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 · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-125521 · Präparat HOS-096081
Capecitabine monotherapy
Table 5 lists ADRs associated with the use of capecitabine monotherapy based on a pooled analysis of
safety data from three major studies including over 1900 patients (studies M66001, SO14695, and
SO14796). ADRs are added to the appropriate frequency grouping according to the overall incidence
from the pooled analysis.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage bdd5e6a1d7c4fcb9217dd40bc117567e8d10c83e1b7a12dd3ed1d367a29431c4 · Zeichen 1551–1896 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-125522 · Präparat HOS-096081
Table 5 Summary of related ADRs reported in patients treated with capecitabine monotherapy
Body System Very Common Common Uncommon Rare/Very Rare
All grades All grades Severe and/or Life- (Post-Marketing
threatening (grade 3-4) Experience)
or considered medically
relevant
Infections and - Herpes viral Sepsis, Urinary tract
infestations infection, infection, Cellulitis,
Nasopharyngitis, Tonsillitis, Pharyngitis,
Lower respiratory Oral candidiasis,
tract infection Influenza, Gastroenteritis,
Fungal infection,
Infection, Tooth abscess
Neoplasm - - Lipoma
benign,
malignant and
unspecified
Blood and - Neutropenia, Febrile neutropenia,
lymphatic system Anaemia Pancytopenia,
disorders Granulocytopenia,
Thrombocytopenia,
Leukopenia, Haemolytic
anaemia, International
Normalised Ratio (INR)
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 08602868d8e4c2b8d4a8b6409b6257fe6e345cfe265e075d12b4e31d8a965f65 · Zeichen 1898–3705 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14
HOS-125523 · Präparat HOS-096081
13
Body System Very Common Common Uncommon Rare/Very Rare
All grades All grades Severe and/or Life- (Post-Marketing
threatening (grade 3-4) Experience)
or considered medically
relevant
increased/Prothrombin
time prolonged
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage c795fde49b36823f5a0ff9e944e1b9363f35ac8b671b24f8497b515984b338d7 · Zeichen 3758–4312 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14
HOS-125524 · Präparat HOS-096081
Immune system - - Hypersensitivity Angioedema (rare)
disorders
Metabolism and Anorexia Dehydration, Diabetes, Hypokalaemia,
nutrition Weight decreased Appetite disorder,
disorders Malnutrition,
Hypertriglyceridaemia
Psychiatric - Insomnia, Confusional state, Panic
disorders Depression attack, Depressed mood,
Libido decreased
Nervous system - Headache, Lethargy Aphasia, Memory Toxic
disorders Dizziness, impairment, Ataxia, leukoencephalopathy
Parasthesia, Syncope, Balance (very rare)
Dysgeusia disorder, Sensory
disorder, Neuropathy
peripheral
Eye disorders - Lacrimation Visual acuity reduced, Lacrimal duct stenosis
increased, Diplopia (rare), Corneal
Conjunctivitis, Eye disorders(rare),
irritation keratitis (rare),
punctate keratitis (rare)
Ear and - - Vertigo, Ear pain
labyrinth
disorders
Cardiac - - Angina unstable, Angina Ventricular fibrillation
disorders pectoris, Myocardial (rare), QT prolongation
ischaemia/infarction, (rare), Torsade de
Atrial fibrillation, pointes (rare),
Arrhythmia, Tachycardia, Bradycardia (rare),
Sinus tachycardia, Vasospasm (rare)
Palpitations
Vascular - Thrombophlebitis Deep vein thrombosis,
disorders Hypertension, Petechiae,
Hypotension, Hot flush,
Peripheral coldness
Respiratory, - Dyspnoea, Pulmonary embolism,
thoracic and Epistaxis, Cough, Pneumothorax,
mediastinal Rhinorrhoea Haemoptysis, Asthma,
disorders Dyspnoea exertional
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage e2da96225ac0a2dec380b1ed7bba49f17b277974c42bff7c41c599ad0f9b2f4c · Zeichen 4317–7205 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15
HOS-125525 · Präparat HOS-096081
14
Body System Very Common Common Uncommon Rare/Very Rare
All grades All grades Severe and/or Life- (Post-Marketing
threatening (grade 3-4) Experience)
or considered medically
relevant
Gastrointestinal Diarrhoea, Gastrointestinal Intestinal obstruction,
disorders Vomiting, Nausea, haemorrhage, Ascites, Enteritis,
Stomatitis, Constipation, Upper Gastritis, Dysphagia,
Abdominal pain abdominal pain, Abdominal pain lower,
Dyspepsia, Oesophagitis, Abdominal
Flatulence, Dry discomfort,
mouth Gastrooesophageal reflux
disease, Colitis, Blood in
stool
Hepatobiliary - Hyperbilirubinemia, Jaundice Hepatic failure (rare),
disorders Liver function test Cholestatic hepatitis
abnormalities (rare)
Skin and Palmar-plantar Rash, Alopecia, Blister, Skin ulcer, Rash, Cutaneous lupus
subcutaneous erythrodysaesthesia Erythema, Dry skin, Urticaria, Photosensitivity erythematosus (rare),
tissue disorders syndrome** Pruritus, Skin reaction, Palmar Severe skin reactions
hyper-pigmentation, erythema, Swelling face, such as Stevens-
Rash macular, Skin Purpura, Radiation recall Johnson Syndrome and
desquamation, syndrome toxic Epidermal
Dermatitis, Necrolysis (very rare)
Pigmentation (see section 4.4.)
