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

Stem definitionDrug idCAS RN
antidepressants, dibenzo[a,d]cycloheptane or cyclopheptene derivatives 180 50-48-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amitriptyline
  • amitriprolidine
  • amitriptylin
  • damitriptyline
  • amitriptyline hydrochloride
  • amitryptiline
  • amitryptiline hydrochloride
  • amitriptyline HCl
  • amitryptiline HCl
Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
  • Molecular weight: 277.41
  • Formula: C20H23N
  • CLOGP: 4.85
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 0
  • TPSA: 3.24
  • ALOGS: -4.79
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
75 mg O
75 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 31.39 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 15.45 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 48 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 8.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.07 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 17 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 7, 1961 FDA ASTRAZENECA

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 689.90 9.71 1607 137023 245643 63104749
Cognitive disorder 450.59 9.71 582 138048 55233 63295159
Completed suicide 426.69 9.71 966 137664 144707 63205685
Sedation complication 419.42 9.71 300 138330 13522 63336870
Sedation 396.64 9.71 456 138174 38353 63312039
Creatinine renal clearance decreased 388.08 9.71 306 138324 16002 63334390
Orthostatic hypotension 386.72 9.71 435 138195 35725 63314667
Pemphigus 374.81 9.71 5 138625 183721 63166671
Depressed level of consciousness 326.06 9.71 528 138102 61550 63288842
Blood calcium decreased 303.17 9.71 330 138300 26121 63324271
Systemic lupus erythematosus 302.97 9.71 47 138583 208871 63141521
Glossodynia 297.35 9.71 25 138605 178851 63171541
Balance disorder 270.88 9.71 581 138049 83841 63266551
Anti-cyclic citrullinated peptide antibody positive 237.67 9.71 3 138627 116209 63234183
Arthropathy 216.08 9.71 122 138508 234670 63115722
Coma 214.58 9.71 450 138180 63914 63286478
Wound 210.59 9.71 49 138581 163214 63187178
Hand deformity 201.47 9.71 50 138580 159407 63190985
Drug abuse 196.77 9.71 467 138163 72051 63278341
Electrocardiogram QRS complex prolonged 194.32 9.71 135 138495 5803 63344589
Serotonin syndrome 174.30 9.71 261 138369 28421 63321971
Duodenal ulcer perforation 167.35 9.71 5 138625 87204 63263188
Hepatic enzyme increased 167.07 9.71 119 138511 202209 63148183
Migraine 166.93 9.71 551 138079 102795 63247597
Drug ineffective for unapproved indication 148.76 9.71 267 138363 33796 63316596
Rheumatoid factor positive 148.24 9.71 9 138621 84397 63265995
Abdominal discomfort 145.92 9.71 301 138329 320584 63029808
Maternal exposure during pregnancy 143.84 9.71 161 138469 219901 63130491
Alopecia 139.26 9.71 334 138296 337202 63013190
Poisoning deliberate 135.62 9.71 144 138486 11074 63339318
Synovitis 134.34 9.71 126 138504 186792 63163600
Fall 133.24 9.71 1375 137255 390959 62959433
Contraindicated product administered 130.81 9.71 170 138460 217478 63132914
Infusion related reaction 125.03 9.71 215 138415 245306 63105086
Disturbance in attention 122.60 9.71 263 138367 37926 63312466
Folliculitis 121.98 9.71 8 138622 70309 63280083
Hypersensitivity 121.97 9.71 288 138342 292397 63057995
Muscle injury 121.00 9.71 5 138625 65340 63285052
Overdose 117.86 9.71 531 138099 114547 63235845
Impaired work ability 116.28 9.71 166 138464 17309 63333083
Pericarditis 113.09 9.71 74 138556 131505 63218887
Swelling 111.54 9.71 275 138355 275103 63075289
Mydriasis 111.33 9.71 134 138496 11822 63338570
Constipation 109.48 9.71 853 137777 224090 63126302
Anticholinergic syndrome 106.91 9.71 66 138564 2316 63348076
Exposure during pregnancy 101.37 9.71 114 138516 155433 63194959
Hypotension 98.45 9.71 968 137662 271636 63078756
Somnolence 96.76 9.71 695 137935 177990 63172402
Hyperhidrosis 94.71 9.71 476 138154 107360 63243032
Discomfort 94.23 9.71 137 138493 167237 63183155
Tension headache 93.67 9.71 83 138547 5103 63345289
Muscle twitching 93.43 9.71 160 138470 19508 63330884
Tinnitus 92.89 9.71 226 138404 35402 63314990
Neutropenia 91.12 9.71 151 138479 174854 63175538
Impaired healing 90.40 9.71 56 138574 102486 63247906
Cardiospasm 88.55 9.71 54 138576 1853 63348539
Derealisation 88.15 9.71 46 138584 1162 63349230
Pruritus genital 86.05 9.71 60 138570 2594 63347798
Palmoplantar keratoderma 86.01 9.71 54 138576 1953 63348439
Intentional overdose 85.74 9.71 355 138275 73797 63276595
Helicobacter infection 85.56 9.71 48 138582 92737 63257655
Suicidal ideation 85.30 9.71 315 138315 62106 63288286
Electrocardiogram QT prolonged 85.23 9.71 305 138325 59225 63291167
Gastric pH decreased 85.11 9.71 39 138591 735 63349657
Synovial fluid analysis 83.58 9.71 57 138573 2376 63348016
Tenosynovitis stenosans 79.75 9.71 63 138567 3301 63347091
Therapeutic product effect decreased 78.90 9.71 192 138438 192995 63157397
Anxiety 78.25 9.71 772 137858 216769 63133623
Tachycardia 77.43 9.71 482 138148 117674 63232718
Feeling jittery 77.22 9.71 119 138511 13284 63337108
Hallucination 76.90 9.71 279 138351 54538 63295854
Scleritis 76.28 9.71 69 138561 4359 63346033
Withdrawal syndrome 75.15 9.71 147 138483 19850 63330542
Pleuritic pain 74.77 9.71 90 138540 7939 63342453
Sleep terror 74.09 9.71 55 138575 2625 63347767
Feeling of despair 71.47 9.71 51 138579 2288 63348104
Irritable bowel syndrome 69.91 9.71 47 138583 82365 63268027
Nightmare 68.40 9.71 138 138492 19056 63331336
Crepitations 68.22 9.71 86 138544 7954 63342438
Dizziness 68.16 9.71 1317 137313 428608 62921784
Drug interaction 67.86 9.71 782 137848 228349 63122043
Product use issue 67.84 9.71 250 138380 220270 63130122
Platelet count decreased 67.37 9.71 93 138537 116029 63234363
Agitation 66.67 9.71 283 138347 59474 63290918
Hallucinations, mixed 65.60 9.71 66 138564 4763 63345629
Lip swelling 65.52 9.71 182 138448 30881 63319511
Cogwheel rigidity 64.95 9.71 45 138585 1925 63348467
Body tinea 64.37 9.71 44 138586 1841 63348551
H1N1 influenza 62.75 9.71 42 138588 1697 63348695
Photophobia 61.90 9.71 126 138504 17509 63332883
Dissociation 61.44 9.71 51 138579 2868 63347524
Visual impairment 61.39 9.71 354 138276 84092 63266300
Poor quality sleep 61.36 9.71 135 138495 19800 63330592
Anaemia 60.37 9.71 384 138246 293046 63057346
Rubber sensitivity 60.36 9.71 46 138584 2285 63348107
Depressed mood 60.17 9.71 209 138421 39982 63310410
Febrile neutropenia 59.98 9.71 104 138526 118345 63232047
Restless legs syndrome 59.90 9.71 128 138502 18403 63331989
Atrial tachycardia 59.54 9.71 59 138571 4181 63346211
Inhibitory drug interaction 58.36 9.71 49 138581 2800 63347592
Hip arthroplasty 58.11 9.71 16 138614 47630 63302762
Ventricular tachycardia 57.80 9.71 132 138498 19847 63330545
Eye pain 57.76 9.71 184 138446 33670 63316722
Lip pruritus 57.73 9.71 32 138598 915 63349477
Knee arthroplasty 57.71 9.71 23 138607 54183 63296209
Dystonia 57.38 9.71 106 138524 13713 63336679
Depersonalisation/derealisation disorder 56.51 9.71 36 138594 1336 63349056
Immunisation 55.95 9.71 34 138596 1159 63349233
Medication overuse headache 55.95 9.71 30 138600 802 63349590
Bradypnoea 52.84 9.71 51 138579 3499 63346893
Aspartate aminotransferase increased 52.66 9.71 72 138558 90205 63260187
Blister 52.20 9.71 130 138500 129684 63220708
Flank pain 51.50 9.71 112 138518 16298 63334094
Swelling face 50.73 9.71 273 138357 63202 63287190
Respiratory depression 50.54 9.71 100 138530 13615 63336777
Brain injury 49.97 9.71 69 138561 6974 63343418
Bone density decreased 49.63 9.71 103 138527 14509 63335883
Liver injury 49.37 9.71 36 138594 60484 63289908
Feeling of body temperature change 49.09 9.71 57 138573 4840 63345552
Insomnia 48.63 9.71 699 137931 214553 63135839
Swollen tongue 47.85 9.71 176 138454 34624 63315768
Carotid artery occlusion 47.66 9.71 55 138575 4639 63345753
Infection susceptibility increased 47.61 9.71 48 138582 3473 63346919
Mobility decreased 47.49 9.71 438 138192 120721 63229671
Feeling abnormal 46.86 9.71 513 138117 147879 63202513
Emotional disorder 46.26 9.71 95 138535 13284 63337108
Atrial fibrillation 45.20 9.71 119 138511 116517 63233875
Sacroiliitis 45.14 9.71 45 138585 3212 63347180
Disease progression 44.77 9.71 129 138501 122629 63227763
Accidental death 44.69 9.71 36 138594 1940 63348452
Hallucination, visual 44.64 9.71 117 138513 19181 63331211
Neovascularisation 44.58 9.71 29 138601 1116 63349276
Cushingoid 44.27 9.71 72 138558 8413 63341979
C-reactive protein abnormal 43.72 9.71 23 138607 46073 63304319
Persistent genital arousal disorder 43.13 9.71 18 138612 268 63350124
Somatic symptom disorder 43.00 9.71 40 138590 2620 63347772
Facial pain 42.59 9.71 80 138550 10481 63339911
Crystal nephropathy 42.17 9.71 26 138604 910 63349482
Tremor 42.13 9.71 458 138172 131781 63218611
Fibromyalgia 41.86 9.71 310 138320 80110 63270282
Malaise 40.89 9.71 1193 137437 414761 62935631
Tenosynovitis 40.86 9.71 92 138538 13703 63336689
Labelled drug-drug interaction issue 40.71 9.71 27 138603 1074 63349318
Myelosuppression 40.22 9.71 3 138627 23700 63326692
Rash 39.85 9.71 927 137703 559944 62790448
Therapeutic product ineffective 39.48 9.71 32 138598 1740 63348652
Sensory loss 39.37 9.71 76 138554 10162 63340230
Drooling 38.74 9.71 45 138585 3823 63346569
Vasculitis 38.70 9.71 107 138523 18102 63332290
Diplopia 38.70 9.71 127 138503 23601 63326791
Suicide attempt 38.32 9.71 246 138384 60672 63289720
Vision blurred 37.89 9.71 336 138294 91588 63258804
Small fibre neuropathy 37.75 9.71 19 138611 444 63349948
Joint swelling 37.56 9.71 497 138133 327169 63023223
