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

Stem definitionDrug idCAS RN
serotonin reuptake inhibitors 2436 79617-96-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sertraline
  • sertraline hydrochloride
  • sertraline HCl
A selective serotonin uptake inhibitor that is used in the treatment of depression.
  • Molecular weight: 306.23
  • Formula: C17H17Cl2N
  • CLOGP: 5.35
  • LIPINSKI: 1
  • HAC: 1
  • HDO: 1
  • TPSA: 12.03
  • ALOGS: -6.32
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 3.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 9.33 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 44 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1991 FDA PFIZER

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 2405.53 34.03 808 12139 20226 2324912
Toxicity to various agents 2384.01 34.03 899 12048 31855 2313283
Drug hypersensitivity 2182.43 34.03 931 12016 45712 2299426
Drug abuse 1880.83 34.03 587 12360 11439 2333699
Serotonin syndrome 1641.38 34.03 406 12541 3134 2342004
Suicide attempt 1602.32 34.03 512 12435 10770 2334368
Drug interaction 1541.68 34.03 637 12310 28526 2316612
Intentional overdose 1457.32 34.03 477 12470 10844 2334294
Anxiety 1199.38 34.03 535 12412 28824 2316314
Depression 1153.21 34.03 514 12433 27618 2317520
Suicidal ideation 1125.05 34.03 391 12556 10696 2334442
Intentional self-injury 1121.98 34.03 310 12637 3817 2341321
Hyponatraemia 1095.52 34.03 402 12545 12923 2332215
Overdose 952.25 34.03 406 12541 19501 2325637
Agitation 887.73 34.03 328 12619 10723 2334415
Tremor 808.33 34.03 366 12581 20295 2324843
Confusional state 757.04 34.03 368 12579 23976 2321162
Drug ineffective 730.61 34.03 605 12342 101019 2244119
Nausea 680.45 34.03 606 12341 111583 2233555
Dizziness 676.03 34.03 464 12483 58201 2286937
Vomiting 663.91 34.03 496 12451 71106 2274032
Somnolence 655.54 34.03 330 12617 23155 2321983
Insomnia 649.29 34.03 338 12609 25449 2319689
Exposure during pregnancy 647.72 34.03 335 12612 24884 2320254
Condition aggravated 554.67 34.03 328 12619 31651 2313487
Electrocardiogram QT prolonged 525.71 34.03 204 12743 7610 2337528
Headache 470.00 34.03 426 12521 79753 2265385
Feeling abnormal 464.68 34.03 263 12684 23318 2321820
Cardiac arrest 464.08 34.03 226 12721 14704 2330434
Diarrhoea 452.94 34.03 425 12522 83139 2261999
Loss of consciousness 448.96 34.03 238 12709 18529 2326609
Sopor 447.30 34.03 152 12795 3843 2341295
Cardio-respiratory arrest 444.19 34.03 189 12758 8957 2336181
Panic attack 413.59 34.03 143 12804 3813 2341325
Seizure 392.66 34.03 239 12708 24227 2320911
Fall 385.97 34.03 304 12643 46795 2298343
Tachycardia 380.77 34.03 204 12743 16205 2328933
Withdrawal syndrome 373.64 34.03 127 12820 3210 2341928
Inappropriate antidiuretic hormone secretion 372.89 34.03 116 12831 2193 2342945
Mania 362.44 34.03 115 12832 2325 2342813
Weight increased 357.82 34.03 218 12729 22119 2323019
Respiratory arrest 354.94 34.03 144 12803 6034 2339104
Coma 351.78 34.03 160 12787 8896 2336242
Aggression 346.86 34.03 132 12815 4654 2340484
Depressed level of consciousness 345.61 34.03 150 12797 7454 2337684
Maternal exposure during pregnancy 339.78 34.03 183 12764 14680 2330458
Hyperhidrosis 338.98 34.03 185 12762 15237 2329901
Myoclonus 331.83 34.03 108 12839 2375 2342763
Fatigue 329.81 34.03 361 12586 84512 2260626
Foetal exposure during pregnancy 320.96 34.03 128 12819 5124 2340014
Hallucination, auditory 320.14 34.03 102 12845 2090 2343048
Mydriasis 318.91 34.03 102 12845 2117 2343021
Hallucination 303.97 34.03 140 12807 8008 2337130
Akathisia 303.80 34.03 92 12855 1582 2343556
Dyskinesia 300.59 34.03 119 12828 4670 2340468
Abnormal behaviour 297.79 34.03 118 12829 4642 2340496
Decreased appetite 290.53 34.03 211 12736 28680 2316458
Palpitations 290.34 34.03 171 12776 16285 2328853
Drug withdrawal syndrome 279.05 34.03 125 12822 6696 2338442
Hypotension 275.27 34.03 214 12733 32222 2312916
Depressed mood 270.79 34.03 113 12834 5085 2340053
Delirium 270.27 34.03 113 12834 5110 2340028
Bruxism 267.86 34.03 70 12877 679 2344459
Disorientation 267.79 34.03 119 12828 6253 2338885
Paraesthesia 265.49 34.03 180 12767 21908 2323230
Restlessness 264.22 34.03 107 12840 4456 2340682
Poisoning 260.46 34.03 93 12854 2727 2342411
Psychotic disorder 258.21 34.03 106 12841 4573 2340565
Muscle rigidity 250.13 34.03 81 12866 1750 2343388
Rhabdomyolysis 246.29 34.03 114 12833 6590 2338548
Syncope 230.51 34.03 149 12798 16726 2328412
Crying 227.05 34.03 95 12852 4301 2340837
Lethargy 226.31 34.03 117 12830 8613 2336525
Hypokalaemia 223.44 34.03 124 12823 10530 2334608
Intentional product misuse 219.93 34.03 118 12829 9371 2335767
Irritability 219.72 34.03 104 12843 6323 2338815
Colitis microscopic 216.09 34.03 62 12885 874 2344264
Tinnitus 209.64 34.03 94 12853 5041 2340097
Hallucination, visual 207.99 34.03 80 12867 2899 2342239
Disturbance in attention 206.70 34.03 96 12851 5589 2339549
Nightmare 204.79 34.03 84 12863 3613 2341525
Malaise 204.11 34.03 230 12717 55355 2289783
Extrapyramidal disorder 203.95 34.03 74 12873 2273 2342865
Weight decreased 199.88 34.03 168 12779 28203 2316935
Product substitution issue 198.08 34.03 90 12857 4979 2340159
Product complaint 194.64 34.03 86 12861 4452 2340686
Asthenia 192.73 34.03 206 12741 46720 2298418
Sedation 191.72 34.03 78 12869 3284 2341854
Dry mouth 189.46 34.03 102 12845 8151 2336987
Treatment noncompliance 187.46 34.03 89 12858 5445 2339693
Anger 184.62 34.03 70 12877 2437 2342701
Caesarean section 183.64 34.03 80 12867 4001 2341137
Neuroleptic malignant syndrome 182.29 34.03 66 12881 2014 2343124
Dystonia 175.17 34.03 65 12882 2129 2343009
Fear 174.61 34.03 68 12879 2548 2342590
Self-injurious ideation 173.65 34.03 47 12900 527 2344611
Gestational diabetes 167.85 34.03 56 12891 1331 2343807
