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

Stem definitionDrug idCAS RN
atropine derivatives 260 51-55-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • atropine
  • (+/-)-Atropine
  • atropin
  • atropinum sulphuricum
  • DL-Hyoscyamine
  • tropine tropate
  • atropine sulfate
An alkaloid, originally from Atropa belladonna, but found in other plants, mainly SOLANACEAE. Hyoscyamine is the 3(S)-endo isomer of atropine.
  • Molecular weight: 289.38
  • Formula: C17H23NO3
  • CLOGP: 1.30
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 49.77
  • ALOGS: -2.06
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 mg O
1.50 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 57 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 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) 3.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.61 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1960 FDA GD SEARLE LLC

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
Therapy interrupted 150.83 12.12 91 17234 20061 50567738
Death 140.07 12.12 329 16996 325050 50262749
Stress cardiomyopathy 135.10 12.12 62 17263 7825 50579974
Bradycardia 73.39 12.12 100 17225 64326 50523473
Therapy cessation 71.22 12.12 64 17261 25947 50561852
Joint swelling 71.17 12.12 3 17322 245283 50342516
Dehydration 67.31 12.12 156 17169 152293 50435506
Cardiac arrest 61.53 12.12 106 17219 83545 50504254
Hypotension 60.94 12.12 198 17127 235271 50352528
Diarrhoea 53.56 12.12 364 16961 588112 49999687
Haemodynamic instability 44.49 12.12 30 17295 7994 50579805
Respiratory depression 41.96 12.12 34 17291 11976 50575823
Arthralgia 37.25 12.12 58 17267 438644 50149155
Polydipsia 36.75 12.12 19 17306 3105 50584694
Dysarthria 36.57 12.12 54 17271 37349 50550450
Drug intolerance 35.97 12.12 15 17310 219089 50368710
Disseminated intravascular coagulation 35.21 12.12 36 17289 17099 50570700
Arthropathy 34.94 12.12 6 17319 157900 50429899
Vomiting 34.32 12.12 272 17053 460486 50127313
Peripheral swelling 33.96 12.12 14 17311 205922 50381877
Anticholinergic syndrome 33.55 12.12 15 17310 1780 50586019
Rheumatoid arthritis 31.46 12.12 15 17310 202535 50385264
Drug monitoring procedure not performed 31.27 12.12 10 17315 469 50587330
Ventricular fibrillation 30.92 12.12 27 17298 10532 50577267
Mydriasis 30.77 12.12 27 17298 10600 50577199
Ventricular tachycardia 30.28 12.12 32 17293 15789 50572010
Anorectal disorder 29.76 12.12 13 17312 1459 50586340
Endophthalmitis 29.39 12.12 16 17309 2900 50584899
Synovitis 29.01 12.12 4 17321 123861 50463938
Treatment failure 28.80 12.12 6 17319 137631 50450168
Enzyme induction 27.89 12.12 6 17319 56 50587743
Systemic lupus erythematosus 27.69 12.12 7 17318 140615 50447184
Neuromuscular blockade 27.22 12.12 8 17317 282 50587517
Hyperthermia malignant 27.03 12.12 10 17315 729 50587070
Ventricular asystole 26.59 12.12 6 17319 71 50587728
Glossodynia 26.44 12.12 4 17321 115565 50472234
Pulmonary oedema 25.99 12.12 54 17271 48884 50538915
Anterior spinal artery syndrome 25.93 12.12 6 17319 80 50587719
Surgery 25.84 12.12 41 17284 30164 50557635
Wound 25.78 12.12 3 17322 105791 50482008
Abdominal discomfort 25.53 12.12 25 17300 231616 50356183
Nasopharyngitis 24.72 12.12 18 17307 192909 50394890
Cardiac assistance device user 23.40 12.12 5 17320 45 50587754
Abdominal pain 23.06 12.12 149 17176 236079 50351720
Swelling 22.93 12.12 21 17304 200851 50386948
Apnoea 22.82 12.12 19 17306 6947 50580852
Therapeutic product effect decreased 22.82 12.12 9 17316 136041 50451758
