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Frovatriptan Succinate 2.5 mg Tablet, Film Coated, 9-count — NDC 69315-0157-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Frovatriptan Succinate 2.5 mg Tablet, Film Coated, 9-count — NDC 69315-157-13 (Billing 69315-0157-13)

by Leading Pharma, LLC · 9 TABLET, FILM COATED in 1 CARTON

This is a package of 9 tablets of Frovatriptan Succinate 2.5 mg Tablet, Film Coated from Leading Pharma, LLC, marketed since Feb 2026 and currently FDA-listed; retail pharmacies pay about $2.72 per tablet (NADAC). It is this product's only package size.

NDC 69315-0157-13
🏷️ FDA NDC (as labeled) 69315-157-13 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 69315-157-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69315 labeler · 157 product · 13 package
Package marketed since
Feb 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
9 EA per package
Barcode (UPC-A, from the NDC)
3 6931515713 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Frovatriptan Succinate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0322-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69315-157-13
Product NDC 69315-157
11-digit billing NDC 69315015713
NCPDP billing unit EA — each (per item)
RxCUI 349462
UNII D28J6W18HY
Application # ANDA216998
SPL Set ID d303af88-e0c1-4fb2-ba8e-83b7e6d163cd
Established class (EPC) Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of action Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-28
Route ORAL
Dosage form TABLET, FILM COATED
Substance FROVATRIPTAN SUCCINATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 349462
Why two NDCs? The FDA registers this code as 69315-157-13 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69315-0157-13. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Frovatriptan is used to treat the symptoms of migraine headaches (severe throbbing headaches that sometimes come with nausea and a strong reaction to sound and light). Frovatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, blocking pain signals from being sent to the brain, and stopping the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Frovatriptan does not stop migraine attacks from coming or reduce the number of headaches you have.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats a migraine attack, with or without aura, once it has started in adults. It will not prevent future migraines, and it has not been shown to work for cluster headache.
  • Take one tablet by mouth with fluids when your migraine begins. If it improves and then returns, a second tablet may be taken at least 2 hours later, but there is a daily limit. Fo...
  • Common ones are dizziness, headache, tingling, dry mouth, tiredness, flushing and indigestion. These are usually mild. Call for help if you have chest pain, stroke-like symptoms or...
  • Tell me what you take. SSRIs, SNRIs, tricyclics and MAO inhibitors can raise the risk of serotonin syndrome. Other triptans and ergot medicines should not be used within 24 hours o...
📖 Read our full Frovatriptan guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.717 $24.45 / 9 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $13.12 $118.08 / 9 tablets
NADAC price history (per ea) — tap or hover for the price & month
Sep 2026 $2.717 $2.717
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69315-0157-13 You're viewing this Main listing 9 TABLET, FILM COATED in 1 CARTON 2026-02-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
frovatriptan succinate 2.5 mg 68462-0694-97 Glenmark 9 tablets $2.717 AB Availability likely —
Frovatriptan 2.5 mg 69238-1539-09 Amneal 9 tablets $2.717 AB Availability likely —
Frovatriptan 2.5 mg 50742-0299-09 Ingenus 9 tablets $2.717 AB Availability likely —
Frovatriptan Succinate 2.5 mgthis 69315-0157-13 Leading 9 tablets $2.717 AB Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintLP;157
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Frovatriptan inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLeading Pharma, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA216998 (ANDA)
Labeler code69315
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio83 products on file

More NDCs from Leading Pharma, LLC labeler code 69315

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 152 words ▾

1 INDICATIONS AND USAGE Frovatriptan succinate 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 has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks.

Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is a serotonin (5-HT 1 B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1) Limitations of Use Use only after a clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)

⏱️ Dosage and Administration 152 words ▾

2 DOSAGE AND ADMINISTRATION Dosing Information The recommended dose is a single tablet of frovatriptan succinate (frovatriptan 2.5 mg) taken orally with fluids. If the migraine recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of frovatriptan succinate tablets should not exceed 3 tablets (3 x 2.5 mg per 24-hour period).

There is no evidence that a second dose of frovatriptan succinate tablets are effective in patients who do not respond to a first dose of the drug for the same headache. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. 1 tablet taken with fluids.

