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
March 27, 2023 PMDA Maruho Co., Ltd.

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 161.13 14.12 44 14113 1841 63473024
Inhibitory drug interaction 138.94 14.12 43 14114 2806 63472059
Infection susceptibility increased 138.04 14.12 45 14112 3476 63471389
Glucose tolerance impaired 110.60 14.12 45 14112 6532 63468333
Poor quality sleep 90.42 14.12 56 14101 19879 63454986
Impaired quality of life 87.07 14.12 48 14109 13735 63461130
Purpura 86.98 14.12 45 14112 11340 63463525
Bone density decreased 84.45 14.12 48 14109 14564 63460301
Toxic epidermal necrolysis 80.50 14.12 57 14100 25277 63449588
Hyperlipidaemia 73.94 14.12 49 14108 19522 63455343
Stevens-Johnson syndrome 65.42 14.12 50 14107 24900 63449965
Impaired work ability 64.20 14.12 43 14114 17432 63457433
Oral herpes 63.47 14.12 50 14107 26024 63448841
Metabolic acidosis 60.96 14.12 62 14095 45007 63429858
Skin disorder 52.05 14.12 47 14110 29460 63445405
Hepatic encephalopathy 49.40 14.12 31 14126 11251 63463614
Chronic obstructive pulmonary disease 47.44 14.12 64 14093 62622 63412243
Joint swelling 45.36 14.12 9 14148 327657 63147208
Coma 44.63 14.12 63 14094 64301 63410564
Tongue oedema 43.50 14.12 21 14136 4565 63470300
Pneumonia 42.77 14.12 208 13949 456559 63018306
Drug interaction 42.72 14.12 130 14027 229001 63245864
Brain oedema 38.43 14.12 29 14128 14166 63460699
Thrombocytopenia 38.33 14.12 96 14061 151061 63323804
Arthropathy 38.15 14.12 4 14153 234788 63240077
Acute hepatic failure 37.97 14.12 32 14125 18295 63456570
Cataract 36.85 14.12 54 14103 56999 63417866
Arthralgia 36.63 14.12 44 14113 569666 62905199
Hepatotoxicity 36.25 14.12 43 14114 36998 63437867
Anaphylactoid reaction 35.17 14.12 17 14140 3706 63471159
Rheumatoid arthritis 35.05 14.12 7 14150 253812 63221053
Brain death 33.51 14.12 16 14141 3394 63471471
Systemic lupus erythematosus 32.83 14.12 4 14153 208914 63265951
Hypercapnia 31.80 14.12 18 14139 5413 63469452
Face oedema 31.40 14.12 30 14127 20182 63454683
Pain 31.24 14.12 75 14082 740553 62734312
Contraindicated product administered 30.05 14.12 6 14151 217642 63257223
Coagulopathy 29.12 14.12 29 14128 20515 63454350
Acute kidney injury 29.06 14.12 126 14031 263289 63211576
Treatment failure 28.52 14.12 5 14152 199038 63275827
Cellulitis 28.48 14.12 59 14098 81899 63392966
Drug intolerance 28.15 14.12 17 14140 308644 63166221
Therapeutic product effect decreased 27.36 14.12 5 14152 193182 63281683
Drug-induced liver injury 27.32 14.12 39 14118 40183 63434682
Respiratory failure 27.18 14.12 66 14091 101792 63373073
Congenital central hypoventilation syndrome 27.18 14.12 5 14152 31 63474834
Glossodynia 26.73 14.12 4 14153 178872 63295993
Rash maculo-papular 26.33 14.12 34 14123 31862 63443003
Overdose 25.98 14.12 70 14087 115008 63359857
Herpes zoster 25.93 14.12 57 14100 82405 63392460
Musculoskeletal stiffness 25.67 14.12 5 14152 184613 63290252
Erysipelas 25.60 14.12 18 14139 7887 63466978
Immune-mediated pancreatitis 25.54 14.12 6 14151 135 63474730
Swelling 25.34 14.12 15 14142 275363 63199502
Discomfort 24.43 14.12 4 14153 167370 63307495
Lymphocytosis 24.24 14.12 12 14145 2755 63472110
Intentional overdose 24.16 14.12 52 14105 74100 63400765
