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Fenfluramine

Fenfluramine is a seizure medicine used to treat seizures linked to two rare forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome, in people 2 years and older.

Brand name Fintepla
Rx Schedule CIV Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 1 clinical label set 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 →

✓No current FDA shortage listed · checked Oct 5, 2026
Fenfluramine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Fenfluramine (Fintepla) is a specialist seizure medicine for Dravet syndrome and Lennox-Gastaut syndrome, two rare, severe epilepsies, in people 2 and older; it acts on serotonin receptors, is usually added to other seizure medicines, and has been on the U.S. market only since the late 2010s. It is usually manageable day to day, though poor appetite, weight loss and sleepiness are what families notice most. Its boxed warning covers heart valve disease and pulmonary arterial hypertension (high pressure in the lungs' arteries), so it is dispensed only through the Fintepla REMS, with heart ultrasounds before, during and after treatment. Never stop it suddenly, because that can trigger status epilepticus, a prolonged, dangerous seizure.

Clinical pearls

  • Measure doses with the pharmacy's oral syringe, never a kitchen spoon, because the dose is weight-based.
  • Antidepressants, triptans, tramadol, dextromethorphan cough medicines and St. John's Wort add serotonin and raise serotonin syndrome risk.
  • If stiripentol and clobazam are also in the regimen, the maximum fenfluramine dose is lower.
  • Weigh children regularly and track growth, since appetite loss can stall weight gain.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Fintepla can cause valvular heart disease (damaged heart valves) and pulmonary arterial hypertension (high blood pressure in the arteries of the lungs). Both are serious.

You need a heart ultrasound (echocardiogram) before starting, during treatment and after you stop. Your doctor will weigh the benefits and risks based on the results. Because of these risks, Fintepla is available only through a restricted program called the Fintepla REMS. Report any new breathing trouble, swelling or heart symptoms promptly.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asOral solution
Earliest FDA record2017
Companies listing it with the FDA1
FDA label last updatedOct 27, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Fenfluramine, written from its FDA label.

What Fenfluramine is used for

▾

Fenfluramine treats seizures in two rare epilepsy syndromes.

  • Seizures associated with Dravet syndrome, in patients 2 years and older (Fintepla oral solution).
  • Seizures associated with Lennox-Gastaut syndrome, in patients 2 years and older (Fintepla oral solution).

How Fenfluramine works

▾

The exact way fenfluramine reduces seizures is unknown. Fenfluramine and its active metabolite, norfenfluramine, activate serotonin 5-HT2 receptors.

This serotonin activity, particularly at 5-HT2B receptors, is linked to heart valve disease and pulmonary arterial hypertension.

Fenfluramine dosage

▾

Fintepla is a liquid taken by mouth twice a day, with or without food. The dose is based on body weight and is usually increased weekly. Doses are lower if you take stiripentol plus clobazam, certain enzyme-blocking drugs, or have kidney or liver problems.

  • Measure with the oral syringe from your pharmacy, never a household spoon.
  • It can be given through gastric or nasogastric feeding tubes.
  • Throw away unused liquid 3 months after first opening or by the “Discard After” date, whichever is sooner.
  • Don't stop suddenly. The dose should be lowered gradually.

