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Acetadote (Acetylcysteine)
Acetylcysteine reduces liver injury from acetaminophen overdose by maintaining glutathione levels or providing alternate conjugation substrate.
Acetylcysteine Injection is an antidote indicated to prevent or lessen hepatic injury after acetaminophen overdose from acute ingestion or repeated supratherapeutic ingestion. The drug maintains or restores glutathione levels and provides an alternate substrate for detoxification of acetaminophen's reactive metabolite. Hypersensitivity reactions are the primary contraindication; hepatic impairment increases exposure 1.6-fold but changes are not considered clinically meaningful. Acetylcysteine remains the standard antidote for acetaminophen toxicity with established efficacy in preventing liver injury.
At a glance
| Generic name | Acetylcysteine |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Antidote |
| Target | Glutathione levels; reactive metabolite of acetaminophen |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1963 |
Mechanism of action
Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Acetaminophen doses of 150 mg/kg or greater have been associated with hepatotoxicity. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.
Approved indications
- 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
Common side effects
- Nausea
- Hypokalaemia
- Diarrhoea
- Headache
- Dyspepsia
- Dizziness
- Vomiting
- Rash
- Chronic gastritis
- Pneumonia
- Nephrolithiasis
- Constipation
Key clinical trials
- Effects of NAC on Symptoms of CHR Patients (NA)
- Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (PHASE4)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis. (PHASE4)
- Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial (PHASE3)
- N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use (PHASE4)
- A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth (PHASE4)
- Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8747894 | 2032-05-08 | Formulation |
| 9327028 | 2031-07-21 | Method of Use |
| 9561204 | 2032-05-08 | Method of Use |
| 8722738 | 2032-04-06 | Method of Use |
| 9427421 | 2032-05-08 | Formulation |
| 8148356 | 2026-05-21 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acetadote CI brief — competitive landscape report
- Acetadote updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI