🇺🇸 PROCAINAMIDE in United States

FDA authorised PROCAINAMIDE on 31 July 1984 · 391 US adverse-event reports

Marketing authorisations

FDA — authorised 31 July 1984

  • Application: ANDA088636
  • Marketing authorisation holder: INTL MEDICATION
  • Status: supplemented

FDA — authorised 12 February 1986

  • Application: ANDA089069
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 13 October 2017

  • Application: ANDA206332
  • Marketing authorisation holder: NEXUS
  • Status: approved

FDA — authorised 22 July 2024

  • Application: ANDA218135
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 4 February 2025

  • Application: ANDA218674
  • Marketing authorisation holder: CAPLIN
  • 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.

Most-reported reactions

  1. Drug Ineffective — 123 reports (31.46%)
  2. Atrial Fibrillation — 42 reports (10.74%)
  3. Off Label Use — 38 reports (9.72%)
  4. Pain — 31 reports (7.93%)
  5. Ventricular Tachycardia — 29 reports (7.42%)
  6. Drug Hypersensitivity — 28 reports (7.16%)
  7. Fatigue — 28 reports (7.16%)
  8. Electrocardiogram Qt Prolonged — 25 reports (6.39%)
  9. Depression — 24 reports (6.14%)
  10. Drug Ineffective For Unapproved Indication — 23 reports (5.88%)

Source database →

PROCAINAMIDE 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 PROCAINAMIDE approved in United States?

Yes. FDA authorised it on 31 July 1984; FDA authorised it on 12 February 1986; FDA authorised it on 13 October 2017.

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

INTL MEDICATION holds the US marketing authorisation.