Salivary hypersecretion 166.51 34.03 54 12893 1171 2343967
Hyperreflexia 165.51 34.03 50 12897 851 2344287
Abdominal pain 160.98 34.03 162 12785 34212 2310926
Muscle twitching 157.13 34.03 64 12883 2701 2342437
Paranoia 152.14 34.03 58 12889 2049 2343089
Dysarthria 150.55 34.03 80 12867 6222 2338916
Mood swings 150.06 34.03 65 12882 3204 2341934
Urinary retention 149.24 34.03 67 12880 3600 2341538
Therapeutic response unexpected 149.11 34.03 68 12879 3791 2341347
Homicidal ideation 148.80 34.03 40 12907 436 2344702
Visual impairment 148.72 34.03 99 12848 11656 2333482
Bradycardia 148.29 34.03 93 12854 9888 2335250
Hypertension 143.06 34.03 137 12810 27224 2317914
Vision blurred 142.34 34.03 105 12842 14563 2330575
Apathy 141.85 34.03 49 12898 1298 2343840
Abdominal pain upper 141.56 34.03 124 12823 21976 2323162
Abortion spontaneous 141.28 34.03 101 12846 13344 2331794
Balance disorder 137.76 34.03 88 12859 9659 2335479
Mental disorder 137.39 34.03 65 12882 3942 2341196
Cognitive disorder 133.32 34.03 70 12877 5311 2339827
Neonatal respiratory distress syndrome 132.78 34.03 38 12909 530 2344608
Psychomotor hyperactivity 131.95 34.03 51 12896 1871 2343267
Sleep disorder 131.81 34.03 74 12873 6415 2338723
Hepatic steatosis 131.69 34.03 59 12888 3154 2341984
Drug dependence 131.49 34.03 58 12889 2987 2342151
Blood creatine phosphokinase increased 130.63 34.03 68 12879 5068 2340070
Mood altered 130.63 34.03 56 12891 2690 2342448
Heart rate increased 129.66 34.03 89 12858 11016 2334122
Dyspepsia 129.59 34.03 85 12862 9759 2335379
Dehydration 128.75 34.03 118 12829 22177 2322961
Death 126.31 34.03 223 12724 81245 2263893
Generalised tonic-clonic seizure 124.94 34.03 67 12880 5305 2339833
Galactorrhoea 124.30 34.03 44 12903 1255 2343883
Tic 123.42 34.03 34 12913 409 2344729
Psychomotor retardation 122.94 34.03 36 12911 547 2344591
Eye movement disorder 122.57 34.03 42 12905 1085 2344053
Parkinsonism 121.64 34.03 45 12902 1460 2343678
Amnesia 121.55 34.03 73 12874 7180 2337958
Altered state of consciousness 121.35 34.03 59 12888 3801 2341337
Anorgasmia 120.83 34.03 29 12918 191 2344947
Gait disturbance 119.92 34.03 114 12833 22431 2322707
Speech disorder 118.64 34.03 69 12878 6395 2338743
Schizophrenia 118.61 34.03 43 12904 1316 2343822
Muscle spasms 118.43 34.03 111 12836 21455 2323683
Agitation neonatal 117.95 34.03 25 12922 84 2345054
Thinking abnormal 117.39 34.03 47 12900 1895 2343243
Maculopathy 114.82 34.03 32 12915 403 2344735
Delusion 114.60 34.03 47 12900 2018 2343120
Libido decreased 112.90 34.03 33 12914 498 2344640
Drug intolerance 112.83 34.03 89 12858 13628 2331510
Cholestasis 111.37 34.03 55 12892 3666 2341472
Small for dates baby 109.68 34.03 34 12913 633 2344505
Dysphagia 109.46 34.03 85 12862 12720 2332418
Homicide 109.36 34.03 24 12923 99 2345039
Unresponsive to stimuli 108.33 34.03 59 12888 4817 2340321
Trismus 108.26 34.03 36 12911 846 2344292
Bradyphrenia 108.10 34.03 38 12909 1061 2344077
Foetal death 107.75 34.03 44 12903 1868 2343270
Social avoidant behaviour 106.88 34.03 32 12915 527 2344611
Maternal drugs affecting foetus 106.01 34.03 41 12906 1506 2343632
Affective disorder 105.48 34.03 35 12912 817 2344321
Memory impairment 104.46 34.03 83 12864 12840 2332298
Hepatitis 104.16 34.03 63 12884 6274 2338864
Upper gastrointestinal haemorrhage 100.97 34.03 43 12904 2031 2343107
Premature baby 100.79 34.03 49 12898 3155 2341983
Night sweats 99.62 34.03 50 12897 3450 2341688
Constipation 99.41 34.03 101 12846 21528 2323610
Euphoric mood 98.90 34.03 34 12913 887 2344251
Pain 97.90 34.03 171 12776 61686 2283452
Melaena 97.69 34.03 52 12895 4054 2341084
Vertigo 97.41 34.03 70 12877 9314 2335824
Obsessive-compulsive disorder 97.13 34.03 31 12916 637 2344501
Abnormal dreams 97.11 34.03 44 12903 2414 2342724
Suicidal behaviour 96.06 34.03 29 12918 492 2344646
Mental status changes 95.64 34.03 57 12890 5525 2339613
Loss of personal independence in daily activities 95.62 34.03 56 12891 5255 2339883
Alanine aminotransferase increased 94.36 34.03 81 12866 13951 2331187
Mental impairment 94.26 34.03 43 12904 2397 2342741
Arrhythmia 94.13 34.03 58 12889 5970 2339168
Poisoning deliberate 94.01 34.03 35 12912 1156 2343982
Restless legs syndrome 94.01 34.03 42 12905 2229 2342909
Hypersensitivity 93.86 34.03 102 12845 23491 2321647
Orthostatic hypotension 93.49 34.03 45 12902 2834 2342304
Impaired work ability 93.02 34.03 39 12908 1771 2343367
Pre-eclampsia 92.99 34.03 37 12910 1467 2343671
Bradykinesia 91.50 34.03 29 12918 582 2344556
Dyspnoea 90.53 34.03 190 12757 78543 2266595
Hepatocellular injury 89.89 34.03 49 12898 4006 2341132
Coordination abnormal 89.50 34.03 39 12908 1949 2343189
Long QT syndrome 89.15 34.03 28 12919 545 2344593
Pyrexia 88.25 34.03 151 12796 53557 2291581
Stillbirth 87.53 34.03 35 12912 1406 2343732
Drug screen positive 87.40 34.03 31 12916 889 2344249
Rash 86.98 34.03 159 12788 59399 2285739
Hyperthermia 86.90 34.03 35 12912 1433 2343705
Haematemesis 86.83 34.03 48 12899 4034 2341104
Drug screen false positive 86.46 34.03 23 12924 240 2344898
Alcohol poisoning 84.85 34.03 24 12923 320 2344818
Asphyxia 84.75 34.03 31 12916 973 2344165
Hypotonia 84.65 34.03 36 12911 1694 2343444
Exposure via ingestion 84.26 34.03 29 12918 759 2344379
Hypotonia neonatal 84.00 34.03 22 12925 215 2344923
Loss of libido 83.69 34.03 23 12924 274 2344864
Product prescribing error 83.40 34.03 42 12905 2918 2342220
Blood cholesterol increased 83.29 34.03 51 12896 5190 2339948
Gamma-glutamyltransferase increased 83.01 34.03 52 12895 5510 2339628
Depressive symptom 82.31 34.03 26 12921 516 2344622
Asthma 81.59 34.03 68 12879 11246 2333892
Discomfort 81.47 34.03 50 12897 5109 2340029
Hypoaesthesia 81.44 34.03 88 12859 20127 2325011
