Acetylcysteine
Active ingredient · 3 therapeutic classes
Sold as Folcyteine · ILUBE 5% W/V
- Drug class
- Mucolytics
- Availability
- Prescription only
- Routes
- Intravenous, Inhalation, Oral
- Markets covered
- 3
- Products on record
- 19
- FDA reports (12 mo)
- 764
Overview
Plain-language summary, compiled from the cited regulatory records
Acetylcysteine is classified as a mucolytic agent [1]. It is approved to provide vitamin supplementation for men and women [1]. Specifically, it is effective in treating megaloblastic anemias that result from folic acid deficiency, such as those seen in tropical or nontropical sprue [1]. It is also used for anemias of nutritional origin, pregnancy, infancy, or childhood [1].
This active ingredient is available under various brand names, including Folcyteine [1]. In the past 12 months, there have been 764 adverse event reports associated with this ingredient [2]. The most frequently reported adverse events include claims of the drug being ineffective, off-label use, pneumonia, dyspnoea, and death [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 13 | May 29, 2026 |
| CA Canada | Health Canada | 5 | March 19, 2026 |
| US United States | FDA | 1 | September 14, 2023 |
GBUnited Kingdom· MHRA
13 products
Uses
Acetylcysteine 600mg Capsules are a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterized by excessive, viscous mucus, including chronic obstructive airways disease
How to take
CACanada· Health Canada
5 products
Uses
AND CLINICAL USE....................................................................................... 3 CONTRAINDICATIONS ............................................................................................................
3 WARNINGS AND PRECAUTIONS .......................................................................................... 3 ADVERSE REACTIONS ............................................................................................................
6 DRUG INTERACTIONS ............................................................................................................. 7 DOSAGE AND ADMINISTRATION .........................................................................................
7 OVERDOSAGE ......................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY .....................................................................
USUnited States· FDA
1 product
Uses
Indications and Usage:
Folcyteine™ is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood
How to take
Drug interactions
Known interactions involving Acetylcysteine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 241. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL556120019 · revised May 29, 2026
- [2]Health Canada (DPD) · 02243098 · revised March 19, 2026
- [3]FDA DailyMed · 04cf0026-e29b-ff… · revised September 14, 2023 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.