atropine 🐶 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) 139 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 57 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 µM/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
Stress cardiomyopathy 163.74 12.03 73 19908 9377 63459664
Macular degeneration 139.45 12.03 90 19891 24286 63444755
Death 137.25 12.03 338 19643 374043 63094998
Therapy interrupted 118.40 12.03 91 19890 32364 63436677
Bradycardia 89.91 12.03 113 19868 73114 63395927
Joint swelling 86.37 12.03 4 19977 327662 63141379
Hypotension 86.13 12.03 233 19748 272371 63196670
Therapy cessation 71.01 12.03 66 19915 30391 63438650
Cardiac arrest 70.87 12.03 114 19867 92431 63376610
Dehydration 70.26 12.03 163 19818 173191 63295850
Anticholinergic syndrome 66.97 12.03 26 19955 2356 63466685
Anterior spinal artery syndrome 56.69 12.03 12 19969 113 63468928
Arthropathy 52.94 12.03 6 19975 234786 63234255
Drug intolerance 50.67 12.03 17 19964 308644 63160397
Contraindicated product administered 50.51 12.03 5 19976 217643 63251398
Haemodynamic instability 47.83 12.03 32 19949 9158 63459883
Paraesthesia oral 47.35 12.03 43 19938 19213 63449828
Apnoea 46.80 12.03 30 19951 7992 63461049
Arthralgia 45.68 12.03 68 19913 569642 62899399
Diarrhoea 45.19 12.03 381 19600 714985 62754056
Respiratory depression 44.70 12.03 36 19945 13679 63455362
Cardiogenic shock 44.01 12.03 40 19941 17892 63451149
Systemic lupus erythematosus 43.16 12.03 7 19974 208911 63260130
Peripheral swelling 43.03 12.03 15 19966 265927 63203114
Treatment failure 42.65 12.03 6 19975 199037 63270004
Glossodynia 41.79 12.03 4 19977 178872 63290169
Dysarthria 41.77 12.03 59 19922 42652 63426389
Polydipsia 41.66 12.03 21 19960 3543 63465498
Synovitis 41.57 12.03 5 19976 186913 63282128
Endophthalmitis 41.50 12.03 21 19960 3571 63465470
Abdominal discomfort 41.23 12.03 25 19956 320860 63148181
Wound 39.92 12.03 3 19978 163260 63305781
Rheumatoid arthritis 39.90 12.03 15 19966 253804 63215237
Disseminated intravascular coagulation 38.19 12.03 38 19943 19013 63450028
Spinal cord injury 37.13 12.03 13 19968 880 63468161
Mydriasis 36.06 12.03 30 19951 11926 63457115
Product use issue 34.71 12.03 13 19968 220507 63248534
Swelling 34.61 12.03 22 19959 275356 63193685
Nasopharyngitis 33.79 12.03 19 19962 254238 63214803
Rhythm idioventricular 33.18 12.03 9 19972 257 63468784
Therapeutic product effect decreased 32.81 12.03 10 19971 193177 63275864
Chronic sinusitis 32.20 12.03 29 19952 12814 63456227
Abdominal pain 32.00 12.03 179 19802 293277 63175764
Alopecia 30.33 12.03 37 19944 337499 63131542
Ventricular fibrillation 30.16 12.03 27 19954 11840 63457201
Ventricular tachycardia 29.69 12.03 34 19947 19945 63449096
Drug monitoring procedure not performed 29.60 12.03 10 19971 608 63468433
Intentional product use issue 29.50 12.03 3 19978 127889 63341152
Vomiting 29.09 12.03 286 19695 559331 62909710
Vasoplegia syndrome 29.02 12.03 13 19968 1686 63467355
Anorectal disorder 28.66 12.03 13 19968 1736 63467305
Enzyme induction 28.39 12.03 6 19975 56 63468985
Lower respiratory tract infection 28.30 12.03 4 19977 132303 63336738
Neuromuscular blockade 27.67 12.03 8 19973 290 63468751
