Substance / Medication

Fenfluramine

Overview

Active Ingredient
fenfluramine
RxNorm CUI
4328

Indications

FINTEPLA 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.

Labeler: UCB, Inc.Updated: 2025-10-27T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Warnings and Precautions (5.1) [see]. FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension Dosage and Administration (2.1 2.6 Warnings and Precautions (5.1) [see,) and]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits v

Contraindications

When this intervention should not be used

FINTEPLA is contraindicated in patients with: Description (11) [see] Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA Warnings and Precautions (5.7) [see] Concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of se

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

Clinical Trials

4 trials linked to this intervention

4
Total Trials
3
Recruiting
0
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Fenfluramine for Treating Dravet Syndrome: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.
Wijnen Ben, Witlox Willem, Wolff Robert et al. · Pharmacoeconomics · 2023
PMID: 36301414Meta-Analysis
Efficacy and tolerability of fenfluramine in patients with Dravet syndrome: A systematic review and meta-analysis.
Sharawat Indar Kumar, Panda Prateek Kumar, Kasinathan Ananthanarayanan et al. · Seizure · 2021
PMID: 33461030Meta-Analysis
Efficacy and safety of fenfluramine in patients with Dravet syndrome: A meta-analysis.
Zhang Lanlan, Li Wei, Wang Chengzhong · Acta Neurol Scand · 2021
PMID: 33336426Meta-Analysis
Risk of valvular heart disease associated with use of fenfluramine.
Hopkins Paul N, Polukoff Gerald I · BMC Cardiovasc Disord · 2003
PMID: 12801402Meta-AnalysisFull text (PMC)
Effect of fenfluramine-derivative diet pills on cardiac valves: a meta-analysis of observational studies.
Sachdev Molly, Miller William C, Ryan Thomas et al. · Am Heart J · 2002
PMID: 12486432Meta-Analysis
Efficacy of fenfluramine and dexfenfluramine in the treatment of obesity: a meta-analysis.
Carvajal A, García del Pozo J, Martín de Diego I et al. · Methods Find Exp Clin Pharmacol · 2000
PMID: 11031729Meta-Analysis
Long-term safety and effectiveness of fenfluramine in children and adults with Dravet syndrome.
Scheffer Ingrid E, Nabbout Rima, Lagae Lieven et al. · Epilepsia · 2025
PMID: 40072476RCTFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Fenfluramine (substance)
SNOMED CT
387451002
UMLS CUI
C0015827
RxNorm CUI
4328
Labeler
UCB, Inc.

Clinical Data

This intervention maps to 11 entities in the Healos knowledge graph.

3
Conditions
3
Biomarkers
3
Specialists
0
Symptoms
4
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.