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.
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Categories have been assigned based on absolute frequencies in the pooled clinical studies data.
Within each system organ class, adverse reactions with the same frequency are presented in order of
decreasing seriousness.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Table 1. Adverse reactions reported in RCC studies in patients who received axitinib (N = 672)
All
System organ Frequency Grade 3b Grade 4b
Adverse reactionsa Gradesb
class category % %
%
Blood and Common Anaemia 6.3 1.2 0.4
lymphatic system Thrombocytopenia 1.6 0.1 0
disorders Polycythaemiac 1.5 0.1 0
Uncommon Neutropaenia 0.3 0.1 0
Leukopaenia 0.4 0 0
Endocrine disorders Very common Hypothyroidismc 24.6 0.3 0
Common Hyperthyroidismc 1.6 0.1 0.1
Metabolism and Very common Decreased appetite 39.0 3.6 0.3
nutrition disorders Common Dehydration 6.7 3.1 0.3
Hyperkalaemia 2.7 1.2 0.1
Hypercalcaemia 2.2 0.1 0.3
Nervous system Very common Headache 16.2 0.7 0
disorders
Dysgeusia 11.5 0 0
Common Dizziness 9.1 0.6 0
Uncommon Posterior reversible 0.3 0.1 0
encephalopathy
syndromee
Ear and labyrinth Common Tinnitus 3.1 0 0
disorders
Cardiac disorders Common Cardiac failure 1.8 0.3 0.7
eventsc,d,f
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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All
System organ Frequency a Grade 3b Grade 4b
Adverse reactions Gradesb
class category % %
%
Vascular disorders Very common Hypertensiong 51.2 22.0 1.0
Haemorrhagec,d,h 25.7 3.0 1.0
Common Venous embolic and 2.8 0.9 1.2
thrombotic eventsc,d,i
Arterial embolic and 2.8 1.2 1.3
thrombotic eventsc,d,j
Not known Aneurysms and artery - - -
dissectionsd
Respiratory, Very common Dyspnoead 17.1 3.6 0.6
thoracic and Cough 20.4 0.6 0
mediastinal Dysphonia 32.7 0 0.1
disorders Common Oropharyngeal pain 7.4 0 0
Gastrointestinal Very common Diarrhoea 55.4 10.1 0.1
disorders Vomiting 23.7 2.7 0.1
Nausea 33.0 2.2 0.1
Abdominal pain 14.7 2.5 0.3
Constipation 20.2 1.0 0
Stomatitis 15.5 1.8 0
Dyspepsia 11.2 0.1 0
Common Upper abdominal pain 9.4 0.9 0
Flatulence 4.5 0 0
Haemorrhoids 3.3 0 0
Glossodynia 2.8 0 0
Gastrointestinal 1.9 0.9 0.3
perforation and
fistulac,k
Hepatobiliary Common Hyperbilirubinaemia 1.3 0.1 0.1
disorders Cholecystitisn 1.0 0.6 0.1
Skin and Very common Palmar-plantar 32.1 7.6 0
subcutaneous tissue erythrodysaesthesia
disorders (hand-foot syndrome)
Rash 14.3 0.1 0
Dry skin 10.1 0.1 0
Common Pruritus 6.0 0 0
Erythema 3.7 0 0
Alopecia 5.7 0 0
Musculoskeletal Very common Arthralgia 17.7 1.9 0.3
and connective Pain in extremity 14.1 1.0 0.3
tissue disorders Common Myalgia 8.2 0.6 0.1
Renal and urinary Very common Proteinurial 21.1 4.8 0.1
disorders Common Renal failurem 1.6 0.9 0.1
General disorders Very common Fatigue 45.1 10.6 0.3
and administration Asthaeniad 13.8 2.8 0.3
site conditions Mucosal inflammation 13.7 1.0 0
Investigations Very common Weight decreased 32.7 4.9 0
Common Lipase increased 3.7 0.7 0.7
Alanine 6.5 1.2 0
aminotransferase
increased
Amylase increased 3.4 0.6 0.4
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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All
System organ Frequency a Grade 3b Grade 4b
Adverse reactions Gradesb
class category % %
%
Aspartate 6.1 1.0 0
aminotransferase
increased
Alkaline phosphatase 4.8 0.3 0
increased
Creatinine increased 5.7 0.4 0
Thyroid stimulating 7.9 0 0
hormone increased
a
Adverse reactions are according to treatment-emergent, all causality frequency.