Postresuscitation encephalopathy 24.09 14.12 4 14153 12 63474853
Breast conserving surgery 24.09 14.12 9 14148 1040 63473825
Brain herniation 23.75 14.12 13 14144 3664 63471201
Herpes simplex hepatitis 23.33 14.12 7 14150 411 63474454
Hypotension 23.22 14.12 121 14036 272483 63202382
Model for end stage liver disease score increased 23.01 14.12 4 14153 17 63474848
Sputum increased 22.54 14.12 11 14146 2448 63472417
Post procedural haematoma 22.31 14.12 9 14148 1276 63473589
Tongue exfoliation 21.80 14.12 5 14152 101 63474764
Respiratory distress 21.72 14.12 32 14125 33919 63440946
Infective pulmonary exacerbation of cystic fibrosis 21.65 14.12 17 14140 8800 63466065
Eyelid myoclonus 21.52 14.12 5 14152 107 63474758
Respiratory tract oedema 21.50 14.12 7 14150 538 63474327
Suicide attempt 21.33 14.12 44 14113 60874 63413991
Tachycardia 21.01 14.12 66 14091 118090 63356775
Brain injury 20.43 14.12 15 14142 7028 63467837
Leukocytosis 20.40 14.12 27 14130 25908 63448957
Abdominal discomfort 20.34 14.12 25 14132 320860 63154005
Product use issue 20.30 14.12 12 14145 220508 63254357
Bronchospasm 20.19 14.12 22 14135 17258 63457607
Dyspnoea 19.94 14.12 230 13927 661083 62813782
Product dose omission issue 19.86 14.12 14 14143 234299 63240566
Infective exacerbation of chronic obstructive airways disease 19.09 14.12 8 14149 1249 63473616
Oliguria 19.07 14.12 16 14141 9085 63465780
Mydriasis 19.05 14.12 18 14139 11938 63462927
Chronic hepatitis C 18.95 14.12 5 14152 183 63474682
Anion gap 18.73 14.12 8 14149 1309 63473556
Hepatic enzyme increased 18.63 14.12 11 14146 202317 63272548
Toxicity to various agents 18.52 14.12 106 14051 247144 63227721
Productive cough 17.98 14.12 42 14115 63166 63411699
Autoimmune hepatitis 17.92 14.12 15 14142 8495 63466370
Infusion related reaction 17.92 14.12 17 14140 245504 63229361
Jaundice 17.89 14.12 27 14130 29224 63445641
Hepatic failure 17.81 14.12 30 14127 35626 63439239
Acute respiratory distress syndrome 17.75 14.12 24 14133 23510 63451355
Peripheral swelling 17.62 14.12 20 14137 265922 63208943
Multiple organ dysfunction syndrome 17.58 14.12 39 14118 56713 63418152
Lower respiratory tract infection 17.53 14.12 4 14153 132303 63342562
Obstruction 17.33 14.12 10 14147 3117 63471748
Angioedema 17.21 14.12 35 14122 47930 63426935
Salivary hypersecretion 17.16 14.12 14 14143 7652 63467213
Urogenital haemorrhage 17.03 14.12 5 14152 272 63474593
Eosinophilia 16.85 14.12 23 14134 22733 63452132
Abscess rupture 16.74 14.12 5 14152 289 63474576
Haemolytic uraemic syndrome 16.58 14.12 9 14148 2494 63472371
Hepatitis fulminant 16.38 14.12 10 14147 3454 63471411
Activated partial thromboplastin time prolonged 16.30 14.12 13 14144 6880 63467985
Macroangiopathy 16.26 14.12 4 14153 110 63474755
Lip pain 16.23 14.12 8 14149 1818 63473047
Epidermolysis 16.23 14.12 6 14151 673 63474192
Anaphylactic shock 16.17 14.12 23 14134 23610 63451255
Junctional ectopic tachycardia 16.02 14.12 4 14153 117 63474748
Decerebrate posture 15.83 14.12 4 14153 123 63474742
Pyrexia 15.22 14.12 166 13991 470312 63004553
Adrenocorticotropic hormone deficiency 14.99 14.12 5 14152 414 63474451
General physical health deterioration 14.84 14.12 86 14071 201316 63273549
