FDA label

What is pregabalin used for?

The FDA-approved uses of pregabalin, 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: “Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy; Management of postherpetic neuralgia; Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older; Management of fibromyalgia; Management of neuropathic pain associated with spinal cord injury.”

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Pregabalin, capsule

Indications and Usage, quoted from the label by ScieGen Pharmaceuticals, Inc (ANDA208677). Cross-references to other label sections are left out.

Pregabalin capsules are indicated for:

  • Management of neuropathic pain associated with diabetic peripheral neuropathy
  • Management of postherpetic neuralgia
  • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
  • Management of fibromyalgia
  • Management of neuropathic pain associated with spinal cord injury

Source: DailyMed label, set id 33ef1a3b-554f-4a51-afdb-92a019e8c16c, version 9, effective October 15, 2025. NDC 50228-350, one of 518 listings for this product.

Pregabalin, tablet, film coated, extended release

Indications and Usage, quoted from the label by Novadoz Pharmaceuticals LLC (ANDA213226). Cross-references to other label sections are left out.

Pregabalin extended-release tablets are indicated for the management of:

  • Neuropathic pain associated with diabetic peripheral neuropathy
  • Postherpetic neuralgia

Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.

Source: DailyMed label, set id f6aa5977-97c8-4a56-8e35-d9ab5cc24369, version 2, effective June 10, 2026. NDC 72205-077, one of 9 listings for this product.

Questions

What is pregabalin used for?

The FDA label says: “Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy; Management of postherpetic neuralgia; Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older; Management of fibromyalgia; Management of neuropathic pain associated with spinal cord injury.”

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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