Dosing details from the FDA-approved label

From the Fenfluramine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Dravet Syndrome
    • Initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability
    • Taken orally with or without food
    • Maximum: 0.35 mg/kg twice daily (maximum daily dosage of 26 mg)
    • Titration: 0.1 mg/kg twice daily initially, 0.2 mg/kg twice daily on Day 7, 0.35 mg/kg twice daily on Day 14 if needed; for patients not on stiripentol needing more rapid titration, dose may be increased every 4 days
  • Lennox-Gastaut Syndrome
    • Initial starting dosage is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability to the recommended maintenance dosage of 0.35 mg/kg twice daily
    • Maximum: 26 mg daily
    • Titration: 0.1 mg/kg twice daily initially, 0.2 mg/kg twice daily on Day 7, 0.35 mg/kg twice daily on Day 14; for patients not on stiripentol needing more rapid titration, dose may be increased every 4 days
  • Dravet Syndrome and Lennox-Gastaut Syndrome with concomitant stiripentol plus clobazam
    • Start at 0.1 mg/kg twice daily, 0.15 mg/kg twice daily on Day 7, 0.2 mg/kg twice daily on Day 14
    • Maximum: 0.2 mg/kg twice daily (maximum daily dosage of 17 mg)
    • Dose adjustment required with concomitant stiripentol plus clobazam
  • Dravet Syndrome and Lennox-Gastaut Syndrome with concomitant strong CYP1A2 or CYP2D6 inhibitors
    • Dosage adjustment recommended
    • Maximum: 20 mg total daily dosage without stiripentol; 17 mg with stiripentol plus clobazam
    • Applies to concomitant use of strong CYP1A2 or CYP2D6 inhibitors
  • Dravet Syndrome and Lennox-Gastaut Syndrome with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2)
    • Dosage adjustment recommended
    • Maximum: 20 mg total daily dosage without stiripentol; 17 mg with stiripentol plus clobazam
    • Severe renal impairment
  • Mild hepatic impairment (Child-Pugh A)
    • Titrate as recommended without concomitant stiripentol
    • Maximum: 20 mg total daily dosage without stiripentol; 13 mg with stiripentol plus clobazam
    • Hepatic impairment
  • Moderate hepatic impairment (Child-Pugh B)
    • Titrate as recommended without concomitant stiripentol
    • Maximum: 20 mg total daily dosage without stiripentol; use with stiripentol plus clobazam not recommended
    • Hepatic impairment
  • Severe hepatic impairment (Child-Pugh C)
    • Titrate as recommended without concomitant stiripentol
    • Maximum: 17 mg total daily dosage without stiripentol; use with stiripentol plus clobazam not recommended
    • Hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION FINTEPLA is to be administered orally and may be taken with or without food. ( 2.2 ) Dravet Syndrome The initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. ( 2.2 ) The maximum daily maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). ( 2.2 ) Lennox-Gastaut Syndrome The initial starting dosage is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability. ( 2.2 ) The recommended maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). ( 2.2 ) Dravet Syndrome and Lennox-Gastaut Syndrome Dose adjustment is required in patients taking concomitant stiripentol plus clobazam: the maximum daily maintenance dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg). ( 2.2 , 2.3 , 2.4 , 7.1 ) Dosage adjustment is recommended in patients: Taking strong CYP1A2 or CYP2D6 inhibitors ( 2.3 , 7.1 ) With severe renal impairment ( 2.4 , 8.6 ) With mild, moderate, and severe hepatic impairment ( 2.5 , 8.7 ) 2.1 Assessments Prior to Initiating FINTEPLA Prior to starting treatment with FINTEPLA, obtain an echocardiogram assessment to evaluate for valvular heart disease and pulmonary arterial hypertension [see Dosage and Administration (2.6) and Warnings and Precautions (5.1) ] . 2.2 Dosing Information FINTEPLA is to be administered orally and may be taken with or without food. Dravet Syndrome The initial starting and maintenance dosage for patients with Dravet syndrome is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. Table 1 provides the recommended titration schedule, if needed. Patients with Dravet syndrome not on concomitant stiripentol who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). Patients with Dravet syndrome taking concomitant stiripentol plus clobazam who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Fenfluramine side effects

▾

Common side effects seen in studies include:

Common side effects

  • Decreased appetite
  • Weight loss
  • Sleepiness, sedation or lethargy
  • Diarrhea
  • Constipation
  • Vomiting
  • Tiredness or weakness
  • Fever
  • Fever and upper respiratory infections
  • Balance or walking problems, drooling and higher blood pressure (in Dravet syndrome studies)

When to get medical help

  • Call your doctor right away about new shortness of breath, swelling, chest symptoms or other signs of heart valve problems or high blood pressure in the lungs.
  • Seek help for signs of serotonin syndrome: agitation, hallucinations, fast heartbeat, fever, muscle twitching or stiffness, poor coordination, nausea, vomiting or diarrhea.
  • Call your doctor about new or worsening depression, suicidal thoughts or unusual mood or behavior changes.
  • Get help right away for sudden vision loss, decreased vision or eye pain, which can signal glaucoma.
  • Tell your doctor if seizures get worse or last longer.
  • Contact your doctor if weight loss is significant or a child is not growing as expected.

