Primidone is an anti-epileptic agent sold in the U.S. under 2 brand and generic names, for partial epilepsies, tonic-clonic epilepsy and tremor. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Mysoline (application NDA009170). Other primidone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Usual Dosage Patients 8 years of age and older who have received no previous treatment may be started on MYSOLINE according to the following regimen using either 50 mg or scored 250 mg MYSOLINE tablets: Days 1 to 3: 100 to 125 mg at bedtime. Days 4 to 6: 100 to 125 mg twice a day. Days 7 to 9: 100 to 125 mg three times a day. Day 10 to maintenance: 250 mg three times a day. For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg MYSOLINE tablets in divided doses (250 mg three times a day or four times a day). If required, an increase to five or six 250 mg tablets daily may be made, but daily doses should not exceed 500 mg four times a day. Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 mcg/mL. INITIAL: ADULTS AND CHILDREN OVER 8 KEY: •=50 mg tablet; ●=250 mg tablet DAY 1 2 3 4 5 6 AM •• •• •• NOON PM •• •• •• •• •• •• DAY 7 8 9 10 11 12 AM •• •• •• ● Adjust to Maintenance NOON •• •• •• ● PM •• •• •• ● Patients Already Receiving Other Anticonvulsants MYSOLINE should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until…
The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to MYSOLINE and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $3 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AN;44 | 50 mg | white | round | — |
| AN;44 | 50 mg | white | round | — |
| AN;545 | 250 mg | white | round | — |
| AN;44 | 50 mg | white | round | — |
| AN;545 | 250 mg | white | round | — |
| DAN;DAN;5321 | 250 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Primidone Tablets
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals, LLC · Jun 3, 2026
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS ).
| $3 |
| View → |
| white |
| round |
| — |
| 684;O | 50 mg | white | round | — |
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| 685;O | 250 mg | yellow | round | — |
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