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 2026-10-27 · 1381 Präparate · 72104 Quellenpassagen · 204 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Fingolimod Accord
Fingolimod Accord 0.5 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14–16
HOS-145260 · Präparat HOS-099320
Very rare: Kaposi’s sarcoma****
Not known: Merkel cell carcinoma***
Blood and lymphatic system disorders
Common: Lymphopenia
Leucopenia
Uncommon: Thrombocytopenia
Not known: Autoimmune haemolytic anaemia***
Peripheral oedema***
Immune system disorders
14
Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon
treatment initiation***
Immune reconstitution inflammatory syndrome (IRIS)**
Psychiatric disorders
Common: Depression
Uncommon: Depressed mood
Nervous system disorders
Very common: Headache
Common: Dizziness
Migraine
Uncommon: Seizure
Rare: Posterior reversible encephalopathy syndrome (PRES)*
Not known: Severe exacerbation of disease after fingolimod discontinuation***
Eye disorders
Common: Vision blurred
Uncommon: Macular oedema
Cardiac disorders
Common: Bradycardia
Atrioventricular block
Very rare: T-wave inversion***
Vascular disorders
Common: Hypertension
Respiratory, thoracic and mediastinal disorders
Very common: Cough
Common: Dyspnoea
Gastrointestinal disorders
Very common: Diarrhoea
Uncommon: Nausea***
Hepatobiliary disorders
Not known: Acute hepatic failure***
Skin and subcutaneous tissue disorders
Common: Eczema
Alopecia
Pruritus
Musculoskeletal and connective tissue disorders
Very common: Back pain
Common: Myalgia
Arthralgia
General disorders and administration site conditions
Common: Asthenia
Investigations
Very common: Hepatic enzyme increased (increased alanine transaminase, gamma
glutamyltransferase, aspartate transaminase)
Common: Weight decreased***
Blood triglycerides increased
Uncommon: Neutrophil count decreased
* The frequency category was based on an estimated exposure of approximately 10 000 patients to
fingolimod in all clinical trials.
** PML, IRIS and cryptococcal infections (including cases of cryptococcal meningitis) have been
reported in the post-marketing setting (see section 4.4).
*** Adverse reactions from spontaneous reports and literature
**** The frequency category and risk assessment were based on an estimated exposure of more than
24 000 patients to fingolimod 0.5 mg in all clinical trials.
15
*****Includes squamous cell carcinoma of the skin and Bowen’s disease
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Nebenwirkungen · Fingolimod Accord
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Description of selected adverse reactions
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Nebenwirkungen · Fingolimod Accord
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Infections
In multiple sclerosis clinical studies the overall rate of infections (65.1%) at the 0.5 mg dose was
similar to placebo. However, lower respiratory tract infections, primarily bronchitis and to a lesser
extent herpes infection and pneumonia were more common in fingolimod-treated patients.
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Nebenwirkungen · Fingolimod Accord
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Some cases of disseminated herpes infection, including fatal cases, have been reported even at the
0.5 mg dose.
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Nebenwirkungen · Fingolimod Accord
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HOS-145264 · Präparat HOS-099320
In the post-marketing setting, cases of infections with opportunistic pathogens, such as viral (e.g.
varicella zoster virus [VZV], John Cunningham virus [JCV] causing Progressive Multifocal
Leukoencephalopathy, herpes simplex virus [HSV]), fungal (e.g. cryptococci including cryptococcal
meningitis) or bacterial (e.g. atypical mycobacterium), have been reported, some of which have been
fatal (see section 4.4).
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Nebenwirkungen · Fingolimod Accord
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Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related
cancer, has been reported under treatment with fingolimod in the post-marketing setting (see section
4.4). Due to the immunosuppressive properties of fingolimod, vaccination against HPV should be
considered prior to treatment initiation with fingolimod taking into account vaccination
recommendations. Cancer screening, including Pap test, is recommended as per standard of care.
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Nebenwirkungen · Fingolimod Accord
Fingolimod Accord 0.5 mg hard capsules · Abschnitt 4.8 · PDF-Seite 16
HOS-145266 · Präparat HOS-099320
Macular oedema
In multiple sclerosis clinical studies macular oedema occurred in 0.5% of patients treated with the
recommended dose of 0.5 mg and 1.1% of patients treated with the higher dose of 1.25 mg. The
majority of cases occurred within the first 3-4 months of therapy. Some patients presented with blurred
vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine
ophthalmological examination. The macular oedema generally improved or resolved spontaneously
after discontinuation of treatment. The risk of recurrence after re-challenge has not been evaluated.
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Nebenwirkungen · Fingolimod Accord
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Macular oedema incidence is increased in multiple sclerosis patients with a history of uveitis (17%
with a history of uveitis vs. 0.6% without a history of uveitis). Fingolimod has not been studied in
multiple sclerosis patients with diabetes mellitus, a disease which is associated with an increased risk
for macular oedema (see section 4.4). In renal transplant clinical studies in which patients with
diabetes mellitus were included, therapy with fingolimod 2.5 mg and 5 mg resulted in a 2-fold increase
in the incidence of macular oedema.
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Nebenwirkungen · Fingolimod Accord
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Bradyarrhythmia
Initiation of treatment results in a transient decrease in heart rate and may also be associated with
atrioventricular conduction delays. In multiple sclerosis clinical studies the maximal decline in heart
rate was seen within 6 hours after treatment initiation, with declines in mean heart rate of 12-13 beats
per minute for fingolimod 0.5 mg. Heart rate below 40 beats per minute in adults, and below 50 beats
per minute in paediatric patients, was rarely observed in patients on fingolimod 0.5 mg. The average
heart rate returned towards baseline within 1 month of chronic treatment. Bradycardia was generally
asymptomatic but some patients experienced mild to moderate symptoms, including hypotension,
dizziness, fatigue and/or palpitations, which resolved within the first 24 hours after treatment initiation
(see also sections 4.4 and 5.1).