Fenfluramine warnings and precautions

▾
  • Heart valve disease and pulmonary arterial hypertension: Echocardiograms are required before, during (every 6 months) and after treatment. Cases have been reported after the drug came to market.
  • Restricted program: Available only through the Fintepla REMS.
  • Appetite and weight loss: Weight and children's growth should be monitored.
  • Sleepiness: Alcohol and other CNS depressants can add to this. Be careful driving.
  • Suicidal thoughts: Seizure medicines can raise this risk. Watch for mood changes.
  • Serotonin syndrome: Potentially life-threatening, especially with other serotonin-raising drugs.
  • Blood pressure: Can rise. Rare significant elevations have been reported in adults.
  • Glaucoma: It can dilate pupils and trigger angle-closure glaucoma.
  • Stopping suddenly: Can increase seizures and cause status epilepticus.

Fenfluramine interactions

▾

Several medicines change fenfluramine levels or raise safety risks.

  • MAO inhibitors: contraindicated within 14 days, due to serotonin syndrome risk.
  • Stiripentol plus clobazam: increase fenfluramine levels, so a lower maximum dose applies.
  • Strong CYP1A2 or CYP2D6 inhibitors: increase levels, so the dose is limited.
  • Strong CYP1A2, CYP2B6 or CYP3A inducers: lower levels and may reduce effect.
  • Cyproheptadine and certain serotonin blockers: may reduce effectiveness.
  • SSRIs, SNRIs, tricyclics, triptans, tramadol, lithium, dextromethorphan and St. John's Wort: add to serotonin syndrome risk.
  • Alcohol and other CNS depressants: can increase sleepiness.

Interactions listed in the FDA-approved label

From the Fenfluramine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Stiripentol plus clobazam (with or without valproate): Increases fenfluramine plasma concentrations. Dose adjustment required; maximum daily dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg).
  • Strong CYP1A2, CYP2B6, or CYP3A inducers: Decrease fenfluramine plasma concentrations, which may lower the efficacy of FINTEPLA. Avoid coadministration. If necessary, monitor for reduced efficacy and consider increasing the FINTEPLA dosage as needed without exceeding the maximum daily dosage; if the inducer is discontinued, consider gradual reduction to the dose administered prior to the inducer.
  • Strong CYP1A2 or CYP2D6 inhibitors: Increase fenfluramine plasma concentrations. Maximum daily dosage of FINTEPLA is 20 mg (17 mg if coadministered with stiripentol); if the inhibitor is discontinued, consider gradual dosage increase to the dose recommended without inhibitors, not exceeding the maximum daily dosage.
  • Cyproheptadine and potent 5-HT1A, 5-HT1D, 5-HT2A, and 5-HT2C serotonin receptor antagonists: May decrease the efficacy of FINTEPLA. Monitor patients appropriately if coadministered.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone), dextromethorphan, St. John's Wort: Drugs, over-the-counter medications or herbal supplements that increase serotonin may increase the risk of serotonin syndrome. Use FINTEPLA with caution with other medications that increase serotonin.
  • MAOIs: Concomitant use of FINTEPLA is contraindicated within 14 days of taking MAOIs. Contraindicated within 14 days of taking MAOIs.
Read the label’s full interactions text