Parosmia 37.02 9.71 56 138574 6150 63344242
Condition aggravated 36.88 9.71 637 137993 401580 62948812
Anosmia 36.87 9.71 59 138571 6801 63343591
Thrombocytopenia 36.32 9.71 188 138442 150969 63199423
Wrist deformity 36.32 9.71 33 138597 2097 63348295
General physical health deterioration 36.23 9.71 274 138356 201128 63149264
Pulmonary eosinophilia 36.18 9.71 17 138613 340 63350052
Pituitary tumour benign 36.17 9.71 32 138598 1963 63348429
Oedema 36.02 9.71 102 138528 97520 63252872
Oesophageal spasm 35.83 9.71 39 138591 3084 63347308
Heart sounds 35.80 9.71 24 138606 972 63349420
Clear cell renal cell carcinoma 35.61 9.71 28 138602 1457 63348935
Conjunctivitis 35.45 9.71 113 138517 20683 63329709
Device expulsion 35.28 9.71 16 138614 34906 63315486
Drug withdrawal syndrome 35.28 9.71 135 138495 27059 63323333
Tenderness 35.18 9.71 119 138511 22459 63327933
Cardiac arrest 34.97 9.71 332 138298 92213 63258179
Allergy to chemicals 34.92 9.71 38 138592 3004 63347388
Cardio-respiratory arrest 34.61 9.71 237 138393 59722 63290670
Glucose tolerance impaired 34.57 9.71 56 138574 6521 63343871
Cardiac failure congestive 34.54 9.71 96 138534 92337 63258055
Ill-defined disorder 34.34 9.71 80 138550 81675 63268717
Autonomic dysreflexia 34.05 9.71 16 138614 320 63350072
Psychotic disorder due to a general medical condition 33.82 9.71 15 138615 261 63350131
Prolonged expiration 33.73 9.71 24 138606 1072 63349320
Cestode infection 33.26 9.71 15 138615 272 63350120
Palpitations 32.94 9.71 384 138246 112386 63238006
Infection 32.71 9.71 331 138299 228842 63121550
Heart rate increased 32.65 9.71 332 138298 93906 63256486
Speech disorder 32.63 9.71 175 138455 40454 63309938
Myoclonus 32.50 9.71 92 138538 15776 63334616
Alanine aminotransferase increased 32.30 9.71 117 138513 103653 63246739
Telangiectasia congenital 32.28 9.71 8 138622 16 63350376
Loss of consciousness 32.21 9.71 397 138233 117724 63232668
Oedema peripheral 32.14 9.71 262 138368 189249 63161143
Oesophageal pain 32.06 9.71 40 138590 3661 63346731
Tension 31.90 9.71 37 138593 3138 63347254
Hyperlactacidaemia 31.68 9.71 35 138595 2814 63347578
Paralysis 31.56 9.71 68 138562 9832 63340560
Septic shock 31.49 9.71 61 138569 66568 63283824
Synovial cyst 31.37 9.71 70 138560 10363 63340029
Blindness 30.89 9.71 111 138519 21588 63328804
Cervix neoplasm 30.53 9.71 13 138617 204 63350188
Akathisia 30.51 9.71 64 138566 9082 63341310
Menstrual disorder 30.36 9.71 47 138583 5266 63345126
Muscle disorder 29.87 9.71 45 138585 4924 63345468
Cardiac failure 29.43 9.71 98 138532 89044 63261348
Amnesia 29.34 9.71 215 138415 55370 63295022
Adverse event 29.27 9.71 65 138565 67494 63282898
Intentional product misuse 29.00 9.71 230 138400 60687 63289705
Urinary retention 28.90 9.71 137 138493 30164 63320228
Type 2 diabetes mellitus 28.88 9.71 60 138570 63808 63286584
Multiple sclerosis relapse 28.80 9.71 193 138437 48285 63302107
Memory impairment 28.68 9.71 351 138279 103907 63246485
Dysarthria 28.43 9.71 175 138455 42536 63307856
Multiple drug therapy 27.81 9.71 37 138593 3609 63346783
Sinusitis 27.35 9.71 340 138290 226313 63124079
Pulmonary fibrosis 27.22 9.71 28 138602 39781 63310611
Live birth 27.08 9.71 11 138619 25619 63324773
Gastrointestinal disorder 26.81 9.71 172 138458 131067 63219325
Bursitis 26.72 9.71 155 138475 36886 63313506
Dyskinesia 26.49 9.71 139 138491 31863 63318529
Pain of skin 26.36 9.71 70 138560 11564 63338828
Vestibular migraine 26.34 9.71 12 138618 223 63350169
CFTR gene mutation 26.21 9.71 10 138620 116 63350276
Depressive symptom 25.88 9.71 38 138592 4064 63346328
Paraesthesia 25.85 9.71 484 138146 156482 63193910
Bone marrow failure 25.79 9.71 16 138614 29274 63321118
Vertigo 25.77 9.71 221 138409 59666 63290726
Impaired reasoning 25.71 9.71 9 138621 80 63350312
Antinuclear antibody positive 25.56 9.71 55 138575 7944 63342448
Neck pain 25.36 9.71 247 138383 69071 63281321
Neuralgia 25.29 9.71 118 138512 25808 63324584
Diaphragmatic rupture 25.09 9.71 12 138618 250 63350142
Joint effusion 24.91 9.71 88 138542 16972 63333420
Red blood cell sedimentation rate increased 24.73 9.71 36 138594 43946 63306446
Malignant neoplasm progression 24.63 9.71 94 138536 82027 63268365
Injection site erythema 24.44 9.71 96 138534 83078 63267314
Pulseless electrical activity 24.36 9.71 52 138578 7469 63342923
Multiple organ dysfunction syndrome 24.26 9.71 55 138575 56697 63293695
Blood creatinine increased 24.18 9.71 104 138526 87740 63262652
Lymphoedema 24.15 9.71 68 138562 11624 63338768
Hospitalisation 23.87 9.71 100 138530 84981 63265411
Incontinence 23.39 9.71 67 138563 11565 63338827
Therapy non-responder 23.34 9.71 86 138544 75815 63274577
Biliary sepsis 23.29 9.71 18 138612 913 63349479
Myofascial pain syndrome 23.27 9.71 27 138603 2291 63348101
Libido increased 23.25 9.71 21 138609 1324 63349068
Dry mouth 23.11 9.71 266 138364 77597 63272795
Eyelid exfoliation 23.08 9.71 10 138620 164 63350228
Forced expiratory volume decreased 23.05 9.71 40 138590 4928 63345464
Drug tolerance decreased 23.00 9.71 5 138625 17468 63332924
Injection site swelling 22.96 9.71 43 138587 47529 63302863
Diet failure 22.96 9.71 7 138623 38 63350354
Hyperaesthesia 22.95 9.71 58 138572 9300 63341092
Eye irritation 22.92 9.71 102 138528 21869 63328523
Pregnancy 22.90 9.71 28 138602 36808 63313584
Neuroleptic malignant syndrome 22.86 9.71 68 138562 11988 63338404
Premenstrual syndrome 22.72 9.71 16 138614 703 63349689
Multiple sclerosis 22.38 9.71 109 138521 24263 63326129
Hepatic function abnormal 22.29 9.71 29 138601 37113 63313279
Sternal fracture 22.20 9.71 26 138604 2228 63348164
CYP3A4 polymorphism 22.02 9.71 8 138622 80 63350312
Accidental overdose 21.95 9.71 105 138525 23204 63327188
Respiration abnormal 21.52 9.71 45 138585 6372 63344020
Neutrophil count decreased 21.50 9.71 58 138572 56348 63294044
Nodule 21.48 9.71 97 138533 20929 63329463
Anti-neutrophil cytoplasmic antibody positive vasculitis 21.47 9.71 29 138601 2870 63347522
Soft tissue injury 21.39 9.71 22 138608 1630 63348762
Renal mass 21.30 9.71 26 138604 2327 63348065
Cellulitis 21.28 9.71 273 138357 81685 63268707
Peripheral venous disease 21.26 9.71 4 138626 15473 63334919
Cerebellar stroke 20.90 9.71 11 138619 283 63350109
Mood swings 20.79 9.71 87 138543 18161 63332231
Extrapyramidal disorder 20.68 9.71 70 138560 13214 63337178
Magnesium deficiency 20.65 9.71 14 138616 578 63349814
Choanal stenosis 20.61 9.71 6 138624 27 63350365
Hypoaesthesia oral 20.58 9.71 69 138561 12964 63337428
Macular degeneration 20.53 9.71 14 138616 24362 63326030
Peritonitis 20.47 9.71 6 138624 17148 63333244
Cyanosis 20.29 9.71 82 138548 16853 63333539
Abdominal pain 20.24 9.71 808 137822 292648 63057744
Eyelid myoclonus 20.15 9.71 8 138622 104 63350288
Postural orthostatic tachycardia syndrome 20.10 9.71 19 138611 1270 63349122
Sensitivity to weather change 20.04 9.71 47 138583 7190 63343202
Drug dependence 20.03 9.71 106 138524 24377 63326015
Confusional state 19.99 9.71 666 137964 235714 63114678
Abortion spontaneous 19.96 9.71 46 138584 47149 63303243
Stomatitis 19.93 9.71 200 138430 138525 63211867
Tubulointerstitial nephritis and uveitis syndrome 19.82 9.71 10 138620 235 63350157
Restlessness 19.80 9.71 121 138509 29332 63321060
Sopor 19.55 9.71 98 138532 22066 63328326
Haemorrhage 19.52 9.71 68 138562 60954 63289438
Seizure 19.48 9.71 402 138228 132232 63218160
Rectal cancer metastatic 19.40 9.71 10 138620 246 63350146
Circulatory collapse 19.35 9.71 97 138533 21841 63328551
Renal failure 19.32 9.71 164 138466 117488 63232904
Anterograde amnesia 19.23 9.71 13 138617 534 63349858
Femoral artery dissection 19.18 9.71 6 138624 36 63350356
Naevus flammeus 19.17 9.71 8 138622 119 63350273
Hostility 19.12 9.71 22 138608 1850 63348542
Gastrointestinal haemorrhage 18.91 9.71 102 138528 81074 63269318
Hyperprolactinaemia 18.88 9.71 32 138598 3868 63346524
Disseminated intravascular coagulation 18.83 9.71 9 138621 19042 63331350
Psychotic symptom 18.80 9.71 20 138610 1541 63348851
Death 18.80 9.71 649 137981 373732 62976660
Subclavian artery embolism 18.75 9.71 5 138625 15 63350377
Personality disorder 18.62 9.71 40 138590 5771 63344621
Skin necrosis 18.34 9.71 4 138626 13946 63336446
Coma scale abnormal 18.30 9.71 37 138593 5116 63345276
Vascular malformation 18.26 9.71 11 138619 369 63350023
Muscle rigidity 18.26 9.71 61 138569 11439 63338953
Dental restoration failure 18.23 9.71 16 138614 971 63349421
White blood cell count decreased 18.18 9.71 205 138425 138899 63211493
Thymus disorder 17.88 9.71 10 138620 291 63350101
Sinus tachycardia 17.80 9.71 102 138528 24166 63326226
Respiratory arrest 17.64 9.71 127 138503 32518 63317874
Paranasal cyst 17.56 9.71 11 138619 396 63349996
Visual snow syndrome 17.48 9.71 6 138624 50 63350342
Delirium 17.47 9.71 178 138452 50363 63300029
Paradoxical drug reaction 17.43 9.71 32 138598 4120 63346272
Lip dry 17.41 9.71 6 138624 15464 63334928
Mood altered 17.36 9.71 71 138559 14672 63335720
Pancytopenia 17.35 9.71 132 138498 96801 63253591
Poliomyelitis 17.28 9.71 6 138624 52 63350340
Mental disorder 17.12 9.71 106 138524 25813 63324579
Respiratory acidosis 16.87 9.71 42 138588 6673 63343719
Purpura 16.86 9.71 59 138571 11326 63339066
Hyperthermia 16.76 9.71 51 138579 9105 63341287
Ventricular arrhythmia 16.70 9.71 30 138600 3798 63346594
Blood bilirubin increased 16.69 9.71 35 138595 37105 63313287
Secondary adrenocortical insufficiency 16.68 9.71 18 138612 1410 63348982
SLE arthritis 16.67 9.71 13 138617 668 63349724
Lichen sclerosus 16.63 9.71 16 138614 1093 63349299
Parkinsonian rest tremor 16.61 9.71 7 138623 107 63350285
