195.17 23.91 1480 23059 22005 2311541
Drug ineffective 3503.93 23.91 2018 22521 99606 2233940
Dizziness 3434.81 23.91 1663 22876 57002 2276544
Drug hypersensitivity 2718.60 23.91 1321 23218 45322 2288224
Feeling abnormal 2716.77 23.91 1080 23459 22501 2311045
Withdrawal syndrome 2629.64 23.91 665 23874 2672 2330874
Malaise 2413.67 23.91 1291 23248 54294 2279252
Fall 2375.61 23.91 1210 23329 45889 2287657
Condition aggravated 2193.28 23.91 1015 23524 30964 2302582
Insomnia 2027.94 23.91 901 23638 24886 2308660
Pain in extremity 2024.37 23.91 1052 23487 41488 2292058
Gait disturbance 1895.61 23.91 826 23713 21719 2311827
Vision blurred 1826.08 23.91 712 23827 13956 2319590
Therapeutic product effect incomplete 1814.65 23.91 649 23890 9882 2323664
Product use issue 1763.27 23.91 660 23879 11509 2322037
Intentional product misuse 1695.94 23.91 601 23938 8888 2324658
Intentional product use issue 1686.61 23.91 476 24063 3126 2330420
Oedema peripheral 1612.83 23.91 750 23789 23013 2310533
Confusional state 1607.92 23.91 754 23785 23590 2309956
Tremor 1301.88 23.91 620 23919 20041 2313505
Memory impairment 1223.86 23.91 516 24023 12407 2321139
Nausea 1158.16 23.91 1082 23457 111107 2222439
Depression 1066.19 23.91 600 23939 27532 2306014
Hypoaesthesia 1032.34 23.91 526 24013 19689 2313857
Headache 1027.29 23.91 875 23664 79304 2254242
Fatigue 990.05 23.91 878 23661 83995 2249551
Fibromyalgia 980.37 23.91 307 24232 2993 2330553
Anxiety 946.97 23.91 564 23975 28795 2304751
Loss of personal independence in daily activities 942.22 23.91 335 24204 4976 2328570
Drug withdrawal syndrome 924.85 23.91 353 24186 6468 2327078
Burning sensation 888.06 23.91 356 24183 7472 2326074
Off label use 880.54 23.91 773 23766 72825 2260721
Balance disorder 865.10 23.91 372 24167 9375 2324171
Disturbance in attention 860.69 23.91 319 24220 5366 2328180
Drug intolerance 857.76 23.91 410 24129 13307 2320239
Muscle spasms 849.05 23.91 472 24067 21094 2312452
Suicidal ideation 819.08 23.91 372 24167 10715 2322831
Visual impairment 810.71 23.91 376 24163 11379 2322167
Loss of consciousness 808.40 23.91 436 24103 18331 2315215
Peripheral swelling 803.43 23.91 425 24114 17172 2316374
Paraesthesia 771.21 23.91 447 24092 21641 2311905
Rash 752.66 23.91 646 23893 58912 2274634
Product use in unapproved indication 734.34 23.91 346 24193 10854 2322692
Swelling 732.45 23.91 390 24149 15960 2317586
Arthralgia 731.28 23.91 611 23928 53674 2279872
Asthenia 724.38 23.91 572 23967 46354 2287192
Back pain 717.69 23.91 487 24052 31172 2302374
Overdose 711.12 23.91 409 24130 19498 2314048
Toxicity to various agents 683.89 23.91 479 24060 32275 2301271
Completed suicide 682.34 23.91 406 24133 20628 2312918
Neuralgia 679.98 23.91 224 24315 2598 2330948
Drug dependence 675.12 23.91 227 24312 2818 2330728
Dry mouth 670.24 23.91 296 24243 7957 2325589
Joint swelling 666.66 23.91 370 24169 16449 2317097
Speech disorder 664.43 23.91 274 24265 6190 2327356
Drug abuse 651.25 23.91 326 24213 11700 2321846
Amnesia 640.56 23.91 276 24263 6977 2326569
Prescribed overdose 640.38 23.91 193 24346 1631 2331915
Weight decreased 634.62 23.91 433 24106 27938 2305608
Coma 634.50 23.91 293 24246 8763 2324783
Oedema 631.43 23.91 303 24236 9900 2323646
Sleep disorder 629.66 23.91 264 24275 6225 2327321
Hyperhidrosis 602.16 23.91 336 24203 15086 2318460
Vomiting 599.10 23.91 618 23921 70984 2262562
Pre-existing condition improved 583.78 23.91 139 24400 400 2333146
Dyspnoea 560.79 23.91 624 23915 78109 2255437
Seizure 541.19 23.91 371 24168 24095 2309451
Feeling drunk 534.06 23.91 140 24399 660 2332886
Thinking abnormal 519.91 23.91 167 24372 1775 2331771
Muscular weakness 510.14 23.91 298 24241 14599 2318947
Drug interaction 509.23 23.91 383 24156 28780 2304766
Dyskinesia 509.01 23.91 208 24331 4581 2328965
Dysarthria 508.19 23.91 225 24314 6077 2327469
Impaired work ability 506.56 23.91 161 24378 1649 2331897
Hallucination 501.03 23.91 241 24298 7907 2325639
Musculoskeletal stiffness 492.03 23.91 272 24267 11975 2321571
Dysstasia 481.80 23.91 175 24364 2764 2330782
Gait inability 468.55 23.91 209 24330 5746 2327800
Body height decreased 464.50 23.91 138 24401 1103 2332443
Therapeutic response unexpected 463.32 23.91 183 24356 3676 2329870
Sciatica 449.60 23.91 153 24386 1972 2331574
Movement disorder 447.26 23.91 164 24375 2664 2330882
Neuropathy peripheral 445.79 23.91 249 24290 11183 2322363
Rheumatoid arthritis 443.87 23.91 299 24240 18841 2314705
Cognitive disorder 443.11 23.91 195 24344 5186 2328360
Disorientation 439.37 23.91 204 24335 6168 2327378
Constipation 431.47 23.91 308 24231 21321 2312225
Road traffic accident 430.28 23.91 179 24360 4129 2329417
Sedation 426.73 23.91 166 24373 3196 2330350
Impaired driving ability 423.66 23.91 124 24415 935 2332611
Intentional overdose 420.87 23.91 239 24300 11082 2322464
Euphoric mood 418.15 23.91 119 24420 802 2332744
Pruritus 416.58 23.91 404 24135 42936 2290610
Myoclonus 415.02 23.91 150 24389 2333 2331213
Myalgia 410.53 23.91 308 24231 23025 2310521
Depressed level of consciousness 408.00 23.91 205 24334 7399 2326147
Musculoskeletal pain 406.26 23.91 230 24309 10600 2322946
Diplopia 400.89 23.91 160 24379 3305 2330241
Vertigo 383.89 23.91 211 24328 9173 2324373
Muscle twitching 370.40 23.91 142 24397 2623 2330923
Hypertension 356.88 23.91 303 24236 27058 2306488
Diarrhoea 355.79 23.91 513 24026 83051 2250495
Nervousness 351.08 23.91 164 24375 5025 2328521
Mental impairment 347.33 23.91 131 24408 2309 2331237
Agitation 341.42 23.91 207 24332 10844 2322702
Neck pain 339.63 23.91 182 24357 7515 2326031
Drug ineffective for unapproved indication 329.39 23.91 133 24406 2833 2330713
Swelling face 324.99 23.91 190 24349 9303 2324243
Hypoacusis 324.18 23.91 137 24402 3288 2330258
Irritability 323.54 23.91 166 24373 6261 2327285
Suicide attempt 322.21 23.91 201 24338 11081 2322465
Treatment failure 321.72 23.91 172 24367 7067 2326479
Pneumonia 316.44 23.91 371 24168 48925 2284621
Crying 316.27 23.91 145 24394 4251 2329295
Blood pressure increased 316.02 23.91 232 24307 16754 2316792
Increased appetite 305.82 23.91 104 24435 1336 2332210
Back disorder 301.33 23.91 106 24433 1516 2332030
Decreased appetite 291.73 23.91 277 24262 28614 2304932
Restlessness 286.50 23.91 137 24402 4426 2329120
Coordination abnormal 283.91 23.91 107 24432 1881 2331665
Psoriatic arthropathy 281.24 23.91 129 24410 3785 2329761
Gastrooesophageal reflux disease 279.95 23.91 170 24369 8925 2324621
Hypotension 275.54 23.91 283 24256 32153 2301393
Dysphagia 272.84 23.91 190 24349 12615 2320931
Arthropathy 270.54 23.91 154 24385 7162 2326384
Pneumonia aspiration 264.70 23.91 122 24417 3620 2329926
Discomfort 258.90 23.91 133 24406 5026 2328520
Sopor 257.08 23.91 122 24417 3873 2329673
Limb discomfort 254.22 23.91 115 24424 3264 2330282
Infection 254.22 23.91 209 24330 17820 2315726
Restless legs syndrome 252.72 23.91 102 24437 2169 2331377
Product dispensing error 248.33 23.91 104 24435 2437 2331109
Panic attack 242.96 23.91 117 24422 3839 2329707
Abnormal behaviour 242.58 23.91 124 24415 4636 2328910
Nerve injury 239.12 23.91 81 24458 1027 2332519
Respiratory arrest 239.10 23.91 134 24405 6044 2327502
Expired product administered 238.84 23.91 84 24455 1200 2332346
Hyponatraemia 238.77 23.91 178 24361 13147 2320399
Visual acuity reduced 238.50 23.91 127 24412 5171 2328375
Cerebrovascular accident 237.65 23.91 211 24328 19975 2313571
Bedridden 237.34 23.91 86 24453 1346 2332200
Arthritis 236.27 23.91 158 24381 9810 2323736
Hallucination, visual 232.42 23.91 104 24435 2875 2330671
Stress 229.86 23.91 136 24403 6802 2326744
Sinusitis 229.67 23.91 190 24349 16336 2317210
Nasopharyngitis 229.28 23.91 215 24324 21841 2311705
Cardiac arrest 225.07 23.91 180 24359 14750 2318796
Diabetes mellitus 220.16 23.91 136 24403 7359 2326187
Cataract 220.12 23.91 125 24414 5783 2327763
