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 · Riximyo
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HOS-141020 · Präparat HOS-098602
MedDRA
Very
System organ Common Uncommon Rare Very rare Not known
common
class
Infections and Bacterial Sepsis, Serious viral PML Enteroviral
+
infestations infections, pneumonia, infection2, meningoence
+
viral febrile infection, pneumocystis phalitis2, 3
+
infections, herpes zoster, jirovecii
+ +
bronchitis respiratory tract
infection, fungal
infections,
infections of
unknown
aetiology, +acute
bronchitis,
+
sinusitis, hepatitis
B1
Blood and Neutropenia, Anaemia, Coagulation Transient Late
+
lymphatic leucopenia, pancytopenia, disorders, increase in neutropenia4
+ +
system febrile granulocytopenia aplastic serum IgM
disorders neutropenia, anaemia, levels4
+
thrombocyt haemolytic
openia anaemia,
lymphadeno
pathy
Immune Infusion Hypersensitivity Anaphylaxis Tumour Infusion-
system related lysis related acute
disorders reactions5, syndrome, reversible
angioedema cytokine thrombocyto
release penia5
syndrome5,
serum
sickness
Metabolism Hyperglycaemia,
and nutrition weight decrease,
disorders oedema peripheral,
face oedema,
increased LDH,
hypocalcaemia
Psychiatric Depression,
disorders nervousness
Nervous Paraesthesia, Dysgeusia Peripheral Cranial
system hypoaesthesia, neuropathy, neuropathy,
disorders agitation, facial nerve loss of other
insomnia, palsy6 senses6
vasodilatation,
dizziness, anxiety
Eye disorders Lacrimation Severe
disorder, vision loss6
conjunctivitis
Ear and Tinnitus, Hearing loss6
labyrinth ear pain
disorders
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Nebenwirkungen · Riximyo
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HOS-141021 · Präparat HOS-098602
17
MedDRA
Very
System organ Common Uncommon Rare Very rare Not known
common
class
+ +
Cardiac Myocardial Left Severe Heart
disorders infarction5, 7, ventricular cardiac failure5, 7
arrhythmia, +atrial failure, disorders 5, 7
+
fibrillation, supraventric
tachycardia, ular
+
cardiac disorder tachycardia,
+
ventricular
tachycardia,
+
angina,
+
myocardial
ischaemia,
bradycardia
Vascular Hypertension, Vasculitis
disorders orthostatic (predominat
hypotension, ely
hypotension cutaneous),
leukocytocla
stic
vasculitis
Respiratory, Bronchospasm5, Asthma, Interstitial Respiratory Lung
thoracic and respiratory bronchiolitis lung disease8 failure5 infiltration
mediastinal disease, chest pain, obliterans,
disorders dyspnoea, lung
increased cough, disorder,
rhinitis hypoxia
Gastrointestin Nausea Vomiting, Abdominal Gastro-
al disorders diarrhoea, enlargement intestinal
abdominal pain, perforation8
dysphagia,
stomatitis,
constipation,
dyspepsia,
anorexia, throat
irritation
Skin and Pruritis, rash, Urticaria, Severe
+
subcutaneous alopecia sweating, night bullous skin
tissue sweats, +skin reactions,
disorders disorder Stevens-
Johnson
Syndrome,
toxic
epidermal
necrolysis
(Lyell’s
Syndrome)8
Musculoskelet Hypertonia,
al and myalgia,
connective arthralgia, back
tissue pain, neck pain,
disorders pain
Renal and Renal
urinary failure5
disorders
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Nebenwirkungen · Riximyo
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HOS-141022 · Präparat HOS-098602
18
MedDRA
Very
System organ Common Uncommon Rare Very rare Not known
common
class
General Fever, chills, Tumour pain, Infusion site
disorders and asthenia, flushing, malaise, pain
administration headache cold syndrome,
+
site conditions fatigue,
+
shivering, +multi-
organ failure5
Investigations Decreased
IgG levels
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms
marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria)
reactions. Only the highest frequency observed in the trials is reported
1
includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL
2
see also section infection below
3
observed during post-marketing surveillance
4 see also section haematologic adverse reactions below
5
see also section infusion-related reactions below. Rarely fatal cases reported
6
signs and symptoms of cranial neuropathy. Occurred at various times up to several months after completion of
rituximab therapy
7
observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly
associated with infusion-related reactions
8
includes fatal cases
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Nebenwirkungen · Riximyo
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HOS-141023 · Präparat HOS-098602
The following terms have been reported as adverse reactions during clinical trials, however, were
reported at a similar or lower incidence in the rituximab arms compared to control arms:
haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
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Nebenwirkungen · Riximyo
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HOS-141024 · Präparat HOS-098602
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of
patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one
to two hours. These symptoms mainly comprised fever, chills and rigors. Other symptoms included
flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat
irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia,
asthenia and features of tumour lysis syndrome. Severe infusion-related reactions (such as
bronchospasm, hypotension) occurred in up to 12% of the cases.