Second tablet may be taken 2 hours after initial dose if headache recurs following initial relief. Total dose not to exceed 3 tablets in any 24-hour period (2)

💊 Dosage Forms and Strengths 30 words ▾

3 DOSAGE FORMS AND STRENGTHS 2.5 mg Tablets: White round film-coated tablets, debossed with "LP" over "157" on one side and plain on the other side. Tablets: 2.5 mg (3)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Frovatriptan succinate tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1) ]. Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ]. History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4) ].

Peripheral vascular disease [see Warnings and Precautions (5.5) ]. Ischemic bowel disease [see Warnings and Precautions (5.5) ]. Uncontrolled hypertension [see Warnings and Precautions (5.8) ].

Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide [see Drug Interactions (7.1 , 7.2) ]. Hypersensitivity to frovatriptan succinate (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9) ]. History of coronary artery disease or coronary artery vasospasm (4) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of treatment with another 5-HT 1 agonist, or an ergotamine-containing medication (4) Hype rsensitivity to frovatriptan succinate (angioedema and anaphylaxis seen).

(4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myocardial ischemia/infarction or Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) Arrhythmias: Discontinue frovatriptan succinate if occurs (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate high risk patients for coronary artery disease (5.3) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue frovatriptan succinate if occurs (5.4) Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue frovatriptan succinate if occurs (5.5) Medication overuse headache: Detoxification may be necessary (5.6) Serotonin syndrome: Discontinue frovatriptan succinate if occurs (5.7, 7.3)

5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina Frovatriptan succinate is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of frovatriptan succinate. Some of these reactions occurred in patients without known CAD.Frovatriptan succinate may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving frovatriptan succinate. Do not administer frovatriptan succinate if there is evidence of CAD or coronary artery vasospasm [ see Contraindications (4) ]. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first Frovatriptan succinate dose in a medically- supervised setting and performing an electrocardiogram (ECG) immediately following frovatriptan succinate administration.

For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of frovatriptan succinate.

5.2Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5- HT 1 agonists. Discontinue frovatriptan succinate if these disturbances occur. Frovatriptan succinate is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Contraindications (4) ].

5.3Chest, Throat, Neck, and Jaw Pain/Tightness/Pressure Sensations of pain, tightness, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with frovatriptan succinate and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of frovatriptan succinate is contraindicated in patients with CAD and those with Prinzmetal’s angina [ see Contraindications (4) ].

5.4Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical of migraine, other potentially serious neurological conditions need to be excluded.

Frovatriptan succinate is contraindicated in patients with a history of stroke or TIA [see Contraindications (4) ].

5.5Other Vasospasm Reactions Frovatriptan succinate may cause non-coronary vasospastic reactions, such as peripheral vascular ische… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ] Cerebrovascular Events [see Warnings and Precautions (5.4) ] Other Vasospasm Reactions [see Warnings and Precautions (5.5) ] Medication Overuse Headache [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Increases in Blood Pressure [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.9) ] Most common adverse reactions (≥2% and >placebo) were dizziness, headache, paresthesia, dry mouth, dyspepsia, fatigue, hot or cold sensation, chest pain, skeletal pain, and flushing (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Frovatriptan succinate was evaluated in four randomized, double-blind, placebo-controlled, short-term trials. These trials involved 2392 patients (1554 on frovatriptan 2.5 mg and 838 on placebo).

In these short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range18 to 69).The treatment-emergent adverse events that occurred most frequently following administration of frovatriptan 2.5 mg ( i.e., in at least 2% of patients), and at an incidence ≥1% greater than with placebo, were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation, dyspepsia, skeletal pain, and chest pain. In a long-term, open-label study where 496 patients were allowed to treat multiple migraine attacks with frovatriptan 2.5 mg for up to 1 year, 5% of patients (n=26) discontinued due to treatment-emergent adverse events.

Table 1 lists treatment-emergent adverse events reported with in 48 hours of drug administration that occurred with frovatriptan 2.5 mg at an incidence of ≥2% and more often than on placebo, in the four placebo-controlled trials. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these incidence estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Table 1: Adverse Reactions Reported within 48 Hours (Incidence ≥2% and Greater Than Placebo) of Patients in Four Pooled Placebo-Controlled Migraine Trials Adverse Reactions Frovatriptan 2.5 mg (n=1554) Placebo (n=838) Central & peripheral nervous system Dizziness Headache Paresthesia 8% 4% 4% 5% 3% 2% Gastrointestinal system disorders Dry mouth Dyspepsia 3% 2% 1% 1% Body as a whole – general disorders Fatigue Hot or cold sensation Chest pain 5% 3% 2% 2% 2% 1% Musculo-skeletal Skeletal pain 3% 2% Vascular Flushing 4% 2% The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours.

