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What the FDA labels say about taking them together

Ganaxolone and primidone

Ganaxolone's FDA label of November 28, 2025 names primidone in its drug interactions section; the primidone label PlainMeds reads does not name ganaxolone. The ganaxolone label: “In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs, the ZTALMY dosage may need to be increased; …”

Check it at the source: the ganaxolone FDA label on DailyMed (effective November 28, 2025, Immedica Pharma US Inc); the primidone FDA label on DailyMed (effective September 10, 2026, Bausch Health US, LLC).

What does the ganaxolone label say about primidone?

Ganaxolone label, drug interactions

In patients on a stable ZTALMY dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, phenobarbital, and primidone), the ZTALMY dosage may need to be increased; however, do not exceed the maximum daily dosage of ZTALMY [see Dosage and Administration (2.1) ].

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 primidone label say about ganaxolone?

Primidone's label (effective September 10, 2026) 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 (Mysoline), NDA009170 (Valeant), as published by Bausch Health US, LLC, effective September 10, 2026 (SPL set af593171-dabb-4ea3-b44c-89ed457b2c46), 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
21Primidone generic labelers
GanaxolonePrimidone
Labeled forn/aSeizures and epilepsy
Boxed warningNoNo
Pharmacy cost (NADAC)n/a$0.0914 per tablet 50 mg tablet
Shortage nowNo current entryNo current entry

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

What next?