Vaccination site oedema 16.49 9.71 4 138626 7 63350385
Bradycardia 16.19 9.71 237 138393 72990 63277402
Vaccination site bruising 16.14 9.71 4 138626 8 63350384
Enlarged uvula 16.09 9.71 8 138622 182 63350210
Leukopenia 15.93 9.71 101 138529 77189 63273203
Burning feet syndrome 15.85 9.71 6 138624 68 63350324
Viral diarrhoea 15.82 9.71 8 138622 189 63350203
Product dispensing error 15.78 9.71 54 138576 10251 63340141
Post-traumatic neck syndrome 15.75 9.71 21 138609 2053 63348339
Psoriatic arthropathy 15.74 9.71 126 138504 91394 63258998
Hot flush 15.73 9.71 176 138454 50983 63299409
Mania 15.72 9.71 61 138569 12306 63338086
Oral herpes 15.60 9.71 104 138526 25970 63324422
Appetite disorder 15.54 9.71 43 138587 7278 63343114
Drug intolerance 15.50 9.71 535 138095 308126 63042266
Sepsis 15.48 9.71 238 138392 152885 63197507
Blood cholesterol increased 15.47 9.71 131 138499 93901 63256491
Injury 15.47 9.71 95 138535 73152 63277240
Caesarean section 15.42 9.71 9 138621 17023 63333369
Eye pruritus 15.38 9.71 81 138549 18590 63331802
Polymenorrhoea 15.34 9.71 16 138614 1205 63349187
Foetal exposure during pregnancy 15.33 9.71 29 138601 31933 63318459
Unevaluable event 15.29 9.71 59 138571 51327 63299065
Dry eye 15.28 9.71 146 138484 40615 63309777
Vaccination site pruritus 15.25 9.71 4 138626 11 63350381
Movement disorder 15.21 9.71 90 138540 21571 63328821
Treatment failure 15.20 9.71 325 138305 198718 63151674
Pulmonary hypertension 15.05 9.71 37 138593 37086 63313306
Renal impairment 15.03 9.71 122 138508 88233 63262159
Adiposis dolorosa 14.88 9.71 9 138621 304 63350088
Premature baby 14.85 9.71 14 138616 20721 63329671
Hyperlipidaemia 14.84 9.71 83 138547 19488 63330904
Muscle spasms 14.78 9.71 446 138184 155704 63194688
Subarachnoid haemorrhage 14.67 9.71 66 138564 14217 63336175
Concussion 14.65 9.71 49 138581 9195 63341197
Vulvovaginal swelling 14.55 9.71 11 138619 540 63349852
Environmental exposure 14.52 9.71 6 138624 87 63350305
Impaired quality of life 14.39 9.71 64 138566 13719 63336673
Abnormal loss of weight 14.35 9.71 36 138594 5746 63344646
Limb injury 14.28 9.71 100 138530 25377 63325015
Immune thrombocytopenia 14.18 9.71 53 138577 10503 63339889
Irritability 14.18 9.71 118 138512 31576 63318816
Myoglobin urine 14.11 9.71 4 138626 16 63350376
Oxalosis 14.04 9.71 5 138625 47 63350345
Slow speech 14.01 9.71 17 138613 1512 63348880
Migraine with aura 13.96 9.71 23 138607 2717 63347675
Asthenia 13.93 9.71 690 137940 382914 62967478
Genital infection female 13.87 9.71 6 138624 98 63350294
Aphasia 13.78 9.71 121 138509 32879 63317513
Ulcer 13.78 9.71 101 138529 26006 63324386
Injection site pain 13.72 9.71 200 138430 129600 63220792
Agranulocytosis 13.71 9.71 21 138609 25113 63325279
Deep vein thrombosis 13.67 9.71 117 138513 83683 63266709
Plasma cell myeloma 13.62 9.71 37 138593 35868 63314524
Laryngeal dyspnoea 13.55 9.71 7 138623 173 63350219
Dehydration 13.54 9.71 282 138348 173072 63177320
Hypoglycaemic seizure 13.38 9.71 10 138620 482 63349910
Diaphragmatic paralysis 13.34 9.71 11 138619 613 63349779
Depression 13.29 9.71 540 138090 195952 63154440
Procedural anxiety 13.19 9.71 12 138618 764 63349628
Ear haemorrhage 13.18 9.71 16 138614 1424 63348968
Pyrexia 13.14 9.71 868 137762 469610 62880782
Muscular weakness 13.10 9.71 355 138275 121998 63228394
Enthesopathy 13.07 9.71 45 138585 8569 63341823
Pneumonia 12.87 9.71 842 137788 455925 62894467
Nail injury 12.81 9.71 11 138619 648 63349744
Stress 12.79 9.71 212 138418 66955 63283437
Grip strength decreased 12.77 9.71 18 138612 22269 63328123
Pleural effusion 12.72 9.71 136 138494 93074 63257318
Chondropathy 12.66 9.71 20 138610 2280 63348112
Maternal condition affecting foetus 12.60 9.71 7 138623 201 63350191
Herpes zoster meningoencephalitis 12.58 9.71 8 138622 296 63350096
Hypoalbuminaemia 12.58 9.71 5 138625 11800 63338592
Naevus haemorrhage 12.55 9.71 6 138624 125 63350267
Autonomic neuropathy 12.48 9.71 14 138616 1145 63349247
Judgement impaired 12.47 9.71 12 138618 820 63349572
HLA marker study positive 12.45 9.71 7 138623 206 63350186
Atelectasis 12.44 9.71 85 138545 21398 63328994
Mouth swelling 12.28 9.71 30 138600 4710 63345682
Rheumatoid arthritis 12.26 9.71 442 138188 253377 63097015
Pericardial effusion 12.15 9.71 30 138600 30028 63320364
Axonal neuropathy 12.14 9.71 13 138617 1009 63349383
Onychophagia 12.13 9.71 5 138625 72 63350320
Angioedema 12.13 9.71 159 138471 47806 63302586
Gait inability 12.08 9.71 67 138563 52892 63297500
Injection site bruising 11.91 9.71 49 138581 41861 63308531
Urticaria aquagenic 11.91 9.71 4 138626 31 63350361
IIIrd nerve paresis 11.89 9.71 6 138624 141 63350251
Acquired diaphragmatic eventration 11.88 9.71 9 138621 443 63349949
Muscle contracture 11.82 9.71 15 138615 1396 63348996
Aorta hypoplasia 11.81 9.71 6 138624 143 63350249
Mastoiditis 11.80 9.71 13 138617 1042 63349350
Urticaria cholinergic 11.80 9.71 4 138626 32 63350360
Injection site reaction 11.79 9.71 77 138553 58447 63291945
Cystitis interstitial 11.78 9.71 16 138614 1592 63348800
Schizophrenia 11.77 9.71 48 138582 9904 63340488
Metastases to central nervous system 11.76 9.71 7 138623 13098 63337294
Overlap syndrome 11.72 9.71 12 138618 884 63349508
Dysphemia 11.71 9.71 21 138609 2654 63347738
Diarrhoea 11.67 9.71 1376 137254 713990 62636402
Lower limb fracture 11.59 9.71 22 138608 24199 63326193
Electrocardiogram QRS complex shortened 11.59 9.71 9 138621 460 63349932
Pancreatitis relapsing 11.57 9.71 12 138618 898 63349494
Complication associated with device 11.54 9.71 12 138618 16966 63333426
Flat affect 11.50 9.71 15 138615 1435 63348957
Linear IgA disease 11.49 9.71 15 138615 1436 63348956
Suspected suicide 11.48 9.71 36 138594 6532 63343860
Respiratory failure 11.46 9.71 155 138475 101703 63248689
Pneumocystis jirovecii pneumonia 11.44 9.71 12 138618 16902 63333490
Chemical burns of eye 11.38 9.71 5 138625 85 63350307
Loss of personal independence in daily activities 11.33 9.71 147 138483 97143 63253249
Glomerulonephritis minimal lesion 11.28 9.71 7 138623 248 63350144
Myelodysplastic syndrome 11.21 9.71 12 138618 16742 63333650
Lymphocytosis 11.21 9.71 21 138609 2746 63347646
Abulia 11.19 9.71 9 138621 484 63349908
Hyperacusis 11.12 9.71 18 138612 2095 63348297
Product dose omission issue 11.10 9.71 409 138221 233904 63116488
Food refusal 11.05 9.71 8 138622 367 63350025
Emphysematous cystitis 11.04 9.71 6 138624 165 63350227
Infrapatellar fat pad inflammation 10.97 9.71 6 138624 167 63350225
Peripheral circulatory failure 10.95 9.71 12 138618 956 63349436
Menstruation delayed 10.88 9.71 16 138614 1713 63348679
Metastases to liver 10.86 9.71 22 138608 23617 63326775
Hypochromic anaemia 10.85 9.71 17 138613 1925 63348467
Open angle glaucoma 10.82 9.71 7 138623 267 63350125
Pulmonary toxicity 10.71 9.71 45 138585 9410 63340982
Haemoglobin decreased 10.69 9.71 239 138391 145246 63205146
Hypovolaemia 10.61 9.71 5 138625 10668 63339724
Ovarian adhesion 10.59 9.71 3 138627 12 63350380
Metabolic myopathy 10.59 9.71 3 138627 12 63350380
Blood creatine phosphokinase decreased 10.57 9.71 9 138621 524 63349868
Hypercholesterolaemia 10.55 9.71 19 138611 21315 63329077
Heliotrope rash 10.53 9.71 6 138624 181 63350211
Systemic infection 10.52 9.71 28 138602 4632 63345760
Intestinal adenocarcinoma 10.50 9.71 6 138624 182 63350210
Delusion 10.50 9.71 53 138577 11964 63338428
Ankylosing spondylitis 10.46 9.71 48 138582 10426 63339966
Platelet count increased 10.45 9.71 14 138616 17697 63332695
Nail bed tenderness 10.43 9.71 8 138622 401 63349991
Hiccups 10.40 9.71 18 138612 2213 63348179
Pulmonary arterial hypertension 10.38 9.71 21 138609 22556 63327836
Red blood cell sedimentation rate abnormal 10.34 9.71 17 138613 19765 63330627
Vitreous detachment 10.30 9.71 17 138613 2010 63348382
Central obesity 10.26 9.71 13 138617 1208 63349184
Therapeutic response changed 10.20 9.71 12 138618 1033 63349359
Synovial disorder 10.19 9.71 17 138613 2028 63348364
Hypoventilation 10.17 9.71 28 138602 4726 63345666
Hypercalcaemia 10.14 9.71 30 138600 28292 63322100
Metastases to bone 10.14 9.71 19 138611 21000 63329392
Pharyngeal mass 10.13 9.71 7 138623 298 63350094
Bacteriuria 10.13 9.71 12 138618 1041 63349351
Cholecystitis chronic 10.08 9.71 5 138625 10356 63340036
Staphylococcal infection 10.08 9.71 51 138579 41205 63309187
Disorientation 10.06 9.71 131 138499 39321 63311071
Aptyalism 10.05 9.71 9 138621 561 63349831
Blood calcium increased 9.90 9.71 4 138626 9346 63341046
Pharyngeal enanthema 9.87 9.71 4 138626 55 63350337
Metastases to lung 9.87 9.71 8 138622 12742 63337650
Cytokine release syndrome 9.86 9.71 10 138620 14304 63336088
Conduction disorder 9.85 9.71 14 138616 1453 63348939
Ear pain 9.79 9.71 43 138587 36075 63314317

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
Migraine 303.01 11.68 222 46182 17256 34893271
Toxicity to various agents 271.29 11.68 726 45678 199636 34710891
Serotonin syndrome 221.25 11.68 195 46209 19738 34890789
Cardiospasm 163.45 11.68 66 46338 1522 34909005
Tension headache 157.05 11.68 78 46326 2964 34907563
Palmoplantar keratoderma 147.05 11.68 65 46339 1888 34908639
Facial pain 145.34 11.68 79 46325 3625 34906902
Completed suicide 137.72 11.68 361 46043 97807 34812720
Pruritus genital 136.43 11.68 64 46340 2140 34908387
Sleep terror 136.40 11.68 65 46339 2253 34908274
Coma 136.25 11.68 229 46175 45449 34865078
Anosmia 120.67 11.68 72 46332 3952 34906575
Muscle twitching 118.77 11.68 103 46301 10195 34900332
Overdose 117.77 11.68 325 46079 90734 34819793
Atrial tachycardia 116.60 11.68 68 46336 3577 34906950
