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

Stem definitionDrug idCAS RN
psychoactive 1816 85650-52-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mirtazapine
  • mepirzapin
  • mepirzepine
  • mirtabene
  • mirtazepine
  • mirtazipine
A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
  • Molecular weight: 265.36
  • Formula: C17H19N3
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 19.37
  • ALOGS: -2.38
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.83 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.15 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 14, 1996 FDA ORGANON USA INC

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
Intentional overdose 677.94 10.03 722 99309 61782 50443311
Serotonin syndrome 528.86 10.03 418 99613 24295 50480798
Intentional self-injury 522.90 10.03 404 99627 22708 50482385
Suicide attempt 507.53 10.03 567 99464 51165 50453928
Toxicity to various agents 479.59 10.03 1197 98834 211302 50293791
Drug abuse 453.51 10.03 575 99456 59271 50445822
Sopor 414.09 10.03 331 99700 19548 50485545
Completed suicide 380.78 10.03 819 99212 131070 50374023
Suicidal ideation 365.12 10.03 497 99534 54888 50450205
Drug interaction 351.02 10.03 1026 99005 198595 50306498
Electrocardiogram QT prolonged 347.18 10.03 469 99562 51417 50453676
Overdose 294.23 10.03 625 99406 99102 50405991
Hyponatraemia 291.16 10.03 609 99422 95530 50409563
Somnolence 267.79 10.03 792 99239 154193 50350900
Agitation 251.09 10.03 409 99622 52975 50452118
Joint swelling 213.88 10.03 109 99922 245177 50259916
Systemic lupus erythematosus 213.81 10.03 17 100014 140605 50364488
Drug ineffective 208.03 10.03 876 99155 818457 49686636
Pemphigus 206.13 10.03 7 100024 120159 50384934
Rheumatoid arthritis 201.98 10.03 74 99957 202476 50302617
Restlessness 190.73 10.03 242 99789 24931 50480162
Treatment failure 190.10 10.03 24 100007 137613 50367480
Arthropathy 186.26 10.03 42 99989 157864 50347229
Depressed level of consciousness 185.86 10.03 353 99678 51600 50453493
Neuroleptic malignant syndrome 185.54 10.03 163 99868 10967 50494126
Tremor 183.11 10.03 571 99460 114332 50390761
Infusion related reaction 179.35 10.03 56 99975 169501 50335592
Disorientation 179.35 10.03 281 99750 35203 50469890
Muscle rigidity 178.14 10.03 151 99880 9678 50495415
Inappropriate antidiuretic hormone secretion 175.43 10.03 170 99861 12973 50492120
Rash 173.47 10.03 380 99651 437091 50068002
Confusional state 171.57 10.03 775 99256 185153 50319940
Tachycardia 171.33 10.03 509 99522 99254 50405839
Swelling 168.09 10.03 94 99937 200778 50304315
Glossodynia 164.93 10.03 18 100013 115551 50389542
Alopecia 160.29 10.03 149 99882 244898 50260195
Contraindicated product administered 159.68 10.03 48 99983 148910 50356183
Coma 157.90 10.03 348 99683 56531 50448562
Dissociation 157.17 10.03 81 99950 2210 50502883
Fall 151.60 10.03 1156 98875 333776 50171317
Sinusitis 149.76 10.03 75 99956 170483 50334610
Disturbance in attention 148.02 10.03 240 99791 30946 50474147
Depersonalisation/derealisation disorder 142.82 10.03 62 99969 1136 50503957
Synovitis 136.26 10.03 38 99993 123827 50381266
Abdominal discomfort 135.45 10.03 155 99876 231486 50273607
Pain 130.79 10.03 645 99386 578258 49926835
Mydriasis 128.02 10.03 130 99901 10497 50494596
Akathisia 126.24 10.03 115 99916 8114 50496979
Dyskinesia 124.93 10.03 209 99822 27652 50477441
Gastric pH decreased 122.64 10.03 47 99984 615 50504478
Nasopharyngitis 119.51 10.03 123 99908 192804 50312289
Drug intolerance 119.22 10.03 155 99876 218949 50286144
Therapeutic product effect decreased 117.65 10.03 61 99970 135989 50369104
Anxiety 116.55 10.03 673 99358 176933 50328160
Nightmare 116.11 10.03 151 99880 15935 50489158
Restless legs syndrome 115.96 10.03 150 99881 15747 50489346
Derealisation 114.56 10.03 51 99980 995 50504098
Feeling of despair 106.65 10.03 60 99971 1958 50503135
Hypersensitivity 104.42 10.03 165 99866 214996 50290097
Peripheral swelling 103.70 10.03 154 99877 205782 50299311
Depressed mood 102.23 10.03 215 99816 33808 50471285
Drug hypersensitivity 101.77 10.03 215 99816 250795 50254298
Dysarthria 101.69 10.03 227 99804 37176 50467917
Arthralgia 101.67 10.03 484 99547 438218 50066875
Urinary retention 101.19 10.03 184 99847 26006 50479087
Cogwheel rigidity 99.83 10.03 55 99976 1722 50503371
Aggression 98.15 10.03 161 99870 20955 50484138
Hallucination 96.70 10.03 255 99776 46402 50458691
Drug withdrawal syndrome 95.38 10.03 175 99856 24906 50480187
Pericarditis 94.61 10.03 20 100011 78669 50426424
Delirium 94.14 10.03 223 99808 37969 50467124
Mania 87.55 10.03 108 99923 10808 50494285
Seizure 87.51 10.03 462 99569 117412 50387681
Helicobacter infection 84.83 10.03 3 100028 49699 50455394
Hyperhidrosis 84.00 10.03 375 99656 89051 50416042
Injection site pain 83.09 10.03 59 99972 110965 50394128
Withdrawal syndrome 82.95 10.03 135 99896 17455 50487638
General physical health deterioration 82.72 10.03 523 99508 141911 50363182
Dystonia 81.51 10.03 109 99922 11817 50493276
Psychotic disorder 81.44 10.03 151 99880 21661 50483432
Discomfort 80.57 10.03 58 99973 108322 50396771
Hallucination, visual 80.56 10.03 129 99902 16453 50488640
Urticaria 79.73 10.03 83 99948 129478 50375615
Rheumatoid factor negative 77.95 10.03 33 99998 567 50504526
Product use issue 77.95 10.03 109 99922 149366 50355727
Duodenal ulcer perforation 76.99 10.03 3 100028 45608 50459485
Tardive dyskinesia 73.38 10.03 81 99950 7198 50497895
H1N1 influenza 72.47 10.03 43 99988 1554 50503539
Schizophrenia 72.31 10.03 81 99950 7316 50497777
Impaired healing 72.04 10.03 24 100007 69762 50435331
Poisoning 70.67 10.03 104 99927 12325 50492768
Parkinsonism 70.10 10.03 87 99944 8760 50496333
Drooling 69.69 10.03 56 99975 3328 50501765
Myoclonus 65.46 10.03 109 99922 14361 50490732
Folliculitis 64.81 10.03 3 100028 39222 50465871
Depression 64.28 10.03 552 99479 164871 50340222
Pleurothotonus 61.58 10.03 36 99995 1265 50503828
Intestinal pseudo-obstruction 61.56 10.03 30 100001 724 50504369
Loss of consciousness 61.06 10.03 384 99647 103969 50401124
Maternal exposure during pregnancy 60.47 10.03 142 99889 159636 50345457
Depressive symptom 59.71 10.03 50 99981 3150 50501943
Mood swings 57.75 10.03 109 99922 15845 50489248
Injection site erythema 57.14 10.03 39 99992 74897 50430196
Hallucination, auditory 57.04 10.03 87 99944 10641 50494452
Parosmia 56.61 10.03 56 99975 4380 50500713
Psoriatic arthropathy 56.43 10.03 12 100019 47020 50458073
Infection 56.10 10.03 166 99865 172788 50332305
Incontinence 55.97 10.03 83 99948 9902 50495191
Hyperkinesia 55.41 10.03 35 99996 1417 50503676
Feeling jittery 54.46 10.03 87 99944 11073 50494020
Wound 54.28 10.03 78 99953 105716 50399377
Sedation 54.21 10.03 158 99873 30452 50474641
Hypertonia 54.16 10.03 52 99979 3921 50501172
Pruritus 52.83 10.03 336 99695 283232 50221861
Lower respiratory tract infection 52.06 10.03 67 99964 95134 50409959
Injection site pruritus 51.26 10.03 9 100022 40402 50464691
Pallor 50.31 10.03 129 99902 23070 50482023
Accidental overdose 50.25 10.03 116 99915 19417 50485676
Drug dependence 49.36 10.03 116 99915 19643 50485450
Psychomotor retardation 49.00 10.03 46 99985 3372 50501721
Asphyxia 48.94 10.03 57 99974 5370 50499723
Fatigue 48.52 10.03 1049 98982 706552 49798541
Speech disorder 47.88 10.03 167 99864 35381 50469712
Knee arthroplasty 47.67 10.03 7 100024 35839 50469254
Muscle injury 47.65 10.03 8 100023 37103 50467990
Arthritis 47.45 10.03 61 99970 86660 50418433
Hepatic enzyme increased 47.39 10.03 128 99903 137252 50367841
Extrapyramidal disorder 47.13 10.03 84 99947 11686 50493407
Abnormal dreams 47.00 10.03 74 99957 9303 50495790
Headache 46.94 10.03 712 99319 505823 49999270
Cardiac arrest 46.57 10.03 304 99727 83347 50421746
Feeling of body temperature change 46.47 10.03 50 99981 4317 50500776
Irritable bowel syndrome 46.04 10.03 22 100009 51419 50453674
Blister 45.80 10.03 61 99970 85357 50419736
Cough 45.36 10.03 285 99746 240979 50264114
Gestational diabetes 44.67 10.03 64 99967 7401 50497692
Hallucinations, mixed 43.70 10.03 47 99984 4056 50501037
Gastrointestinal disorder 43.37 10.03 75 99956 94381 50410712
C-reactive protein abnormal 43.26 10.03 3 100028 27806 50477287
Muscle disorder 43.15 10.03 48 99983 4302 50500791
Rhabdomyolysis 43.10 10.03 172 99859 38855 50466238
Delusion 43.05 10.03 76 99955 10493 50494600
Polydipsia 42.80 10.03 41 99990 3083 50502010
Pain in extremity 42.68 10.03 340 99691 272525 50232568
Nasal congestion 42.58 10.03 24 100007 51096 50453997
Device expulsion 42.36 10.03 4 100027 28818 50476275
Intentional product use issue 42.19 10.03 54 99977 76864 50428229
Altered state of consciousness 41.62 10.03 116 99915 21794 50483299
Off label use 41.52 10.03 674 99357 473752 50031341
Acute motor-sensory axonal neuropathy 41.31 10.03 17 100014 271 50504822
Menstrual disorder 41.26 10.03 47 99984 4323 50500770
Chorea 40.68 10.03 28 100003 1312 50503781
Hypertonia neonatal 40.51 10.03 16 100015 228 50504865
Poisoning deliberate 40.43 10.03 63 99968 7849 50497244
Panic attack 40.35 10.03 106 99925 19236 50485857
Abnormal behaviour 40.26 10.03 107 99924 19551 50485542
Product dose omission issue 40.02 10.03 207 99824 183631 50321462
Sleep paralysis 39.96 10.03 20 100011 512 50504581
Major depression 39.71 10.03 58 99973 6826 50498267
Therapeutic product ineffective 39.65 10.03 27 100004 1243 50503850
Psychomotor hyperactivity 39.34 10.03 68 99963 9233 50495860
Decreased appetite 39.28 10.03 586 99445 200337 50304756
Product administration error 39.12 10.03 106 99925 19593 50485500
Impulsive behaviour 38.55 10.03 28 100003 1430 50503663
Anger 38.04 10.03 75 99956 11258 50493835
Ventricular fibrillation 38.04 10.03 72 99959 10487 50494606
Persecutory delusion 37.87 10.03 34 99997 2353 50502740
Sleep disorder 37.44 10.03 217 99814 57066 50448027
Unresponsive to stimuli 37.15 10.03 139 99892 30470 50474623
Dysphagia 36.25 10.03 270 99761 77248 50427845
Hypoaesthesia oral 36.01 10.03 71 99960 10657 50494436
Back pain 35.39 10.03 272 99759 219758 50285335
Galactorrhoea 35.08 10.03 40 99991 3683 50501410
Panic reaction 34.74 10.03 39 99992 3530 50501563
Cyanosis 34.56 10.03 86 99945 15098 50489995
Stomatitis 34.51 10.03 95 99936 101249 50403844
Aphasia 34.25 10.03 129 99902 28365 50476728
Hip arthroplasty 34.07 10.03 9 100022 30420 50474673
Injection site bruising 34.03 10.03 15 100016 36753 50468340
Erythema 33.49 10.03 162 99869 146252 50358841
Aspiration 33.16 10.03 63 99968 9201 50495892
Intentional product misuse 33.16 10.03 181 99850 46553 50458540
Hypophagia 32.89 10.03 125 99906 27603 50477490
Opisthotonus 32.73 10.03 15 100016 314 50504779
Epilepsy 32.30 10.03 105 99926 21462 50483631
Product prescribing error 32.25 10.03 103 99928 20858 50484235
Abulia 31.92 10.03 16 100015 411 50504682
Fracture 31.85 10.03 89 99942 16744 50488349
Paranoia 31.78 10.03 66 99965 10282 50494811
Tonic clonic movements 31.00 10.03 23 100008 1214 50503879
Drug withdrawal syndrome neonatal 30.75 10.03 27 100004 1814 50503279
Ballismus 30.69 10.03 10 100021 78 50505015
Bradypnoea 30.63 10.03 34 99997 3040 50502053
Miosis 30.52 10.03 49 99982 6261 50498832
Syncope 30.20 10.03 324 99707 102678 50402415
Injection site swelling 30.19 10.03 23 100008 41750 50463343
Coma scale abnormal 30.17 10.03 42 99989 4729 50500364
