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 · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12–13
HOS-130525 · Präparat HOS-096931
12
Table 1 Tabulated list of adverse reactions
Adverse reactions
MedDRA Frequency of All CTCAE grades Frequency of CTCAE grade 3
System Organ and above
Class
Neoplasms Uncommon Uncommon
benign, Myelodysplastic syndrome/ Acute myeloid Myelodysplastic syndrome/
malignant and leukaemiaa Acute myeloid leukaemia
unspecified
(including cysts
and polyps)
Blood and Very common Very common
lymphatic Anaemiaa, Neutropeniaa, Leukopeniaa Anaemiaa
system Common Common
disordersb Lymphopeniaa, Thrombocytopeniaa Neutropeniaa,
Thrombocytopeniaa,
Leukopeniaa, Lymphopeniaa
Immune system Uncommon Rare
disorders Hypersensitivitya Hypersensitivitya
Rare
Angioedema*
Hepatobiliary Common
disorders Transaminases increaseda
Not known
Drug-induced liver injury*
Metabolism and Very common Uncommon
nutrition Decreased appetite Decreased appetite
disorders
Nervous system Very common Uncommon
disorders Dizziness, Headache, Dysgeusiaa Dizziness, Headache
Respiratory, Very common Common
thoracic and Cougha, Dyspnoeaa Dyspnoeaa
mediastinal Uncommon Uncommon
disorders
Pneumonitisa Cougha, Pneumonitisa
Gastrointestinal Very common Common
disorders Vomiting, Diarrhoea, Nausea, Dyspepsia Vomiting, Nausea
Common Uncommon
Stomatitisa, Upper abdominal pain Stomatitisa, Diarrhoea
Rare
Dyspepsia, Upper abdominal
pain
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 1a2d47a767b203132dd888f53affc9bf19a811c2efe5935e391e4d82b0f43a1d · Zeichen 4354–7019 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14
HOS-130526 · Präparat HOS-096931
13
Adverse reactions
MedDRA Frequency of All CTCAE grades Frequency of CTCAE grade 3
System Organ and above
Class
Skin and Common Uncommon
subcutaneous Rasha Rasha
tissue disorders Uncommon Rare
Dermatitisa Dermatitisa
Rare
Erythema nodosum
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage afebf497f139e378d36a49fcc742fe4c7cefb3c43a37710f31a70f0bb54c83ca · Zeichen 7076–7749 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14
HOS-130527 · Präparat HOS-096931
General Very common Common
disorders and Fatigue (including asthenia) Fatigue (including asthenia)
administration
site conditions
Investigationsb Common Rare
Blood creatinine increased Blood creatinine increased
Uncommon
Mean cell volume increased
Vascular Common Common
disorders Venous thromboembolisma Venous thromboembolisma
a MDS/AML includes preferred terms (PTs) of acute myeloid leukaemia, myelodysplastic syndrome and
myeloid leukaemia.
Anaemia includes PTs of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased,
haemoglobin decreased, normocytic anaemia and red blood cell count decreased.
Neutropenia includes PTs of febrile neutropenia, neutropenia, neutropenic infection, neutropenic sepsis
and neutrophil count decreased.
Thrombocytopenia includes PTs of platelet count decreased and thrombocytopenia.
Leukopenia includes PTs of leukopenia and white blood cell count decreased.
Lymphopenia includes PTs of lymphocyte count decreased and lymphopenia.
Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity.
Transaminases increased includes PTs of alanine aminotransferase increased, aspartate aminotransferase
increased, hepatic enzyme increased, and hypertransaminasaemia
Dysgeusia includes PTs of dysgeusia and taste disorder.
Cough includes PTs of cough and productive cough.
Dyspnoea includes PTs of dyspnoea and dyspnoea exertional.
Pneumonitis includes PTs of pneumonitis, interstitial lung disease, acute interstitial pneumonitis,
eosinophilic pneumonia, eosinophilic pneumonia acute and hypersensitivity pneumonitis.
Stomatitis includes PTs of aphthous ulcer, mouth ulceration and stomatitis.
Rash includes PTs of erythema, exfoliative rash, rash, rash erythematous, rash macular, rash
maculopapular, rash papular and rash pruritic.
Dermatitis includes PTs of dermatitis and dermatitis allergic.
Venous thromboembolism includes PTs of embolism, pulmonary embolism, thrombosis, deep vein
thrombosis, vena cava thrombosis and venous thrombosis.
b Registered laboratory data are presented below under Haematological toxicity and Other laboratory
findings.
