Skip to main content

What the FDA labels say about taking them together

Ganaxolone and valproic acid

Ganaxolone's FDA label of November 28, 2025 names valproic acid in its drug interactions section; the valproic acid label PlainMeds reads does not name ganaxolone. The ganaxolone label: “Inhibitors on ZTALMY Concomitant use of ZTALMY and UGT inhibitors (e.g., valproic acid) may increase the exposure of ganaxolone, which may increase the risk of ZTALMY associated adverse reactions in patients who have …”

Check it at the source: the ganaxolone FDA label on DailyMed (effective November 28, 2025, Immedica Pharma US Inc); the valproic acid FDA label on DailyMed (effective January 24, 2025, PAI Holdings, LLC dba PAI Pharma).

What does the ganaxolone label say about valproic acid?

Ganaxolone label, drug interactions

Inhibitors on ZTALMY Concomitant use of ZTALMY and UGT inhibitors (e.g., valproic acid) may increase the exposure of ganaxolone, which may increase the risk of ZTALMY associated adverse reactions in patients who have titrated to a stable ZTALMY dosage.

Source: FDA drug label (ZTALMY), Immedica Pharma US Inc, effective November 28, 2025 (SPL set d91612c4-b03a-4be4-a1ee-6a13e3b83d4e), via openFDA; the full label on DailyMed

What does the valproic acid label say about ganaxolone?

Valproic acid's label (effective January 24, 2025) does not name ganaxolone in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (VALPROIC ACID), PAI Holdings, LLC dba PAI Pharma, effective January 24, 2025 (SPL set 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6), 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

0Ganaxolone generic labelers
22Valproic acid generic labelers
GanaxoloneValproic acid
Labeled forn/aSeizures and epilepsy, Migraine
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.243 per capsule 250 mg capsule
Shortage nowNo current entryListed; available

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

What next?