Histrionic personality disorder 30.08 10.03 9 100022 51 50505042
Self-injurious ideation 30.05 10.03 29 100002 2200 50502893
Herpes zoster 30.01 10.03 59 99972 70727 50434366
Psoriasis 29.69 10.03 57 99974 68943 50436150
Irritability 29.58 10.03 123 99908 28303 50476790
Therapeutic product effect incomplete 29.53 10.03 88 99943 91427 50413666
Hypokalaemia 29.24 10.03 284 99747 87708 50417385
Generalised tonic-clonic seizure 29.08 10.03 116 99915 26194 50478899
Respiratory arrest 29.02 10.03 127 99904 29882 50475211
Cardio-respiratory arrest 28.86 10.03 194 99837 53698 50451395
Circulatory collapse 28.72 10.03 96 99935 19904 50485189
Autonomic nervous system imbalance 28.40 10.03 29 100002 2356 50502737
Chemical burn of oral cavity 28.34 10.03 9 100022 64 50505029
Immune reconstitution inflammatory syndrome 28.29 10.03 44 99987 5472 50499621
Sensory loss 28.17 10.03 53 99978 7685 50497408
Paralysis 27.48 10.03 56 99975 8608 50496485
Language disorder 27.45 10.03 25 100006 1763 50503330
Cognitive disorder 27.44 10.03 165 99866 43958 50461135
Rhonchi 27.38 10.03 28 100003 2279 50502814
Blood prolactin increased 27.03 10.03 32 99999 3067 50502026
Crush syndrome 26.95 10.03 10 100021 119 50504974
Urinary hesitation 26.61 10.03 26 100005 2003 50503090
Acute psychosis 26.45 10.03 27 100004 2193 50502900
Ill-defined disorder 26.38 10.03 42 99989 54612 50450481
Helplessness 26.23 10.03 12 100019 250 50504843
Swollen tongue 25.32 10.03 118 99913 28512 50476581
Agranulocytosis 24.94 10.03 96 99935 21325 50483768
Norepinephrine increased 24.71 10.03 8 100023 61 50505032
Asthma 24.64 10.03 92 99939 89245 50415848
Social avoidant behaviour 24.59 10.03 29 100002 2768 50502325
Injection site reaction 24.57 10.03 38 99993 49994 50455099
Neonatal hypoxia 24.55 10.03 14 100017 469 50504624
Visceral congestion 24.24 10.03 12 100019 300 50504793
Agitation neonatal 24.02 10.03 14 100017 489 50504604
Phagophobia 23.96 10.03 7 100024 36 50505057
Sudden death 23.79 10.03 54 99977 8937 50496156
Haematemesis 23.59 10.03 113 99918 27612 50477481
Pyelonephritis 23.37 10.03 74 99957 14915 50490178
Progressive multifocal leukoencephalopathy 23.10 10.03 62 99969 11395 50493698
Facial nerve disorder 22.96 10.03 14 100017 532 50504561
Sensorimotor disorder 22.92 10.03 13 100018 431 50504662
CYP3A4 polymorphism 22.80 10.03 8 100023 80 50505013
Tachycardia paroxysmal 22.78 10.03 11 100020 260 50504833
Psychotic symptom 22.74 10.03 19 100012 1193 50503900
Orgasm abnormal 22.71 10.03 8 100023 81 50505012
Injection site haemorrhage 22.63 10.03 7 100024 21339 50483754
Salivary hypersecretion 22.58 10.03 44 99987 6547 50498546
Cerebral ventricle dilatation 22.54 10.03 17 100014 920 50504173
Respiratory disorder neonatal 22.48 10.03 17 100014 924 50504169
Alkalosis hypochloraemic 22.43 10.03 9 100022 134 50504959
Upper respiratory tract infection 22.26 10.03 62 99969 65836 50439257
On and off phenomenon 22.18 10.03 20 100011 1392 50503701
Non-cardiogenic pulmonary oedema 22.16 10.03 14 100017 567 50504526
Orthostatic hypotension 22.15 10.03 116 99915 29365 50475728
Platelet count decreased 22.13 10.03 113 99918 100613 50404480
Osteoporosis 22.12 10.03 34 99997 44845 50460248
Osteoarthritis 22.11 10.03 66 99965 68540 50436553
Incoherent 22.06 10.03 34 99997 4196 50500897
Suicidal behaviour 21.86 10.03 25 100006 2309 50502784
Thirst 21.84 10.03 58 99973 10592 50494501
Emotional disorder 21.83 10.03 62 99969 11774 50493319
Abnormal weight gain 21.70 10.03 20 100011 1432 50503661
Radial nerve palsy 21.51 10.03 13 100018 486 50504607
Thymus disorder 21.45 10.03 10 100021 218 50504875
Giant cell arteritis 21.44 10.03 22 100009 1798 50503295
Pneumonia aspiration 21.27 10.03 119 99912 30885 50474208
Breast discomfort 21.07 10.03 12 100019 401 50504692
Fungal infection 21.02 10.03 17 100014 29948 50475145
Neuropathy peripheral 21.00 10.03 109 99922 96648 50408445
Bradykinesia 20.99 10.03 32 99999 3911 50501182
Affective disorder 20.77 10.03 37 99994 5144 50499949
Cerebellar syndrome 20.72 10.03 29 100002 3282 50501811
Mutism 20.60 10.03 19 100012 1362 50503731
Hypotonia 20.58 10.03 48 99983 8086 50497007
Medication error 20.56 10.03 132 99899 35972 50469121
Gamma-glutamyltransferase increased 20.52 10.03 114 99917 29509 50475584
Natural killer cell count decreased 20.52 10.03 6 100025 31 50505062
Therapy non-responder 20.37 10.03 44 99987 50978 50454115
Infantile vomiting 20.32 10.03 8 100023 113 50504980
Euphoric mood 20.32 10.03 32 99999 4023 50501070
Hyperthermia 20.12 10.03 46 99985 7650 50497443
Blood sodium decreased 20.07 10.03 89 99942 21058 50484035
Cerebral mass effect 19.97 10.03 15 100016 807 50504286
Stoma site discharge 19.91 10.03 18 100013 1257 50503836
Blood pressure increased 19.81 10.03 168 99863 132964 50372129
Bradyphrenia 19.79 10.03 40 99991 6112 50498981
Postmortem blood drug level increased 19.67 10.03 13 100018 569 50504524
Apathy 19.60 10.03 45 99986 7503 50497590
Bradycardia neonatal 19.58 10.03 15 100016 831 50504262
Thinking abnormal 19.51 10.03 52 99979 9515 50495578
Hepatocellular injury 19.43 10.03 102 99929 25845 50479248
Akinesia 19.27 10.03 19 100012 1480 50503613
Hallucination, synaesthetic 19.23 10.03 6 100025 40 50505053
Neonatal seizure 19.22 10.03 11 100020 371 50504722
Activation syndrome 19.14 10.03 9 100022 200 50504893
Purple glove syndrome 18.98 10.03 9 100022 204 50504889
Foetal exposure during pregnancy 18.76 10.03 105 99926 27254 50477839
Cataract 18.71 10.03 41 99990 47259 50457834
Retinal detachment 18.51 10.03 35 99996 5094 50499999
Sialoadenitis 18.47 10.03 18 100013 1382 50503711
Nephrolithiasis 18.36 10.03 25 100006 34668 50470425
Mental impairment 18.36 10.03 59 99972 11985 50493108
Tachyphrenia 18.32 10.03 17 100014 1228 50503865
Mental disorder 18.26 10.03 89 99942 21902 50483191
Drop attacks 18.16 10.03 13 100018 649 50504444
Vitamin B12 decreased 18.13 10.03 25 100006 2790 50502303
Skin exfoliation 18.01 10.03 24 100007 33588 50471505
Tinnitus 18.00 10.03 106 99925 28026 50477067
Illusion 17.92 10.03 15 100016 944 50504149
Red blood cell sedimentation rate increased 17.90 10.03 19 100012 29397 50475696
Acute abdomen 17.88 10.03 18 100013 1438 50503655
Cellulitis orbital 17.83 10.03 11 100020 427 50504666
Rhinorrhoea 17.81 10.03 48 99983 51535 50453558
Tongue movement disturbance 17.75 10.03 9 100022 237 50504856
Pyroglutamic acidosis 17.71 10.03 11 100020 432 50504661
Serum serotonin increased 17.65 10.03 8 100023 163 50504930
Spina bifida 17.56 10.03 13 100018 684 50504409
Suspected suicide 17.44 10.03 35 99996 5322 50499771
Agonal rhythm 17.40 10.03 5 100026 24 50505069
Snoring 17.37 10.03 27 100004 3357 50501736
Drug dose titration not performed 17.25 10.03 11 100020 453 50504640
Compulsive shopping 17.21 10.03 13 100018 705 50504388
Brief psychotic disorder with marked stressors 17.19 10.03 6 100025 59 50505034
Cytomegalovirus infection 17.14 10.03 7 100024 17955 50487138
Bundle branch block right 17.14 10.03 32 99999 4613 50500480
Respiratory distress 17.14 10.03 21 100010 30468 50474625
Negative thoughts 17.13 10.03 14 100017 852 50504241
Febrile neutropenia 16.99 10.03 118 99913 97549 50407544
Tearfulness 16.98 10.03 28 100003 3659 50501434
Merycism 16.81 10.03 8 100023 183 50504910
Reduced facial expression 16.52 10.03 18 100013 1576 50503517
Chest pain 16.51 10.03 248 99783 176634 50328459
Dementia 16.47 10.03 69 99962 15928 50489165
Joint range of motion decreased 16.43 10.03 8 100023 18504 50486589
Aptyalism 16.40 10.03 11 100020 494 50504599
Status epilepticus 16.36 10.03 61 99970 13345 50491748
Medulloblastoma 16.33 10.03 5 100026 31 50505062
Alcoholism 16.28 10.03 18 100013 1602 50503491
Skin ulcer 16.24 10.03 28 100003 35290 50469803
Bursitis 16.24 10.03 12 100019 22123 50482970
Binge eating 16.24 10.03 10 100021 387 50504706
Personality disorder 16.22 10.03 30 100001 4294 50500799
Pulmonary renal syndrome 16.17 10.03 10 100021 390 50504703
Dry mouth 16.12 10.03 176 99855 56002 50449091
Vertigo 16.10 10.03 165 99866 51667 50453426
Inflammation 16.09 10.03 58 99973 56854 50448239
Empty sella syndrome 16.07 10.03 5 100026 33 50505060
Sneezing 16.01 10.03 4 100027 14040 50491053
Anaphylactic reaction 16.01 10.03 54 99977 54001 50451092
Bulimia nervosa 16.01 10.03 10 100021 397 50504696
Stoma site inflammation 16.01 10.03 10 100021 397 50504696
Injection site rash 15.94 10.03 6 100025 16171 50488922
Premature delivery 15.89 10.03 14 100017 23649 50481444
Obsessive-compulsive symptom 15.81 10.03 5 100026 35 50505058
Respiratory depression 15.80 10.03 56 99975 11954 50493139
Hypothermia 15.79 10.03 56 99975 11960 50493133
Myocardial infarction 15.77 10.03 107 99924 88920 50416173
COVID-19 15.68 10.03 44 99987 46618 50458475
Cardiac failure congestive 15.66 10.03 100 99931 84282 50420811
Drowning 15.65 10.03 10 100021 413 50504680
Neck pain 15.58 10.03 59 99972 57008 50448085
Homicidal ideation 15.55 10.03 18 100013 1684 50503409
Gastrooesophageal reflux disease 15.54 10.03 88 99943 76340 50428753
Premature labour 15.52 10.03 54 99977 11422 50493671
Cardiac hypertrophy 15.52 10.03 14 100017 975 50504118
Parkinsonian gait 15.25 10.03 10 100021 432 50504661
Aspergillus test positive 15.25 10.03 9 100022 322 50504771
Pulse absent 15.17 10.03 31 100000 4775 50500318
Decubitus ulcer 15.15 10.03 47 99984 9371 50495722
Resuscitation 15.14 10.03 14 100017 1007 50504086
Blood cholesterol increased 15.13 10.03 57 99974 55158 50449935
Parkinson's disease 15.09 10.03 15 100016 1180 50503913
Post-traumatic stress disorder 15.08 10.03 29 100002 4274 50500819
Hyperreflexia 14.97 10.03 32 99999 5086 50500007
Hypotension 14.95 10.03 588 99443 234881 50270212
Stupor 14.90 10.03 26 100005 3557 50501536
Faecaloma 14.87 10.03 39 99992 7069 50498024
Therapeutic response decreased 14.81 10.03 46 99985 47185 50457908
Loss of libido 14.80 10.03 15 100016 1208 50503885
Pneumonia 14.73 10.03 605 99426 377796 50127297
Neglect of personal appearance 14.73 10.03 6 100025 93 50505000
Substance abuse 14.71 10.03 28 100003 4096 50500997
Basophil count decreased 14.62 10.03 6 100025 95 50504998
Product quality issue 14.62 10.03 24 100007 30834 50474259
Palmar-plantar erythrodysaesthesia syndrome 14.61 10.03 11 100020 20087 50485006
Enterococcus test positive 14.53 10.03 14 100017 1060 50504033
Granulocytopenia neonatal 14.51 10.03 4 100027 16 50505077
Viral infection 14.51 10.03 23 100008 29963 50475130
Antidepressant drug level increased 14.45 10.03 8 100023 253 50504840
Psychiatric decompensation 14.44 10.03 15 100016 1243 50503850
Drug reaction with eosinophilia and systemic symptoms 14.43 10.03 101 99930 28323 50476770
Dyspraxia 14.39 10.03 8 100023 255 50504838
Vasodilatation 14.32 10.03 20 100011 2259 50502834
Skull fracture 14.32 10.03 13 100018 913 50504180
Mixed anxiety and depressive disorder 14.29 10.03 7 100024 171 50504922
Spontaneous haemorrhage 14.22 10.03 8 100023 261 50504832
No adverse event 14.21 10.03 28 100003 33550 50471543
Balance disorder 14.20 10.03 207 99824 70383 50434710
Vagus nerve disorder 14.18 10.03 6 100025 103 50504990
Intrusive thoughts 14.14 10.03 7 100024 175 50504918
Shared psychotic disorder 14.13 10.03 4 100027 18 50505075
Developmental hip dysplasia 14.12 10.03 15 100016 1276 50503817
Catatonia 14.11 10.03 26 100005 3710 50501383
Refusal of treatment by patient 14.10 10.03 31 100000 5022 50500071