Neuromuscular block prolonged 22.76 12.12 8 17317 503 50587296
Sinus tachycardia 22.57 12.12 32 17293 21322 50566477
Lower respiratory tract infection 22.46 12.12 3 17322 95198 50492601
Atrioventricular block complete 22.15 12.12 19 17306 7236 50580563
Cardiogenic shock 22.11 12.12 27 17298 15572 50572227
Blood pressure systolic decreased 21.65 12.12 17 17308 5722 50582077
Hypovolaemia 21.50 12.12 21 17304 9444 50578355
Anterior chamber flare 21.38 12.12 5 17320 70 50587729
Macular degeneration 20.55 12.12 25 17300 14363 50573436
Product use issue 20.40 12.12 13 17312 149462 50438337
Generalised tonic-clonic seizure 20.19 12.12 34 17291 26276 50561523
Intestinal obstruction 20.12 12.12 34 17291 26349 50561450
Crohn's disease 20.01 12.12 15 17310 4718 50583081
Agitation postoperative 19.74 12.12 4 17321 27 50587772
Arteriospasm coronary 19.53 12.12 13 17312 3389 50584410
Therapeutic product effect incomplete 19.12 12.12 4 17321 91511 50496288
Sinus arrest 19.03 12.12 10 17315 1688 50586111
Sinus bradycardia 18.98 12.12 23 17302 13160 50574639
Spleen congestion 18.89 12.12 5 17320 119 50587680
Purpura senile 18.77 12.12 7 17318 522 50587277
Small intestinal obstruction 18.36 12.12 25 17300 16043 50571756
Seizure 17.99 12.12 84 17241 117790 50470009
Musculoskeletal stiffness 17.77 12.12 11 17314 128470 50459329
N-terminal prohormone brain natriuretic peptide 17.60 12.12 4 17321 49 50587750
Alopecia 17.50 12.12 36 17289 245011 50342788
Systolic dysfunction 17.45 12.12 9 17316 1463 50586336
Rash 17.32 12.12 84 17241 437387 50150412
Intentional dose omission 17.02 12.12 14 17311 5036 50582763
Mental status changes 16.94 12.12 38 17287 36234 50551565
Spinal cord injury 16.90 12.12 7 17318 689 50587110
Intentional product use issue 16.83 12.12 3 17322 76915 50510884
Weight increased 16.79 12.12 27 17298 201864 50385935
Choroidal detachment 16.65 12.12 5 17320 190 50587609
Polyuria 16.55 12.12 16 17309 7105 50580694
Hospitalisation 16.50 12.12 56 17269 67881 50519918
Atrioventricular block second degree 16.48 12.12 12 17313 3609 50584190
Oliguria 16.40 12.12 17 17308 8199 50579600
Needle issue 16.26 12.12 16 17309 7259 50580540
Sinusitis 15.96 12.12 21 17304 170537 50417262
pH body fluid abnormal 15.91 12.12 4 17321 77 50587722
Corneal perforation 15.73 12.12 6 17319 476 50587323
Bronchospasm 15.32 12.12 22 17303 14832 50572967
Tarsal tunnel syndrome 15.08 12.12 6 17319 533 50587266
Post procedural complication 15.04 12.12 22 17303 15082 50572717
Cerebral congestion 14.97 12.12 3 17322 19 50587780
Completed suicide 14.79 12.12 14 17311 131875 50455924
Supraventricular tachycardia 14.75 12.12 20 17305 12781 50575018
Electrocardiogram ST segment elevation 14.66 12.12 11 17314 3462 50584337
Atrioventricular block first degree 14.54 12.12 14 17311 6187 50581612
Cardio-respiratory arrest 14.50 12.12 46 17279 53846 50533953
Bundle branch block left 14.48 12.12 14 17311 6216 50581583
Resuscitation 14.33 12.12 7 17318 1014 50586785
Failure to thrive 14.24 12.12 14 17311 6344 50581455
Drug ineffective 14.09 12.12 197 17128 819136 49768663
Opsoclonus myoclonus 14.07 12.12 4 17321 125 50587674
Discomfort 14.01 12.12 10 17315 108370 50479429
Hypopyon 13.82 12.12 6 17319 663 50587136
Tongue oedema 13.69 12.12 11 17314 3828 50583971
Anaesthetic complication 13.42 12.12 8 17317 1722 50586077
Retinal vascular occlusion 13.40 12.12 5 17320 373 50587426
Accidental overdose 13.36 12.12 24 17301 19509 50568290
Respiratory failure 13.20 12.12 64 17261 91117 50496682
