Prescription and over-the-counter medicine
Magnesium sulfate
Magnesium sulfate is a prescription and over-the-counter medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.0039 per gram (Epsom salt) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the magnesium sulfate FDA label on DailyMed (effective August 24, 2026, Hospira, Inc.); the NDA 19316 record on Drugs@FDA; every magnesium sulfate label on DailyMed.
Highlights of the record
FDA label of August 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMagnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
Forms and strengths
- 1 g/100ml
- 2 g/50ml
- 3 g/100ml
- 4 g/100ml
- 4 g/50ml
- 10 mg/ml
- 20 g/500ml
- 40 mg/ml
- 40 g/1000ml
- 80 mg/ml
- 500 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- September 8, 1986 Magnesium Sulfate, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first April 25, 2000; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 17 under generic applications, 7 under brand applications, repackagers included; 47 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0039 per gram Epsom salt
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2012 5 Class I among all firms' recalls; latest March 18, 2026; 6 more by firms not listed as its makers
- FAERS reports
- 13,130 through July 30, 2026
What is magnesium sulfate used for?
From the label: indications and usageMagnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
Conditions named in the indications of magnesium sulfate's FDA labels, with every medicine labeled for each:
From other magnesium sulfate labelsSeizures and epilepsy: INDICATIONS AND USAGE Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.
Constipation: relieves occasional constipation (irregularity)
Pain: Relieves pain from minor sprains and bruises
FDA pharmacologic class: Calculi Dissolution Agent and Osmotic Laxative.
Source: FDA drug label (Magnesium Sulfate in Water), Hospira, Inc., effective August 24, 2026 (SPL set 22ca78b4-f5a3-4144-cf89-5f633acf1e6d), via openFDA; the full label on DailyMed
Is there a generic for magnesium sulfate?
The FDA approved the first generic magnesium sulfate on April 25, 2000. 18 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists magnesium sulfate from 17 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 2000 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for magnesium sulfate?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0039 per gram (Epsom salt), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Epsom salt (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Epsom salt | Generic | $0.0039 per gram | n/a | -0.3% |
| Epsom salt granules | Generic | $0.0039 per gram | n/a | -0.3% |
| Ft epsom salt granules | Generic | $0.0039 per gram | n/a | -0.3% |
| Qc epsom salt granules | Generic | $0.0039 per gram | n/a | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has magnesium sulfate been recalled?
The FDA's Enforcement Report lists 16 recalls naming magnesium sulfate since 2012: 5 Class I (the most serious), 8 Class II, 3 Class III; 3 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of magnesium sulfate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 18, 2026 | Class I | Amneal Pharmaceuticals, LLC | 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. |
| October 3, 2018 | Class II | Pfizer Inc. | Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03 … |
| May 17, 2018 | Class II | Guardian Pharmacy Services not a listed maker | Lack of sterility assurance. |
| July 14, 2017 | Class II | SCA Pharmaceuticals | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. |
| March 23, 2016 | Class III | Hospira Inc. | Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. |
| March 23, 2016 | Class I | Hospira Inc. | Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. |
| January 5, 2016 | Class I | Hospira Inc. | Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. |
| October 16, 2015 | Class II | Downing Labs, LLC not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the magnesium sulfate label say about other medicines?
The magnesium sulfate label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name magnesium sulfate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amlodipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Amphotericin b | drug interactions | Drugs that May Induce Magnesium Loss Clinical Impact: • Reduced magnesium concentrations may impact efficacy … concentrations in the target range [see ]. Examples: • Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics |
| Atracurium | drug interactions | Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents. … neuromuscular blockers: succinylcholine • Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium |
| Cisatracurium | drug interactions | Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents. … blockers: succinylcholine • Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium |
| Cisplatin | drug interactions | Drugs that May Induce Magnesium Loss Clinical Impact: • Reduced magnesium concentrations may impact efficacy … target range [see ]. Examples: • Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics |
| Clevidipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Cyclosporine | drug interactions | Drugs that May Induce Magnesium Loss Clinical Impact: • Reduced magnesium concentrations may impact efficacy … [see ]. Examples: • Alcohol, aminoglycosides, amphotericin B, cisplatin, cyclosporine, digitalis, loop diuretics, thiazide diuretics |
| Diltiazem | drug interactions | Dihydropyridine Calcium Channel Blockers Clinical Impact: • An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. … Intervention: • Monitor vital signs (heart rate, blood pressure, respiration) frequently. • Supportive care and/or discontinuation of the calcium channel blocker may be required. … |
| Felodipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Isradipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Nicardipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Nifedipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Nimodipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
| Nisoldipine | drug interactions | Supportive care and/or discontinuation of the calcium channel blocker may be required. Amlodipine, clevidipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine, and nisoldipine. |
Every other medicine the magnesium sulfate label names
| Medicine named | Section | What the label says |
|---|---|---|
| Propofol | drug interactions | Narcotics and/or Propofol Clinical Impact: • Potentiation and prolongation of analgesia and CNS depression is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with narcotics and/or propofol. … Intervention: • Monitor the depth of CNS depression frequently using a reliable instrument. • Adjust the narcotic and/or propofol dosage accordingly to maintain the desired level of analgesia and sedation. … |
| Rocuronium | drug interactions | Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents. … Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium |
| Succinylcholine | drug interactions | Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents. … (s) may also be increased. Examples: • Depolarizing neuromuscular blockers: succinylcholine • Non-depolarizing neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium |
| Terbutaline | warnings and precautions | Co-administration with unapproved tocolytics: Do not use concomitantly with beta adrenergic agents such as terbutaline and calcium channel blockers such as nifedipine |
| Vecuronium | drug interactions | Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents. … neuromuscular blockers: atracurium, cisatracurium, pancuronium, rocuronium, vecuronium |
| Verapamil | drug interactions | Dihydropyridine Calcium Channel Blockers Clinical Impact: • An exaggerated hypotensive response is possible with the concomitant use of Magnesium Sulfate in 5% Dextrose Injection with dihydropyridine calcium channel blockers. … Intervention: • Monitor vital signs (heart rate, blood pressure, respiration) frequently. • Supportive care and/or discontinuation of the calcium channel blocker may be required. … |
Source: FDA drug label (Magnesium Sulfate in Water), Hospira, Inc., effective August 24, 2026 (SPL set 22ca78b4-f5a3-4144-cf89-5f633acf1e6d), via openFDA; the full label on DailyMed
What do FAERS reports show for magnesium sulfate?
The FDA Adverse Event Reporting System holds 13,130 reports that list magnesium sulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,139 are coded as a death and 6,772 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as magnesium sulfate?
3 other medicines are given the same way (oral) and in the same FDA class as magnesium sulfate or labeled mainly for the same use (constipation), the same class first. Constipation lists all 20 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Polyethylene glycol 3350 | Constipation | 73 labelers | $0.0286 per gram 3350 powd | No current entry |
| Lactulose | Constipation | 22 labelers | $8.22 per packet 10 g packet | No current entry |
| Sodium phosphate dibasic and sodium phosphate monobasic | Constipation | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as magnesium sulfate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to magnesium sulfate
- 3 medicines for the same use
- Other calculi dissolution agents
- the pharmacologic class, with prices and generics
- Magnesium sulfate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other