The incidence of adverse events in placebo-controlled clinical trials was not affected by gender, age, or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events. Other Events Observed in Association with the Administration of frovatriptan succinate The incidence of frequently reported adverse events in four placebo-controlled trials is presented below.

Events are further classified within body system categories. Frequent a… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Ergot-containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and frovatriptan succinate within 24 hours of each other is contraindicated [ see Contraindications (4) ]. 7.2 5-HT 1B/1D Agonists Because their vasospastic effects may be additive, co-administration of frovatriptan succinate and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated [ see Contraindications (4) ].

7.3Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during combined use of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [ see Warnings and Precautions (5.7) ].

7.1Ergot-containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and frovatriptan succinate within 24 hours of each other is contraindicated [ see Contraindications (4) ].

7.25-HT 1B/1D Agonists Because their vasospastic effects may be additive, co-administration of frovatriptan succinate and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated [ see Contraindications (4) ].

7.3Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during combined use of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [ see Warnings and Precautions (5.7) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1)

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of frovatriptan succinate in pregnant women. In animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically [see Animal Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy. Data Animal Data When pregnant rats were administered frovatriptan (oral doses of 0, 100, 500, or 1000 mg/kg/day) throughout organogenesis, increased embryofetal mortality and an increased incidence of fetal malformations were observed at the high dose; decreased fetal body weights and increased incidences of fetal structural variations associated with growth impairment were observed at all doses.

The lowest effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) is approximately 130 times the maximum recommended human dose (MRHD) of 7.5 mg/day on a body surface area (mg/m 2 ) basis. When pregnant rabbits were administered frovatriptan (oral doses of 0, 5, 20, or 80 mg/kg/day) throughout organogenesis, embryofetal mortality was increased at the mid and high doses. The no- effect dose for embryofetal developmental toxicity in rabbits (5 mg/kg/day) is approximately 13 times the MRHD on a mg/m 2 basis.

Oral administration of frovatriptan (0, 100, 500, or 1000 mg/kg/day) to female rats throughout pregnancy and lactation resulted in increased embryofetal mortality at the high dose. The no effect dose for pre- and postnatal developmental toxicity in rats (500 mg/kg/day) is approximately 650 times the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary There are no data on the presence of frovatriptan in human milk, the effects of frovatriptan on the breastfed infant, or the effects of frovatriptan on milk production. In rats, oral dosing with frovatriptan resulted in levels of frovatriptan and/or its metabolites in milk up to four times higher than in plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for frovatriptan succinate and any potential adverse effects on the breastfed infant from frovatriptan or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, frovatriptan succinate is not recommended for use in patients under 18 years of age. There are no additional adverse reactions identified in pediatric patients based on postmarketing experience that were not previously identified in adults.

8.5Geriatric Use Mean blood concentrations of frovatriptan in elderly patients were 1.5 to 2 times higher than those seen in younger adults [ see Clinical Pharmacology (12.3) ]. No dosage adjustment is necessary.

8.6Patients with Hepatic Impairment No dosage adjustment is necessary when frovatriptan is given to patients with mild to moderate hepatic impairment. There is no clinical or pharmacokinetic experience with frovatriptan succinate in patients with severe hepatic impairment. Because a greater than two-fold increase in AUC is predicted in patients with severe hepatic impairment, there is a greater potential for adverse events in these patients, and frovatriptan succinate should therefore be us… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of frovatriptan succinate in pregnant women. In animal studies, frovatriptan produced developmental toxicity (embryofetal lethality, fetal abnormalities, and decreased embryofetal growth) when administered to pregnant rats and rabbits at doses greater than those used clinically [see Animal Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraines may be at increased risk of preeclampsia during pregnancy. Data Animal Data When pregnant rats were administered frovatriptan (oral doses of 0, 100, 500, or 1000 mg/kg/day) throughout organogenesis, increased embryofetal mortality and an increased incidence of fetal malformations were observed at the high dose; decreased fetal body weights and increased incidences of fetal structural variations associated with growth impairment were observed at all doses.