Hot flush 220.06 23.91 134 24405 7065 2326481
Product prescribing error 217.17 23.91 99 24440 2861 2330685
Contusion 211.55 23.91 163 24376 12647 2320899
Eye pain 211.06 23.91 114 24425 4777 2328769
Dry eye 210.16 23.91 106 24433 3850 2329696
Delirium 209.51 23.91 116 24423 5107 2328439
Tenderness 209.47 23.91 85 24454 1833 2331713
Emotional disorder 209.04 23.91 88 24451 2089 2331457
Migraine 205.93 23.91 149 24390 10504 2323042
Abdominal distension 204.41 23.91 147 24392 10264 2323282
Blood glucose increased 197.75 23.91 154 24385 12136 2321410
Acute kidney injury 194.14 23.91 220 24319 27902 2305644
Aggression 193.90 23.91 107 24432 4679 2328867
Abdominal discomfort 192.67 23.91 176 24363 17280 2316266
Hypersomnia 192.26 23.91 85 24454 2281 2331265
Depressed mood 191.01 23.91 109 24430 5089 2328457
Altered state of consciousness 189.29 23.91 98 24441 3762 2329784
Dementia 188.31 23.91 87 24452 2594 2330952
Palpitations 187.66 23.91 169 24370 16287 2317259
Hypersensitivity 186.12 23.91 198 24341 23395 2310151
Intentional self-injury 185.93 23.91 99 24440 4028 2329518
Cough 185.68 23.91 233 24306 32884 2300662
Intervertebral disc protrusion 183.88 23.91 89 24450 2952 2330594
Chills 183.85 23.91 163 24376 15389 2318157
Abdominal pain 183.49 23.91 236 24303 34138 2299408
Fluid retention 182.29 23.91 118 24421 6928 2326618
Abdominal pain upper 180.60 23.91 189 24350 21911 2311635
Neoplasm malignant 179.67 23.91 104 24435 4989 2328557
Blister 179.13 23.91 115 24424 6656 2326890
International normalised ratio fluctuation 178.71 23.91 49 24490 282 2333264
Tachycardia 178.27 23.91 164 24375 16245 2317301
Syncope 178.19 23.91 166 24373 16709 2316837
Respiratory depression 176.46 23.91 78 24461 2092 2331454
Contraindicated product administered 175.41 23.91 86 24453 2935 2330611
Urinary incontinence 175.24 23.91 96 24443 4137 2329409
Erythema 173.93 23.91 197 24342 24962 2308584
Bradycardia 173.56 23.91 131 24408 9850 2323696
Dysphemia 173.28 23.91 52 24487 431 2333115
Product dose omission 172.63 23.91 242 24297 38015 2295531
Wheezing 170.30 23.91 109 24430 6275 2327271
Formication 169.87 23.91 59 24480 810 2332736
Mobility decreased 167.47 23.91 122 24417 8688 2324858
Influenza 167.45 23.91 143 24396 12835 2320711
Nightmare 167.43 23.91 89 24450 3608 2329938
Head injury 165.65 23.91 91 24448 3943 2329603
Aphasia 164.25 23.91 97 24442 4831 2328715
Diabetic neuropathy 161.93 23.91 49 24490 419 2333127
Disease recurrence 161.73 23.91 85 24454 3366 2330180
Ataxia 159.98 23.91 76 24463 2416 2331130
Dehydration 159.94 23.91 178 24361 22117 2311429
Pyrexia 157.86 23.91 279 24260 53429 2280117
Blood cholesterol increased 156.17 23.91 96 24443 5145 2328401
Mood altered 155.94 23.91 77 24462 2669 2330877
Urinary retention 154.10 23.91 84 24455 3583 2329963
Chest pain 152.96 23.91 195 24344 27942 2305604
Synovial fluid analysis 152.52 23.91 28 24511 3 2333543
Feeling cold 151.65 23.91 79 24460 3071 2330475
Face oedema 151.01 23.91 85 24454 3863 2329683
Cardio-respiratory arrest 150.13 23.91 116 24423 9030 2324516
Feeling jittery 149.26 23.91 67 24472 1865 2331681
Photophobia 144.47 23.91 69 24470 2220 2331326
Lethargy 143.89 23.91 111 24428 8619 2324927
Interstitial lung disease 139.06 23.91 104 24435 7708 2325838
Eating disorder 138.63 23.91 67 24472 2214 2331332
Limb injury 138.43 23.91 69 24470 2441 2331105
Therapeutic product effect decreased 137.37 23.91 118 24421 10671 2322875
Swollen tongue 137.01 23.91 89 24450 5254 2328292
Cholestasis 136.62 23.91 78 24461 3643 2329903
Mental disorder 136.50 23.91 80 24459 3927 2329619
Nervous system disorder 135.45 23.91 73 24466 3043 2330503
Alopecia 134.86 23.91 162 24377 21839 2311707
Hepatitis 134.81 23.91 94 24445 6243 2327303
Drug tolerance 132.75 23.91 41 24498 378 2333168
Bradyphrenia 131.41 23.91 52 24487 1047 2332499
Epilepsy 130.69 23.91 82 24457 4557 2328989
Eye disorder 130.46 23.91 72 24467 3147 2330399
Tenosynovitis stenosans 126.55 23.91 31 24508 104 2333442
Tinnitus 125.49 23.91 83 24456 5052 2328494
Bursitis 124.96 23.91 59 24480 1849 2331697
Thrombosis 124.59 23.91 104 24435 9040 2324506
Bronchitis 124.16 23.91 124 24415 13590 2319956
Generalised oedema 123.56 23.91 63 24476 2340 2331206
Abnormal dreams 122.21 23.91 63 24476 2395 2331151
Hyperaesthesia 121.85 23.91 51 24488 1192 2332354
Paralysis 120.70 23.91 57 24482 1787 2331759
Blood creatine phosphokinase increased 120.65 23.91 81 24458 5055 2328491
Agranulocytosis 119.87 23.91 70 24469 3412 2330134
Dysgraphia 118.42 23.91 40 24499 502 2333044
Antinuclear antibody positive 118.30 23.91 48 24491 1034 2332512
Hypokinesia 117.21 23.91 55 24484 1699 2331847
Dysuria 116.93 23.91 72 24467 3869 2329677
Drug effective for unapproved indication 116.73 23.91 33 24506 216 2333330
Rhabdomyolysis 116.54 23.91 88 24451 6616 2326930
Feeling of body temperature change 115.43 23.91 42 24497 665 2332881
Renal failure 115.01 23.91 133 24406 17216 2316330
Blindness 114.79 23.91 69 24470 3549 2329997
Back injury 113.53 23.91 45 24494 910 2332636
Middle insomnia 113.39 23.91 51 24488 1426 2332120
Fracture 113.20 23.91 62 24477 2669 2330877
Spinal disorder 113.12 23.91 48 24491 1162 2332384
Myocardial infarction 111.62 23.91 137 24402 18876 2314670
Lung disorder 111.22 23.91 83 24456 6129 2327417
Cardiac disorder 110.69 23.91 91 24448 7742 2325804
Cardiac failure 110.67 23.91 110 24429 11984 2321562
Crepitations 110.36 23.91 40 24499 626 2332920
Urinary tract infection 109.90 23.91 172 24367 29770 2303776
Disease progression 109.89 23.91 129 24410 16966 2316580
Anger 109.71 23.91 59 24480 2448 2331098
Feeling hot 109.62 23.91 86 24453 6842 2326704
Osteoarthritis 109.43 23.91 86 24453 6860 2326686
Upper limb fracture 107.86 23.91 60 24479 2663 2330883
Hepatocellular injury 107.54 23.91 69 24470 3986 2329560
Multiple allergies 106.72 23.91 42 24497 833 2332713
Cold sweat 105.97 23.91 54 24485 2003 2331543
Poisoning 105.90 23.91 60 24479 2760 2330786
Psychotic disorder 105.62 23.91 72 24467 4607 2328939
Joint stiffness 105.57 23.91 68 24471 3955 2329591
Motor dysfunction 105.43 23.91 46 24493 1194 2332352
Weight fluctuation 105.23 23.91 39 24500 652 2332894
Angioedema 105.18 23.91 91 24448 8305 2325241
Sleep apnoea syndrome 104.28 23.91 54 24485 2072 2331474
Musculoskeletal discomfort 104.00 23.91 54 24485 2084 2331462
Heart rate increased 101.60 23.91 101 24438 11004 2322542
Influenza like illness 101.39 23.91 105 24434 12009 2321537
Scleritis 101.23 23.91 31 24508 277 2333269
Joint effusion 100.95 23.91 45 24494 1231 2332315
Hypoglycaemia 99.06 23.91 88 24451 8319 2325227
Mental status changes 98.63 23.91 74 24465 5508 2328038
Renal impairment 98.32 23.91 95 24444 9997 2323549
Asthma 98.18 23.91 100 24439 11214 2322332
Prescription drug used without a prescription 97.30 23.91 28 24511 197 2333349
Synovial cyst 96.51 23.91 39 24500 831 2332715
Ulcer 95.82 23.91 49 24490 1831 2331715
Herpes zoster 95.59 23.91 92 24447 9633 2323913
Dysphonia 94.27 23.91 76 24463 6288 2327258
Blood pressure decreased 93.87 23.91 89 24450 9147 2324399
Arrhythmia 93.58 23.91 74 24465 5954 2327592
Visual field defect 93.54 23.91 45 24494 1471 2332075
Hepatic function abnormal 92.89 23.91 74 24465 6018 2327528
Gastrointestinal disorder 92.68 23.91 87 24452 8830 2324716
Mood swings 92.61 23.91 58 24481 3211 2330335
Pollakiuria 92.47 23.91 61 24478 3695 2329851
Dependence 91.70 23.91 31 24508 390 2333156
Frustration tolerance decreased 91.23 23.91 37 24502 796 2332750
Inflammation 89.50 23.91 73 24466 6140 2327406
Fear 88.49 23.91 52 24487 2564 2330982
General physical health deterioration 88.05 23.91 105 24434 14034 2319512
Cushingoid 87.68 23.91 33 24506 577 2332969
Urticaria 87.10 23.91 138 24401 24123 2309423
Joint injury 86.80 23.91 50 24489 2374 2331172
Dissociation 85.31 23.91 30 24509 428 2333118
Foot fracture 84.57 23.91 52 24487 2786 2330760
Night sweats 84.12 23.91 56 24483 3444 2330102
