FDA — authorised 31 July 2001
- Application: ANDA075442
- Marketing authorisation holder: AMNEAL PHARM
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 FLECAINIDE ACETATE in United States
FDA authorised FLECAINIDE ACETATE on 31 July 2001 · 2,499 US adverse-event reports
Marketing authorisations
FDA — authorised 28 October 2002
- Application: ANDA075882
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2002
- Application: ANDA076030
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2003
- Application: ANDA076278
- Marketing authorisation holder: HIKMA
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2009
- Application: ANDA079164
- Marketing authorisation holder: CHARTWELL
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2017
- Application: ANDA202821
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2020
- Application: ANDA210683
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA215599
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: FLECAINIDE ACETATE
- Indication: TABLET — ORAL
- Status: approved
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: 20 April 2025 – 20 April 2026
- Total reports: 2,499
Most-reported reactions
- Atrial Fibrillation — 356 reports (14.25%)
- Dyspnoea — 288 reports (11.52%)
- Fatigue — 286 reports (11.44%)
- Dizziness — 265 reports (10.6%)
- Nausea — 256 reports (10.24%)
- Headache — 221 reports (8.84%)
- Drug Ineffective — 220 reports (8.8%)
- Diarrhoea — 215 reports (8.6%)
- Asthenia — 206 reports (8.24%)
- Fall — 186 reports (7.44%)
FLECAINIDE ACETATE 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 FLECAINIDE ACETATE approved in United States?
Yes. FDA authorised it on 31 July 2001; FDA authorised it on 28 October 2002; FDA authorised it on 28 October 2002.
Who is the marketing authorisation holder for FLECAINIDE ACETATE in United States?
AMNEAL PHARM holds the US marketing authorisation.