* As observed in the post-marketing setting.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 83a2213e414562ef475c362750749aa0322ececb3d8c46f0e437e4073074a942 · Zeichen 7755–10471 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15
HOS-130528 · Präparat HOS-096931
For patients receiving Lynparza in combination with durvalumab following treatment with
durvalumab in combination with platinum-based chemotherapy, most adverse reactions occurred at the
14
same or lower frequency (all grades and CTCAE Grade ≥ 3 AEs) as those shown in the tabulated list
of adverse reactions for Lynparza monotherapy above. Adverse reactions reported at a higher
frequency in patients receiving Lynparza in combination with durvalumab were thrombocytopenia and
rash (Very Common) and hypersensitivity (Common). The following additional adverse reaction was
also identified:
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage fc6e99524397c9d0742dc74986404a6d072c2893a1f5ed1060f20091f9481e51 · Zeichen 10473–11120 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130529 · Präparat HOS-096931
Table 2 Additional adverse drug reaction reported in a clinical trial with Lynparza in
combination with durvalumab
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 97268fafff2b53341d18ff2c1cd1f05ece24f9ffaf9dd4d01b86402e7ba61f01 · Zeichen 11122–11262 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130530 · Präparat HOS-096931
MedDRA SOC MedDRA Term CIOMS descriptor/ Frequency of CTCAE
Overall Frequency grade 3 and above
(All CTCAE grades)
Blood and Pure red cell aplasia Common Common
lymphatic system
disorders
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 1a9ae77985e87511037d037198ad282a0764c5387dd325e17ba7f681b1995870 · Zeichen 11265–11632 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130531 · Präparat HOS-096931
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 11634–11675 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130532 · Präparat HOS-096931
Haematological toxicity
Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or 2),
however, there were reports of CTCAE grade 3 and higher events. Anaemia was the most common
CTCAE grade ≥3 adverse reaction reported in clinical studies. Median time to first onset of anaemia
was approximately 4 weeks (approximately 7 weeks for CTCAE grade ≥3 events). Anaemia was
managed with dose interruptions and dose reductions (see section 4.2), and where appropriate with
blood transfusions. In clinical studies with the tablet formulation, the incidence of anaemia adverse
reactions was 35.2% (CTCAE grade ≥3 14.8%) and the incidences of dose interruptions, reductions
and discontinuations for anaemia were 16.4%, 11.1% and 2.1%, respectively; 15.6% of patients
treated with olaparib needed one or more blood transfusions. An exposure-response relationship
between olaparib and decreases in haemoglobin has been demonstrated. In clinical studies with
Lynparza the incidence of CTCAE grade ≥ 2 shifts (decreases) from baseline in haemoglobin was
21%, absolute neutrophils 17%, platelets 5%, lymphocytes 26% and leucocytes 19% (all %
approximate).
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage ceef05e2ad4e483a535f2bc19a4b447d6a815a987d87fc590ff39f7a1814f657 · Zeichen 11677–12845 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130533 · Präparat HOS-096931
The incidence of elevations in mean corpuscular volume from low or normal at baseline to above the
ULN was approximately 51%. Levels appeared to return to normal after treatment discontinuation and
did not appear to have any clinical consequences.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 2f399112510721a966a494bb745ff968489e9cc2afbda456c03b344fcc2607dc · Zeichen 12847–13094 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-130534 · Präparat HOS-096931
Baseline testing, followed by monthly monitoring of complete blood counts is recommended for the
first 12 months of treatment and periodically after this time to monitor for clinically significant
changes in any parameter during treatment which may require dose interruption or reduction and/or
further treatment (see sections 4.2 and 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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 68a50a676aac70c42d7ffe56d2f108cade1fe45cf3ee946c2d13525addd4f046 · Zeichen 13096–13436 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16
HOS-130535 · Präparat HOS-096931
15
Myelodysplastic syndrome/Acute myeloid leukaemia
MDS/AML are serious adverse reactions that occurred uncommonly in monotherapy clinical studies at
the therapeutic dose, across all indications (0.9%). The incidence was 0.5% including events reported
during the long term safety follow up (rate calculated based on overall safety population of 18576
patients exposed to at least one dose of oral olaparib in clinical studies). All patients had potential
contributing factors for the development of MDS/AML, having received previous chemotherapy with
platinum agents. Many had also received other DNA damaging agents and radiotherapy. The majority
of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers. The
incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.6% and 1.2%,
respectively). Some of the patients had a history of previous cancer or of bone marrow dysplasia.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage bc2a7d905c4db81094830bc596713bc0c50b09b2a6fd3ebeebc9d29a3c3a9b66 · Zeichen 13491–14430 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130536 · Präparat HOS-096931
In patients with BRCAm platinum-sensitive relapsed ovarian cancer who had received at least two
prior lines of platinum chemotherapy and received study treatment until disease progression (SOLO2
study, with olaparib treatment ≥2 years in 45% of patients), the incidence of MDS/AML was 8% in
patients receiving olaparib and 4% in patients receiving placebo at a follow-up of 5 years. In the
olaparib arm, 9 out of 16 MDS/AML cases occurred after discontinuation of olaparib during the
