FDA — authorised 15 January 1974
- Application: NDA017443
- Marketing authorisation holder: PH HEALTH
- Local brand name: DANTRIUM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 DANTROLENE SODIUM in United States
FDA authorised DANTROLENE SODIUM on 15 January 1974 · 301 US adverse-event reports
Marketing authorisations
FDA — authorised 19 September 1979
- Application: NDA018264
- Marketing authorisation holder: PH HEALTH
- Local brand name: DANTRIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 March 2005
- Application: ANDA076856
- Marketing authorisation holder: IMPAX LABS
- Local brand name: DANTROLENE SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 October 2005
- Application: ANDA076686
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: DANTROLENE SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 July 2007
- Application: ANDA078378
- Marketing authorisation holder: USWM
- Local brand name: REVONTO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 2014
- Application: NDA205579
- Marketing authorisation holder: EAGLE PHARMS
- Status: supplemented
FDA — authorised 18 February 2016
- Application: ANDA205239
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: DANTROLENE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 June 2017
- Application: ANDA204762
- Marketing authorisation holder: HIKMA
- Local brand name: DANTROLENE SODIUM
- Indication: INJECTABLE — INJECTION
- 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: 301
Most-reported reactions
- Neuroleptic Malignant Syndrome — 48 reports (15.95%)
- Respiratory Failure — 36 reports (11.96%)
- Asthenia — 30 reports (9.97%)
- Drug Ineffective — 30 reports (9.97%)
- Muscular Weakness — 30 reports (9.97%)
- Pyrexia — 30 reports (9.97%)
- Convulsion — 27 reports (8.97%)
- Diarrhoea — 24 reports (7.97%)
- Fatigue — 23 reports (7.64%)
- Vomiting — 23 reports (7.64%)
DANTROLENE SODIUM 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 DANTROLENE SODIUM approved in United States?
Yes. FDA authorised it on 15 January 1974; FDA authorised it on 19 September 1979; FDA authorised it on 1 March 2005.
Who is the marketing authorisation holder for DANTROLENE SODIUM in United States?
PH HEALTH holds the US marketing authorisation.