Delayed recovery from anaesthesia 13.17 12.12 6 17319 743 50587056
Dermatitis acneiform 13.15 12.12 11 17314 4046 50583753
Product dose omission issue 13.13 12.12 27 17298 183811 50403988
Aortic valve calcification 13.04 12.12 5 17320 402 50587397
Haemoperitoneum 12.86 12.12 9 17316 2546 50585253
Thirst 12.82 12.12 17 17308 10633 50577166
Hepatic enzyme increased 12.76 12.12 17 17308 137363 50450436
Electrocardiogram QRS complex shortened 12.73 12.12 5 17320 429 50587370
Anaphylactoid reaction 12.66 12.12 10 17315 3396 50584403
Gastroenteritis radiation 12.64 12.12 5 17320 437 50587362
Mycobacterium chelonae infection 12.59 12.12 5 17320 442 50587357
Chemical submission 12.54 12.12 4 17321 186 50587613
Rectal haemorrhage 12.34 12.12 35 17290 38523 50549276
Tachycardia 12.33 12.12 67 17258 99696 50488103
Neonatal hypoxia 12.21 12.12 5 17320 478 50587321
Metabolic acidosis 12.19 12.12 35 17290 38790 50549009
Coma 12.19 12.12 45 17280 56834 50530965
Gastrointestinal motility disorder 12.15 12.12 11 17314 4498 50583301
Haematuria 12.14 12.12 27 17298 25586 50562213

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
Death 95.53 12.76 400 15549 341684 29216894
Therapy interrupted 67.61 12.76 47 15902 8339 29550239
Hyperthermia malignant 60.70 12.76 26 15923 1758 29556820
Diarrhoea 59.54 12.76 343 15606 332355 29226223
Anticholinergic syndrome 58.75 12.76 21 15928 873 29557705
Dehydration 46.73 12.76 152 15797 114596 29443982
Cardiac arrest 43.90 12.76 123 15826 85468 29473110
Bradycardia 43.64 12.76 104 15845 65525 29493053
Alopecia 37.80 12.76 49 15900 19035 29539543
Emotional disorder 35.96 12.76 26 15923 4905 29553673
Stoma site pain 33.38 12.76 12 15937 507 29558071
Therapy cessation 33.23 12.76 40 15909 14422 29544156
Mouth ulceration 33.03 12.76 34 15915 10321 29548257
Change of bowel habit 32.22 12.76 14 15935 980 29557598
Tachycardia 31.33 12.76 98 15851 72312 29486266
Pulse absent 30.70 12.76 24 15925 5089 29553489
Cholinergic syndrome 30.37 12.76 11 15938 475 29558103
Oral pain 28.68 12.76 30 15919 9277 29549301
Stress cardiomyopathy 28.49 12.76 15 15934 1609 29556969
Corneal oedema 27.27 12.76 13 15936 1129 29557449
Hypertension 25.99 12.76 128 15821 116486 29442092
Ventricular fibrillation 25.82 12.76 37 15912 15796 29542782
Arteriospasm coronary 24.56 12.76 16 15933 2549 29556029
Electrocardiogram QRS complex prolonged 24.05 12.76 19 15930 4091 29554487
Vasoplegia syndrome 23.85 12.76 13 15936 1495 29557083
Mydriasis 23.15 12.76 22 15927 6063 29552515
Dermatitis acneiform 23.11 12.76 21 15928 5470 29553108
Surgery 22.94 12.76 30 15919 11749 29546829
Anaesthetic complication 22.86 12.76 11 15938 975 29557603
Pupil fixed 22.42 12.76 13 15936 1683 29556895
Blood pressure decreased 21.01 12.76 63 15886 45414 29513164
Keratic precipitates 20.41 12.76 6 15943 132 29558446
Laryngospasm 20.07 12.76 11 15938 1279 29557299
Blood creatinine decreased 19.62 12.76 14 15935 2587 29555991
Rebound psychosis 19.54 12.76 6 15943 154 29558424
Scleritis 19.09 12.76 7 15942 313 29558265
Vomiting 18.92 12.76 186 15763 212074 29346504
Sinus tachycardia 18.65 12.76 31 15918 15038 29543540
Ileus 18.32 12.76 30 15919 14372 29544206
Choroidal detachment 18.16 12.76 7 15942 360 29558218
Cardiogenic shock 18.02 12.76 35 15914 19155 29539423
Decreased appetite 17.99 12.76 137 15812 145205 29413373
Acute pulmonary oedema 17.65 12.76 20 15929 6759 29551819
Intraocular pressure increased 17.62 12.76 17 15932 4772 29553806
Proteinuria 17.57 12.76 31 15918 15773 29542805