Encephalopathy 14.84 14.12 29 14128 38591 63436274
Mental impairment 14.79 14.12 17 14140 14134 63460731
Dose calculation error 14.77 14.12 4 14153 162 63474703
Respiratory tract haemorrhage 14.58 14.12 5 14152 451 63474414
Pain in extremity 14.36 14.12 33 14124 331453 63143412
Flank pain 14.34 14.12 18 14139 16392 63458473

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 155.86 13.52 41 14049 803 34942038
Breath sounds abnormal 97.45 13.52 50 14040 6831 34936010
Toxic epidermal necrolysis 90.95 13.52 73 14017 21573 34921268
Malignant melanoma in situ 79.87 13.52 29 14061 1699 34941142
Bronchiectasis 78.40 13.52 49 14041 9752 34933089
Chronic obstructive pulmonary disease 77.47 13.52 97 13993 48821 34894020
Stevens-Johnson syndrome 66.11 13.52 57 14033 18582 34924259
Dyspnoea 65.43 13.52 312 13778 376470 34566371
Pneumonia 64.94 13.52 303 13787 362324 34580517
Productive cough 63.10 13.52 77 14013 37736 34905105
Benign prostatic hyperplasia 52.77 13.52 45 14045 14450 34928391
Transient ischaemic attack 44.07 13.52 55 14035 27558 34915283
Micturition urgency 43.26 13.52 29 14061 6496 34936345
General physical health deterioration 39.95 13.52 128 13962 128141 34814700
Dermatillomania 38.18 13.52 8 14082 54 34942787
Full blood count abnormal 37.79 13.52 42 14048 18626 34924215
Hypercholesterolaemia 37.74 13.52 30 14060 8732 34934109
Cyanosis 37.28 13.52 35 14055 12729 34930112
Joint injury 36.53 13.52 30 14060 9143 34933698
Respiratory failure 34.39 13.52 109 13981 108463 34834378
Asthma 33.51 13.52 61 14029 42595 34900246
Obstructive airways disorder 33.34 13.52 36 14054 15458 34927383
Wrong dose 31.26 13.52 11 14079 588 34942253
Product dose omission issue 29.81 13.52 6 14084 119705 34823136
Wheezing 26.15 13.52 54 14036 41348 34901493
Cell death 24.62 13.52 14 14076 2343 34940498
Completed suicide 24.27 13.52 5 14085 98163 34844678
Acute hepatic failure 24.01 13.52 29 14061 14045 34928796
Oral herpes 23.90 13.52 19 14071 5528 34937313
Bilirubin conjugated abnormal 23.38 13.52 6 14084 106 34942735
Mucosal erosion 20.82 13.52 9 14081 835 34942006
Anion gap 20.59 13.52 9 14081 858 34941983
Middle ear inflammation 20.45 13.52 3 14087 0 34942841
Klebsiella infection 20.45 13.52 21 14069 8510 34934331
Dyspnoea exertional 20.13 13.52 50 14040 43229 34899612
Drug abuse 19.12 13.52 8 14082 99088 34843753
Pyrexia 18.42 13.52 210 13880 332803 34610038
Death 18.01 13.52 91 13999 397958 34544883
Hypokalaemia 17.10 13.52 57 14033 58157 34884684
Acute respiratory failure 16.84 13.52 38 14052 30890 34911951
Gastrooesophageal reflux disease 16.79 13.52 43 14047 37881 34904960
Bronchospasm 16.52 13.52 21 14069 10710 34932131
Skin irritation 15.72 13.52 15 14075 5562 34937279
Nikolsky's sign 15.70 13.52 5 14085 196 34942645
Deafness bilateral 15.49 13.52 8 14082 1106 34941735
Kidney rupture 15.43 13.52 5 14085 207 34942634
Alanine aminotransferase increased 15.41 13.52 69 14021 80746 34862095
Prader-Willi syndrome 14.92 13.52 3 14087 16 34942825
Impaired healing 14.75 13.52 24 14066 15310 34927531
Hepatotoxicity 14.72 13.52 29 14061 21456 34921385
Acidosis 14.65 13.52 20 14070 10925 34931916
Blister 14.65 13.52 30 14060 22828 34920013
Sputum purulent 14.61 13.52 6 14084 490 34942351