Musculoskeletal stiffness 27.23 12.03 12 19969 184606 63284435
Hyperthermia malignant 26.67 12.03 10 19971 824 63468217
Coma 26.55 12.03 61 19920 64303 63404738
Discomfort 26.11 12.03 10 19971 167364 63301677
Pulmonary oedema 26.02 12.03 55 19926 54818 63414223
Atrioventricular block complete 25.50 12.03 21 19960 8230 63460811
Ventricular asystole 24.86 12.03 6 19975 106 63468935
Rash 24.75 12.03 92 19889 560779 62908262
Sedation 23.36 12.03 43 19938 38766 63430275
Cardiac assistance device user 23.26 12.03 5 19976 51 63468990
Blood pressure systolic decreased 23.22 12.03 19 19962 7378 63461663
Surgery 23.16 12.03 41 19940 35871 63433170
Hepatic enzyme increased 22.99 12.03 18 19963 202310 63266731
Weight increased 22.98 12.03 29 19952 260763 63208278
Neuromuscular block prolonged 22.96 12.03 8 19973 534 63468507
Sinus tachycardia 22.95 12.03 33 19948 24235 63444806
Hypovolaemia 22.72 12.03 22 19959 10651 63458390
Respiratory failure 22.58 12.03 77 19904 101781 63367260
Seizure 21.72 12.03 91 19890 132543 63336498
Rebound psychosis 21.47 12.03 6 19975 192 63468849
Procedural pain 21.38 12.03 30 19951 21539 63447502
Sedation complication 21.35 12.03 24 19957 13798 63455243
Sinusitis 21.25 12.03 24 19957 226629 63242412
Anterior chamber flare 21.24 12.03 5 19976 79 63468962
Generalised tonic-clonic seizure 21.17 12.03 35 19946 28981 63440060
Intestinal obstruction 20.86 12.03 36 19945 30863 63438178
Crohn's disease 20.63 12.03 15 19966 4898 63464143
Paralysis 20.31 12.03 20 19961 9880 63459161
BRASH syndrome 20.16 12.03 7 19974 462 63468579
Agitation postoperative 20.08 12.03 4 19977 27 63469014
Rectal haemorrhage 19.70 12.03 46 19935 48984 63420057
Needle issue 19.52 12.03 20 19961 10356 63458685
Spleen congestion 19.27 12.03 5 19976 120 63468921
Polyuria 18.92 12.03 18 19963 8524 63460517
Purpura senile 18.91 12.03 7 19974 556 63468485
Sinus bradycardia 18.71 12.03 23 19958 14528 63454513
Arteriospasm coronary 18.71 12.03 13 19968 3955 63465086
Thrombocytopenic purpura 18.65 12.03 9 19972 1382 63467659
Sinus arrest 18.53 12.03 10 19971 1939 63467102
Fatigue 17.96 12.03 186 19795 887842 62581199
Serpiginous choroiditis 17.90 12.03 3 19978 6 63469035
N-terminal prohormone brain natriuretic peptide 17.79 12.03 4 19977 51 63468990
Anterior segment ischaemia 17.51 12.03 4 19977 55 63468986
Somnolence 17.49 12.03 106 19875 178579 63290462
Systolic dysfunction 17.46 12.03 9 19972 1590 63467451
Small intestinal obstruction 17.43 12.03 25 19956 18312 63450729
Pressure of speech 17.19 12.03 7 19974 719 63468322
Hypopyon 17.13 12.03 7 19974 725 63468316
Mental status changes 16.84 12.03 38 19943 39561 63429480
Product dose omission issue 16.81 12.03 30 19951 234283 63234758
Toxicity to various agents 16.73 12.03 134 19847 247116 63221925
Atrioventricular block second degree 16.55 12.03 12 19969 3902 63465139
Choroidal detachment 16.25 12.03 5 19976 225 63468816
Oliguria 16.15 12.03 17 19964 9084 63459957
Vaginal flatulence 16.02 12.03 11 19970 3282 63465759
pH body fluid abnormal 16.01 12.03 4 19977 82 63468959
Bundle branch block left 15.87 12.03 15 19966 7044 63461997
Cardio-respiratory arrest 15.71 12.03 48 19933 59911 63409130
Bronchospasm 15.61 12.03 23 19958 17257 63451784