The lowest effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) is approximately 130 times the maximum recommended human dose (MRHD) of 7.5 mg/day on a body surface area (mg/m 2 ) basis. When pregnant rabbits were administered frovatriptan (oral doses of 0, 5, 20, or 80 mg/kg/day) throughout organogenesis, embryofetal mortality was increased at the mid and high doses. The no- effect dose for embryofetal developmental toxicity in rabbits (5 mg/kg/day) is approximately 13 times the MRHD on a mg/m 2 basis.

Oral administration of frovatriptan (0, 100, 500, or 1000 mg/kg/day) to female rats throughout pregnancy and lactation resulted in increased embryofetal mortality at the high dose. The no effect dose for pre- and postnatal developmental toxicity in rats (500 mg/kg/day) is approximately 650 times the MRHD on a mg/m 2 basis.

🧒 Pediatric Use 50 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, frovatriptan succinate is not recommended for use in patients under 18 years of age. There are no additional adverse reactions identified in pediatric patients based on postmarketing experience that were not previously identified in adults.

🧓 Geriatric Use 34 words ▾

8.5Geriatric Use Mean blood concentrations of frovatriptan in elderly patients were 1.5 to 2 times higher than those seen in younger adults [ see Clinical Pharmacology (12.3) ]. No dosage adjustment is necessary.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE The elimination half-life of frovatriptan is 26 hours [ see Clinical Pharmacology (12.3) ]. Therefore, monitoring of patients after overdose with frovatriptan should continue for at least 48 hours or while symptoms or signs persist. There is no specific antidote to frovatriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of frovatriptan.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Frovatriptan binds with high affinity to 5-HT 1B/1D receptors. The therapeutic activity of frovatriptan succinate is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

12.3Pharmacokinetics The pharmacokinetics of frovatriptan are similar in migraine patients and healthy subjects. Absorption Mean maximum blood concentrations (C max ) in patients are achieved approximately 2 to 4 hours after administration of a single oral dose of frovatriptan 2.5 mg. The absolute bioavailability of an oral dose of frovatriptan 2.5 mg in healthy subjects is about 20% in males and 30% in females.

Food has no significant effect on the bioavailability of frovatriptan, but delays tmax by one hour. Distribution Binding of frovatriptan to serum proteins is low (approximately 15%). Reversible binding to blood cells at equilibrium is approximately 60%, resulting in a blood: plasma ratio of about 2:1 in both males and females.

The mean steady state volume of distribution of frovatriptan following intravenous administration of 0.8 mg is

4.2 L/kg in males and

3.0L/kg in females. Metabolism In vitro, cytochrome P450 1A2 appears to be the principal enzyme involved in the metabolism of frovatriptan. Following administration of a single oral dose of radiolabeled frovatriptan 2.5 mg to healthy male and female subjects, 32% of the dose was recovered in urine and 62% in feces.

Radiolabeled compounds excreted in urine were unchanged frovatriptan, hydroxylated frovatriptan, N- acetyl desmethyl frovatriptan, hydroxylated N-acetyl desmethyl frovatriptan and desmethyl frovatriptan, together with several other minor metabolites. Desmethyl frovatriptan has lower affinity for 5-HT 1B/1D receptors compared to the parent compound. The N-acetyl desmethyl metabolite has no significant affinity for 5-HT receptors.

The activity of the other metabolites is unknown. Elimination After an intravenous dose, mean clearance of frovatriptan was 220 and 130 mL/min in males and females, respectively. Renal clearance accounted for about 40% (82 mL/min) and 45% (60 mL/min) of total clearance in males and females, respectively.

The mean terminal elimination half-life of frovatriptan in both males and females is approximately 26 hours. Special Populations Hepatic Impairment The AUC of frovatriptan in patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-9) hepatic impairment was about twice that of young, healthy subjects, but within the range observed in healthy elderly subjects and was considerably lower than the values attained with higher doses of frovatriptan (up to 40 mg), which were not associated with any serious adverse effects .

