FDA-filed SPL labeling · retrieved through openFDA

Frovatriptan

Frovatriptan is a triptan medication used to treat acute migraine attacks, with or without aura, in adults.

Brand name Frova
Drug classes Serotonin 1b Receptor Agonists
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 26, 2025
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 2001
FDA-listed product records 18
Boxed warningNone found in compared labels
How we combine label and product data →
Frovatriptan at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Frovatriptan is a prescription triptan tablet taken at the start of a migraine attack to relieve headache pain — it does not prevent migraines. It works best when taken early in an attack and has a long duration of action. Because it affects blood vessels, it is not safe for people with certain heart, blood vessel, or stroke conditions, so always share your full medical history with your prescriber.

📖 Frovatriptan: Patient Information Guide

A plain-language walkthrough of Frovatriptan — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Frovatriptan is a triptan indicated for the acute (as-needed) treatment of migraine in adults. Here is what the evidence supports:

  • Treats migraine headaches with or without aura in adults when taken at the onset of an attack
  • Applies only after a confirmed diagnosis of migraine has been established
  • Not indicated for the prevention of migraine attacks
  • Not established as effective for cluster headaches
  • If a patient does not respond to the first dose for a given attack, the migraine diagnosis should be re-evaluated before using frovatriptan again
⚙️How it works

Frovatriptan binds tightly to serotonin receptors — specifically the 5-HT1B and 5-HT1D subtypes — located on blood vessels inside the skull and on pain-sensing nerve fibers of the trigeminal system (the main nerve network involved in migraine pain). Activating these receptors causes those vessels to narrow (constrict) and blocks the release of inflammatory substances that cause the throbbing pain and other migraine symptoms. The result is relief from the headache and associated discomfort.

💊How it's taken

Frovatriptan succinate is taken orally as a tablet, swallowed with fluids, at the start of a migraine attack. Food does not significantly affect how much of the drug gets absorbed, though it may slightly delay the time to peak effect.

  • One tablet is taken at migraine onset
  • If the headache returns after initial relief, a second tablet may be taken — but at least 2 hours must pass between doses
  • No more than 3 tablets in any 24-hour period
  • If the first dose does not work for that attack, a second dose for the same headache is not expected to help
  • The safety of treating more than 4 migraine attacks per month has not been established
🤒Side effects — in detail

The most commonly reported side effects in clinical trials include:

  • Dizziness
  • Flushing (feeling of warmth or redness)
  • Fatigue
  • Paresthesia (tingling or prickling sensations)
  • Dry mouth
  • Indigestion (dyspepsia)
  • Hot or cold sensations
  • Skeletal (bone or muscle) pain
  • Chest pain or tightness (usually not heart-related, but worth reporting)

Serious reactions — including heart events, stroke, severe allergic reactions, and serotonin syndrome — have been reported rarely. Seek emergency care immediately if you experience chest pain, sudden neurological symptoms, signs of a severe allergic reaction, or agitation with rapid heart rate and high fever.

⚠️Warnings & precautions
  • Heart and blood vessel risks: Frovatriptan can cause coronary artery spasm and, rarely, serious heart events including heart attack. People with known heart disease, a history of stroke or TIA, peripheral vascular disease, or uncontrolled high blood pressure must not take it. Those with multiple heart risk factors should be evaluated before use.
  • Dangerous heart rhythms: Life-threatening arrhythmias (irregular heartbeats), including ventricular tachycardia and ventricular fibrillation, have been reported. Stop taking frovatriptan and seek emergency help if this occurs.
  • Serotonin syndrome: Combining frovatriptan with SSRIs, SNRIs, tricyclic antidepressants, or MAO inhibitors can trigger serotonin syndrome — a potentially life-threatening condition. Symptoms include agitation, hallucinations, rapid heart rate, high fever, and loss of coordination.
  • Medication overuse headache: Using acute migraine treatments — including frovatriptan — too frequently (10 or more days per month) can cause headaches to become more frequent and harder to treat. If this happens, supervised withdrawal may be needed.
  • Blood pressure spikes: Significant blood pressure elevations have been reported, even in people without a history of high blood pressure. Blood pressure should be monitored.
  • Severe allergic reactions: Anaphylaxis and angioedema (dangerous swelling) have been reported and can be life-threatening. Do not take frovatriptan if you have had an allergic reaction to it before.
🔀What it interacts with

Frovatriptan has several important drug interactions to be aware of:

  • Ergot-containing drugs (ergotamine, dihydroergotamine, methysergide) — combining within 24 hours is contraindicated due to additive blood vessel narrowing that can be dangerous
  • Other triptans or 5-HT1 agonists — also contraindicated within 24 hours for the same reason
  • SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors — risk of serotonin syndrome; use with caution and watch for warning signs
  • Oral contraceptives (birth control pills) — can increase frovatriptan blood levels by about 30%, which may increase side effect risk
  • Propranolol — can significantly increase frovatriptan blood levels, particularly in males

