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 · 871 Präparate · 48256 Quellenpassagen · 124 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 41
HOS-090960 · Präparat HOS-084155
Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous
and subcutaneous formulations) to date are cardiac dysfunction, administration-related reactions,
haematotoxicity (in particular neutropenia), infections and pulmonary 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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage dc5736b9bedda5719aba58c8c41de4d89b0af2e8d8ea1e3fa3c1bd65292d639a · Zeichen 31–315 im Abschnitt
Nebenwirkungen · Herceptin
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HOS-090961 · Präparat HOS-084155
41
The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated
with the intravenous and subcutaneous formulations respectively) from the pivotal trial in EBC was
overall similar to the known safety profile of the intravenous formulation.
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage f61ca6476949d6624b087ce809216da753f3dfa92e79db1c5fe6c5071707d228 · Zeichen 368–646 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090962 · Präparat HOS-084155
Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both
Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous
formulation respectively).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 12b138d3db0b0f0c7e72c7876a7d73ed13532f0926a173e0277ece34d27454a0 · Zeichen 648–959 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090963 · Präparat HOS-084155
Some adverse events / reactions were reported with a higher frequency for the subcutaneous
formulation:
Serious adverse events (most of which were identified because of in-patient hospitalisation or
prolongation of existing hospitalisation): 14.1 % for the intravenous formulation versus
21.5 % for the subcutaneous formulation. The difference in serious adverse event rates
between formulations was mainly due to infections with or without neutropenia (4.4 % versus
8.1 %) and cardiac disorders (0.7 % versus 1.7 %);
Post-operative wound infections (severe and/or serious): 1.7 % versus 3.0 % for the
intravenous formulation versus subcutaneous formulation, respectively;
Administration-related reactions: 37.2 % versus 47.8 % for the intravenous formulation versus
subcutaneous formulation, respectively during the treatment phase;
Hypertension: 4.7 % versus 9.8 % for the intravenous formulation versus subcutaneous
formulation 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
Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage f213efc3167385a8f73decc21a7a604645fa0752a2f9fc31188e890b5f351747 · Zeichen 961–1978 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090964 · Präparat HOS-084155
Tabulated list of adverse reactions with the intravenous formulation
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage fb104cefe8ddd8d821951456590a25961a0e629a7e2e9c0c93a8af49ee42c96b · Zeichen 1980–2048 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090965 · Präparat HOS-084155
In this section, the following categories of frequency have been used: very common (≥1/10), common
(≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
(<1/10,000), not known (cannot be estimated from the available data). Within each frequency
grouping, adverse reactions 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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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage a9d6142a460eff6e5a675c3b64e8e792e323a7ba9124e2e7c69a71c94fccfc51 · Zeichen 2050–2408 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090966 · Präparat HOS-084155
Presented in Table 1 are adverse reactions that have been reported in association with the use of
intravenous Herceptin alone or in combination with chemotherapy in pivotal clinical trials and in the
post-marketing setting.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage e74f07189d4e69c9df2bff23d1c3976e59146ada5d42bff6a77ff1d2c9bf3d49 · Zeichen 2410–2633 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090967 · Präparat HOS-084155
All the terms included are based on the highest percentage seen in pivotal clinical trials. In addition,
terms reported in the post marketing setting are included in Table 1.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage c6233fae98f912e0c28c0d0a1f82ccaffa49ac75f5677d8c9c66660c1d1d55f8 · Zeichen 2635–2809 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42
HOS-090968 · Präparat HOS-084155
Table 1: Undesirable effects reported with intravenous Herceptin monotherapy or in combination with
chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 20348cde510aff44416ed9c1aa1f2abaf8029afa49ab5496ea09d32552b95d0b · Zeichen 2811–2983 im Abschnitt
Nebenwirkungen · Herceptin
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HOS-090969 · Präparat HOS-084155
System organ class Adverse reaction Frequency
Infections and infestations Infection Very common
Nasopharyngitis Very common
Neutropenic sepsis Common
Cystitis Common
Influenza Common
Sinusitis Common
Skin infection Common
Rhinitis Common