Pulmonary vein occlusion 14.07 10.03 6 100025 105 50504988
Productive cough 14.05 10.03 55 99976 52639 50452454
Logorrhoea 14.02 10.03 20 100011 2304 50502789
Sinus tachycardia 14.01 10.03 81 99950 21273 50483820
Interstitial lung disease 13.86 10.03 56 99975 53120 50451973
B-lymphocyte count increased 13.82 10.03 6 100025 110 50504983
Blood pressure diastolic decreased 13.80 10.03 8 100023 16773 50488320
Influenza 13.76 10.03 112 99919 89426 50415667
Dystrophic calcification 13.72 10.03 6 100025 112 50504981
Orthostatic intolerance 13.71 10.03 13 100018 965 50504128
Flushing 13.71 10.03 77 99954 66938 50438155
False positive investigation result 13.69 10.03 10 100021 515 50504578
Stoma site hypergranulation 13.69 10.03 8 100023 281 50504812
Indifference 13.67 10.03 6 100025 113 50504980
Intestinal mucosal atrophy 13.61 10.03 3 100028 3 50505090
Compulsive sexual behaviour 13.51 10.03 5 100026 59 50505034
Congenital hand malformation 13.48 10.03 8 100023 289 50504804
Dysdiadochokinesis 13.48 10.03 6 100025 117 50504976
Retrograde amnesia 13.46 10.03 9 100022 402 50504691
Diarrhoea 13.42 10.03 992 99039 587484 49917609
Fluid retention 13.42 10.03 53 99978 50596 50454497
Polydipsia psychogenic 13.36 10.03 5 100026 61 50505032
Paranasal sinus inflammation 13.34 10.03 9 100022 408 50504685
Basal cell carcinoma 13.22 10.03 16 100015 23340 50481753
Optic nerve disorder 13.20 10.03 11 100020 688 50504405
Hyperacusis 13.12 10.03 17 100014 1787 50503306
Bronchitis 13.11 10.03 137 99894 104022 50401071
Long QT syndrome 12.95 10.03 22 100009 2945 50502148
Rabbit syndrome 12.93 10.03 8 100023 312 50504781
Selective eating disorder 12.91 10.03 17 100014 1815 50503278
Gait disturbance 12.89 10.03 388 99643 149617 50355476
Maternal drugs affecting foetus 12.89 10.03 30 100001 5047 50500046
Lower limb fracture 12.89 10.03 6 100025 14240 50490853
Insomnia 12.87 10.03 444 99587 174421 50330672
Systemic infection 12.83 10.03 19 100012 2264 50502829
Essential tremor 12.79 10.03 12 100019 879 50504214
Increased appetite 12.78 10.03 41 99990 8320 50496773
Skin necrosis 12.58 10.03 3 100028 10864 50494229
Nail avulsion 12.57 10.03 6 100025 138 50504955
Dreamy state 12.53 10.03 4 100027 29 50505064
Glassy eyes 12.49 10.03 5 100026 74 50505019
Chemical burns of eye 12.49 10.03 5 100026 74 50505019
Kussmaul respiration 12.48 10.03 7 100024 227 50504866
Sinus congestion 12.46 10.03 6 100025 13965 50491128
Gambling 12.43 10.03 7 100024 229 50504864
Fibula agenesis 12.40 10.03 3 100028 6 50505087
Phaeochromocytoma 12.40 10.03 9 100022 459 50504634
Visual acuity reduced transiently 12.38 10.03 6 100025 143 50504950
Transfusion 12.36 10.03 5 100026 12900 50492193
Tendonitis 12.32 10.03 9 100022 16696 50488397
Lipohypertrophy 12.32 10.03 10 100021 603 50504490
Abdominal rigidity 12.30 10.03 16 100015 1688 50503405
Injection site warmth 12.30 10.03 6 100025 13860 50491233
Peripheral paralysis 12.25 10.03 5 100026 78 50505015
Polyneuropathy 12.23 10.03 52 99979 12079 50493014
Poor feeding infant 12.21 10.03 7 100024 237 50504856
Bipolar I disorder 12.14 10.03 15 100016 1503 50503590
Agoraphobia 12.13 10.03 8 100023 349 50504744
Formication 12.08 10.03 24 100007 3622 50501471
Dyspnoea at rest 12.08 10.03 24 100007 3623 50501470
Tenosynovitis 12.06 10.03 3 100028 10562 50494531
Haemoptysis 12.01 10.03 20 100011 25553 50479540
Cerebellar haematoma 11.97 10.03 8 100023 357 50504736
Motor dysfunction 11.93 10.03 39 99992 7992 50497101
Extensor plantar response 11.91 10.03 13 100018 1141 50503952
Inappropriate affect 11.84 10.03 11 100020 796 50504297
Snake bite 11.80 10.03 3 100028 8 50505085
Antiphospholipid antibodies 11.77 10.03 6 100025 160 50504933
C-reactive protein increased 11.72 10.03 80 99951 66394 50438699
Disseminated intravascular coagulation 11.67 10.03 10 100021 17125 50487968
Staphylococcal infection 11.66 10.03 34 99997 35582 50469511
Anticholinergic syndrome 11.65 10.03 16 100015 1779 50503314
Migraine 11.64 10.03 94 99937 75186 50429907
Macular degeneration 11.63 10.03 7 100024 14381 50490712
Product confusion 11.54 10.03 3 100028 9 50505084
Generalised anxiety disorder 11.48 10.03 16 100015 1804 50503289
Freezing phenomenon 11.47 10.03 12 100019 1003 50504090
Product complaint 11.45 10.03 49 99982 11417 50493676
Failure to thrive 11.43 10.03 33 99998 6325 50498768
Product monitoring error 11.42 10.03 20 100011 2744 50502349
Tic 11.34 10.03 13 100018 1204 50503889
Potentiating drug interaction 11.32 10.03 24 100007 3792 50501301
Somnambulism 11.32 10.03 28 100003 4896 50500197
Upper gastrointestinal haemorrhage 11.30 10.03 62 99969 15973 50489120
Mucosal inflammation 11.29 10.03 41 99990 40101 50464992
Injection site urticaria 11.28 10.03 5 100026 12212 50492881
Central nervous system inflammation 11.24 10.03 6 100025 176 50504917
Anaphylactic shock 11.20 10.03 14 100017 20141 50484952
Paraesthesia 11.15 10.03 314 99717 119929 50385164
Sinus disorder 11.15 10.03 12 100019 18446 50486647
Bipolar disorder 11.13 10.03 34 99997 6723 50498370
Heart rate decreased 11.13 10.03 36 99995 36461 50468632
Infantile apnoea 11.10 10.03 11 100020 862 50504231
Antipsychotic drug level below therapeutic 11.02 10.03 7 100024 286 50504807
Pyrexia 11.02 10.03 627 99404 379576 50125517
Rash pruritic 10.89 10.03 53 99978 47793 50457300
Sleep terror 10.89 10.03 10 100021 713 50504380
Somatic delusion 10.88 10.03 9 100022 557 50504536
Post viral fatigue syndrome 10.83 10.03 7 100024 295 50504798
Ear pain 10.79 10.03 25 100006 28258 50476835
Blood pressure systolic increased 10.78 10.03 35 99996 35414 50469679
Secretion discharge 10.76 10.03 3 100028 9788 50495305
Creatinine renal clearance decreased 10.75 10.03 5 100026 11876 50493217
Skin lesion 10.71 10.03 23 100008 26704 50478389
Neuropsychiatric symptoms 10.71 10.03 9 100022 570 50504523
Ear infection 10.70 10.03 22 100009 25948 50479145
Adrenal cyst 10.68 10.03 5 100026 110 50504983
Arachnoid cyst 10.63 10.03 6 100025 197 50504896
Pulmonary haematoma 10.60 10.03 4 100027 50 50505043
Hypernatraemia 10.59 10.03 32 99999 6289 50498804
Acne 10.49 10.03 14 100017 19581 50485512
Hyperphagia 10.46 10.03 14 100017 1518 50503575
Pharyngeal erythema 10.46 10.03 14 100017 1518 50503575
Exostosis 10.40 10.03 5 100026 11648 50493445
Compulsions 10.39 10.03 6 100025 206 50504887
Musculoskeletal stiffness 10.37 10.03 185 99846 128296 50376797
Ocular hyperaemia 10.36 10.03 15 100016 20277 50484816
Decreased interest 10.36 10.03 20 100011 2956 50502137
Bradycardia 10.35 10.03 182 99849 64244 50440849
Dyspnoea 10.35 10.03 937 99094 546671 49958422
Poverty of thought content 10.34 10.03 3 100028 15 50505078
Oropharyngeal pain 10.34 10.03 101 99930 77700 50427393
Gamma-glutamyltransferase abnormal 10.34 10.03 6 100025 208 50504885
Abdominal pain upper 10.30 10.03 238 99793 159071 50346022
Glomerular filtration rate decreased 10.28 10.03 48 99983 11604 50493489
Electrocardiogram T wave inversion 10.25 10.03 21 100010 3240 50501853
Rash erythematous 10.20 10.03 35 99996 34817 50470276
Acquired epidermolysis bullosa 10.19 10.03 4 100027 56 50505037
Ataxia 10.19 10.03 54 99977 13732 50491361
Communication disorder 10.18 10.03 17 100014 2244 50502849
Postural tremor 10.16 10.03 6 100025 215 50504878
Bifascicular block 10.10 10.03 5 100026 125 50504968
Large for dates baby 10.08 10.03 8 100023 467 50504626
Drug withdrawal headache 10.07 10.03 4 100027 58 50505035
Granulocyte percentage 10.07 10.03 4 100027 58 50505035
Arrhythmia 10.06 10.03 105 99926 33027 50472066
HIV-associated neurocognitive disorder 10.06 10.03 5 100026 126 50504967
Dissociative disorder 10.06 10.03 6 100025 219 50504874
Blood pressure diastolic abnormal 10.05 10.03 3 100028 9358 50495735
Crying 10.04 10.03 72 99959 20344 50484749

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 460.59 10.57 1153 67984 172508 29332882
Intentional overdose 429.51 10.57 489 68648 38039 29467351
Intentional self-injury 356.29 10.57 268 68869 12193 29493197
Completed suicide 333.15 10.57 684 68453 89562 29415828
Suicide attempt 325.56 10.57 400 68737 33710 29471680
Agitation 269.75 10.57 453 68684 50851 29454539
Serotonin syndrome 243.60 10.57 250 68887 17262 29488128
Suicidal ideation 238.84 10.57 347 68790 34369 29471021
Somnolence 213.63 10.57 590 68547 93365 29412025
Confusional state 203.46 10.57 709 68428 127168 29378222
Overdose 203.44 10.57 523 68614 79296 29426094
Drug abuse 177.92 10.57 498 68639 79385 29426005
Sopor 175.92 10.57 169 68968 10765 29494625
Coma 148.78 10.57 302 68835 39148 29466242
Restlessness 147.39 10.57 218 68919 21927 29483463
Anxiety 127.58 10.57 464 68673 84901 29420489
Extrapyramidal disorder 111.36 10.57 132 69005 10699 29494691
Sedation 108.21 10.57 166 68971 17239 29488151
Aggression 106.49 10.57 248 68889 35293 29470097
Restless legs syndrome 103.10 10.57 103 69034 6881 29498509
Fall 102.07 10.57 736 68401 176442 29328948
Drug interaction 98.64 10.57 793 68344 196592 29308798
Delirium 95.96 10.57 254 68883 39143 29466247
Nightmare 93.22 10.57 124 69013 11293 29494097
Hallucination, visual 91.64 10.57 142 68995 14873 29490517
Drug withdrawal syndrome 88.07 10.57 154 68983 17830 29487560
Neuroleptic malignant syndrome 86.62 10.57 144 68993 16004 29489386
Accidental overdose 86.61 10.57 151 68986 17442 29487948
Intrusive thoughts 84.26 10.57 29 69108 226 29505164
Febrile neutropenia 82.94 10.57 84 69053 112156 29393234
Depressed mood 82.04 10.57 142 68995 16306 29489084
Electrocardiogram QT prolonged 80.03 10.57 225 68912 35912 29469478
Mania 78.40 10.57 99 69038 8564 29496826
Tremor 77.51 10.57 359 68778 73179 29432211
Parkinsonism 72.02 10.57 87 69050 7191 29498199
Wrong patient received product 71.76 10.57 52 69085 2230 29503160
Withdrawal syndrome 71.38 10.57 107 69030 10885 29494505
Insomnia 68.99 10.57 398 68739 88363 29417027
Dyskinesia 67.91 10.57 147 68990 19914 29485476
Logorrhoea 67.12 10.57 50 69087 2238 29503152
Bradyphrenia 65.64 10.57 64 69073 4150 29501240
Disorientation 65.57 10.57 184 68953 29331 29476059
Depressed level of consciousness 64.86 10.57 212 68925 36730 29468660
Abnormal behaviour 63.45 10.57 156 68981 22971 29482419
Pneumonia aspiration 61.10 10.57 207 68930 36530 29468860
Hallucination, auditory 60.33 10.57 92 69045 9501 29495889
Myoclonus 60.07 10.57 110 69027 13199 29492191
Muscle twitching 59.21 10.57 83 69054 7943 29497447
Depression 58.64 10.57 370 68767 84777 29420613
Paranoia 58.31 10.57 92 69045 9785 29495605
Psychotic disorder 56.58 10.57 138 68999 20216 29485174
Hallucination 55.24 10.57 229 68908 44483 29460907
Psychomotor hyperactivity 54.83 10.57 81 69056 8132 29497258
Akathisia 54.69 10.57 73 69064 6669 29498721
Interstitial lung disease 52.77 10.57 35 69102 57683 29447707
Apathy 51.88 10.57 68 69069 6103 29499287
Delusion 51.00 10.57 93 69044 11123 29494267
Homicidal ideation 50.31 10.57 44 69093 2480 29502910
Tachycardia 50.06 10.57 315 68822 72095 29433295
Antidepressant drug level above therapeutic 49.93 10.57 18 69119 163 29505227
Panic attack 49.76 10.57 78 69059 8248 29497142
Inappropriate antidiuretic hormone secretion 48.89 10.57 90 69047 10842 29494548
Pruritus 47.53 10.57 129 69008 116720 29388670
Tachyphrenia 47.03 10.57 31 69106 1138 29504252
Muscle rigidity 46.60 10.57 81 69056 9330 29496060
Sleep disorder 46.50 10.57 144 68993 24242 29481148
Disturbance in attention 46.06 10.57 132 69005 21292 29484098
