Data updated: May 26, 2026
MAGNESIUM SULFATE IN PLASTIC CONTAINER (magnesium sulfate)
CNS
Approved 1994-06-24
Magnesium Sulfate in 5% Dextrose Injection is a therapeutic agent used in obstetric care for the management of hypertensive disorders of pregnancy. It is indicated for the prevention of eclampsia in patients diagnosed with preeclampsia. Additionally, the medication is used to treat active seizures and prevent their recurrence in patients who have progressed to eclampsia.
Source: FDA Label • MILLA PHARMS
How MAGNESIUM SULFATE IN PLASTIC CONTAINER Works
Magnesium sulfate prevents and controls seizures by blocking neuromuscular transmission and decreasing the amount of acetylcholine released at the motor nerve end plate. The drug also exerts a depressant effect on the central nervous system. Furthermore, it acts peripherally to produce vasodilation.
8
Indications
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Phase 3 Trials
31
Years on Market
Details
- Status
- Prescription
- First Approved
- 1994-06-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MAGNESIUM SULFATE IN PLASTIC CONTAINER Approval History
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Original
New Indication
New Form
Label Update
110 FDA actions from 1994 to 2026
Jan 2026 SUPPL
Mfg · Manufacturing (CMC)
Jul 2023 SUPPL
Label · Labeling
Feb 2023 ORIGINAL
Update
May 2022 SUPPL
Mfg
Nov 2021 ORIGINAL
Update
Jul 2020 ORIGINAL
Update
Jun 2020 ORIGINAL
Update
Sep 2018 ORIGINAL
Update
Dec 2017 ORIGINAL
Update
Mar 2016 ORIGINAL
Update
Nov 2014 SUPPL
Mfg
Nov 2013 SUPPL
Mfg
Nov 2002 SUPPL
Mfg
Oct 1998 SUPPL
Label
Oct 1998 SUPPL
Mfg
Jul 1997 SUPPL
Mfg
Apr 1997 SUPPL
Label
Aug 1996 SUPPL
Mfg
Aug 1996 SUPPL
Mfg
Mar 1996 SUPPL
Mfg
Oct 1995 SUPPL
Label
Jan 1995 SUPPL
Mfg
Jun 1994 ORIGINAL
Update
What MAGNESIUM SULFATE IN PLASTIC CONTAINER Treats
3 indicationsMAGNESIUM SULFATE IN PLASTIC CONTAINER is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Eclampsia
- Preeclampsia
- Seizures
Source: FDA Label
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Clinical Trial Registry
96 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04740294 | 20.1171 | Ph 2, Ph 3 | withdrawn | Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis |
| NCT04938765 | 5210244 | Ph 4 | recruiting | Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring |
| NCT06811233 | 2024-1369 NCI-2025-00860, CDMRP-TX230317 | Ph 2 | recruiting | Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study |
| NCT07524972 | Suez Canal-MD-2025 | Ph 3 | recruiting | Antenatal Magnesium Sulphate in High-Risk Preterm Patients |
| NCT06455514 | 20-00262 1R34HL166859-01A1 | Ph 1 | recruiting | Post-CA Neuroprotection With Magnesium |
| NCT06513013 | TAP in cs using us | Ph 2, Ph 3 | completed | MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section |
| NCT07478055 | 108288 | Ph 4 | not yet recruiting | Biomarkers in Management of Post Partum Preeclampsia |
| NCT06477133 | 24-00463 | Ph 4 | active not recruiting | Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery |
| NCT07443163 | MD-313-2025 | Ph 3 | not yet recruiting | Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries |
| NCT04275661 | ESPB in breast cancer surgery | Ph 2 | completed | Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery |
| NCT06785272 MAGICIAN | 5274 | Ph 3 | recruiting | Magnesium Trial in Acute Asthma in Emergency Department |
| NCT05730816 MAGIC-AKI | 2023p000276 K23DK125672 | Ph 2 | recruiting | MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI |
| NCT07220902 LEVMag | 1559 | Ph 3 | not yet recruiting | Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure |
| NCT07213037 | Magnesium Sulfate vs Lidocaine | Ph 3 | not yet recruiting | Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery |
| NCT03925025 CCBOC | AC19003 | Ph 3 | completed | Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning |
| NCT05829317 ATOMIC | ATOMIC | Ph 4 | recruiting | Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients |
| NCT07126795 | HCMC Pediatric Burn Study | Ph 1 | not yet recruiting | Magnesium Sulfate in Pediatric Burn Dressing Changes |
| NCT06745388 | 2024-115 | Ph 4 | recruiting | Magnesium and Cramping |
| NCT07131033 | CLanXie | Ph 1, Ph 2 | active not recruiting | Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy |
| NCT06979141 MgSO4/DEX | MD/AZ.AST./AIP029/7/240/2/2025 | Ph 3 | recruiting | Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia |
| NCT06956521 | H-50731 | Ph 1 | not yet recruiting | Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke |
| NCT06955559 | Mg bronchialasthma bronchiolis | Ph 3 | not yet recruiting | Magnesium Sulfate in Bronchial Asthma and Acute Bronchiolitis in Children |
| NCT06920576 | CLXie | Ph 1, Ph 2 | active not recruiting | Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery |
| NCT06848595 mg/dex/rSO2 | 36265MD317/11/24 | Ph 3 | not yet recruiting | Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation |
| NCT06414356 | 954942 | Ph 4 | recruiting | The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD |
| NCT05554848 | N-62-2022 | Ph 4 | completed | Dexmedetomidine and Magnesium Sulfate in Preventing Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery |
| NCT06026527 | MagSulf1234 | Ph 3 | completed | Intra-operative Magnesium Sulphate for Post-operative Pain in Patients Undergoing Total Abdominal Hysterectomy Under General Anesthesia |
| NCT04898114 | Neb-Mag-2 | Ph 1, Ph 2 | recruiting | Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn |
| NCT04812028 results posted | PEDS-2019-27677 | Ph 2 | completed | Magnesium Sulfate for Analgesia in Pediatric Transplant |
| NCT01950520 results posted | 130200 13-DK-0200 | Ph 2 | completed | Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate |
| NCT05967442 MAGraine results posted | AHC-7192-D5000322 | Ph 3 | completed | Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines |
| NCT05855798 | esp01 | Ph 4 | completed | Ketamine and Magnesium in Erector Spinae Plane Block |
| NCT06578000 Iontophoresis | P.T.REC/012/004798 | Ph 1 | recruiting | Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients |
| NCT05669417 POMPAE | T-21-118 | Ph 2, Ph 3 | terminated | Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated. |
| NCT05671081 | FMASU R263/2022 | Ph 3 | completed | Dexmedetomidine Versus Magnesium Sulfate in Ultrasound Guided Bilateral Bi-level Erector Spinae Plane Block in Corrective Scoliosis Surgery |
| NCT06367595 | Intrathecal MgSO4 | Ph 2 | not yet recruiting | Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy |
| NCT04638881 MgPOEM results posted | 58859 | Ph 2 | completed | Magnesium for Peroral Endoscopic Myotomy |
| NCT05261516 Volmag | 2019-02104/CE3541 | Ph 4 | recruiting | Interaction of Volatile Anesthetics With Magnesium |
| NCT05565664 | MD-60-2022 | Ph 4 | completed | Ketamine Versus Magnesium as Analgesic Adjuvants in Pediatric Adenotonsillectomy |
| NCT05325580 | Emergency Monastir | Ph 3 | recruiting | Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department |
| NCT05858957 | Extubation quality | Ph 4 | completed | Magnesium Sulphate and Extubation Quality |
| NCT04330755 | MD-223-2019 | Ph 4 | completed | Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy |
| NCT03208452 | B1605/346-002 | Ph 4 | completed | The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation |
| NCT05880693 | Sameh | Ph 1 | completed | Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries |
| NCT05850832 | 0305810 | Ph 2, Ph 3 | completed | Efficacy of Esmolol Versus Magnesium Sulphate on Quality of Recovery in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Controlled Study |
| NCT03497923 MagNeoSug | CCER 2016-00018 | Ph 4 | completed | Interaction Between Magnesium and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block |
| NCT02680626 | ANAE-275-15 | Ph 4 | terminated | Bilateral Transversus Abdominis Plane Block With or Without Magnesium |
| NCT04300985 | CAAE 28455419.9.0000.5448 | Ph 3 | completed | Magnesium Sulfate Versus Dexmedetomidine on Anesthesia Awakening. |
| NCT01099449 results posted | N08CB NCCTG-N08CB, CDR0000669660 | Ph 3 | completed | Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy |
| NCT04554862 | M419 | Ph 4 | completed | The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block |
Showing 50 of 96 trials
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MAGNESIUM SULFATE IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)MAGNESIUM SULFATE IN PLASTIC CONTAINER is indicated for the treatment of Eclampsia; Preeclampsia; Seizures.
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Data Sources
FDA Approval: ANDA209642 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.