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 · Nubeqa
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HOS-142100 · Präparat HOS-098752
7
f
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence is based on
values reported as laboratory abnormalities.
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
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Nebenwirkungen · Nubeqa
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HOS-142101 · Präparat HOS-098752
Table 2: Adverse reactions reported in mHSPC patients treated with darolutamide in
combination with docetaxel in the ARASENS studya, b
System organ class Very common Common
(MedDRA)
Vascular disorders Hypertensionc
Skin and subcutaneous tissue disorders Rashd, e
Musculoskeletal and connective tissue Fractures
disorders
Reproductive system and breast Gynaecomastia
disorders
Investigationsf Neutrophil count decreased
Blood bilirubin increased
ALT increased
AST increased
a
The median duration of exposure was 41.0 months (range: 0.1 to 56.5 months) in patients treated with
darolutamide+docetaxel and 16.7 months (range: 0.3 to 55.8 months) in patients treated with
placebo+docetaxel.
b
Adverse reactions incidences may not be attributable to darolutamide alone but may contain contributions
from other medicinal products used in combination.
c
Includes hypertension, blood pressure increased, hypertensive emergency.
d
Includes rash, drug eruption, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash
papular, rash pruritic, rash pustular, rash vesicular, erythema, dermatitis.
e
The incidence was highest during the first 6 months of treatment.
f
Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The incidence is based on
values reported as laboratory abnormalities.
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
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Nebenwirkungen · Nubeqa
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HOS-142102 · Präparat HOS-098752
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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 4913–4954 im Abschnitt
Nebenwirkungen · Nubeqa
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HOS-142103 · Präparat HOS-098752
Liver function tests
Cases of idiosyncratic druginduced liver injury with grade 3 and 4 increases in alanine
aminotransferase (ALT) and/or aspartate aminotransferase (AST) to ≥ 5 and ≥ 20 x upper limit of
normal (ULN) have been reported with darolutamide treatment including increased transaminases
along with a simultaneous increase in total bilirubin to ≥ 2 x ULN. Time to onset ranged from 1 month
to 12 months after initiation of darolutamide. In many cases the ALT and AST elevations were
reversible upon darolutamide discontinuation. For specific recommendations, 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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage 97b71425d24a0e6630777cb6327cc795fa61ea3a0ba8063d4ffdd2f3d82fb733 · Zeichen 4956–5542 im Abschnitt
Nebenwirkungen · Nubeqa
NUBEQA 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-142104 · Präparat HOS-098752
non-metastatic castration resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive
prostate cancer (mHSPC) - treatment with darolutamide
Fatigue
Fatigue/asthenic conditions were reported in 13.7% of patients treated with darolutamide and in 11.7%
of patients treated with placebo. Events with worst grade of 3 were reported in 0.4% of patients treated
with darolutamide and in 0.9% of patients treated with placebo. Fatigue (not including asthenia,
lethargy or malaise) occurred in the majority of patients (10.0% of patients treated with darolutamide
and 8.5% of patients treated with 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
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Nebenwirkungen · Nubeqa
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HOS-142105 · Präparat HOS-098752
Fractures
Fractures occurred in 4.1% of patients treated with darolutamide and in 3.2% of patients treated with
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
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Nebenwirkungen · Nubeqa
NUBEQA 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-142106 · Präparat HOS-098752
Ischaemic heart disease and heart failure
Ischaemic heart disease occurred in 3.4% of patients treated with darolutamide and in 2.2% of patients
treated with placebo. Grade 5 events occurred in 0.4% of patients treated with darolutamide and 0.4%
of patients treated with placebo. Heart failure occurred in 1.6% of patients treated with darolutamide
and in 0.9% of patients treated with 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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage db0ab52fa5585b57250ebf85f37f924fe879aceb590f33a6fcff757343f54973 · Zeichen 6274–6668 im Abschnitt
Nebenwirkungen · Nubeqa
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HOS-142107 · Präparat HOS-098752
8
Neutrophil count decreased
Neutrophil count decreased was reported as a laboratory abnormality in 17.3% of patients treated with
darolutamide and in 7.4% of patients treated with placebo. The median time to nadir was 225 days.
The laboratory tests abnormalities manifested predominantly as grade 1 or 2 intensity. Neutrophil
count decreased of grade 3 and 4 was reported in 2.6% and 0.3% of patients, respectively. Only one
patient permanently discontinued darolutamide due to neutropenia. Neutropenia was either transient or
reversible (83% of patients) and were not associated with any clinically relevant signs or symptoms.
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
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Nebenwirkungen · Nubeqa
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HOS-142108 · Präparat HOS-098752
Blood bilirubin increased
Bilirubin increased was reported as a laboratory abnormality in 16.1% of patients treated with
darolutamide and in 6.1% of patients treated with placebo. The episodes were predominantly of
grade 1 or 2 intensity, not associated with any clinically relevant signs or symptoms, and reversible
after darolutamide was discontinued. Bilirubin increased of grade 3 and 4 was reported in 0.2% of
patients treated with darolutamide and in 0% of patients treated with placebo. In the darolutamide arm,
the mean time to first onset of increased bilirubin was 187 days, and the mean duration of the first
episode was 172 days. One patient was discontinued from treatment due to increase in bilirubin.
