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What the FDA labels say about taking them together

Fosamprenavir and midazolam

Fosamprenavir's FDA label of September 15, 2023 names midazolam in its contraindications section; the midazolam labels PlainMeds reads (4) do not name fosamprenavir. The fosamprenavir label: “Coadministration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.”

Check it at the source: the fosamprenavir FDA label on DailyMed (effective September 15, 2023, Mylan Pharmaceuticals Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).

What does the fosamprenavir label say about midazolam?

Fosamprenavir label, contraindications

Sildenafil (REVATIO ® ) (for treatment of pulmonary arterial hypertension) o Sedative/hypnotics: Midazolam, triazolam

Fosamprenavir label, drug interactions

Concomitant Drug Class/Drug Name: Sedative/hypnotics: Midazolam, triazolam; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Midazolam ↑ Triazolam; Clinical Comment: Coadministration is contraindicated due to potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression [see ].

Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed

What does the midazolam label say about fosamprenavir?

Midazolam's label (effective January 1, 2024) and its 3 other brand-application labels do not name fosamprenavir 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

2Fosamprenavir generic labelers
22Midazolam generic labelers
FosamprenavirMidazolam
Labeled forHIVn/a
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.233 per mL 2 mg/2 mL vial
Shortage nowNo current entryIn shortage

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

What next?