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Nebenwirkungen · Riximyo
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HOS-141025 · Präparat HOS-098602
Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary
oedema and acute reversible thrombocytopenia. Exacerbations of pre-existing cardiac conditions such
as angina pectoris or congestive heart failure or severe cardiac disorders (heart failure, myocardial
infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine
release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is
< 1% of patients by the eighth cycle of rituximab (containing) treatment.
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Nebenwirkungen · Riximyo
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HOS-141026 · Präparat HOS-098602
Description of selected adverse reactions
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Nebenwirkungen · Riximyo
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HOS-141027 · Präparat HOS-098602
Infections
Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased
serum immunoglobulins only in a minority of patients.
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Nebenwirkungen · Riximyo
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HOS-141028 · Präparat HOS-098602
Localised candida infections as well as Herpes zoster were reported at a higher incidence in the
rituximab-containing arm of randomised studies. Severe infections were reported in about 4% of
patients treated with rituximab monotherapy. Higher frequencies of infections overall, including grade
3 or 4 infections, were observed during rituximab maintenance treatment up to 2 years when compared
to observation. There was no cumulative toxicity in terms of infections reported over a 2-year
treatment period. In addition, other serious viral infections either new, reactivated or exacerbated,
some of which were fatal, have been reported with rituximab treatment. The majority of patients had
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Nebenwirkungen · Riximyo
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HOS-141029 · Präparat HOS-098602
19
received rituximab in combination with chemotherapy or as part of a haematopoietic stem cell
transplant. Examples of these serious viral infections are infections caused by the herpes viruses
(Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal
leukoencephalopathy [PML]), enterovirus (meningoencephalitis) and hepatitis C virus (see section
4.4.). Cases of fatal PML that occurred after disease progression and retreatment have also been
reported in clinical trials. Cases of hepatitis B reactivation, have been reported, the majority of which
were in patients receiving rituximab in combination with cytotoxic chemotherapy. In patients with
relapsed/refractory CLL, the incidence of grade 3/4 hepatitis B infection (reactivation and primary
infection) was 2% in R-FC vs. 0% FC. Progression of Kaposi’s sarcoma has been observed in
rituximab-exposed patients with pre-existing Kaposi’s sarcoma. These cases occurred in non-approved
indications and the majority of patients were HIV positive.
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Nebenwirkungen · Riximyo
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HOS-141030 · Präparat HOS-098602
Haematologic adverse reactions
In clinical trials with rituximab monotherapy given for 4 weeks, haematological abnormalities
occurred in a minority of patients and were usually mild and reversible. Severe (grade 3/4) neutropenia
was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients. During
rituximab maintenance treatment for up to 2 years, leucopenia (5% vs. 2%, grade 3/4) and neutropenia
(10% vs. 4%, grade 3/4) were reported at a higher incidence when compared to observation. The
incidence of thrombocytopenia was low (< 1%, grade 3/4) and was not different between treatment
arms. During the treatment course in studies with rituximab in combination with chemotherapy,
grade 3/4 leucopenia (R-CHOP 88% vs. CHOP 79%, R-FC 23% vs. FC 12%), neutropenia (R-CVP
24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%, R-FC 30% vs. FC 19% in previously untreated
CLL), pancytopenia (R-FC 3% vs. FC 1% in previously untreated CLL) were usually reported with
higher frequencies when compared to chemotherapy alone. However, the higher incidence of
neutropenia in patients treated with rituximab and chemotherapy was not associated with a higher
incidence of infections and infestations compared to patients treated with chemotherapy alone. Studies
in previously untreated and relapsed/refractory CLL have established that in up to 25% of patients
treated with R-FC neutropenia was prolonged (defined as neutrophil count remaining below 1 x 109/L
between Day 24 and 42 after the last dose) or occurred with a late onset (defined as neutrophil count
below 1 x 109/L later than 42 days after last dose in patients with no previous prolonged neutropenia
or who recovered prior to Day 42) following treatment with rituximab plus FC. There were no
differences reported for the incidence of anaemia. Some cases of late neutropenia occurring more than
four weeks after the last infusion of rituximab were reported. In the CLL first-line study, Binet stage C
patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC
71%). In the relapsed/refractory CLL study grade 3/4 thrombocytopenia was reported in 11% of
patients in the R-FC group compared to 9% of patients in the FC group.