Premature rupture of membranes 80.30 34.03 29 12918 877 2344261
Psychomotor skills impaired 80.00 34.03 24 12923 398 2344740
Coeliac disease 78.90 34.03 28 12919 804 2344334
Contusion 78.20 34.03 70 12877 12740 2332398
Tension 77.77 34.03 25 12922 526 2344612
Blood alkaline phosphatase increased 77.65 34.03 53 12894 6492 2338646
Ventricular septal defect 75.77 34.03 27 12920 785 2344353
Hallucinations, mixed 75.39 34.03 25 12922 582 2344556
Muscle tightness 74.93 34.03 34 12913 1871 2343267
Bundle branch block right 74.56 34.03 27 12920 823 2344315
Circulatory collapse 74.37 34.03 42 12905 3678 2341460
Personality disorder 74.24 34.03 22 12925 349 2344789
Drowning 74.04 34.03 18 12929 126 2345012
Emotional disorder 73.64 34.03 35 12912 2142 2342996
Liver function test abnormal 73.46 34.03 54 12893 7436 2337702
Cerebral vasoconstriction 72.97 34.03 21 12926 299 2344839
Multiple organ dysfunction syndrome 72.50 34.03 54 12893 7587 2337551
Pancreatic fibrosis 72.40 34.03 12 12935 2 2345136
Tardive dyskinesia 72.08 34.03 32 12915 1672 2343466
Emotional distress 71.34 34.03 43 12904 4252 2340886
Clonus 71.30 34.03 24 12923 586 2344552
Activation syndrome 71.24 34.03 16 12931 75 2345063
Medication error 71.20 34.03 49 12898 6082 2339056
Abnormal weight gain 70.14 34.03 20 12927 275 2344863
Anticholinergic syndrome 70.07 34.03 20 12927 276 2344862
Pruritus 70.02 34.03 121 12826 43219 2301919
Impulsive behaviour 69.96 34.03 21 12926 349 2344789
Body temperature increased 69.40 34.03 38 12909 3133 2342005
Aspartate aminotransferase increased 69.34 34.03 65 12882 12547 2332591
Photophobia 68.98 34.03 34 12913 2255 2342883
Bradycardia neonatal 68.81 34.03 18 12929 175 2344963
Migraine 68.58 34.03 60 12887 10593 2334545
Chest pain 68.55 34.03 95 12852 28042 2317096
Hypertonia 68.26 34.03 28 12919 1202 2343936
Stress 68.00 34.03 50 12897 6888 2338250
Catatonia 67.16 34.03 25 12922 825 2344313
Infantile apnoea 66.96 34.03 18 12929 196 2344942
Nystagmus 66.51 34.03 27 12920 1128 2344010
Bipolar disorder 66.39 34.03 28 12919 1290 2343848
Diplopia 66.25 34.03 38 12909 3427 2341711
Victim of chemical submission 65.83 34.03 14 12933 48 2345090
Epilepsy 65.79 34.03 42 12905 4597 2340541
Aspiration 65.51 34.03 29 12918 1505 2343633
Foaming at mouth 65.35 34.03 19 12928 281 2344857
Respiratory disorder neonatal 65.29 34.03 17 12930 162 2344976
Swollen tongue 65.12 34.03 44 12903 5299 2339839
Hypothyroidism 64.82 34.03 41 12906 4416 2340722
Myalgia 64.82 34.03 84 12863 23249 2321889
Hypomania 64.73 34.03 24 12923 783 2344355
Hyperprolactinaemia 63.58 34.03 23 12924 699 2344439
Pneumonia aspiration 63.54 34.03 38 12909 3704 2341434
Aphasia 63.47 34.03 42 12905 4886 2340252
Hyponatraemic seizure 63.17 34.03 14 12933 61 2345077
Chills 63.15 34.03 68 12879 15484 2329654
Pneumonia 62.51 34.03 124 12823 49172 2295966
Major depression 62.24 34.03 25 12922 1016 2344122
Movement disorder 62.19 34.03 34 12913 2794 2342344
Therapeutic product effect decreased 62.00 34.03 57 12890 10732 2334406
Dysuria 61.72 34.03 38 12909 3903 2341235
Urinary incontinence 61.72 34.03 39 12908 4194 2340944
Feeling cold 61.45 34.03 35 12912 3115 2342023
Torsade de pointes 60.73 34.03 31 12916 2215 2342923
Logorrhoea 60.17 34.03 20 12927 469 2344669
Abdominal discomfort 60.04 34.03 70 12877 17386 2327752
Sluggishness 59.97 34.03 24 12923 966 2344172
Pregnancy 59.85 34.03 49 12898 7900 2337238
Musculoskeletal stiffness 59.55 34.03 59 12888 12188 2332950
Nervousness 59.14 34.03 41 12906 5148 2339990
Conversion disorder 59.09 34.03 19 12928 400 2344738
Neonatal asphyxia 58.89 34.03 14 12933 88 2345050
Maternal exposure timing unspecified 58.74 34.03 19 12928 408 2344730
Pleurothotonus 58.62 34.03 17 12930 249 2344889
Conjunctival abrasion 58.51 34.03 10 12937 4 2345134
Psychotic symptom 58.34 34.03 16 12931 189 2344949
Blood prolactin increased 58.23 34.03 24 12923 1043 2344095
Tachypnoea 58.06 34.03 30 12917 2199 2342939
Drug level increased 57.16 34.03 32 12915 2755 2342383
Subarachnoid haemorrhage 56.83 34.03 29 12918 2071 2343067
Human herpesvirus 6 infection 56.75 34.03 18 12929 362 2344776
Alcohol use 56.48 34.03 19 12928 463 2344675
Visceral congestion 56.01 34.03 12 12935 43 2345095
Respiratory depression 55.93 34.03 29 12918 2141 2342997
Sedation complication 55.91 34.03 15 12932 162 2344976
Borderline personality disorder 55.84 34.03 14 12933 113 2345025
Tremor neonatal 55.58 34.03 12 12935 45 2345093
Acute kidney injury 55.52 34.03 86 12861 28036 2317102
Amenorrhoea 55.07 34.03 29 12918 2210 2342928
Depersonalisation/derealisation disorder 55.01 34.03 16 12931 237 2344901
Epistaxis 54.90 34.03 51 12896 9728 2335410
Sexual dysfunction 54.90 34.03 17 12930 315 2344823
Polyhydramnios 54.75 34.03 17 12930 318 2344820
Brain injury 54.70 34.03 22 12925 897 2344241
Product use in unapproved indication 54.54 34.03 54 12893 11146 2333992
Somatic delusion 54.51 34.03 13 12934 83 2345055
Sinus tachycardia 54.47 34.03 33 12914 3292 2341846
Sleep-related eating disorder 54.29 34.03 14 12933 128 2345010
Slow response to stimuli 54.02 34.03 15 12932 186 2344952
Alcoholism 53.59 34.03 17 12930 342 2344796
Hemivertebra 53.55 34.03 10 12937 13 2345125
Bipolar I disorder 53.32 34.03 17 12930 348 2344790
Skin burning sensation 52.89 34.03 27 12920 1929 2343209
Self esteem decreased 52.37 34.03 14 12933 149 2344989
Arthralgia 52.10 34.03 122 12825 54163 2290975
Metabolic acidosis 51.62 34.03 40 12907 5958 2339180
Amniotic cavity infection 51.55 34.03 16 12931 299 2344839
Premature labour 51.01 34.03 27 12920 2079 2343059
Haematoma 50.39 34.03 37 12910 5084 2340054
Inhibitory drug interaction 50.09 34.03 15 12932 247 2344891
Blood pressure increased 50.07 34.03 63 12884 16923 2328215
Off label use 49.71 34.03 145 12802 73453 2271685
Eosinophilic pneumonia 49.68 34.03 17 12930 437 2344701