Bradykinesia 45.73 10.57 48 69089 3399 29501991
Poisoning 45.61 10.57 83 69054 9910 29495480
Hypomania 45.55 10.57 39 69098 2136 29503254
On and off phenomenon 45.41 10.57 37 69100 1891 29503499
Platelet count decreased 45.29 10.57 112 69025 104560 29400830
Loss of consciousness 45.03 10.57 312 68825 73744 29431646
Myocardial infarction 43.20 10.57 124 69013 110172 29395218
Illusion 42.03 10.57 24 69113 678 29504712
Priapism 41.74 10.57 52 69085 4436 29500954
Off label use 40.66 10.57 479 68658 300321 29205069
Nasopharyngitis 40.34 10.57 48 69089 59617 29445773
Illness anxiety disorder 39.78 10.57 15 69122 156 29505234
Antipsychotic drug level above therapeutic 39.04 10.57 27 69110 1074 29504316
Poisoning deliberate 38.95 10.57 57 69080 5674 29499716
Disease progression 38.36 10.57 84 69053 81832 29423558
Neuropathy peripheral 38.31 10.57 67 69070 70960 29434430
Systemic infection 36.70 10.57 34 69103 2067 29503323
Mood swings 36.67 10.57 63 69074 7188 29498202
Altered state of consciousness 36.58 10.57 116 69021 19773 29485617
Pulmonary congestion 36.37 10.57 86 69051 12350 29493040
Cough 36.00 10.57 163 68974 126564 29378826
Dystonia 35.96 10.57 74 69063 9675 29495715
Anger 35.94 10.57 79 69058 10811 29494579
Pneumonia 35.89 10.57 530 68607 319642 29185748
Vestibular disorder 35.40 10.57 25 69112 1029 29504361
Renal failure 35.23 10.57 150 68987 118449 29386941
Pyrexia 34.38 10.57 470 68667 287152 29218238
Hyponatraemic coma 33.91 10.57 9 69128 24 29505366
Tardive dyskinesia 33.87 10.57 51 69086 5207 29500183
Analgesic drug level above therapeutic 33.81 10.57 15 69122 243 29505147
Hyponatraemia 33.77 10.57 272 68865 67361 29438029
Miosis 33.40 10.57 64 69073 7945 29497445
Atrial fibrillation 33.01 10.57 131 69006 105515 29399875
Drug dependence 32.93 10.57 116 69021 20865 29484525
Rheumatoid arthritis 32.92 10.57 17 69120 32135 29473255
Urogenital haemorrhage 32.73 10.57 18 69119 472 29504918
Accidental death 32.67 10.57 32 69105 2086 29503304
Persecutory delusion 32.38 10.57 32 69105 2109 29503281
Urinary retention 32.30 10.57 154 68983 31744 29473646
Mental disorder 32.21 10.57 84 69053 12821 29492569
Infusion related reaction 32.20 10.57 33 69104 43853 29461537
Blood creatine phosphokinase increased 32.02 10.57 183 68954 40461 29464929
Aptyalism 31.60 10.57 15 69122 286 29505104
Cardiac failure congestive 31.53 10.57 84 69053 76497 29428893
Rash 31.42 10.57 288 68849 189531 29315859
Thrombocytopenia 31.21 10.57 186 68951 134637 29370753
Respiratory arrest 30.87 10.57 131 69006 25702 29479688
Decreased gait velocity 30.75 10.57 12 69125 138 29505252
Arthralgia 30.56 10.57 196 68941 139421 29365969
Substance abuse 30.50 10.57 56 69081 6731 29498659
Product prescribing error 30.50 10.57 102 69035 17874 29487516
Rhabdomyolysis 30.05 10.57 244 68893 60564 29444826
Catatonia 29.73 10.57 44 69093 4424 29500966
Drug hypersensitivity 29.72 10.57 73 69064 68333 29437057
Irritability 29.37 10.57 116 69021 22036 29483354
Selective eating disorder 29.22 10.57 27 69110 1636 29503754
Injection site pain 29.21 10.57 20 69117 32426 29472964
Cytomegalovirus infection 29.11 10.57 9 69128 23206 29482184
Pleural effusion 28.75 10.57 80 69057 71828 29433562
Loss of libido 28.74 10.57 31 69106 2265 29503125
Asphyxia 27.96 10.57 47 69090 5268 29500122
Respiratory depression 27.79 10.57 82 69055 13441 29491949
Herpes zoster 27.76 10.57 18 69119 30034 29475356
Platypnoea 27.69 10.57 8 69129 32 29505358
Drug ineffective 27.61 10.57 643 68494 362527 29142863
Diarrhoea 27.58 10.57 581 68556 332117 29173273
Electrocardiogram abnormal 27.50 10.57 56 69081 7266 29498124
Stomatitis 27.12 10.57 28 69109 37085 29468305
Feelings of worthlessness 27.10 10.57 13 69124 254 29505136
Alcohol use 27.09 10.57 35 69102 3097 29502293
Oesophageal obstruction 26.85 10.57 15 69122 406 29504984
General physical health deterioration 26.66 10.57 362 68775 102495 29402895
Prescription drug used without a prescription 26.53 10.57 23 69114 1281 29504109
Dysarthria 26.22 10.57 142 68995 30769 29474621
Sarcopenia 26.13 10.57 14 69123 348 29505042
Feeling jittery 25.95 10.57 37 69100 3596 29501794
Hyperhidrosis 25.70 10.57 247 68890 64293 29441097
Macrophages increased 25.62 10.57 11 69126 164 29505226
Hyperreflexia 25.59 10.57 32 69105 2740 29502650
Hallucinations, mixed 25.58 10.57 30 69107 2403 29502987
Depersonalisation/derealisation disorder 24.82 10.57 16 69121 565 29504825
Asthma 24.21 10.57 26 69111 33823 29471567
Benign gastrointestinal neoplasm 24.18 10.57 10 69127 135 29505255
Mucosal inflammation 24.05 10.57 23 69114 31572 29473818
Dysphoria 24.03 10.57 27 69110 2065 29503325
Congenital cerebrovascular anomaly 23.80 10.57 6 69131 12 29505378
Sepsis 23.80 10.57 216 68921 142466 29362924
Postictal state 23.58 10.57 17 69120 723 29504667
Product monitoring error 23.57 10.57 30 69107 2615 29502775
Dementia with Lewy bodies 23.46 10.57 16 69121 622 29504768
Erythema 23.44 10.57 94 69043 75512 29429878
Urticaria 23.22 10.57 59 69078 54601 29450789
Depressive symptom 22.94 10.57 24 69113 1693 29503697
Product prescribing issue 22.57 10.57 20 69117 1147 29504243
Circulatory collapse 22.55 10.57 95 69042 18578 29486812
Pleurothotonus 22.53 10.57 19 69118 1019 29504371
Cold sweat 22.52 10.57 58 69079 8784 29496606
Slow speech 22.46 10.57 18 69119 898 29504492
IVth nerve disorder 22.09 10.57 6 69131 18 29505372
Arthritis 21.76 10.57 16 69121 25003 29480387
Suspected suicide 21.75 10.57 36 69101 3984 29501406
Cogwheel rigidity 21.49 10.57 20 69117 1223 29504167
Mood altered 21.49 10.57 54 69083 8057 29497333
Cardiac failure 21.30 10.57 104 69033 79183 29426207
Bipolar disorder 21.28 10.57 32 69105 3263 29502127
Dysgraphia 21.21 10.57 25 69112 2013 29503377
Septic shock 21.20 10.57 75 69062 62485 29442905
Acute kidney injury 21.14 10.57 466 68671 264801 29240589
Activation syndrome 20.58 10.57 8 69129 91 29505299
Pressure of speech 20.53 10.57 13 69124 445 29504945
Alcoholism 20.35 10.57 28 69109 2633 29502757
Hypertonia 20.33 10.57 34 69103 3795 29501595
Parkinsonian gait 20.27 10.57 13 69124 455 29504935
Congenital hyperinsulinaemic hypoglycaemia 20.24 10.57 4 69133 0 29505390
Postoperative respiratory failure 20.19 10.57 8 69129 96 29505294
Homicide 20.17 10.57 17 69120 911 29504479
Nervousness 19.93 10.57 65 69072 11241 29494149
Bezoar 19.89 10.57 16 69121 803 29504587
Acute psychosis 19.76 10.57 22 69115 1665 29503725
Perforated ulcer 19.68 10.57 9 69128 157 29505233
Neutropenia 19.59 10.57 205 68932 131506 29373884
Urinary hesitation 19.56 10.57 25 69112 2188 29503202
Feeling guilty 19.32 10.57 11 69126 309 29505081
Respiratory disorder neonatal 19.18 10.57 20 69117 1405 29503985
Seizure 19.15 10.57 315 68822 92808 29412582
Helplessness 18.99 10.57 7 69130 68 29505322
Verbal abuse 18.89 10.57 9 69128 173 29505217
Sinusitis 18.88 10.57 32 69105 34318 29471072
Psychomotor skills impaired 18.86 10.57 27 69110 2634 29502756
Myelodysplastic syndrome 18.83 10.57 9 69128 17785 29487605
Myelosuppression 18.83 10.57 3 69134 12224 29493166
Hanging 18.71 10.57 8 69129 118 29505272
Peripheral swelling 18.67 10.57 81 69056 63658 29441732
Tubulointerstitial nephritis 18.55 10.57 9 69128 17634 29487756
Joint swelling 18.54 10.57 57 69080 49573 29455817
COVID-19 18.49 10.57 35 69102 35979 29469411
Upper respiratory tract infection 18.48 10.57 22 69115 27327 29478063
Mental impairment 18.37 10.57 55 69082 9086 29496304
Amnestic disorder 18.17 10.57 9 69128 189 29505201
Eosinophilic myocarditis 18.14 10.57 12 69125 443 29504947
Respiratory tract infection 18.02 10.57 7 69130 15644 29489746
Hypervigilance 17.95 10.57 8 69129 131 29505259
Back pain 17.85 10.57 153 68984 102131 29403259
Acute myocardial infarction 17.83 10.57 56 69081 48382 29457008
Arachnoid cyst 17.79 10.57 9 69128 198 29505192
Derealisation 17.76 10.57 13 69124 566 29504824
Tracheal pain 17.75 10.57 6 69131 44 29505346
White blood cell count decreased 17.72 10.57 118 69019 83244 29422146
Dry skin 17.70 10.57 17 69120 23290 29482100
Sudden cardiac death 17.63 10.57 29 69108 3193 29502197
Eosinophilic pleural effusion 17.63 10.57 9 69128 202 29505188
Temperature regulation disorder 17.62 10.57 13 69124 573 29504817
Malignant neoplasm progression 17.54 10.57 101 69036 73758 29431632
Antipsychotic drug level increased 17.49 10.57 29 69108 3214 29502176
Fear of weight gain 17.48 10.57 4 69133 4 29505386
Hangover 17.43 10.57 16 69121 961 29504429
Inappropriate schedule of product administration 17.38 10.57 50 69087 44422 29460968
Electrocardiogram QRS complex prolonged 17.33 10.57 33 69104 4077 29501313
Implant site extravasation 17.25 10.57 11 69126 381 29505009
Haemoglobin decreased 17.22 10.57 166 68971 108209 29397181
Posture abnormal 17.22 10.57 22 69115 1925 29503465
Intentional product use issue 17.19 10.57 47 69090 42451 29462939
Alcohol interaction 17.10 10.57 26 69111 2677 29502713
Progressive multifocal leukoencephalopathy 17.09 10.57 52 69085 8667 29496723
Gait disturbance 16.93 10.57 253 68884 73096 29432294
Mastication disorder 16.92 10.57 17 69120 1143 29504247
Anaemia 16.57 10.57 351 68786 200600 29304790
Ejaculation failure 16.57 10.57 14 69123 753 29504637
Ataxia 16.54 10.57 64 69073 12039 29493351
Epilepsy 16.54 10.57 86 69051 18346 29487044
Osteonecrosis of jaw 16.50 10.57 9 69128 16501 29488889
Loose associations 16.48 10.57 6 69131 56 29505334
Hypersomnia 16.48 10.57 59 69078 10695 29494695
Nephrolithiasis 16.46 10.57 21 69116 25313 29480077
Tumour lysis syndrome 16.33 10.57 6 69131 13878 29491512
Intentional device misuse 16.33 10.57 8 69129 164 29505226
Urine sodium decreased 16.24 10.57 8 69129 166 29505224
Cellulitis 16.17 10.57 54 69083 45786 29459604
Sleep deficit 16.01 10.57 11 69126 433 29504957
Chest pain 15.95 10.57 176 68961 111797 29393593
Rapid eye movements sleep abnormal 15.94 10.57 8 69129 173 29505217
Blood creatinine increased 15.90 10.57 125 69012 84977 29420413
Hyporesponsive to stimuli 15.86 10.57 15 69122 936 29504454
Gout 15.79 10.57 10 69127 16901 29488489
Tricuspid valve sclerosis 15.65 10.57 5 69132 30 29505360
Ejaculation disorder 15.64 10.57 15 69122 953 29504437
Hyperkinesia 15.63 10.57 19 69118 1580 29503810
JC virus CSF test positive 15.53 10.57 7 69130 118 29505272
Stupor 15.42 10.57 25 69112 2719 29502671
Speech disorder 15.42 10.57 101 69036 23415 29481975
Small for dates baby 15.42 10.57 29 69108 3550 29501840
Loss of proprioception 15.24 10.57 10 69127 364 29505026
Drug withdrawal syndrome neonatal 15.24 10.57 28 69109 3367 29502023
Metabolic syndrome 15.22 10.57 18 69119 1455 29503935
Abdominal discomfort 15.20 10.57 59 69078 47844 29457546
Oesophageal haemorrhage 15.19 10.57 16 69121 1137 29504253
Balance disorder 15.17 10.57 140 68997 36030 29469360
Hyperbilirubinaemia 15.13 10.57 8 69129 14926 29490464
Acute myeloid leukaemia 15.10 10.57 10 69127 16503 29488887
Neonatal hyponatraemia 15.07 10.57 6 69131 73 29505317
Incoherent 15.02 10.57 31 69106 4061 29501329
Blood ethanol increased 15.01 10.57 11 69126 480 29504910
Obsessive-compulsive disorder 14.88 10.57 33 69104 4543 29500847
Palmar-plantar erythrodysaesthesia syndrome 14.82 10.57 8 69129 14751 29490639
Sinus bradycardia 14.77 10.57 60 69077 11543 29493847
Dementia 14.61 10.57 60 69077 11598 29493792
Abnormal weight gain 14.55 10.57 14 69123 893 29504497
Mumps 14.51 10.57 6 69131 81 29505309