There is no clinical or pharmacokinetic experience with frovatriptan succinate in patients with severe hepatic impairment. Renal Impairment The pharmacokinetics of frovatriptan following a single oral dose of 2.5 mg was not different in patients with renal impairment (5 males and 6 females, creatinine clearance 16 - 73 mL/min) compared to subjects with normal renal function. Age Mean AUC of frovatriptan was 1.5- to 2-fold higher in healthy elderly subjects (age 65 to 77 years) compared to those in healthy younger subjects (age 21 to 37 years).

There was no difference in tmax or t 1/2 between the two populations. Sex There was no difference in the mean terminal elimination half-life of frovatriptan in males and females. Bioavailability was higher, and systemic exposure to frovatriptan was approximately 2-fold greater, in females than males, irrespective of age.

Race The effect of race on the pharmacokinetics of frovatriptan has not been examined Drug Interaction Studies Frovatriptan is not an inhibitor of human monoamine oxidase (MAO) enzymes or cytochrome P450 (isoz… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 60 words ▾

12.1Mechanism of Action Frovatriptan binds with high affinity to 5-HT 1B/1D receptors. The therapeutic activity of frovatriptan succinate is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Frovatriptan succinate tablets, containing 2.5 mg are supplied as White round film-coated tablets, debossed with "LP" over "157" on one side and plain on the other side. The tablets are available in: Carton of 9 Tablets: (NDC 69315-157-13) (Packages of 9 unit doses, 1 card of 9 tablets each) Store at 20ºC to 25ºC (68º to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 120 words ▾

11 DESCRIPTION Frovatriptan succinate tablets contain frovatriptan succinate, a selective 5-hydroxytryptamine 1 (5-HT 1B/1D ) receptor subtype agonist (triptan), as the active ingredient. Frovatriptan succinate is chemically designated as R-(+) 3-methylamino-6-carboxamido-1,2,3,4­ tetrahydrocarbazole monosuccinate monohydrate and it has the following structure: The empirical formula is C 18 H 23 N 3 O 5 .H 2 O, representing a molecular weight of 379.4 g/mol. Frovatriptan succinate is a white to off-white powder that is soluble in water.

Each frovatriptan succinate tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains the inactive ingredients anhydrous lactose, hypromellose, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, magnesium stearate, polyethylene glycol, triacetin and titanium dioxide. chemstruct

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA approved patient labeling (Patient Information). Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospastic Reactions, and Cerebrovascular Events Inform patients that frovatriptan succinate may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms.

Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5 , and 5.8) ]. Hypersensitivity Reactions Inform patients that anaphylactic reactions have occurred in patients receiving frovatriptan succinate. Inform patients that such reactions can be life threatening or fatal and to seek immediate medical attention if they have anaphylactic symptoms.

In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) ]. Medication Overuse Headache Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)]. Serotonin Syndrome Inform patients about the risk of serotonin syndrome with the use of frovatriptan succinate or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.3) ].

Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1) ]. Lactation Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2) ]. Manufactured by : LIFEPharma FZE Near Round-About 13, Plot No MO0502, Dubai, P.O.

Box 17404, United Arab Emirates (ARE). Distributed by: Leading Pharma, LLC Fairfield, NJ-07004 USA Rev. 01 01/23

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of frovatriptan are similar in migraine patients and healthy subjects. Absorption Mean maximum blood concentrations (C max ) in patients are achieved approximately 2 to 4 hours after administration of a single oral dose of frovatriptan 2.5 mg. The absolute bioavailability of an oral dose of frovatriptan 2.5 mg in healthy subjects is about 20% in males and 30% in females.

Food has no significant effect on the bioavailability of frovatriptan, but delays tmax by one hour. Distribution Binding of frovatriptan to serum proteins is low (approximately 15%). Reversible binding to blood cells at equilibrium is approximately 60%, resulting in a blood: plasma ratio of about 2:1 in both males and females.

The mean steady state volume of distribution of frovatriptan following intravenous administration of 0.8 mg is

4.2 L/kg in males and

3.0L/kg in females. Metabolism In vitro, cytochrome P450 1A2 appears to be the principal enzyme involved in the metabolism of frovatriptan. Following administration of a single oral dose of radiolabeled frovatriptan 2.5 mg to healthy male and female subjects, 32% of the dose was recovered in urine and 62% in feces.

