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 · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11
HOS-115675 · Präparat HOS-094337
Nervous system Dizziness Neuropathy Cerebral Posterior Hyperammonaemic
disorders Headache peripheral haemorrhage* reversible encephalopathy
Taste disturbancej Paraesthesia Cerebrovascular encephalopathy
Hypoaesthesia accident* syndrome*
Hyperaesthesia Transient ischaemic
attack
Eye disorders Periorbital oedema
Eyelid oedema
Lacrimation
increased
Cardiac disorders Myocardial Cardiac failure Left ventricular
ischemiak,* congestive failure*
Ejection fraction Myocardial Torsade de
decreasedl infarctionm,* pointes
Cardiac failure*
Cardiomyopathy*
Pericardial effusion
Electrocardiogram
QT prolonged
Vascular disorders Hypertension Deep vein thrombosis Tumour Aneurysms and
Hot flush haemorrhage* artery dissections*
Flushing
Respiratory, Dyspnoea Pulmonary Pulmonary
thoracic and Epistaxis embolism* haemorrhage*
*
mediastinal Cough Pleural effusion Respiratory failure*
disorders Haemoptysis
Dyspnoea exertional
Oropharyngeal painn
Nasal congestion
Nasal dryness
Gastrointestinal Stomatitiso Gastro-oesophageal Gastrointestinal
disorders Abdominal painp reflux disease perforationq,*
Vomiting Dysphagia Pancreatitis
Diarrhoea Gastrointestinal Anal fistula
Dyspepsia haemorrhage* Colitisr
Nausea Oesophagitis*
Constipation Abdominal distension
Abdominal
discomfort
Rectal haemorrhage
Gingival bleeding
Mouth ulceration
Proctalgia
Cheilitis
Haemorrhoids
Glossodynia
Oral pain
Dry mouth
Flatulence
Oral discomfort
Eructation
Hepatobiliary Hepatic failure* Hepatitis
disorders Cholecystitiss,*
Hepatic function
abnormal
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 027070c4c1bacd7d7913c8d065bc4b0e277cdbc62e16ed8b4df32f5a5ccb1c05 · Zeichen 3596–7592 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11–12
HOS-115676 · Präparat HOS-094337
11
System organ class Very common Common Uncommon Rare Not known
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 8c798c13f44ecf87003ceacbf6ffc2745934e16e8fc1c7622cb4131fd4ba794a · Zeichen 7656–7776 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12
HOS-115677 · Präparat HOS-094337
Skin and Skin discolourationt Skin exfoliation Erythema
subcutaneous Palmar-plantar Skin reactionv multiforme*
tissue disorders erythrodysaesthesia Eczema Stevens-Johnson
syndrome Blister syndrome*
u
Rash Erythema Pyoderma
Hair colour changes Alopecia gangrenosum
Dry skin Acne Toxic epidermal
Pruritus necrolysis*
Skin
hyperpigmentation
Skin lesion
Hyperkeratosis
Dermatitis
Nail disorderw
Musculoskeletal Pain in extremity Musculoskeletal pain Osteonecrosis of the Rhabdomyolysis
and connective *
Arthralgia Muscle spasms jaw
*
tissue disorders Back pain Myalgia Fistula Myopathy
Muscular weakness
Renal and urinary Renal failure* Haemorrhage Nephrotic
disorders Renal failure acute* urinary tract syndrome
Chromaturia
Proteinuria
General disorders Mucosal Chest pain Impaired healing
and administration inflammation Pain
site conditions Fatiguex Influenza like illness
Oedemay Chills
Pyrexia
Investigations Weight decreased Blood creatine
White blood cell phosphokinase
count decreased increased
Lipase increased Blood thyroid
Platelet count stimulating hormone
decreased increased
Haemoglobin
decreased
Amylase increasedz
Aspartate
aminotransferase
increased
Alanine
aminotransferase
increased
Blood creatinine
increased
Blood pressure
increased
Blood uric acid
increased
* Including fatal events.
The following terms have been combined:
a Nasopharyngitis and oral herpes.
b Bronchitis, lower respiratory tract infection, pneumonia, and respiratory tract infection.
c Abscess, abscess limb, anal abscess, gingival abscess, liver abscess, pancreatic abscess, perineal abscess, perirectal
abscess, rectal abscess, subcutaneous abscess, and tooth abscess.
d Oesophageal candidiasis and oral candidiasis.
e Cellulitis and skin infection.
f Sepsis and sepsis shock.
g Abdominal abscess, abdominal sepsis, diverticulitis, and osteomyelitis.
h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome.
i Decreased appetite and anorexia
j Dysgeusia, ageusia, and taste disturbance.
k Acute coronary syndrome, angina pectoris, angina unstable, coronary artery occlusion, and myocardial ischaemia.
l Ejection fraction decreased/abnormal.
m Acute myocardial infarction, myocardial infarction, and silent myocardial infarction.
n Oropharyngeal and pharyngolaryngeal pain.
o Stomatitis and aphtous stomatitis.
p Abdominal pain, abdominal pain lower, and abdominal pain upper.
q
Gastrointestinal perforation and intestinal perforation.