Upper respiratory tract infection Common
Urinary tract infection Common
Pharyngitis Common
Neoplasms benign, Malignant neoplasm progression Not known
malignant and unspecified Neoplasm progression Not known
(incl. Cysts and polyps)
Febrile neutropenia Very common
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 22b047cfaef7dae5b1e15761c4796cb3fbf46749518d6e6567d2bb8cf6953c37 · Zeichen 2986–4264 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42–43
HOS-090970 · Präparat HOS-084155
42
System organ class Adverse reaction Frequency
Blood and lymphatic Anaemia Very common
system disorders Neutropenia Very common
White blood cell count Very common
decreased/leukopenia
Thrombocytopenia Very common
Hypoprothrombinaemia Not known
Immune thrombocytopenia Not known
Immune system disorders Hypersensitivity Common
+
Anaphylactic reaction Rare
+
Anaphylactic shock Rare
Metabolism and nutrition Weight decreased/Weight loss Very common
disorders Anorexia Very common
Tumour lysis syndrome Not known
Hyperkalaemia Not known
Psychiatric disorders Insomnia Very common
Anxiety Common
Depression Common
1
Nervous system disorders Tremor Very common
Dizziness Very common
Headache Very common
Paraesthesia Very common
Dysgeusia Very common
Peripheral neuropathy Common
Hypertonia Common
Somnolence Common
Eye disorders Conjunctivitis Very common
Lacrimation increased Very common
Dry eye Common
Papilloedema Not known
Retinal haemorrhage Not known
Ear and labyrinth disorders Deafness Uncommon
1
Cardiac disorders Blood pressure decreased Very common
1
Blood pressure increased Very common
1
Heart beat irregular Very common
1
Cardiac flutter Very common
Ejection fraction decreased* Very common
+
Cardiac failure (congestive) Common
+1
Supraventricular tachyarrhythmia Common
Cardiomyopathy Common
1
Palpitation Common
Pericardial effusion Uncommon
Cardiogenic shock Not known
Gallop rhythm present Not known
Vascular disorders Hot flush Very common
+1
Hypotension Common
Vasodilatation Common
+
Respiratory, thoracic and Dyspnoea Very common
mediastinal disorders Cough Very common
Epistaxis Very common
Rhinorrhoea Very common
+
Pneumonia Common
Asthma Common
Lung disorder Common
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage ea66870e4eae25bda9eee6b6f5b954cf1d73e9381d5cb6b22bdd0cf520b41002 · Zeichen 4318–8912 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 43–44
HOS-090971 · Präparat HOS-084155
43
System organ class Adverse reaction Frequency
+
Pleural effusion Common
+1
Wheezing Uncommon
Pneumonitis Uncommon
+
Pulmonary fibrosis Not known
+
Respiratory distress Not known
+
Respiratory failure Not known
+
Lung infiltration Not known
+
Acute pulmonary oedema Not known
+
Acute respiratory distress syndrome Not known
+
Bronchospasm Not known
+
Hypoxia Not known
+
Oxygen saturation decreased Not known
Laryngeal oedema Not known
Orthopnoea Not known
Pulmonary oedema Not known
Interstitial lung disease Not known
Gastrointestinal disorders Diarrhoea Very common
Vomiting Very common
Nausea Very common
1
Lip swelling Very common
Abdominal pain Very common
Dyspepsia Very common
Constipation Very common
Stomatitis Very common
Haemorrhoids Common
Dry mouth Common
Hepatobiliary disorders Hepatocellular Injury Common
Hepatitis Common
Liver Tenderness Common
Jaundice Rare
Skin and subcutaneous Erythema Very common
tissue disorders Rash Very common
1
Swelling face Very common
Alopecia Very common
Nail disorder Very common
Palmar-plantar erythrodysaesthesia Very common
syndrome
Acne Common
Dry skin Common
Ecchymosis Common
Hyperhydrosis Common
Maculopapular rash Common
Pruritus Common
Onychoclasis Common
Dermatitis Common
Urticaria Uncommon
Angioedema Not known
Musculoskeletal and Arthralgia Very common
connective tissue disorders 1
Muscle tightness Very common
Myalgia Very common
Arthritis Common
Back pain Common
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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage f73be159955fa7313bfc0d918c22744a1fce59b92b0da69ac149cb42c8a61b90 · Zeichen 8962–13591 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 44–45
HOS-090972 · Präparat HOS-084155
44
System organ class Adverse reaction Frequency
Bone pain Common
Muscle spasms Common
Neck pain Common
Pain in extremity Common
Renal and urinary disorders Renal disorder Common
Glomerulonephritis membranous Not known
Glomerulonephropathy Not known
Renal failure Not known
Pregnancy, puerperium and Oligohydramnios Not known
perinatal conditions Renal hypoplasia Not known
Pulmonary hypoplasia Not known
Reproductive system and Breast inflammation/mastitis Common
breast disorders
General disorders and Asthenia Very common
administration site Chest pain Very common
conditions Chills Very common
Fatigue Very common
Influenza-like symptoms Very common
Infusion related reaction Very common
Pain Very common
Pyrexia Very common
Mucosal inflammation Very common
Peripheral oedema Very common
Malaise Common
Oedema Common
Injury, poisoning and Contusion Common
procedural complications
+ Denotes adverse reactions that have been reported in association with a fatal outcome.
