Evigrade

Acetylcysteine

AEMPS

Mucolytic; paracetamol overdose antidote; glutathione precursor

ATC code: R05CB01

Brand names: Cetylev, Mucomyst, Acetadote

Updated · Methodology

Indications

A

Paracetamol overdose

First line

First-line antidote for paracetamol overdose. AEMPS and approve oral and intravenous routes; maximum benefit when started within 8 hours of ingestion. IV Prescott protocol: 150 mg/kg over 1 hour, then 50 mg/kg over 4 hours, then 100 mg/kg over 16 hours. Efficacy declines after 10 hours but Cochrane 2018 shows benefit even with late initiation. The only NAC indication with tier A.

ICD-10: T39.1 · ICD-11: PB24

C

Obsessive-compulsive disorder

Adjunct

Add-on to SSRIs in treatment-resistant OCD and conditions with shared neurobiology (trichotillomania, excoriation disorder). Evidence base is limited: small randomised trials at 2400–3000 mg/day show weak signal. and AEMPS do not approve NAC for OCD; this use is off-label. The decision belongs to the psychiatrist after standard therapy fails. Before self-prescribing, consider seeking a second medical opinion.

ICD-10: F42 · ICD-11: 6B20

C

Productive cough

Individual decision

Mucolytic for productive cough with thick sputum. AEMPS keeps acetylcysteine indicated, but the clinical effect is modest: systematic reviews show cough duration reduced by about 0.5 days vs placebo. In cystic fibrosis, Cochrane 2013 did not confirm benefit from oral NAC. In common colds a 5–10 day course is appropriate. If cough persists beyond 7–10 days or dyspnoea appears, in-person evaluation is required.

ICD-10: R05 · ICD-11: MD12

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Liver support and “hepatoprotection”

Not recommended

Acetylcysteine is a mucolytic that thins mucus, and in high intravenous doses it works as an antidote for paracetamol poisoning. It is often marketed as a supplement for "liver support" and liver protection in healthy people. There is no convincing benefit for this use: the evidence that regular intake protects the liver or improves its function outside paracetamol overdose is lacking. What actually helps liver health is avoiding alcohol, keeping a healthy weight, hepatitis vaccination, and treating any underlying condition with your doctor. Do not take acetylcysteine instead of treatment with proven benefit – that can mean missing the care you need.

F

Anti-aging and longevity

Not recommended

Biohacker community frames NAC as an «anti-aging drug», «universal antioxidant» and «mitochondrial protector». There are no long-term randomised trials in healthy people with mortality or age-related disease endpoints. NIH ODS 2024 notes that benefit in healthy adults is unproven; in animal models antioxidant excess even accelerated tumour growth. AEMPS and have not registered the drug as a geroprotector. For evidence-based prevention of ageing, lifestyle, sleep, physical activity and diet – confirmed in large cohorts – are appropriate topics to discuss with a clinician.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

In the body the acetyl group is cleaved and the molecule becomes L-cysteine – the rate-limiting substrate for glutathione synthesis. Glutathione binds the toxic paracetamol metabolite NAPQI and protects hepatocytes. Free SH groups break disulfide bonds between mucoprotein chains in sputum, which thins the secretion. The IV route delivers the maximum hepatic concentration; oral bioavailability is lower because of first-pass metabolism.

Safety

Contraindications

  • Hypersensitivity to acetylcysteine
  • Active peptic ulcer disease
  • Haemoptysis and pulmonary haemorrhage

Serious adverse effects

  • Anaphylactoid reactions with IV use (especially in asthma patients)
  • Bronchospasm
  • Severe stomatitis and haemorrhagic erosions
  • Reduced platelet aggregation at high doses

Common adverse effects

  • Nausea, vomiting, heartburn
  • Diarrhoea
  • Unpleasant sulphurous breath
  • Rash and pruritus

Pregnancy: can you take Acetylcysteine?