Obesity 84.03 23.91 42 24497 1494 2332052
Blood creatinine increased 84.03 23.91 89 24450 10444 2323102
Carpal tunnel syndrome 84.00 23.91 46 24493 1979 2331567
Rheumatoid nodule 83.66 23.91 32 24507 586 2332960
Lower limb fracture 82.82 23.91 46 24493 2035 2331511
Glaucoma 82.53 23.91 46 24493 2049 2331497
Poor quality sleep 82.47 23.91 45 24494 1922 2331624
Joint range of motion decreased 82.11 23.91 44 24495 1812 2331734
Conjunctivitis 82.08 23.91 48 24491 2345 2331201
Pleuritic pain 82.04 23.91 32 24507 619 2332927
Ankle fracture 81.85 23.91 47 24492 2218 2331328
Pharyngeal oedema 81.82 23.91 55 24484 3438 2330108
Generalised tonic-clonic seizure 81.36 23.91 65 24474 5307 2328239
Electrocardiogram QT prolonged 80.74 23.91 76 24463 7738 2325808
Blood potassium decreased 79.94 23.91 64 24475 5241 2328305
Hunger 79.30 23.91 32 24507 679 2332867
Chronic obstructive pulmonary disease 79.26 23.91 72 24467 7005 2326541
Somnambulism 78.88 23.91 34 24505 856 2332690
Temperature intolerance 78.36 23.91 35 24504 962 2332584
Drug screen positive 77.80 23.91 34 24505 886 2332660
Parkinson's disease 77.72 23.91 38 24501 1288 2332258
Abortion spontaneous 77.46 23.91 96 24443 13349 2320197
Cardiac failure congestive 77.21 23.91 105 24434 15996 2317550
Eye swelling 77.12 23.91 58 24481 4332 2329214
Lip swelling 76.59 23.91 60 24479 4761 2328785
Panic reaction 76.16 23.91 32 24507 755 2332791
Renal disorder 75.98 23.91 58 24481 4430 2329116
Hip fracture 75.63 23.91 59 24480 4653 2328893
Injury 75.51 23.91 65 24474 5889 2327657
Intervertebral disc disorder 75.48 23.91 30 24509 611 2332935
Facial pain 74.76 23.91 37 24502 1288 2332258
Atrial fibrillation 74.07 23.91 95 24444 13673 2319873
Breakthrough pain 73.87 23.91 22 24517 177 2333369
Drug eruption 73.20 23.91 50 24489 3209 2330337
Tension 72.69 23.91 28 24511 523 2333023
Ocular hyperaemia 72.16 23.91 54 24485 4002 2329544
Gastric disorder 71.88 23.91 52 24487 3658 2329888
Incontinence 71.51 23.91 37 24502 1417 2332129
Toxic skin eruption 71.42 23.91 43 24496 2217 2331329
Spinal pain 71.29 23.91 36 24503 1309 2332237
Ligament sprain 71.29 23.91 37 24502 1426 2332120
Poor quality product administered 71.25 23.91 31 24508 799 2332747
Blood urea increased 70.93 23.91 51 24488 3554 2329992
Sensory loss 70.71 23.91 34 24505 1110 2332436
Muscle disorder 70.54 23.91 31 24508 819 2332727
Eyelid oedema 70.41 23.91 45 24494 2581 2330965
Rheumatoid factor negative 69.58 23.91 14 24525 11 2333535
Musculoskeletal disorder 69.47 23.91 44 24495 2484 2331062
Flank pain 69.39 23.91 37 24502 1508 2332038
Macular degeneration 68.55 23.91 34 24505 1189 2332357
Miosis 68.53 23.91 34 24505 1190 2332356
Incoherent 68.35 23.91 31 24508 884 2332662
Anal incontinence 67.34 23.91 38 24501 1734 2331812
Transient ischaemic attack 67.30 23.91 61 24478 5917 2327629
Psychomotor hyperactivity 67.10 23.91 39 24500 1883 2331663
Incorrect dose administered 67.04 23.91 76 24463 9619 2323927
Encephalopathy 66.55 23.91 54 24485 4507 2329039
Rib fracture 66.11 23.91 43 24496 2542 2331004
Hyperkalaemia 66.08 23.91 60 24479 5833 2327713
Body mass index increased 65.50 23.91 19 24520 138 2333408
Eye irritation 65.27 23.91 48 24491 3464 2330082
Death 65.16 23.91 260 24279 81208 2252338
Haematoma 65.13 23.91 56 24483 5065 2328481
Hallucination, auditory 64.89 23.91 40 24499 2152 2331394
Deafness 64.39 23.91 43 24496 2658 2330888
Blood triglycerides increased 64.05 23.91 40 24499 2203 2331343
Blood iron abnormal 63.57 23.91 19 24520 155 2333391
Poisoning deliberate 63.48 23.91 32 24507 1159 2332387
Sjogren's syndrome 62.06 23.91 30 24509 991 2332555
Concussion 62.03 23.91 29 24510 888 2332658
Bloody discharge 62.02 23.91 18 24521 131 2333415
Appetite disorder 61.98 23.91 26 24513 611 2332935
Nodule 61.81 23.91 39 24500 2187 2331359
Synovitis 61.64 23.91 42 24497 2684 2330862
Intentional underdose 61.43 23.91 23 24516 396 2333150
Hypokalaemia 61.25 23.91 76 24463 10578 2322968
Gamma-glutamyltransferase increased 61.13 23.91 56 24483 5506 2328040
C-reactive protein increased 61.13 23.91 59 24480 6196 2327350
Red blood cell sedimentation rate increased 60.74 23.91 38 24501 2099 2331447
Alanine aminotransferase increased 60.55 23.91 87 24452 13945 2319601
Bipolar disorder 60.42 23.91 32 24507 1286 2332260
Nerve compression 60.36 23.91 29 24510 945 2332601
Unevaluable event 60.29 23.91 69 24470 8822 2324724
Erythema multiforme 60.13 23.91 38 24501 2137 2331409
No adverse event 59.70 23.91 71 24468 9457 2324089
Presyncope 59.70 23.91 47 24492 3756 2329790
Oropharyngeal pain 59.64 23.91 78 24461 11440 2322106
Ear pain 58.97 23.91 41 24498 2708 2330838
Paranoia 58.72 23.91 37 24502 2070 2331476
Flatulence 58.60 23.91 50 24489 4475 2329071
Aspartate aminotransferase increased 58.58 23.91 81 24458 12531 2321015
Atelectasis 58.53 23.91 36 24503 1929 2331617
Peripheral coldness 58.47 23.91 34 24505 1643 2331903
Eosinophilia 58.39 23.91 42 24497 2928 2330618
Generalised anxiety disorder 58.35 23.91 19 24520 211 2333335
Spinal stenosis 58.23 23.91 32 24507 1386 2332160
Trigeminal neuralgia 57.90 23.91 25 24514 632 2332914
Affective disorder 57.80 23.91 27 24512 825 2332721
Wrist fracture 57.61 23.91 34 24505 1689 2331857
Hypoaesthesia oral 57.47 23.91 37 24502 2149 2331397
Reading disorder 57.42 23.91 18 24521 175 2333371
Skin lesion 57.35 23.91 47 24492 3978 2329568
Intervertebral disc degeneration 57.10 23.91 33 24506 1576 2331970
Spinal osteoarthritis 57.00 23.91 34 24505 1723 2331823
Mydriasis 56.96 23.91 37 24502 2182 2331364
Parkinsonism 56.45 23.91 32 24507 1473 2332073
Head discomfort 56.31 23.91 33 24506 1618 2331928
Tunnel vision 56.01 23.91 18 24521 191 2333355
Irritable bowel syndrome 55.53 23.91 34 24505 1807 2331739
Sensitivity to weather change 55.44 23.91 22 24517 446 2333100
Radiculopathy 55.31 23.91 25 24514 707 2332839
Skin disorder 55.12 23.91 44 24495 3587 2329959
Laryngitis 54.98 23.91 31 24508 1412 2332134
Feeding disorder 54.68 23.91 31 24508 1427 2332119
Medication error 54.65 23.91 55 24484 6076 2327470
Skin discolouration 54.62 23.91 52 24487 5368 2328178
Dry skin 54.45 23.91 57 24482 6595 2326951
Facial paralysis 54.05 23.91 37 24502 2382 2331164
Apparent death 53.44 23.91 20 24519 344 2333202
Inappropriate antidiuretic hormone secretion 53.22 23.91 36 24503 2273 2331273
Thirst 52.93 23.91 32 24507 1662 2331884
Drug screen false positive 51.95 23.91 18 24521 245 2333301
Osteoporosis 51.57 23.91 46 24493 4368 2329178
White blood cell count increased 51.53 23.91 57 24482 7021 2326525
Sensory disturbance 51.24 23.91 37 24502 2595 2330951
Anorgasmia 51.09 23.91 17 24522 203 2333343
Logorrhoea 51.09 23.91 21 24518 468 2333078
Chest discomfort 50.95 23.91 82 24457 14513 2319033
Lyme disease 50.84 23.91 20 24519 396 2333150
Liver disorder 50.79 23.91 54 24485 6360 2327186
Rotator cuff syndrome 50.74 23.91 32 24507 1793 2331753
Tongue disorder 50.73 23.91 27 24512 1096 2332450
Akathisia 50.71 23.91 31 24508 1643 2331903
Type 2 diabetes mellitus 50.07 23.91 34 24505 2160 2331386
Intestinal obstruction 49.79 23.91 45 24494 4348 2329198
Accidental overdose 49.63 23.91 43 24496 3929 2329617
Libido decreased 49.42 23.91 21 24518 510 2333036
Grip strength decreased 49.41 23.91 26 24513 1031 2332515
Hyperprolactinaemia 49.35 23.91 23 24516 699 2332847
Stevens-Johnson syndrome 49.00 23.91 44 24495 4215 2329331
Hernia 48.74 23.91 27 24512 1188 2332358
Haemorrhage subcutaneous 48.67 23.91 22 24517 622 2332924
Clumsiness 48.45 23.91 18 24521 303 2333243
Accident 48.26 23.91 24 24515 844 2332702
Hypotonia 47.26 23.91 30 24509 1700 2331846
Aura 47.25 23.91 17 24522 260 2333286
Liver function test abnormal 47.23 23.91 56 24483 7434 2326112
Hepatic enzyme increased 47.09 23.91 64 24475 9738 2323808
Oxygen saturation decreased 46.65 23.91 56 24483 7530 2326016
Suicidal behaviour 46.49 23.91 20 24519 501 2333045
Impaired gastric emptying 46.14 23.91 24 24515 929 2332617