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 38f41b8b1133e957ed328d1feaa3e9e767dcbe8685068f1ff0fea0ee175fe453 · Zeichen 7778–12700 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 12–13
HOS-115678 · Präparat HOS-094337
12
System organ class Very common Common Uncommon Rare Not known
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 0ff0badb76260d0feda78d7d99429952e39c3e47d5f8a555a22ddd0509c32483 · Zeichen 12764–12882 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115679 · Präparat HOS-094337
r Colitis and colitis ischaemic.
s Cholecystitis and acalculous cholecystitis.
t Yellow skin, skin discolouration, and pigmentation disorder.
u Dermatitis psoriasiform, exfoliative rash, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash
maculo-papular, rash papular, and rash pruritic.
v Skin reaction and skin disorder.
w Nail disorder and discolouration.
x Fatigue and asthenia.
y Face oedema, oedema, and oedema peripheral.
z Amylase and amylase increased.
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 4efe1dfaa369e341a917b804fcb6a423e49f0771cd0ecfa4387a9a3f9d062d4b · Zeichen 12884–13394 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115680 · Präparat HOS-094337
Description of selected adverse reactions
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 13396–13437 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115681 · Präparat HOS-094337
Infections and infestations
Cases of serious infection (with or without neutropenia), including cases with fatal outcome, have
been reported. Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been
reported (see also section 4.4).
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage f7746e892485581eebda3df78af07aad1b1d2c4bb67e31e8a4a0ce0df05817b6 · Zeichen 13439–13699 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115682 · Präparat HOS-094337
Blood and lymphatic system disorders
Decreased absolute neutrophil counts of Grade 3 and 4 severities, respectively, were reported in 10%
and 1.7% of patients on the Phase 3 GIST study, in 16% and 1.6% of patients on the Phase 3 MRCC
study, and in 13% and 2.4% of patients on the Phase 3 pNET study. Decreased platelet counts of
Grade 3 and 4 severities, respectively, were reported in 3.7% and 0.4% of patients on the Phase 3
GIST study, in 8.2% and 1.1% of patients on the Phase 3 MRCC study, and in 3.7% and 1.2% of
patients on the Phase 3 pNET study (see section 4.4).
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 958bad9c04c26fd0db021bac9e7cc9a593120c4dc0f9a580eaa136a580c3698f · Zeichen 13701–14273 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115683 · Präparat HOS-094337
Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17%
of patients receiving placebo. In patients receiving sunitinib for treatment-naïve MRCC, 39% had
bleeding events vs 11% of patients receiving interferon- (IFN-α). Seventeen (4.5%) patients on
sunitinib versus 5 (1.7%) patients on IFN-α experienced Grade 3 or greater bleeding events. Of
patients receiving sunitinib for cytokine-refractory MRCC, 26% experienced bleeding. Bleeding
events, excluding epistaxis, were reported in 21.7% of patients receiving sunitinib in the Phase 3
pNET study compared to 9.85% of patients receiving placebo (see section 4.4)
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage b1fa91130fa872eabc9e567c5354efa7b338367911ccb3fe062db1adcefc00d0 · Zeichen 14275–14932 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115684 · Präparat HOS-094337
In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 00b82f3c1a734ff962fd3914b0591cc8d6489e839993ea92c24b818046706851 · Zeichen 14934–15028 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115685 · Präparat HOS-094337
Immune system disorders
Hypersensitivity reactions, including angioedema, have been reported (see section 4.4).
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage dd2e06f4beace0b601f008422de8d11f23e008102ef94645dcee8c7a02ccaeaf · Zeichen 15030–15141 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115686 · Präparat HOS-094337
Endocrine disorders
Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the
2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the
IFN- arm in the treatment-naïve MRCC study.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 024d45d3a903657d334b778ef7c3e4e86a889cbd42142fbe9b0129a3b65554af · Zeichen 15143–15407 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115687 · Präparat HOS-094337
Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory
MRCC patients (2%). Overall, 7% of the MRCC population had either clinical or laboratory evidence
of treatment-emergent hypothyroidism. Acquired hypothyroidism was noted in 6.2% of GIST patients
on sunitinib versus 1% on placebo. In the Phase 3 pNET study hypothyroidism was reported in
6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo.