Corneal perforation 15.47 12.03 6 19975 542 63468499
Completed suicide 15.26 12.03 14 19967 145659 63323382
Tarsal tunnel syndrome 15.20 12.03 6 19975 568 63468473
Catatonia 15.12 12.03 12 19969 4465 63464576
Female genital tract fistula 15.00 12.03 15 19966 7544 63461497
Sudden infant death syndrome 14.80 12.03 5 19976 304 63468737
Metabolic acidosis 14.65 12.03 39 19942 45030 63424011
Cerebral congestion 14.40 12.03 3 19978 26 63469015
Post procedural complication 14.39 12.03 22 19959 17052 63451989
Supraventricular tachycardia 14.37 12.03 20 19961 14251 63454790
Blood calcium decreased 14.30 12.03 28 19953 26423 63442618
Electrocardiogram ST segment elevation 14.29 12.03 11 19970 3916 63465125
Intentional dose omission 14.18 12.03 15 19966 8060 63460981
Infection 14.16 12.03 32 19949 229141 63239900
Resuscitation 14.13 12.03 7 19974 1137 63467904
Colitis 13.80 12.03 40 19941 48488 63420553
Failure to thrive 13.77 12.03 14 19967 7184 63461857
Creatinine renal clearance decreased 13.73 12.03 21 19960 16287 63452754
Constipation 13.66 12.03 119 19862 224824 63244217
Atrioventricular block first degree 13.65 12.03 14 19967 7259 63461782
Hospitalisation 13.63 12.03 58 19923 85023 63384018
Opsoclonus myoclonus 13.63 12.03 4 19977 153 63468888
Delayed recovery from anaesthesia 13.49 12.03 6 19975 765 63468276
Antipsychotic drug level increased 13.33 12.03 10 19971 3425 63465616
Retinal vascular occlusion 13.22 12.03 5 19976 422 63468619
Thirst 13.14 12.03 19 19962 14022 63455019
Anaesthetic complication 13.12 12.03 8 19973 1952 63467089
Proctitis 13.08 12.03 12 19969 5429 63463612
Judgement impaired 13.05 12.03 6 19975 826 63468215
Accidental overdose 13.00 12.03 25 19956 23284 63445757
Haemoperitoneum 12.97 12.03 9 19972 2732 63466309
Strabismus 12.92 12.03 8 19973 2006 63467035
Hirsutism 12.82 12.03 7 19974 1388 63467653
Tongue oedema 12.79 12.03 11 19970 4575 63464466
Electrocardiogram QRS complex shortened 12.76 12.03 5 19976 464 63468577
Gastroenteritis radiation 12.73 12.03 5 19976 467 63468574
Anaphylactoid reaction 12.62 12.03 10 19971 3713 63465328
Vaginal discharge 12.58 12.03 15 19966 9183 63459858
Haematuria 12.42 12.03 28 19953 29129 63439912
Mycobacterium chelonae infection 12.34 12.03 5 19976 507 63468534
Fibromyalgia 12.21 12.03 5 19976 80415 63388626
Troponin I increased 12.15 12.03 8 19973 2230 63466811
Tachycardia 12.13 12.03 71 19910 118085 63350956
Neuropathy peripheral 12.13 12.03 69 19912 113598 63355443
Depressed level of consciousness 12.10 12.03 45 19936 62033 63407008
Aortic valve calcification 12.09 12.03 5 19976 534 63468507

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 93.69 12.49 417 16917 397632 34541965
Anticholinergic syndrome 60.41 12.49 23 17311 1246 34938351
Cardiac arrest 58.72 12.49 140 17194 96019 34843578
Diarrhoea 57.94 12.49 360 16974 389552 34550045
Hyperthermia malignant 57.82 12.49 26 17308 2151 34937446
Bradycardia 54.03 12.49 117 17217 75301 34864296
Therapy interrupted 50.76 12.49 47 17287 13650 34925947
Dehydration 45.71 12.49 155 17179 129814 34809783
Tachycardia 43.94 12.49 116 17218 84656 34854941
Pulse absent 40.90 12.49 29 17305 5774 34933823
Electrocardiogram QRS complex prolonged 38.10 12.49 26 17308 4868 34934729
