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Molecule

Acetylcysteine

Antidote
Available on requestOrphanCold chainOphthalmologyAntidotes
Presentations
8
Brands
1
Manufacturers
1
Available from stock
0

Acetylcysteine is an antidote indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients, among other approved uses. MedsAcross supplies Acetylcysteine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Antidote, Antidote for Acetaminophen Overdose, Mucolytic, Reduction Activity, Decreased Respiratory Secretion Viscosity, Increased Glutathione Concentration
ATC classification
R05CB01 Acetylcysteine · MucolyticS01XA08 Acetylcysteine · Eye medicines, subgroup S01X, subgroup S01XAV03AB23 Acetylcysteine · Antidote
US FDA first approval
14 September 1963
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Inhalation, Intravenous, Oral
Dosage forms
Inhalation solution, Injection, Inhalant
Identifiers
UNII WYQ7N0BPYCRxCUI 197CAS 616-91-1DrugBank DB06151Q375613

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

Pre-Treatment Assessment Following Acute Ingestion: Prior to initiating treatment with Acetylcysteine Injection, decide whether the three-bag or two-bag regimen will be used. Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. • If the time of acetaminophen ingestion is unknown: o Administer a loading dose of Acetylcysteine Injection immediately. o Obtain an acetaminophen concentration to determine need for continued treatment. • If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity: o Administer a loading dose of Acetylcysteine Injection immediately and continue treatment for a total of three doses over 21 hours.

Source: US FDA prescribing information

Contraindications

Acetylcysteine Injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine. Patients with a previous hypersensitivity reaction to acetylcysteine

Source: US FDA prescribing information

Warnings and precautions

• Hypersensitivity Reactions: Fatal or life-threatening anaphylaxis, rash, hypotension, wheezing, shortness of breath, and/or bronchospasm have been observed. Observe patients during and after the infusion, immediately discontinue infusion if a serious reaction occurs and initiate appropriate treatment. Acetylcysteine Injection infusion may be carefully restarted after treatment of hypersensitivity has been initiated and acute symptoms have resolved. • Fluid Overload: Total volume administered should be reduced for patients weighing less than 40 kg and for those requiring fluid restriction.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

8 presentations of Acetylcysteine, sorted by availability.

MedicineManufacturerRegisterAvailability
Acetylcysteine 6000 mg/30 mL injectionIntravenousGeneric name—US FDAAvailable on request
Acetylcysteine 200 mg/mL inhalation solutionInhalation, oral Cold chainGeneric name—US FDAAvailable on request
Acetylcysteine 100 mg/mL inhalation solutionInhalation, oral Cold chainGeneric name—US FDAAvailable on request
Acetylcysteine 100 mg/mL inhalantInhalation Cold chainGeneric name—US FDAAvailable on request
Acetylcysteine 200 mg/mL inhalation solutionInhalation Cold chainGeneric name—US FDAAvailable on request
Acetylcysteine 200 mg/mL inhalantInhalation Cold chainGeneric name—US FDAAvailable on request
Acetylcysteine 100 mg/mL inhalation solutionInhalation Cold chainGeneric name—US FDAAvailable on request
Acetadote 6000 mg/30 mL injectionIntravenousCumberland PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Acetadote

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 September 1963Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Acetylcysteine in public data. This is not a list of approved uses, see the clinical information.

Acute bronchitis Amyloidosis BronchiectasisRare disease Contrast-induced nephropathy Cystic fibrosis Lung disease Paracetamol toxicity Pneumonia Pulmonary emphysema Respiratory distress

Questions and answers

Is Acetylcysteine available for export from India?

Yes, on request. MedsAcross lists 8 presentations of Acetylcysteine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Acetylcysteine have?

The catalogue lists 1 brand names for Acetylcysteine, including Acetadote.

Is Acetylcysteine approved by the US FDA?

Yes. The US FDA first approved Acetylcysteine on 14 September 1963, according to Drugs@FDA.

Does Acetylcysteine need cold chain shipping?

At least one listed presentation of Acetylcysteine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Acetylcysteine in?

Acetylcysteine is classified under ATC code R05CB01 (Acetylcysteine).

References

  1. acetylcysteine prescribing information (Padagis). U.S. National Library of Medicine, DailyMed. Retrieved 31 July 2025

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