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 · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 10
HOS-127108 · Präparat HOS-096369
Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
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Nebenwirkungen · Stivarga
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HOS-127109 · Präparat HOS-096369
Table 3: Adverse drug reactions (ADRs) reported in clinical trials and postmarketing in patients
treated with Stivarga
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Nebenwirkungen · Stivarga
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HOS-127110 · Präparat HOS-096369
System
Organ Class Very common Common Uncommon Rare Not known
(MedDRA)
Infections and Infection
infestations *
Neoplasms Keratoacan-
benign, thoma/
malignant and Squamous
unspecified cell
(including carcinoma of
cysts and the skin
polyps)
Blood and Thrombo- Leucopenia Thrombotic
lymphatic cytopenia microangiop
system Anaemia athy
disorders
Immune Hypersensiti-
system vity reaction
disorders
Endocrine Hypo-
disorders thyroidism
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Nebenwirkungen · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 10–11
HOS-127111 · Präparat HOS-096369
10
System
Organ Class Very common Common Uncommon Rare Not known
(MedDRA)
Metabolism Decreased Hypo-
and nutrition appetite and kalaemia
disorders food intake Hypophos-
phatemia
Hypo-
calcaemia
Hypo-
natraemia
Hypomag-
nesaemia
Hyperuri-
caemia
Dehy-
dration
Nervous Headache Posterior Hyperammon
system Tremor reversible aemic
disorders Peripheral encephalo- encephalopat
neuropathy pathy hy
syndrome
(PRES)
Cardiac Myocardial
disorders infarction
Myocardial
ischaemia
Vascular Haemorrhage* Hypertensive Aneurysms
disorders Hypertension crisis and artery
dissections
Respiratory, Dysphonia
thoracic and
mediastinal
disorders
Gastro- Diarrhoea Taste Gastro-
intestinal Stomatitis disorders intestinal
disorders Vomiting Dry mouth perforation*
Nausea Gastro- Gastro-
Constipation oesopha- intestinal
geal reflux fistula
Gastro- Pancreatitis
enteritis
Hepatobiliary Hyper- Severe liver
disorders bilirubinaemia injury
Increase in (including
transaminases hepatic
failure)*#
Skin and Hand-foot Alopecia Nail disorder Stevens-
subcutaneous skin Dry skin Erythema Johnson
tissue reaction** Exfoliative multiforme syndrome
disorders Rash rash Toxic
epidermal
necrolysis
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Stivarga
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HOS-127112 · Präparat HOS-096369
11
System
Organ Class Very common Common Uncommon Rare Not known
(MedDRA)
Musculo- Muscle
skeletal and spasms
connective
tissue
disorders
Renal and Proteinuria
urinary
disorders
General Asthenia/
disorders and fatigue
administration Pain***
site Fever
conditions Mucosal
inflammation
Investigations Weight loss Increase in
amylase
Increase in
lipase
Abnormal
Inter-
national
normalised
ratio
* fatal cases have been reported
** palmar-plantar erythrodysesthesia syndrome in MedDRA terminology
***Most frequently reported types of pain (≥10%) are abdominal pain and back pain
#
according to drug-induced liver injury (DILI) criteria of the international DILI expert working
group
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-03-24T12:26:00Z · SHA-256 188477d5802aa3c29bbcc6435c9e581d56ccf3178a537b51e23d7bce8cf4f8be · Passage a533e23fadd2ff11381a657602c3f746541d94bde1992d305bcf864859f3dc39 · Zeichen 6025–7238 im Abschnitt
Nebenwirkungen · Stivarga
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HOS-127113 · Präparat HOS-096369
Description of selected adverse reactions
In most cases of severe liver injury, liver dysfunction had an onset within the first 2 months of therapy,
and was characterized by a hepatocellular pattern of injury with transaminase elevations >20xULN,
followed by bilirubin increase. In clinical trials, a higher incidence of severe liver injury with fatal
outcome was observed in Japanese patients (~1.5%) treated with Stivarga, compared with non-
Japanese patients (<0.1%).
In the placebo-controlled phase III trials, the overall incidence of haemorrhage was 18.2% in patients
treated with Stivarga and 9.5% in patients receiving placebo. Most cases of bleeding events in patients
treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 15.2%), most notably
epistaxis (6.1%). Fatal outcome in patients treated with Stivarga was uncommon (0.7%), and included
cerebral, respiratory, gastrointestinal and genitourinary events.
