FDA label

What is selegiline used for?

The FDA-approved uses of selegiline, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.”

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Selegiline Hydrochloride, capsule

Indications and Usage, quoted from the label by Apotex Corp. (ANDA075321). Cross-references to other label sections are left out.

Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).

Source: DailyMed label, set id 1924db3d-6a16-4496-cfd0-6903be146925, version 9, effective September 17, 2026. NDC 60505-0055, one of 7 listings for this product.

Selegiline Hydrochloride, tablet

Indications and Usage, quoted from the label by Apotex Corp. (ANDA074871). Cross-references to other label sections are left out.

Selegiline Hydrochloride Tablets USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).

Source: DailyMed label, set id 2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2, version 8, effective September 17, 2026. NDC 60505-3438, one of 6 listings for this product.

Questions

What is selegiline used for?

The FDA label says: “Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.”

What drug class is selegiline?

FDA lists selegiline in the Monoamine Oxidase Inhibitor and Monoamine Oxidase Type B Inhibitor established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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