7 DRUG INTERACTIONS Dose adjustment is required for patients taking stiripentol plus clobazam. ( 2.2 , 2.3 , 7.1 ) Strong CYP1A2 or CYP2D6 inhibitors: a dose adjustment is recommended ( 2.3 , 7.1 ) Strong CYP1A2, CYP2B6, or CYP3A4 inducers: it is recommended to avoid coadministration with FINTEPLA. If coadministration is necessary, consider a FINTEPLA dosage increase. ( 7.1 ) 7.1 Effect of Other Drugs on FINTEPLA Stiripentol Plus Clobazam Coadministration of FINTEPLA with stiripentol plus clobazam, with or without valproate, increases fenfluramine plasma concentrations [see Clinical Pharmacology (12.3) ]. If FINTEPLA is coadministered with stiripentol plus clobazam, the maximum daily dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Dosage and Administration (2.2) ] . Strong CYP1A2, CYP2B6, or CYP3A Inducers Coadministration of FINTEPLA with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of FINTEPLA [see Clinical Pharmacology (12.3) ] . It is recommended to avoid coadministration of strong CYP1A2, CYP2B6 or CYP3A inducers. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed; however, do not exceed the maximum daily dosage of FINTEPLA [see Dosage and Administration (2.2) ]. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer [see Warnings and Precautions (5.6) ]. Strong CYP1A2 or CYP2D6 Inhibitors Coadministration of FINTEPLA with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations [see Clinical Pharmacology (12.3) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Fenfluramine

▾
  • Don't use if allergic to fenfluramine or its ingredients, or if taking or recently on an MAO inhibitor.
  • A baseline echocardiogram and ongoing heart monitoring are required.
  • Pregnancy: animal data suggest possible fetal harm. Talk to your doctor before changing seizure treatment, and consider the pregnancy registry.
  • Breastfeeding: no data on milk transfer. Discuss with your doctor.
  • Children: studied in ages 2 and older. Growth should be watched. Safety under 2 is not established.
  • Older adults: not studied at 65 and over. Dosing is cautious.
  • Severe kidney impairment: lower maximum dose. Not studied when eGFR is below 15.
  • Liver impairment: lower maximum doses. Use with stiripentol plus clobazam is not recommended in moderate or severe impairment.

Fenfluramine overdose

▾

Overdose of fenfluramine has been reported at higher doses than those used in trials, and some cases were fatal. Effects include enlarged pupils, fast heartbeat, flushing, tremors or muscle spasms, agitation, breathing problems and seizures. There is no specific antidote, so contact a poison control center or seek emergency care right away.

What Fenfluramine does in the body

▾

At four times the maximum recommended dose, Fintepla did not lengthen the QT interval (a heart rhythm measure) in adults. Fenfluramine and norfenfluramine act on serotonin 5-HT2 receptors.

How your body processes Fenfluramine

▾

Fenfluramine reaches peak blood levels about 3 to 5 hours after a dose at steady state. Food does not affect how it is absorbed. Its half-life is about 20 hours. Most of it is converted to the active metabolite norfenfluramine by liver enzymes (mainly CYP1A2, CYP2B6 and CYP2D6). More than 90% leaves in the urine. Levels rise with liver impairment and severe kidney impairment.

How to store Fenfluramine

▾

Store FINTEPLA at room temperature between 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) . Do not refrigerate or freeze. Store the bottle and syringe together.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

208

Supplements & herbs that interact with Fenfluramine

208 supplements and herbal products have documented interactions with Fenfluramine 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 · 8
  • Moderate · 163
  • Minor · 37
Every supplement checked against Fenfluramine — ranked by severity The full interaction hub: 8 major · 141 moderate · 33 minor · every one linked to its full report. Check Fenfluramine 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.

Fenfluramine: pharmacist answers to common questions

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

What is this medicine for?

▾
Fintepla treats seizures from two rare epilepsy types, Dravet syndrome and Lennox-Gastaut syndrome. It's approved for people 2 years and older.

How do I give it?

▾
It's a liquid taken twice a day, with or without food. Use the oral syringe from the pharmacy, because a kitchen spoon isn't accurate. It can also go through a feeding tube. Throw away leftovers 3 months after opening.

Why do I need heart ultrasounds?

▾
Fenfluramine can cause heart valve disease and high blood pressure in the lung arteries. Echocardiograms are done before you start, every 6 months, and 3 to 6 months after your last dose. They can catch problems before symptoms show up.

What side effects should I expect?

▾
Lower appetite, weight loss, sleepiness, diarrhea, constipation, vomiting and tiredness are common. Call your doctor for breathing trouble, swelling, mood changes, suicidal thoughts, eye pain or vision changes, or signs of serotonin syndrome.