Self esteem decreased 14.50 10.57 11 69126 506 29504884
Renal disorder 14.40 10.57 19 69118 22576 29482814
Lung disorder 14.31 10.57 31 69106 30331 29475059
Failure to thrive 14.29 10.57 45 69092 7639 29497751
Pancytopenia 14.24 10.57 125 69012 83043 29422347
Insulin resistance 14.19 10.57 11 69126 523 29504867
Neonatal respiratory distress syndrome 14.14 10.57 29 69108 3781 29501609
Multiple organ dysfunction syndrome 14.09 10.57 88 69049 63028 29442362
Housebound 14.07 10.57 8 69129 224 29505166
Thinking abnormal 14.02 10.57 35 69102 5201 29500189
Major depression 14.01 10.57 29 69108 3806 29501584
Sinus tachycardia 14.00 10.57 71 69066 14998 29490392
Arthropathy 13.87 10.57 18 69119 21536 29483854
Brain oedema 13.85 10.57 61 69076 12159 29493231
Respiratory tract haemorrhage 13.83 10.57 14 69123 950 29504440
Xanthoma 13.82 10.57 6 69131 92 29505298
Sensory disturbance 13.64 10.57 36 69101 5533 29499857
Splenomegaly 13.62 10.57 7 69130 13272 29492118
Renal impairment 13.60 10.57 123 69014 81210 29424180
Hepatic steatosis 13.59 10.57 70 69067 14876 29490514
Sepsis neonatal 13.55 10.57 8 69129 241 29505149
Spinal cord injury thoracic 13.54 10.57 6 69131 97 29505293
Limited symptom panic attack 13.52 10.57 5 69132 49 29505341
Rebound effect 13.51 10.57 20 69117 2011 29503379
Stoma site infection 13.50 10.57 12 69125 691 29504699
Consciousness fluctuating 13.49 10.57 14 69123 978 29504412
Locked-in syndrome 13.49 10.57 8 69129 243 29505147
Dyspnoea 13.39 10.57 626 68511 326106 29179284
Potentiating drug interaction 13.31 10.57 31 69106 4407 29500983
Abnormal dreams 13.31 10.57 41 69096 6879 29498511
Psychiatric decompensation 13.31 10.57 17 69120 1487 29503903
Alcohol poisoning 13.27 10.57 25 69112 3064 29502326
Basal cell carcinoma 13.23 10.57 12 69125 16898 29488492
Blood pressure increased 13.05 10.57 110 69027 73693 29431697
Fungal infection 12.91 10.57 8 69129 13677 29491713
Acute pulmonary oedema 12.89 10.57 40 69097 6739 29498651
Rash erythematous 12.88 10.57 19 69118 21543 29483847
Mitral valve sclerosis 12.85 10.57 6 69131 110 29505280
Drug reaction with eosinophilia and systemic symptoms 12.85 10.57 29 69108 27963 29477427
Erectile dysfunction 12.83 10.57 79 69058 17930 29487460
Body temperature abnormal 12.72 10.57 10 69127 485 29504905
Respiratory rate decreased 12.72 10.57 19 69118 1926 29503464
Sexual dysfunction 12.66 10.57 36 69101 5778 29499612
Neoplasm progression 12.54 10.57 15 69122 18597 29486793
Infant irritability 12.52 10.57 4 69133 24 29505366
Intentional product misuse 12.50 10.57 130 69007 34531 29470859
Abulia 12.44 10.57 10 69127 501 29504889
Electric shock 12.43 10.57 6 69131 119 29505271
Oedema peripheral 12.39 10.57 169 68968 103388 29402002
Bacteraemia 12.28 10.57 12 69125 16311 29489079
Pseudomonas infection 12.25 10.57 5 69132 10847 29494543
Light chain disease 12.25 10.57 6 69131 123 29505267
Polypectomy 12.22 10.57 10 69127 514 29504876
Cerebellar ataxia 12.19 10.57 13 69124 937 29504453
Hyperthermia 12.19 10.57 49 69088 9381 29496009
Gallbladder enlargement 12.18 10.57 13 69124 938 29504452
Non-alcoholic steatohepatitis 12.18 10.57 12 69125 788 29504602
Pelvic fracture 12.10 10.57 20 69117 2211 29503179
Jealous delusion 12.09 10.57 7 69130 203 29505187
Prostate cancer 12.08 10.57 26 69111 25501 29479889
Suspiciousness 12.01 10.57 8 69129 299 29505091
Inferior vena caval occlusion 11.99 10.57 4 69133 28 29505362
Fear 11.98 10.57 49 69088 9455 29495935
Dysaesthesia 11.97 10.57 19 69118 2031 29503359
Bronchopulmonary aspergillosis 11.95 10.57 7 69130 12337 29493053
Bladder dilatation 11.91 10.57 15 69122 1293 29504097
Nasal congestion 11.91 10.57 16 69121 18863 29486527
Pneumocystis jirovecii pneumonia 11.87 10.57 13 69124 16766 29488624
Neuroblastoma 11.86 10.57 6 69131 132 29505258
Wrong product administered 11.83 10.57 30 69107 4501 29500889
Ascites 11.68 10.57 45 69092 36574 29468816
Accidental poisoning 11.67 10.57 10 69127 548 29504842
Respiratory acidosis 11.66 10.57 29 69108 4299 29501091
Product dose omission issue 11.63 10.57 157 68980 96226 29409164
Productive cough 11.60 10.57 36 69101 31223 29474167
Hypotonia 11.56 10.57 39 69098 6863 29498527
Feeling abnormal 11.49 10.57 185 68952 54260 29451130
Formication 11.47 10.57 16 69121 1524 29503866
Gastrointestinal disorder 11.42 10.57 32 69105 28674 29476716
Panic disorder 11.41 10.57 14 69123 1176 29504214
JC polyomavirus test positive 11.40 10.57 10 69127 566 29504824
Agitated depression 11.39 10.57 7 69130 227 29505163
Mutism 11.37 10.57 11 69126 706 29504684
Contraindication to medical treatment 11.37 10.57 9 69128 441 29504949
Initial insomnia 11.36 10.57 22 69115 2753 29502637
Pneumonitis 11.35 10.57 31 69106 28013 29477377
Rash maculo-papular 11.28 10.57 25 69112 24264 29481126
Nasal discomfort 11.20 10.57 14 69123 1198 29504192
Hepatic failure 11.20 10.57 37 69100 31475 29473915
Hypersensitivity 11.18 10.57 75 69062 52828 29452562
Fluid retention 11.15 10.57 24 69113 23536 29481854
Pulmonary fibrosis 11.11 10.57 12 69125 15570 29489820
Suprapubic pain 11.06 10.57 8 69129 342 29505048
Psychotic symptom 10.99 10.57 15 69122 1399 29503991
Fear of disease 10.99 10.57 7 69130 242 29505148
Kidney congestion 10.94 10.57 7 69130 244 29505146
Dysstasia 10.91 10.57 51 69086 10423 29494967
Serum serotonin increased 10.90 10.57 5 69132 88 29505302
Frequent bowel movements 10.86 10.57 4 69133 9235 29496155
Product use issue 10.84 10.57 73 69064 51371 29454019
Diabetes insipidus 10.83 10.57 20 69117 2414 29502976
Shock 10.81 10.57 21 69116 21383 29484007
Stoma site induration 10.75 10.57 4 69133 40 29505350
Bronchitis 10.70 10.57 47 69090 36821 29468569
Drug abuser 10.69 10.57 26 69111 3801 29501589
Staphylococcal infection 10.62 10.57 34 69103 29206 29476184
Hypertrophic scar 10.59 10.57 3 69134 11 29505379
Tachypnoea 10.58 10.57 66 69071 15049 29490341
Localised infection 10.58 10.57 10 69127 13806 29491584
Bronchial aspiration procedure 10.57 10.57 4 69133 42 29505348

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 870.98 9.95 2262 142188 361251 63993031
Intentional overdose 728.38 9.95 951 143499 88993 64265289
Serotonin syndrome 685.49 9.95 623 143827 38659 64315623
Suicide attempt 674.05 9.95 813 143637 70194 64284088
Completed suicide 626.52 9.95 1482 142968 222932 64131350
Intentional self-injury 612.18 9.95 513 143937 28531 64325751
Drug abuse 532.44 9.95 1015 143435 131359 64222923
Suicidal ideation 531.40 9.95 699 143751 65843 64288439
Sopor 516.60 9.95 470 143980 29191 64325091
Overdose 447.23 9.95 1056 143394 158510 64195772
Agitation 426.97 9.95 734 143716 87633 64266649
Somnolence 415.01 9.95 1196 143254 202449 64151833
Drug interaction 360.92 9.95 1685 142765 360398 63993884
Electrocardiogram QT prolonged 351.52 9.95 635 143815 78813 64275469
Confusional state 334.72 9.95 1312 143138 259832 64094450
Restlessness 273.72 9.95 389 144061 39396 64314886
Coma 269.64 9.95 602 143848 87013 64267269
Hyponatraemia 262.14 9.95 829 143621 147510 64206772
Fall 228.56 9.95 1656 142794 415170 63939112
Neuroleptic malignant syndrome 228.51 9.95 281 144169 24715 64329567
Disorientation 225.26 9.95 429 144021 55399 64298883
Tremor 218.98 9.95 780 143670 147450 64206832
Restless legs syndrome 218.78 9.95 229 144221 16887 64337395
Inappropriate antidiuretic hormone secretion 196.41 9.95 246 144204 22043 64332239
Nightmare 191.89 9.95 236 144214 20757 64333525
Delirium 186.06 9.95 451 143999 68743 64285539
Depressed level of consciousness 185.97 9.95 499 143951 80937 64273345
Muscle rigidity 185.44 9.95 212 144238 17261 64337021
Anxiety 184.69 9.95 920 143530 201729 64152553
Rheumatoid arthritis 183.76 9.95 69 144381 164225 64190057
Infusion related reaction 179.11 9.95 72 144378 164395 64189887
Disturbance in attention 177.38 9.95 325 144125 40749 64313533
Aggression 173.98 9.95 345 144105 45887 64308395
Synovitis 166.65 9.95 15 144435 99075 64255207
Joint swelling 165.90 9.95 143 144307 215239 64139043
Tachycardia 158.05 9.95 709 143741 148870 64205412
Depressed mood 157.89 9.95 309 144141 40703 64313579
Drug withdrawal syndrome 157.69 9.95 265 144185 31026 64323256
Akathisia 154.31 9.95 158 144292 11352 64342930
Dyskinesia 151.92 9.95 297 144153 39091 64315191
Hallucination, visual 151.42 9.95 244 144206 27590 64326692
Nasopharyngitis 148.79 9.95 132 144318 195941 64158341
Rash 148.57 9.95 528 143922 458021 63896261
Mania 147.10 9.95 182 144268 16104 64338178
Extrapyramidal disorder 143.13 9.95 197 144253 19355 64334927
Depersonalisation/derealisation disorder 142.97 9.95 71 144379 1569 64352713
Arthropathy 140.02 9.95 48 144402 120919 64233363
Dissociation 139.70 9.95 86 144364 2925 64351357
Accidental overdose 135.49 9.95 258 144192 33299 64320983
Sinusitis 131.65 9.95 82 144368 145846 64208436
Withdrawal syndrome 130.61 9.95 208 144242 23284 64330998
Arthralgia 127.92 9.95 533 143917 441727 63912555
Psychotic disorder 126.45 9.95 255 144195 34323 64319959
Systemic lupus erythematosus 124.64 9.95 14 144436 77598 64276684
Parkinsonism 124.03 9.95 157 144293 14216 64340066
Drug ineffective 121.43 9.95 1251 143199 838996 63515286
Drug hypersensitivity 119.32 9.95 219 144231 237596 64116686
Sedation 118.72 9.95 277 144173 41185 64313097
Urinary retention 116.87 9.95 306 144144 48895 64305387
Swelling 116.63 9.95 112 144338 160106 64194176
Derealisation 116.52 9.95 60 144390 1435 64352847
Cogwheel rigidity 116.12 9.95 75 144375 2778 64351504
Hallucination 115.15 9.95 392 144058 72396 64281886
Myoclonus 111.29 9.95 201 144249 24917 64329365
Peripheral swelling 110.90 9.95 186 144264 208967 64145315
General physical health deterioration 110.40 9.95 810 143640 203615 64150667
Pemphigus 108.24 9.95 7 144443 60694 64293588
Alopecia 108.11 9.95 127 144323 165563 64188719
Dystonia 107.59 9.95 169 144281 18696 64335586
Gastric pH decreased 102.23 9.95 44 144406 691 64353591
Dysarthria 102.05 9.95 329 144121 59077 64295205
Poisoning 101.97 9.95 179 144271 21700 64332582
Mydriasis 99.84 9.95 146 144304 15166 64339116
Treatment failure 99.46 9.95 70 144380 116746 64237536
Feeling of despair 98.39 9.95 65 144385 2503 64351779
Loss of consciousness 98.04 9.95 618 143832 147747 64206535
Hyperhidrosis 96.43 9.95 542 143908 124378 64229904
Psychomotor hyperactivity 95.99 9.95 139 144311 14312 64339970
Injection site pain 95.86 9.95 66 144384 111342 64242940
Hallucination, auditory 95.57 9.95 151 144299 16788 64337494
Abdominal discomfort 94.02 9.95 165 144285 182157 64172125
Glossodynia 93.70 9.95 16 144434 64680 64289602
Intrusive thoughts 93.39 9.95 34 144416 333 64353949
Urticaria 92.83 9.95 116 144334 147201 64207081
Pain 91.27 9.95 797 143653 552714 63801568
Cough 91.11 9.95 358 144092 301790 64052492
Therapeutic product effect decreased 89.46 9.95 76 144374 115275 64239007
Drug intolerance 88.27 9.95 180 144270 187812 64166470
Mood swings 86.76 9.95 147 144303 17321 64336961
Abnormal behaviour 85.94 9.95 215 144235 33407 64320875
Seizure 84.26 9.95 651 143799 166241 64188041
Contraindicated product administered 82.46 9.95 72 144378 107757 64246525
Depression 82.26 9.95 696 143754 182595 64171687
Feeling jittery 82.15 9.95 110 144340 10525 64343757
Febrile neutropenia 82.03 9.95 187 144263 187470 64166812
Drug dependence 82.00 9.95 210 144240 33102 64321180
Tardive dyskinesia 80.37 9.95 101 144349 9077 64345205