Carotid artery occlusion 112.41 11.68 67 46337 3670 34906857
Immunisation 111.67 11.68 45 46359 1032 34909495
Drug abuse 110.14 11.68 335 46069 98761 34811766
Disturbance in attention 106.77 11.68 151 46253 25794 34884733
Pain of skin 102.22 11.68 76 46328 6033 34904494
Electrocardiogram QRS complex prolonged 100.57 11.68 69 46335 4825 34905702
Sedation 95.06 11.68 128 46276 20878 34889649
Coombs positive haemolytic anaemia 91.85 11.68 38 46366 934 34909593
Vasculitis 84.56 11.68 89 46315 11207 34899320
Poisoning deliberate 81.57 11.68 74 46330 7770 34902757
Nightmare 79.78 11.68 97 46307 14294 34896233
Eye pruritus 70.81 11.68 67 46337 7422 34903105
Lymphadenitis 70.65 11.68 40 46364 1988 34908539
Hyperhidrosis 70.53 11.68 241 46163 75451 34835076
Intentional overdose 69.92 11.68 169 46235 43505 34867022
Nephrolithiasis 63.89 11.68 131 46273 30202 34880325
Cognitive disorder 62.91 11.68 126 46278 28567 34881960
Tinnitus 61.46 11.68 102 46302 20016 34890511
Hallucination 60.83 11.68 178 46226 51320 34859207
Pericarditis 60.53 11.68 76 46328 11569 34898958
Head discomfort 59.63 11.68 47 46357 4069 34906458
Subarachnoid haemorrhage 58.70 11.68 78 46326 12557 34897970
Platelet count decreased 58.56 11.68 44 46360 119673 34790854
Lip swelling 56.63 11.68 87 46317 15993 34894534
Ventricular tachycardia 56.23 11.68 115 46289 26464 34884063
Memory impairment 53.35 11.68 152 46252 43166 34867361
Product used for unknown indication 53.10 11.68 26 46378 957 34909570
Rash papular 51.71 11.68 66 46338 10212 34900315
Visual impairment 51.47 11.68 133 46271 35669 34874858
Blindness 51.26 11.68 80 46324 14906 34895621
Anxiety 50.50 11.68 263 46141 99165 34811362
Disease progression 49.99 11.68 42 46362 108035 34802492
Diplopia 49.58 11.68 84 46320 16759 34893768
Amnesia 48.21 11.68 108 46296 26455 34884072
Allodynia 47.97 11.68 23 46381 808 34909719
Suicide attempt 46.95 11.68 136 46268 38980 34871547
Palpitations 44.17 11.68 135 46269 39851 34870676
Feeling abnormal 41.35 11.68 180 46224 63055 34847472
Intentional product misuse 40.52 11.68 143 46261 45468 34865059
Anaemia 39.80 11.68 167 46237 233168 34677359
Foetal disorder 39.17 11.68 20 46384 806 34909721
Headache 38.82 11.68 422 45982 200213 34710314
Insomnia 38.55 11.68 253 46151 103654 34806873
White blood cell count decreased 38.40 11.68 42 46362 95403 34815124
Confusional state 37.11 11.68 322 46082 143838 34766689
Somnolence 36.16 11.68 262 46142 110854 34799673
Pain 35.76 11.68 422 45982 204253 34706274
Transient ischaemic attack 35.07 11.68 98 46306 27515 34883012
Delusion of replacement 34.00 11.68 11 46393 130 34910397
Death 33.75 11.68 352 46052 397697 34512830
Neutropenia neonatal 33.07 11.68 17 46387 695 34909832
Heart rate increased 32.68 11.68 135 46269 46208 34864319
Substance abuse 32.20 11.68 45 46359 7596 34902931
Dry skin 31.22 11.68 102 46302 31185 34879342
Thrombocytopenia 31.05 11.68 105 46299 156142 34754385
Colour blindness acquired 30.53 11.68 9 46395 76 34910451
Sepsis 30.40 11.68 116 46288 166445 34744082
Patient dissatisfaction with treatment 30.32 11.68 9 46395 78 34910449
Haemoglobin decreased 29.19 11.68 74 46330 120698 34789829
Drug ineffective for unapproved indication 28.98 11.68 83 46321 23632 34886895
Renal failure 28.56 11.68 84 46320 130473 34780054
Carbon dioxide abnormal 27.05 11.68 10 46394 180 34910347
Muscular weakness 26.72 11.68 177 46227 72720 34837807
Tachycardia 26.49 11.68 198 46206 84574 34825953
Febrile neutropenia 25.81 11.68 94 46310 136755 34773772
Hypotension 25.43 11.68 181 46223 221468 34689059
Withdrawal syndrome 24.13 11.68 52 46352 12403 34898124
Abdominal pain upper 24.07 11.68 170 46234 71320 34839207
Suicidal ideation 23.43 11.68 111 46293 40277 34870250
Haemolysis 23.33 11.68 40 46364 8054 34902473
HIV peripheral neuropathy 23.05 11.68 6 46398 30 34910497
Intentional product use issue 22.99 11.68 147 46257 59669 34850858
Delirium 22.74 11.68 117 46287 43874 34866653
Chemical submission 21.99 11.68 6 46398 37 34910490
Interstitial lung disease 21.83 11.68 33 46371 65249 34845278
Alopecia 21.31 11.68 76 46328 24279 34886248
Neck pain 21.25 11.68 78 46326 25271 34885256
Back pain 21.17 11.68 251 46153 121538 34788989
Drug withdrawal syndrome neonatal 21.04 11.68 25 46379 3594 34906933
Alcoholic ketoacidosis 20.98 11.68 5 46399 16 34910511
Foetal exposure during pregnancy 20.86 11.68 103 46301 37998 34872529
Oedema peripheral 20.85 11.68 85 46319 119727 34790800
Respiratory failure 20.85 11.68 74 46330 108498 34802029
Hyperaesthesia 20.61 11.68 28 46376 4602 34905925
Drug dispensed to wrong patient 20.07 11.68 11 46393 513 34910014
Depression 20.02 11.68 207 46197 96891 34813636
Mydriasis 19.86 11.68 35 46369 7202 34903325
Femoral nerve palsy 19.82 11.68 6 46398 56 34910471
Device effect decreased 19.74 11.68 4 46400 4 34910523
Anophthalmos 19.74 11.68 4 46400 4 34910523
Sopor 19.44 11.68 47 46357 12089 34898438
Sitting disability 19.36 11.68 8 46396 196 34910331
Brain stem syndrome 19.29 11.68 11 46393 554 34909973
Type III immune complex mediated reaction 19.15 11.68 9 46395 302 34910225
Astigmatism 19.14 11.68 14 46390 1083 34909444
Angioedema 19.04 11.68 99 46305 37275 34873252
Pulmonary embolism 18.71 11.68 59 46345 89687 34820840
Multiple organ dysfunction syndrome 18.42 11.68 47 46357 76519 34834008
Venous angioma of brain 17.90 11.68 5 46399 34 34910493
Behaviour disorder 17.90 11.68 27 46377 4883 34905644
Hallucination, visual 17.74 11.68 58 46346 17733 34892794
Agoraphobia 17.73 11.68 8 46396 244 34910283
Peripheral swelling 17.63 11.68 167 46237 76374 34834153
Quality of life decreased 17.51 11.68 24 46380 3977 34906550
Thoracic vertebral fracture 17.36 11.68 16 46388 1714 34908813
Pneumonia 17.23 11.68 359 46045 362268 34548259
Rash 17.20 11.68 201 46203 222551 34687976
Acute lung injury 17.20 11.68 15 46389 1495 34909032
Myoclonus 16.52 11.68 50 46354 14675 34895852
Acute psychosis 16.50 11.68 16 46388 1827 34908700
Blood bilirubin increased 16.35 11.68 16 46388 38280 34872247
Pulmonary artery stenosis 16.18 11.68 8 46396 301 34910226
Onycholysis 16.13 11.68 11 46393 761 34909766
Haematuria 16.08 11.68 26 46378 50040 34860487
CADASIL 16.03 11.68 6 46398 112 34910415
Neutrophil count decreased 15.98 11.68 27 46377 51077 34859450
Dry age-related macular degeneration 15.88 11.68 6 46398 115 34910412
Multiple drug therapy 15.81 11.68 9 46395 452 34910075
Adjustment disorder with disturbance of conduct 15.79 11.68 6 46398 117 34910410
Brugada syndrome 15.77 11.68 11 46393 790 34909737
Burning sensation 15.75 11.68 57 46347 18337 34892190
Bradyphrenia 15.56 11.68 25 46379 4773 34905754
Velopharyngeal incompetence 15.53 11.68 4 46400 19 34910508
Clumsiness 15.43 11.68 15 46389 1717 34908810
Pleural effusion 15.37 11.68 56 46348 81490 34829037
Ascites 15.13 11.68 24 46380 46547 34863980
Cardiotoxicity 15.10 11.68 27 46377 5621 34904906
Depressed level of consciousness 15.07 11.68 103 46301 42738 34867789
Blood urea increased 15.03 11.68 11 46393 30353 34880174
Blood creatinine increased 14.92 11.68 70 46334 94906 34815621
Mast cell degranulation present 14.81 11.68 5 46399 68 34910459
Victim of crime 14.56 11.68 8 46396 375 34910152
Haemoptysis 14.52 11.68 15 46389 34991 34875536
Urticaria 14.46 11.68 39 46365 62338 34848189
Skull fracture 14.39 11.68 11 46393 910 34909617
Medical device site dryness 14.35 11.68 4 46400 27 34910500
Electric shock 14.30 11.68 6 46398 153 34910374
Pulmonary hypertension 14.21 11.68 5 46399 20919 34889608
Neurosis 14.15 11.68 6 46398 157 34910370
Ventricular hypoplasia 14.07 11.68 5 46399 80 34910447
Atrial fibrillation 13.98 11.68 100 46304 122293 34788234
Hyperthermia 13.88 11.68 38 46366 10539 34899988
General physical health deterioration 13.61 11.68 107 46297 128162 34782365
Deep vein thrombosis 13.52 11.68 43 46361 65205 34845322
Disseminated intravascular coagulation 13.52 11.68 6 46398 21810 34888717
Sensorimotor disorder 13.49 11.68 8 46396 434 34910093
Depressed mood 13.39 11.68 56 46348 19261 34891266
Cardiac failure congestive 13.30 11.68 61 46343 83209 34827318
Hypomania 13.23 11.68 16 46388 2343 34908184
Blood lactate dehydrogenase increased 13.22 11.68 7 46397 22983 34887544
Post herpetic neuralgia 13.17 11.68 11 46393 1034 34909493
Agitation 13.10 11.68 125 46279 57274 34853253
Neuralgia 13.08 11.68 47 46357 15066 34895461
Cyclic vomiting syndrome 13.06 11.68 4 46400 39 34910488
Lipids increased 13.03 11.68 11 46393 1049 34909478
Diarrhoea 12.89 11.68 407 45997 389505 34521022
Insulin resistance 12.87 11.68 9 46395 649 34909878
Neovascular age-related macular degeneration 12.78 11.68 6 46398 201 34910326
Mucosal dryness 12.76 11.68 12 46392 1319 34909208
Lid lag 12.73 11.68 3 46401 9 34910518
Agitation neonatal 12.71 11.68 11 46393 1085 34909442
Neutropenia 12.66 11.68 140 46264 156638 34753889
Leukopenia 12.63 11.68 42 46362 62814 34847713
Renal pain 12.56 11.68 18 46386 3110 34907417
Tongue spasm 12.54 11.68 4 46400 45 34910482
Tremor 12.53 11.68 166 46238 82421 34828106
Dysarthria 12.46 11.68 84 46320 34698 34875829
Benzodiazepine drug level therapeutic 12.31 11.68 4 46400 48 34910479
Anaphylactic shock 12.30 11.68 3 46401 15938 34894589
Generalised tonic-clonic seizure 12.13 11.68 58 46346 21116 34889411
Multiple sclerosis 12.03 11.68 27 46377 6618 34903909
Blood creatine phosphokinase increased 12.01 11.68 26 46378 44831 34865696
Victim of homicide 12.01 11.68 5 46399 125 34910402
Bursitis 11.99 11.68 24 46380 5434 34905093
Mucocutaneous disorder 11.93 11.68 5 46399 127 34910400
Aspartate aminotransferase increased 11.84 11.68 48 46356 67735 34842792
Haematoma 11.76 11.68 10 46394 25595 34884932