Hostility 49.65 34.03 15 12932 255 2344883
Drug withdrawal syndrome neonatal 49.57 34.03 17 12930 440 2344698
Oliguria 49.54 34.03 23 12924 1334 2343804
Abortion missed 49.53 34.03 17 12930 441 2344697
Gastritis 49.42 34.03 35 12912 4546 2340592
Subdural haematoma 49.38 34.03 27 12920 2219 2342919
Product communication issue 49.08 34.03 10 12937 26 2345112
Dysphemia 48.64 34.03 17 12930 466 2344672
Pulmonary oedema 48.45 34.03 42 12905 7321 2337817
Congenital hydronephrosis 48.39 34.03 11 12936 55 2345083
Flashback 48.23 34.03 11 12936 56 2345082
Panic reaction 47.39 34.03 19 12928 768 2344370
Product use issue 47.28 34.03 52 12895 12117 2333021
Hypochloraemia 47.28 34.03 15 12932 302 2344836
Dysgeusia 47.26 34.03 44 12903 8415 2336723
Ventricular tachycardia 47.06 34.03 29 12918 2982 2342156
Amniotic fluid volume increased 46.86 34.03 10 12937 35 2345103
Head injury 46.26 34.03 32 12915 4002 2341136
Eating disorder 46.26 34.03 26 12921 2255 2342883
Cholestasis of pregnancy 46.21 34.03 12 12935 113 2345025
Chest discomfort 46.02 34.03 56 12891 14539 2330599
Myocardial fibrosis 45.84 34.03 12 12935 117 2345021
General physical health deterioration 45.80 34.03 55 12892 14084 2331054
Oculogyric crisis 45.48 34.03 15 12932 343 2344795
Miosis 45.48 34.03 21 12926 1203 2343935
Affect lability 45.47 34.03 25 12922 2077 2343061
Hypersomnia 45.37 34.03 26 12921 2340 2342798
Hypothermia 44.96 34.03 25 12922 2123 2343015
Drug ineffective for unapproved indication 44.92 34.03 28 12919 2938 2342200
Food interaction 44.66 34.03 13 12934 193 2344945
Feeling jittery 44.63 34.03 24 12923 1908 2343230
Accidental overdose 44.36 34.03 31 12916 3941 2341197
Psychogenic seizure 44.35 34.03 14 12933 277 2344861
Joint swelling 44.28 34.03 59 12888 16760 2328378
Tearfulness 44.17 34.03 19 12928 919 2344219
Neurological symptom 44.13 34.03 19 12928 921 2344217
Personality change 44.11 34.03 19 12928 922 2344216
Renal dysplasia 43.99 34.03 10 12937 50 2345088
Gallbladder cholesterolosis 43.96 34.03 12 12935 139 2344999
Eosinophilic pneumonia acute 43.85 34.03 11 12936 89 2345049
Environmental exposure 43.74 34.03 9 12938 25 2345113
Hypoacusis 43.64 34.03 29 12918 3396 2341742
Cold sweat 43.22 34.03 24 12923 2033 2343105
Hyponatraemic syndrome 43.01 34.03 11 12936 97 2345041
Mixed liver injury 42.71 34.03 14 12933 314 2344824
Flight of ideas 42.61 34.03 11 12936 101 2345037
Screaming 42.50 34.03 17 12930 683 2344455
Non-Hodgkin's lymphoma recurrent 42.46 34.03 10 12937 60 2345078
Stevens-Johnson syndrome 42.42 34.03 31 12916 4228 2340910
Fibromyalgia 42.19 34.03 28 12919 3272 2341866
Photosensitivity reaction 42.12 34.03 25 12922 2402 2342736
Rabbit syndrome 42.04 34.03 10 12937 63 2345075
Hypoaesthesia oral 41.86 34.03 24 12923 2162 2342976
Maternal exposure during breast feeding 41.56 34.03 16 12931 580 2344558
Ataxia 41.51 34.03 25 12922 2467 2342671
Sepsis 41.41 34.03 60 12887 18428 2326710
Blood sodium decreased 41.33 34.03 27 12920 3073 2342065
Torticollis 41.09 34.03 14 12933 355 2344783
Disease recurrence 41.05 34.03 28 12919 3423 2341715
Neonatal disorder 40.96 34.03 13 12934 262 2344876
Cyanosis 40.66 34.03 27 12920 3158 2341980
Reversible cerebral vasoconstriction syndrome 40.55 34.03 13 12934 271 2344867
Interstitial lung disease 40.52 34.03 39 12908 7773 2337365
Amylase increased 40.48 34.03 19 12928 1130 2344008
Muscular weakness 40.36 34.03 53 12894 14844 2330294
Social anxiety disorder 40.30 34.03 10 12937 77 2345061
Back pain 39.31 34.03 79 12868 31580 2313558
Erythema multiforme 39.31 34.03 23 12924 2152 2342986
Depression suicidal 39.14 34.03 13 12934 304 2344834
Erythromelalgia 39.11 34.03 9 12938 48 2345090
Formication 38.95 34.03 17 12930 852 2344286
Alcohol abuse 38.94 34.03 13 12934 309 2344829
Nervous system disorder 38.78 34.03 26 12921 3090 2342048
Anaemia 38.73 34.03 83 12864 34709 2310429
Antipsychotic drug level increased 38.69 34.03 15 12932 554 2344584
Presyncope 38.60 34.03 28 12919 3775 2341363
Mobility decreased 38.37 34.03 40 12907 8770 2336368
Blood osmolarity decreased 38.26 34.03 11 12936 156 2344982
Persistent foetal circulation 38.24 34.03 10 12937 97 2345041
Transaminases increased 38.19 34.03 30 12917 4557 2340581
Opisthotonus 37.97 34.03 10 12937 100 2345038
Alopecia 37.55 34.03 63 12884 21938 2323200
Hot flush 37.45 34.03 36 12911 7163 2337975
Shock 37.31 34.03 28 12919 3976 2341162
Electrocardiogram T wave abnormal 37.04 34.03 13 12934 361 2344777
Feeling drunk 37.00 34.03 16 12931 784 2344354
Flat affect 36.99 34.03 12 12935 260 2344878
Oedema 36.89 34.03 42 12905 10161 2334977
Urticaria 36.88 34.03 66 12881 24195 2320943
Anhedonia 36.58 34.03 18 12929 1189 2343949
Frustration tolerance decreased 36.38 34.03 16 12931 817 2344321
Burning mouth syndrome 36.30 34.03 9 12938 69 2345069
Stupor 35.87 34.03 15 12932 676 2344462
Delusion of reference 35.71 34.03 8 12939 37 2345101
Eye disorder 35.66 34.03 25 12922 3194 2341944
Ureteric stenosis 35.51 34.03 10 12937 131 2345007
Retroplacental haematoma 35.36 34.03 8 12939 39 2345099
Bradypnoea 35.15 34.03 13 12934 421 2344717
Urinary tract infection 35.14 34.03 73 12874 29869 2315269
Respiratory failure 34.91 34.03 47 12900 13481 2331657
Dissociation 34.47 34.03 13 12934 445 2344693
Body mass index increased 34.45 34.03 10 12937 147 2344991
Stubbornness 34.41 34.03 7 12940 18 2345120
Thoracic vertebral fracture 34.39 34.03 14 12933 589 2344549
Oromandibular dystonia 34.35 34.03 9 12938 88 2345050

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1627.98 30.57 560 7001 15752 1723468
Toxicity to various agents 1474.39 30.57 608 6953 28533 1710687
Serotonin syndrome 1363.14 30.57 331 7230 2457 1736763
Drug abuse 1133.09 30.57 410 7151 13279 1725941
Drug interaction 911.74 30.57 430 7131 27528 1711692
