🇺🇸 Citicholine in United States

11 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

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: 27 March 2025 – 27 March 2026
• Total reports: 11

Most-reported reactions

1. Dyspnoea — 2 reports (18.18%)
2. Anaemia — 1 report (9.09%)
3. Cardio-Respiratory Arrest — 1 report (9.09%)
4. Depressed Level Of Consciousness — 1 report (9.09%)
5. Dizziness — 1 report (9.09%)
6. Haemorrhagic Transformation Stroke — 1 report (9.09%)
7. Headache — 1 report (9.09%)
8. Heart Rate Decreased — 1 report (9.09%)
9. Hypokalaemia — 1 report (9.09%)
10. Lung Infection — 1 report (9.09%)

Source database →

Frequently asked questions

Is Citicholine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Citicholine in United States?

Ain Shams University is the originator. The local marketing authorisation holder may differ — check the official source linked above.