Sports injury 11.75 11.68 5 46399 132 34910395
Decreased appetite 11.75 11.68 153 46251 166239 34744288
Liver disorder 11.70 11.68 16 46388 32981 34877546

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 805.01 9.95 2308 164000 419232 79158848
Cognitive disorder 522.93 9.95 686 165622 69240 79508840
Sedation 469.31 9.95 560 165748 51335 79526745
Sedation complication 454.50 9.95 325 165983 15344 79562736
Completed suicide 445.13 9.95 1322 164986 244445 79333635
Migraine 393.82 9.95 677 165631 86816 79491264
Creatinine renal clearance decreased 379.93 9.95 316 165992 18686 79559394
Serotonin syndrome 327.68 9.95 436 165872 44591 79533489
Coma 312.36 9.95 665 165643 99984 79478096
Orthostatic hypotension 304.73 9.95 473 165835 55691 79522389
Depressed level of consciousness 300.41 9.95 639 165669 96013 79482067
Electrocardiogram QRS complex prolonged 294.36 9.95 216 166092 10617 79567463
Balance disorder 288.31 9.95 637 165671 98220 79479860
Blood calcium decreased 283.74 9.95 341 165967 31478 79546602
Cardiospasm 215.72 9.95 115 166193 3186 79574894
Disturbance in attention 210.25 9.95 379 165929 50422 79527658
Tension headache 210.10 9.95 150 166158 7061 79571019
Drug abuse 205.01 9.95 775 165533 161916 79416164
Palmoplantar keratoderma 200.28 9.95 114 166194 3602 79574478
Overdose 197.26 9.95 834 165474 183372 79394708
Pruritus genital 193.03 9.95 119 166189 4367 79573713
Poisoning deliberate 188.22 9.95 214 166094 18614 79559466
Pemphigus 188.01 9.95 4 166304 99578 79478502
Muscle twitching 185.08 9.95 243 166065 24521 79553559
Sleep terror 183.58 9.95 115 166193 4343 79573737
Tinnitus 158.86 9.95 311 165997 44022 79534058
Anti-cyclic citrullinated peptide antibody positive 158.31 9.95 3 166305 83140 79494940
Facial pain 148.99 9.95 155 166153 12195 79565885
Platelet count decreased 144.91 9.95 116 166192 194548 79383532
Atrial tachycardia 141.28 9.95 118 166190 7015 79571065
Immunisation 140.22 9.95 75 166233 2092 79575988
Hyperhidrosis 138.84 9.95 655 165653 150837 79427243
Systemic lupus erythematosus 137.24 9.95 41 166267 121108 79456972
Drug ineffective for unapproved indication 133.61 9.95 316 165992 50922 79527158
Carotid artery occlusion 132.14 9.95 117 166191 7530 79570550
Intentional overdose 131.95 9.95 503 165805 105457 79472623
Anosmia 130.76 9.95 124 166184 8720 79569360
Glossodynia 130.47 9.95 28 166280 103309 79474771
Anxiety 125.00 9.95 917 165391 247595 79330485
Neutropenia 122.10 9.95 261 166047 287449 79290631
Anaemia 120.63 9.95 498 165810 444517 79133563
Mydriasis 119.44 9.95 165 166143 17478 79560602
Arthropathy 118.05 9.95 117 166191 176994 79401086
Constipation 116.34 9.95 997 165311 282053 79296027
Febrile neutropenia 114.30 9.95 191 166117 230808 79347272
Duodenal ulcer perforation 113.32 9.95 6 166302 66205 79511875
Lip swelling 111.79 9.95 257 166051 40654 79537426
Hallucination 111.69 9.95 413 165895 85332 79492748
Anticholinergic syndrome 109.56 9.95 77 166231 3534 79574546
Nightmare 108.33 9.95 194 166114 25667 79552413
Impaired work ability 105.65 9.95 165 166143 19516 79558564
Pain of skin 103.97 9.95 140 166168 14473 79563607
Visual impairment 102.32 9.95 422 165886 91709 79486371
Fall 99.86 9.95 1498 164810 486131 79091949
Somnolence 99.34 9.95 844 165464 238137 79339943
Wound 98.65 9.95 60 166248 116119 79461961
Ventricular tachycardia 95.94 9.95 246 166062 41689 79536391
Vasculitis 95.94 9.95 181 166127 24921 79553159
Hand deformity 93.48 9.95 50 166258 103869 79474211
Feeling abnormal 90.87 9.95 606 165702 158593 79419487
Withdrawal syndrome 89.74 9.95 183 166125 26671 79551409
Rheumatoid factor positive 89.59 9.95 10 166298 59829 79518251
Disease progression 88.83 9.95 155 166153 184207 79393873
Suicidal ideation 85.81 9.95 351 165957 75989 79502091
Synovial fluid analysis 85.13 9.95 56 166252 2303 79575777
Tenosynovitis stenosans 85.04 9.95 62 166246 3016 79575064
Rubber sensitivity 81.94 9.95 49 166259 1700 79576380
Synovitis 81.84 9.95 117 166191 150617 79427463
Gastric pH decreased 81.79 9.95 39 166269 847 79577233
Tachycardia 81.48 9.95 642 165666 177126 79400954
Muscle injury 81.26 9.95 5 166303 48556 79529524
Feeling jittery 80.85 9.95 116 166192 12725 79565355
Thrombocytopenia 80.06 9.95 284 166024 264975 79313105
Scleritis 77.98 9.95 68 166240 4288 79573792
Derealisation 76.74 9.95 46 166262 1603 79576477
Cytomegalovirus infection 75.79 9.95 3 166305 42641 79535439
Diplopia 75.20 9.95 195 166113 33271 79544809
Poor quality sleep 74.93 9.95 154 166154 22568 79555512
Palpitations 73.48 9.95 484 165824 126126 79451954
Depressed mood 72.13 9.95 244 166064 48236 79529844
Aspartate aminotransferase increased 71.97 9.95 111 166197 138530 79439550
Dizziness 71.93 9.95 1517 164791 524924 79053156
Blindness 70.70 9.95 172 166136 28211 79549869
Coombs positive haemolytic anaemia 70.01 9.95 38 166270 1092 79576988
Eye pruritus 69.71 9.95 141 166167 20429 79557651
Insomnia 69.67 9.95 800 165508 244370 79333710
Fibromyalgia 68.53 9.95 291 166017 64049 79514031
Hypersensitivity 68.15 9.95 298 166010 261941 79316139
Myelosuppression 67.88 9.95 4 166304 40292 79537788
Suicide attempt 67.66 9.95 347 165961 82585 79495495
Electrocardiogram QT prolonged 67.45 9.95 369 165939 90017 79488063
Mobility decreased 66.08 9.95 459 165849 121716 79456364
Folliculitis 65.95 9.95 17 166291 55363 79522717
Pain 64.88 9.95 1923 164385 701879 78876201
Memory impairment 64.75 9.95 427 165881 111307 79466773
Body tinea 64.45 9.95 43 166265 1811 79576269
Maternal exposure during pregnancy 63.77 9.95 117 166191 136421 79441659
Atrial fibrillation 63.69 9.95 206 166102 197680 79380400
Medication overuse headache 63.07 9.95 33 166275 879 79577201
Feeling of despair 62.89 9.95 50 166258 2771 79575309
Pleuritic pain 62.88 9.95 91 166217 10061 79568019
Amnesia 62.42 9.95 279 166029 62778 79515302
Swelling face 60.22 9.95 301 166007 70911 79507169
Sepsis 59.68 9.95 324 165984 269104 79308976
Heart rate increased 58.63 9.95 442 165866 120282 79457798
Hallucinations, mixed 58.34 9.95 72 166236 6827 79571253
Hepatic enzyme increased 58.14 9.95 191 166117 182419 79395661
Malaise 57.88 9.95 1383 164925 488486 79089594
Eye pain 57.56 9.95 191 166117 37387 79540693
Lip pruritus 57.43 9.95 31 166277 881 79577199
C-reactive protein abnormal 57.31 9.95 15 166293 48352 79529728
Swollen tongue 57.06 9.95 207 166101 42363 79535717
Alanine aminotransferase increased 56.03 9.95 164 166144 162406 79415674
Flank pain 54.58 9.95 125 166183 19719 79558361
Multiple organ dysfunction syndrome 54.43 9.95 105 166203 120141 79457939
Photophobia 53.93 9.95 127 166181 20401 79557679
Crepitations 53.79 9.95 84 166224 9933 79568147
General physical health deterioration 53.53 9.95 345 165963 274893 79303187
Hallucination, visual 53.42 9.95 170 166138 32559 79545521
H1N1 influenza 52.66 9.95 43 166265 2476 79575604
Cardiac failure congestive 52.53 9.95 139 166169 142263 79435817
Restless legs syndrome 52.46 9.95 124 166184 19968 79558112
Agitation 52.38 9.95 372 165936 99343 79478737
Tremor 51.94 9.95 563 165745 169520 79408560
Renal failure 51.81 9.95 229 166079 200739 79377341
Dissociation 51.28 9.95 52 166256 3969 79574111
Cogwheel rigidity 50.89 9.95 46 166262 3042 79575038
Blood creatinine increased 50.87 9.95 160 166148 154897 79423183
Oedema peripheral 50.20 9.95 314 165994 251974 79326106
Malignant neoplasm progression 49.96 9.95 133 166175 135857 79442223
Subarachnoid haemorrhage 49.36 9.95 137 166171 24328 79553752
Infusion related reaction 49.27 9.95 280 166028 229957 79348123
White blood cell count decreased 48.87 9.95 214 166094 188074 79390006
Depersonalisation/derealisation disorder 48.05 9.95 36 166272 1826 79576254
Neutrophil count decreased 48.01 9.95 76 166232 93883 79484197
Intentional product misuse 47.09 9.95 350 165958 94815 79483265
Bone density decreased 47.03 9.95 93 166215 13254 79564826
Emotional disorder 45.67 9.95 96 166212 14291 79563789
Confusional state 45.18 9.95 922 165386 317075 79261005
Rheumatic fever 44.70 9.95 4 166304 28521 79549559
Dystonia 44.34 9.95 121 166187 21278 79556802
Persistent genital arousal disorder 44.23 9.95 18 166290 263 79577817
Drug withdrawal syndrome 44.16 9.95 166 166142 34552 79543528
Feeling of body temperature change 44.10 9.95 55 166253 5271 79572809
Discomfort 43.80 9.95 126 166182 125491 79452589
Impaired healing 43.76 9.95 72 166236 87583 79490497
Infection susceptibility increased 43.63 9.95 46 166262 3675 79574405
Neovascularisation 43.58 9.95 29 166279 1216 79576864
Inhibitory drug interaction 43.46 9.95 50 166258 4403 79573677
Sacroiliitis 43.29 9.95 46 166262 3708 79574372
Helicobacter infection 43.11 9.95 49 166259 69655 79508425
Neck pain 42.35 9.95 286 166022 75131 79502949
Death 42.21 9.95 881 165427 565633 79012447
Multiple drug therapy 41.86 9.95 47 166261 4031 79574049
Allergy to chemicals 41.39 9.95 38 166270 2564 79575516
Haemoglobin decreased 40.38 9.95 284 166024 221835 79356245
Respiratory failure 40.34 9.95 217 166091 180694 79397386
Respiratory depression 40.16 9.95 138 166170 27492 79550588
Bradypnoea 40.06 9.95 56 166252 5996 79572084
Pituitary tumour benign 39.77 9.95 37 166271 2539 79575541
Pneumonia 39.69 9.95 1061 165247 659185 78918895
Exposure during pregnancy 39.39 9.95 96 166212 101036 79477044
Septic shock 39.38 9.95 128 166180 122673 79455407
Oesophageal spasm 39.24 9.95 42 166266 3414 79574666
Cushingoid 39.16 9.95 71 166237 9481 79568599
Small fibre neuropathy 38.46 9.95 20 166288 526 79577554
Allodynia 38.44 9.95 30 166278 1618 79576462
Somatic symptom disorder 38.33 9.95 36 166272 2501 79575579
Hyperaesthesia 38.15 9.95 81 166227 12141 79565939
