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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