FDA label
What is rizatriptan benzoate used for?
The FDA-approved uses of rizatriptan benzoate, 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: “Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.”
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Rizatriptan Benzoate, tablet
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA202490). Cross-references to other label sections are left out.
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
- Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
- Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine.
- Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
- Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Source: DailyMed label, set id 222f77ff-d3f7-40f9-989c-e5902f44ef1e, version 10, effective February 17, 2024. NDC 57237-087, one of 32 listings for this product.
Rizatriptan Benzoate, tablet, orally disintegrating
Indications and Usage, quoted from the label by Panacea Biotec Limited (ANDA204722). Cross-references to other label sections are left out.
Rizatriptan Benzoate Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
- Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks.
- Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications].
- Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
- Safety and effectiveness of Rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
Source: DailyMed label, set id 9c70370d-72ac-e062-e25c-97d57e6397ab, version 8, effective December 9, 2024. NDC 43817-133, one of 29 listings for this product.
Questions
What is rizatriptan benzoate used for?
The FDA label says: “Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.”
What drug class is rizatriptan benzoate?
FDA lists rizatriptan benzoate 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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