Wrist deformity 37.80 9.95 33 166275 2084 79575996
Blood bilirubin increased 37.34 9.95 50 166258 66182 79511898
Vision blurred 37.30 9.95 361 165947 105537 79472543
Bursitis 37.30 9.95 161 166147 35683 79542397
Sensory loss 37.03 9.95 83 166225 12908 79565172
Synovial cyst 36.52 9.95 71 166237 9994 79568086
Therapeutic product ineffective 36.42 9.95 31 166277 1891 79576189
Oedema 36.06 9.95 128 166180 119452 79458628
Pleural effusion 35.95 9.95 168 166140 145094 79432986
Pancytopenia 35.75 9.95 201 166107 165544 79412536
Contraindicated product administered 35.66 9.95 188 166120 157350 79420730
Brain injury 35.57 9.95 76 166232 11441 79566639
Menstrual disorder 35.29 9.95 43 166265 4024 79574056
Tenderness 35.17 9.95 119 166189 23523 79554557
Haemorrhage 35.09 9.95 87 166221 91031 79487049
Heart sounds 35.02 9.95 23 166285 943 79577137
Cardiac failure 34.93 9.95 185 166123 154657 79423423
Knee arthroplasty 34.43 9.95 24 166284 43224 79534856
Cestode infection 34.38 9.95 15 166293 263 79577817
Dysarthria 34.19 9.95 250 166058 67372 79510708
Myoclonus 34.15 9.95 131 166177 27529 79550551
Headache 34.08 9.95 1678 164630 652094 78925986
Hip arthroplasty 33.95 9.95 16 166292 35740 79542340
Condition aggravated 33.95 9.95 791 165517 500333 79077747
Psychotic disorder due to a general medical condition 33.72 9.95 15 166293 276 79577804
Renal impairment 33.68 9.95 192 166116 157591 79420489
Labelled drug-drug interaction issue 33.56 9.95 26 166282 1387 79576693
Oesophageal pain 33.54 9.95 43 166265 4236 79573844
Neuralgia 33.25 9.95 148 166160 33236 79544844
Crystal nephropathy 32.89 9.95 26 166282 1429 79576651
Cervix neoplasm 32.58 9.95 13 166295 180 79577900
Parosmia 32.48 9.95 55 166253 6959 79571121
Leukopenia 32.35 9.95 129 166179 116384 79461696
Irritable bowel syndrome 32.12 9.95 50 166258 62191 79515889
Transient ischaemic attack 32.11 9.95 204 166104 52491 79525589
Muscular weakness 32.08 9.95 492 165816 160237 79417843
Paraesthesia 31.91 9.95 531 165777 175792 79402288
Deep vein thrombosis 31.63 9.95 137 166171 120782 79457298
Hyperlactacidaemia 31.56 9.95 48 166260 5547 79572533
Tenosynovitis 31.28 9.95 87 166221 15467 79562613
Hepatic function abnormal 31.23 9.95 66 166242 73041 79505039
Abdominal discomfort 30.89 9.95 354 165954 250373 79327707
Muscle disorder 30.84 9.95 48 166260 5659 79572421
Swelling 30.75 9.95 296 166012 216415 79361665
Rash papular 30.59 9.95 108 166200 21808 79556272
Clear cell renal cell carcinoma 30.48 9.95 32 166276 2544 79575536
Bone marrow failure 30.45 9.95 37 166271 51070 79527010
Sopor 30.40 9.95 143 166165 32867 79545213
Autonomic dysreflexia 30.38 9.95 16 166292 432 79577648
Accidental death 30.36 9.95 41 166267 4250 79573830
Cytokine release syndrome 29.98 9.95 19 166289 35979 79542101
Disseminated intravascular coagulation 29.73 9.95 19 166289 35823 79542257
Lymphoedema 29.62 9.95 74 166234 12339 79565741
Haematuria 29.52 9.95 62 166246 68774 79509306
Product used for unknown indication 29.46 9.95 25 166283 1519 79576561
Prolonged expiration 29.35 9.95 23 166285 1248 79576832
Lymphadenitis 29.23 9.95 42 166266 4613 79573467
Hospitalisation 28.99 9.95 100 166208 94136 79483944
Eye irritation 28.94 9.95 102 166206 20579 79557501
Multiple sclerosis relapse 28.89 9.95 181 166127 46352 79531728
Gastrointestinal haemorrhage 28.77 9.95 185 166123 147534 79430546
Liver injury 28.72 9.95 46 166262 56568 79521512
Urinary retention 28.42 9.95 209 166099 56421 79521659
Drooling 28.10 9.95 47 166261 5887 79572193
Pulmonary embolism 28.09 9.95 226 166082 171428 79406652
Impaired reasoning 27.98 9.95 10 166298 100 79577980
Loss of consciousness 27.94 9.95 499 165809 167444 79410636
Antinuclear antibody positive 27.83 9.95 55 166253 7835 79570245
Decreased appetite 27.71 9.95 525 165783 341893 79236187
Infection 27.59 9.95 347 165961 241365 79336715
Akathisia 27.49 9.95 75 166233 13184 79564896
Speech disorder 27.36 9.95 201 166107 54244 79523836
Blister 27.36 9.95 142 166166 119334 79458746
Blood urea increased 27.34 9.95 37 166271 48753 79529327
Pneumocystis jirovecii pneumonia 27.29 9.95 17 166291 32491 79545589
Delusion of replacement 27.20 9.95 11 166297 158 79577922
Premenstrual syndrome 26.89 9.95 16 166292 550 79577530
Aspergillus infection 26.76 9.95 4 166304 19157 79558923
Pulmonary hypertension 26.40 9.95 37 166271 48043 79530037
Therapy non-responder 26.38 9.95 101 166207 92204 79485876
Conjunctivitis 26.37 9.95 115 166193 25600 79552480
Incontinence 26.32 9.95 77 166231 14087 79563993
Pyrexia 26.20 9.95 1153 165155 677556 78900524
Ascites 26.18 9.95 76 166232 75486 79502594
Hyperthermia 26.14 9.95 90 166218 17947 79560133
Prostate cancer 25.78 9.95 19 166289 33249 79544831
Glucose tolerance impaired 25.72 9.95 54 166254 8030 79570050
Pulmonary eosinophilia 25.31 9.95 17 166291 724 79577356
Head discomfort 25.21 9.95 77 166231 14425 79563655
Tension 25.15 9.95 38 166270 4366 79573714
Eyelid exfoliation 24.83 9.95 10 166298 142 79577938
Cardio-respiratory arrest 24.75 9.95 340 165968 108170 79469910
Nephrolithiasis 24.68 9.95 193 166115 53098 79524982
Delirium 24.38 9.95 277 166031 84350 79493730
Substance abuse 24.33 9.95 62 166246 10464 79567616
Back pain 24.18 9.95 817 165491 303363 79274717
Asthenia 24.14 9.95 849 165459 510840 79067240
CFTR gene mutation 23.94 9.95 9 166299 105 79577975
Diaphragmatic rupture 23.89 9.95 11 166297 220 79577860
Paralysis 23.88 9.95 71 166237 13106 79564974
Red blood cell sedimentation rate increased 23.62 9.95 37 166271 45905 79532175
Diet failure 23.28 9.95 7 166301 38 79578042
Bladder cancer 23.24 9.95 6 166302 19520 79558560
Dental restoration failure 23.14 9.95 18 166290 966 79577114
Dyskinesia 22.90 9.95 166 166142 44607 79533473
Joint effusion 22.80 9.95 86 166222 17928 79560152
Bronchopulmonary aspergillosis 22.72 9.95 9 166299 22285 79555795
Drug interaction 22.71 9.95 1071 165237 414112 79163968
Soft tissue injury 22.65 9.95 23 166285 1758 79576322
Sensitivity to weather change 22.47 9.95 51 166257 7996 79570084
Angioedema 22.41 9.95 250 166058 75785 79502295
Adverse event 22.02 9.95 59 166249 60155 79517925
Product use issue 21.83 9.95 307 166001 209515 79368565
Dry mouth 21.82 9.95 280 166028 87739 79490341
Peritonitis 21.74 9.95 16 166292 28020 79550060
Drug resistance 21.70 9.95 34 166274 42179 79535901
International normalised ratio increased 21.54 9.95 97 166211 84624 79493456
Pregnancy 21.24 9.95 15 166293 26836 79551244
Device expulsion 21.06 9.95 14 166294 25847 79552233
Rash 20.99 9.95 989 165319 577369 79000711
Hostility 20.98 9.95 25 166283 2285 79575795
Migraine with aura 20.92 9.95 27 166281 2678 79575402
Hypotension 20.81 9.95 1120 165188 439197 79138883
Palmar-plantar erythrodysaesthesia syndrome 20.81 9.95 23 166285 33111 79544969
Biliary sepsis 20.78 9.95 21 166287 1596 79576484
Peripheral venous disease 20.72 9.95 4 166304 15905 79562175
Dry eye 20.69 9.95 140 166168 36791 79541289
Shock haemorrhagic 20.60 9.95 8 166300 20052 79558028
Cerebral infarction 20.56 9.95 40 166268 45636 79532444
Diarrhoea 20.53 9.95 1570 164738 878919 78699161
White blood cell count increased 20.48 9.95 83 166225 74550 79503530
Mood swings 20.46 9.95 89 166219 19791 79558289
Eyelid myoclonus 20.43 9.95 8 166300 105 79577975
Panic attack 20.21 9.95 102 166206 24114 79553966
Myelodysplastic syndrome 20.19 9.95 20 166288 30281 79547799
Hypoaesthesia oral 20.05 9.95 70 166238 14054 79564026
Circulatory collapse 20.05 9.95 141 166167 37527 79540553
Haematoma 19.97 9.95 50 166258 52145 79525935
Unevaluable event 19.93 9.95 55 166253 55530 79522550
Alopecia 19.86 9.95 351 165957 231004 79347076
Accidental overdose 19.81 9.95 146 166162 39435 79538645
Patient dissatisfaction with treatment 19.69 9.95 9 166299 177 79577903
CYP3A4 polymorphism 19.59 9.95 7 166301 70 79578010
Mental disorder 19.58 9.95 122 166186 31180 79546900
Postural orthostatic tachycardia syndrome 19.55 9.95 16 166292 924 79577156
Sinus tachycardia 19.55 9.95 138 166170 36770 79541310
HIV peripheral neuropathy 19.45 9.95 6 166302 36 79578044
Multiple sclerosis 19.41 9.95 95 166213 22187 79555893
Electrocardiogram PR prolongation 19.33 9.95 20 166288 1563 79576517
Staphylococcal infection 19.22 9.95 60 166248 58235 79519845
Sternal fracture 19.17 9.95 25 166283 2505 79575575
Haemodialysis 19.07 9.95 7 166301 18161 79559919
Drug dependence 19.07 9.95 148 166160 40621 79537459
Injection site erythema 19.01 9.95 91 166217 78106 79499974
Subclavian artery embolism 18.97 9.95 5 166303 15 79578065
Premature labour 18.96 9.95 49 166259 8341 79569739
Plasma cell myeloma 18.87 9.95 53 166255 53206 79524874
Breath sounds abnormal 18.85 9.95 5 166303 15979 79562101
Acute myeloid leukaemia 18.78 9.95 22 166286 30863 79547217
Lichen sclerosus 18.77 9.95 16 166292 978 79577102
Abdominal pain upper 18.76 9.95 605 165703 223214 79354866
Alcoholic ketoacidosis 18.73 9.95 5 166303 16 79578064
Pericardial effusion 18.71 9.95 43 166265 46194 79531886
Polymenorrhoea 18.66 9.95 16 166292 986 79577094
Pulmonary arterial hypertension 18.58 9.95 19 166289 28347 79549733
Respiratory distress 18.56 9.95 61 166247 58278 79519802
CADASIL 18.54 9.95 6 166302 43 79578037
Anaphylactic shock 18.49 9.95 29 166279 35967 79542113
Drug eruption 18.48 9.95 40 166268 43895 79534185
Thymus disorder 18.44 9.95 10 166298 287 79577793
Depression 18.43 9.95 587 165721 216203 79361877
Femoral artery dissection 18.30 9.95 6 166302 45 79578035
Enterococcal infection 18.28 9.95 5 166303 15655 79562425
Depressive symptom 18.26 9.95 41 166267 6382 79571698
Vascular malformation 18.26 9.95 11 166297 387 79577693
Magnesium deficiency 18.22 9.95 13 166295 611 79577469