In the placebo-controlled phase III trials, infections were more often observed in patients treated with
Stivarga, compared to patients receiving placebo (all grades: 31.6% vs. 17.2%). Most infections in
patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 23.0%), and included
urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections
(3.3%) as well as pneumonia (2.6%). Fatal outcomes associated with infection were observed more
often in patients treated with Stivarga (1.0%), compared to patients receiving placebo (0.3%), and
were mainly respiratory events.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Stivarga
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HOS-127114 · Präparat HOS-096369
In the placebo-controlled phase III trials, the overall incidence of hand-foot skin reaction was higher in
patients treated with Stivarga, compared to patients receiving placebo (all grades: 51.4% vs. 6.5%
CRC, 66.7% vs. 15.2% GIST and 51.6% vs.7.3% HCC). Most cases of hand-foot skin reaction in
patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in
severity (Grades 1 and 2: 34.3%%, CRC, 44.7%, GIST and 39.3%, HCC). The incidence of Grade 3
12
hand-foot skin reaction was 17.1% (CRC), 22.0% (GIST) and 12.3% (HCC). The overall incidence of
hand-foot skin reaction (74.8%, CRC, 88.2%, GIST and 67.1%, HCC) was higher in Stivarga-treated
Asian patients, compared to other ethnicities. The incidence of Grade 3 hand-foot skin reaction in
Asians was 20.5% (CRC), 23.5% (GIST) and 13.5% (HCC) (see sections 4.2 and 4.4).
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Nebenwirkungen · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 13
HOS-127115 · Präparat HOS-096369
In the placebo-controlled phase III trials, the overall incidence of hypertension was higher in patients
treated with Stivarga, compared to patients receiving placebo (29.6% vs. 7.5% CRC, 60.6% vs. 25.8%
GIST and 31.0% vs. 6.2% HCC). Most cases of hypertension in patients treated with Stivarga
appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2:
20.9%, CRC, 31.8%, GIST and 15.8% HCC). The incidence of Grade 3 hypertension was 8.7%
(CRC), 28.0% (GIST) and 15.2% (HCC). One case of Grade 4 hypertension was reported in the GIST
trial.
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Nebenwirkungen · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 13
HOS-127116 · Präparat HOS-096369
In the placebo-controlled phase III trials, the overall incidence of treatment emergent proteinuria was
9.1% in patients treated with Stivarga, compared to 1.9% in patients receiving placebo. Of these
events, 35.6% in the Stivarga arm and 54.5% in the placebo arm have been reported as not
recovered/not resolved.
Across all clinical trials, cardiac disorder events (all grades) have been more often (13.7% vs. 6.5%)
reported in Stivarga-treated patients aged 75 years or older (N=410), compared to Stivarga-treated
patients below 75 years (N=4108).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 13
HOS-127117 · Präparat HOS-096369
Laboratory test abnormalities
Treatment-emergent laboratory abnormalities observed in the placebo-controlled phase III trials are
shown in Table 4 and Table 4a (see also section 4.4).
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Version 2026-03-24T12:26:00Z · SHA-256 188477d5802aa3c29bbcc6435c9e581d56ccf3178a537b51e23d7bce8cf4f8be · Passage c3b9c67d6fb96631aa1135a35659eef152e1f1789fac64dcf0d9afddd8327ccc · Zeichen 10875–11058 im Abschnitt
Nebenwirkungen · Stivarga
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HOS-127118 · Präparat HOS-096369
13
Table 4: Treatment-emergent laboratory test abnormalities reported in placebo-controlled phase III trials in patients with metastatic CRC
(CORRECT), GIST (GRID) and HCC (RESORCE)
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Nebenwirkungen · Stivarga
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HOS-127119 · Präparat HOS-096369
mCRC (CORRECT) GIST (GRID) HCC (RESORCE)
Stivarga Placebo Stivarga Placebo Stivarga Placebo Stivarga Placebo Stivarga Placebo Stivarga Placebo
Laboratory plus plus plus BSC plus plus plus plus BSC plus plus BSC plus BSC plus plus
Parameter BSC BSC (n= 500) BSC BSC BSC (n=132) BSC (n= 374) (n=193) BSC BSC
