FDA label

What is sumatriptan used for?

The FDA-approved uses of sumatriptan, 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: “Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attac...”

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Sumatriptan Succinate, tablet

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA078327). Cross-references to other label sections are left out.

Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:

  • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks.
  • Sumatriptan tablets are not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.

Source: DailyMed label, set id b2503fff-c978-4efa-b1b4-d7740b6b26f2, version 18, effective May 12, 2026. NDC 65862-146, one of 44 listings for this product.

Sumatriptan Succinate, injection

Indications and Usage, quoted from the label by Alembic Pharmaceuticals Inc. (ANDA213518). Cross-references to other label sections are left out.

Sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache.

Limitations of Use

  • Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks.
  • Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.

Source: DailyMed label, set id 0e8b65f7-9d3b-42f2-8d7e-69b143365980, version 7, effective January 29, 2026. NDC 62332-656, one of 15 listings for this product.

Questions

What is sumatriptan used for?

The FDA label says: “Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attac...”

What drug class is sumatriptan?

FDA lists sumatriptan in the Serotonin-1b and Serotonin-1d Receptor Agonist 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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