Limb mass 17.33 12.76 8 15941 646 29557932
Atrioventricular block 17.17 12.76 20 15929 6962 29551616
Agitation postoperative 16.91 12.76 4 15945 36 29558542
Nausea 16.67 12.76 233 15716 289022 29269556
Drug intolerance 16.62 12.76 3 15946 48376 29510202
Neuromuscular block prolonged 16.59 12.76 7 15942 456 29558122
Post procedural complication 16.53 12.76 24 15925 10365 29548213
Endophthalmitis 16.31 12.76 13 15936 2835 29555743
Foot fracture 16.27 12.76 15 15934 3980 29554598
Apnoea 15.88 12.76 18 15931 6084 29552494
Visual acuity tests abnormal 15.72 12.76 4 15945 50 29558528
Dysarthria 15.40 12.76 44 15905 30867 29527711
Shock 15.39 12.76 35 15914 21369 29537209
Ventricular tachycardia 15.22 12.76 36 15913 22538 29536040
Hypocapnia 15.12 12.76 5 15944 164 29558414
Nail bed inflammation 15.09 12.76 5 15944 165 29558413
Muscle twitching 14.95 12.76 20 15929 8006 29550572
Anaphylactic shock 14.62 12.76 26 15923 13310 29545268
Anterior chamber flare 14.58 12.76 4 15945 68 29558510
Anaphylactic reaction 14.47 12.76 40 15909 27533 29531045
Peritumoural oedema 14.38 12.76 3 15946 14 29558564
Arthralgia 14.32 12.76 34 15915 139583 29418995
Dysprosody 14.21 12.76 3 15946 15 29558563
Jugular vein thrombosis 14.06 12.76 9 15940 1391 29557187
Exostosis 13.70 12.76 13 15936 3576 29555002
Product use in unapproved indication 13.69 12.76 16 15933 86859 29471719
Compartment syndrome 13.63 12.76 11 15938 2441 29556137
Hypoxic-ischaemic encephalopathy 13.54 12.76 14 15935 4270 29554308
Drug abuse 13.37 12.76 14 15935 79869 29478709
Adulterated product 12.89 12.76 3 15946 25 29558553
Respiration abnormal 12.77 12.76 11 15938 2669 29555909

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
Therapy interrupted 245.11 11.78 133 26465 19903 64452231
Death 186.21 11.78 526 26072 482179 63989955
Stress cardiomyopathy 158.24 11.78 77 26521 9180 64462954
Therapy cessation 118.59 11.78 102 26496 32387 64439747
Cardiac arrest 103.81 11.78 209 26389 153855 64318279
Bradycardia 96.43 11.78 174 26424 118045 64354089
Hyperthermia malignant 86.46 11.78 34 26564 2425 64469709
Diarrhoea 76.52 11.78 534 26064 722170 63749964
Anticholinergic syndrome 63.73 11.78 28 26570 2641 64469493
Surgery 61.99 11.78 67 26531 28146 64443988
Dehydration 60.75 11.78 212 26386 216551 64255583
Arthralgia 60.56 11.78 56 26542 442204 64029930
Hypotension 56.20 11.78 307 26291 380667 64091467
Ventricular fibrillation 47.82 11.78 54 26544 23806 64448328
Joint swelling 47.24 11.78 15 26583 215367 64256767
Mydriasis 45.83 11.78 43 26555 15269 64456865
Endophthalmitis 45.29 11.78 28 26570 5337 64466797
Drug intolerance 45.13 11.78 11 26587 187981 64284153
Ventricular tachycardia 43.86 11.78 62 26536 34203 64437931
Nasopharyngitis 42.39 11.78 14 26584 196059 64276075
Arteriospasm coronary 42.31 11.78 27 26571 5438 64466696
Cardiogenic shock 41.99 11.78 59 26539 32368 64439766
Dysarthria 40.42 11.78 81 26517 59325 64412809
Tachycardia 39.89 11.78 144 26454 149435 64322699
Anaesthetic complication 39.75 11.78 20 26578 2559 64469575
Neuromuscular block prolonged 39.66 11.78 15 26583 962 64471172
Anorectal disorder 38.86 11.78 18 26580 1921 64470213
Pulse absent 38.69 11.78 31 26567 8915 64463219
Peripheral swelling 38.59 11.78 19 26579 209134 64263000
Corneal oedema 38.57 11.78 19 26579 2324 64469810
Sinus tachycardia 37.92 11.78 56 26542 32132 64440002
Pulmonary oedema 37.45 11.78 93 26505 78581 64393553
Dermatitis acneiform 35.97 11.78 29 26569 8414 64463720
Anterior chamber flare 35.53 11.78 9 26589 147 64471987