Anxiety 837.96 30.57 341 7220 15186 1724034
Suicidal ideation 602.43 30.57 228 7333 8290 1730930
Depression 580.03 30.57 269 7292 16400 1722820
Foetal exposure during pregnancy 551.99 30.57 198 7363 6161 1733059
Hyponatraemia 551.18 30.57 217 7344 8783 1730437
Suicide attempt 537.77 30.57 202 7359 7179 1732041
Tremor 523.07 30.57 233 7328 12898 1726322
Overdose 517.78 30.57 249 7312 16452 1722768
Agitation 511.88 30.57 218 7343 10808 1728412
Drug hypersensitivity 509.94 30.57 239 7322 14896 1724324
Intentional self-injury 487.15 30.57 146 7415 2527 1736693
Confusional state 430.12 30.57 238 7323 21040 1718180
Somnolence 422.03 30.57 217 7344 16522 1722698
Intentional overdose 413.99 30.57 169 7392 7501 1731719
Insomnia 370.14 30.57 197 7364 16079 1723141
Drug ineffective 369.75 30.57 331 7230 63470 1675750
Condition aggravated 342.73 30.57 205 7356 20945 1718275
Aggression 338.61 30.57 149 7412 7966 1731254
Maternal exposure during pregnancy 332.95 30.57 82 7479 638 1738582
Dyskinesia 243.45 30.57 95 7466 3724 1735496
Cardiac arrest 233.50 30.57 145 7416 15785 1723435
Fall 227.02 30.57 175 7386 27039 1712181
Irritability 225.45 30.57 100 7461 5432 1733788
Restlessness 218.50 30.57 91 7470 4230 1734990
Erectile dysfunction 218.33 30.57 92 7469 4405 1734815
Hyperhidrosis 212.14 30.57 125 7436 12363 1726857
Seizure 212.13 30.57 150 7411 20291 1718929
Exposure during pregnancy 211.58 30.57 79 7482 2738 1736482
Dizziness 201.21 30.57 180 7381 34181 1705039
Neonatal respiratory distress syndrome 198.28 30.57 56 7505 773 1738447
Obsessive-compulsive disorder 193.82 30.57 55 7506 773 1738447
Nausea 193.38 30.57 211 7350 50985 1688235
Headache 191.27 30.57 175 7386 34201 1705019
Drug withdrawal syndrome neonatal 189.88 30.57 52 7509 636 1738584
Agitation neonatal 187.00 30.57 42 7519 206 1739014
Feeling abnormal 184.96 30.57 110 7451 11056 1728164
Respiratory arrest 183.03 30.57 88 7473 5751 1733469
Colitis microscopic 180.91 30.57 44 7517 322 1738898
Cardio-respiratory arrest 176.30 30.57 100 7461 9193 1730027
Respiratory disorder neonatal 176.18 30.57 41 7520 242 1738978
Electrocardiogram QT prolonged 169.05 30.57 82 7479 5463 1733757
Disorientation 167.10 30.57 81 7480 5388 1733832
Premature baby 165.84 30.57 67 7494 2875 1736345
Rhabdomyolysis 164.99 30.57 102 7459 10988 1728232
Sopor 164.53 30.57 60 7501 1941 1737279
Withdrawal syndrome 160.30 30.57 61 7500 2227 1736993
Vomiting 158.68 30.57 166 7395 38149 1701071
Loss of consciousness 156.08 30.57 110 7451 14765 1724455
Delusion 154.57 30.57 59 7502 2172 1737048
Extrapyramidal disorder 154.47 30.57 60 7501 2317 1736903
Mania 149.90 30.57 57 7504 2076 1737144
Neuroleptic malignant syndrome 148.06 30.57 63 7498 3085 1736135
Sexual dysfunction 147.42 30.57 54 7507 1769 1737451
Pulmonary oedema 147.21 30.57 79 7482 6507 1732713
Abnormal behaviour 147.18 30.57 78 7483 6264 1732956
Syncope 144.52 30.57 103 7458 14066 1725154
Disturbance in attention 139.31 30.57 66 7495 4168 1735052
Akathisia 136.46 30.57 47 7514 1281 1737939
Asthenia 135.97 30.57 146 7415 34524 1704696
Priapism 135.78 30.57 48 7513 1416 1737804
Delirium 132.96 30.57 73 7488 6289 1732931
Treatment noncompliance 132.19 30.57 68 7493 5133 1734087
Fatigue 131.62 30.57 173 7388 50608 1688612
Atrial septal defect 131.58 30.57 46 7515 1312 1737908
Hallucination 131.33 30.57 79 7482 8091 1731129
Amnesia 130.26 30.57 66 7495 4825 1734395
Sleep disorder 129.59 30.57 62 7499 4001 1735219
Large for dates baby 129.48 30.57 28 7533 111 1739109
Maternal exposure during breast feeding 128.24 30.57 34 7527 364 1738856
Psychotic disorder 128.19 30.57 66 7495 4990 1734230
Inappropriate antidiuretic hormone secretion 127.47 30.57 48 7513 1700 1737520
Weight increased 126.11 30.57 87 7474 11270 1727950
Malaise 125.65 30.57 130 7431 29435 1709785
Intentional product misuse 123.07 30.57 73 7488 7285 1731935
Blood creatine phosphokinase increased 122.95 30.57 78 7483 8778 1730442
Diarrhoea 122.18 30.57 172 7389 53680 1685540
Paranoia 120.59 30.57 49 7512 2132 1737088
Anhedonia 120.32 30.57 38 7523 783 1738437
Dysarthria 120.07 30.57 64 7497 5195 1734025
Bradyphrenia 119.60 30.57 36 7525 628 1738592
Small for dates baby 118.74 30.57 35 7526 566 1738654
Hypotension 118.17 30.57 126 7435 29528 1709692
Depressed mood 114.72 30.57 52 7509 2964 1736256
Mydriasis 113.67 30.57 41 7520 1283 1737937
Tachycardia 113.32 30.57 85 7476 12543 1726677
Myoclonus 111.45 30.57 47 7514 2248 1736972
Blepharospasm 110.99 30.57 28 7533 242 1738978
Coma 110.98 30.57 68 7493 7194 1732026
Psychomotor hyperactivity 109.72 30.57 44 7517 1849 1737371
Drug withdrawal syndrome 108.77 30.57 57 7504 4468 1734752
Maternal drugs affecting foetus 107.08 30.57 38 7523 1133 1738087
Dystonia 107.08 30.57 44 7517 1970 1737250
Bruxism 106.53 30.57 28 7533 289 1738931
Sedation 105.49 30.57 51 7510 3366 1735854
Parkinsonism 104.95 30.57 39 7522 1330 1737890
Product substitution issue 104.34 30.57 50 7511 3236 1735984
Speech disorder 102.83 30.57 55 7506 4493 1734727
Hallucination, auditory 101.62 30.57 43 7518 2074 1737146
Hypernatraemia 101.42 30.57 35 7526 959 1738261
Paraesthesia 99.69 30.57 73 7488 10378 1728842
Stress 98.75 30.57 45 7516 2596 1736624
Mental disorder 98.67 30.57 46 7515 2797 1736423
Circulatory collapse 95.85 30.57 48 7513 3419 1735801
Depressed level of consciousness 93.81 30.57 59 7502 6533 1732687
Generalised tonic-clonic seizure 91.66 30.57 49 7512 3997 1735223
Drug level increased 90.43 30.57 43 7518 2734 1736486
Ventricular septal defect 89.59 30.57 30 7531 748 1738472
Lethargy 89.17 30.57 59 7502 7125 1732095
Loss of libido 87.53 30.57 29 7532 699 1738521
Haemangioma congenital 87.32 30.57 19 7542 78 1739142
Gait disturbance 87.25 30.57 73 7488 12597 1726623
Panic attack 86.83 30.57 37 7524 1815 1737405
Hypomania 86.75 30.57 27 7534 529 1738691
Dyspnoea 85.10 30.57 143 7418 51916 1687304
Dysgraphia 84.73 30.57 23 7538 271 1738949
Nightmare 84.22 30.57 41 7520 2746 1736474
Major depression 84.12 30.57 28 7533 685 1738535
Hallucination, visual 83.98 30.57 40 7521 2552 1736668
Urinary hesitation 83.90 30.57 24 7537 347 1738873
Apathy 81.65 30.57 32 7529 1264 1737956
Thinking abnormal 81.26 30.57 32 7529 1280 1737940
Mood swings 80.84 30.57 36 7525 1966 1737254
Anger 79.90 30.57 39 7522 2627 1736593
Urinary incontinence 78.94 30.57 39 7522 2697 1736523
Hepatic steatosis 78.04 30.57 38 7523 2546 1736674
Muscle twitching 77.92 30.57 34 7527 1768 1737452
Libido decreased 77.47 30.57 31 7530 1294 1737926
Homicide 77.43 30.57 22 7539 310 1738910
Derealisation 77.28 30.57 19 7542 146 1739074
Movement disorder 77.09 30.57 33 7528 1637 1737583
Bradykinesia 76.09 30.57 24 7537 492 1738728
Urinary retention 76.03 30.57 48 7513 5347 1733873
Poisoning deliberate 75.75 30.57 27 7534 815 1738405
Decreased appetite 75.45 30.57 90 7471 23781 1715439
Pulmonary congestion 74.62 30.57 33 7528 1772 1737448
Tardive dyskinesia 74.53 30.57 29 7532 1123 1738097
Alcohol poisoning 72.13 30.57 23 7538 489 1738731
Drug dependence 71.74 30.57 39 7522 3288 1735932
Multiple organ dysfunction syndrome 71.48 30.57 57 7504 9185 1730035
Miosis 70.85 30.57 30 7531 1448 1737772
Muscle rigidity 70.69 30.57 32 7529 1816 1737404
Weight decreased 70.60 30.57 85 7476 22668 1716552
Muscle spasms 69.92 30.57 62 7499 11559 1727661
Apgar score low 69.90 30.57 19 7542 225 1738995
Antipsychotic drug level increased 69.00 30.57 24 7537 673 1738547
Myalgia 68.43 30.57 70 7491 15588 1723632
Alcohol interaction 68.21 30.57 20 7541 317 1738903
Personality change 68.11 30.57 27 7534 1099 1738121
Crying 67.60 30.57 29 7532 1446 1737774
Hypertension 67.56 30.57 77 7484 19371 1719849
Poisoning 66.88 30.57 34 7527 2498 1736722
Psychomotor retardation 66.60 30.57 21 7540 430 1738790
Accidental overdose 66.16 30.57 40 7521 4124 1735096
Patent ductus arteriosus 65.76 30.57 23 7538 656 1738564
Foetal growth restriction 65.59 30.57 23 7538 661 1738559
Therapeutic response unexpected 65.34 30.57 33 7528 2391 1736829
Death 64.98 30.57 174 7387 87269 1651951
Anorgasmia 63.85 30.57 17 7544 185 1739035
Exposure via breast milk 63.72 30.57 18 7543 248 1738972
Restless legs syndrome 63.67 30.57 25 7536 992 1738228
Dry mouth 63.23 30.57 38 7523 3875 1735345
Macrophages increased 63.04 30.57 11 7550 7 1739213
Pain 62.96 30.57 87 7474 26570 1712650
Hypertonia 62.86 30.57 27 7534 1350 1737870
Oromandibular dystonia 61.74 30.57 15 7546 109 1739111
Ventricular tachycardia 61.68 30.57 37 7524 3761 1735459
Jaundice 61.54 30.57 44 7517 6018 1733202
Torticollis 61.40 30.57 18 7543 285 1738935
Human herpesvirus 6 infection 61.24 30.57 19 7542 368 1738852
Heart rate increased 60.97 30.57 45 7516 6465 1732755
Abdominal pain upper 60.87 30.57 56 7505 10945 1728275
Mood altered 60.47 30.57 30 7531 2092 1737128
Muscle tightness 60.03 30.57 24 7537 999 1738221
Bipolar disorder 59.46 30.57 22 7539 740 1738480
Social avoidant behaviour 59.42 30.57 21 7540 618 1738602
Hypotonia neonatal 59.41 30.57 17 7544 246 1738974
Agitated depression 59.10 30.57 12 7549 32 1739188
Hypertonia neonatal 58.33 30.57 14 7547 96 1739124
Impaired work ability 58.07 30.57 24 7537 1089 1738131
Bradycardia neonatal 57.35 30.57 16 7545 210 1739010
Antidepressant drug level increased 57.34 30.57 12 7549 39 1739181
Hypokalaemia 57.32 30.57 43 7518 6331 1732889
Gastrooesophageal reflux disease 57.24 30.57 38 7523 4609 1734611
Cognitive disorder 57.21 30.57 37 7524 4293 1734927
Catatonia 56.26 30.57 22 7539 863 1738357
Pressure of speech 56.11 30.57 14 7547 115 1739105
Peripheral artery thrombosis 56.08 30.57 18 7543 391 1738829
Memory impairment 55.62 30.57 43 7518 6620 1732600
Gastrointestinal motility disorder 54.10 30.57 17 7544 344 1738876
Balance disorder 54.03 30.57 40 7521 5772 1733448
Hypospadias 53.63 30.57 19 7542 563 1738657
Therapeutic product effect decreased 53.35 30.57 41 7520 6256 1732964
Feeling jittery 53.24 30.57 21 7540 843 1738377
Product complaint 53.15 30.57 29 7532 2461 1736759
Schizophrenia 52.66 30.57 27 7534 2019 1737201
Palpitations 52.62 30.57 42 7519 6772 1732448
Maternal exposure timing unspecified 52.52 30.57 13 7548 103 1739117
Hyperreflexia 52.43 30.57 19 7542 602 1738618
Tearfulness 52.36 30.57 16 7545 294 1738926
Pallor 52.22 30.57 32 7529 3379 1735841
Asphyxia 51.96 30.57 22 7539 1061 1738159
Visual impairment 51.62 30.57 40 7521 6178 1733042
Tinnitus 51.55 30.57 31 7530 3164 1736056
Infantile apnoea 51.08 30.57 15 7546 239 1738981
Dysphagia 50.96 30.57 49 7512 10119 1729101
Vision blurred 50.76 30.57 45 7516 8378 1730842
Upper gastrointestinal haemorrhage 50.73 30.57 30 7531 2969 1736251
Dysuria 50.05 30.57 32 7529 3640 1735580
Status epilepticus 49.78 30.57 26 7535 2020 1737200
Gangrene neonatal 49.78 30.57 8 7553 0 1739220
Affective disorder 49.74 30.57 19 7542 699 1738521
Haematemesis 49.62 30.57 34 7527 4343 1734877
Orthostatic hypotension 49.51 30.57 31 7530 3400 1735820
Musculoskeletal stiffness 49.21 30.57 38 7523 5838 1733382
Performance status decreased 49.13 30.57 19 7542 723 1738497
Tic 48.84 30.57 19 7542 735 1738485
Dysphoria 48.47 30.57 19 7542 750 1738470
Neonatal respiratory acidosis 48.39 30.57 9 7552 12 1739208
Cerebral haemorrhage neonatal 48.14 30.57 10 7551 31 1739189
Emotional disorder 48.13 30.57 21 7540 1091 1738129
Constipation 48.06 30.57 57 7504 14943 1724277
Unresponsive to stimuli 47.90 30.57 34 7527 4595 1734625
Epilepsy 47.85 30.57 32 7529 3927 1735293
Skin turgor decreased 47.68 30.57 11 7550 62 1739158
Compartment syndrome 47.11 30.57 17 7544 532 1738688
Vertigo 47.02 30.57 33 7528 4380 1734840