disorder, Nail
disorder
Muskuloskeletal - Pain in extremity, Joint swelling, Bone pain,
and connective Back pain, Facial pain,
tissue disorders Arthralgia Musculoskeletal stiffness,
Muscular weakness
Renal and - - Hydronephrosis, Urinary
urinary incontinence, Haematuria,
disorders Nocturia, Blood
creatinine increased
Reproductive - - Vaginal haemorrhage
system and
breast disorders
General Fatigue, Asthenia Pyrexia, Oedema Oedema, Chills, Influenza
disorders and peripheral, Malaise, like illness, Rigors, Body
administration Chest pain temperature increased
site conditions
** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome
can eventually lead to loss of fingerprints (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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage a65220c3beb88d6ebdde1dcff766825d04b38f8fd970004934588576a9eb7f75 · Zeichen 7250–10957 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15
HOS-125526 · Präparat HOS-096081
Capecitabine in combination therapy
Table 6 lists ADRs associated with the use of capecitabine in combination with different
chemotherapy regimens in multiple indications based on safety data from over 3000 patients. ADRs
are added to the appropriate frequency grouping (very common or common) according to the highest
incidence seen in any of the major clinical trials and are only added when they were seen in addition
to those seen with capecitabine monotherapy or seen at a higher frequency grouping compared to
capecitabine monotherapy (see Table 5). Uncommon ADRs reported for capecitabine in combination
therapy are consistent with the ADRs reported for capecitabine monotherapy or reported for
monotherapy with the combination medicinal product (in literature and/or respective summary of
product characteristics).
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage af9298df6dd6d082c023445d39b524d49a65c95221437409c65c538be2d17127 · Zeichen 10959–11781 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16
HOS-125527 · Präparat HOS-096081
15
Some of the ADRs are reactions commonly seen with the combination medicinal product (e.g.