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take if you have ischemic heart disease (angina, history of heart attack), coronary artery vasospasm (Prinzmetal's angina), or Wolff-Parkinson-White syndrome
  • Do not take if you have had a stroke, TIA (mini-stroke), or a history of hemiplegic or basilar migraine
  • Do not take if you have peripheral vascular disease, ischemic bowel disease, or uncontrolled high blood pressure
  • Do not take if you have had a serious allergic reaction (anaphylaxis or angioedema) to frovatriptan before
  • Pregnancy: Animal studies suggest potential harm to the fetus. There are no adequate studies in pregnant women. Discuss the risks and benefits with your prescriber.
  • Breastfeeding: It is unknown whether frovatriptan passes into human milk. The benefits of breastfeeding should be weighed against potential risks with your doctor.
  • Children under 18: Safety and effectiveness have not been established; not recommended for this age group
  • Older adults (65+): Blood levels of frovatriptan are 1.5 to 2 times higher than in younger adults; no dose adjustment required, but prescribers should be aware
  • Severe liver disease: No experience exists in this population; significantly higher drug levels are expected, so use with caution
  • Multiple cardiovascular risk factors (diabetes, high blood pressure, smoking, obesity, strong family history of heart disease): a cardiovascular evaluation should be done before starting frovatriptan
🚑If you take too much

Frovatriptan has a long half-life of about 26 hours, so if too much is taken, monitoring should continue for at least 48 hours or until symptoms resolve. There is no specific antidote. It is not known whether dialysis can remove frovatriptan from the blood. If you suspect an overdose, seek emergency medical care immediately.

📡Pharmacodynamics — effects in the body

Frovatriptan activates 5-HT1B/1D serotonin receptors on the blood vessels and nerve fibers involved in migraine. This causes narrowing (constriction) of dilated intracranial blood vessels and reduces the release of inflammatory neuropeptides (pain-promoting chemicals) from trigeminal nerve fibers. Together, these effects interrupt the migraine process and relieve headache pain.

🔬Pharmacokinetics — how your body processes it

After an oral dose, frovatriptan reaches peak blood levels in about 2 to 4 hours. Its bioavailability (the proportion that actually reaches circulation) is relatively low — around 20% in males and 30% in females — and women who take oral contraceptives may see about 30% higher levels. One notable feature of frovatriptan is its long half-life of approximately 26 hours, meaning it stays in the body much longer than most other triptans. It is primarily broken down by the liver enzyme CYP1A2 and eliminated mostly through feces (about 62%) and urine (about 32%). In people with mild to moderate liver impairment or in elderly individuals, drug levels can be about twice as high as in younger healthy adults, though no dose adjustment is required for mild to moderate liver impairment or for older adults.

📦How to store it

Store frovatriptan succinate tablets at controlled room temperature, 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from moisture.

📄 Written from Frovatriptan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

38

Supplements & herbs that interact with Frovatriptan

38 supplements and herbal products have documented interactions with Frovatriptan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 25
  • Minor · 11
Every supplement checked against Frovatriptan — ranked by severity The full interaction hub: 2 major · 25 moderate · 11 minor · every one linked to its full report. Check Frovatriptan against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Frovatriptan — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does frovatriptan do — does it prevent migraines or stop them?
Frovatriptan is a treatment you take once a migraine has already started — it's not a preventive medication. You take it at the onset of a migraine attack to relieve the headache and related symptoms. It won't stop future migraines from happening, so if you're getting migraines frequently, talk to your prescriber about separate prevention options.
When should I take it during a migraine attack?
Take it as soon as you recognize a migraine coming on. Swallow the tablet with a full glass of fluid — you can take it with or without food. If your headache goes away and then comes back, you can take a second tablet, but you must wait at least 2 hours after the first one. Just don't take more than 3 tablets in a single day.
What side effects are most likely, and which ones should make me call a doctor?
The most common things people notice are dizziness, flushing, fatigue, tingling sensations, dry mouth, and an upset stomach. Those are generally manageable. What you want to call a doctor about right away is chest pain or tightness, sudden severe headache, vision changes, weakness, an irregular heartbeat, abdominal pain with bloody diarrhea, or any signs of a serious allergic reaction like swelling of the throat or face. These are rare, but they're real risks worth knowing about.
Can I take it with my antidepressant or other migraine medicines?
This is really important to check with your pharmacist or prescriber before combining. Frovatriptan should not be taken within 24 hours of ergot-based migraine medicines (like dihydroergotamine) or other triptans. Combining it with certain antidepressants — SSRIs like fluoxetine, SNRIs like venlafaxine, tricyclics, or MAO inhibitors — can trigger a serious condition called serotonin syndrome, so your doctor needs to weigh those risks carefully.
Is it safe to use frovatriptan if I'm pregnant or breastfeeding?
There aren't good human studies on frovatriptan during pregnancy, but animal studies showed potential harm to developing fetuses at higher doses. For breastfeeding, it's unknown whether frovatriptan passes into human milk. Neither situation means you absolutely can't use it, but you and your doctor should have an honest conversation about the risks versus the benefit of treating your migraines — especially since uncontrolled migraines during pregnancy also carry risks.
I've been taking this a lot — is that a problem?
It can be, yes. If you're taking any acute migraine medicine — including frovatriptan — on 10 or more days per month, there's a real risk of what's called medication overuse headache, where the medicine itself starts causing more frequent headaches. If you feel like you're reaching for your migraine tablet more and more often, bring that up with your prescriber. You may need a different management plan, and stopping overused medicines (with guidance) can actually improve headache control over time.
Is Frovatriptan available over the counter?
Frovatriptan is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Frovatriptan first available?
Frovatriptan has been available in the United States since at least 2001, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Frovatriptan?
Frovatriptan is supplied by 12 manufacturers listed in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, Glenmark Pharmaceuticals Inc., USA, Ingenus Pharmaceuticals, LLC.

