A fixed combination of 3 drugs in one pill.
Sold as Sutab, Tis-U-Sol.
A combination is graded by its riskiest ingredient: each part of the score is the lowest of the ingredients' scores. This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Each ingredient has its own full page with the FDA label, side-effect reports, recalls, evidence, and payments. Open them for the detail behind this grade.
Score breakdown (63/100)
Safety ×35%
B
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
F
Safety: 85
Graded by its riskiest ingredient, magnesium sulfate (85)
FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2013 (-8)
Death appears in 1.7x the share of reports seen across all of FAERS (-2)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 0
Graded by its riskiest ingredient, potassium sulfate (0)
0 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
No Cochrane review found (-5)
Only 32% of completed registered trials posted results (-15)
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)
Regulatory history: 95
Graded by its riskiest ingredient, magnesium sulfate (95)
No recalls on record since 2016
Label lists recent major changes to warnings or indications (-5)
Money & lawsuits: 100
Graded by its riskiest ingredient, magnesium sulfate (100)
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 40
Graded by its riskiest ingredient, potassium sulfate (40)
No generic version approved: brand-only pricing (-30)
No same-class alternatives found: little leverage to switch (-30)
Money and lawsuits
In 2024, drug companies reported $65,845 in payments to US physicians and hospitals tied to this combination's brands across 2,230 transactions (Sutab $65,845).
No pending federal MDL names this combination or its brands.
The ingredients' own payments and lawsuits are on their pages and already count toward this grade.
Who takes it and what it costs
Not in the Medicare Part D spending file.
Questions to ask your prescriber
This is a fixed combination of magnesium sulfate and potassium sulfate and sodium sulfate. Why both together, instead of only the one I need?
In 2013 the FDA issued a safety communication about this drug (FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Expose). Does that risk apply to me?
The most-reported problems in FDA's adverse event data are foetal exposure during pregnancy, maternal exposure during pregnancy. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over ammonium chloride, calcium chloride, calcium gluconate? What would make you pick one of those instead?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)
The most-reported problems in FDA's adverse event data are nausea, fatigue, constipation. How would we recognize and handle those?
There is no generic. Is there an older generic in the same class that works as well for my situation?
The most-reported problems in FDA's adverse event data are macular degeneration, nausea. How would we recognize and handle those?
Why this one over lactitol, lactulose, magnesium carbonate? What would make you pick one of those instead?