AEMPS summary of product characteristics (section 4.6): clinical data on acetylcysteine in pregnant women are limited, and animal studies have not shown direct or indirect reproductive toxicity. As a precaution, it is preferable to avoid acetylcysteine during pregnancy. If it is used, the risks are weighed against the potential benefits beforehand, and treatment is given under medical supervision.

Breastfeeding: can you take Acetylcysteine?

Compatible. Hale L2. Milk transfer data are limited, but with short courses and standard doses no infant adverse events have been reported. eLactancia rates the risk as low.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Effervescent tablets and powders are dissolved in a glass of water. Take after meals — reduces gastric irritation. Do not combine with cough suppressants (butamirate, codeine) — suppressed cough plus thinned secretions causes airway pooling. Sputum-thinning effect at 1–2 hours.

Special situations

Parenteral administration (IV or inhaled) may cause paradoxical bronchospasm in asthma — pretreat with bronchodilator. IV use in the antidote protocol can cause anaphylactoid reactions (up to 15 % of patients) — premedicate with diphenhydramine and infuse the first dose slowly. Do not co-mix with antibiotics in the same inhalation or solution.
Label mentions6 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majorantihistamínicosclass named in the label
    «Antitusivos: Dado que los antitusivos provocan la inhibición del reflejo de la tos, no se recomienda la administración de acetilcisteína con estos fármacos o con sustancias inhibidoras de las…»

    AEMPS, section 4.5 · Open on CIMA

  • «Antibióticos: Si se administra acetilcisteína junto con antibióticos como anfotericina B, ampicilina sódica, cefalosporinas, lactobionato de eritromicina o algunas tetraciclinas, pueden ser…»

    AEMPS, section 4.5 · Open on CIMA

  • «Antibióticos: El uso concomitante de acetilcisteína y carbamazepina puede dar lugar a niveles subterapéuticos de carbamazepina.»

    AEMPS, section 4.5 · Open on CIMA

  • «Antibióticos: Si se administra acetilcisteína junto con antibióticos como anfotericina B, ampicilina sódica, cefalosporinas, lactobionato de eritromicina o algunas tetraciclinas, pueden ser…»

    AEMPS, section 4.5 · Open on CIMA

  • «Antibióticos: Se ha demostrado que la administración simultánea de nitroglicerina y acetilcisteína produce una hipotensión significativa e incremento de la dilatación de la arteria temporal. Si es…»

    AEMPS, section 4.5 · Open on CIMA

  • tetraciclinasclass named in the label
    «Antibióticos: Si se administra acetilcisteína junto con antibióticos como anfotericina B, ampicilina sódica, cefalosporinas, lactobionato de eritromicina o algunas tetraciclinas, pueden ser…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Acetylcysteine used for?

Acetylcysteine is evaluated for the following indications with varying evidence strength: Paracetamol overdose (evidence tier A), Productive cough (evidence tier C), Obsessive-compulsive disorder (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Acetylcysteine?

Common side effects of Acetylcysteine (≥ 1 in 100): Nausea, vomiting, heartburn, Diarrhoea, Unpleasant sulphurous breath, Rash and pruritus. See the Safety section for uncommon and serious reactions.

Is Acetylcysteine safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): clinical data on acetylcysteine in pregnant women are limited, and animal studies have not shown direct or indirect reproductive toxicity. As a precaution, it is preferable to avoid acetylcysteine during pregnancy. If it is used, the risks are weighed against the potential benefits beforehand, and treatment is given under medical supervision.

Is Acetylcysteine compatible with breastfeeding?

Compatible. Hale L2. Milk transfer data are limited, but with short courses and standard doses no infant adverse events have been reported. eLactancia rates the risk as low.

Who should not take Acetylcysteine?

Acetylcysteine is contraindicated in: Hypersensitivity to acetylcysteine; Active peptic ulcer disease; Haemoptysis and pulmonary haemorrhage. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Ambroxol, Bromhexine, Carbocisteine, Cloperastine, Dextromethorphan, Guaifenesin, Ivy leaf dry extract (Hedera helix), Paracetamol + Chlorpheniramine + Phenylephrine