Skip to main content

What the FDA labels say about taking them together

Glycerol phenylbutyrate and midazolam

Glycerol phenylbutyrate's FDA label of October 29, 2025 names midazolam in its drug interactions section; the midazolam labels PlainMeds reads (4) do not name glycerol phenylbutyrate. The glycerol phenylbutyrate label: “Decreased exposure; monitor for suboptimal effect of midazolam.”

Check it at the source: the glycerol phenylbutyrate FDA label on DailyMed (effective October 29, 2025, Horizon Therapeutics USA, Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).

What does the glycerol phenylbutyrate label say about midazolam?

Glycerol phenylbutyrate label, drug interactions

Decreased exposure; monitor for suboptimal effect of midazolam.

Source: FDA drug label (Ravicti), Horizon Therapeutics USA, Inc., effective October 29, 2025 (SPL set 900e7dc0-9afe-4f50-80de-90567bb78519), via openFDA; the full label on DailyMed

What does the midazolam label say about glycerol phenylbutyrate?

Midazolam's label (effective January 1, 2024) and its 3 other brand-application labels do not name glycerol phenylbutyrate in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

7Glycerol phenylbutyrate generic labelers
22Midazolam generic labelers
Glycerol phenylbutyrateMidazolam
Labeled forn/an/a
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.233 per mL 2 mg/2 mL vial
Shortage nowA presentation being discontinuedIn shortage

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?