💬 Answers drafted from Frovatriptan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Frovatriptan comes

Frovatriptan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Frova
How this form is used
What it may be used for
  • Used to treat acute migraine attacks with or without aura in adults
  • Not for migraine prevention or cluster headache treatment
Important instructions
  • Swallow one tablet with fluids at the onset of a migraine
  • A second tablet may be taken at least 2 hours after the first if the headache returns after initial relief
  • Do not take more than 3 tablets in any 24-hour period
  • Can be taken with or without food, though food may slightly delay when the drug reaches peak levels
Available strengths 1 strength
14 FDA-listed product records

📊 Frovatriptan across the U.S. market

How Frovatriptan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
12
Manufacturers
3
Brand names
18
FDA-listed product records
2001
First marketed

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals NY LLC17%
Glenmark Pharmaceuticals Inc., USA17%
Ingenus Pharmaceuticals, LLC17%
Alivus Life Sciences Limited6%
Almac Pharma Services Limited6%
Endo Pharmaceuticals, Inc.6%
Other makers33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Frovatriptan is used

A general measure of how commonly Frovatriptan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Frovatriptan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,620
Medicaid prescriptions filled (Q1–Q4 2025)
$252,103 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Frovatriptan prescribed? Of the 1,596 medications we measure, Frovatriptan ranks #1,096 by Medicaid prescriptions — more than 31% of them.

Where Frovatriptan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Frovatriptan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

frovatriptan 2.5 MG Oral Tablet

3,620 Medicaid prescriptions (Q1–Q4 2025) 100% of Frovatriptan prescriptions shown $252,103 gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349462

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Frovatriptan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 10 listed Frovatriptan NDCs with Medicaid activity.

🔍 Compare Frovatriptan products

A representative set of FDA-listed product records for Frovatriptan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Tablet
2.5 mg Almac Pharma Services Limited DRUG FOR FURTHER PROCESSING View NDC →
2.5 mg Oral Amneal Pharmaceuticals NY LLC × 3 listings ANDA View NDC →
2.5 mg Oral Endo Pharmaceuticals, Inc. NDA View NDC →
2.5 mg Oral Glenmark Pharmaceuticals Inc., USA × 3 listings ANDA View NDC →
2.5 mg Oral Ingenus Pharmaceuticals, LLC × 3 listings ANDA View NDC →
2.5 mg Oral Leading Pharma, LLC ANDA View NDC →
2.5 mg Oral Mylan Pharmaceuticals Inc. ANDA View NDC →
2.5 mg Oral Par Pharmaceutical NDA View NDC →
💊Bulk drug substance
1 kg/kg Alivus Life Sciences Limited BULK INGREDIENT View NDC →
1 kg/kg Mylan Laboratories Limited BULK INGREDIENT View NDC →
1 kg/kg Sionc Pharmaceutical Private Limited BULK INGREDIENT View NDC →
1 kg/kg Viyash Life Sciences Private Limited BULK INGREDIENT View NDC →

Showing 18 of 18 products — FDA National Drug Code Directory. See every product, package size and price: browse all 18 Frovatriptan NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Frovatriptan RxCUI 228783 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 378697 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 349462

Look up RxCUI 228783 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Frova

🏭 Manufacturers & labelers

Amneal Pharmaceuticals NY LLC 3 Glenmark Pharmaceuticals Inc., USA 3 Ingenus Pharmaceuticals, LLC 3 Alivus Life Sciences Limited 1 Almac Pharma Services Limited 1 Endo Pharmaceuticals, Inc. 1 Leading Pharma, LLC 1 Mylan Laboratories Limited 1 Mylan Pharmaceuticals Inc. 1 Par Pharmaceutical 1 Sionc Pharmaceutical Private Limited 1 Viyash Life Sciences Private Limited 1

RxNorm drug class

Frovatriptan belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.

Pharmacologic class Serotonin-1b and Serotonin-1d Receptor Agonist
Drug family (ATC) Selective serotonin (5HT1) agonists
How it works Serotonin 1b Receptor Agonists, Serotonin 1d Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 26, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Frovatriptan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Frovatriptan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
18
Distinct labelers/manufacturers represented
12
Linked representative label
Ingenus Pharmaceuticals, LLC
Linked label effective
Nov 26, 2025
Composite sections available
21
Linked SPL Set ID
92c91060-c06e-4a8a-b586-a3fb25c33433
Linked SPL Document ID
447a8874-8a78-84a6-e063-6294a90aa3b8
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Ingenus Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.