Cough 14.57 13.52 107 13983 150033 34792808
Graft loss 14.21 13.52 7 14083 876 34941965
Cardiac failure congestive 14.12 13.52 8 14082 83262 34859579
Adenoviral hepatitis 14.08 13.52 6 14084 538 34942303
Empyema 13.76 13.52 11 14079 3225 34939616

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
Congenital hiatus hernia 161.91 12.82 40 25009 784 79718555
Toxic epidermal necrolysis 152.01 12.82 120 24929 44461 79674878
Body tinea 142.60 12.82 43 25006 1811 79717528
Stevens-Johnson syndrome 121.99 12.82 100 24949 39066 79680273
Infection susceptibility increased 120.49 12.82 45 25004 3676 79715663
Inhibitory drug interaction 112.64 12.82 45 25004 4408 79714931
Chronic obstructive pulmonary disease 105.36 12.82 132 24917 85287 79634052
Pneumonia 96.41 12.82 436 24613 659810 79059529
Glucose tolerance impaired 89.83 12.82 46 25003 8038 79711301
Oral herpes 77.01 12.82 66 24983 27388 79691951
Malignant melanoma in situ 73.40 12.82 28 25021 2424 79716915
Breath sounds abnormal 72.29 12.82 51 24998 15933 79703406
Benign prostatic hyperplasia 69.25 12.82 44 25005 11568 79707771
Bone density decreased 68.41 12.82 46 25003 13301 79706038
Impaired quality of life 62.98 12.82 45 25004 14341 79704998
Poor quality sleep 62.46 12.82 54 24995 22668 79696671
Productive cough 59.96 12.82 103 24946 88228 79631111
Bronchiectasis 59.11 12.82 52 24997 22334 79697005
Dyspnoea 58.03 12.82 463 24586 856562 78862777
Purpura 56.92 12.82 48 25001 19479 79699860
Respiratory failure 55.55 12.82 153 24896 180758 79538581
Metabolic acidosis 54.40 12.82 95 24954 82434 79636905
Joint swelling 50.63 12.82 14 25035 288632 79430707
Arthralgia 48.81 12.82 65 24984 571738 79147601
Impaired work ability 48.56 12.82 44 25005 19637 79699702
Hepatotoxicity 47.47 12.82 69 24980 51283 79668056
Acute hepatic failure 46.12 12.82 52 24997 30061 79689278
General physical health deterioration 45.49 12.82 189 24860 275049 79444290
Hyperlipidaemia 45.07 12.82 48 25001 26045 79693294
Brain oedema 44.57 12.82 47 25002 25216 79694123
Product dose omission issue 43.42 12.82 12 25037 247525 79471814
Arthropathy 41.16 12.82 4 25045 177107 79542232
Tongue oedema 40.04 12.82 26 25023 7091 79712248
Pain 39.69 12.82 103 24946 703699 79015640
Rheumatoid arthritis 38.69 12.82 9 25040 208461 79510878
Anaphylactoid reaction 38.58 12.82 23 25026 5399 79713940
Anion gap 38.29 12.82 17 25032 2164 79717175
Completed suicide 37.70 12.82 15 25034 245752 79473587
Skin disorder 36.42 12.82 49 25000 33894 79685445
Drug intolerance 36.04 12.82 19 25030 264100 79455239
Full blood count abnormal 35.41 12.82 53 24996 40421 79678918
Coma 32.74 12.82 87 24962 100562 79618777
Thrombocytopenia 32.57 12.82 167 24882 265092 79454247
Acute respiratory failure 32.25 12.82 63 24986 59478 79659861
Bronchospasm 31.55 12.82 39 25010 24820 79694519
Coagulopathy 31.29 12.82 47 25002 35959 79683380
Cyanosis 31.15 12.82 39 25010 25143 79694196
Lymphocytosis 31.05 12.82 19 25030 4674 79714665
Hepatic encephalopathy 30.81 12.82 38 25011 24128 79695211
Micturition urgency 30.67 12.82 28 25021 12613 79706726
Hepatitis fulminant 30.15 12.82 22 25027 7240 79712099
Dermatillomania 30.08 12.82 8 25041 212 79719127
Musculoskeletal stiffness 29.73 12.82 9 25040 174999 79544340
