🇺🇸 N-acetylcysteine in United States

536 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 536

Most-reported reactions

1. Acute Kidney Injury — 154 reports (28.73%)
2. Drug Ineffective — 68 reports (12.69%)
3. Toxicity To Various Agents — 54 reports (10.07%)
4. Nephropathy Toxic — 50 reports (9.33%)
5. Fatigue — 38 reports (7.09%)
6. Dyspnoea — 37 reports (6.9%)
7. Overdose — 36 reports (6.72%)
8. Nausea — 35 reports (6.53%)
9. Off Label Use — 33 reports (6.16%)
10. Insomnia — 31 reports (5.78%)

Source database →

Frequently asked questions

Is N-acetylcysteine approved in United States?

N-acetylcysteine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for N-acetylcysteine in United States?

University of Turin, Italy is the originator. The local marketing authorisation holder may differ — check the official source linked above.