Petechiae 46.92 30.57 23 7538 1562 1737658
Dehydration 46.80 30.57 61 7500 17597 1721623
Abulia 46.73 30.57 12 7549 112 1739108
Neutrophil count increased 46.66 30.57 27 7534 2566 1736654
Fear 46.61 30.57 22 7539 1374 1737846
Male sexual dysfunction 46.54 30.57 11 7550 70 1739150
Flatulence 46.13 30.57 28 7533 2906 1736314
Tremor neonatal 45.63 30.57 11 7550 77 1739143
Hypovolaemic shock 45.42 30.57 19 7542 889 1738331
Obsessive thoughts 45.18 30.57 13 7548 192 1739028
Ejaculation disorder 45.04 30.57 16 7545 478 1738742
Pulmonary fibrosis 44.86 30.57 26 7535 2478 1736742
Hot flush 44.66 30.57 26 7535 2499 1736721
Drug screen false positive 44.57 30.57 13 7548 202 1739018
Weight decrease neonatal 44.33 30.57 9 7552 24 1739196
Hypoglycaemia neonatal 43.79 30.57 14 7547 300 1738920
Euphoric mood 43.34 30.57 18 7543 827 1738393
Therapeutic product effect incomplete 42.95 30.57 34 7527 5414 1733806
Self esteem decreased 42.91 30.57 12 7549 159 1739061
Blood cholesterol increased 42.81 30.57 27 7534 2999 1736221
Dysaesthesia 42.67 30.57 15 7546 434 1738786
Drug screen positive 42.64 30.57 19 7542 1038 1738182
Medication error 42.64 30.57 32 7529 4711 1734509
Nervousness 42.24 30.57 24 7537 2203 1737017
Off label use 41.75 30.57 89 7472 38482 1700738
Caesarean section 41.62 30.57 16 7545 599 1738621
Resting tremor 41.24 30.57 10 7551 72 1739148
Gangrene 40.97 30.57 17 7544 779 1738441
Lymphomatoid papulosis 40.88 30.57 10 7551 75 1739145
Moaning 40.80 30.57 11 7550 126 1739094
Head injury 40.33 30.57 26 7535 2998 1736222
Parkinsonism hyperpyrexia syndrome 40.06 30.57 8 7553 19 1739201
Respiratory failure 39.82 30.57 51 7510 14454 1724766
Selective eating disorder 39.77 30.57 14 7547 407 1738813
Hypoaesthesia 39.40 30.57 42 7519 9793 1729427
Fallot's tetralogy 39.24 30.57 11 7550 147 1739073
Food interaction 39.04 30.57 12 7549 225 1738995
Grunting 38.69 30.57 10 7551 96 1739124
Cardiomegaly 38.57 30.57 23 7538 2311 1736909
Alcohol abuse 38.51 30.57 15 7546 582 1738638
Neonatal disorder 38.37 30.57 13 7548 336 1738884
Acute kidney injury 38.23 30.57 81 7480 34863 1704357
Gastrointestinal disorder 38.22 30.57 30 7531 4718 1734502
Implant site extravasation 37.89 30.57 11 7550 168 1739052
Fear of disease 37.78 30.57 7 7554 9 1739211
Homicidal ideation 37.70 30.57 15 7546 616 1738604
Mental status changes 37.68 30.57 33 7528 6042 1733178
Scratch 37.61 30.57 14 7547 479 1738741
Blood ethanol increased 37.46 30.57 9 7552 62 1739158
Radiologically isolated syndrome 37.33 30.57 6 7555 0 1739220
Pain in extremity 37.28 30.57 56 7505 18416 1720804
Shock 37.24 30.57 28 7533 4133 1735087
Sinus bradycardia 37.11 30.57 21 7540 1912 1737308
Panic disorder 37.11 30.57 12 7549 267 1738953
Transient tachypnoea of the newborn 36.85 30.57 9 7552 67 1739153
Incontinence 36.82 30.57 17 7544 1009 1738211
Impulsive behaviour 36.78 30.57 14 7547 510 1738710
Generalised anxiety disorder 36.44 30.57 10 7551 123 1739097
Morose 36.22 30.57 7 7554 13 1739207
Onychomycosis 35.50 30.57 12 7549 308 1738912
Pneumonia aspiration 35.49 30.57 30 7531 5236 1733984
Bradycardia 35.34 30.57 41 7520 10493 1728727
Abdominal discomfort 35.00 30.57 38 7523 9043 1730177
Abnormal dreams 34.85 30.57 20 7541 1871 1737349
Accidental exposure to product by child 34.78 30.57 15 7546 757 1738463
Head discomfort 34.73 30.57 14 7547 595 1738625
Vanishing bile duct syndrome 34.67 30.57 10 7551 149 1739071
General physical health deterioration 34.24 30.57 45 7516 13073 1726147
Autism spectrum disorder 34.21 30.57 12 7549 345 1738875
Muscle contractions involuntary 34.19 30.57 13 7548 472 1738748
Respiratory depression 34.18 30.57 21 7540 2226 1736994
Cardiac failure 34.09 30.57 44 7517 12558 1726662
Physical assault 34.08 30.57 12 7549 349 1738871
Hallucinations, mixed 33.96 30.57 13 7548 481 1738739
Road traffic accident 33.87 30.57 25 7536 3588 1735632
Depressive symptom 33.76 30.57 12 7549 359 1738861
Neutropenia 33.54 30.57 53 7508 18207 1721013
Coordination abnormal 33.52 30.57 18 7543 1479 1737741
Self-injurious ideation 33.48 30.57 12 7549 368 1738852
Delusion of replacement 32.94 30.57 7 7554 25 1739195
Loss of personal independence in daily activities 32.92 30.57 21 7540 2378 1736842
Optic ischaemic neuropathy 32.86 30.57 13 7548 526 1738694
Communication disorder 32.50 30.57 12 7549 401 1738819
Nervous system disorder 32.48 30.57 21 7540 2433 1736787
Congenital skin dimples 32.31 30.57 7 7554 28 1739192
Hypoxia 32.27 30.57 30 7531 5933 1733287
Persistent foetal circulation 32.20 30.57 9 7552 119 1739101
Abdominal distension 32.17 30.57 31 7530 6413 1732807
Product use in unapproved indication 32.15 30.57 37 7524 9385 1729835
Rapid eye movements sleep abnormal 32.03 30.57 8 7553 66 1739154
Alanine aminotransferase increased 31.86 30.57 42 7519 12236 1726984
Persecutory delusion 31.71 30.57 12 7549 430 1738790
Feelings of worthlessness 31.51 30.57 8 7553 71 1739149
Increased appetite 31.49 30.57 15 7546 956 1738264
Blood triglycerides increased 31.37 30.57 21 7540 2579 1736641
Male orgasmic disorder 31.21 30.57 8 7553 74 1739146
Therapy non-responder 31.01 30.57 30 7531 6236 1732984
Abdominal pain 31.00 30.57 56 7505 21434 1717786
Psychiatric symptom 30.95 30.57 14 7547 792 1738428
Stevens-Johnson syndrome 30.95 30.57 23 7538 3334 1735886
Attention deficit/hyperactivity disorder 30.80 30.57 12 7549 466 1738754
Disorganised speech 30.74 30.57 8 7553 79 1739141
Acidosis 30.74 30.57 17 7544 1480 1737740

Pharmacologic Action:

SourceCodeDescription
ATC N06AB06 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Selective serotonin reuptake inhibitors
FDA EPC N0000175696 Serotonin Reuptake Inhibitor
CHEBI has role CHEBI:50949 serotonin uptake inhibitor
CHEBI has role CHEBI:35469 antidepressant
MeSH PA D000928 Antidepressive Agents