Cholinergic syndrome 36.68 12.49 13 17321 574 34939023
Emotional disorder 34.47 12.49 26 17308 5690 34933907
Vasoplegia syndrome 33.50 12.49 17 17317 1839 34937758
Mouth ulceration 33.21 12.49 35 17299 11875 34927722
Alopecia 33.16 12.49 50 17284 24305 34915292
Change of bowel habit 32.70 12.49 14 17320 1029 34938568
Corneal oedema 32.31 12.49 15 17319 1336 34938261
Stress cardiomyopathy 31.84 12.49 17 17317 2042 34937555
Stoma site pain 31.14 12.49 12 17322 672 34938925
Therapy cessation 30.79 12.49 40 17294 16933 34922664
Oral pain 28.74 12.49 31 17303 10796 34928801
Hypertension 28.17 12.49 138 17196 136305 34803292
Arteriospasm coronary 26.41 12.49 18 17316 3364 34936233
Foot fracture 26.32 12.49 21 17313 4990 34934607
Pupil fixed 25.43 12.49 14 17320 1787 34937810
Mydriasis 25.21 12.49 24 17310 7213 34932384
Tendon disorder 24.12 12.49 16 17318 2859 34936738
Rebound psychosis 23.44 12.49 7 17327 178 34939419
Compartment syndrome 23.41 12.49 16 17318 3002 34936595
Exostosis 23.13 12.49 19 17315 4704 34934893
Intraocular pressure increased 22.96 12.49 20 17314 5363 34934234
Ileus 22.63 12.49 34 17300 16465 34923132
Dermatitis acneiform 22.47 12.49 21 17313 6168 34933429
Anaesthetic complication 22.41 12.49 11 17323 1109 34938488
Blood creatinine decreased 21.43 12.49 15 17319 2926 34936671
Choroidal detachment 21.36 12.49 8 17326 414 34939183
Endophthalmitis 21.25 12.49 16 17318 3492 34936105
Acute pulmonary oedema 21.22 12.49 22 17312 7321 34932276
Ankle fracture 21.05 12.49 17 17317 4108 34935489
Surgery 20.61 12.49 30 17304 14127 34925470
Blood pressure decreased 20.37 12.49 64 17270 51451 34888146
Limb mass 20.33 12.49 9 17325 717 34938880
Retinal occlusive vasculitis 20.21 12.49 4 17330 15 34939582
Keratic precipitates 20.04 12.49 6 17328 154 34939443
Coma scale abnormal 19.37 12.49 16 17318 3992 34935605
Laryngospasm 19.24 12.49 11 17323 1510 34938087
Arthralgia 18.62 12.49 35 17299 170006 34769591
Dysarthria 18.41 12.49 48 17286 34734 34904863
Ventricular fibrillation 18.02 12.49 37 17297 22917 34916680
Product use in unapproved indication 18.02 12.49 19 17315 117480 34822117
Anaphylactic shock 17.93 12.49 30 17304 15911 34923686
Foot deformity 17.64 12.49 16 17318 4521 34935076
Cardiogenic shock 17.57 12.49 40 17294 26578 34913019
Prinzmetal angina 17.43 12.49 9 17325 1010 34938587
Sinus tachycardia 17.34 12.49 31 17303 17329 34922268
Proteinuria 17.00 12.49 32 17302 18610 34920987
Hypotension 16.90 12.49 176 17158 221473 34718124
Agitation postoperative 16.78 12.49 4 17330 41 34939556
Vomiting 16.76 12.49 192 17142 247429 34692168
Decreased appetite 16.63 12.49 140 17194 166252 34773345
Neuromuscular block prolonged 16.62 12.49 7 17327 494 34939103
Post procedural complication 16.38 12.49 24 17310 11364 34928233
Atrioventricular block 16.20 12.49 20 17314 8043 34931554
Visual acuity tests abnormal 16.05 12.49 4 17330 50 34939547
Respiration abnormal 16.02 12.49 13 17321 3163 34936434
Apnoea 15.82 12.49 18 17316 6646 34932951
Scleritis 15.82 12.49 7 17327 557 34939040
Brain stem syndrome 15.81 12.49 7 17327 558 34939039
Hypocapnia 15.36 12.49 5 17329 170 34939427
Nail bed inflammation 15.27 12.49 5 17329 173 34939424
Drug abuse 15.22 12.49 16 17318 99080 34840517