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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage 9c6d64ec99c81b8e34853e7c7c7d51a30a9eb93d404c16b83ed750467bc3c080 · Zeichen 7356–8071 im Abschnitt
Nebenwirkungen · Nubeqa
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HOS-142109 · Präparat HOS-098752
ALT and AST increased
ALT increased was reported as a laboratory abnormality in 13.3% of patients treated with
darolutamide and in 9.7% of patients treated with placebo. AST increased was reported as a laboratory
abnormality in 22.0% of patients treated with darolutamide and in 13.4% of patients treated with
placebo. The episodes were predominantly of grade 1 or 2 intensity, not associated with any clinically
relevant signs or symptoms, and reversible after darolutamide was discontinued. ALT increased of
grade 3 and 4 was reported in 0.9% of patients treated with darolutamide and in 0.3% of patients
treated with placebo. AST increased of grade 3 and 4 was reported in 1.2% of patients treated with
darolutamide and in 0.3% of patients treated with placebo. In the darolutamide arm, the mean time to
first onset of increased ALT was 253 days and for increased AST 257 days. The mean duration of the
first episode was 122 days for ALT increase and 121 days for AST increase. Two and 3 patients were
discontinued from treatment due to increase in ALT and AST, respectively.
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
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Nebenwirkungen · Nubeqa
NUBEQA 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-142110 · Präparat HOS-098752
metastatic hormone-sensitive prostate cancer (mHSPC) - treatment with darolutamide in combination
with docetaxel
Hypertension
In the ARASENS study hypertension was reported in 13.8% of patients treated with
darolutamide+docetaxel and 9.4% of patients treated with placebo+docetaxel.
Grade 3 hypertension was reported in 6.4% of patients treated with darolutamide+docetaxel compared
to 3.5% of patients treated with placebo+docetaxel. One patient had grade 4 hypertension in each
treatment arm.
One case was reported as grade 5 hypertension with grade 5 arteriosclerosis in the
darolutamide+docetaxel arm. This patient had a long-standing history of hypertension and smoking
and the case occurred more than 3 years after starting darolutamide treatment. Events of hypertension
were reported more commonly in patients with no medical history of hypertension in both treatment
arms.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Nubeqa
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HOS-142111 · Präparat HOS-098752
Fractures
Fractures occurred in 7.5% of patients treated with darolutamide+docetaxel and in 5.1% of patients
treated with placebo+docetaxel.
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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage 3d4f704b5edfe52df049cc2575cec8f71969fa76c9470d49e94eb6a17f8e1a57 · Zeichen 10034–10174 im Abschnitt
Nebenwirkungen · Nubeqa
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HOS-142112 · Präparat HOS-098752
Neutrophil count decreased
Neutrophil count decreased was reported as a laboratory abnormality in 50.6% of patients treated with
darolutamide+docetaxel and in 45.5% of patients treated with placebo+docetaxel. Grade 3 and 4
neutrophil count decreased was reported in 34.4% of patients treated with darolutamide+docetaxel and
in 31.4% of patients treated with placebo+docetaxel. In both treatment arms, the incidences of
neutrophil count decreased and neutropenia were highest during the first months of treatment, after
which the incidence and severity of the events decreased.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Nubeqa
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HOS-142113 · Präparat HOS-098752
9
Blood bilirubin increased
Bilirubin increased was reported as a laboratory abnormality in 19.6% of patients treated with
darolutamide+docetaxel and in 10.0% of patients treated with placebo+docetaxel. The events were
predominantly of grade 1 or 2 intensity. Grade 3 and 4 bilirubin increased was reported in 0.5% of
patients treated with darolutamide+docetaxel and in 0.3% of patients treated with placebo+docetaxel.
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 2025-08-21T11:00:00Z · SHA-256 da13d7ad15d93e78a0008f5eb25e09dc0942552321540cdc62987578c964dccb · Passage 06ae20f827fc06927920fac2bb479b015a0c8bc0939c3d12f1d7caa0d982a9c4 · Zeichen 10806–11225 im Abschnitt
Nebenwirkungen · Nubeqa
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HOS-142114 · Präparat HOS-098752
ALT and AST increased
Alanine aminotransferase (ALT) increased was reported as a laboratory abnormality in 42.3% of
patients treated with darolutamide+docetaxel and in 38.0% of patients treated with placebo+docetaxel.
Aspartate aminotransferase (AST) increased was reported as a laboratory abnormality in 43.9% of
patients treated with darolutamide+docetaxel and in 39.3% of patients treated with placebo+docetaxel.
ALT and AST elevations were predominantly of grade 1 intensity. Grade 3 and 4 ALT increased was
reported in 3.7% of patients treated with darolutamide+docetaxel and in 3.0% of patients treated with
placebo+docetaxel. Grade 3 and 4 AST increased was reported in 3.6% of patients treated with
darolutamide+docetaxel and in 2.3% of patients treated with placebo+docetaxel.
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
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Nebenwirkungen · Nubeqa
NUBEQA 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-142115 · Präparat HOS-098752
Reporting of suspected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Nubeqa
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HOS-142116 · Präparat HOS-098752
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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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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.