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 D011619 Psychotropic Drugs
MeSH PA D018490 Serotonin Agents
MeSH PA D017367 Serotonin Uptake Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Social phobia indication 25501002 DOID:11257
Depressive disorder indication 35489007
Posttraumatic stress disorder indication 47505003 DOID:2055
Obsessive-compulsive disorder indication 191736004 DOID:10933
Panic disorder indication 371631005 DOID:594
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Seasonal affective disorder off-label use 247803002
Suicidal thoughts contraindication 6471006
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Upper gastrointestinal hemorrhage contraindication 37372002
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Blood coagulation disorder contraindication 64779008 DOID:1247
Weight loss contraindication 89362005
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Mania contraindication 231494001
Hypomania contraindication 231496004
Disease of liver contraindication 235856003 DOID:409
Serotonin syndrome contraindication 371089000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.61 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 serotonin transporter Transporter INHIBITOR Kd 9.54 CHEMBL CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 6.13 PDSP
Muscarinic acetylcholine receptor M5 GPCR Ki 5.72 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 5.85 PDSP
Muscarinic acetylcholine receptor M2 GPCR Ki 5.68 PDSP
Alpha-2A adrenergic receptor GPCR Ki 6.97 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel Ki 5.17 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 6.11 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.67 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.25 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 7.08 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.19 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 5.37 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.24 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 7.60 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 6.86 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 5.89 PDSP
Sodium-dependent noradrenaline transporter Transporter Kd 6.38 WOMBAT-PK
Alpha-1B adrenergic receptor GPCR Ki 6.48 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 5.88 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter Ki 9.07 CHEMBL
Transporter Transporter Ki 6.80 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 7.11 CHEMBL
Transcriptional activator protein luxR Unclassified IC50 4.57 CHEMBL

External reference:

IDSource
4020551 VUID
N0000148257 NUI
C0074393 UMLSCUI
D00825 KEGG_DRUG
321958004 SNOMEDCT_US
4020551 VANDF
004615 NDDF
36437 RXNORM
372594008 SNOMEDCT_US
d00880 MMSL
169461 MMSL
CHEBI:9123 CHEBI
CHEMBL809 ChEMBL_ID
DB01104 DRUGBANK_ID
CHEMBL1709 ChEMBL_ID
QUC7NX6WMB UNII
5277 INN_ID
79559-97-0 SECONDARY_CAS_RN
SRE PDB_CHEM_ID
68617 PUBCHEM_CID
D020280 MESH_DESCRIPTOR_UI
4798 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Zoloft HUMAN PRESCRIPTION DRUG LABEL 1 0049-0050 SOLUTION, CONCENTRATE 20 mg ORAL NDA 20 sections
Zoloft HUMAN PRESCRIPTION DRUG LABEL 1 0049-4900 TABLET, FILM COATED 50 mg ORAL NDA 20 sections
Zoloft HUMAN PRESCRIPTION DRUG LABEL 1 0049-4910 TABLET, FILM COATED 100 mg ORAL NDA 20 sections
Zoloft HUMAN PRESCRIPTION DRUG LABEL 1 0049-4960 TABLET, FILM COATED 25 mg ORAL NDA 20 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9580 TABLET, FILM COATED 100 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9581 TABLET, FILM COATED 50 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9582 TABLET, FILM COATED 25 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0143-9654 TABLET, FILM COATED 100 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0143-9655 TABLET, FILM COATED 50 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0143-9656 TABLET, FILM COATED 25 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-6558 TABLET 25 mg ORAL ANDA 14 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-6559 TABLET 50 mg ORAL ANDA 14 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-6560 TABLET 100 mg ORAL ANDA 14 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-7989 TABLET, FILM COATED 25 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-7990 TABLET, FILM COATED 50 mg ORAL ANDA 15 sections
Sertraline HUMAN PRESCRIPTION DRUG LABEL 1 0615-7991 TABLET, FILM COATED 100 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-694 SOLUTION 20 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13107-011 TABLET 25 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13107-012 TABLET 50 mg ORAL ANDA 15 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13107-013 TABLET 100 mg ORAL ANDA 15 sections
ZOLOFT HUMAN PRESCRIPTION DRUG LABEL 1 16590-250 TABLET, FILM COATED 50 mg ORAL NDA 15 sections
ZOLOFT HUMAN PRESCRIPTION DRUG LABEL 1 16590-251 TABLET, FILM COATED 100 mg ORAL NDA 15 sections
SERTRALINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-416 TABLET 100 mg ORAL ANDA 14 sections
SERTRALINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-457 TABLET 50 mg ORAL ANDA 14 sections
SERTRALINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-700 TABLET 25 mg ORAL ANDA 14 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-601 SOLUTION 20 mg ORAL ANDA 20 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-611 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-612 TABLET, FILM COATED 50 mg ORAL ANDA 20 sections
Sertraline Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16714-613 TABLET, FILM COATED 100 mg ORAL ANDA 20 sections
SERTRALINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16729-215 TABLET, FILM COATED 25 mg ORAL ANDA 20 sections