Salivary hypersecretion 15.10 12.49 20 17314 8624 34930973
Blood sodium increased 15.09 12.49 12 17322 2836 34936761
Angle closure glaucoma 15.08 12.49 8 17326 949 34938648
Shock 14.50 12.49 35 17299 24144 34915453
Dysprosody 14.46 12.49 3 17331 15 34939582
Anterior chamber flare 14.45 12.49 4 17330 77 34939520
Nausea 14.24 12.49 242 17092 339666 34599931
Peritumoural oedema 14.15 12.49 3 17331 17 34939580
Intentional product use issue 14.09 12.49 6 17328 59810 34879787
Treatment failure 14.04 12.49 3 17331 46694 34892903
Drug intolerance 13.99 12.49 6 17328 59564 34880033
Hypoxic-ischaemic encephalopathy 13.86 12.49 14 17320 4518 34935079
Hyperhidrosis 13.81 12.49 74 17260 75618 34863979
Anaphylactic reaction 13.57 12.49 41 17293 32260 34907337
Nasopharyngitis 13.57 12.49 9 17325 69959 34869638
Influenza 13.37 12.49 4 17330 49662 34889935
Ventricular tachycardia 13.37 12.49 36 17298 26543 34913054
Interstitial lung disease 13.21 12.49 8 17326 65274 34874323
Jugular vein thrombosis 13.09 12.49 9 17325 1706 34937891
Flushing 12.56 12.49 40 17294 32380 34907217

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 200.46 12.06 133 30076 31208 79682971
Death 185.05 12.06 551 29658 565963 79148216
Stress cardiomyopathy 183.44 12.06 88 30121 11078 79703101
Cardiac arrest 129.43 12.06 233 29976 171863 79542316
Bradycardia 122.28 12.06 199 30010 135358 79578821
Therapy cessation 117.23 12.06 104 30105 37458 79676721
Anticholinergic syndrome 93.05 12.06 39 30170 3572 79710607
Hypotension 86.71 12.06 363 29846 439954 79274225
Hyperthermia malignant 83.62 12.06 34 30175 2883 79711296
Arthralgia 73.75 12.06 65 30144 571738 79142441
Diarrhoea 67.76 12.06 566 29643 879923 78834256
Vasoplegia syndrome 63.87 12.06 30 30179 3600 79710579
Dehydration 62.17 12.06 221 29988 247966 79466213
Cardiogenic shock 58.94 12.06 76 30133 41838 79672341
Surgery 58.42 12.06 67 30142 32699 79681480
Endophthalmitis 55.47 12.06 33 30176 6395 79707784
Drug intolerance 54.84 12.06 16 30193 264103 79450076
Nasopharyngitis 53.41 12.06 15 30194 253866 79460313
Mydriasis 53.35 12.06 48 30161 17595 79696584
Anterior spinal artery syndrome 52.95 12.06 12 30197 130 79714049
Tachycardia 48.58 12.06 163 30046 177605 79536574
Pulse absent 48.53 12.06 36 30173 10067 79704112
Dysarthria 47.52 12.06 89 30120 67533 79646646
Peripheral swelling 46.47 12.06 22 30187 269595 79444584
Rebound psychosis 45.89 12.06 13 30196 361 79713818
Contraindicated product administered 44.92 12.06 4 30205 157534 79556645
Arteriospasm coronary 44.13 12.06 29 30180 6687 79707492
Corneal oedema 44.09 12.06 21 30188 2599 79711580
Joint swelling 43.31 12.06 28 30181 288618 79425561
Ventricular tachycardia 41.11 12.06 64 30145 41871 79672308
Neuromuscular block prolonged 40.13 12.06 15 30194 1015 79713164
Treatment failure 39.93 12.06 8 30201 170478 79543701
Anaesthetic complication 39.41 12.06 20 30189 2839 79711340
Ventricular fibrillation 38.92 12.06 54 30155 31872 79682307
Intentional product use issue 38.10 12.06 6 30203 152106 79562073
Anorectal disorder 37.44 12.06 18 30191 2275 79711904
Sinus tachycardia 37.12 12.06 57 30152 36851 79677328
Paraesthesia oral 36.73 12.06 42 30167 20429 79693750
