acetylcysteine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
mucolytics	66	616-91-1

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
1.60	g	Inhal.solution
0.50	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	61.28 µM/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:

Date	Agency	Company	Orphan
Sept. 14, 1963	FDA	APOTHECON
March 27, 2023	PMDA	Maruho Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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
Infusion related reaction	17.92	14.12	17	14140	245504	63229361
Autoimmune hepatitis	17.92	14.12	15	14142	8495	63466370
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.22	acidic
pKa2	9.96	acidic
pKa3	12.92	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

Target	Class	Pharos	UniProt	Action	Bioact source
Cytochrome c	Enzyme	P99999	CYC_HUMAN		WOMBAT-PK
Vascular endothelial growth factor A	Secreted	P15692	VEGFA_HUMAN		WOMBAT-PK
Superoxide dismutase [Mn], mitochondrial	Enzyme	P04179	SODM_HUMAN		WOMBAT-PK
Glutathione synthetase	Enzyme	P48637	GSHB_HUMAN	MODULATOR	DRUGBANK
Cystine/glutamate transporter	Transporter	Q9UPY5	XCT_HUMAN	MODULATOR	SCIENTIFIC LITERATURE

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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