Regulatory PathRegulatory requirements compared

Active substance

Magnesium sulfate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MAGNESIUM SULFATE 50% AMPOULE50 %Solution for injection · Parenteral use1 AmpouleSAR 4.20Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
MAGNESIUM SULFATE 50% I.V. Injection*50 %Solution for injection · Parenteral use1 VialSAR 7.10Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
MAGNESIUM SULPHATE 10% Injection*10 %Solution for injection · Parenteral use1 VialSAR 3.20Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
MAGNESIUM SULPHATE 10% Injection*10 %Solution for injection · Parenteral use1 VialSAR 1.80Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
MAGNESIUM SULFATE 50% AMP50 %Solution for injection · Parenteral use1 AmpouleSAR 3.15Generic · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; ARRHYTHMIA; ASTHMA; BURKITT`S LYMPHOMA; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); ESOPHAGEAL CANCER-RENAL TOXICITY; FOLLICULAR LYMPHOMA; GASTRIC CANCER-RENAL TOXICITY; HODGKIN'S LYMPHOMA; HYPOPARATHYROIDISM; MANTLE CELL LYMPHOMA; MATERNAL AND CHILD HEALTHCARE- PERINATAL,INTRAPARTUM AND POSTPARTUM CARE; MULTIPLE MYELOMA; NEONATAL RESPIRATORY DISTRESS SYNDROME (NRDS); T-CELL LYMPHOMA-RENAL TOXICITY; VENTRICULAR TACHYCARDIA

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
MAGNESIUM SULFATE5GM/10ML (500MG/ML); 1GM/2ML (500MG/ML); 10GM/20ML (500MG/ML); 25GM/50ML (500MG/ML)solution · intramuscular, intravenousFRESENIUS KABI USAPrescription8 Sep 1986
MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML); 2GM/50ML (40MG/ML); 20GM/500ML (40MG/ML); 40GM/1000ML (40MG/ML)injectable · injectionHOSPIRAPrescription24 Jun 1994
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100ML; 2GM/100MLinjectable · injectionHOSPIRAPrescription11 Jul 1995
MAGNESIUM SULFATE5GM/10ML (500MG/ML)solution · intramuscular, intravenousHOSPIRAPrescription25 Apr 2000
MAGNESIUM SULFATE10GM/20ML (500MG/ML)solution · intramuscular, intravenousHOSPIRAPrescription14 May 2015
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100MLinjectable · injectionHQ SPCLT PHARMAPrescription2 Mar 2016
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100MLinjectable · injectionFRESENIUS KABI USAPrescription7 Mar 2016
MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/100ML (40MG/ML); 4GM/50ML (80MG/ML); 2GM/50ML (40MG/ML); 20GM/500ML (40MG/ML); 40GM/1000ML (40MG/ML)injectable · injectionFRESENIUS KABI USAPrescription15 Mar 2016
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML); 4GM/50ML (80MG/ML); 20GM/500ML (40MG/ML); 40GM/1000ML (40MG/ML)injectable · injectionHQ SPCLT PHARMAPrescription6 Dec 2017
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/50ML (80MG/ML); 4GM/100ML (40MG/ML)injectable · injectionBAXTER HLTHCARE CORPPrescription1 Jun 2020
MAGNESIUM SULFATE3GM/100ML (30MG/ML)injectable · injectionBAXTER HLTHCARE CORPPrescription1 Jun 2020
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML)injectable · injectionGLANDPrescription10 Jul 2020
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100MLinjectable · injectionBAXTER HLTHCARE CORPPrescription11 Aug 2020
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100MLinjectable · injectionB BRAUN MEDICALPrescription27 Oct 2020
MAGNESIUM SULFATE2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML); 4GM/50ML (80MG/ML)injectable · injectionB BRAUN MEDICALPrescription26 Apr 2021
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML); 4GM/50ML (80MG/ML)injectable · injectionMILLA PHARMSPrescription8 Nov 2021
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML)injectable · injectionAMNEALPrescription15 Feb 2023
MAGNESIUM SULFATE1GM/2ML (500MG/ML); 5GM/10ML (500MG/ML); 10GM/20ML (500MG/ML); 25GM/50ML (500MG/ML)solution · intramuscular, intravenousASPIROPrescription28 May 2025
MAGNESIUM SULFATE1GM/2ML (500MG/ML); 5GM/10ML (500MG/ML); 10GM/20ML (500MG/ML); 25GM/50ML (500MG/ML)solution · intramuscular, intravenousADAPTISPrescription9 Jul 2026
MAGNESIUM SULFATE IN PLASTIC CONTAINER4GM/50ML (80MG/ML)injectable · injectionHOSPIRADiscontinued24 Jun 1994
MAGNESIUM SULFATE5GM/10ML (500MG/ML)solution · intramuscular, intravenousEXELA PHARMADiscontinued18 Dec 2014
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER1GM/100MLinjectable · injectionPHARMOBEDIENTDiscontinued10 Sep 2018
MAGNESIUM SULFATE IN PLASTIC CONTAINER2GM/50ML (40MG/ML); 4GM/100ML (40MG/ML)injectable · injectionPHARMOBEDIENTDiscontinued14 Sep 2018

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MAGNESIUM SULFATE IN WATER FOR INJECTION0254215340 MG / MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
MAGNESIUM SULFATE INJECTION USP00392618200 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
MAGNESIUM SULFATE INJECTION USP02562235500 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSTERIMAX INC
MAGNESIUM SULFATE INJECTION, BP 49.3%02513161493 MG / MLSOLUTION · INTRAVENOUSBAXTER CORPORATION
MAGNESIUM SULFATE INJECTION, USP02139499500 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARFRESENIUS KABI CANADA LTD

WHO WHO Model List of Essential Medicines (2025)

  • 5.1.1. Antiseizure medicines · core
    Severe pre-eclampsia; Eclampsia
    Parenteral > General injections > IV: 500 mg per mL in 2 mL ampoule (equivalent to 1 g in 2 mL; 50% weight/volume) | Parenteral > General injections > IM: 500 mg per mL in 10 mL ampoule (equivalent to 5 g in 10 mL; 50% weight/volume)

Safety signals and safety-related labeling changes

All safety entries for magnesium sulfate →

Combinations containing Magnesium sulfate

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.