Active substance
Dantrolene
- US FDA 8
- Health Canada 3
- US price lines 3
- NHS prices 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DANTRIUM | 25MG; 100MG; 50MG | capsule · oral | PH HEALTH | Prescription | 15 Jan 1974 |
| DANTRIUM | 20MG/VIAL | injectable · injection | PH HEALTH | Prescription | 19 Sep 1979 |
| DANTROLENE SODIUM | 25MG; 50MG; 100MG | capsule · oral | IMPAX LABS | Prescription | 1 Mar 2005 |
| DANTROLENE SODIUM | 25MG; 50MG; 100MG | capsule · oral | ELITE LABS INC | Prescription | 24 Oct 2005 |
| REVONTO | 20MG/VIAL | injectable · injection | USWM | Prescription | 24 Jul 2007 |
| RYANODEX | 250MG/VIAL | for suspension · intravenous | EAGLE PHARMS | Prescription | 22 Jul 2014 |
| DANTROLENE SODIUM | 20MG/VIAL | injectable · injection | HIKMA | Prescription | 19 Jun 2017 |
| DANTROLENE SODIUM | 20MG/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Discontinued | 18 Feb 2016 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DANTRIUM CAPSULES | 01997602 | 25 MG | CAPSULE · ORAL | KNIGHT THERAPEUTICS INC. |
| DANTRIUM INTRAVENOUS | 01997572 | 20 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | KNIGHT THERAPEUTICS INC. |
| DANTROLENE SODIUM FOR INJECTION, USP | 02529998 | 20 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | HIKMA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DANTROLENE SODIUM 100 MG CAP | $1.00732 | per EA | 23 Sep 2026 |
| US NADAC | DANTROLENE SODIUM 25 MG CAP | $0.4088 | per EA | 23 Sep 2026 |
| US NADAC | DANTROLENE SODIUM 50 MG CAP | $0.55379 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Dantrolene 100mg capsules | £43.07 | 100 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Dantrolene 25mg capsules | £16.87 | 100 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 2 Apr 2024 DANTRIUM — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 2 Apr 2024 RYANODEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.