Arthropathy 36.26 12.06 11 30198 177100 79537079
Rheumatoid arthritis 35.93 12.06 17 30192 208453 79505726
Anterior chamber flare 35.79 12.06 9 30200 156 79714023
Pulmonary oedema 35.64 12.06 93 30116 88161 79626018
Haemodynamic instability 35.21 12.06 38 30171 17344 79696835
Abdominal discomfort 34.10 12.06 27 30182 250700 79463479
Dermatitis acneiform 33.84 12.06 29 30180 9964 79704215
Intraocular pressure increased 33.83 12.06 28 30181 9177 79705002
Apnoea 33.73 12.06 31 30178 11673 79702506
Cholinergic syndrome 32.29 12.06 13 30196 1074 79713105
Systemic lupus erythematosus 32.16 12.06 4 30205 121145 79593034
Rhythm idioventricular 31.48 12.06 11 30198 613 79713566
Choroidal detachment 31.28 12.06 11 30198 625 79713554
Spinal cord injury 30.10 12.06 13 30196 1282 79712897
Pupil fixed 29.97 12.06 18 30191 3548 79710631
Anaphylactic shock 29.93 12.06 51 30158 35945 79678234
Macular degeneration 28.89 12.06 28 30181 11268 79702911
Disseminated intravascular coagulation 28.78 12.06 50 30159 35792 79678387
Pericarditis 28.78 12.06 3 30206 104233 79609946
Swelling 28.64 12.06 24 30185 216687 79497492
Post procedural complication 28.59 12.06 40 30169 23789 79690390
Polydipsia 28.33 12.06 22 30187 6583 79707596
Respiratory depression 28.24 12.06 43 30166 27587 79686592
Laryngospasm 28.08 12.06 18 30191 3979 79710200
Product use issue 28.02 12.06 23 30186 209799 79504380
Atrioventricular block complete 27.99 12.06 33 30176 16577 79697602
Electrocardiogram QRS complex prolonged 27.98 12.06 27 30182 10806 79703373
Shock 27.75 12.06 55 30154 43493 79670686
Chronic sinusitis 27.30 12.06 29 30180 12997 79701182
Hospitalisation 27.14 12.06 88 30121 94148 79620031
Coma scale abnormal 27.01 12.06 24 30185 8654 79705525
Hypertension 27 12.06 216 29993 330776 79383403
Seizure 26.29 12.06 141 30068 188693 79525486
Blood pressure decreased 26.09 12.06 90 30119 99376 79614803
Glossodynia 26.04 12.06 4 30205 103333 79610846
Therapeutic product effect decreased 25.81 12.06 15 30194 163848 79550331
Ileus 25.68 12.06 40 30169 26171 79688008
Sinusitis 25.40 12.06 22 30187 195479 79518700
Acute pulmonary oedema 25.20 12.06 29 30180 14201 79699978
Anaphylactic reaction 24.84 12.06 79 30130 83664 79630515
Hypovolaemia 24.74 12.06 32 30177 17659 79696520
Atrioventricular block second degree 24.32 12.06 21 30188 7291 79706888
Compartment syndrome 24.17 12.06 18 30191 5064 79709115
Delayed recovery from anaesthesia 23.93 12.06 12 30197 1661 79712518
Coma 23.77 12.06 88 30121 100561 79613618
Discomfort 23.62 12.06 9 30200 125608 79588571
Musculoskeletal stiffness 23.59 12.06 19 30190 174989 79539190
Enzyme induction 23.29 12.06 6 30203 115 79714064
Hypoxic-ischaemic encephalopathy 23.10 12.06 21 30188 7799 79706380
Drug monitoring procedure not performed 23.01 12.06 10 30199 1001 79713178
Completed suicide 22.95 12.06 36 30173 245731 79468448
Back pain 22.73 12.06 51 30158 304129 79410050
Sinus bradycardia 22.63 12.06 37 30172 25210 79688969
Hyperhidrosis 22.38 12.06 115 30094 151377 79562802
Ventricular asystole 22.00 12.06 7 30202 291 79713888
Weight increased 21.98 12.06 45 30164 277341 79436838
Wound 20.75 12.06 9 30200 116170 79598009
Keratic precipitates 20.65 12.06 7 30202 356 79713823
