Drug Landscape ›
n-acetylcystine ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 12
Most-reported reactions
Cough — 2 reports (16.67%) Hypotension — 2 reports (16.67%) Acute Hepatic Failure — 1 report (8.33%) Akathisia — 1 report (8.33%) Alanine Aminotransferase Increased — 1 report (8.33%) Anxiety — 1 report (8.33%) Apgar Score Low — 1 report (8.33%) Aspartate Aminotransferase Increased — 1 report (8.33%) Atrial Fibrillation — 1 report (8.33%) Atrial Flutter — 1 report (8.33%)
Source database →
n-acetylcystine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is n-acetylcystine approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for n-acetylcystine in United States?
Assiut University is the originator. The local marketing authorisation holder may differ — check the official source linked above.