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 7a45d3e766cf1e3e2bad2f2f73d5f3152a8a76a67327bd5906ccf99a13e6b76f · Zeichen 15409–15867 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-115688 · Präparat HOS-094337
Thyroid function was monitored prospectively in 2 studies in patients with breast cancer; Sutent is not
approved for use in breast cancer. In 1 study, hypothyroidism was reported in 15 (13.6%) patients on
sunitinib and 3 (2.9%) patients on standard of care. Blood TSH increase was reported in 1 (0.9%)
patient on sunitinib and no patients on standard of care. Hyperthyroidism was reported in no
sunitinib-treated patients and 1 (1.0%) patient receiving standard of care. In the other study
hypothyroidism was reported in a total of 31 (13%) patients on sunitinib and 2 (0.8%) patients on
capecitabine. Blood TSH increase was reported in 12 (5.0%) patients on sunitinib and no patients on
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage eabea48c8f4fe8ce22652704cf320f60e994c71c35ab7c14c1bc7e06ff81150f · Zeichen 15869–16556 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13–14
HOS-115689 · Präparat HOS-094337
13
capecitabine. Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on
capecitabine. Blood TSH decrease was reported in 3 (1.3%) patients on sunitinib and no patients on
capecitabine. T4 increase was reported in 2 (0.8%) patients on sunitinib and 1 (0.4%) patient on
capecitabine. T3 increase was reported in 1 (0.8%) patient on sunitinib and no patients on
capecitabine. All thyroid-related events reported were Grade 1-2 (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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 3065096d25eabe91372f16c1a92a08530bf3f1d53c1cb159006a1eeab2840e75 · Zeichen 16619–17089 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-115690 · Präparat HOS-094337
Metabolism and nutrition disorders
A higher incidence rate of hypoglycaemia events was reported in patients with pNET in comparison to
MRCC and GIST. Nevertheless, most of these adverse events observed in clinical studies were not
considered related to study treatment (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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 3308757caa9c162642a1f0937d2b523d699fda8d001cedbeecc54f355e29d56f · Zeichen 17091–17378 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-115691 · Präparat HOS-094337
Nervous system disorders
In clinical studies of sunitinib and from postmarketing surveillance, there have been few reports
(< 1%), some fatal, of subjects presenting with seizures and radiological evidence of RPLS. Seizures
have been observed in patients with or without radiological evidence of brain metastases (see section
4.4).
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 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage a4c5730b6654f410f77dfcd472dbeaf401e1074c5d1e1294de5285b4afcf0fc8 · Zeichen 17380–17711 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-115692 · Präparat HOS-094337
Cardiac disorders
In clinical trials, decreases in left ventricular ejection fraction (LVEF) of 20% and below the lower
limit of normal were reported in approximately 2% of sunitinib-treated GIST patients, 4% of
cytokine-refractory MRCC patients, and 2% of placebo-treated GIST patients. These LVEF declines
do not appear to have been progressive and often improved as treatment continued. In the
treatment-naïve MRCC study, 27% of patients on sunitinib and 15% of patients on IFN- had an
LVEF value below the lower limit of normal. Two patients (< 1%) who received sunitinib were
diagnosed with CHF.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 3d7685b668c0b2d9e2403ced7619ba255c61aad9924c0d9aeca4f286a6b19b67 · Zeichen 17713–18316 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-115693 · Präparat HOS-094337
In GIST patients ‘cardiac failure’, ‘cardiac failure congestive’, or ‘left ventricular failure’ were
reported in 1.2% of patients treated with sunitinib and 1% of patients treated with placebo. In the
pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of
patients on each arm of the study (i.e. sunitinib and placebo arms). In a Phase 2 study in
cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial
infarction and in the Phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN-
arm and 0% of patients on the sunitinib arm experienced fatal cardiac events. In the Phase 3 pNET
study, 1 (1%) patient who received sunitinib had treatment-related fatal cardiac failure.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage f7c87b5fc4e8d39ddf078bf27b094ac0a259776e413ebae179779533e35b22f0 · Zeichen 18318–19099 im Abschnitt
Nebenwirkungen · Sutent
Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules · Abschnitt 4.8 · PDF-Seite 14
HOS-115694 · Präparat HOS-094337
Vascular disorders
Hypertension
Hypertension was a very common adverse reaction reported in clinical trials. The dose of sunitinib
was reduced or its administration temporarily suspended in approximately 2.7% of the patients who
experienced hypertension. Sunitinib was not permanently discontinued in any of these patients. Severe
hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with
solid tumours. Hypertension was reported in approximately 33.9% of patients receiving sunitinib for
treatment-naïve MRCC compared to 3.6% of patients receiving IFN-. Severe hypertension was
reported in 12% of treatment-naïve patients on sunitinib and < 1% of patients on IFN-. Hypertension
was reported in 26.5% of patients receiving sunitinib in a Phase 3 pNET study, compared to 4.9% of
patients receiving placebo. Severe hypertension was reported in 10% of pNET patients on sunitinib
and 3% of patients on placebo.
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Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-03-10T16:28:00Z · SHA-256 d4826c56622b44e469b640c130fb21e1e289d4b954183f420d9e8d3bf8379fe6 · Passage 3b206ec68226fae6fcff1e54ea4b19bb66462f9cd5d791567e1f7470a9a34436 · Zeichen 19101–20046 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.