Pain in extremity 20.61 12.06 70 30139 364468 79349711
Pulseless electrical activity 20.41 12.06 26 30183 14134 79700045
Supraventricular tachycardia 20.20 12.06 32 30177 21238 79692941
Electrocardiogram ST segment elevation 19.96 12.06 20 30189 8377 79705802
Angle closure glaucoma 19.92 12.06 13 30196 2963 79711216
Hepatic enzyme increased 19.80 12.06 24 30185 182586 79531593
Cardiac assistance device user 19.76 12.06 5 30204 89 79714090
Intestinal obstruction 19.09 12.06 47 30162 42973 79671206
Corneal perforation 18.86 12.06 8 30201 755 79713424
Hypopyon 18.75 12.06 9 30200 1133 79713046
Lower respiratory tract infection 18.74 12.06 13 30196 129207 79584972
Paralysis 18.68 12.06 24 30185 13153 79701026
Product dose omission issue 18.08 12.06 42 30167 247495 79466684
Vomiting 17.71 12.06 352 29857 665476 79048703
Sinus arrest 17.61 12.06 13 30196 3609 79710570
Hyphaema 17.55 12.06 8 30201 896 79713283
Influenza 17.55 12.06 14 30195 129592 79584587
Neuromuscular blockade 17.45 12.06 7 30202 573 79713606
Generalised tonic-clonic seizure 17.44 12.06 46 30163 43864 79670315
Synovitis 17.22 12.06 19 30190 150715 79563464
Cataract subcapsular 17.08 12.06 8 30201 953 79713226
Flat anterior chamber of eye 17.06 12.06 5 30204 157 79714022
Blood pressure systolic decreased 17.02 12.06 21 30188 11055 79703124
Anterior segment ischaemia 16.77 12.06 4 30205 55 79714124
Loss of personal independence in daily activities 16.71 12.06 9 30200 102571 79611608
Muscle twitching 16.66 12.06 32 30177 24732 79689447
Vaginal flatulence 16.63 12.06 11 30198 2564 79711615
Bronchospasm 16.57 12.06 32 30177 24827 79689352
Blood calcium decreased 16.56 12.06 37 30172 31782 79682397
Rash 16.50 12.06 140 30069 578218 79135961
Ventricular extrasystoles 16.49 12.06 28 30181 19676 79694503
Bundle branch block left 16.37 12.06 21 30188 11492 79702687
Sedation 16.35 12.06 50 30159 51845 79662334
Atrioventricular block 16.00 12.06 23 30186 14018 79700161
N-terminal prohormone brain natriuretic peptide 15.93 12.06 4 30205 69 79714110
Retinal occlusive vasculitis 15.82 12.06 4 30205 71 79714108
Injection site erythema 15.74 12.06 5 30204 78192 79635987
Procedural pain 15.74 12.06 30 30179 23054 79691125
Kounis syndrome 15.68 12.06 13 30196 4269 79709910
Intentional dose omission 15.66 12.06 18 30191 8799 79705380
Sedation complication 15.47 12.06 24 30185 15645 79698534
Interstitial lung disease 15.45 12.06 12 30197 112588 79601591
Prinzmetal angina 15.28 12.06 9 30200 1711 79712468
Dysprosody 15.27 12.06 3 30206 15 79714164
Pressure of speech 15.22 12.06 8 30201 1220 79712959
Fibromyalgia 15.10 12.06 3 30206 64337 79649842
Tendon disorder 15.06 12.06 16 30193 7170 79707009
Malnutrition 15.04 12.06 29 30180 22473 79691706
Judgement impaired 14.80 12.06 8 30201 1292 79712887
Thrombocytopenic purpura 14.63 12.06 10 30199 2459 79711720
Metabolic acidosis 14.60 12.06 66 30143 82463 79631716
Purpura senile 14.59 12.06 6 30203 524 79713655
Headache 14.57 12.06 168 30041 653604 79060575
Tarsal tunnel syndrome 14.52 12.06 6 30203 530 79713649
Iris adhesions 14.41 12.06 6 30203 540 79713639
Peritumoural oedema 14.41 12.06 3 30206 21 79714158
Cardio-respiratory arrest 14.40 12.06 80 30129 108430 79605749