Hospitalisation 32.78 11.78 86 26512 75121 64397013
Apnoea 32.60 11.78 30 26568 10392 64461742
Hypertension 32.34 11.78 200 26398 259061 64213073
Haemodynamic instability 32.03 11.78 35 26563 14877 64457257
Contraindicated product administered 30.86 11.78 4 26594 107825 64364309
Post procedural complication 29.36 11.78 40 26558 21313 64450821
Laryngospasm 29.13 11.78 18 26580 3427 64468707
Shock 28.27 11.78 54 26544 38186 64433948
Choroidal detachment 28.23 11.78 10 26588 532 64471602
Intraocular pressure increased 28.14 11.78 25 26573 8277 64463857
Cholinergic syndrome 27.35 11.78 11 26587 832 64471302
Rheumatoid arthritis 27.30 11.78 17 26581 164277 64307857
Disseminated intravascular coagulation 26.82 11.78 48 26550 32300 64439834
Intentional product use issue 26.21 11.78 4 26594 95360 64376774
Treatment failure 25.84 11.78 8 26590 116808 64355326
Blood pressure decreased 25.58 11.78 86 26512 86113 64386021
Anaphylactic shock 25.15 11.78 45 26553 30283 64441851
Pupil fixed 25.10 11.78 16 26582 3216 64468918
Atrioventricular block second degree 25.05 11.78 21 26577 6433 64465701
Polydipsia 24.81 11.78 20 26578 5801 64466333
Drug monitoring procedure not performed 24.19 11.78 10 26588 812 64471322
Delayed recovery from anaesthesia 23.99 11.78 12 26586 1516 64470618
Anterior spinal artery syndrome 23.75 11.78 6 26592 97 64472037
Anaphylactic reaction 23.55 11.78 72 26526 68592 64403542
Hypoxic-ischaemic encephalopathy 23.18 11.78 21 26577 7131 64465003
Enzyme induction 23.09 11.78 6 26592 109 64472025
Atrioventricular block complete 22.91 11.78 29 26569 14389 64457745
Vomiting 22.86 11.78 336 26262 550781 63921353
Hypovolaemia 22.81 11.78 30 26568 15456 64456678
Completed suicide 22.61 11.78 36 26562 224378 64247756
Respiratory depression 22.34 11.78 37 26561 23406 64448728
Ventricular asystole 22.33 11.78 7 26591 254 64471880
Arthropathy 22.28 11.78 11 26587 120956 64351178
Rebound psychosis 21.32 11.78 6 26592 149 64471985
Keratic precipitates 21.28 11.78 7 26591 297 64471837
Intentional dose omission 21.13 11.78 18 26580 5634 64466500
Cardiac assistance device user 21.02 11.78 5 26593 62 64472072
Electrocardiogram ST segment elevation 20.99 11.78 20 26578 7239 64464895
Weight increased 20.77 11.78 35 26563 213313 64258821
Acute pulmonary oedema 20.73 11.78 26 26572 12783 64459351
Abdominal discomfort 20.58 11.78 27 26571 182295 64289839
Pain in extremity 20.31 11.78 61 26537 303024 64169110
Ileus 20.23 11.78 35 26563 22931 64449203
Back pain 20.07 11.78 46 26552 250125 64222009
Vasoplegia syndrome 19.77 11.78 13 26585 2754 64469380
Systemic lupus erythematosus 19.70 11.78 4 26594 77608 64394526
Seizure 19.69 11.78 127 26471 166765 64305369
Muscle twitching 19.48 11.78 31 26567 18967 64453167
Sinusitis 19.31 11.78 19 26579 145909 64326225
Pulseless electrical activity 19.26 11.78 25 26573 12714 64459420
Hyperhidrosis 19.24 11.78 102 26496 124818 64347316
Electrocardiogram QRS complex prolonged 18.65 11.78 21 26577 9223 64462911
Supraventricular tachycardia 18.23 11.78 30 26568 18877 64453257
Therapeutic product effect incomplete 18.18 11.78 10 26588 103472 64368662
Coma scale abnormal 18.02 11.78 19 26579 7755 64464379
Swelling 17.80 11.78 24 26574 160194 64311940
Sinus bradycardia 17.75 11.78 33 26565 22860 64449274
Neuromuscular blockade 17.69 11.78 7 26591 507 64471627
Product use issue 17.60 11.78 22 26576 151693 64320441
Ventricular extrasystoles 17.15 11.78 28 26570 17501 64454633
Flat anterior chamber of eye 16.74 11.78 5 26593 154 64471980