1 Denotes adverse reactions that are reported largely in association with administration-related reactions.
Specific percentages for these are not available.
* Observed with combination therapy following anthracyclines and combined with taxanes
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 57565d8f747c45348879a6397aa524c1a0bb5a023339db70f04311876d619556 · Zeichen 13641–16381 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 45
HOS-090973 · Präparat HOS-084155
Description of selected adverse reactions
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 16383–16424 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 45
HOS-090974 · Präparat HOS-084155
Cardiac dysfunction
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 82d0fd2187dd323ce98afcc35c14ec89281c4b5a3b13d80496c1709fa818d444 · Zeichen 16426–16445 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 45
HOS-090975 · Präparat HOS-084155
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction to Herceptin. It has been
associated with a fatal outcome. Signs and symptoms of cardiac dysfunction such as dyspnoea,
orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction,
have been observed in patients treated with Herceptin (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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage fcb67207ee971b3e5df5c04e03eea97bb6c4af998a78f4f9ef34927e1c6f5349 · Zeichen 16447–16811 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 45
HOS-090976 · Präparat HOS-084155
In 3 pivotal EBC clinical trials of adjuvant intravenous Herceptin given in combination with
chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive
heart failure) was similar in patients who were administered chemotherapy alone (ie did not receive
Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
The rate was highest in patients who were administered Herceptin concurrently with a taxane (2.0 %).
In the neoadjuvant setting, the experience of concurrent administration of Herceptin and low dose
anthracycline regimen is limited (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 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage c28e760f0115a33eab7beedb462294ae829acb8e3b896b942f0214068a1f2851 · Zeichen 16813–17454 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 45
HOS-090977 · Präparat HOS-084155
When Herceptin was administered after completion of adjuvant chemotherapy NYHA Class III-IV
heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12
months. In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA
Class III & IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and
asymptomatic left ventricular dysfunction was 4.6 %.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 8fba0dd3a1114fd96939f8d1ae0974abb57c398ed4a30115f77bdf667adfb81f · Zeichen 17456–17897 im Abschnitt
Nebenwirkungen · Herceptin
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HOS-090978 · Präparat HOS-084155
45
Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50 %
after the event) was evident for 71.4 % of Herceptin-treated patients. Reversibility of mild
symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Approximately 17 % of cardiac dysfunction related events occurred after completion of Herceptin.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 0e7d7d25138b1d1af9bf8d2bb83eb45d585b8e36fda592328463a5260b25fc8c · Zeichen 17955–18344 im Abschnitt
Nebenwirkungen · Herceptin
Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 46
HOS-090979 · Präparat HOS-084155
In the pivotal metastatic trials of intravenous Herceptin, the incidence of cardiac dysfunction varied
between 9 % and 12 % when it was combined with paclitaxel compared with 1 % – 4 % for paclitaxel
alone. For monotherapy, the rate was 6 % – 9 %. The highest rate of cardiac dysfunction was seen in
patients receiving Herceptin concurrently with anthracycline/cyclophosphamide (27 %), and was
significantly higher than for anthracycline/cyclophosphamide alone (7 % – 10 %). In a subsequent trial
with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in
patients receiving Herceptin and docetaxel, compared with 0 % in patients receiving docetaxel alone.
Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an
improvement after receiving standard treatment for CHF.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-11-25T17:43:00Z · SHA-256 4737cd7c26cd2805fc40be61983542b3a3127abbce7e3ca6ebc3b5c0895dda53 · Passage 523560063dbc5023cfec4666013d7728d505ddf722ced0d840483667dbd5f459 · Zeichen 18346–19187 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.