survival follow-up. The incidence of MDS/AML was observed in the context of extended overall
survival in the olaparib arm and late onset of MDS/AML. The risk of MDS/AML remains low in the
first-line setting when olaparib maintenance treatment is given after one line of platinum
chemotherapy for a duration of 2 years (1.5%) in SOLO1 study at 7 year follow up and 1.1% in
PAOLA-1 study at 5 year follow up. For risk mitigation and management (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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage e74924e86c41ce7dd1650a9421b793f43a257c99866ff5fdc1fa97dbaa3d2e28 · Zeichen 14432–15376 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130537 · Präparat HOS-096931
Pure Red Cell Aplasia
Pure Red Cell Aplasia (PRCA) has been reported when Lynparza has been used in combination with
durvalumab. In a clinical study of patients with endometrial cancer treated with Lynparza in
combination with durvalumab, the incidence of PRCA was 1.6%. All events were CTCAE Grade 3 or
4. Events were manageable following discontinuation of both Lynparza and durvalumab. The majority
of events were managed with blood transfusion and immunosuppression and recovered; there were no
fatal events. For risk mitigation and management 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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage e07e4b8b47ca17113e58684b23e970925ba069545482d0767988543a0a79d9dc · Zeichen 15378–15942 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130538 · Präparat HOS-096931
Venous Thromboembolic Events
In men who received olaparib plus abiraterone as first line therapy for mCRPC (PROpel study), the
incidence of venous thromboembolic events was 8% in the olaparib plus abiraterone arm, and 3.3% in
the placebo plus abiraterone arm. The median time to onset in this study was 170 days (range: 12 to
906 days). The majority of patients recovered from the event and were able to continue olaparib with
standard medical treatment.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 53d84f6148b57cac07254d82c988d9c2f89a6d342388e24b06fb2924d1e40c2e · Zeichen 15944–16398 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130539 · Präparat HOS-096931
Patients with significant cardiovascular disease were excluded. Please refer to the product information
for abiraterone for cardiovascular exclusion criteria (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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 738ed08ac3f500cab00785fb2deb3900d03498a9d17b8bf3619b562e2f6c2173 · Zeichen 16400–16572 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130540 · Präparat HOS-096931
Other laboratory findings
In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (elevations) from baseline in
blood creatinine was approximately 11%. Data from a double-blind placebo-controlled study showed
median increase up to 23% from baseline remaining consistent over time and returning to baseline
after treatment discontinuation, with no apparent clinical sequelae. 90% of patients had creatinine
values of CTCAE grade 0 at baseline and 10% were CTCAE grade 1 at baseline.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 95744227438036e2d9d8e4a09850c9c8513639fe357f3a39227c683014042d0a · Zeichen 16574–17072 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-130541 · Präparat HOS-096931
Gastrointestinal toxicities
Nausea was generally reported very early, with first onset within the first month of Lynparza treatment
in the majority of patients. Vomiting was reported early, with first onset within the first two months of
Lynparza treatment in the majority of patients. Both nausea and vomiting were reported to be
intermittent for the majority of patients and can be managed by dose interruption, dose reduction
and/or antiemetic therapy. Antiemetic prophylaxis is not required.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 14868dff97a17133ac3b63077189b307ce819955d601cbccb058a9ef907c12ad · Zeichen 17074–17569 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16–17
HOS-130542 · Präparat HOS-096931
16
In first-line ovarian cancer maintenance treatment, patients experienced nausea events (77% on
olaparib, 38% on placebo), vomiting (40% on olaparib, 15% on placebo), diarrhoea (34% on olaparib,
25% on placebo) and dyspepsia (17% on olaparib, 12% on placebo). Nausea events led to
discontinuation in 2.3% of olaparib-treated patients (CTCAE Grade 2) and 0.8% of placebo-treated
patients (CTCAE Grade 1); 0.8% and 0.4% of olaparib-treated patients discontinued treatment due to
low grade (CTCAE Grade 2) vomiting and dyspepsia, respectively. No olaparib or placebo-treated
patients discontinued due to diarrhoea. No placebo-treated patients discontinued due to vomiting or
dyspepsia. Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of
olaparib-treated patients. Vomiting events led to interruption in 10% of olaparib-treated patients; no
olaparib-treated patients experienced a vomiting event leading to dose reduction.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 9819f356b8e0ba84b05479bd189c4d47065ada0d82a4c6d1850a53c7045643c2 · Zeichen 17622–18583 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-130543 · Präparat HOS-096931
Paediatric population
No new safety signals were observed in the study population relative to the known safety profile of
Lynparza in adults, based on the limited number of paediatric patients treated with olaparib in study
D0816C00025 (see section 5.1).
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 4f620ff5ba23c1cd9b84936f1cf4ab18d9553cf2debd2d095798ece72781ff84 · Zeichen 18585–18839 im Abschnitt
Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-130544 · Präparat HOS-096931
Other special populations
Limited safety data are available in non-Caucasian patients.
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 2026-02-19T16:20:00Z · SHA-256 04cb6a8e4fff66099a345e60858378068000de050b0e7fedaddb3d5347849598 · Passage 1ae7d314682f8d395c3930a3e7d3ccb498904e174f36b5dc295e078ce0b60934 · Zeichen 18841–18927 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.