Malnutrition 16.66 11.78 29 26569 19096 64453038
Drug abuse 16.64 11.78 18 26580 132356 64339778
N-terminal prohormone brain natriuretic peptide 16.57 11.78 4 26594 53 64472081
Influenza 16.38 11.78 12 26586 106519 64365615
Pericarditis 16.34 11.78 3 26595 62513 64409621
Product dose omission issue 16.28 11.78 35 26563 194712 64277422
Sinus arrest 16.19 11.78 12 26586 3078 64469056
Hyphaema 16.06 11.78 7 26591 648 64471486
Blood pressure systolic decreased 16.05 11.78 19 26579 8801 64463333
Hypopyon 15.92 11.78 8 26590 1021 64471113
Corneal perforation 15.76 11.78 7 26591 677 64471457
Bundle branch block left 15.65 11.78 20 26578 10014 64462120
Peritumoural oedema 15.56 11.78 3 26595 12 64472122
Angle closure glaucoma 15.47 11.78 11 26587 2646 64469488
Injection site erythema 15.38 11.78 5 26593 70795 64401339
Therapeutic product effect decreased 15.28 11.78 15 26583 115336 64356798
Bronchospasm 15.27 11.78 30 26568 21652 64450482
Glossodynia 15.10 11.78 4 26594 64692 64407442
Interstitial lung disease 15.04 11.78 11 26587 97721 64374413
Dysprosody 15.01 11.78 3 26595 15 64472119
Generalised tonic-clonic seizure 14.80 11.78 43 26555 39814 64432320
Tarsal tunnel syndrome 14.37 11.78 6 26592 499 64471635
Vitreous opacities 14.33 11.78 6 26592 503 64471631
Purpura senile 14.31 11.78 6 26592 505 64471629
Kounis syndrome 14.19 11.78 11 26587 3014 64469120
Injection site pain 14.17 11.78 15 26583 111393 64360741
Musculoskeletal stiffness 14.15 11.78 18 26580 123188 64348946
Lower respiratory tract infection 14.11 11.78 11 26587 94603 64377531
Pupillary reflex impaired 14.04 11.78 11 26587 3062 64469072
Iris adhesions 14.04 11.78 6 26592 529 64471605
Cataract subcapsular 14.01 11.78 7 26591 882 64471252
Bradycardia foetal 14.00 11.78 4 26594 105 64472029
Panophthalmitis 14.00 11.78 4 26594 105 64472029
Antipsychotic drug level decreased 13.62 11.78 7 26591 937 64471197
Cardio-respiratory arrest 13.58 11.78 78 26520 98315 64373819
Failure to thrive 13.57 11.78 19 26579 10385 64461749
Visual acuity tests abnormal 13.55 11.78 4 26594 118 64472016
Spinal cord injury 13.50 11.78 7 26591 954 64471180
pH body fluid abnormal 13.43 11.78 4 26594 122 64472012
Fibrinolysis increased 13.29 11.78 3 26595 29 64472105
Choroidal effusion 13.27 11.78 6 26592 606 64471528
Glaucoma 13.22 11.78 24 26574 16324 64455810
Atrioventricular block first degree 13.11 11.78 19 26579 10715 64461419
Synovitis 12.99 11.78 13 26585 99077 64373057
Pain 12.98 11.78 156 26442 553355 63918779
Compartment syndrome 12.88 11.78 12 26586 4220 64467914
Atrioventricular block 12.87 11.78 20 26578 11995 64460139
Myalgia 12.85 11.78 29 26569 158588 64313546
Keratitis bacterial 12.69 11.78 4 26594 148 64471986
Corneal epithelium defect 12.62 11.78 6 26592 679 64471455
Discomfort 12.57 11.78 9 26589 80869 64391265
Wound 12.57 11.78 8 26590 76469 64395665
Stoma site pain 12.42 11.78 7 26591 1126 64471008
Scleritis 12.24 11.78 10 26588 2956 64469178
Sudden infant death syndrome 12.22 11.78 4 26594 167 64471967
Product use in unapproved indication 12.21 11.78 35 26563 176583 64295551
Needle issue 12.19 11.78 17 26581 9255 64462879
Limb mass 12.08 11.78 10 26588 3011 64469123
Hepatic enzyme increased 12.02 11.78 22 26576 129921 64342213
Cerebral congestion 11.96 11.78 3 26595 47 64472087
Keratitis fungal 11.92 11.78 4 26594 181 64471953
Coma 11.79 11.78 69 26529 87546 64384588

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A03BA01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