Personality disorder 45.91 23.91 18 24521 353 2333193
Glycosylated haemoglobin increased 45.66 23.91 30 24509 1804 2331742
Thrombocytopenia 45.60 23.91 91 24448 19040 2314506
Mental status changes postoperative 45.58 23.91 10 24529 17 2333529
Hypothyroidism 45.37 23.91 43 24496 4414 2329132
Sluggishness 45.28 23.91 24 24515 966 2332580
Bladder disorder 45.21 23.91 25 24514 1096 2332450
Confusion postoperative 44.86 23.91 10 24529 19 2333527
Head titubation 44.71 23.91 15 24524 184 2333362
Heart rate irregular 44.71 23.91 33 24506 2394 2331152
Neck injury 44.55 23.91 17 24522 309 2333237
Hyperreflexia 44.51 23.91 23 24516 878 2332668
Pain of skin 44.33 23.91 27 24512 1421 2332125
Blood glucose decreased 44.30 23.91 37 24502 3215 2330331
Complex regional pain syndrome 44.25 23.91 17 24522 315 2333231
Asthenopia 44.17 23.91 18 24521 392 2333154
Sinus disorder 43.99 23.91 34 24505 2644 2330902
Screaming 43.86 23.91 21 24518 679 2332867
Anuria 43.38 23.91 29 24510 1795 2331751
Metabolic acidosis 43.14 23.91 48 24491 5950 2327596
Skin ulcer 42.92 23.91 40 24499 4019 2329527
Social anxiety disorder 42.92 23.91 12 24527 75 2333471
Skin exfoliation 42.79 23.91 47 24492 5743 2327803
Language disorder 42.49 23.91 16 24523 280 2333266
Delusion 42.43 23.91 30 24509 2035 2331511
Tooth disorder 42.39 23.91 40 24499 4083 2329463
Unresponsive to stimuli 42.10 23.91 43 24496 4833 2328713
Orthostatic hypotension 41.82 23.91 34 24505 2845 2330701
Eosinophilic colitis 41.57 23.91 11 24528 54 2333492
Creatinine renal clearance decreased 41.31 23.91 22 24517 894 2332652
Dyspepsia 40.95 23.91 60 24479 9784 2323762
Personality change 40.76 23.91 22 24517 919 2332627
Eye haemorrhage 40.67 23.91 25 24514 1338 2332208
Therapeutic product effect delayed 40.42 23.91 18 24521 491 2333055
Spinal fracture 40.33 23.91 33 24506 2786 2330760
Photopsia 40.24 23.91 22 24517 943 2332603
Hostility 40.24 23.91 15 24524 255 2333291
Anaphylactic reaction 40.15 23.91 59 24480 9646 2323900
Haemorrhage 39.87 23.91 63 24476 10976 2322570
Bone disorder 39.84 23.91 35 24504 3257 2330289
Peroneal nerve palsy 39.84 23.91 20 24519 718 2332828
Inadequate analgesia 39.74 23.91 19 24520 612 2332934
Scar 39.73 23.91 28 24511 1889 2331657
Blood sodium decreased 39.62 23.91 34 24505 3066 2330480
Initial insomnia 39.61 23.91 20 24519 727 2332819
Skin burning sensation 39.23 23.91 28 24511 1928 2331618
Forceps delivery 39.06 23.91 10 24529 42 2333504
Staphylococcal infection 38.95 23.91 43 24496 5283 2328263
Product prescribing issue 38.93 23.91 13 24526 157 2333389
Transaminases increased 38.79 23.91 40 24499 4547 2328999
Overweight 38.72 23.91 17 24522 448 2333098
Drug level increased 38.57 23.91 32 24507 2755 2330791
Multiple sclerosis 38.46 23.91 45 24494 5889 2327657
Pulmonary oedema 38.32 23.91 50 24489 7313 2326233
Vitamin D decreased 38.29 23.91 22 24517 1039 2332507
Chronic fatigue syndrome 38.28 23.91 13 24526 166 2333380
Vitamin D deficiency 38.26 23.91 25 24514 1489 2332057
Drug-induced liver injury 38.25 23.91 36 24503 3663 2329883
Product administration error 38.16 23.91 37 24502 3906 2329640
Rhinorrhoea 37.60 23.91 50 24489 7450 2326096
Muscle tightness 37.58 23.91 27 24512 1878 2331668
Raynaud's phenomenon 37.43 23.91 21 24518 947 2332599
Glossodynia 37.08 23.91 27 24512 1918 2331628
Psychomotor skills impaired 37.00 23.91 16 24523 406 2333140
Hypothermia 36.88 23.91 28 24511 2120 2331426
Hypersensitivity vasculitis 36.62 23.91 23 24516 1279 2332267
Hepatic steatosis 36.58 23.91 33 24506 3180 2330366
Neurosis 36.25 23.91 10 24529 59 2333487
Anaemia 36.15 23.91 121 24418 34671 2298875
Pain in jaw 35.89 23.91 45 24494 6327 2327219
Respiratory disorder 35.83 23.91 36 24503 3968 2329578
Drug use disorder 35.77 23.91 15 24524 352 2333194
Facial bones fracture 35.66 23.91 17 24522 544 2333002
Diabetes mellitus inadequate control 35.53 23.91 26 24513 1861 2331685
Choking 35.49 23.91 24 24515 1514 2332032
Skin warm 35.01 23.91 18 24521 680 2332866
Pyelonephritis 34.77 23.91 27 24512 2114 2331432
Face injury 34.67 23.91 16 24523 475 2333071
Dementia Alzheimer's type 34.48 23.91 19 24520 827 2332719
Hippocampal sclerosis 34.39 23.91 8 24531 20 2333526
Glucose tolerance impaired 34.39 23.91 17 24522 590 2332956
Immobile 34.34 23.91 17 24522 592 2332954
Purpura 34.22 23.91 25 24514 1785 2331761
Angina pectoris 34.13 23.91 35 24504 3952 2329594
Decreased activity 34.11 23.91 19 24520 845 2332701
Sepsis 33.79 23.91 79 24460 18409 2315137
Developmental hip dysplasia 33.75 23.91 12 24527 177 2333369
Mania 33.73 23.91 28 24511 2412 2331134
Localised infection 33.65 23.91 30 24509 2846 2330700
Hypertrophic cardiomyopathy 33.64 23.91 13 24526 245 2333301
Cystitis 33.63 23.91 41 24498 5601 2327945
Lower respiratory tract infection 33.28 23.91 40 24499 5384 2328162
Dysphoria 33.11 23.91 23 24516 1516 2332030
Wound 33.00 23.91 29 24510 2699 2330847
Eyelid skin dryness 32.85 23.91 8 24531 26 2333520
Breast cancer female 32.82 23.91 22 24517 1368 2332178
Gastroenteritis viral 32.81 23.91 28 24511 2506 2331040
Intentional dose omission 32.57 23.91 14 24525 350 2333196
Blindness unilateral 32.48 23.91 21 24518 1228 2332318
Food craving 32.34 23.91 13 24526 273 2333273
Self-injurious ideation 32.29 23.91 16 24523 558 2332988
Snoring 32.21 23.91 15 24524 455 2333091
Nephrolithiasis 32.06 23.91 36 24503 4507 2329039
Therapeutic response changed 31.97 23.91 12 24527 208 2333338
Skin abrasion 31.96 23.91 20 24519 1105 2332441
Oral discomfort 31.67 23.91 21 24518 1282 2332264
Hyperglycaemia 31.58 23.91 37 24502 4848 2328698
Dysgeusia 31.55 23.91 49 24490 8410 2325136
Hyperlipidaemia 31.50 23.91 28 24511 2646 2330900
Nystagmus 31.48 23.91 20 24519 1135 2332411
Hepatitis cholestatic 31.44 23.91 20 24519 1137 2332409
Body temperature decreased 31.38 23.91 21 24518 1302 2332244
Dermatitis bullous 31.25 23.91 22 24517 1482 2332064
Nasal congestion 31.23 23.91 44 24495 6922 2326624
Drug reaction with eosinophilia and systemic symptoms 31.12 23.91 39 24500 5479 2328067
Panic disorder 31.04 23.91 15 24524 495 2333051
Antineutrophil cytoplasmic antibody positive 31.04 23.91 10 24529 107 2333439
Apathy 31.04 23.91 21 24518 1326 2332220
Somatic symptom disorder 30.65 23.91 13 24526 314 2333232
Bone pain 30.65 23.91 50 24489 8946 2324600
Negative thoughts 30.58 23.91 12 24527 236 2333310
Rash maculo-papular 30.53 23.91 34 24505 4218 2329328
Thyroid disorder 30.36 23.91 22 24517 1551 2331995
Accommodation disorder 30.29 23.91 11 24528 173 2333373
Emotional distress 30.25 23.91 34 24505 4261 2329285
Lacrimation increased 30.14 23.91 28 24511 2802 2330744
Gastrointestinal motility disorder 30.04 23.91 15 24524 532 2333014
Gout 29.57 23.91 21 24518 1434 2332112
Arterial thrombosis 29.38 23.91 13 24526 349 2333197
Throat tightness 29.35 23.91 34 24505 4402 2329144
Narcolepsy 29.29 23.91 11 24528 191 2333355
Energy increased 29.17 23.91 14 24525 455 2333091
Pancytopenia 29.13 23.91 56 24483 11396 2322150
Pelvic deformity 28.92 23.91 7 24532 22 2333524
Affect lability 28.80 23.91 24 24515 2078 2331468
Temporal lobe epilepsy 28.66 23.91 9 24530 88 2333458
Drooling 28.65 23.91 16 24523 715 2332831
Ear discomfort 28.64 23.91 19 24520 1161 2332385
Mutism 28.60 23.91 12 24527 282 2333264
Decreased interest 28.56 23.91 14 24525 477 2333069
Weight loss poor 28.43 23.91 11 24528 208 2333338
Prescription form tampering 28.41 23.91 10 24529 143 2333403
Foaming at mouth 28.37 23.91 12 24527 288 2333258
Hypertonic bladder 28.33 23.91 13 24526 381 2333165
Pelvic fracture 28.30 23.91 20 24519 1355 2332191
Major depression 28.30 23.91 18 24521 1023 2332523
Jaundice 28.04 23.91 37 24502 5471 2328075
Adverse reaction 27.97 23.91 21 24518 1563 2331983
Cerebral disorder 27.93 23.91 15 24524 620 2332926
Dystonia 27.91 23.91 24 24515 2170 2331376
Muscle atrophy 27.70 23.91 18 24521 1062 2332484
Oral pain 27.60 23.91 29 24510 3368 2330178