Can I take it with my other medicines?

▾
Tell me about everything you take. MAO inhibitors are not allowed. Antidepressants, triptans, tramadol, dextromethorphan and St. John's Wort raise serotonin syndrome risk. Stiripentol with clobazam changes your dose limit.

Can I stop it if I feel fine?

▾
Don't stop suddenly. That can bring on more seizures or a prolonged dangerous seizure. Your doctor will lower the dose gradually. If you're pregnant or planning to be, talk to your doctor first rather than stopping.

Is Fenfluramine available over the counter?

▾
No. Fenfluramine is a prescription medicine: every Fenfluramine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Fenfluramine a controlled substance?

▾
Yes — Fenfluramine is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Fenfluramine first available?

▾
The earliest FDA record we hold for Fenfluramine is from 2017: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fenfluramine was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fenfluramine on HelloPharmacist

Detailed data & references for Fenfluramine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Fenfluramine forms and strengths (how it comes)

Fenfluramine 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.

Oral solution

By mouth
Brands Fintepla
How this form is used
What it may be used for
  • Fintepla is used for seizures associated with Dravet syndrome in patients 2 years and older.
  • Fintepla is used for seizures associated with Lennox-Gastaut syndrome in patients 2 years and older.
Important instructions
  • Fintepla is taken by mouth twice daily, with or without food.
  • Fintepla should be measured with the oral syringe from the pharmacy, not a household spoon.
  • Fintepla can be given through commercially available gastric and nasogastric feeding tubes.
  • Fintepla oral solution should be discarded 3 months after first opening or by the “Discard After” date, whichever comes first.
Available strengths 2 strengths
4 FDA-listed product records ⓘ

Fenfluramine on the U.S. market: products, makers and brands

How Fenfluramine 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 company lists 1 Fenfluramine product record with the FDA, mostly as oral solution; the earliest marketing or approval year on record is 2017. Brand names on the directory include Fintepla; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2017
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Fenfluramine is used (Medicaid data)

A general measure of how commonly Fenfluramine 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 Fenfluramine 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.

17,553
Medicaid prescriptions filled (Q1–Q4 2025)
$239.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fenfluramine prescribed? Of the 1,601 medications we measure, Fenfluramine ranks #823 by Medicaid prescriptions — more than 49% of them.

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

Utilization by Fenfluramine 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.

fenfluramine 2.2 MG/ML Oral Solution

17,553 Medicaid prescriptions (Q1–Q4 2025) 100% of Fenfluramine prescriptions shown $239.9M gross reimbursement (before rebates) ≈ $13,668 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2381138

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 Fenfluramine, 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 1 of 2 listed Fenfluramine NDCs with Medicaid activity.

Compare Fenfluramine products

A representative set of FDA-listed product records for Fenfluramine — 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
💊Oral solution
2.2 mg/mL Oral UCB, Inc. NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Fenfluramine NDCs →

Fenfluramine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Fenfluramine recalls since July 2021.

✅No Fenfluramine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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) Fenfluramine RxCUI 4328 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Solution RxCUI 2381137 In current FDA listings
    Clinical drug / strength (SCD) 2.2 MG/ML RxCUI 2381138

Look up RxCUI 4328 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.

Fenfluramine brand names

Fenfluramine is sold under one brand name in the FDA directory — Fintepla. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Fintepla

Who makes Fenfluramine: manufacturers and labelers

One company lists Fenfluramine products with the FDA. By number of product records, the largest are UCB, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

UCB, Inc. 1

Fenfluramine drug class (RxNorm)

Fenfluramine belongs to the Centrally acting antiobesity products class.

Drug family (ATC) Centrally acting antiobesity products, Other antiepileptics

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.

Sources for this Fenfluramine page

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 Oct 27, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fenfluramine.
📈
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 Fenfluramine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Zogenix, Inc.
Linked label effective
Oct 27, 2025
Composite sections available
25
Linked SPL Set ID
e88f360e-33ad-4cd6-b2de-5ef885857c5d
Linked SPL Document ID
42264a61-0fc3-3a99-e063-6294a90a9595
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Zogenix, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →