FDA — authorised 3 May 1951
- Application: NDA007959
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: TENSILON PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 EDROPHONIUM CHLORIDE in United States
FDA authorised EDROPHONIUM CHLORIDE on 3 May 1951 · 18 US adverse-event reports
Marketing authorisations
FDA — authorised 6 August 1985
- Application: ANDA088873
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ENLON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 1988
- Application: ANDA089624
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: REVERSOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 1998
- Application: ANDA040131
- Marketing authorisation holder: HOSPIRA
- Local brand name: EDROPHONIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA040043
- Marketing authorisation holder: WATSON LABS
- Local brand name: EDROPHONIUM CHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA040044
- Marketing authorisation holder: WATSON LABS
- Local brand name: EDROPHONIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- 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: 18
Most-reported reactions
- Agitation — 2 reports (11.11%)
- Bradycardia — 2 reports (11.11%)
- Bronchospasm — 2 reports (11.11%)
- Crepitations — 2 reports (11.11%)
- Miosis — 2 reports (11.11%)
- Ophthalmoplegia — 2 reports (11.11%)
- Pulmonary Oedema — 2 reports (11.11%)
- Salivary Hypersecretion — 2 reports (11.11%)
- Accidental Overdose — 1 report (5.56%)
- Asthenia — 1 report (5.56%)
EDROPHONIUM CHLORIDE 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 EDROPHONIUM CHLORIDE approved in United States?
Yes. FDA authorised it on 3 May 1951; FDA authorised it on 6 August 1985; FDA authorised it on 13 May 1988.
Who is the marketing authorisation holder for EDROPHONIUM CHLORIDE in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.