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

Stem definitionDrug idCAS RN
mucolytics 66 616-91-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • N-Acetylcysteine
  • acetylcysteine
  • acetadote
  • acetilcysteina
  • L-Acetylcysteine
The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates. N-Acetylcystene (NAC) as a precursor to the antioxidant glutathione modulates glutamatergic, neurotrophic, and inflammatory pathways. The potential applications of NAC to facilitate recovery after traumatic brain injury, cerebral ischemia, and in treatment of cerebrovascular vasospasm after subarachnoid hemorrhage.
  • Molecular weight: 163.19
  • Formula: C5H9NO3S
  • CLOGP: -0.62
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 66.40
  • ALOGS: -1.51
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.60 g Inhal.solution
0.50 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 61.28 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 5 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.55 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.17 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1963 FDA APOTHECON

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
Body tinea 116.92 14.12 32 11721 1295 50592076
Infection susceptibility increased 99.88 14.12 33 11720 2551 50590820
Inhibitory drug interaction 96.37 14.12 31 11722 2202 50591169
Glucose tolerance impaired 77.91 14.12 33 11720 5085 50588286
Impaired quality of life 75.75 14.12 34 11719 6022 50587349
Bone density decreased 61.62 14.12 36 11717 11039 50582332
Purpura 57.22 14.12 33 11720 9878 50583493
Poor quality sleep 50.48 14.12 37 11716 16609 50576762
Stevens-Johnson syndrome 49.95 14.12 41 11712 21711 50571660
Hyperlipidaemia 48.85 14.12 37 11716 17453 50575918
Oral herpes 43.32 14.12 37 11716 20688 50572683
Toxic epidermal necrolysis 42.91 14.12 37 11716 20955 50572416
Chronic obstructive pulmonary disease 40.87 14.12 56 11697 53379 50539992
Impaired work ability 40.64 14.12 30 11723 13610 50579761
Tongue oedema 40.03 14.12 19 11734 3820 50589551
Hepatic encephalopathy 40.03 14.12 26 11727 9610 50583761
Metabolic acidosis 39.68 14.12 47 11706 38778 50554593
Drug interaction 34.23 14.12 113 11640 199508 50393863
Joint swelling 33.37 14.12 8 11745 245278 50348093
Skin disorder 33.05 14.12 34 11719 23996 50569375
Anaphylactoid reaction 32.91 14.12 16 11737 3390 50589981
Acute hepatic failure 32.79 14.12 28 11725 15649 50577722
Pneumonia 31.68 14.12 172 11581 378229 50215142
Thrombocytopenia 31.18 14.12 82 11671 127591 50465780
Hypercapnia 31.03 14.12 17 11736 4610 50588761
Immune-mediated pancreatitis 30.31 14.12 6 11747 55 50593316
Hepatotoxicity 29.55 14.12 34 11719 27192 50566179
Rash maculo-papular 28.46 14.12 33 11720 26608 50566763
Brain oedema 27.73 14.12 23 11730 12347 50581024
Drug-induced liver injury 27.04 14.12 33 11720 28062 50565309
Congenital central hypoventilation syndrome 26.98 14.12 5 11748 31 50593340
Rheumatoid arthritis 26.78 14.12 7 11746 202543 50390828
Respiratory failure 25.85 14.12 62 11691 91119 50502252
Erysipelas 25.43 14.12 17 11736 6591 50586780
Sputum increased 25.01 14.12 11 11742 1856 50591515
Herpes simplex hepatitis 24.62 14.12 7 11746 326 50593045
Postresuscitation encephalopathy 23.93 14.12 4 11749 12 50593359
Arthropathy 23.86 14.12 4 11749 157902 50435469
Arthralgia 23.73 14.12 41 11712 438661 50154710
Model for end stage liver disease score increased 23.46 14.12 4 11749 14 50593357
Coma 23.41 14.12 45 11708 56834 50536537
Cataract 22.71 14.12 40 11713 47260 50546111
Systemic lupus erythematosus 22.53 14.12 3 11750 140619 50452752
Pain 22.42 14.12 65 11688 578838 50014533
Post procedural haematoma 22.41 14.12 9 11744 1211 50592160
Contraindicated product administered 22.01 14.12 4 11749 148954 50444417
