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Fenfluramine Side Effects

The most commonly reported side effects of fenfluramine include seizure, off label use, and decreased appetite, based on 4,777 FDA adverse event reports from 2004 to 2025. 14.6% of reports found the drug to be ineffective.

Fenfluramine side effects

Percentages show how often each reaction appears relative to total reports for fenfluramine.

1
Seizure40.3%1,925
2
Drug Ineffective14.6%697
3
Off Label Use13.8%661
4
Decreased Appetite11.5%551
5
Tricuspid Valve Incompetence11.5%547
6
Somnolence9.5%454
7
Weight Decreased8.3%395
8
Mitral Valve Incompetence6.9%329
9
Diarrhoea6.6%314
10
Fatigue6.5%310
11
Generalised Tonic-clonic Seizure5.5%264
12
Pneumonia4.8%230
13
Hospitalisation4.1%197
14
Pulmonary Valve Incompetence4.1%197
15
Pyrexia4.0%190

These are voluntary reports and do not establish that fenfluramine caused these reactions.

Report severity

80.3%Serious3,836 reports
28.6%Hospitalizations1,365 reports
2.3%Fatal110 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fenfluramine drug interactions

Other drugs that appear in adverse event reports alongside fenfluramine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levetiracetam5.2%247
2
Stiripentol5.0%241
3
Cannabidiol3.9%187
4
Clobazam3.5%165
5
Lacosamide2.1%99
6
Brivaracetam2.1%98
7
Valproic-acid1.8%87
8
Topiramate1.3%61
9
Lamotrigine1.0%48
10
Valproate-sodium0.9%44
11
Perampanel0.9%43
12
Midazolam0.8%39
13
Divalproex-sodium0.7%34
14
Phenobarbital-sodium0.7%33
15
Zonisamide0.7%32

Taken alongside

1
Clobazam18.5%883
2
Cannabidiol11.7%557
3
Diazepam7.5%358
4
Levetiracetam7.1%338
5
Clonazepam6.7%319
6
Divalproex-sodium5.8%279
7
Topiramate5.8%276
8
Stiripentol5.4%260
9
Valproate-sodium5.4%256
10
Valproic-acid4.8%227
11
Midazolam4.5%217
12
Lamotrigine4.2%202
13
Levocarnitine4.2%200
14
Zonisamide3.7%179
15
Perampanel3.7%176

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports fenfluramine side effects

35.9% of fenfluramine adverse event reports involve female patients and 38.0% involve male patients. The largest age group is child at 39%. These figures reflect who reports side effects, not underlying risk.

Sex

Female35.9%
Male38.0%
Unknown26.1%

Age group

< 22.4%
2–1138.8%
12–1720.9%
18–6437.2%
65+0.7%

What is fenfluramine used for

Conditions and purposes for which patients were taking fenfluramine when the adverse event was reported.

Adverse Drug ReactionAortic Valve StenosisAtonic SeizuresAutism Spectrum DisorderCdkl5 Deficiency DisorderCoronary Arterial Stent InsertionCerebral PalsyCraniocerebral InjuryDrug Use For Unknown IndicationDepressionEpilepsyEarly Infantile Epileptic Encephalopathy With Burst-suppressionEpilepsyEpilepsy CongenitalEpilepsy With Myoclonic-atonic Seizures

Showing 15 of 67 indications

Fenfluramine brand names and reporting trend

Fenfluramine is sold under brand names including Fenfluramine, Fintepla.

Brand names

Fenfluramine4,358
Fintepla5

Quarterly reports (20042025)

20052025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking fenfluramine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.