Prescription medicine
Fenfluramine Brand names: Fintepla
Fenfluramine (Fintepla) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the fenfluramine FDA label on DailyMed (effective October 27, 2025, UCB, Inc.); the NDA 212102 record on Drugs@FDA; every fenfluramine label on DailyMed.
Highlights of the record
FDA label of October 27, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
VALVULAR HEART.
DISEASE and PULMONARY ARTERIAL HYPERTENSION FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings [see Dosage and Administration (2.1 , 2.6 ) and Warnings and Precautions (5.1) ]. Because of the risks of valvular heart disease and pulmonary arterial hypertension, FINTEPLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FINTEPLA REMS [see Warnings and Precautions (5.2) ]. WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION See full prescribing information for complete boxed warning. FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension. ( 5.1 ) Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. ( 2.1 , 2.6 , 5.1 ) FINTEPLA is available only through a restricted program called the FINTEPLA REMS.
Used for
From the label: indications and usageFINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
Forms and strengths
- 2.2 mg/ml
Solution.
On the market
- Earliest approval on file
- June 25, 2020 Fintepla, Ucb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 29, 2038 Fintepla oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,666 through July 30, 2026
What is fenfluramine used for?
From the label: indications and usageFINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
Source: FDA drug label (Fintepla), NDA212102 (Ucb Inc), as published by UCB, Inc., effective October 27, 2025 (SPL set e88f360e-33ad-4cd6-b2de-5ef885857c5d), via openFDA; the full label on DailyMed
What does the patient leaflet for fenfluramine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FINTEPLA?FINTEPLA can cause serious side effects, including: Problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with FINTEPLA. Your healthcare provider will do a test called an echocardiogram to check your heart and for high blood pressure in the arteries of the lungs before you start taking FINTEPLA, again every 6 months during treatment, and one time 3 to 6 months after you take your last dose of FINTEPLA. Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with FINTEPLA: shortness of breath tiredness or weakness, especially with increased activity lightheadedness or fainting swollen ankles or feet chest pain sensations of a rapid, fluttering heartbeat (palpitations) irregular pulse bluish color to your lips and skin (cyanosis) Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in arteries of lungs (pulmonary arterial hypertension) FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Before you or your child receives FINTEPLA, your healthcare provider or pharmacist will make sure you understand how to take FINTEPLA safely. If you have any questions about FINTEPLA, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649. Decreased appetite and decreased weight. Decreased appetite and decreased weight are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). Your weight should be checked regularly during your treatment with FINTEPLA. […]
From the patient leaflet: What should I avoid while taking FINTEPLA?Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you. FINTEPLA may cause you to feel sleepy.
From the patient leaflet: How should I store FINTEPLA?Store FINTEPLA at room temperature between 68°F to 77°F (20°C and 25°C). Do not refrigerate or freeze. Store the FINTEPLA bottle and syringe together in a clean area. Throw away (discard) any unused FINTEPLA 3 months after first opening the bottle or if the Discard After date on the package or bottle has passed. Whichever one comes first. Keep FINTEPLA and all medicines out of the reach of children.
Source: FDA drug label (Fintepla), NDA212102 (Ucb Inc), as published by UCB, Inc., effective October 27, 2025 (SPL set e88f360e-33ad-4cd6-b2de-5ef885857c5d), via openFDA; the full label on DailyMed
Is there a generic for fenfluramine (Fintepla)?
No generic fenfluramine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Fintepla oral solution: the compound patent runs to December 20, 2036 (pediatric exclusivity to June 20, 2037), and the last listed entry to December 29, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fenfluramine label say about other medicines?
The fenfluramine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name fenfluramine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bupropion | warnings and precautions | … reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (e.g., St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with … |
| Clobazam | drug interactions | 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. |
| Cyproheptadine | drug interactions | Cyproheptadine and potent 5-HT1A, 5-HT1D, 5-HT2A, and 5-HT2C serotonin receptor antagonists may decrease the efficacy of FINTEPLA. |
| Dextromethorphan | drug interactions | Concomitant administration of FINTEPLA and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the-counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John's Wort) that increase serotonin may increase the risk of serotonin syndrome [see Warnings and Precautions (5.7) ]. |
| Lithium | warnings and precautions | … inhibitors [MAOIs], which are contraindicated with FINTEPLA [see Contraindications (4) ], dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. |
| Stiripentol | drug interactions | 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. |
| Tramadol | warnings and precautions | … [MAOIs], which are contraindicated with FINTEPLA [see Contraindications (4) ], dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. |
| Trazodone | drug interactions | Concomitant administration of FINTEPLA and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the-counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John's Wort) that increase serotonin may increase the risk of serotonin syndrome [see Warnings and Precautions (5.7) ]. |
Other labels that name fenfluramine
Source: FDA drug label (Fintepla), NDA212102 (Ucb Inc), as published by UCB, Inc., effective October 27, 2025 (SPL set e88f360e-33ad-4cd6-b2de-5ef885857c5d), via openFDA; the full label on DailyMed
What do FAERS reports show for fenfluramine?
The FDA Adverse Event Reporting System holds 4,666 reports that list fenfluramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 114 are coded as a death and 1,399 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,307, against a median of 44 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fenfluramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other