Tongue exfoliation 21.88 14.12 5 11748 95 50593276
Product dose omission issue 21.35 14.12 8 11745 183830 50409541
Toxicity to various agents 20.80 14.12 101 11652 212398 50380973
Face oedema 20.58 14.12 23 11730 17816 50575555
Coagulopathy 20.47 14.12 23 11730 17921 50575450
Respiratory distress 20.42 14.12 30 11723 30459 50562912
Musculoskeletal stiffness 19.98 14.12 3 11750 128478 50464893
Oliguria 19.94 14.12 16 11737 8200 50585171
Treatment failure 19.69 14.12 4 11749 137633 50455738
Chronic hepatitis C 19.46 14.12 5 11748 158 50593213
Overdose 19.38 14.12 59 11694 99668 50493703
Jaundice 19.15 14.12 27 11726 26402 50566969
Respiratory tract oedema 18.43 14.12 6 11747 442 50592929
Infective pulmonary exacerbation of cystic fibrosis 18.34 14.12 15 11738 7894 50585477
Cellulitis 17.80 14.12 46 11707 70752 50522619
Leukocytosis 17.76 14.12 24 11729 22555 50570816
Hepatic failure 17.75 14.12 29 11724 32254 50561117
Urogenital haemorrhage 17.46 14.12 5 11748 239 50593132
Therapeutic product effect decreased 17.41 14.12 5 11748 136045 50457326
Acute kidney injury 17.26 14.12 101 11652 227957 50365414
Hepatitis fulminant 17.13 14.12 10 11743 3058 50590313
Abscess rupture 17.13 14.12 5 11748 256 50593115
Swelling 17.09 14.12 13 11740 200859 50392512
Brain herniation 17.06 14.12 10 11743 3082 50590289
Adrenocorticotropic hormone deficiency 16.99 14.12 5 11748 263 50593108
Autoimmune hepatitis 16.90 14.12 14 11739 7505 50585866
Bronchospasm 16.88 14.12 19 11734 14835 50578536
Lip pain 16.77 14.12 8 11745 1626 50591745
Anaphylactic shock 16.74 14.12 22 11731 20133 50573238
Activated partial thromboplastin time prolonged 16.68 14.12 13 11740 6389 50586982
Dose calculation error 16.46 14.12 4 11749 100 50593271
Injection site pain 16.35 14.12 3 11750 111021 50482350
Intentional overdose 16.12 14.12 41 11712 62463 50530908
Macroangiopathy 16.10 14.12 4 11749 110 50593261
Junctional ectopic tachycardia 16.00 14.12 4 11749 113 50593258
Acute respiratory distress syndrome 15.95 14.12 22 11731 21077 50572294
Pyrexia 15.86 14.12 146 11607 380057 50213314
Decerebrate posture 15.80 14.12 4 11749 119 50593252
Angioedema 15.73 14.12 30 11723 37646 50555725
General physical health deterioration 15.61 14.12 70 11683 142364 50451007
Delirium 15.45 14.12 30 11723 38162 50555209
Brain death 15.35 14.12 9 11744 2774 50590597
Drug intolerance 15.30 14.12 17 11736 219087 50374284
Flank pain 15.28 14.12 17 11736 13098 50580273
Glossodynia 15.25 14.12 4 11749 115565 50477806
Dyspnoea 14.86 14.12 193 11560 547415 50045956
Herpes zoster 14.81 14.12 43 11710 70743 50522628
Respiratory tract haemorrhage 14.61 14.12 5 11748 430 50592941
Normochromic normocytic anaemia 14.37 14.12 10 11743 4136 50589235
Bronchial secretion retention 14.30 14.12 7 11746 1506 50591865
Poisoning deliberate 14.28 14.12 13 11740 7899 50585472
Medication error 14.16 14.12 28 11725 36076 50557295
Haemolytic uraemic syndrome 14.13 14.12 8 11745 2311 50591060

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
Congenital hiatus hernia 88.89 12.65 23 11954 419 29562131
Toxic epidermal necrolysis 73.43 12.65 60 11917 18093 29544457
Dyspnoea 60.11 12.65 276 11701 326456 29236094
Breath sounds abnormal 55.78 12.65 32 11945 5425 29557125
Pneumonia 53.42 12.65 263 11714 319909 29242641
General physical health deterioration 49.95 12.65 121 11856 102736 29459814
Bronchiectasis 47.75 12.65 31 11946 6554 29555996
Chronic obstructive pulmonary disease 46.06 12.65 69 11908 40886 29521664
Stevens-Johnson syndrome 45.68 12.65 44 11933 16453 29546097
Productive cough 32.79 12.65 51 11926 31208 29531342
Dermatillomania 27.82 12.65 6 11971 47 29562503
Malignant melanoma in situ 27.03 12.65 12 11965 1182 29561368
Cell death 26.43 12.65 14 11963 2030 29560520
Product dose omission issue 25.97 12.65 4 11973 96379 29466171
Cyanosis 25.59 12.65 27 11950 11240 29551310
Respiratory failure 23.93 12.65 90 11887 97041 29465509
Bilirubin conjugated abnormal 23.91 12.65 6 11971 96 29562454
Systemic infection 23.30 12.65 13 11964 2088 29560462
Klebsiella infection 23.02 12.65 21 11956 7328 29555222
Benign prostatic hyperplasia 23.00 12.65 26 11951 11684 29550866
Transient ischaemic attack 21.70 12.65 36 11941 23234 29539316
Completed suicide 21.64 12.65 5 11972 90241 29472309
Middle ear inflammation 20.44 12.65 3 11974 0 29562550
Cough 18.80 12.65 101 11876 126626 29435924
Wrong dose 18.54 12.65 7 11970 455 29562095
Oral herpes 18.36 12.65 15 11962 4517 29558033
Asthma 17.66 12.65 41 11936 33808 29528742
Medication error 17.40 12.65 31 11946 21180 29541370
Acute respiratory failure 17.22 12.65 35 11942 26367 29536183
Product prescribing error 17.02 12.65 28 11949 17948 29544602
Bronchospasm 16.64 12.65 20 11957 9589 29552961
Deafness bilateral 16.34 12.65 8 11969 983 29561567
Nikolsky's sign 16.05 12.65 5 11972 181 29562369
Death 15.89 12.65 78 11899 342006 29220544
Kidney rupture 15.67 12.65 5 11972 196 29562354
Pyrexia 15.44 12.65 181 11796 287441 29275109
Sputum purulent 15.29 12.65 6 11971 433 29562117
Prader-Willi syndrome 15.24 12.65 3 11974 14 29562536
Acidosis 14.88 12.65 19 11958 9686 29552864
Hypokalaemia 14.47 12.65 49 11928 50154 29512396
Graft loss 14.45 12.65 7 11970 841 29561709
Multiple organ dysfunction syndrome 14.32 12.65 57 11920 63059 29499491
Skin odour abnormal 14.23 12.65 7 11970 869 29561681
Electrocardiogram abnormal 13.94 12.65 16 11961 7306 29555244
Septic shock 13.79 12.65 56 11921 62504 29500046
Anaphylactoid reaction 13.71 12.65 9 11968 1936 29560614
Full blood count abnormal 13.69 12.65 23 11954 14990 29547560
Intestinal prolapse 13.59 12.65 4 11973 119 29562431
Drug abuse 13.20 12.65 8 11969 79875 29482675
Chronic hepatitis C 13.03 12.65 5 11972 340 29562210
Empyema 12.97 12.65 10 11967 2769 29559781
Wheezing 12.90 12.65 36 11941 33204 29529346
Increased bronchial secretion 12.85 12.65 8 11969 1573 29560977
Haemoptysis 12.76 12.65 34 11943 30516 29532034
Mucosal erosion 12.68 12.65 6 11971 684 29561866
Impaired healing 12.67 12.65 21 11956 13537 29549013

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
Body tinea 102.79 12.75 31 20917 1262 64476522
Toxic epidermal necrolysis 97.04 12.75 87 20861 37079 64440705
Congenital hiatus hernia 89.87 12.75 22 20926 400 64477384
Infection susceptibility increased 87.31 12.75 33 20915 2693 64475091
Stevens-Johnson syndrome 85.15 12.75 78 20870 34171 64443613
Inhibitory drug interaction 78.18 12.75 33 20915 3594 64474190
Pneumonia 74.20 12.75 368 20580 559208 63918576
Chronic obstructive pulmonary disease 65.49 12.75 97 20851 70951 64406833
Glucose tolerance impaired 62.91 12.75 34 20914 6409 64471375
Impaired quality of life 60.00 12.75 33 20915 6438 64471346
General physical health deterioration 52.75 12.75 166 20782 204259 64273525
Oral herpes 52.24 12.75 49 20899 22103 64455681
Bone density decreased 49.26 12.75 34 20914 9918 64467866
Dyspnoea 46.85 12.75 395 20553 718279 63759505
Respiratory failure 44.46 12.75 134 20814 161049 64316735
Breath sounds abnormal 42.23 12.75 33 20915 11636 64466148
Completed suicide 39.33 12.75 12 20936 224402 64253382
Tongue oedema 38.26 12.75 24 20924 5966 64471818
Anaphylactoid reaction 38.07 12.75 22 20926 4716 64473068
Product dose omission issue 36.77 12.75 9 20939 194738 64283046
Purpura 36.60 12.75 36 20912 17210 64460574
Acute hepatic failure 35.32 12.75 43 20905 26069 64451715
Joint swelling 35.15 12.75 13 20935 215369 64262415
Bronchiectasis 34.73 12.75 32 20916 14108 64463676
Metabolic acidosis 34.27 12.75 73 20875 70885 64406899
Poor quality sleep 33.76 12.75 36 20912 18915 64458869
Hepatotoxicity 33.19 12.75 52 20896 39910 64437874
Impaired work ability 32.73 12.75 32 20916 15187 64462597
Brain oedema 32.57 12.75 38 20910 22037 64455747
Bronchospasm 31.45 12.75 37 20911 21645 64456139
Arthralgia 31.43 12.75 60 20888 442200 64035584
Benign prostatic hyperplasia 31.19 12.75 25 20923 9140 64468644
Chronic hepatitis C 30.56 12.75 10 20938 533 64477251
Thrombocytopenia 28.64 12.75 146 20802 223655 64254129
Acute respiratory failure 28.42 12.75 55 20893 49879 64427905
Rheumatoid arthritis 28.39 12.75 9 20939 164285 64313499
Hyperlipidaemia 28.13 12.75 36 20912 22940 64454844
Pain 27.70 12.75 90 20858 553421 63924363
Productive cough 27.28 12.75 68 20880 73135 64404649
Arthropathy 26.18 12.75 4 20944 120963 64356821
Congenital central hypoventilation syndrome 25.30 12.75 5 20943 31 64477753
Bilirubin conjugated abnormal 25.11 12.75 6 20942 98 64477686
Immune-mediated pancreatitis 25.06 12.75 6 20942 99 64477685
Multiple organ dysfunction syndrome 24.88 12.75 81 20867 101332 64376452
Leukocytosis 24.52 12.75 44 20904 37696 64440088
Anion gap 24.43 12.75 12 20936 1855 64475929
Skin disorder 24.36 12.75 37 20911 27643 64450141
Sputum increased 24.32 12.75 15 20933 3620 64474164
Hepatic encephalopathy 24.22 12.75 32 20916 21034 64456750
Product prescribing error 24.05 12.75 42 20906 35227 64442557
Medication error 23.66 12.75 51 20897 49915 64427869
Pyrexia 23.60 12.75 281 20667 558363 63919421
Acute respiratory distress syndrome 23.53 12.75 44 20904 38891 64438893
Jaundice 23.53 12.75 50 20898 48462 64429322
Hepatitis fulminant 23.26 12.75 18 20930 6256 64471528
Middle ear inflammation 22.59 12.75 4 20944 12 64477772
Model for end stage liver disease score increased 22.12 12.75 4 20944 14 64477770
Post procedural haematoma 22.08 12.75 12 20936 2286 64475498
Respiratory distress 22.07 12.75 51 20897 52280 64425504
Drug interaction 21.87 12.75 196 20752 361887 64115897
Malignant melanoma in situ 21.75 12.75 11 20937 1809 64475975
Cyanosis 21.49 12.75 31 20917 22124 64455660
Graft loss 21.16 12.75 9 20939 998 64476786
Dermatillomania 21.10 12.75 6 20942 198 64477586
Musculoskeletal stiffness 20.84 12.75 7 20941 123199 64354585
Respiratory tract haemorrhage 20.81 12.75 10 20938 1474 64476310
Pain in extremity 20.74 12.75 42 20906 303043 64174741
Cell death 20.42 12.75 14 20934 4040 64473744
Herpes simplex hepatitis 20.31 12.75 7 20941 438 64477346
Hypercapnia 20.05 12.75 18 20930 7676 64470108
Drug intolerance 19.92 12.75 19 20929 187973 64289811
Klebsiella infection 19.82 12.75 23 20925 13258 64464526
Angioedema 19.53 12.75 54 20894 61767 64416017
Autoimmune hepatitis 19.47 12.75 20 20928 10064 64467720
Coagulopathy 19.20 12.75 36 20912 31884 64445900
Face oedema 18.88 12.75 31 20917 24730 64453054
Postresuscitation encephalopathy 18.83 12.75 4 20944 37 64477747
Hypokalaemia 18.82 12.75 84 20864 121819 64355965
Lip pain 18.73 12.75 10 20938 1839 64475945
Tongue exfoliation 18.62 12.75 5 20943 133 64477651
Haemolytic uraemic syndrome 18.18 12.75 13 20935 4008 64473776
Hepatic failure 18.11 12.75 49 20899 55345 64422439
Dose calculation error 17.92 12.75 5 20943 154 64477630
Injection site pain 17.71 12.75 7 20941 111401 64366383
Drug-induced liver injury 17.48 12.75 44 20904 47599 64430185
Systemic infection 17.35 12.75 13 20935 4308 64473476
Septic shock 17.30 12.75 74 20874 105363 64372421
Lower respiratory tract infection 16.67 12.75 5 20943 94609 64383175
Abdominal discomfort 16.48 12.75 21 20927 182301 64295483
Hypoxia 16.14 12.75 64 20884 88085 64389699
Swelling 16.05 12.75 17 20931 160201 64317583
Treatment failure 16.01 12.75 9 20939 116807 64360977
Cholestasis 16.00 12.75 41 20907 44831 64432953
Prader-Willi syndrome 15.90 12.75 3 20945 14 64477770
Deafness bilateral 15.85 12.75 9 20939 1867 64475917
Systemic lupus erythematosus 15.83 12.75 3 20945 77609 64400175