Respiration abnormal 18.13 9.95 46 166262 7742 79570338
Slow speech 18.02 9.95 24 166284 2454 79575626
Neurotoxicity 17.87 9.95 25 166283 32493 79545587
Vulvovaginal swelling 17.83 9.95 11 166297 404 79577676
Hyperbilirubinaemia 17.74 9.95 15 166293 24503 79553577
Therapeutic product effect decreased 17.67 9.95 238 166070 163625 79414455
Visual snow syndrome 17.35 9.95 6 166302 54 79578026
Tubulointerstitial nephritis and uveitis syndrome 17.31 9.95 10 166298 325 79577755
Limb injury 17.18 9.95 113 166195 29415 79548665
Poliomyelitis 17.15 9.95 6 166302 56 79578024
Cerebellar stroke 17.14 9.95 12 166296 547 79577533
Food refusal 17.13 9.95 12 166296 548 79577532
Libido increased 17.11 9.95 21 166287 1980 79576100
Anaemia of malignant disease 17.07 9.95 14 166294 811 79577269
Anterograde amnesia 17.04 9.95 13 166295 678 79577402
Paranasal cyst 16.90 9.95 11 166297 444 79577636
Gout 16.88 9.95 16 166292 24733 79553347
Agoraphobia 16.78 9.95 12 166296 566 79577514
Post procedural complication 16.73 9.95 15 166293 23814 79554266
Hypovolaemia 16.67 9.95 8 166300 17683 79560397
Vaccination site bruising 16.67 9.95 4 166304 7 79578073
Product dose omission issue 16.64 9.95 391 165917 247146 79330934
Renal mass 16.55 9.95 27 166281 3313 79574767
Post-traumatic neck syndrome 16.35 9.95 21 166287 2073 79576007
Therapy interrupted 16.34 9.95 25 166283 31316 79546764
Vaccination site oedema 16.32 9.95 4 166304 8 79578072
Colitis 16.29 9.95 88 166220 73219 79504861
Cyanosis 16.29 9.95 99 166209 25083 79552997
Bradyphrenia 16.22 9.95 54 166254 10586 79567494
Blood uric acid increased 16.10 9.95 4 166304 13356 79564724
Genital infection female 16.04 9.95 6 166302 69 79578011
Dyspnoea exertional 15.97 9.95 111 166197 86962 79491118
Skin necrosis 15.83 9.95 9 166299 18078 79560002
Dry age-related macular degeneration 15.76 9.95 9 166299 286 79577794
Treatment noncompliance 15.72 9.95 56 166252 52212 79525868
Hypohidrosis 15.71 9.95 9 166299 288 79577792
Pulmonary fibrosis 15.55 9.95 44 166264 44068 79534012
Haemoptysis 15.54 9.95 62 166246 55937 79522143
Respiratory arrest 15.52 9.95 186 166122 57364 79520716
Live birth 15.46 9.95 10 166298 18734 79559346
Vaccination site pruritus 15.44 9.95 4 166304 11 79578069
Adiposis dolorosa 15.27 9.95 9 166299 304 79577776
Impaired quality of life 15.26 9.95 65 166243 14321 79563759
Ill-defined disorder 15.24 9.95 78 166230 65797 79512283
Femoral nerve palsy 15.17 9.95 6 166302 81 79577999
Burning sensation 15.16 9.95 188 166120 58444 79519636
Dialysis 15.02 9.95 10 166298 18452 79559628
Pulmonary haemorrhage 14.90 9.95 6 166302 14711 79563369
Carbon dioxide abnormal 14.89 9.95 10 166298 426 79577654
Mood altered 14.77 9.95 75 166233 17772 79560308
Eosinophilia 14.71 9.95 47 166261 45298 79532782
Dry skin 14.67 9.95 211 166097 67784 79510296
Pulmonary alveolar haemorrhage 14.67 9.95 3 166305 11454 79566626
Musculoskeletal stiffness 14.64 9.95 473 165835 174535 79403545
Acute respiratory failure 14.64 9.95 69 166239 59472 79518608
Vestibular migraine 14.64 9.95 7 166301 153 79577927
Nodule 14.62 9.95 90 166218 22904 79555176
Tumour lysis syndrome 14.61 9.95 17 166291 23922 79554158
Hyperprolactinaemia 14.61 9.95 31 166277 4645 79573435
Haematocrit decreased 14.53 9.95 72 166236 61240 79516840
Hepatic failure 14.43 9.95 72 166236 61140 79516940
Anti-neutrophil cytoplasmic antibody positive vasculitis 14.38 9.95 27 166281 3702 79574378
Metastases to liver 14.37 9.95 23 166285 28291 79549789
Vertigo 14.37 9.95 213 166095 68869 79509211
Mouth swelling 14.36 9.95 36 166272 6015 79572065
Maternal condition affecting foetus 14.31 9.95 7 166301 161 79577919
Concussion 14.28 9.95 48 166260 9455 79568625
SLE arthritis 14.28 9.95 11 166297 582 79577498
Interstitial lung disease 14.24 9.95 158 166150 112442 79465638
Type 2 diabetes mellitus 14.16 9.95 66 166242 57056 79521024
Basal cell carcinoma 14.14 9.95 36 166272 37339 79540741
Wrong technique in product usage process 14.13 9.95 93 166215 73782 79504298
Abnormal loss of weight 14.12 9.95 44 166264 8332 79569748
Pericarditis 14.09 9.95 144 166164 104092 79473988
Rectal cancer metastatic 14.09 9.95 10 166298 466 79577614
Muscle spasms 14.04 9.95 470 165838 174260 79403820
Personality disorder 14.00 9.95 36 166272 6110 79571970
Oesophageal carcinoma 13.99 9.95 3 166305 11081 79566999
Injection site swelling 13.84 9.95 51 166257 47081 79530999
Procedural anxiety 13.80 9.95 12 166296 754 79577326
Stomatitis 13.78 9.95 219 166089 146538 79431542
Restlessness 13.76 9.95 153 166155 46339 79531741
Nail injury 13.72 9.95 11 166297 617 79577463
Bacteraemia 13.71 9.95 30 166278 32794 79545286
Post-traumatic stress disorder 13.70 9.95 31 166277 4850 79573230
Rectal haemorrhage 13.63 9.95 98 166210 76202 79501878
Drug tolerance decreased 13.62 9.95 5 166303 12973 79565107
Haematochezia 13.60 9.95 117 166191 87528 79490552
Complication associated with device 13.55 9.95 10 166298 17486 79560594
Quality of life decreased 13.40 9.95 50 166258 10370 79567710
Hot flush 13.35 9.95 174 166134 54703 79523377
Hyperuricaemia 13.34 9.95 4 166304 11795 79566285
Hypervolaemia 13.33 9.95 45 166263 42645 79535435
Ejection fraction decreased 13.32 9.95 33 166275 34544 79543536
Transaminases increased 13.30 9.95 59 166249 51684 79526396
Metastases to lung 13.28 9.95 11 166297 18152 79559928
Autonomic neuropathy 13.24 9.95 18 166290 1877 79576203
Coma scale abnormal 13.19 9.95 44 166264 8634 79569446
Blood lactate dehydrogenase increased 13.13 9.95 40 166268 39130 79538950
Right ventricular failure 12.98 9.95 18 166290 23479 79554601
Hepatotoxicity 12.93 9.95 59 166249 51293 79526787
Haemolysis 12.91 9.95 57 166251 12755 79565325
Sleep deficit 12.84 9.95 14 166294 1162 79576918
Naevus haemorrhage 12.81 9.95 6 166302 125 79577955
Haemophagocytic lymphohistiocytosis 12.81 9.95 16 166292 21821 79556259
Second primary malignancy 12.76 9.95 7 166301 14343 79563737
Metastases to lymph nodes 12.75 9.95 3 166305 10394 79567686
Cystitis interstitial 12.62 9.95 15 166293 1368 79576712
Mast cell degranulation present 12.61 9.95 5 166303 68 79578012
Hypoxia 12.61 9.95 146 166162 103097 79474983
Drug dispensed to wrong patient 12.59 9.95 11 166297 695 79577385
Pseudomonas infection 12.59 9.95 15 166293 20888 79557192
Myoglobin urine 12.57 9.95 4 166304 27 79578053
Appetite disorder 12.45 9.95 40 166268 7699 79570381
Blood pressure decreased 12.41 9.95 140 166168 99326 79478754
Acute graft versus host disease 12.34 9.95 3 166305 10164 79567916
Blood alkaline phosphatase increased 12.25 9.95 80 166228 63584 79514496
Menstruation delayed 12.25 9.95 15 166293 1411 79576669
Myofascial pain syndrome 12.24 9.95 18 166290 2019 79576061
Forced expiratory volume decreased 12.22 9.95 40 166268 7774 79570306
Poor peripheral circulation 12.19 9.95 25 166283 3658 79574422
Hyperammonaemia 12.12 9.95 4 166304 11089 79566991
Urticaria aquagenic 12.09 9.95 4 166304 31 79578049
Sleep disorder 12.00 9.95 248 166060 85429 79492651
Urticaria cholinergic 11.98 9.95 4 166304 32 79578048
Dysphemia 11.94 9.95 24 166284 3460 79574620
Metastases to central nervous system 11.87 9.95 10 166298 16365 79561715
Oliguria 11.77 9.95 10 166298 16299 79561781
Full blood count abnormal 11.75 9.95 44 166264 40430 79537650
Diaphragmatic paralysis 11.73 9.95 13 166295 1099 79576981
Injection site reaction 11.50 9.95 67 166241 54718 79523362
Behaviour disorder 11.42 9.95 34 166274 6279 79571801
Acute lung injury 11.41 9.95 22 166286 3078 79575002
Oral herpes 11.40 9.95 97 166211 27357 79550723
Injury 11.34 9.95 105 166203 77391 79500689
Faecaloma 11.31 9.95 51 166257 11513 79566567
Binge eating 11.30 9.95 9 166299 500 79577580
Sinoatrial block 11.26 9.95 14 166294 1337 79576743
Acquired diaphragmatic eventration 11.23 9.95 10 166298 648 79577432
Infrapatellar fat pad inflammation 11.23 9.95 6 166302 167 79577913
Phonophobia 11.19 9.95 9 166299 507 79577573
Activated partial thromboplastin time prolonged 11.19 9.95 8 166300 14220 79563860
Pharyngeal oedema 11.18 9.95 65 166243 16207 79561873
Bacterial infection 11.17 9.95 31 166277 31249 79546831
Synovial disorder 11.17 9.95 17 166291 1966 79576114
Sports injury 11.13 9.95 6 166302 170 79577910
Viral diarrhoea 11.12 9.95 8 166300 381 79577699
Cerebrovascular accident 11.08 9.95 243 166065 155049 79423031
Acute myocardial infarction 11.01 9.95 105 166203 76931 79501149
Urticaria 10.97 9.95 298 166010 184903 79393177
Sinusitis 10.96 9.95 317 165991 195184 79382896
Parkinsonian rest tremor 10.95 9.95 7 166301 274 79577806
Iron binding capacity total decreased 10.94 9.95 8 166300 391 79577689
Gastrointestinal disorder 10.93 9.95 184 166124 122021 79456059
Muscle rigidity 10.92 9.95 75 166233 19807 79558273
Lipase increased 10.82 9.95 11 166297 16455 79561625
Blood creatine phosphokinase increased 10.81 9.95 87 166221 66003 79512077
Hospice care 10.80 9.95 4 166304 10320 79567760
Candida infection 10.80 9.95 42 166266 38172 79539908
Venous angioma of brain 10.69 9.95 4 166304 46 79578034
Nail bed tenderness 10.67 9.95 8 166300 406 79577674
Allergic sinusitis 10.67 9.95 11 166297 856 79577224
Onychophagia 10.64 9.95 5 166303 105 79577975
Intraocular pressure increased 10.63 9.95 3 166305 9202 79568878
Disorientation 10.60 9.95 187 166121 62589 79515491
Cystitis haemorrhagic 10.57 9.95 3 166305 9169 79568911
Benzodiazepine drug level therapeutic 10.54 9.95 4 166304 48 79578032
Laryngeal dyspnoea 10.51 9.95 7 166301 294 79577786
Metastases to bone 10.47 9.95 22 166286 24405 79553675
Wrong patient received product 10.47 9.95 27 166281 4591 79573489
Lenticular opacities 10.45 9.95 9 166299 558 79577522