Chronic hepatitis C 29.08 12.82 10 25039 643 79718696
Transient ischaemic attack 28.84 12.82 56 24993 52639 79666700
Obstructive airways disorder 28.68 12.82 42 25007 31417 79687922
Leukocytosis 28.59 12.82 50 24999 43405 79675934
Face oedema 27.75 12.82 39 25010 28097 79691242
Abdominal discomfort 27.51 12.82 23 25026 250704 79468635
Drug interaction 27.22 12.82 223 24826 414960 79304379
Congenital central hypoventilation syndrome 25.47 12.82 5 25044 31 79719308
Brain death 25.40 12.82 18 25031 5659 79713680
Treatment failure 25.18 12.82 11 25038 170475 79548864
Multiple organ dysfunction syndrome 25.11 12.82 89 24960 120157 79599182
Systemic lupus erythematosus 25.07 12.82 4 25045 121145 79598194
Respiratory distress 24.91 12.82 56 24993 58283 79661056
Asthma 24.86 12.82 96 24953 134999 79584340
Pyrexia 24.63 12.82 323 24726 678386 79040953
Hypokalaemia 24.61 12.82 100 24949 143940 79575399
Bilirubin conjugated abnormal 24.17 12.82 6 25043 120 79719219
Discomfort 24.15 12.82 5 25044 125612 79593727
Pain in extremity 24.00 12.82 49 25000 364489 79354850
Product prescribing error 23.76 12.82 47 25002 44766 79674573
Jaundice 23.67 12.82 52 24997 53297 79666042
Swelling 23.62 12.82 20 25029 216691 79502648
Therapeutic product effect decreased 23.53 12.82 11 25038 163852 79555487
Product use issue 23.32 12.82 19 25030 209803 79509536
Septic shock 23.20 12.82 88 24961 122713 79596626
Acute respiratory distress syndrome 23.11 12.82 46 25003 44021 79675318
Wrong dose 22.85 12.82 11 25038 1683 79717656
Acute kidney injury 22.65 12.82 256 24793 519148 79200191
Cataract 22.58 12.82 56 24993 62064 79657275
Wheezing 22.37 12.82 84 24965 116580 79602759
Mucosal erosion 22.36 12.82 12 25037 2306 79717033
Alanine aminotransferase increased 21.81 12.82 105 24944 162465 79556874
Post procedural haematoma 21.77 12.82 12 25037 2430 79716909
Model for end stage liver disease score increased 21.64 12.82 4 25045 17 79719322
Peripheral swelling 21.60 12.82 32 25017 269585 79449754
Sputum increased 21.51 12.82 15 25034 4598 79714741
Mobility decreased 21.26 12.82 6 25043 122169 79597170
Graft loss 21.15 12.82 9 25040 1034 79718305
Respiratory depression 21.12 12.82 34 25015 27596 79691743
Tachycardia 20.48 12.82 110 24939 177658 79541681
Hypercapnia 20.15 12.82 19 25030 8916 79710423
Hypotension 20.09 12.82 219 24830 440098 79279241
Breast conserving surgery 20.04 12.82 8 25041 782 79718557
Eyelid myoclonus 19.78 12.82 5 25044 108 79719231
Hypertension 19.67 12.82 174 24875 330818 79388521
Haemolytic uraemic syndrome 19.66 12.82 14 25035 4435 79714904
Lower respiratory tract infection 19.62 12.82 8 25041 129212 79590127
Respiratory tract haemorrhage 19.18 12.82 10 25039 1813 79717526
Autoimmune hepatitis 19.16 12.82 21 25028 11762 79707577
Herpes simplex hepatitis 19.15 12.82 7 25042 538 79718801
Immune-mediated pancreatitis 19.04 12.82 6 25043 293 79719046
Diarrhoea 19.02 12.82 181 24868 880308 78839031
Cell death 18.98 12.82 14 25035 4685 79714654
Klebsiella infection 18.89 12.82 24 25025 15696 79703643
Hypercholesterolaemia 18.45 12.82 29 25020 23066 79696273
Angioedema 18.26 12.82 59 24990 75976 79643363
Middle ear inflammation 18.26 12.82 4 25045 45 79719294