Neurogenic bladder 27.45 23.91 13 24526 410 2333136
Pituitary tumour benign 27.37 23.91 12 24527 315 2333231
Haemoglobin decreased 27.30 23.91 72 24467 18079 2315467
Joint dislocation 27.28 23.91 20 24519 1436 2332110
Haemorrhagic diathesis 27.25 23.91 14 24525 528 2333018
Hangover 27.19 23.91 11 24528 235 2333311
Respiratory failure 27.16 23.91 60 24479 13468 2320078
Neutropenia 27.02 23.91 80 24459 21468 2312078
Toxic encephalopathy 26.98 23.91 16 24523 802 2332744
Eyelid ptosis 26.84 23.91 18 24521 1120 2332426
Injection site erythema 26.83 23.91 4 24535 27883 2305663
Vasculitis 26.77 23.91 24 24515 2294 2331252
Pemphigoid 26.75 23.91 17 24522 965 2332581
Disability 26.73 23.91 16 24523 816 2332730
Bronchospasm 26.71 23.91 27 24512 2997 2330549
Adverse event 26.67 23.91 43 24496 7616 2325930
Rash macular 26.67 23.91 29 24510 3502 2330044
Retching 26.64 23.91 23 24516 2091 2331455
Blood pressure abnormal 26.60 23.91 21 24518 1684 2331862
Chronic kidney disease 26.31 23.91 31 24508 4087 2329459
Polyuria 26.22 23.91 18 24521 1164 2332382
Periorbital oedema 26.19 23.91 17 24522 1001 2332545
Ileus 26.10 23.91 23 24516 2149 2331397
Breast pain 26.06 23.91 19 24520 1352 2332194
Cellulitis 25.91 23.91 47 24492 9154 2324392
Blood potassium increased 25.88 23.91 23 24516 2173 2331373
Monoplegia 25.82 23.91 14 24525 590 2332956
Hallucinations, mixed 25.76 23.91 14 24525 593 2332953
Atrioventricular block 25.74 23.91 18 24521 1199 2332347
Cyst 25.67 23.91 20 24519 1573 2331973
Bradykinesia 25.67 23.91 14 24525 597 2332949
Skin laceration 25.64 23.91 25 24514 2657 2330889
Periodic limb movement disorder 25.57 23.91 7 24532 40 2333506
Quality of life decreased 25.54 23.91 15 24524 738 2332808
Feeling of despair 25.50 23.91 12 24527 373 2333173
Red blood cell count decreased 25.42 23.91 31 24508 4235 2329311
Hypertensive crisis 25.11 23.91 24 24515 2489 2331057
Lipase increased 24.97 23.91 19 24520 1443 2332103
Electrocardiogram QRS complex prolonged 24.96 23.91 17 24522 1085 2332461
Tearfulness 24.96 23.91 16 24523 922 2332624
Arthritis infective 24.88 23.91 14 24525 635 2332911
Meningioma 24.86 23.91 14 24525 636 2332910
Tachyphrenia 24.84 23.91 11 24528 296 2333250
Galactorrhoea 24.69 23.91 18 24521 1281 2332265
Oedema mouth 24.65 23.91 15 24524 788 2332758
Muscle contractions involuntary 24.62 23.91 13 24526 519 2333027
Gingival swelling 24.50 23.91 15 24524 797 2332749
Dysaesthesia 24.48 23.91 14 24525 655 2332891
Sciatic nerve injury 24.47 23.91 8 24531 90 2333456
Intraocular pressure increased 24.44 23.91 19 24520 1490 2332056
Lymphoedema 24.37 23.91 17 24522 1128 2332418
Cervical spinal stenosis 24.33 23.91 11 24528 311 2333235
Intracranial aneurysm 24.33 23.91 14 24525 663 2332883
Libido increased 24.30 23.91 9 24530 150 2333396
Dermatitis 24.29 23.91 23 24516 2357 2331189
Red blood cell count increased 24.17 23.91 11 24528 316 2333230
Stomatitis 24.10 23.91 47 24492 9663 2323883
Self esteem decreased 24.09 23.91 9 24530 154 2333392
Sneezing 24.08 23.91 23 24516 2383 2331163
Heart rate decreased 24.03 23.91 28 24511 3648 2329898

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
Pain 1772.88 24.97 793 12199 25864 1707925
Somnolence 1768.00 24.97 693 12299 16046 1717743
Drug ineffective 1243.90 24.97 843 12149 62958 1670831
Dizziness 1178.75 24.97 653 12339 33708 1700081
Drug abuse 1146.94 24.97 481 12511 13208 1720581
Withdrawal syndrome 1091.40 24.97 298 12694 1990 1731799
Toxicity to various agents 946.27 24.97 535 12457 28606 1705183
Fall 897.73 24.97 505 12487 26709 1707080
Weight increased 886.77 24.97 380 12612 10977 1722812
Intentional product misuse 855.90 24.97 328 12664 7030 1726759
Insomnia 800.59 24.97 395 12597 15881 1717908
Pain in extremity 796.52 24.97 410 12582 18062 1715727
Confusional state 789.25 24.97 427 12565 20851 1712938
Overdose 785.00 24.97 393 12599 16308 1717481
Drug dependence 771.16 24.97 248 12744 3079 1730710
Condition aggravated 755.36 24.97 414 12578 20736 1713053
Drug hypersensitivity 713.45 24.97 357 12635 14778 1719011
Feeling abnormal 707.92 24.97 323 12669 10843 1722946
Vision blurred 657.24 24.97 282 12710 8141 1725648
Gait disturbance 647.79 24.97 316 12676 12354 1721435
Therapeutic product effect incomplete 622.73 24.97 240 12752 5208 1728581
Burning sensation 549.82 24.97 191 12801 3044 1730745
Oedema peripheral 533.87 24.97 297 12695 15253 1718536
Hypoaesthesia 513.40 24.97 249 12743 9586 1724203
Suicidal ideation 506.77 24.97 236 12756 8282 1725507
Tremor 503.76 24.97 270 12722 12861 1720928
Product use issue 480.68 24.97 228 12764 8343 1725446
Intentional product use issue 471.48 24.97 163 12829 2556 1731233
Malaise 453.59 24.97 340 12652 29225 1704564
Drug withdrawal syndrome 414.42 24.97 170 12822 4355 1729434
Prescribed overdose 414.04 24.97 133 12859 1637 1732152
Memory impairment 409.78 24.97 189 12803 6474 1727315
Depression 365.73 24.97 239 12753 16430 1717359
Anxiety 351.32 24.97 227 12765 15300 1718489
Neuralgia 338.75 24.97 108 12884 1294 1732495
Balance disorder 329.82 24.97 156 12836 5656 1728133
Off label use 329.72 24.97 317 12675 38254 1695535
Completed suicide 329.05 24.97 222 12770 16090 1717699
Intentional overdose 328.62 24.97 170 12822 7500 1726289
Loss of consciousness 327.96 24.97 214 12778 14661 1719128
Dysarthria 322.68 24.97 149 12843 5110 1728679
Drug interaction 322.11 24.97 272 12720 27686 1706103
Seizure 314.91 24.97 236 12756 20205 1713584
Paraesthesia 310.77 24.97 182 12810 10269 1723520
Disturbance in attention 307.58 24.97 135 12857 4099 1729690
Fatigue 300.83 24.97 343 12649 50438 1683351
Agitation 299.15 24.97 181 12811 10845 1722944
Pre-existing condition improved 296.04 24.97 69 12923 210 1733579
Suicide attempt 294.49 24.97 156 12836 7225 1726564
Disorientation 277.55 24.97 136 12856 5333 1728456
Headache 277.55 24.97 274 12718 34102 1699687
Road traffic accident 271.50 24.97 118 12874 3495 1730294
Depressed level of consciousness 267.69 24.97 141 12851 6451 1727338
Visual impairment 266.78 24.97 138 12854 6080 1727709
Myoclonus 265.02 24.97 102 12890 2193 1731596
Asthenia 260.84 24.97 266 12726 34404 1699385
Rhabdomyolysis 260.17 24.97 166 12826 10924 1722865
Coma 257.62 24.97 142 12850 7120 1726669
Amnesia 255.29 24.97 124 12868 4767 1729022
Hallucination 252.63 24.97 146 12846 8024 1725765
Muscle spasms 240.93 24.97 161 12831 11460 1722329
Muscular weakness 239.35 24.97 153 12839 10096 1723693
Dry mouth 237.24 24.97 110 12882 3803 1729986
Euphoric mood 237.12 24.97 73 12919 772 1733017
Oedema 235.88 24.97 132 12860 6816 1726973
Sedation 235.39 24.97 105 12887 3312 1730477
Aggression 235.01 24.97 139 12853 7976 1725813
Prescription drug used without a prescription 228.86 24.97 54 12938 176 1733613
Urinary retention 226.41 24.97 118 12874 5277 1728512
Loss of personal independence in daily activities 225.85 24.97 92 12900 2307 1731482
Abnormal behaviour 211.21 24.97 119 12873 6223 1727566
Therapeutic response unexpected 207.99 24.97 87 12905 2337 1731452
Visual acuity reduced 207.16 24.97 100 12892 3788 1730001
Neuropathy peripheral 205.82 24.97 134 12858 9119 1724670
Peripheral swelling 203.63 24.97 126 12866 7845 1725944
Product use in unapproved indication 203.61 24.97 134 12858 9288 1724501
Hyperhidrosis 202.80 24.97 149 12843 12339 1721450
Nausea 199.53 24.97 281 12711 50915 1682874
Speech disorder 198.07 24.97 102 12890 4446 1729343
Diplopia 196.50 24.97 85 12907 2485 1731304
Restlessness 194.23 24.97 99 12893 4222 1729567
Drug ineffective for unapproved indication 192.43 24.97 76 12916 1753 1732036
Back pain 191.65 24.97 162 12830 16451 1717338
Sleep disorder 188.19 24.97 95 12897 3968 1729821
Dyspnoea 175.61 24.97 267 12725 51792 1681997
Impaired work ability 170.86 24.97 61 12931 1052 1732737
Hepatocellular injury 168.78 24.97 82 12910 3149 1730640
Feeling drunk 168.68 24.97 48 12944 376 1733413
Cognitive disorder 162.68 24.97 88 12904 4242 1729547
Irritability 160.71 24.97 95 12897 5437 1728352
Coordination abnormal 160.26 24.97 63 12929 1434 1732355
Constipation 158.18 24.97 139 12853 14861 1718928
Cardiac failure 157.96 24.97 129 12863 12473 1721316
Thinking abnormal 157.47 24.97 60 12932 1252 1732537
Hypoacusis 153.37 24.97 71 12921 2442 1731347
Dysstasia 150.60 24.97 63 12929 1691 1732098
Vertigo 147.40 24.97 83 12909 4330 1729459
Dyskinesia 147.33 24.97 79 12913 3740 1730049
Acute kidney injury 146.63 24.97 199 12793 34745 1699044
Delirium 145.98 24.97 94 12898 6268 1727521
Syncope 144.80 24.97 129 12863 14040 1719749
Bradycardia 142.98 24.97 113 12879 10421 1723368
Nervousness 142.42 24.97 65 12927 2162 1731627
Arthralgia 140.92 24.97 160 12832 23284 1710505
Limb discomfort 138.46 24.97 56 12936 1376 1732413
Dysphagia 137.84 24.97 109 12883 10059 1723730
Erectile dysfunction 135.26 24.97 79 12913 4418 1729371
Rash 133.86 24.97 201 12791 38492 1695297
Impaired driving ability 133.66 24.97 43 12949 530 1733259
Swelling 133.11 24.97 92 12900 6904 1726885
Hallucination, visual 133.01 24.97 65 12927 2527 1731262
Gamma-glutamyltransferase increased 131.17 24.97 81 12911 5017 1728772
Blood creatine phosphokinase increased 128.84 24.97 99 12893 8757 1725032
Vomiting 128.22 24.97 196 12796 38119 1695670
Gait inability 128.12 24.97 69 12923 3294 1730495
Cholestasis 125.29 24.97 70 12922 3595 1730194
Weight decreased 124.52 24.97 148 12844 22605 1711184
Pneumonia aspiration 121.27 24.97 78 12914 5188 1728601
Interstitial lung disease 120.92 24.97 99 12893 9597 1724192
Hypertension 117.27 24.97 133 12859 19315 1714474
Joint swelling 117.24 24.97 82 12910 6271 1727518
Altered state of consciousness 114.68 24.97 65 12927 3432 1730357
Respiratory depression 114.25 24.97 56 12936 2191 1731598
Ataxia 111.80 24.97 56 12936 2297 1731492
Myalgia 111.67 24.97 117 12875 15541 1718248
Drug intolerance 111.29 24.97 78 12914 5984 1727805
Urinary incontinence 109.46 24.97 58 12934 2678 1731111
Nerve injury 109.32 24.97 36 12956 480 1733309
Movement disorder 107.58 24.97 49 12943 1621 1732168
Sopor 105.12 24.97 51 12941 1950 1731839
Muscle twitching 97.90 24.97 47 12945 1755 1732034
Blood glucose increased 97.57 24.97 91 12901 10493 1723296
Increased appetite 97.41 24.97 39 12953 932 1732857
Discomfort 97.38 24.97 53 12939 2583 1731206
Pruritus 96.86 24.97 132 12860 23090 1710699
Mental impairment 96.81 24.97 48 12944 1925 1731864
Blindness 94.46 24.97 53 12939 2743 1731046
Drug tolerance 94.12 24.97 30 12962 358 1733431
Dementia 94.07 24.97 48 12944 2048 1731741
Drug use disorder 92.81 24.97 31 12961 433 1733356
Renal failure 91.48 24.97 119 12873 19898 1713891
Anger 91.32 24.97 51 12941 2615 1731174
Dependence 91.00 24.97 28 12964 295 1733494
Mood altered 90.62 24.97 47 12945 2075 1731714
Epilepsy 89.56 24.97 58 12934 3901 1729888
Diabetic neuropathy 85.67 24.97 30 12962 487 1733302
Miosis 84.72 24.97 40 12952 1438 1732351
Pneumonia 84.71 24.97 182 12810 46000 1687789
Visual field defect 84.31 24.97 37 12955 1119 1732670
Death 81.87 24.97 268 12724 87175 1646614
Intervertebral disc protrusion 80.79 24.97 39 12953 1474 1732315
Peripheral coldness 80.43 24.97 36 12956 1142 1732647
Hypotension 80.38 24.97 138 12854 29516 1704273
Blood creatinine increased 79.99 24.97 93 12899 13853 1719936
Blood pressure decreased 78.79 24.97 70 12922 7576 1726213
Sleep apnoea syndrome 78.70 24.97 43 12949 2111 1731678
Fibromyalgia 78.00 24.97 25 12967 304 1733485
Transaminases increased 77.99 24.97 53 12939 3864 1729925
Decreased appetite 76.72 24.97 120 12872 23751 1710038
Cardiac arrest 76.36 24.97 97 12895 15833 1717956
Acute pulmonary oedema 76.16 24.97 35 12957 1182 1732607
Body height decreased 75.74 24.97 27 12965 463 1733326
Neck pain 75.36 24.97 49 12943 3317 1730472
Diabetes mellitus 74.69 24.97 65 12927 6843 1726946
Unresponsive to stimuli 74.49 24.97 55 12937 4574 1729215
Back disorder 73.40 24.97 32 12960 952 1732837
Hepatitis 73.35 24.97 56 12936 4899 1728890
Intentional self-injury 72.63 24.97 44 12948 2629 1731160
Product prescribing error 71.55 24.97 42 12950 2368 1731421
Respiratory arrest 71.45 24.97 59 12933 5780 1728009
Palpitations 71.43 24.97 63 12929 6751 1727038
Musculoskeletal stiffness 71.13 24.97 59 12933 5817 1727972
Nightmare 70.94 24.97 44 12948 2743 1731046
Panic attack 70.52 24.97 38 12954 1814 1731975
Contusion 69.93 24.97 56 12936 5253 1728536
Hypersomnia 69.85 24.97 37 12955 1706 1732083
Brain injury 68.77 24.97 31 12961 1000 1732789
Hyperaesthesia 68.64 24.97 28 12964 703 1733086
Depressed mood 67.75 24.97 44 12948 2972 1730817
Mental disorder 67.63 24.97 43 12949 2800 1730989
Diarrhoea 67.29 24.97 183 12809 53669 1680120
Swelling face 67.09 24.97 51 12941 4432 1729357
Dysuria 66.79 24.97 47 12945 3625 1730164
Psychotic disorder 65.89 24.97 53 12939 5003 1728786
Blood pressure increased 65.51 24.97 74 12918 10679 1723110
Blood alkaline phosphatase increased 64.62 24.97 53 12939 5142 1728647
Renal impairment 63.82 24.97 78 12914 12236 1721553
Hepatic function abnormal 63.58 24.97 60 12932 7014 1726775
Chest pain 62.42 24.97 99 12893 19815 1713974
Abdominal pain 62.15 24.97 103 12889 21387 1712402
Cerebrovascular accident 61.85 24.97 93 12899 17773 1716016
Toxic skin eruption 61.71 24.97 35 12957 1848 1731941
Hyperkalaemia 61.11 24.97 64 12928 8483 1725306
Motor dysfunction 60.79 24.97 29 12963 1067 1732722
Tinnitus 60.69 24.97 42 12950 3153 1730636
Blood urea increased 60.57 24.97 49 12943 4662 1729127
Abdominal distension 60.50 24.97 56 12936 6388 1727401
Face oedema 59.76 24.97 37 12955 2299 1731490
Atrial fibrillation 58.60 24.97 83 12909 15028 1718761
Deafness 57.67 24.97 34 12958 1932 1731857
Pulmonary oedema 57.55 24.97 55 12937 6531 1727258
Emotional disorder 57.37 24.97 28 12964 1084 1732705
Blood homocysteine increased 56.50 24.97 14 12978 59 1733730
Alanine aminotransferase increased 56.04 24.97 73 12919 12205 1721584
Cataract 55.98 24.97 39 12953 2959 1730830
Aspartate aminotransferase increased 55.52 24.97 68 12924 10688 1723101
Hypersensitivity 55.49 24.97 67 12925 10377 1723412
Accident 55.47 24.97 25 12967 806 1732983
Musculoskeletal pain 55.36 24.97 48 12944 5026 1728763
Cardio-respiratory arrest 54.99 24.97 63 12929 9230 1724559
Post herpetic neuralgia 54.85 24.97 16 12976 138 1733651
Product dispensing error 54.69 24.97 31 12961 1635 1732154
Thrombocytopenia 53.76 24.97 96 12896 21153 1712636
Circulatory collapse 53.11 24.97 40 12952 3427 1730362
Nasopharyngitis 52.82 24.97 64 12928 9946 1723843
Hyperpyrexia 52.40 24.97 22 12970 595 1733194
Maternal exposure during pregnancy 52.35 24.97 23 12969 697 1733092
Dysphemia 52.34 24.97 19 12973 344 1733445
Blood potassium increased 52.19 24.97 35 12957 2495 1731294
Arrhythmia 52.11 24.97 50 12942 5966 1727823
Lethargy 51.72 24.97 54 12938 7130 1726659
Blister 51.42 24.97 42 12950 4050 1729739
Head injury 51.07 24.97 37 12955 2987 1730802
Sciatica 50.14 24.97 23 12969 773 1733016
Swollen tongue 48.89 24.97 35 12957 2773 1731016
Heart rate increased 48.78 24.97 50 12942 6460 1727329
Limb injury 48.71 24.97 27 12965 1363 1732426
Accidental overdose 48.70 24.97 41 12951 4123 1729666
Cardiac disorder 48.67 24.97 54 12938 7637 1726152
Glaucoma 48.56 24.97 25 12967 1086 1732703
Glycosylated haemoglobin increased 48.49 24.97 30 12962 1861 1731928
Abnormal dreams 48.49 24.97 30 12962 1861 1731928
Arthropathy 48.23 24.97 35 12957 2832 1730957
Generalised oedema 47.90 24.97 29 12963 1730 1732059
Spinal stenosis 47.75 24.97 21 12971 638 1733151
Agitation neonatal 47.34 24.97 16 12976 232 1733557
Aphasia 46.62 24.97 37 12955 3424 1730365
Anorgasmia 46.46 24.97 15 12977 187 1733602
Stress 46.16 24.97 33 12959 2608 1731181
Mental status changes 46.14 24.97 47 12945 6028 1727761
Prescription form tampering 45.79 24.97 14 12978 144 1733645
Neoplasm malignant 45.23 24.97 40 12952 4299 1729490