BELLADONNA AND DERIVATIVES, PLAIN
Belladonna alkaloids, tertiary amines
ATC A03CB03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
ANTISPASMODICS IN COMBINATION WITH PSYCHOLEPTICS
Belladonna and derivatives in combination with psycholeptics
ATC S01FA01 SENSORY ORGANS
OPHTHALMOLOGICALS
MYDRIATICS AND CYCLOPLEGICS
Anticholinergics
FDA MoA N0000000125 Cholinergic Muscarinic Antagonists
FDA MoA N0000175370 Cholinergic Antagonists
FDA EPC N0000175574 Anticholinergic
MeSH PA D000759 Adjuvants, Anesthesia
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D001993 Bronchodilator Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018680 Cholinergic Antagonists
MeSH PA D018727 Muscarinic Antagonists
MeSH PA D009184 Mydriatics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D010276 Parasympatholytics
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175700 Cholinergic Muscarinic Antagonist
CHEBI has role CHEBI:35523 bronchodilator
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:48876 muscarinic antagonists
CHEBI has role CHEBI:50370 parasympatholytics
CHEBI has role CHEBI:50513 mydriatics
CHEBI has role CHEBI:60807 anaesthestic adjuvant
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:146270 oneirogens

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Perioperative Mydriasis indication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Rodents Treatment of Syphacia obvelata (pinworm) Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Freed No. 10, Freed No. 25 Zoetis Inc. 2
Dyrex Powder Zoetis Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.24 acidic
pKa2 9.26 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.25MG/5ML (0.05MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
0.5MG/5ML (0.1MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
1MG/10ML (0.1MG/ML) ATROPINE SULFATE ACCORD HLTHCARE A212868 July 26, 2021 RX SOLUTION INTRAVENOUS Jan. 26, 2022 COMPETITIVE GENERIC THERAPY
1% ATROPINE SULFATE APOTEX INC A215624 Nov. 26, 2021 RX SOLUTION/DROPS OPHTHALMIC May 25, 2022 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Muscarinic acetylcholine receptor M1 GPCR ANTAGONIST Ki 9.31 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M2 GPCR ANTAGONIST Ki 8.97 WOMBAT-PK CHEMBL
Muscarinic acetylcholine receptor M3 GPCR ANTAGONIST Ki 9.50 WOMBAT-PK CHEMBL
Histamine H1 receptor GPCR Ki 5.91 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 9.39 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 9.29 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR Ki 6.18 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.91 CHEMBL
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 4.85 IUPHAR
5-hydroxytryptamine receptor 2A GPCR Ki 5.16 PDSP
5-hydroxytryptamine receptor 2C GPCR Ki 6.28 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 9.15 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 9.59 CHEMBL
Acetylcholinesterase Enzyme Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 9.46 CHEMBL
Muscarinic acetylcholine receptor M3 GPCR Ki 9.92 CHEMBL
Muscarinic receptor M1 GPCR Ki 9.70 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 9.07 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 9.28 CHEMBL
Muscarinic acetylcholine receptor GPCR Kd 8.99 CHEMBL
Nicotinic acetylcholine receptor alpha 5 subunit Ion channel Ki 4.49 CHEMBL
Muscarinic acetylcholine receptor GPCR Ki 9.52 CHEMBL

External reference:

IDSource
4019591 VUID
N0000147687 NUI
D00113 KEGG_DRUG
5908-99-6 SECONDARY_CAS_RN
1223 RXNORM