Oxalosis 10.43 9.95 5 166303 110 79577970
Injection site bruising 10.39 9.95 47 166261 40955 79537125
Heliotrope rash 10.36 9.95 6 166302 196 79577884
Burning feet syndrome 10.30 9.95 6 166302 198 79577882
Epistaxis 10.27 9.95 167 166141 111348 79466732
Enlarged uvula 10.24 9.95 8 166300 432 79577648
Organising pneumonia 10.23 9.95 5 166303 10934 79567146
Sensory disturbance 10.22 9.95 60 166248 15017 79563063
Tender joint count 10.17 9.95 6 166302 203 79577877
Miosis 10.17 9.95 62 166246 15727 79562353
Hypoalbuminaemia 10.16 9.95 18 166290 21279 79556801
Chemical burns of eye 10.11 9.95 5 166303 118 79577962
Mania 10.10 9.95 69 166239 18191 79559889
Venoocclusive liver disease 10.10 9.95 6 166302 11765 79566315
Melaena 10.03 9.95 80 166228 60810 79517270
Lactic acidosis 10.01 9.95 96 166212 70263 79507817

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AA09 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Non-selective monoamine reuptake inhibitors
ATC N06CA01 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOLEPTICS AND PSYCHOANALEPTICS IN COMBINATION
Antidepressants in combination with psycholeptics
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:140489 TrkB receptor agonist
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000928 Antidepressive Agents
MeSH PA D000929 Antidepressive Agents, Tricyclic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
FDA EPC N0000175752 Tricyclic Antidepressant

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

DiseaseRelationSNOMED_IDDOID
Depressive disorder indication 35489007
Mixed anxiety and depressive disorder indication 231504006
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Bulimia nervosa off-label use 78004001
Fibromyalgia off-label use 203082005 DOID:631
Neuropathic pain off-label use 247398009
Migraine Prevention off-label use
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Organophosphate poisoning contraindication 8260003
Weight gain finding contraindication 8943002
Sinus tachycardia contraindication 11092001
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Chronic disease of respiratory system contraindication 17097001
Disorder of lung contraindication 19829001 DOID:850
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Orthostatic hypotension contraindication 28651003
Torsades de pointes contraindication 31722008
Parkinsonism contraindication 32798002
Hyperthyroidism contraindication 34486009 DOID:7998
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Paralytic ileus contraindication 55525008 DOID:8442
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Extrapyramidal disease contraindication 76349003
Hyperglycemia contraindication 80394007 DOID:4195
Chronic idiopathic constipation contraindication 82934008
Open-angle glaucoma contraindication 84494001 DOID:1067
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Stupor contraindication 89458003
Kidney disease contraindication 90708001 DOID:557
Tardive dyskinesia contraindication 102449007
Prolonged QT interval contraindication 111975006
Hypoalbuminemia contraindication 119247004
Acute disease of cardiovascular system contraindication 128487001
Bipolar affective disorder, current episode manic contraindication 191618007
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Syncope contraindication 271594007
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Severe chronic obstructive pulmonary disease contraindication 313299006
Coma contraindication 371632003
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Myocardial infarction in recovery phase contraindication 418044006
Porphyria contraindication 418470004
Congenital long QT syndrome contraindication 442917000
Carcinoma of female breast contraindication 447782002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.66 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Kd 7.46 WOMBAT-PK CHEMBL
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 8.37 WOMBAT-PK CHEMBL
D(2) dopamine receptor GPCR Ki 6.71 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 6.88 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 6.25 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 6.72 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 7.96 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.40 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR Ki 8.10 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 7.05 WOMBAT-PK
5-hydroxytryptamine receptor 7 GPCR Ki 6.40 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR IC50 7.90 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR IC50 8 WOMBAT-PK
D(3) dopamine receptor GPCR Ki 6.69 WOMBAT-PK
D(1B) dopamine receptor GPCR Ki 6.77 WOMBAT-PK
Histamine H1 receptor GPCR ANTAGONIST Ki 9.30 WOMBAT-PK
Histamine H2 receptor GPCR IC50 6.80 WOMBAT-PK
Histamine H4 receptor GPCR Ki 8.14 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 7.83 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 8.10 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 7.89 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 8.14 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 7.80 WOMBAT-PK
Aldehyde oxidase Enzyme IC50 6.59 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 8.07 DRUG MATRIX
Sodium channel protein type 2 subunit alpha Ion channel IC50 5.51 CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel IC50 6 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.21 CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 8.25 DRUG MATRIX
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase IC50 6 CHEMBL
High affinity nerve growth factor receptor Kinase IC50 4.22 CHEMBL
Voltage-dependent N-type calcium channel subunit alpha-1B Ion channel IC50 4.92 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.77 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.85 WOMBAT-PK
Sodium channel protein type 5 subunit alpha Ion channel IC50 5.80 CHEMBL
D(1A) dopamine receptor GPCR Ki 7.05 WOMBAT-PK
Alpha-1B adrenergic receptor GPCR Ki 7.38 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 5.77 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 10.70 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 5.70 CHEMBL
Sodium-dependent serotonin transporter Transporter IC50 5.07 CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.40 IUPHAR
Transporter Transporter IC50 5.60 CHEMBL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 7 IUPHAR
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 6.40 IUPHAR
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 8.10 IUPHAR
Histamine H1 receptor GPCR IC50 10.70 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 7.20 IUPHAR
Muscarinic acetylcholine receptor GPCR IC50 6.52 CHEMBL
G protein-activated inward rectifier potassium channel 2 Ion channel BLOCKER IC50 4 IUPHAR

External reference:

IDSource
4019607 VUID
N0000147702 NUI
D00809 KEGG_DRUG
549-18-8 SECONDARY_CAS_RN
203168 RXNORM
C0002600 UMLSCUI
CHEBI:2666 CHEBI
TP0 PDB_CHEM_ID
CHEMBL629 ChEMBL_ID
DB00321 DRUGBANK_ID
CHEMBL1200964 ChEMBL_ID
D000639 MESH_DESCRIPTOR_UI
2160 PUBCHEM_CID
200 IUPHAR_LIGAND_ID
976 INN_ID
1806D8D52K UNII
4178 MMSL
4240 MMSL
d00146 MMSL
372726002 SNOMEDCT_US
40589005 SNOMEDCT_US
48384000 SNOMEDCT_US
4017743 VANDF
4019607 VANDF
001501 NDDF
004600 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0042 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0042 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0073 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0073 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0211 TABLET, FILM COATED 14 mg ORAL ANDA 25 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0211 TABLET, FILM COATED 14 mg ORAL ANDA 25 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0211 TABLET, FILM COATED 14 mg ORAL ANDA 25 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0277 TABLET, FILM COATED 27.98 mg ORAL ANDA 25 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0277 TABLET, FILM COATED 27.98 mg ORAL ANDA 25 sections
Chlordiazepoxide and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0277 TABLET, FILM COATED 27.98 mg ORAL ANDA 25 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0330 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0330 TABLET, FILM COATED 10 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0442 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0442 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0574 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Perphenazine and Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-0574 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6351 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6352 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0463-6354 TABLET, FILM COATED 100 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2212 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2212 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2213 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2213 TABLET, FILM COATED 25 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2214 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2214 TABLET, FILM COATED 50 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2215 TABLET, FILM COATED 75 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2215 TABLET, FILM COATED 75 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2216 TABLET, FILM COATED 100 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2216 TABLET, FILM COATED 100 mg ORAL ANDA 23 sections
Amitriptyline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0603-2217 TABLET, FILM COATED 150 mg ORAL ANDA 23 sections