Radiolabeled compounds excreted in urine were unchanged frovatriptan, hydroxylated frovatriptan, N- acetyl desmethyl frovatriptan, hydroxylated N-acetyl desmethyl frovatriptan and desmethyl frovatriptan, together with several other minor metabolites. Desmethyl frovatriptan has lower affinity for 5-HT 1B/1D receptors compared to the parent compound. The N-acetyl desmethyl metabolite has no significant affinity for 5-HT receptors.

The activity of the other metabolites is unknown. Elimination After an intravenous dose, mean clearance of frovatriptan was 220 and 130 mL/min in males and females, respectively. Renal clearance accounted for about 40% (82 mL/min) and 45% (60 mL/min) of total clearance in males and females, respectively.

The mean terminal elimination half-life of frovatriptan in both males and females is approximately 26 hours. Special Populations Hepatic Impairment The AUC of frovatriptan in patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-9) hepatic impairment was about twice that of young, healthy subjects, but within the range observed in healthy elderly subjects and was considerably lower than the values attained with higher doses of frovatriptan (up to 40 mg), which were not associated with any serious adverse effects .

There is no clinical or pharmacokinetic experience with frovatriptan succinate in patients with severe hepatic impairment. Renal Impairment The pharmacokinetics of frovatriptan following a single oral dose of 2.5 mg was not different in patients with renal impairment (5 males and 6 females, creatinine clearance 16 - 73 mL/min) compared to subjects with normal renal function. Age Mean AUC of frovatriptan was 1.5- to 2-fold higher in healthy elderly subjects (age 65 to 77 years) compared to those in healthy younger subjects (age 21 to 37 years).

There was no difference in tmax or t 1/2 between the two populations. Sex There was no difference in the mean terminal elimination half-life of frovatriptan in males and females. Bioavailability was higher, and systemic exposure to frovatriptan was approximately 2-fold greater, in females than males, irrespective of age.

Race The effect of race on the pharmacokinetics of frovatriptan has not been examined Drug Interaction Studies Frovatriptan is not an inhibitor of human monoamine oxidase (MAO) enzymes or cytochrome P450 (isozymes 1A2, 2C9, 2C19, 2D6, 2E1, 3A4) in vitro at concentrations up to 250- to 500- fold higher than the highest blood concentrations observed in man at a dose of 2.5 mg. No induction of drug metabolizing enzymes was observed following multiple dosing of frovatriptan to rats or on addition to human hepatocytes in vitro .

Although no clinical trials have been performed, it is unlikely that frovatriptan will affect the metabolism of co-administered drugs… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of frovatriptan succinate in the acute treatment of migraine headaches was demonstrated in four randomized, double-blind, placebo-controlled, short-term outpatient trials. In these trials, patients received doses of frovatriptan from 0.5 mg to 40 mg. In these controlled short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 to 69).

Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed for up to 24 hours after dosing. The associated symptoms nausea, vomiting, photophobia, and phonophobia were also assessed.

Maintenance of response was assessed for up to 24 hours post dose. In two of the trials a second dose of frovatriptan succinate was provided after the initial treatment, to treat recurrence of the headache within 24 hours. Other medication, excluding other 5-HT 1 agonists and ergotamine containing compounds, was permitted from 2 hours after the first dose of frovatriptan succinate.

The frequency and time to use of additional medications were also recorded. In all four placebo-controlled trials, the percentage of patients achieving a headache response 2 hours after treatment was significantly greater for those taking frovatriptan 2.5 mg compared to those taking placebo (Table 2). Lower doses of frovatriptan (1 mg or 0.5 mg) were not effective at 2 hours.

Higher doses (5 mg to 40 mg) of frovatriptan showed no added benefit over 2.5 mg but did cause a greater incidence of adverse events. Table 2: Percentage of Patients with Headache Response (Mild or No Headache) 2 Hours Following Treatment ITT observed data, excludes patients who had missing data or were asleep Study Frovatriptan 2.5 mg Placebo 1 42% p<0.05. (n=90) 22% (n=91) 2 39% (n=187) 21% (n=99) 3 46% p<0.001 in comparison with placebo.

(n=672) 27% (n=347) 4 37% (n=438) 23% (n=225) The estimated probability of achieving an initial headache response by 2 hours following treatment is depicted in Figure 1. Figure 1: Estimated Probability of Achieving Initial Headache Response Within 2 Hours Figure 1 shows a Kaplan-Meier plot of the probability over time of obtaining headache response (no or mild pain) following treatment with frovatriptan 2.5 mg or placebo. The probabilities displayed are based on pooled data from the four placebo-controlled trials described in Table 2.

