Acetylcysteine: uses, dosing, side effects & brands
Acetylcysteine is an antidote sold in the U.S. under 2 brand and generic names, for amyloidosis, bronchiectasis and bronchitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antidote
- Treats (across its forms)
- Amyloidosis, Bronchiectasis and Bronchitis
- Available as
- Injectable · Solution
- Sold as
- 2 products — Acetadote and Mucomyst
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $1 per ml — not your price
How Acetadote is dosed
From the FDA label for Acetadote (application NDA021539). Other acetylcysteine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Pre-Treatment Assessment Following Acute Ingestion ( 2.1 ) : Prior to initiating treatment with ACETADOTE, 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: Administer a loading dose of ACETADOTE immediately. 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: Administer a loading dose of ACETADOTE immediately and continue treatment for a total of two doses over 20 hours or three doses over 21 hours ( 2.5 ). If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of ACETADOTE immediately Obtain acetaminophen concentration to determine need for continued treatment If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known: Use the revised Rumack-Matthew nomogram ( Figure 1 ) to determine whether or not to initiate treatment with ACETADOTE ( 2.2 ) Nomogram for Estimating Potential for…
Everything below is the FDA label for Acetadote (injectable). Acetylcysteine is also sold as solution, and those are different medicines to take — follow the label for the one you were prescribed.
Acetadote side effects
Most common adverse reactions (> 2%) are rash, urticaria/facial flushing and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Fluid Overload [see Warnings and Precautions ( 5.2 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the literature, the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine. Loading Dose/Infusion Rate Study In a randomized, open-label, multi-center clinical study conducted in Australia in patients with acetaminophen poisoning, the rates of hypersensitivity reactions between a 15-minute and 60-minute intravenous infusion for the 150 mg/kg loading dose of acetylcysteine were compared. The incidence of…
Who shouldn’t take Acetadote
ACETADOTE is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see Warnings and Precautions ( 5.1 )] . Patients with a previous hypersensitivity reaction to acetylcysteine ( 4 )
Every acetylcysteine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | Generic | $1 | View → | |
| 2 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
Combination products containing acetylcysteine
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
How long acetylcysteine keeps
The date on a sealed pack is not the only one: some acetylcysteine labels start a second clock once the product is opened or mixed, as short as 24 hours.
Does acetylcysteine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about acetylcysteine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 10,900 reports naming acetylcysteine, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea867 reports
- pneumonia707 reports
- pyrexia554 reports
- fatigue546 reports
- nausea507 reports
- acute kidney injury423 reports
- diarrhoea414 reports
- vomiting388 reports
Read these as a signal, not a rate. A report does not mean acetylcysteine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Acetadote?
Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor.
What kind of drug is acetylcysteine?
The FDA classifies acetylcysteine as an antidote. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take acetylcysteine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run acetylcysteine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is acetylcysteine sold under?
We track 2 acetylcysteine-containing products in the U.S.: Acetadote and Mucomyst. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does acetylcysteine come in?
Across the brands we track, acetylcysteine is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic acetylcysteine?
We do not currently list a generic-labelled acetylcysteine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Acetylcysteine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/acetylcysteine
- MLA
- “Acetylcysteine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/acetylcysteine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for acetylcysteine on DailyMed (NIH) ↗.