Intervertebral disc degeneration 45.07 24.97 20 12972 621 1733168
Drug effective for unapproved indication 44.95 24.97 14 12978 154 1733635
Dysgraphia 44.68 24.97 16 12976 278 1733511
Inflammation 44.59 24.97 36 12956 3414 1730375
Musculoskeletal disorder 44.21 24.97 23 12969 1021 1732768
Optic neuritis 44.21 24.97 21 12971 765 1733024
Tachycardia 44.06 24.97 66 12926 12562 1721227
Retinal haemorrhage 43.79 24.97 24 12968 1185 1732604
Generalised anxiety disorder 43.78 24.97 13 12979 120 1733669
Parkinsonism 43.66 24.97 25 12967 1344 1732445
Incorrect dose administered 43.44 24.97 50 12942 7359 1726430
Haemorrhage subcutaneous 42.80 24.97 18 12974 489 1733300
Personality change 42.58 24.97 23 12969 1103 1732686
Paranoia 42.19 24.97 29 12963 2152 1731637
Blood cholesterol increased 42.16 24.97 33 12959 2993 1730796
Abdominal pain upper 42.00 24.97 60 12932 10941 1722848
Product dose omission 41.66 24.97 89 12903 22351 1711438
Blood folate decreased 41.61 24.97 11 12981 63 1733726
Herpes zoster 41.49 24.97 39 12953 4534 1729255
Pyrexia 41.23 24.97 140 12852 46260 1687529
Hypercapnia 40.98 24.97 18 12974 545 1733244
Erythema 40.98 24.97 68 12924 14120 1719669
Drug eruption 40.96 24.97 32 12960 2894 1730895
Myoclonic epilepsy 40.87 24.97 14 12978 212 1733577
Depersonalisation/derealisation disorder 40.49 24.97 13 12979 159 1733630
C-reactive protein increased 40.16 24.97 43 12949 5842 1727947
Pulmonary congestion 39.72 24.97 26 12966 1779 1732010
Myocardial infarction 39.65 24.97 98 12894 27076 1706713
Generalised tonic-clonic seizure 39.60 24.97 36 12956 4010 1729779
Apathy 39.56 24.97 23 12969 1273 1732516
Sexual dysfunction 39.48 24.97 26 12966 1797 1731992
Restless legs syndrome 39.09 24.97 21 12971 996 1732793
Middle insomnia 38.99 24.97 20 12972 862 1732927
Retinal vein occlusion 38.13 24.97 16 12976 432 1733357
Parkinson's disease 38.10 24.97 25 12967 1717 1732072
Lower limb fracture 37.83 24.97 19 12973 783 1733006
Lung disorder 37.77 24.97 39 12953 5080 1728709
Foot fracture 37.66 24.97 18 12974 665 1733124
Suicide threat 37.38 24.97 8 12984 14 1733775
Sensory loss 37.36 24.97 19 12973 804 1732985
Stevens-Johnson syndrome 37.10 24.97 32 12960 3325 1730464
Weight fluctuation 37.07 24.97 16 12976 464 1733325
Trigeminal neuralgia 37.06 24.97 13 12979 212 1733577
Derealisation 36.92 24.97 12 12980 153 1733636
Somnambulism 36.90 24.97 18 12974 696 1733093
Head discomfort 36.50 24.97 17 12975 592 1733197
Aspiration 36.49 24.97 25 12967 1845 1731944
Hepatic congestion 36.42 24.97 14 12978 299 1733490
Rash maculo-papular 36.34 24.97 33 12959 3670 1730119
Arthritis 36.25 24.97 34 12958 3941 1729848
Creatinine renal clearance decreased 35.96 24.97 18 12974 736 1733053
Mobility decreased 35.92 24.97 34 12958 3986 1729803
Homicidal ideation 35.92 24.97 17 12975 614 1733175
Accidental death 35.75 24.97 15 12977 405 1733384
Neutropenia 35.72 24.97 74 12918 18186 1715603
Hypokalaemia 35.66 24.97 42 12950 6332 1727457
Drug screen positive 35.59 24.97 20 12972 1037 1732752
Eye disorder 35.50 24.97 23 12969 1546 1732243
Agranulocytosis 35.35 24.97 32 12960 3544 1730245
Urinary tract infection 35.32 24.97 53 12939 10100 1723689
Chromaturia 34.98 24.97 28 12964 2622 1731167
Mood swings 34.95 24.97 25 12967 1977 1731812
Salivary hypersecretion 34.44 24.97 22 12970 1443 1732346
Therapeutic product effect decreased 34.42 24.97 41 12951 6256 1727533
Crying 34.31 24.97 22 12970 1453 1732336
Pulmonary fibrosis 34.22 24.97 27 12965 2477 1731312
General physical health deterioration 34.09 24.97 60 12932 13058 1720731
Eyelid oedema 34.09 24.97 21 12971 1292 1732497
Fear of disease 33.99 24.97 7 12985 9 1733780
Hyperglycaemia 33.94 24.97 37 12955 5128 1728661
Migraine 33.93 24.97 26 12966 2285 1731504
Heart rate irregular 33.92 24.97 23 12969 1669 1732120
Fluid retention 33.63 24.97 32 12960 3777 1730012
Poor quality sleep 33.38 24.97 20 12972 1170 1732619
Allodynia 33.23 24.97 10 12982 97 1733692
Encephalopathy 32.99 24.97 34 12958 4418 1729371
Skull fracture 32.86 24.97 12 12980 221 1733568
Dehydration 32.72 24.97 70 12922 17588 1716201
Social avoidant behaviour 32.69 24.97 16 12976 623 1733166
Abdominal discomfort 32.44 24.97 48 12944 9033 1724756
Chills 32.39 24.97 55 12937 11632 1722157
Jaundice 32.36 24.97 39 12953 6023 1727766
Spinal disorder 31.66 24.97 15 12977 543 1733246
Dysphonia 31.64 24.97 30 12962 3525 1730264
Lip swelling 31.61 24.97 27 12965 2768 1731021
Hyperthermia 31.57 24.97 22 12970 1669 1732120
Eye pain 31.56 24.97 25 12967 2306 1731483
Bedridden 31.55 24.97 16 12976 673 1733116
Hallucination, auditory 31.48 24.97 24 12968 2093 1731696
Petit mal epilepsy 31.41 24.97 15 12977 553 1733236
Libido decreased 31.40 24.97 20 12972 1305 1732484
Disease recurrence 31.38 24.97 26 12966 2556 1731233
Facial paralysis 31.34 24.97 23 12969 1893 1731896
Brain natriuretic peptide increased 31.33 24.97 15 12977 556 1733233
Gynaecomastia 31.33 24.97 24 12968 2108 1731681
Anal incontinence 31.17 24.97 19 12973 1147 1732642
Accessory spleen 31.17 24.97 7 12985 17 1733772
Musculoskeletal discomfort 31.04 24.97 18 12974 991 1732798
Transient ischaemic attack 30.92 24.97 34 12958 4757 1729032
Chondrocalcinosis 30.84 24.97 8 12984 42 1733747
Urinary hesitation 30.74 24.97 13 12979 358 1733431
Cold sweat 30.71 24.97 22 12970 1744 1732045
Body mass index increased 30.66 24.97 10 12982 129 1733660
Accidental poisoning 30.38 24.97 10 12982 133 1733656
Cardiovascular insufficiency 29.84 24.97 12 12980 290 1733499
Poisoning 29.75 24.97 25 12967 2507 1731282
Pharyngeal oedema 29.68 24.97 21 12971 1632 1732157
Liver disorder 29.66 24.97 36 12956 5600 1728189
Chest discomfort 29.48 24.97 41 12951 7290 1726499
Phantom limb syndrome 29.27 24.97 8 12984 53 1733736
Head circumference abnormal 29.16 24.97 7 12985 25 1733764
Upper limb fracture 28.96 24.97 16 12976 802 1732987
Influenza virus test positive 28.95 24.97 7 12985 26 1733763
Hepatic ischaemia 28.89 24.97 8 12984 56 1733733
Rash erythematous 28.88 24.97 30 12962 3935 1729854
Skin disorder 28.85 24.97 23 12969 2141 1731648
Drug diversion 28.83 24.97 11 12981 230 1733559
Paralysis 28.59 24.97 19 12973 1333 1732456
Hyponatraemia 28.51 24.97 45 12947 8955 1724834
Substance abuse 28.51 24.97 17 12975 986 1732803
Intervertebral disc disorder 28.46 24.97 12 12980 328 1733461
Intraocular pressure increased 28.42 24.97 18 12974 1163 1732626
Formication 28.28 24.97 13 12979 439 1733350
Affective disorder 28.08 24.97 15 12977 703 1733086
Expired product administered 27.54 24.97 15 12977 731 1733058
Therapeutic response changed 27.53 24.97 9 12983 117 1733672
Heart rate decreased 27.50 24.97 25 12967 2784 1731005
Feeling of body temperature change 27.46 24.97 11 12981 263 1733526
Muscle contractions involuntary 27.40 24.97 13 12979 472 1733317
Eating disorder 27.33 24.97 18 12974 1244 1732545
Joint injury 27.19 24.97 17 12975 1074 1732715
Breakthrough pain 27.18 24.97 9 12983 122 1733667
Self-injurious ideation 27.18 24.97 12 12980 368 1733421
Agitated depression 26.95 24.97 7 12985 37 1733752
Stupor 26.86 24.97 14 12978 624 1733165
Urticaria 26.79 24.97 52 12940 12189 1721600
Sinus bradycardia 26.75 24.97 21 12971 1912 1731877
Gastrooesophageal reflux disease 26.62 24.97 31 12961 4616 1729173
Nystagmus 26.60 24.97 16 12976 943 1732846
Chronic obstructive pulmonary disease 26.53 24.97 35 12957 5918 1727871
Drug screen false positive 26.39 24.97 10 12982 205 1733584
Renal disorder 26.38 24.97 29 12963 4057 1729732
Nervous system disorder 26.32 24.97 23 12969 2431 1731358
Rib fracture 26.23 24.97 20 12972 1744 1732045
Spinal fracture 26.20 24.97 16 12976 969 1732820
Sepsis 26.14 24.97 68 12924 19370 1714419
Benign prostatic hyperplasia 25.66 24.97 18 12974 1380 1732409
Bladder disorder 25.63 24.97 13 12979 547 1733242
Hypokinesia 25.62 24.97 17 12975 1190 1732599
Craniocerebral injury 25.29 24.97 12 12980 436 1733353
Alcohol interaction 25.26 24.97 11 12981 326 1733463
Dysaesthesia 25.26 24.97 12 12980 437 1733352
Anuria 25.03 24.97 20 12972 1868 1731921

Pharmacologic Action:

SourceCodeDescription
ATC N03AX16 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
CHEBI has role CHEBI:35623 anticonvulsant
MeSH PA D000700 Analgesics
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postherpetic neuralgia indication 2177002
Generalized anxiety disorder indication 21897009 DOID:14320
Fibromyalgia indication 203082005 DOID:631
Diabetic peripheral neuropathy indication 424736006
Partial Epilepsy Treatment Adjunct indication
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Reduced visual acuity contraindication 13164000
Depressive disorder contraindication 35489007
Angioedema contraindication 41291007 DOID:1558
Chronic heart failure contraindication 48447003
Disorder of muscle contraindication 129565002 DOID:423
Decompensated cardiac failure contraindication 195111005
Impaired renal function disorder contraindication 197663003
Atrioventricular block contraindication 233917008 DOID:0050820
Rhabdomyolysis contraindication 240131006
Drowsy contraindication 271782001
Peripheral edema contraindication 271809000
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Dizziness contraindication 404640003

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.97 acidic
pKa2 10.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
150MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
200MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
225MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
25MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
300MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
50MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
75MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
20MG/ML LYRICA PF PRISM CV N022488 Jan. 4, 2010 RX SOLUTION ORAL June 22, 2020 PEDIATRIC EXCLUSIVITY
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL Oct. 11, 2020 NEW PRODUCT
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL Oct. 11, 2020 NEW PRODUCT
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL Oct. 11, 2020 NEW PRODUCT
165MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL April 11, 2021 PEDIATRIC EXCLUSIVITY
330MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL April 11, 2021 PEDIATRIC EXCLUSIVITY
82.5MG LYRICA CR PF PRISM CV N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL April 11, 2021 PEDIATRIC EXCLUSIVITY
100MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
150MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
200MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
225MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
25MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
300MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
50MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
75MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 3, 2021 NEW PATIENT POPULATION
20MG/ML LYRICA PF PRISM CV N022488 Jan. 4, 2010 RX SOLUTION ORAL May 3, 2021 NEW PATIENT POPULATION
100MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
150MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
200MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
225MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
25MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
300MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
50MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
75MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
20MG/ML LYRICA PF PRISM CV N022488 Jan. 4, 2010 RX SOLUTION ORAL Nov. 3, 2021 PEDIATRIC EXCLUSIVITY
100MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
150MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
200MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
225MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
25MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
300MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
50MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
75MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
20MG/ML LYRICA PF PRISM CV N022488 Jan. 4, 2010 RX SOLUTION ORAL May 23, 2022 NEW PATIENT POPULATION
100MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
150MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
200MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
225MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
25MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
300MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
50MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
75MG LYRICA PF PRISM CV N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
20MG/ML LYRICA PF PRISM CV N022488 Jan. 4, 2010 RX SOLUTION ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel MODULATOR IC50 7.10 WOMBAT-PK CHEMBL
Voltage-dependent calcium channel subunit alpha-2/delta-2 Ion channel MODULATOR IC50 7.26 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Large neutral amino acids transporter small subunit 1 Transporter IC50 3.80 WOMBAT-PK
Uncharacterized protein; Voltage-dependent calcium channel alpha-2 delta subunit Ion channel IC50 7.14 CHEMBL

External reference:

IDSource
D000069583 MESH_DESCRIPTOR_UI
4024924 VUID
N0000171595 NUI
C0657912 UMLSCUI
D02716 KEGG_DRUG
55JG375S6M UNII
7643 INN_ID
415159003 SNOMEDCT_US
79550 MMSL
415160008 SNOMEDCT_US
19649 MMSL
d05508 MMSL
187832 RXNORM
4024924 VANDF
010083 NDDF
5486971 PUBCHEM_CID
CHEBI:64356 CHEBI
CHEMBL1059 ChEMBL_ID
DB00230 DRUGBANK_ID
5484 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1012 CAPSULE 25 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1013 CAPSULE 50 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1014 CAPSULE 75 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1015 CAPSULE 100 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1016 CAPSULE 150 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1017 CAPSULE 200 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1018 CAPSULE 300 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1019 CAPSULE 225 mg ORAL NDA 20 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1020 SOLUTION 20 mg ORAL NDA 20 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1026 TABLET, FILM COATED, EXTENDED RELEASE 82.50 mg ORAL NDA 20 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1027 TABLET, FILM COATED, EXTENDED RELEASE 165 mg ORAL NDA 20 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1029 TABLET, FILM COATED, EXTENDED RELEASE 330 mg ORAL NDA 20 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7621 CAPSULE 300 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7622 CAPSULE 25 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7623 CAPSULE 50 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7624 CAPSULE 75 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7625 CAPSULE 100 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7626 CAPSULE 150 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7627 CAPSULE 200 mg ORAL ANDA 18 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7628 CAPSULE 225 mg ORAL ANDA 18 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-6991 CAPSULE 25 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-6992 CAPSULE 50 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7000 CAPSULE 75 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7001 CAPSULE 100 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7002 CAPSULE 150 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7003 CAPSULE 200 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7004 CAPSULE 225 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7005 CAPSULE 300 mg ORAL ANDA 19 sections
LYRICA HUMAN PRESCRIPTION DRUG LABEL 1 16590-503 CAPSULE 50 mg ORAL NDA 19 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 21695-276 CAPSULE 25 mg ORAL NDA 19 sections