Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 10–11
HOS-132984 · Präparat HOS-097342
10
Skin and subcutaneous tissue Rash
disorders
General disorders and Fatigue
administration site conditions
Investigations Weight decreased
Blood glucose decreased
Blood prolactin increased
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 4c8c93006d547ea990ab963069a970cd1e5ec0c8bf4af94a704caf8607dd80cf · Zeichen 2234–2625 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11
HOS-132985 · Präparat HOS-097342
Description of selected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 2627–2668 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11
HOS-132986 · Präparat HOS-097342
Decreased appetite and weight loss
Fenfluramine can cause decreased appetite and weight loss. In the controlled trials of children and
young adults with Dravet syndrome 34.7% of fenfluramine-treated patients had an adverse reaction of
decreased appetite, compared to 7.6% of patients on placebo, and approximately 7.4% of
fenfluramine-treated patients had a decrease in weight, compared to 0.8% of patients on placebo. In
the controlled clinical trials of children and adults with Lennox-Gastaut syndrome, 28.8% of
fenfluramine-treated patients had an adverse reaction of decreased appetite, compared to 15.3% of
patients on placebo, and approximately 8.1% of fenfluramine-treated patients had a decrease in
weight, compared to 3.1% of patients on placebo. The decreases in appetite and weight appeared to be
dose related. Most subjects resumed weight gain over time while continuing fenfluramine treatment.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage f95107979d17cf6f3a8f1f8caacc0c40fa91624f8d034cbd3933ea852cbd0584 · Zeichen 2670–3577 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11
HOS-132987 · Präparat HOS-097342
Status epilepticus and seizures (Epilepsy, Seizure cluster, Change in seizure)
In the Dravet syndrome phase 3 clinical trials, the observed frequency of status epilepticus was 1.5%
in the placebo group and 5.1% in the combined fenfluramine group. In the LGS phase 3 clinical trial,
the observed frequency of status epilepticus was 1.0% in the placebo group and 1.5% in the
fenfluramine group. There were no discontinuations due to status epilepticus in the Dravet syndrome
and the LGS phase 3 clinical trials.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 85192fd67ced77356844a1d4b241ae0c53cc9798ed21de2863b39538d2defa13 · Zeichen 3579–4088 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11
HOS-132988 · Präparat HOS-097342
In the controlled trials in patients with Dravet syndrome seizures were reported less frequently in the
fenfluramine treated patients (6.9%) than in patients on placebo (10.6%). However, seizures assessed
as related to the study drug were more commonly reported in fenfluramine treated patients than
placebo, 3.7% of fenfluramine-treated patients compared to 1.5% of patients on placebo. In the LGS
trial, seizures were reported with a similar frequency in the fenfluramine treated patients (9.1%) and
patients on placebo (9.2%). However, seizures assessed as related to the study drug were more
commonly reported in fenfluramine treated patients than placebo, 6.1% of fenfluramine-treated
patients compared to 1.0% of patients on placebo.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 9061d713eee0578b990f0aec0a334afe6ff1a22cfa988ae1bd7fb53185b71ad6 · Zeichen 4090–4829 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11
HOS-132989 · Präparat HOS-097342
The mean days to onset of seizure events in the LGS phase 3 trial after starting treatment was
44.4 days in the combined fenfluramine groups and 36.6 days in the placebo group.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 54bea3ad151791992b04f91d0082fcfd2496c7492f453ded992c7995dce5815b · Zeichen 4831–5007 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11–12
HOS-132990 · Präparat HOS-097342
Echocardiographic safety assessments
Valvular heart disease and pulmonary arterial hypertension were evaluated via echocardiography in
the clinical studies for Dravet syndrome and Lennox-Gastaut syndrome. No patient developed valvular
heart disease or pulmonary arterial hypertension in the completed clinical studies for both indications.
The percentage of trace and mild mitral regurgitation and trace aortic regurgitation from pooled double
blinded DS and LGS clinical studies are shown below. These are defined as non-pathologic findings
by the ESC/EACTS guidelines. Where trace mitral or aortic regurgitation were observed, the results
were often transient.
