Magnesium sulfate: clinical trials recruiting now
3
Recruiting trials
6
Conditions studied
0
US states with sites
2
Countries
FDA drug label
- FDA-approved
- Yes. Magnesium sulfate appears in the FDA drug-label database. Marketed as Epsom Salt.
FDA-approved use
Uses for relief of occasional constipation (irregularity) this product generally produces bowel movement in 1/2 to 6 hours
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. — Hospira, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2012-04-05 |
| Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. — Amneal Pharmaceuticals, LLC | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2026-03-18 |
| Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2016-01-05 |
| Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2015-04-28 |
| Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection. — Hospira Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2015-03-06 |
Phase breakdown
Phase 1 1
Phase 2 1
Phase 3 1
Phase 4 1
Conditions being studied
| Condition | Trials |
|---|---|
| Asthma | 1 |
| Atrial fibrillation | 1 |
| Critical Illness | 1 |
| Hypertension | 1 |
| New Onset Atrial Fibrillation | 1 |
| Persistent Pulmonary Hypertension of Newborn | 1 |
Recruiting trials involving Magnesium sulfate
- Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
- Magnesium Trial in Acute Asthma in Emergency Department
- Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Common questions
Is Magnesium sulfate FDA-approved?
Yes, marketed as Epsom Salt.
How many recruiting trials involve Magnesium sulfate?
3 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.