Salivary hypersecretion 14.34 12.06 22 30187 14202 79699977
Hirsutism 14.34 12.06 8 30201 1374 79712805
Needle issue 14.30 12.06 21 30188 13047 79701132
Large intestinal obstruction 14.18 12.06 11 30198 3288 79710891
Injection site pain 14.14 12.06 17 30192 129821 79584358
Pupillary reflex impaired 14.02 12.06 11 30198 3342 79710837
Myalgia 13.96 12.06 31 30178 185610 79528569
Therapeutic response decreased 13.95 12.06 4 30205 66849 79647330
Visual acuity tests abnormal 13.89 12.06 4 30205 118 79714061
Seasonal affective disorder 13.86 12.06 5 30204 306 79713873
Restrictive cardiomyopathy 13.74 12.06 7 30202 1001 79713178
Keratitis fungal 13.66 12.06 5 30204 319 79713860
pH body fluid abnormal 13.61 12.06 4 30205 127 79714052
Fibrinolysis increased 13.55 12.06 3 30206 29 79714150
Bradycardia foetal 13.52 12.06 4 30205 130 79714049
Chemical submission 13.47 12.06 5 30204 332 79713847
Limb mass 13.33 12.06 11 30198 3588 79710591
Vitreous opacities 13.19 12.06 6 30203 669 79713510
Abdominal pain 13.18 12.06 214 29995 389355 79324824
Choroidal effusion 13.17 12.06 6 30203 671 79713508
Failure to thrive 12.91 12.06 19 30190 11825 79702354
Panophthalmitis 12.84 12.06 4 30205 155 79714024
Corneal epithelium defect 12.83 12.06 6 30203 713 79713466
Musculoskeletal pain 12.71 12.06 12 30197 102342 79611837
Keratitis bacterial 12.67 12.06 4 30205 162 79714017
Antipsychotic drug level decreased 12.47 12.06 7 30202 1217 79712962
Agitated depression 12.27 12.06 5 30204 426 79713753
Atrioventricular block first degree 12.15 12.06 19 30190 12472 79701707

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

DiseaseRelationSNOMED_IDDOID
Perioperative Mydriasis indication




🐶 Veterinary Drug Use

SpeciesUseRelation
Rodents Treatment of Syphacia obvelata (pinworm) Indication

🐶 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
0.4MG/ML (0.4MG/ML) ATROPINE SULFATE AM REGENT A216120 May 26, 2022 RX SOLUTION INTRAVENOUS Jan. 29, 2023 COMPETITIVE GENERIC THERAPY
1MG/ML (1MG/ML) ATROPINE SULFATE AM REGENT A216120 May 26, 2022 RX SOLUTION INTRAVENOUS Jan. 29, 2023 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
372832002 SNOMEDCT_US
73949004 SNOMEDCT_US
74237004 SNOMEDCT_US
4017410 VANDF
4019591 VANDF
001715 NDDF
001717 NDDF

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
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 21 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0054-3194 SOLUTION 0.03 mg ORAL ANDA 21 sections
Isopto Atropine HUMAN PRESCRIPTION DRUG LABEL 1 0065-0303 SOLUTION 10 mg OPHTHALMIC NDA 26 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
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 0404-9821 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 0404-9822 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 0404-9823 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
ATROPINE SULFATE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9990 INJECTION 0.40 mg ENDOTRACHEAL ANDA 15 sections
Diphenoxylate Hydrochloride and Atropine Sulfate HUMAN PRESCRIPTION DRUG LABEL 2 0406-1236 TABLET 0.03 mg ORAL ANDA 23 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 0517-1001 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 23 sections