C0004259 UMLSCUI
CHEBI:16684 CHEBI
OIN PDB_CHEM_ID
CHEMBL2146146 ChEMBL_ID
CHEMBL517712 ChEMBL_ID
DB00572 DRUGBANK_ID
D001285 MESH_DESCRIPTOR_UI
174174 PUBCHEM_CID
320 IUPHAR_LIGAND_ID
7C0697DR9I UNII
27333 MMSL
405 MMSL
4229 MMSL
d00174 MMSL
001715 NDDF
001717 NDDF
4017410 VANDF
4019591 VANDF
372832002 SNOMEDCT_US
73949004 SNOMEDCT_US
74237004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lomotil HUMAN PRESCRIPTION DRUG LABEL 2 0025-0061 TABLET 0.03 mg ORAL NDA 23 sections
Lomotil HUMAN PRESCRIPTION DRUG LABEL 2 0025-0061 TABLET 0.03 mg ORAL NDA 23 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0054-3194 SOLUTION 0.03 mg ORAL ANDA 20 sections
Isopto Atropine HUMAN PRESCRIPTION DRUG LABEL 1 0065-0303 SOLUTION 10 mg OPHTHALMIC NDA 26 sections
atropine sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0065-0817 SOLUTION 10 mg OPHTHALMIC NDA 25 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0378-0415 TABLET 0.03 mg ORAL ANDA 20 sections
ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9819 INJECTION, SOLUTION 1 mg INTRAVENOUS unapproved drug other 11 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9820 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR unapproved drug other 10 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9821 INJECTION, SOLUTION 0.10 mg INTRAVENOUS unapproved drug other 13 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9822 INJECTION, SOLUTION 0.10 mg INTRAMUSCULAR unapproved drug other 14 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9823 INJECTION, SOLUTION 0.05 mg INTRAMUSCULAR NDA 15 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9823 INJECTION, SOLUTION 0.05 mg INTRAMUSCULAR NDA 15 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9824 INJECTION 0.40 mg INTRAMUSCULAR unapproved drug other 11 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0406-1236 TABLET 0.03 mg ORAL ANDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1630 INJECTION, SOLUTION 0.10 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-4910 INJECTION, SOLUTION 0.10 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-4911 INJECTION, SOLUTION 0.10 mg INTRAVENOUS NDA 23 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-9630 INJECTION, SOLUTION 0.05 mg INTRAVENOUS NDA 23 sections
Belladonna Alkaloids with Phenobartbital HUMAN PRESCRIPTION DRUG LABEL 4 0440-7183 TABLET 0.02 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-0401 INJECTION, SOLUTION 0.40 mg INTRAMUSCULAR UNAPPROVED DRUG OTHER 11 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0517-1010 INJECTION, SOLUTION 1 mg INTRAMUSCULAR UNAPPROVED DRUG OTHER 11 sections
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 2 0527-1170 TABLET 0.03 mg ORAL ANDA 12 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6006 INJECTION 0.40 mg INTRAMUSCULAR unapproved drug other 16 sections
Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6251 INJECTION 0.40 mg ENDOTRACHEAL ANDA 22 sections
Diphenoxylate hydrochloride and atropine sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0832-0590 TABLET 0.03 mg ORAL ANDA 21 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-101 INJECTION 2 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-101 INJECTION 2 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-104 INJECTION 0.50 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-104 INJECTION 0.50 mg INTRAMUSCULAR NDA 26 sections
ATROPEN Auto-Injector HUMAN PRESCRIPTION DRUG LABEL 1 11704-105 INJECTION 1 mg INTRAMUSCULAR NDA 26 sections