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Nebenwirkungen · Fingolimod Accord
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In multiple sclerosis clinical studies first-degree atrioventricular block (prolonged PR interval on
ECG) was detected after treatment initiation in adult and paediatric patients. In adult clinical trials it
occurred in 4.7% of patients on fingolimod 0.5 mg, in 2.8% of patients on intramuscular interferon
beta-1a, and in 1.6% of patients on placebo. Second-degree atrioventricular block was detected in less
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Nebenwirkungen · Fingolimod Accord
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HOS-145270 · Präparat HOS-099320
16
than 0.2% adult patients on fingolimod 0.5 mg. In the post-marketing setting, isolated reports of
transient, spontaneously resolving complete AV block have been observed during the six hour
monitoring period following the first dose of fingolimod. The patients recovered spontaneously. The
conduction abnormalities observed both in clinical trials and post-marketing were typically transient,
asymptomatic and resolved within the first 24 hours after treatment initiation. Although most patients
did not require medical intervention, one patient on fingolimod 0.5 mg received isoprenaline for
asymptomatic second-degree Mobitz I atrioventricular block.
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Nebenwirkungen · Fingolimod Accord
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In the post-marketing setting, isolated delayed onset events, including transient asystole and
unexplained death, have occurred within 24 hours of the first dose. These cases have been confounded
by concomitant medicinal products and/or pre-existing disease. The relationship of such events to
fingolimod is uncertain.
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Nebenwirkungen · Fingolimod Accord
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HOS-145272 · Präparat HOS-099320
Blood pressure
In multiple sclerosis clinical studies fingolimod 0.5 mg was associated with an average increase of
approximately 3 mmHg in systolic pressure and approximately 1 mmHg in diastolic pressure,
manifesting approximately 1 month after treatment initiation. This increase persisted with continued
treatment. Hypertension was reported in 6.5% of patients on fingolimod 0.5 mg and in 3.3% of
patients on placebo. In the post-marketing setting, cases of hypertension have been reported within the
first month of treatment initiation and on the first day of treatment that may require treatment with
antihypertensive agents or discontinuation of fingolimod (see also section 4.4, Blood pressure effects).
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Nebenwirkungen · Fingolimod Accord
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Liver function
Increased hepatic enzymes have been reported in adult and paediatric multiple sclerosis patients
treated with fingolimod. In clinical studies 8.0% and 1.8% of adult patients treated with fingolimod
0.5 mg experienced an asymptomatic elevation in serum levels of ALT of ≥3x ULN (upper limit of
normal) and ≥5x ULN, respectively. Recurrence of liver transaminase elevations has occurred upon re-
challenge in some patients, supporting a relationship to the medicinal product. In clinical studies,
transaminase elevations occurred at any time during treatment although the majority occurred within
the first 12 months. ALT levels returned to normal within approximately 2 months after
discontinuation of treatment. In a small number of patients (N=10 on 1.25 mg, N=2 on 0.5 mg) who
experienced ALT elevations ≥5x ULN and who continued on fingolimod therapy, the ALT levels
returned to normal within approximately 5 months (see also section 4.4, Liver function).
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Nebenwirkungen · Fingolimod Accord
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HOS-145274 · Präparat HOS-099320
Nervous system disorders
In clinical studies, rare events involving the nervous system occurred in patients treated with
fingolimod at higher doses (1.25 or 5.0 mg) including ischaemic and haemorrhagic strokes and
neurological atypical disorders, such as acute disseminated encephalomyelitis (ADEM)-like events.
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Nebenwirkungen · Fingolimod Accord
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Cases of seizures, including status epilepticus, have been reported with the use of fingolimod in
clinical studies and in the post-marketing setting.
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Nebenwirkungen · Fingolimod Accord
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HOS-145276 · Präparat HOS-099320
Vascular disorders
Rare cases of peripheral arterial occlusive disease occurred in patients treated with fingolimod at
higher doses (1.25 mg).
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Nebenwirkungen · Fingolimod Accord
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Respiratory system
Minor dose-dependent reductions in values for forced expiratory volume (FEV1) and diffusion
capacity for carbon monoxide (DLCO) were observed with fingolimod treatment starting at month 1
and remaining stable thereafter. At month 24, the reduction from baseline values in percentage of
predicted FEV1 was 2.7% for fingolimod 0.5 mg and 1.2% for placebo, a difference that resolved after
treatment discontinuation. For DLCO the reductions at month 24 were 3.3% for fingolimod 0.5 mg
and 2.7% for placebo (see also section 4.4, Respiratory effects).
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Nebenwirkungen · Fingolimod Accord
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HOS-145278 · Präparat HOS-099320
Lymphomas
17
There have been cases of lymphoma of different varieties, in both clinical studies and the post-
marketing setting, including a fatal case of Epstein-Barr virus (EBV) positive B-cell lymphoma. The
incidence of non-Hodgkin’s lymphoma (B-cell and T-cell) cases was higher in clinical trials than
expected in the general population. Some T-cell lymphoma cases were also reported in the
post-marketing setting, including cases of cutaneous T-cell lymphoma (mycosis fungoides) (see also
section 4.4, Malignancies).
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Nebenwirkungen · Fingolimod Accord
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HOS-145279 · Präparat HOS-099320
Haemophagocytic syndrome
Very rare cases of haemophagocytic syndrome (HPS) with fatal outcome have been reported in
patients treated with fingolimod in the context of an infection. HPS is a rare condition that has been
described in association with infections, immunosuppression and a variety of autoimmune diseases.
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This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.