b
National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0
c
See Description of selected adverse reactions section.
d
Fatal (Grade 5) cases were reported.
e
Including Leukoencephalopathy.
f
Including cardiac failure, cardiac failure congestive, cardiopulmonary failure, ejection fraction decreased, left
ventricular dysfunction and right ventricular failure.
g
Including accelerated hypertension, blood pressure increased, hypertension and hypertensive crisis.
h
Including activated partial thromboplastin time prolonged, anal haemorrhage, arterial haemorrhage, blood
urine present, central nervous system haemorrhage, cerebral haemorrhage, coagulation time prolonged,
conjunctival haemorrhage, contusion, diarrhea haemorrhagic, dysfunctional uterine bleeding, epistaxis, gastric
haemorrhage, gastrointestinal haemorrhage, gingival bleeding, haematemesis, haematochezia, haematocrit
decreased, haematoma, haematuria, haemoglobin decreased, haemoptysis, haemorrhage, haemorrhage
coronary artery, haemorrhage urinary tract, haemorrhoidal haemorrhage, haemostasis, increased tendency to
bruise, international normalized ratio increased, lower gastrointestinal haemorrhage, melaena, petechiae,
pharyngeal haemorrhage, prothrombin time prolonged, pulmonary haemorrhage, purpura, rectal haemorrhage,
red blood cell count decreased, renal haemorrhage, scleral haemorrhage, scrotal haematocoele, splenic
haemotoma, splinter haemorrhage, subarachnoid haemorrhage, tongue haemorrhage, upper gastrointestinal
haemorrhage and vaginal haemorrhage.
i
Including Budd-Chiari syndrome, deep vein thrombosis, jugular vein thrombosis, pelvic venous thrombosis,
pulmonary embolism, retinal vein occlusion, retinal vein thrombosis, subclavian vein thrombosis, venous
thrombosis, and venous thrombosis limb.
j
Including acute myocardial infarction, embolism, myocardial infarction, retinal artery occlusion and transient
ischaemic attack.
k
Gastrointestinal perforation and fistula includes the following preferred terms: abdominal abscess, anal
abscess, anal fistula, fistula, gastrointestinal anastomotic leak, gastrointestinal perforation, large intestine
perforation, oesophagobronchial fistula and peritonitis.
l
Proteinuria includes the following preferred terms: protein urine, protein urine present and proteinuria.
m
Including acute renal failure
n
Cholecystitis includes Cholecystitis acute, Cholecystitis, Cholecystitis infective.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Description of selected adverse reactions
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Cardiac failure events (see section 4.4)
In a controlled clinical study with axitinib (N = 359) for the treatment of patients with RCC, cardiac
failure events were reported in 1.7 % patients receiving axitinib, including cardiac failure (0.6%),
cardiopulmonary failure (0.6%), left ventricular dysfunction (0.3%), and right ventricular failure
(0.3%). Grade 4 cardiac failure adverse reactions were reported in 0.6 % of patients receiving axitinib.
Fatal cardiac failure was reported in 0.6 % of patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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In monotherapy studies with axitinib (N = 672) for the treatment of patients with RCC, cardiac failure
events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular
dysfunction, ejection fraction decreased, and right ventricular failure) were reported in 1.8% patients
receiving axitinib. Grade 3/4 cardiac failure events were reported in 1.0% patients and fatal cardiac
failure events were reported in 0.3% patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Thyroid dysfunction (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was
reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients. Thyroid
stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients
receiving axitinib. During routine laboratory assessments, in patients who had TSH < 5 μU/mL before
treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC,
hypothyroidism was reported in 24.6% of patients receiving axitinib. Hyperthyroidism was reported in
1.6% of patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Venous embolic and thrombotic events (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and
thrombotic adverse reactions were reported in 3.9% of patients receiving axitinib, including
pulmonary embolism (2.2%), retinal vein occlusion/thrombosis (0.6%) and deep vein
thrombosis (0.6%). Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1%
of patients receiving axitinib. Fatal pulmonary embolism was reported in one patient (0.3%) receiving
axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, venous
embolic and thrombotic events were reported in 2.8% of patients receiving axitinib. Grade 3 venous
embolic and thrombotic events were reported in 0.9% of patients. Grade 4 venous embolic and
thrombotic events were reported in 1.2% of patients. Fatal venous embolic and thrombotic events were
reported 0.1% patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Arterial embolic and thrombotic events (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and
thrombotic adverse reactions were reported in 4.7% of patients receiving axitinib, including
myocardial infarction (1.4%), transient ischemic attack (0.8%) and cerebrovascular accident (0.6%).
