Acetylcysteine

Antidote — RESPIRATORY SYSTEM

Key facts

Acetylcysteine is an ofp drug in the Antidote class catalogued in DrugCentral. It was first approved by the FDA in 1963. Its mechanism of action is classified as Reduction Activity. DrugCentral lists 5 molecular targets, including CYCS, VEGFA and SOD2. Recorded indications include Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis and Bronchitis.

• Approval status: ofp (first approved 1963 by the FDA).
• Drug class: Antidote; Antidote for Acetaminophen Overdose.
• Mechanism of action: Reduction Activity.
• Molecular targets: CYCS, VEGFA, SOD2 and GSS (5 listed in DrugCentral).
• Indications: Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis, Bronchitis and Contrast Media-Induced Nephrotoxicity Prevention and others.
• ATC code: R05CB01 (Mucolytics).
• Molecular formula: C5H9NO3S; molecular weight 163.19 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (10)

• Amyloidosis
• Atelectasis due to Mucous Obstruction
• Bronchiectasis
• Bronchitis
• Contrast Media-Induced Nephrotoxicity Prevention
• Cystic fibrosis of the lung
• General anesthesia
• Poisoning by acetaminophen
• Support of pincer nail correction
• Thick Bronchial Secretions

Off-label uses (2)

• Bronchial Studies
• Meconium ileus

Contraindications (6)

• Acute exacerbation of asthma
• Bronchospasm
• Decreased respiratory function
• Esophageal varices
• Low blood pressure
• Peptic ulcer

Mechanism & targets

• Mechanism of action (MoA): Reduction Activity
• Established pharmacologic class: Antidote; Antidote for Acetaminophen Overdose; Mucolytic

Molecular targets (5)

Target	Gene	Action	Activity
Cytochrome c	CYCS	unknown	—
Vascular endothelial growth factor A	VEGFA	unknown	—
Superoxide dismutase [Mn], mitochondrial	SOD2	unknown	—
Glutathione synthetase	GSS	modulator	—
Cystine/glutamate transporter	SLC7A11	modulator	—

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2023-03-27	PMDA	—	Maruho Co., Ltd.
1963-09-14	FDA	—	APOTHECON	Yes

ATC classification

ATC code	Therapeutic hierarchy
R05CB01	RESPIRATORY SYSTEM › COUGH AND COLD PREPARATIONS › EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS › Mucolytics
S01XA08	SENSORY ORGANS › OPHTHALMOLOGICALS › OTHER OPHTHALMOLOGICALS › Other ophthalmologicals
V03AB23	VARIOUS › ALL OTHER THERAPEUTIC PRODUCTS › ALL OTHER THERAPEUTIC PRODUCTS › Antidotes

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Synovitis	273.2
Systemic lupus erythematosus	243.8
Congenital hiatus hernia	211.0
Contraindicated product administered	209.1
Glossodynia	192.8
Malignant melanoma in situ	181.9
Infusion related reaction	180.0
Pneumonia	178.7
Duodenal ulcer perforation	174.0
Helicobacter infection	168.5
Treatment failure	168.1
Pericarditis	167.5

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Acetylcysteine is on its molecule page.

• Molecular formula: C₅H₉NO₃S
• Molecular weight: 163.19 g/mol
• CAS number: 616-91-1
• InChIKey: PWKSKIMOESPYIA-BYPYZUCNSA-N
• PubChem CID: 12035

CC(=O)N[C@@H](CS)C(O)=O

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Acetylcysteine used for?

DrugCentral lists the following indications for Acetylcysteine: Amyloidosis, Atelectasis due to Mucous Obstruction, Bronchiectasis, Bronchitis, Contrast Media-Induced Nephrotoxicity Prevention, Cystic fibrosis of the lung, General anesthesia and Poisoning by acetaminophen and others.

How does Acetylcysteine work?

Acetylcysteine is classified as Reduction Activity; its molecular targets in DrugCentral include CYCS, VEGFA, SOD2 and GSS (modulator).

When was Acetylcysteine first approved?

Acetylcysteine was first approved by the FDA in 1963.

What drug class does Acetylcysteine belong to?

Acetylcysteine is in the Antidote class.

What is the chemical formula of Acetylcysteine?

Acetylcysteine has the molecular formula C5H9NO3S and a molecular weight of 163.19 g/mol.

Sources

• DrugCentral drug card 66 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL600 — compound record and bioactivity
• PubChem CID 12035 — chemical identifiers
• DrugBank DB06151 — drug record
• FDA UNII WYQ7N0BPYC — substance identity
• DailyMed: FDA labels for Acetylcysteine — current prescribing information (label search)
• UniProt P99999 (CYCS) — target protein
• UniProt P15692 (VEGFA) — target protein
• UniProt P04179 (SOD2) — target protein
• UniProt P48637 (GSS) — target protein
• UniProt Q9UPY5 (SLC7A11) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.