Patients who did not achieve a response were censored at 24 hours. In patients with migraine-associated nausea, photophobia, and phonophobia at baseline there was a decreased incidence of these symptoms in frovatriptan succinate treated patients compared to placebo. The estimated probability of patients taking a second dose or other medication for their migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2: Estimated Probability of Patients Taking a Second Dose or Other Medication for Migraine Over the 24 Hours Following the Initial Dose of Study Treatment Figure 2 is a Kaplan-Meier plot showing the probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study medication based on the data from the four placebo-controlled trials described in Table 2. The plot includes those patients who had a response to the initial dose and those who did not.

The protocols did not permit remedication within 2 hours of the initial dose. Efficacy was unaffected by a history of aura; gender; age, or concomitant medications commonly used by migraine patients. figure01 figure02

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of orally administered frovatriptan was evaluated in an 84-week study in mice (4, 13, and 40 mg/kg/day), a 104-week study in rats (8.5, 27, and 85 mg/kg/day), and a 26-week study in p53(+/-) transgenic mice (20, 62.5, 200, and 400 mg/kg/day). Although a maximum tolerated dose was not achieved in the 84-week mouse study and in female rats, plasma exposures at the highest doses studied were higher than that achieved in humans at the MRHD of 7.5 mg/day.

There were no increases in tumor incidence in the 84-week mouse study at doses producing plasma exposures (AUC) 140 times that in humans at the MRHD. In the rat study, there was a statistically significant increase in the incidence of pituitary adenomas in males only at 85 mg/kg/day, a dose associated with a plasma AUC 250 times that in humans at the MRHD. In the 26-week p53(+/-) transgenic mouse study, the incidence of subcutaneous sarcomas was increased in females at doses of 200 and 400 mg/kg/day.

These sarcomas were associated with subcutaneously implanted animal identification transponders and are not considered to be relevant to humans. There were no other increases in tumor incidence of any type in any dose group. Mutagenesis Frovatriptan was clastogenic in human lymphocyte cultures, in the absence of metabolic activation.

In the bacterial reverse mutation assay (Ames test), frovatriptan produced an equivocal response in the absence of metabolic activation. Frovatriptan was negative in an in vitro mouse lymphoma tk assay and an in vivo mouse bone marrow micronucleus test. Impairment of Fertility Male and female rats were dosed orally with frovatriptan prior to and during mating and in females up to implantation, at doses of 100, 500, and 1000 mg/kg/day (equivalent to approximately 130, 650, and 1300 times the MRHD on a mg/m2 basis).

At all dose levels, there was an increase in the number of females that mated on the first day of pairing compared to control animals. This occurred in conjunction with a prolongation of the estrous cycle. In addition, females had a decreased mean number of corpora lutea, and consequently a lower number of live fetuses per litter, which suggested a partial impairment of ovulation.

There were no other fertility-related effects.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of orally administered frovatriptan was evaluated in an 84-week study in mice (4, 13, and 40 mg/kg/day), a 104-week study in rats (8.5, 27, and 85 mg/kg/day), and a 26-week study in p53(+/-) transgenic mice (20, 62.5, 200, and 400 mg/kg/day). Although a maximum tolerated dose was not achieved in the 84-week mouse study and in female rats, plasma exposures at the highest doses studied were higher than that achieved in humans at the MRHD of 7.5 mg/day.

There were no increases in tumor incidence in the 84-week mouse study at doses producing plasma exposures (AUC) 140 times that in humans at the MRHD. In the rat study, there was a statistically significant increase in the incidence of pituitary adenomas in males only at 85 mg/kg/day, a dose associated with a plasma AUC 250 times that in humans at the MRHD. In the 26-week p53(+/-) transgenic mouse study, the incidence of subcutaneous sarcomas was increased in females at doses of 200 and 400 mg/kg/day.

These sarcomas were associated with subcutaneously implanted animal identification transponders and are not considered to be relevant to humans. There were no other increases in tumor incidence of any type in any dose group. Mutagenesis Frovatriptan was clastogenic in human lymphocyte cultures, in the absence of metabolic activation.