(in % of samples (n= 500) (n=253) (n=253) (n= 132) (n= 66) (n= 66) (n= 374) (n=193)
investigated) Grade a Grade b Grade b
All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Blood and lymphatic
system disorders
Haemoglobin 78.5 66.3 5.3 2.8 75.0 72.7 3.0 1.5 72.5 71.3 6.0 4.8
decreased
Thrombocytopenia 40.5 16.8 2.8 0.4 12.9 1.5 0.8 1.5 63.1 50.0 5.4 0
Neutropenia 2.8 0 0.6 0 15.9 12.1 3.1 3.0 13.6 14.9 3.0 1.0
Lymphopenia 54.1 34.8 9.3 4.0 29.9 24.2 7.6 3.0 67.8 58.5 17.4 11.7
Metabolism and
nutrition disorders
Hypocalcaemia 59.3 18.3 1.2 1.2 16.7 4.5 1.5 0 23.4 10.1 0.3 0
Hypokalemia 25.7 8.3 4.3 0.4 20.5 3.0 3.0 0 30.7 9.0 4.3 2.1
Hypophosphatemia 57.4 11.1 31.1 3.6 54.5 3.1 21.2 1.5 70.4 31.4 33.9 6.9
Hepatobiliary
disorders
Hyperbilirubinemia 44.6 17.1 12.2 8.4 33.3 12.1 3.8 1.5 78.2 54.5 15.9 15.7
Increased AST 65.0 45.6 5.9 5.2 58.3 47.0 3.8 3.0 92.7 84.3 17.8 19.9
Increased ALT 45.2 29.8 5.5 3.2 39.4 39.4 4.6 1.5 70.4 58.6 6.2 4.7
Renal and urinary
disorders
Proteinuria 83.6 61.0 1.8 0.8 59.2 52.5 3.1 3.4 51.0 36.5 16.7 3.1
Investigations
Increased INR* 23.7 16.6 4.2 1.6 9.3 12.5 1.6 4.7 44.4 35.4 0.7 2.1
Increased Lipase 46.0 18.7 11.4 4.4 14.4 4.6 0.8 0 40.5 27.0 14.2 8.7
Increased Amylase 25.5 16.7 2.6 2.4 - - - - 23.0 19.0 2.8 2.7
a
Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
b
Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
* International normalized ratio
BSC = Best Supportive Care
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Nebenwirkungen · Stivarga
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HOS-127120 · Präparat HOS-096369
14
Compared to the global phase III CRC trial (CORRECT) with predominantly (~80%) Caucasian
patients enrolled, a higher incidence of liver enzyme increases was observed in Stivarga-treated
patients in the Asian phase III CRC trial (CONCUR) with predominantly (> 90%) East Asian patients
enrolled.
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Nebenwirkungen · Stivarga
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HOS-127121 · Präparat HOS-096369
Table 4a: Treatment emergent liver enzyme test abnormalities reported in placebo-controlled
phase III trial in Asian patients with metastatic CRC (CONCUR)
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Nebenwirkungen · Stivarga
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HOS-127122 · Präparat HOS-096369
Stivarga plus BSC§ Placebo plus BSC§
(N=136) (N=68)
Laboratory parameter,
(in % of samples
All Grade Grade All Grade Grade
investigated)
Grades* 3* 4* Grades* 3* 4*
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Nebenwirkungen · Stivarga
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HOS-127123 · Präparat HOS-096369
Bilirubin increased 66.7 7.4 4.4 32.8 4.5 0.0
AST increased 69.6 10.4 0.7 47.8 3.0 0.0
ALT increased 54.1 8.9 0.0 29.9 1.5 0.0
§
Best Supportive Care
* Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
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Nebenwirkungen · Stivarga
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HOS-127124 · Präparat HOS-096369
In the placebo-controlled phase III trials, tests on thyroid stimulating hormone (TSH) showed post
baseline >ULN in 34.6% of patients treated with Stivarga and in 17.2% of patients receiving placebo.
TSH post baseline >4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3%
of patients receiving placebo. Concentration of free triiodothyronine (FT3) post baseline below lower
limit of normal (<LLN) was reported in 29.2% of patients treated with Stivarga and in 20.4% of
patients receiving placebo. Concentration of free thyroxin (FT4) post baseline <LLN was reported in
8.1% of patients treated with Stivarga and 5.6% of patients receiving placebo. Overall approximately
4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement
treatment.
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Nebenwirkungen · Stivarga
Stivarga 40 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 15
HOS-127125 · Präparat HOS-096369
Reporting of suspected adverse reactions
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.
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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.