Erysipelas 15.73 12.75 17 20931 9064 64468720
Blood immunoglobulin E decreased 15.41 12.75 4 20944 93 64477691
Alanine aminotransferase increased 15.25 12.75 87 20861 138944 64338840
Diarrhoea 15.14 12.75 156 20792 722548 63755236
Abscess rupture 14.89 12.75 5 20943 289 64477495
Rash maculo-papular 14.78 12.75 41 20907 46985 64430799
Haemoptysis 14.66 12.75 42 20906 49006 64428778
Empyema 14.65 12.75 11 20937 3654 64474130
Mobility decreased 14.30 12.75 5 20943 85835 64391949
Therapeutic product effect decreased 14.27 12.75 10 20938 115341 64362443
Transaminases increased 14.13 12.75 39 20909 44555 64433229
Macroangiopathy 13.90 12.75 4 20944 138 64477646
Respiratory tract oedema 13.62 12.75 6 20942 724 64477060
Oliguria 13.56 12.75 20 20928 14556 64463228
Peripheral swelling 13.45 12.75 30 20918 209123 64268661
Wrong dose 13.39 12.75 7 20941 1234 64476550
Flank pain 13.34 12.75 21 20927 16168 64461616
Drug abuse 13.31 12.75 14 20934 132360 64345424
Skin odour abnormal 13.25 12.75 8 20940 1859 64475925
Product use issue 13.17 12.75 18 20930 151697 64326087
Aspartate aminotransferase increased 13.16 12.75 75 20873 119713 64358071
Cystic fibrosis 13.05 12.75 10 20938 3424 64474360
Sepsis 13.03 12.75 123 20825 230218 64247566
Muscle spasms 13.00 12.75 16 20932 141007 64336777
Discomfort 12.98 12.75 5 20943 80873 64396911
Prothrombin level abnormal 12.96 12.75 4 20944 176 64477608
Tympanic membrane disorder 12.90 12.75 4 20944 179 64477605
Herpes simplex sepsis 12.86 12.75 3 20945 44 64477740
Acute kidney injury 12.85 12.75 211 20737 449029 64028755
Decerebrate posture 12.81 12.75 4 20944 183 64477601
Wheezing 12.79 12.75 56 20892 80523 64397261
Asthma 12.78 12.75 63 20885 95162 64382622

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R05CB01 RESPIRATORY SYSTEM
COUGH AND COLD PREPARATIONS
EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
Mucolytics
ATC S01XA08 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
ATC V03AB23 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Antidotes
FDA PE N0000008867 Decreased Respiratory Secretion Viscosity
FDA EPC N0000175429 Antidote
FDA MoA N0000175547 Reduction Activity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000975 Antioxidants
MeSH PA D000998 Antiviral Agents
MeSH PA D005100 Expectorants
MeSH PA D016166 Free Radical Scavengers
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175776 Mucolytic
FDA PE N0000175960 Increased Glutathione Concentration
FDA EPC N0000175961 Antidote for Acetaminophen Overdose
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:35441 antiinfective agents
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:48578 free radical scavengers
CHEBI has role CHEBI:73336 wound-healing drug
CHEBI has role CHEBI:74529 antidotes to acetaminophen poisoning
CHEBI has role CHEBI:77034 mucolytics
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:173084 ferroptosis inhibitors
CHEBI has role CHEBI:176497 geroprotectors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Bronchiectasis indication 12295008 DOID:9563
Amyloidosis indication 17602002 DOID:9120
Bronchitis indication 32398004 DOID:6132
General anesthesia indication 50697003
Poisoning by acetaminophen indication 70273001
Cystic fibrosis of the lung indication 86555001
Atelectasis due to Mucous Obstruction indication
Thick Bronchial Secretions indication
Contrast Media-Induced Nephrotoxicity Prevention indication
Meconium ileus off-label use 206523001
Bronchial Studies off-label use
Bronchospasm contraindication 4386001
Peptic ulcer contraindication 13200003 DOID:750
Esophageal varices contraindication 28670008
Low blood pressure contraindication 45007003
Decreased respiratory function contraindication 80954004
Acute exacerbation of asthma contraindication 708038006




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.22 acidic
pKa2 9.96 acidic
pKa3 12.92 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8399445 Aug. 24, 2025 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8653061 Aug. 24, 2025 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 9327028 July 21, 2031 COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
6GM/30ML (200MG/ML) ACETADOTE CUMBERLAND PHARMS N021539 Jan. 23, 2004 RX INJECTABLE INTRAVENOUS 8722738 April 6, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 8747894 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG CETYLEV ARBOR PHARMS LLC N207916 Jan. 29, 2016 DISCN TABLET, EFFERVESCENT ORAL 9561204 May 8, 2032 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cytochrome c Enzyme WOMBAT-PK
Vascular endothelial growth factor A Secreted WOMBAT-PK
Superoxide dismutase [Mn], mitochondrial Enzyme WOMBAT-PK
Glutathione synthetase Enzyme MODULATOR DRUGBANK
Cystine/glutamate transporter Transporter MODULATOR SCIENTIFIC LITERATURE

External reference:

IDSource
4018810 VUID
N0000147113 NUI
D00221 KEGG_DRUG
197 RXNORM
C0001047 UMLSCUI
CHEBI:28939 CHEBI
1ZT PDB_CHEM_ID
SC2 PDB_CHEM_ID
CHEMBL600 ChEMBL_ID
DB06151 DRUGBANK_ID
D000111 MESH_DESCRIPTOR_UI
12035 PUBCHEM_CID
1535 INN_ID
10945 IUPHAR_LIGAND_ID
WYQ7N0BPYC UNII
4127 MMSL
48605 MMSL
893 MMSL
d00762 MMSL
000720 NDDF
003524 NDDF
4018810 VANDF
387440002 SNOMEDCT_US
77731008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3307 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0409-3308 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7504 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7510 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7604 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7610 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0517-7630 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0805 INJECTION 200 mg INTRAVENOUS NDA 22 sections
ACETYLCYSTEINE Human Prescription Drug Label 1 14445-412 INJECTION 200 mg INTRAVENOUS ANDA 21 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 17478-660 INJECTION 200 mg INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 25021-812 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 25021-812 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 51754-0104 INJECTION 200 mg INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 54868-5670 SOLUTION 200 mg ORAL ANDA 18 sections
Acetylcysteine Human Prescription Drug Label 1 55150-259 INJECTION, SOLUTION 6 g INTRAVENOUS ANDA 22 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5730 INHALANT 100 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 55154-5731 INHALANT 200 mg RESPIRATORY (INHALATION) ANDA 18 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-690 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-690 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-691 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-692 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-693 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-694 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-694 SOLUTION 200 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-695 SOLUTION 100 mg ORAL ANDA 17 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-963 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 24 sections
Acetylcysteine HUMAN PRESCRIPTION DRUG LABEL 1 63323-963 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 24 sections
ACETADOTE HUMAN PRESCRIPTION DRUG LABEL 1 66220-207 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 22 sections
ACETYLCYSTEINE HUMAN PRESCRIPTION DRUG LABEL 1 70710-1015 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 20 sections
ACETYLCYSTEINE HUMAN PRESCRIPTION DRUG LABEL 1 70771-1412 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 1 sections