Aspartate aminotransferase increased 18.20 12.82 89 24960 138552 79580787
Tongue exfoliation 18.18 12.82 5 25044 151 79719188
Postresuscitation encephalopathy 18.18 12.82 4 25045 46 79719293
Hepatic failure 18.00 12.82 51 24998 61161 79658178
Drug abuse 17.74 12.82 15 25034 162676 79556663
Lip pain 17.73 12.82 10 25039 2117 79717222
Sepsis 17.24 12.82 144 24905 269284 79450055
Anion gap increased 17.12 12.82 12 25037 3708 79715631
Hypoxia 17.10 12.82 71 24978 103172 79616167
Dyspnoea exertional 16.94 12.82 63 24986 87010 79632329
Drug hypersensitivity 16.59 12.82 44 25005 298872 79420467
Pericarditis 16.58 12.82 6 25043 104230 79615109
Drug-induced liver injury 16.51 12.82 52 24997 66065 79653274
Medication error 16.25 12.82 53 24996 68589 79650750
Pneumonia aspiration 16.12 12.82 52 24997 66915 79652424
Overdose 16.08 12.82 106 24943 184100 79535239
Dose calculation error 16.07 12.82 5 25044 234 79719105
Headache 16.03 12.82 130 24919 653642 79065697
Dermatitis bullous 15.95 12.82 21 25028 14224 79705115
Respiratory tract oedema 15.95 12.82 7 25042 867 79718472
Prader-Willi syndrome 15.67 12.82 3 25046 16 79719323
Empyema 15.62 12.82 12 25037 4264 79715075
Erysipelas 15.37 12.82 18 25031 10832 79708507
Anaemia 15.35 12.82 210 24839 444805 79274534
Transaminases increased 15.10 12.82 43 25006 51700 79667639
Tachypnoea 15.07 12.82 32 25017 32031 79687308
Cholestasis 14.91 12.82 43 25006 52066 79667273
Blood immunoglobulin E decreased 14.90 12.82 4 25045 110 79719229
Haemoptysis 14.88 12.82 45 25004 55954 79663385
Deafness bilateral 14.85 12.82 9 25040 2176 79717163
Brain injury 14.50 12.82 18 25031 11499 79707840
Cystic fibrosis 14.42 12.82 11 25038 3869 79715470
Gait disturbance 14.41 12.82 27 25022 207479 79511860
Abscess rupture 14.37 12.82 5 25044 333 79719006
Injection site pain 14.12 12.82 12 25037 129826 79589513
Blood creatinine increased 14.00 12.82 90 24959 154967 79564372
Intentional overdose 13.89 12.82 68 24981 105892 79613447
Suicide attempt 13.70 12.82 57 24992 82875 79636464
Macroangiopathy 13.56 12.82 4 25045 156 79719183
Hepatic enzyme increased 13.37 12.82 23 25026 182587 79536752
Glossodynia 13.27 12.82 8 25041 103329 79616010
Weight 13.09 12.82 3 25046 42 79719297
Prothrombin level abnormal 13.01 12.82 4 25045 180 79719159
Muscular weakness 12.94 12.82 19 25030 160710 79558629
Tympanic membrane disorder 12.86 12.82 4 25045 187 79719152

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 | Suggest Off label Use Form| |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
Support of pincer nail correction indication 247486000
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
387440002 SNOMEDCT_US
77731008 SNOMEDCT_US
4018810 VANDF
4127 MMSL
48605 MMSL
893 MMSL
d00762 MMSL
000720 NDDF
003524 NDDF

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 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 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 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 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 55154-5730 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 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 63323-690 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 63323-691 SOLUTION 100 mg ORAL ANDA 17 sections