Hypersensitivity 78.60 9.95 205 144245 196247 64158035
Delusion 78.33 9.95 143 144307 17871 64336411
Pruritus 78.01 9.95 397 144053 312003 64042279
Pleurothotonus 78.01 9.95 54 144396 2248 64352034
Hypertonia 77.93 9.95 83 144367 6242 64348040
Pneumonia aspiration 77.45 9.95 300 144150 58971 64295311
Paranoia 76.48 9.95 134 144316 16218 64338064
Logorrhoea 75.93 9.95 67 144383 3992 64350290
Depressive symptom 75.81 9.95 70 144380 4426 64349856
Off label use 74.89 9.95 984 143466 631822 63722460
Sleep disorder 74.61 9.95 298 144152 59411 64294871
Poisoning deliberate 74.59 9.95 119 144331 13339 64340943
Altered state of consciousness 72.56 9.95 218 144232 37684 64316598
Anger 69.77 9.95 126 144324 15615 64338667
Hallucinations, mixed 68.60 9.95 76 144374 5976 64348306
Rhabdomyolysis 66.85 9.95 392 144058 91334 64262948
Product prescribing error 66.71 9.95 202 144248 35067 64319215
Asphyxia 66.45 9.95 94 144356 9472 64344810
Respiratory arrest 65.85 9.95 264 144186 52721 64301561
Panic attack 65.54 9.95 145 144305 20808 64333474
Arthritis 65.25 9.95 55 144395 83759 64270523
Myocardial infarction 64.83 9.95 175 144275 165646 64188636
Bradyphrenia 64.71 9.95 92 144358 9314 64344968
Pericarditis 63.84 9.95 30 144420 62486 64291796
Incontinence 63.11 9.95 104 144346 11977 64342305
Abnormal dreams 60.76 9.95 94 144356 10262 64344020
On and off phenomenon 60.42 9.95 48 144402 2471 64351811
Impaired healing 60.25 9.95 30 144420 60443 64293839
Product use issue 60.15 9.95 159 144291 151556 64202726
Irritability 59.94 9.95 200 144250 36546 64317736
Injection site erythema 59.50 9.95 43 144407 70757 64283525
Homicidal ideation 59.41 9.95 53 144397 3204 64351078
Wrong patient received product 58.50 9.95 56 144394 3706 64350576
Injection site pruritus 57.86 9.95 8 144442 37818 64316464
Insomnia 57.60 9.95 687 143763 197149 64157133
Nasal congestion 57.36 9.95 31 144419 59627 64294655
Miosis 57.29 9.95 105 144345 13161 64341121
Illusion 55.97 9.95 38 144412 1532 64352750
Interstitial lung disease 55.46 9.95 83 144367 97649 64256633
Apathy 55.09 9.95 94 144356 11138 64343144
Folliculitis 55.04 9.95 3 144447 30074 64324208
Platelet count decreased 54.88 9.95 192 144258 167519 64186763
Erythema 54.21 9.95 225 144225 186845 64167437
Schizophrenia 54.16 9.95 93 144357 11075 64343207
Bradykinesia 53.99 9.95 70 144380 6490 64347792
H1N1 influenza 53.97 9.95 43 144407 2223 64352059
Psychomotor retardation 53.89 9.95 62 144388 5081 64349201
Drooling 53.85 9.95 63 144387 5256 64349026
Respiratory depression 53.82 9.95 144 144306 23299 64330983
Persecutory delusion 53.79 9.95 56 144394 4102 64350180
Feeling of body temperature change 53.78 9.95 60 144390 4754 64349528
Speech disorder 52.88 9.95 232 144218 48209 64306073
Product administration error 51.98 9.95 158 144292 27485 64326797
Antidepressant drug level above therapeutic 51.41 9.95 25 144425 527 64353755
Parosmia 50.42 9.95 57 144393 4583 64349699
Herpes zoster 50.23 9.95 62 144388 79125 64275157
Major depression 50.19 9.95 74 144376 7742 64346540
Pain in extremity 49.99 9.95 436 144014 302649 64051633
Substance abuse 49.90 9.95 81 144369 9211 64345071
Loss of libido 49.67 9.95 42 144408 2362 64351920
Pneumonia 49.24 9.95 920 143530 558656 63795626
Cardiac failure congestive 48.66 9.95 141 144309 130439 64223843
Back pain 48.64 9.95 344 144106 249827 64104455
Urinary hesitation 48.53 9.95 49 144401 3461 64350821
Intentional product use issue 48.50 9.95 87 144363 95277 64259005
Infection 47.78 9.95 232 144218 184648 64169634
Intestinal pseudo-obstruction 47.73 9.95 38 144412 1962 64352320
Tachyphrenia 47.70 9.95 37 144413 1839 64352443
Asthma 47.42 9.95 88 144362 95137 64259145
Helplessness 46.94 9.95 20 144430 306 64353976
Systemic infection 46.81 9.95 53 144397 4268 64350014
Stomatitis 46.44 9.95 111 144339 109494 64244788
Neuropathy peripheral 45.94 9.95 124 144326 117401 64236881
Acute psychosis 45.81 9.95 49 144401 3703 64350579
Epilepsy 45.67 9.95 172 144278 33359 64320923
Aptyalism 45.17 9.95 25 144425 694 64353588
Duodenal ulcer perforation 45.08 9.95 11 144439 34614 64319668
Cardiac arrest 44.82 9.95 535 143915 153529 64200753
Injection site bruising 44.62 9.95 13 144437 36360 64317922
Psoriatic arthropathy 43.83 9.95 21 144429 43260 64311022
Fatigue 43.40 9.95 1312 143138 747418 63606864
Mental disorder 43.19 9.95 144 144306 26301 64327981
Irritable bowel syndrome 42.92 9.95 15 144435 37354 64316928
Gastrointestinal disorder 42.84 9.95 85 144365 89624 64264658
Galactorrhoea 42.80 9.95 44 144406 3175 64351107
Discomfort 42.75 9.95 72 144378 80806 64273476
Cytomegalovirus infection 42.61 9.95 15 144435 37184 64317098
Hyperkinesia 41.69 9.95 39 144411 2507 64351775
Hepatic enzyme increased 41.67 9.95 150 144300 129793 64224489
Antipsychotic drug level above therapeutic 41.54 9.95 34 144416 1827 64352455
Diarrhoea 41.23 9.95 1269 143181 721435 63632847
Menstrual disorder 41.18 9.95 44 144406 3321 64350961
Knee arthroplasty 40.62 9.95 6 144444 26993 64327289
Injection site swelling 40.47 9.95 21 144429 41332 64312950
Abulia 40.20 9.95 25 144425 866 64353416
Priapism 40.16 9.95 47 144403 3923 64350359
Pyrexia 39.05 9.95 953 143497 557691 63796591
Intentional product misuse 38.68 9.95 286 144164 72009 64282273
Bronchitis 38.66 9.95 120 144330 108623 64245659
Thrombocytopenia 38.65 9.95 318 144132 223483 64130799
Unresponsive to stimuli 38.42 9.95 218 144232 50175 64304107
Maternal exposure during pregnancy 38.36 9.95 100 144350 95784 64258498
Incoherent 38.16 9.95 62 144388 7056 64347226
Blister 37.57 9.95 78 144372 80889 64273393
Product dose omission issue 37.25 9.95 269 144181 194478 64159804
Circulatory collapse 37.16 9.95 162 144288 33570 64320712
Myelosuppression 36.54 9.95 5 144445 23825 64330457
Abnormal weight gain 36.43 9.95 34 144416 2179 64352103
Device expulsion 36.07 9.95 3 144447 21133 64333149
Accidental death 35.86 9.95 43 144407 3682 64350600
Polydipsia 35.79 9.95 54 144396 5767 64348515
Osteoarthritis 35.72 9.95 54 144396 63282 64291000
Fungal infection 35.64 9.95 16 144434 34235 64320047
Upper respiratory tract infection 35.59 9.95 68 144382 72717 64281565
Fracture 35.07 9.95 107 144343 18648 64335634
Therapeutic product ineffective 34.52 9.95 28 144422 1485 64352797
Septic shock 34.28 9.95 121 144329 105316 64248966
Suspected suicide 34.26 9.95 66 144384 8588 64345694
Hyponatraemic coma 33.77 9.95 9 144441 26 64354256
Activation syndrome 33.72 9.95 15 144435 256 64354026
Acute motor-sensory axonal neuropathy 33.46 9.95 17 144433 395 64353887
Anaphylactic shock 33.44 9.95 13 144437 30315 64323967
Muscle disorder 33.43 9.95 48 144402 4903 64349379
Gestational diabetes 33.16 9.95 51 144399 5539 64348743
Product monitoring error 32.69 9.95 50 144400 5404 64348878
Hyperreflexia 32.68 9.95 58 144392 7090 64347192
Lower respiratory tract infection 32.51 9.95 106 144344 94508 64259774
Catatonia 32.51 9.95 60 144390 7560 64346722
Progressive multifocal leukoencephalopathy 32.23 9.95 102 144348 18130 64336152
Blood pressure increased 32.20 9.95 240 144210 172312 64181970
Social avoidant behaviour 31.98 9.95 45 144405 4512 64349770
Cognitive disorder 31.83 9.95 222 144228 54865 64299417
Illness anxiety disorder 31.74 9.95 14 144436 234 64354048
Muscle injury 31.43 9.95 10 144440 26427 64327855
Sleep paralysis 31.27 9.95 18 144432 540 64353742
Chest pain 31.16 9.95 358 144092 235622 64118660
Impulsive behaviour 31.15 9.95 34 144416 2629 64351653
Feelings of worthlessness 30.81 9.95 17 144433 469 64353813
Cataract 30.59 9.95 42 144408 51220 64303062
Decreased gait velocity 30.21 9.95 12 144438 152 64354130
Headache 30.05 9.95 930 143520 528537 63825745
Hypomania 29.97 9.95 49 144401 5605 64348677
Analgesic drug level above therapeutic 29.79 9.95 16 144434 418 64353864
Muscle twitching 29.74 9.95 102 144348 18896 64335386
Pallor 29.71 9.95 168 144282 38613 64315669
Hypoaesthesia oral 29.53 9.95 74 144376 11506 64342776
Feeling guilty 29.53 9.95 20 144430 803 64353479
Dysphagia 29.35 9.95 367 144083 106445 64247837
Hyperthermia 29.34 9.95 89 144361 15461 64338821
Coma scale abnormal 29.21 9.95 58 144392 7716 64346566
COVID-19 29.18 9.95 64 144386 65076 64289206
Sarcopenia 29.00 9.95 15 144435 362 64353920
Parkinsonian gait 28.97 9.95 20 144430 829 64353453
Hypotonia 28.96 9.95 72 144378 11140 64343142
Syncope 28.90 9.95 505 143945 157130 64197152
Language disorder 28.88 9.95 33 144417 2684 64351598
Blood creatine phosphokinase increased 28.72 9.95 227 144223 58331 64295951
Sepsis 28.66 9.95 354 144096 229987 64124295
Bipolar disorder 28.55 9.95 53 144397 6708 64347574
Mental impairment 28.49 9.95 91 144359 16252 64338030
Productive cough 28.03 9.95 78 144372 73125 64281157
Platypnoea 28.03 9.95 8 144442 32 64354250
Nephrolithiasis 27.91 9.95 34 144416 43649 64310633
Disease progression 27.91 9.95 194 144256 141486 64212796
Bradypnoea 27.74 9.95 45 144405 5114 64349168
Osteoporosis 27.69 9.95 32 144418 42048 64312234
Rhinorrhoea 27.62 9.95 58 144392 59911 64294371
Pleural effusion 27.62 9.95 168 144282 126391 64227891
Mucosal inflammation 27.61 9.95 62 144388 62522 64291760
Posture abnormal 27.49 9.95 36 144414 3370 64350912
Mutism 27.40 9.95 28 144422 2006 64352276
Serum serotonin increased 27.13 9.95 13 144437 265 64354017
Acute myeloid leukaemia 26.79 9.95 14 144436 27449 64326833
Thrombotic microangiopathy 26.74 9.95 3 144447 16652 64337630
Ejaculation failure 26.73 9.95 14 144436 347 64353935
Blood prolactin increased 26.50 9.95 36 144414 3492 64350790
Psoriasis 26.28 9.95 78 144372 71625 64282657
Generalised tonic-clonic seizure 26.27 9.95 166 144284 39691 64314591
Palmar-plantar erythrodysaesthesia syndrome 26.24 9.95 16 144434 28803 64325479
Malignant neoplasm progression 26.13 9.95 147 144303 112724 64241558
Dyspnoea 26.09 9.95 1330 143120 717344 63636938
Pressure of speech 26.01 9.95 20 144430 981 64353301
Multiple organ dysfunction syndrome 25.75 9.95 128 144322 101285 64252997
Basal cell carcinoma 25.55 9.95 19 144431 30819 64323463
Urogenital haemorrhage 25.54 9.95 17 144433 663 64353619
Thinking abnormal 25.54 9.95 70 144380 11486 64342796
Fluid retention 25.53 9.95 60 144390 59546 64294736
Electrocardiogram abnormal 25.29 9.95 77 144373 13404 64340878
Medication error 25.22 9.95 195 144255 49771 64304511
Crush syndrome 25.20 9.95 11 144439 179 64354103
Rash erythematous 25.05 9.95 44 144406 48589 64305693
Ataxia 25.04 9.95 107 144343 21977 64332305
Sudden death 24.85 9.95 100 144350 19996 64334286
Formication 24.80 9.95 39 144411 4318 64349964
Psychiatric decompensation 24.65 9.95 29 144421 2434 64351848
Erectile dysfunction 24.51 9.95 73 144377 12554 64341728
Ill-defined disorder 24.42 9.95 38 144412 44014 64310268
Macrophages increased 24.40 9.95 11 144439 194 64354088
Alcoholism 24.36 9.95 34 144416 3383 64350899
Benign gastrointestinal neoplasm 24.34 9.95 10 144440 139 64354143
Tonic clonic movements 24.33 9.95 26 144424 1963 64352319
Pyroglutamic acidosis 24.32 9.95 17 144433 719 64353563
Injection site haemorrhage 24.25 9.95 12 144438 24266 64330016
Stoma site discharge 24.21 9.95 24 144426 1658 64352624
Suicidal behaviour 24.06 9.95 31 144419 2856 64351426
Bursitis 24.04 9.95 9 144441 21476 64332806
Antipsychotic drug level increased 24.03 9.95 42 144408 5073 64349209
Akinesia 24.01 9.95 32 144418 3047 64351235
Blood pressure diastolic decreased 23.87 9.95 10 144440 22291 64331991