• Trace of mitral regurgitation:
- Combined fenfluramine group: 18.6% (77/414)
- Placebo: 13.9% (32/230)
• Mild mitral regurgitation:
- Combined fenfluramine group: 0.7% (3/414)
- Placebo: 0% (0/230)
• Trace aortic regurgitation:
- Combined fenfluramine group: 2.4% (10/414)
- Placebo: 0.9% (2/230)
11
Nevertheless, pulmonary arterial hypertension and valvular heart disease associated with fenfluramine
for Dravet syndrome and Lennox-Gastaut syndrome have been reported. Resolution of pulmonary
arterial hypertension has been reported following discontinuation in at least one case (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 2cef773fb94d7dfb3dbf839cc3a9675341671a77d896d288b96949d5948f2805 · Zeichen 5009–6417 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132991 · Präparat HOS-097342
Lethargy, somnolence, and fatigue (grouping of fatigue/asthenia/malaise/decreased activity)
In the controlled trials in subjects with Dravet syndrome, lethargy was commonly reported in 9.7%,
and somnolence and fatigue were very commonly reported in 13.9% and 19%, respectively in the
fenfluramine treatment groups combined. In the controlled study with Lennox-Gastaut syndrome,
lethargy was commonly reported in 4.5% of subjects in the fenfluramine treatment group. Fatigue and
somnolence were very commonly reported in 16.2% and 16.2% of subjects, respectively. The majority
of the adverse reactions of lethargy, somnolence, and fatigue/asthenia were reported in the first 2
weeks of treatment with fenfluramine and were mild or moderate in severity. Discontinuation due to
lethargy, somnolence, and fatigue/asthenia was rare and, in most cases, these adverse reactions
resolved or improved with ongoing treatment. In the controlled trials with Dravet syndrome, 0.5% and
1.4% of subjects in the fenfluramine treatment groups combined discontinued due to lethargy and
somnolence, respectively. In the LGS study 4, 1.5% of subjects in the fenfluramine treatment group
discontinued due to somnolence.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 9b4e856c59243a95c687a10ca94b3846f6f36d1a20ba37e2c2b08d8e3415c008 · Zeichen 6419–7617 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132992 · Präparat HOS-097342
Gastrointestinal disorders
In the Phase 3 LGS controlled trial in children and young adults, diarrhoea (13.1%) and vomiting
(10.6%) were observed more frequently in the combined fenfluramine groups than in the placebo
group (4.1% and 6.1%, respectively) during the 14-week titration and maintenance periods. In Study 4
the mean time to onset of diarrhoea in the combined fenfluramine groups was 25.4 days versus 46.0
days in the placebo group while the mean time to onset of vomiting in the combined fenfluramine
groups was 36.7 days versus 38.2 days in the placebo group.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage f0f12e96f38854cd9a50b7a3f6dc22971a990fe264ff09fad78de2b1005e0b36 · Zeichen 7619–8191 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132993 · Präparat HOS-097342
In the LGS controlled trial through the open-label trial, diarrhoea and constipation were observed
more frequently in the higher dose groups. The mean time to onset of diarrhoea was 215.7 days, 95.2
days, and 79.6 days in the >0 - <0.4 mg/kg/day, 0.4 - <0.6 mg/kg/day, and ≥0.6 mg/kg/day mean daily
dose groups respectively while the mean time to onset of constipation was 113.0 days, 173.7 days, and
140.1 days in the >0 - <0.4 mg/kg/day, 0.4 - <0.6 mg/kg/day, and ≥0.6 mg/kg/day mean daily dose
groups respectively.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 1bcfad33a90297f2ff99dcb0e82a8e41f352bb151dcaf49e408b3bd9c989c5af · Zeichen 8193–8710 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132994 · Präparat HOS-097342
All events reported for diarrhoea and constipation were mild or moderate in severity.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage dc3c292603344b7171d8fda9d123c69c56499002e57645df433b0e6d3565ad86 · Zeichen 8712–8797 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132995 · Präparat HOS-097342
Reporting of suspected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 822da43363cee11e87abeb55cf82453415269315377df150bb5de7dde8dd938f · Zeichen 8799–8839 im Abschnitt
Nebenwirkungen · Fintepla
Fintepla 2.2 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 12
HOS-132996 · Präparat HOS-097342
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-04-09T15:00:00Z · SHA-256 e175f94af1e49d4a11fbbc3e861df1256bc1a0a5d612baaf0706babc5f1fc781 · Passage 591ce3aa6d6555db7032d0551da929e990b92080da2928085827a75c666ec353 · Zeichen 8841–9155 im Abschnitt
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