Grade 3/4 arterial embolic and thrombotic adverse reactions were reported in 3.3% of patients
receiving axitinib. A fatal acute myocardial infarction and cerebrovascular accident was reported in
one patient each (0.3%). In monotherapy studies with axitinib (N = 850), arterial embolic and
thrombotic adverse reactions (including transient ischemic attack, myocardial infarction, and
cerebrovascular accident) were reported in 5.3% of patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, arterial
embolic and thrombotic events were reported in 2.8% of patients receiving axitinib. Grade 3 arterial
embolic and thrombotic events were reported in 1.2% of patients. Grade 4 arterial embolic and
thrombotic events were reported in 1.3% of patients. Fatal arterial embolic and thrombotic events were
reported in 0.3% patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Polycythaemia (see Elevation of haemoglobin or haematocrit in section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was
reported in 1.4% of patients receiving axitinib. Routine laboratory assessments detected elevated
haemoglobin above ULN in 9.7% of patients receiving axitinib. In four clinical studies with axitinib
for the treatment of patients with RCC (N = 537), elevated haemoglobin above ULN was observed in
13.6% receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC,
polycythaemia was reported in 1.5% of patients receiving axitinib.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Haemorrhage (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC that excluded
patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in 21.4% of
patients receiving axitinib. The haemorrhagic adverse reactions in patients treated with axitinib
included epistaxis (7.8%), haematuria (3.6%), haemoptysis (2.5%), rectal haemorrhage (2.2%),
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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gingival bleeding (1.1%), gastric haemorrhage (0.6%), cerebral haemorrhage (0.3%) and lower
gastrointestinal haemorrhage (0.3%). Grade > 3 haemorrhagic adverse reactions were reported in 3.1%
of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower
gastrointestinal haemorrhage and haemoptysis). Fatal haemorrhage was reported in one patient (0.3%)
receiving axitinib (gastric haemorrhage). In monotherapy studies with axitinib (N = 850), haemoptysis
was reported in 3.9% of patients; Grade > 3 haemoptysis was reported in 0.5% of patients.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-01-22T16:24:00Z · SHA-256 cc612ad4d90bdaa4ab6d3ad8d8feba6a08fdb9fc507a44800c7d74bb2da0dd43 · Passage 7be2849d20f9127b048715acbb88f23b16d55064815cba723eeeecb407c3fdb0 · Zeichen 17741–18319 im Abschnitt
Nebenwirkungen · Inlyta
Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-125808 · Präparat HOS-096155
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, haemorrhagic
events were reported in 25.7% of patients receiving axitinib. Grade 3 haemorrhagic adverse reactions
were reported in 3% of patients. Grade 4 haemorrhagic adverse reactions were reported in 1% of
patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
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 2025-01-22T16:24:00Z · SHA-256 cc612ad4d90bdaa4ab6d3ad8d8feba6a08fdb9fc507a44800c7d74bb2da0dd43 · Passage 47c45c11bc421ccb08518efd3cb698d1e2382a0ae4d2a70de5f2906ceb308223 · Zeichen 18321–18705 im Abschnitt
Nebenwirkungen · Inlyta
Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-125809 · Präparat HOS-096155
Gastrointestinal perforation and fistula formation (see section 4.4)
In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal
perforation-type events were reported in 1.7% of patients receiving axitinib, including anal
fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with
axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal
gastrointestinal perforation was reported in one patient (0.1%).
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 2025-01-22T16:24:00Z · SHA-256 cc612ad4d90bdaa4ab6d3ad8d8feba6a08fdb9fc507a44800c7d74bb2da0dd43 · Passage 11a23e6cd27079ab303a65b292e4e89000c880b36e4f00c8dd9f0457b46e197b · Zeichen 18707–19239 im Abschnitt
Nebenwirkungen · Inlyta
Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-125810 · Präparat HOS-096155
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC,
gastrointestinal perforation and fistula were reported in 1.9% of patients receiving axitinib.
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 2025-01-22T16:24:00Z · SHA-256 cc612ad4d90bdaa4ab6d3ad8d8feba6a08fdb9fc507a44800c7d74bb2da0dd43 · Passage 2af377ce6edfc7c04ca55193265c2d68ea979f706117471d11e608d5e439e49d · Zeichen 19241–19426 im Abschnitt
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