Stupor 23.86 9.95 46 144404 5989 64348293
Hip arthroplasty 23.79 9.95 9 144441 21342 64332940
Balance disorder 23.76 9.95 290 144160 83636 64270646
Transplant rejection 23.71 9.95 5 144445 17396 64336886
Chemical burn of oral cavity 23.40 9.95 8 144442 64 64354218
Premature labour 23.01 9.95 52 144398 7568 64346714
Increased appetite 22.96 9.95 62 144388 10084 64344198
Phagophobia 22.94 9.95 7 144443 37 64354245
Panic reaction 22.85 9.95 36 144414 3991 64350291
Oesophageal obstruction 22.69 9.95 17 144433 802 64353480
Mood altered 22.62 9.95 83 144367 15896 64338386
Norepinephrine increased 22.57 9.95 8 144442 72 64354210
Rhonchi 22.55 9.95 33 144417 3430 64350852
Chorea 22.47 9.95 25 144425 1975 64352307
IVth nerve disorder 22.35 9.95 6 144444 18 64354264
Cellulitis 22.21 9.95 121 144329 93536 64260746
Histrionic personality disorder 22.20 9.95 7 144443 42 64354240
Product prescribing issue 22.17 9.95 26 144424 2175 64352107
Agranulocytosis 22.04 9.95 154 144296 38075 64316207
Inappropriate schedule of product administration 22.01 9.95 119 144331 92167 64262115
Atrial fibrillation 22.01 9.95 261 144189 170828 64183454
Tumour lysis syndrome 21.99 9.95 8 144442 19432 64334850
Potentiating drug interaction 21.97 9.95 52 144398 7800 64346482
Alcohol use 21.89 9.95 38 144412 4564 64349718
Sensory loss 21.88 9.95 61 144389 10108 64344174
Inflammation 21.85 9.95 74 144376 65226 64289056
Cardio-respiratory arrest 21.68 9.95 325 144125 98068 64256214
Heart rate decreased 21.59 9.95 58 144392 55009 64299273
Somnambulism 21.33 9.95 40 144410 5101 64349181
Hallucination, synaesthetic 21.28 9.95 7 144443 49 64354233
Glassy eyes 21.22 9.95 9 144441 136 64354146
Hyporesponsive to stimuli 21.12 9.95 23 144427 1774 64352508
Opisthotonus 21.02 9.95 15 144435 656 64353626
Blood pressure systolic increased 21.00 9.95 50 144400 49403 64304879
Influenza 20.91 9.95 146 144304 106385 64247897
Gait disturbance 20.87 9.95 519 143931 171636 64182646
Anaemia 20.75 9.95 668 143782 378012 63976270
Acute myocardial infarction 20.71 9.95 83 144367 69635 64284647
Merycism 20.60 9.95 10 144440 210 64354072
Gastrooesophageal reflux disease 20.51 9.95 106 144344 83037 64271245
Stoma site infection 20.38 9.95 19 144431 1216 64353066
Myelodysplastic syndrome 20.37 9.95 19 144431 27560 64326722
Thymus disorder 20.22 9.95 10 144440 219 64354063
Hanging 20.16 9.95 8 144442 101 64354181
Congenital cerebrovascular anomaly 20.05 9.95 5 144445 10 64354272
Pulmonary congestion 20.01 9.95 106 144344 23774 64330508
Sinus tachycardia 19.95 9.95 132 144318 32056 64322226
Euphoric mood 19.92 9.95 45 144405 6546 64347736
Oropharyngeal pain 19.89 9.95 117 144333 88750 64265532
Ejaculation disorder 19.81 9.95 13 144437 495 64353787
Vestibular disorder 19.71 9.95 25 144425 2268 64352014
Bulimia nervosa 19.69 9.95 10 144440 232 64354050
Faecaloma 19.61 9.95 57 144393 9671 64344611
Obsessive-compulsive disorder 19.39 9.95 37 144413 4781 64349501
Breast discomfort 19.35 9.95 11 144439 322 64353960
Aspiration 19.29 9.95 82 144368 16803 64337479
Osteomyelitis 19.23 9.95 20 144430 27567 64326715
Alcohol interaction 19.21 9.95 35 144415 4366 64349916
Injection site reaction 19.17 9.95 48 144402 46616 64307666
Pseudomonas infection 19.17 9.95 8 144442 17875 64336407
Hypophagia 19.16 9.95 153 144297 39434 64314848
Postictal state 19.15 9.95 21 144429 1632 64352650
Rapid eye movements sleep abnormal 19.13 9.95 10 144440 247 64354035
Failure to thrive 19.12 9.95 59 144391 10345 64343937
CYP3A4 polymorphism 19.10 9.95 7 144443 70 64354212
White blood cell count decreased 19.08 9.95 244 144206 157593 64196689
Sleep terror 18.96 9.95 18 144432 1179 64353103
Bezoar 18.90 9.95 24 144426 2179 64352103
Neutropenia 18.87 9.95 401 144049 239223 64115059
Cold sweat 18.87 9.95 80 144370 16375 64337907
Tendonitis 18.83 9.95 11 144439 20271 64334011
Thirst 18.82 9.95 72 144378 14065 64340217
Obsessive-compulsive personality disorder 18.80 9.95 8 144442 122 64354160
Osteonecrosis of jaw 18.78 9.95 38 144412 39787 64314495
Binge eating 18.73 9.95 12 144438 438 64353844
Self-injurious ideation 18.73 9.95 29 144421 3168 64351114
Amnestic disorder 18.68 9.95 13 144437 546 64353736
Psychomotor skills impaired 18.62 9.95 32 144418 3813 64350469
Wound 18.58 9.95 98 144352 76379 64277903
Eosinophilic pleural effusion 18.56 9.95 10 144440 263 64354019
Coronary artery disease 18.55 9.95 71 144379 60362 64293920
Drug dose titration not performed 18.53 9.95 14 144436 669 64353613
Anaphylactic reaction 18.40 9.95 85 144365 68579 64285703
Stoma site inflammation 18.37 9.95 13 144437 561 64353721
Therapeutic product effect incomplete 18.32 9.95 146 144304 103336 64250946
Hypersomnia 18.25 9.95 90 144360 19627 64334655
Dementia with Lewy bodies 18.10 9.95 14 144436 693 64353589
Salivary hypersecretion 18.07 9.95 64 144386 12049 64342233
Natural killer cell count decreased 18.00 9.95 6 144444 44 64354238
Tracheal pain 18.00 9.95 6 144444 44 64354238
Paralysis 17.93 9.95 62 144388 11533 64342749
Skin necrosis 17.80 9.95 5 144445 14324 64339958
Renal failure 17.73 9.95 293 144157 181395 64172887
Tachypnoea 17.72 9.95 111 144339 26460 64327822
Cyanosis 17.65 9.95 97 144353 22058 64332224
Neglect of personal appearance 17.65 9.95 8 144442 143 64354139
Haemoglobin decreased 17.61 9.95 319 144131 194744 64159538
Conjunctivitis 17.57 9.95 12 144438 20342 64333940
Sputum discoloured 17.57 9.95 9 144441 17847 64336435
Electrocardiogram QRS complex prolonged 17.53 9.95 53 144397 9191 64345091
Negative thoughts 17.50 9.95 18 144432 1300 64352982
Emotional disorder 17.44 9.95 65 144385 12542 64341740
Mitral valve incompetence 17.26 9.95 19 144431 25519 64328763
Haemophagocytic lymphohistiocytosis 17.14 9.95 9 144441 17600 64336682
Postoperative respiratory failure 17.11 9.95 8 144442 154 64354128
Skin lesion 17.04 9.95 35 144415 36447 64317835
Disinhibition 17.02 9.95 23 144427 2220 64352062
Communication disorder 16.85 9.95 30 144420 3676 64350606
Treatment noncompliance 16.84 9.95 160 144290 43322 64310960
Blood osmolarity decreased 16.83 9.95 17 144433 1201 64353081
Haemoptysis 16.81 9.95 55 144395 48993 64305289
Antidepressant drug level decreased 16.76 9.95 4 144446 6 64354276
Sensorimotor disorder 16.68 9.95 14 144436 779 64353503
Stoma site erythema 16.59 9.95 17 144433 1222 64353060
Facial nerve disorder 16.55 9.95 13 144437 658 64353624
Wrong technique in product usage process 16.50 9.95 82 144368 64892 64289390
Loose associations 16.46 9.95 6 144444 59 64354223
Anorgasmia 16.44 9.95 15 144435 934 64353348
Respiratory acidosis 16.39 9.95 54 144396 9801 64344481
Swollen tongue 16.32 9.95 134 144316 34820 64319462
Decreased interest 16.32 9.95 28 144422 3332 64350950
Respiratory rate decreased 16.27 9.95 33 144417 4458 64349824
Drug screen positive 16.09 9.95 38 144412 5691 64348591
Status epilepticus 16.04 9.95 93 144357 21570 64332712
Hypervigilance 16.04 9.95 11 144439 451 64353831
Premature delivery 15.99 9.95 11 144439 18578 64335704
Rash maculo-papular 15.93 9.95 53 144397 46973 64307309
Dementia 15.93 9.95 90 144360 20676 64333606
Staphylococcal infection 15.91 9.95 59 144391 50619 64303663
Purple glove syndrome 15.91 9.95 9 144441 261 64354021
Tricuspid valve sclerosis 15.86 9.95 5 144445 30 64354252
Flushing 15.82 9.95 107 144343 78541 64275741
Acne 15.79 9.95 17 144433 23064 64331218
Homicide 15.79 9.95 16 144434 1135 64353147
Circadian rhythm sleep disorder 15.76 9.95 12 144438 580 64353702
Sensory disturbance 15.76 9.95 65 144385 13143 64341139
Antidepressant drug level increased 15.73 9.95 10 144440 360 64353922
Autonomic nervous system imbalance 15.73 9.95 31 144419 4101 64350181
Hepatic steatosis 15.64 9.95 121 144329 30886 64323396
Renal disorder 15.63 9.95 35 144415 35330 64318952
Frequent bowel movements 15.53 9.95 11 144439 18294 64335988
Gout 15.53 9.95 15 144435 21398 64332884
Dyspraxia 15.51 9.95 9 144441 274 64354008
Neoplasm progression 15.42 9.95 44 144406 40920 64313362
Rash pruritic 15.42 9.95 71 144379 57333 64296949
Haematemesis 15.36 9.95 167 144283 46832 64307450
Bacterial infection 15.33 9.95 20 144430 24930 64329352
Drowning 15.30 9.95 13 144437 736 64353546
Cerebral mass effect 15.30 9.95 19 144431 1687 64352595
Tachycardia paroxysmal 15.21 9.95 10 144440 382 64353900
Postmortem blood drug level increased 15.12 9.95 13 144437 748 64353534
Giant cell arteritis 15.07 9.95 22 144428 2281 64352001
Self esteem decreased 14.93 9.95 14 144436 903 64353379
Skin exfoliation 14.93 9.95 51 144399 44834 64309448
Diverticulitis 14.89 9.95 41 144409 38577 64315705
Neck pain 14.86 9.95 79 144371 61454 64292828
Psychotic symptom 14.84 9.95 21 144429 2117 64352165
Prostatism 14.69 9.95 6 144444 82 64354200
Joint range of motion decreased 14.68 9.95 13 144437 19330 64334952
Food craving 14.64 9.95 17 144433 1407 64352875
Therapy non-responder 14.62 9.95 87 144363 65812 64288470
Skin ulcer 14.60 9.95 50 144400 43924 64310358
Immune reconstitution inflammatory syndrome 14.59 9.95 61 144389 12409 64341873
Dissociative disorder 14.56 9.95 10 144440 411 64353871
Hypothermia 14.54 9.95 85 144365 19771 64334511
Hypervolaemia 14.50 9.95 41 144409 38244 64316038
Epstein-Barr virus infection 14.36 9.95 5 144445 12483 64341799
Disseminated intravascular coagulation 14.30 9.95 32 144418 32316 64321966
Blood sodium decreased 14.29 9.95 114 144336 29368 64324914
Thrombosis 14.26 9.95 96 144354 70546 64283736
Blood osmolarity increased 14.26 9.95 11 144439 542 64353740
JC virus CSF test positive 14.16 9.95 7 144443 153 64354129
Somatic delusion 14.14 9.95 12 144438 678 64353604
Ear infection 14.14 9.95 19 144431 23385 64330897
Sexual dysfunction 14.10 9.95 39 144411 6432 64347850
Second primary malignancy 14.08 9.95 5 144445 12332 64341950
Violence-related symptom 14.07 9.95 12 144438 683 64353599
Paresis 14.06 9.95 27 144423 3505 64350777
Hyperthyroidism 14.06 9.95 12 144438 18167 64336115
Somatic symptom disorder 13.94 9.95 19 144431 1849 64352433
Fear 13.91 9.95 85 144365 20086 64334196
Dry mouth 13.87 9.95 201 144249 60217 64294065
Emotional poverty 13.86 9.95 12 144438 697 64353585
Vertigo 13.82 9.95 197 144253 58814 64295468
Decreased appetite 13.80 9.95 766 143684 280523 64073759
Cardiac failure 13.73 9.95 211 144239 132162 64222120
Limited symptom panic attack 13.73 9.95 5 144445 49 64354233
Drop attacks 13.72 9.95 14 144436 1001 64353281
Aspergillus infection 13.69 9.95 10 144440 16369 64337913
Drug abuser 13.66 9.95 36 144414 5772 64348510
Suspiciousness 13.62 9.95 11 144439 580 64353702
Impaired self-care 13.57 9.95 21 144429 2292 64351990
Hepatotoxicity 13.57 9.95 45 144405 39917 64314365
Hypertension 13.55 9.95 460 143990 258801 64095481
Cytokine release syndrome 13.53 9.95 16 144434 20813 64333469
Wrong product administered 13.47 9.95 43 144407 7677 64346605
Sinus congestion 13.47 9.95 9 144441 15430 64338852
Orgasm abnormal 13.46 9.95 7 144443 171 64354111
Panic disorder 13.42 9.95 23 144427 2734 64351548
Oral herpes 13.37 9.95 18 144432 22134 64332148
Pulmonary oedema 13.33 9.95 249 144201 78425 64275857
Dysphoria 13.31 9.95 30 144420 4358 64349924
Indifference 13.29 9.95 8 144442 261 64354021
Sinus disorder 13.27 9.95 11 144439 16897 64337385
Dependence 13.26 9.95 20 144430 2135 64352147
Blood pressure systolic abnormal 13.25 9.95 3 144447 9939 64344343
Blood creatinine increased 13.23 9.95 219 144231 135563 64218719