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Nebenwirkungen · Riximyo
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HOS-141031 · Präparat HOS-098602
In studies of rituximab in patients with Waldenstrom’s macroglobulinaemia, transient increases in
serum IgM levels have been observed following treatment initiation, which may be associated with
hyperviscosity and related symptoms. The transient IgM increase usually returned to at least baseline
level within 4 months.
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Nebenwirkungen · Riximyo
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HOS-141032 · Präparat HOS-098602
Cardiovascular adverse reactions
Cardiovascular reactions during clinical trials with rituximab monotherapy were reported in 18.8% of
patients with the most frequently reported events being hypotension and hypertension. Cases of
grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris
during infusion were reported. During maintenance treatment, the incidence of grade 3/4 cardiac
disorders was comparable between patients treated with rituximab and observation. Cardiac events
were reported as serious adverse reactions (including atrial fibrillation, myocardial infarction, left
ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to < 1%
on observation. In studies evaluating rituximab in combination with chemotherapy, the incidence of
grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia
and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the
CHOP group (3 patients, 1.5%). All of these arrhythmias either occurred in the context of a rituximab
infusion or were associated with predisposing conditions such as fever, infection, acute myocardial
infarction or pre-existing respiratory and cardiovascular disease. No difference between the R-CHOP
and CHOP group was observed in the incidence of other grade 3 and 4 cardiac events including heart
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Nebenwirkungen · Riximyo
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HOS-141033 · Präparat HOS-098602
20
failure, myocardial disease and manifestations of coronary artery disease. In CLL, the overall
incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and
in the relapsed/refractory study (4% R-FC, 4% FC).
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Nebenwirkungen · Riximyo
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HOS-141034 · Präparat HOS-098602
Respiratory system
Cases of interstitial lung disease, some with fatal outcome have been reported.
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Nebenwirkungen · Riximyo
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HOS-141035 · Präparat HOS-098602
Neurologic disorders
During the treatment period (induction treatment phase comprising of R-CHOP for at most eight
cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced
thromboembolic cerebrovascular accidents during the first treatment cycle. There was no difference
between the treatment groups in the incidence of other thromboembolic events. In contrast, three
patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the
follow-up period. In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both
in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
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Nebenwirkungen · Riximyo
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HOS-141036 · Präparat HOS-098602
Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior
leukoencephalopathy syndrome (RPLS) have been reported. Signs and symptoms included visual
disturbance, headache, seizures and altered mental status, with or without associated hypertension. A
diagnosis of PRES/RPLS requires confirmation by brain imaging. The reported cases had recognized
risk factors for PRES/RPLS, including the patients’ underlying disease, hypertension,
immunosuppressive therapy and/or chemotherapy.
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Nebenwirkungen · Riximyo
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HOS-141037 · Präparat HOS-098602
Gastrointestinal disorders
Gastrointestinal perforation in some cases leading to death has been observed in patients receiving
rituximab for treatment of NHL. In the majority of these cases, rituximab was administered with
chemotherapy.
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Version 2026-09-04T16:41:00Z · SHA-256 4fe21e50fef50537643123868d3f044762b7d55eab7d50a56c1d469305291ee4 · Passage 1b8c1388690350126005393584dac7a023b74fab33f00e6190f6d665409f5d12 · Zeichen 22201–22437 im Abschnitt
Nebenwirkungen · Riximyo
Riximyo 100 mg concentrate for solution for infusion Riximyo 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 21
HOS-141038 · Präparat HOS-098602
IgG levels
In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular
lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction
treatment in both the observation and the rituximab groups. In the observation group, the median IgG
level subsequently increased to above the LLN, but remained constant in the rituximab group. The
proportion of patients with IgG levels below the LLN was about 60% in the rituximab group
throughout the 2-year treatment period, while it decreased in the observation group (36% after
2 years).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-09-04T16:41:00Z · SHA-256 4fe21e50fef50537643123868d3f044762b7d55eab7d50a56c1d469305291ee4 · Passage 47d08b626503afa356054f61f8af04c045e0d0f8da7563a4b5d983ecdb205670 · Zeichen 22439–23038 im Abschnitt
Nebenwirkungen · Riximyo
Riximyo 100 mg concentrate for solution for infusion Riximyo 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 21
HOS-141039 · Präparat HOS-098602
A small number of spontaneous and literature cases of hypogammaglobulinaemia have been observed
in paediatric patients treated with rituximab, in some cases severe and requiring long-term
immunoglobulin substitution therapy. The consequences of long term B-cell depletion in paediatric
patients are unknown.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-04T16:41:00Z · SHA-256 4fe21e50fef50537643123868d3f044762b7d55eab7d50a56c1d469305291ee4 · Passage 79d09be5f7585cd0eeff42d1d2221bfd02eb6087ae62ccae808cb87d40b65f81 · Zeichen 23040–23347 im Abschnitt
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.