In the bacterial reverse mutation assay (Ames test), frovatriptan produced an equivocal response in the absence of metabolic activation. Frovatriptan was negative in an in vitro mouse lymphoma tk assay and an in vivo mouse bone marrow micronucleus test. Impairment of Fertility Male and female rats were dosed orally with frovatriptan prior to and during mating and in females up to implantation, at doses of 100, 500, and 1000 mg/kg/day (equivalent to approximately 130, 650, and 1300 times the MRHD on a mg/m2 basis).

At all dose levels, there was an increase in the number of females that mated on the first day of pairing compared to control animals. This occurred in conjunction with a prolongation of the estrous cycle. In addition, females had a decreased mean number of corpora lutea, and consequently a lower number of live fetuses per litter, which suggested a partial impairment of ovulation.

There were no other fertility-related effects.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Frovatriptan Succinate (froe” va trip’ tan sux’ i nate) tablets What is the most important information I should know about frovatriptan succinate tablets? Frovatriptan succinate tablets can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death.

Stop taking frovatriptan succinate tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Frovatriptan succinate tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem.

You have a higher risk for heart disease if you: have high blood pressure smoke have diabetes have high cholesterol levels are overweight have a family history of heart disease What are frovatriptan succinate tablets? Frovatriptan succinate tablets are a prescription medicine used to treat migraine headaches with or without aura in adults. Frovatriptan succinate tablets are not used to treat other types of headaches.

Frovatriptan succinate tablets are not used to prevent or decrease the number of migraine headaches. It is not known if frovatriptan succinate tablets are safe and effective to treat cluster headaches. It is not known if frovatriptan succinate tablets are safe and effective in children under 18 years of age.

Who should not take frovatriptan succinate tablets? Do not take frovatriptan succinate tablets if you have: heart problems, a history of heart problems, or problems with the electrical system of your heart. had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation. had hemiplegic migraines or basilar migraines. If you are not sure if you have had these types of migraines ask your healthcare provider. narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease). injury to your bowel (intestine) due to poor blood circulation (ischemic bowel disease). uncontrolled high blood pressure. taken any of the following medicines in the last 24 hours: almotriptan (AXERT®) eletriptan (RELPAX®) naratriptan (AMERGE®) rizatriptan (MAXALT®, MAXALT-MLT®) sumatriptan (IMITREX®, IMITREX STATDOSE, ONZETRA TM XSAIL TM , ZEMBRACE TM , SYMTOUCH TM ) sumatriptan and naproxen (TREXIMET®) zolmitriptan (ZOMIG®, ZOMIG-ZMT) ergotamine or ergotamine-type medicines (CAFERGOT®, ERGOMAR®, D.H.E.45®, MIGRANAL®, MIGERGOT) Ask your healthcare provider if you are not sure if your medicine is listed above. an allergy to frovatriptan or any of the ingredients in frovatriptan succinate tablets.

See the end of this leaflet for a complete list of ingredients in frovatriptan succinate tablets. What should I tell my doctor before taking frovatriptan succinate tablets? Before taking frovatriptan succinate tablets, tell your doctor about all of your medical conditions, including if you: have high blood pressure. have high cholesterol. have diabetes. have liver problems. smoke. are overweight. have heart disease or a family history of heart disease or stroke. have any allergies. are pregnant or plan to become pregnant.

It is not known if frovatriptan succinate tablets can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if frovatriptan succinate passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take frovatriptan succinate tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Frovatriptan succinate tablets and certain other medicines can affect each other, causing serious… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 12 words ▾

Principal Display Panel Frovatriptan succinate tablets 2 mg NDC 69315-157-13 foildlabel cartonlabel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Frovatriptan Succinate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Frovatriptan Succinate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$339.6K
Claims incl. refills
2K
Beneficiaries
1.2K
Spend / beneficiary
$289.28
Spend / claim
$169.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Frovatriptan Succinate — the ingredient across all brands.

Top reported reactions

Headache260
Drug Ineffective For Unapproved Indication212
Hypersensitivity210
Drug Intolerance209
Swelling Face203
Swollen Tongue203
Angioedema201

Age at onset

Neonate8
Infant4
Child1
Adult156
Elderly7

Reporter sex

772 reports
Male · 7%
Female · 92%
Unknown · 0%

Serious outcomes

Death6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 135 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 69315-0155-01 · Leading 69315-0158-01 · Leading →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.