Mass 13.20 9.95 9 144441 15267 64339015
Vasodilatation 13.17 9.95 24 144426 2994 64351288
Dysgraphia 13.17 9.95 26 144424 3445 64350837
Kidney congestion 13.16 9.95 8 144442 266 64354016
Lymphadenopathy 12.98 9.95 57 144393 46629 64307653
Poverty of thought content 12.98 9.95 5 144445 58 64354224
Personality disorder 12.96 9.95 31 144419 4680 64349602
Compulsive shopping 12.91 9.95 12 144438 765 64353517
Kussmaul respiration 12.72 9.95 9 144441 388 64353894
Injection site rash 12.66 9.95 10 144440 15732 64338550
Ballismus 12.63 9.95 7 144443 195 64354087
Dyspnoea exertional 12.60 9.95 105 144345 73625 64280657
Blood ethanol increased 12.59 9.95 11 144439 647 64353635
Resuscitation 12.57 9.95 19 144431 2032 64352250
Dystrophic calcification 12.53 9.95 6 144444 122 64354160
Antiphospholipid antibodies 12.53 9.95 6 144444 122 64354160
Spinal cord injury thoracic 12.53 9.95 6 144444 122 64354160
Pneumocystis jirovecii pneumonia 12.50 9.95 27 144423 27607 64326675
Polydipsia psychogenic 12.44 9.95 7 144443 201 64354081
Surgery 12.40 9.95 28 144422 28185 64326097
Visceral congestion 12.34 9.95 12 144438 810 64353472
Oedema 12.30 9.95 139 144311 91796 64262486
Drug resistance 12.28 9.95 39 144411 35063 64319219
Loss of proprioception 12.25 9.95 11 144439 671 64353611
Light chain disease 12.22 9.95 7 144443 208 64354074
Hangover 12.21 9.95 18 144432 1883 64352399
Agonal rhythm 12.20 9.95 5 144445 69 64354213
Cellulitis orbital 12.18 9.95 11 144439 676 64353606
Ascites 12.15 9.95 85 144365 61916 64292366
Pulmonary vein occlusion 12.15 9.95 6 144444 131 64354151
Reduced facial expression 12.14 9.95 19 144431 2094 64352188
Generalised anxiety disorder 12.11 9.95 18 144432 1897 64352385
Respiratory tract congestion 12.10 9.95 11 144439 16154 64338128
Pulmonary fibrosis 12.07 9.95 31 144419 29847 64324435
Ocular hyperaemia 12.00 9.95 20 144430 22544 64331738
Injection site urticaria 11.99 9.95 5 144445 11176 64343106
Eosinophilic myocarditis 11.97 9.95 12 144438 840 64353442
Spontaneous haemorrhage 11.97 9.95 9 144441 427 64353855
Increased tendency to bruise 11.93 9.95 3 144447 9252 64345030
Post-traumatic stress disorder 11.93 9.95 28 144422 4177 64350105
Arachnoid cyst 11.93 9.95 8 144442 316 64353966
Sneezing 11.87 9.95 10 144440 15241 64339041
Jealous delusion 11.87 9.95 7 144443 220 64354062
Migraine 11.76 9.95 87 144363 62590 64291692
Oxygen saturation decreased 11.75 9.95 169 144281 107007 64247275
B-lymphocyte count increased 11.75 9.95 6 144444 141 64354141
Foot fracture 11.74 9.95 14 144436 18143 64336139
Blood pressure diastolic abnormal 11.74 9.95 6 144444 11911 64342371
Haemolysis 11.73 9.95 5 144445 11034 64343248
Repetitive speech 11.73 9.95 8 144442 325 64353957
Pulmonary renal syndrome 11.72 9.95 10 144440 569 64353713
Accidental exposure to product 11.72 9.95 26 144424 26338 64327944
Oesophageal haemorrhage 11.65 9.95 16 144434 1568 64352714
Localised infection 11.65 9.95 32 144418 30129 64324153
Labelled drug-drug interaction medication error 11.64 9.95 87 144363 21975 64332307
Libido decreased 11.60 9.95 30 144420 4754 64349528
Abdominal rigidity 11.60 9.95 21 144429 2606 64351676
Bacteraemia 11.59 9.95 27 144423 26884 64327398
Inferior vena caval occlusion 11.59 9.95 4 144446 33 64354249
Bronchial aspiration procedure 11.59 9.95 7 144443 230 64354052
Alkalosis hypochloraemic 11.54 9.95 9 144441 451 64353831
Injection site warmth 11.54 9.95 8 144442 13454 64340828
Medulloblastoma 11.48 9.95 5 144445 81 64354201
COVID-19 pneumonia 11.46 9.95 12 144438 16492 64337790
Red blood cell sedimentation rate increased 11.43 9.95 34 144416 31201 64323081
Rabbit syndrome 11.41 9.95 8 144442 340 64353942
Implant site extravasation 11.40 9.95 11 144439 735 64353547
Sudden cardiac death 11.37 9.95 29 144421 4558 64349724
Pathogen resistance 11.37 9.95 7 144443 12536 64341746
Cytomegalovirus viraemia 11.36 9.95 5 144445 10823 64343459
Abscess 11.33 9.95 16 144434 19288 64334994
Pulmonary arterial hypertension 11.29 9.95 25 144425 25342 64328940
Sialoadenitis 11.27 9.95 16 144434 1617 64352665
Gamma-glutamyltransferase abnormal 11.22 9.95 9 144441 470 64353812
Drug withdrawal headache 11.20 9.95 5 144445 86 64354196
Perforated ulcer 11.20 9.95 10 144440 605 64353677
Disorganised speech 11.14 9.95 16 144434 1634 64352648
Adrenal cyst 11.10 9.95 5 144445 88 64354194
Insulin resistance 11.09 9.95 13 144437 1087 64353195
Rebound effect 11.08 9.95 30 144420 4887 64349395
Lung disorder 11.04 9.95 85 144365 60615 64293667
Electroencephalogram abnormal 10.99 9.95 31 144419 5172 64349110
Hypertriglyceridaemia 10.98 9.95 52 144398 11153 64343129
Mood disorder due to a general medical condition 10.91 9.95 4 144446 40 64354242
Immunodeficiency 10.89 9.95 12 144438 16112 64338170
Verbal abuse 10.89 9.95 7 144443 257 64354025
Memory impairment 10.88 9.95 260 144190 85422 64268860
Peritonitis 10.86 9.95 25 144425 24998 64329284
Enthesopathy 10.84 9.95 4 144446 9634 64344648
Hypernatraemia 10.83 9.95 55 144395 12134 64342148
Pharyngitis streptococcal 10.81 9.95 3 144447 8665 64345617
Coagulopathy 10.80 9.95 36 144414 31884 64322398
Tenderness 10.78 9.95 17 144433 19585 64334697
Drug eruption 10.74 9.95 43 144407 36093 64318189
Malignant melanoma 10.72 9.95 8 144442 12956 64341326
Cachexia 10.71 9.95 45 144405 9172 64345110
Wheezing 10.71 9.95 122 144328 80457 64273825
Paraesthesia 10.71 9.95 385 144065 134137 64220145
Carbon monoxide poisoning 10.70 9.95 7 144443 265 64354017
Shared psychotic disorder 10.66 9.95 4 144446 43 64354239
Haematotoxicity 10.61 9.95 8 144442 12888 64341394
Creatinine renal clearance decreased 10.58 9.95 10 144440 14411 64339871
Prescription drug used without a prescription 10.50 9.95 20 144430 2580 64351702
Amnesia 10.46 9.95 159 144291 48110 64306172
Nausea 10.41 9.95 1573 142877 784227 63570055
Lower limb fracture 10.40 9.95 9 144441 13536 64340746
Hyperprolactinaemia 10.39 9.95 26 144424 4039 64350243
Skin infection 10.37 9.95 11 144439 15026 64339256
Chemical burns of eye 10.34 9.95 5 144445 104 64354178
Peripheral T-cell lymphoma unspecified recurrent 10.34 9.95 4 144446 47 64354235
Fibromyalgia 10.32 9.95 43 144407 35688 64318594
Gambling 10.31 9.95 7 144443 282 64354000
Coordination abnormal 10.28 9.95 63 144387 14901 64339381
Pericardial effusion 10.28 9.95 49 144401 39205 64315077
Unemployment 10.26 9.95 4 144446 48 64354234
Hyperuricaemia 10.23 9.95 5 144445 10186 64344096
Hypokalaemia 10.23 9.95 351 144099 121552 64232730
Melaena 10.21 9.95 74 144376 53474 64300808
Gallbladder enlargement 10.19 9.95 14 144436 1372 64352910
Viral infection 10.13 9.95 44 144406 36096 64318186
Bladder cancer 10.12 9.95 6 144444 10968 64343314
Autoscopy 10.12 9.95 4 144446 50 64354232
Mixed anxiety and depressive disorder 10.05 9.95 6 144444 193 64354089
Personality change 10.03 9.95 42 144408 8551 64345731
Aspergillus test positive 10.00 9.95 10 144440 698 64353584
Post viral fatigue syndrome 9.99 9.95 7 144443 297 64353985
Resting tremor 9.98 9.95 14 144436 1400 64352882
Feeling drunk 9.97 9.95 26 144424 4141 64350141
Brain oedema 9.97 9.95 84 144366 21991 64332291
Product confusion 9.97 9.95 3 144447 15 64354267
Toxicologic test abnormal 9.97 9.95 13 144437 1212 64353070
Flight of ideas 9.97 9.95 10 144440 701 64353581

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX11 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D018663 Adrenergic Agents
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:146270 oneirogens

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Excessive vomiting in pregnancy off-label use 14094001
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Low blood pressure contraindication 45007003
Cerebrovascular disease contraindication 62914000 DOID:6713
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Bipolar affective disorder, current episode manic contraindication 191618007
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Akathisia contraindication 285145004
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Serotonin syndrome contraindication 371089000
Obesity contraindication 414916001 DOID:9970
Acute Thromboembolic Stroke contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Management of weight loss in cats Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Mirataz Dechra, Ltd. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.67 Basic
pKa2 2.91 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
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.41 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.16 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 7.70 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 PDSP
5-hydroxytryptamine receptor 1A GPCR Kd 5.30 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 6.58 CHEMBL
Alpha-1A adrenergic receptor GPCR IC50 5.50 CHEMBL
Alpha-2B adrenergic receptor GPCR ANTAGONIST IC50 6.65 CHEMBL
D(3) dopamine receptor GPCR Ki 5.24 CHEMBL
Histamine H1 receptor GPCR Ki 8.80 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR WOMBAT-PK
Alpha-2C adrenergic receptor GPCR ANTAGONIST Ki 7.74 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 5.54 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.38 PDSP
D(2) dopamine receptor GPCR Ki 5.26 PDSP
D(2) dopamine receptor GPCR Ki 5.84 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 8.70 CHEMBL
Transporter Transporter Ki 5.79 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.38 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 8.26 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 6.22 CHEMBL

External reference:

IDSource
4020978 VUID
N0000148449 NUI
D00563 KEGG_DRUG
4020978 VANDF
C0049506 UMLSCUI
CHEBI:6950 CHEBI
CHEMBL654 ChEMBL_ID
DB00370 DRUGBANK_ID
D000078785 MESH_DESCRIPTOR_UI
4205 PUBCHEM_CID
7241 IUPHAR_LIGAND_ID
6481 INN_ID
A051Q2099Q UNII
15996 RXNORM
46110 MMSL
5120 MMSL
d04025 MMSL
006054 NDDF
108430001 SNOMEDCT_US
386847004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0105 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0106 TABLET, ORALLY DISINTEGRATING 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0107 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0108 TABLET, ORALLY DISINTEGRATING 30 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0109 TABLET, FILM COATED 45 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0110 TABLET, ORALLY DISINTEGRATING 45 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4364 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4365 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8078 TABLET 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8268 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8269 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 28 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-153 TABLET, FILM COATED 15 mg ORAL ANDA 26 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-154 TABLET, FILM COATED 30 mg ORAL ANDA 26 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-155 TABLET, FILM COATED 45 mg ORAL ANDA 26 sections
Mirtazapine Human Prescription Drug Label 1 17856-0101 TABLET, FILM COATED 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-081 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-082 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-083 TABLET, FILM COATED 45 mg ORAL ANDA 29 sections