peripheral sensory neuropathy with docetaxel or oxaliplatin, hypertension seen with bevacizumab);
however an exacerbation by capecitabine therapy can not be excluded.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 2db2ad3b3aadb0fd9de8a9e079c61d2fd80d70479bf6ffd01aa6fd54d941a53f · Zeichen 11839–12099 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16
HOS-125528 · Präparat HOS-096081
Table 6 Summary of related ADRs reported in patients treated with capecitabine in combination
treatment in addition to those seen with capecitabine monotherapy or seen at a higher
frequency grouping compared to capecitabine monotherapy
Body System Very Common Common Rare/Very Rare
All grades All grades (Post-Marketing
Experience)
Infections and - Herpes zoster, Urinary tract
infestations infection, Oral candidiasis,
Upper respiratory tract
infection , Rhinitis,
Influenza, +Infection, Oral
herpes
+
Blood and lymphatic Neutropenia, Bone marrow depression,
+
system disorders Leucopenia, +Anaemia, +Febrile Neutropenia
+
Neutropenic fever,
Thrombocytopenia
Immune system - Hypersensitivity
disorders
Metabolism and Appetite decreased Hypokalaemia,
nutrition disorders Hyponatraemia,
Hypomagnesaemia,
Hypocalcaemia,
Hyperglycaemia
Psychiatric disorders - Sleep disorder, Anxiety
Nervous system Paraesthesia, Neurotoxicity, Tremor,
disorders Dysaesthesia, Peripheral Neuralgia, Hypersensitivity
neuropathy, Peripheral reaction, Hypoaesthesia
sensory neuropathy,
Dysgeusia, Headache
Eye disorders Lacrimation increased Visual disorders, Dry eye,
Eye pain, Visual
impairment, Vision blurred
Ear and labyrinth - Tinnitus, Hypoacusis
disorders
Cardiac disorders - Atrial fibrillation, Cardiac
ischaemia/infarction
Vascular disorders Lower limb oedema, Flushing, Hypotension,
Hypertension, +Embolism Hypertensive crisis, Hot
and thrombosis flush, Phlebitis
Respiratory, thoracic Sore throat, Dysaesthesia Hiccups,
and mediastinal system pharynx Pharyngolaryngeal pain,
disorders Dysphonia
Gastrointestinal Constipation, Dyspepsia Upper gastrointestinal
disorders haemorrhage, Mouth
ulceration, Gastritis,
Abdominal distension,
Gastroesophageal reflux
disease, Oral pain,
Dysphagia, Rectal
haemorrhage, Abdominal
pain lower, Oral
dysaesthesia, Paraesthesia
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage db838d2926611455720a8192ece8e8bb9d335f32f0503447e954c2343daef5f7 · Zeichen 12101–15927 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16–17
HOS-125529 · Präparat HOS-096081
16
Body System Very Common Common Rare/Very Rare
All grades All grades (Post-Marketing
Experience)
oral, Hypoaesthesia oral,
Abdominal discomfort
Hepatobiliary - Hepatic function abnormal
disorders
Skin and subcutaneous Alopecia, Nail disorder Hyperhidrosis, Rash
tissue disorders erythematous, Urticaria,
Night sweats
Musculoskeletal and Myalgia, Arthralgia, Pain Pain in jaw , Muscle
connective tissue in extremity spasms, Trismus, Muscular
disorders weakness
Renal and urinary - Haematuria, Proteinuria, Acute renal failure
disorders Creatinine renal clearance secondary to
decreased, Dysuria dehydration (rare)
General disorders and Pyrexia, Weakness, Mucosal inflammation,
+
administration site Lethargy, Temperature Pain in limb, Pain, Chills,
conditions intolerance Chest pain, Influenza-like
illness, +Fever, Infusion
related reaction, Injection
site reaction, Infusion site
pain, Injection site 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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 863803b606437a1bc2b4f1eea02d6f71f5871cb53f2597500ff3da07d8bf808f · Zeichen 15978–17853 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-125530 · Präparat HOS-096081
Injury, poisoning and - Contusion
procedural
complications
+
For each term, the frequency count was based on ADRs of all grades. For terms marked with a “+”, the
frequency count was based on grade 3-4 ADRs. ADRs are added according to the highest incidence seen in any
of the major combination trials.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 25854848463882b88e8f6507468e452326001e5461a09c32115d96ba715e0f6e · Zeichen 17855–18191 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-125531 · Präparat HOS-096081
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 18193–18234 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-125532 · Präparat HOS-096081
Hand-foot syndrome (HFS) (see section 4.4)
For the capecitabine dose of 1250 mg/m2 twice daily on days 1 to 14 every 3 weeks, a frequency of
53% to 60% of all-grades HFS was observed in capecitabine monotherapy trials (comprising studies in
adjuvant therapy in colon cancer, treatment of metastatic colorectal cancer, and treatment of breast
cancer) and a frequency of 63% was observed in the capecitabine/docetaxel arm for the treatment of
metastatic breast cancer. For the capecitabine dose of 1000 mg/m2 twice daily on days 1 to 14 every
3weeks, a frequency of 22% to 30% of all-grade HFS was observed in capecitabine combination
therapy.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 6ae47192d8decc76a09247488c1dbf1d432779be337bea59f0ddf33ce2bc42c7 · Zeichen 18236–18877 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-125533 · Präparat HOS-096081
A meta-analysis of 14 clinical trials with data from over 4700 patients treated with capecitabine
monotherapy or capecitabine in combination with different chemotherapy regimens in multiple
indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in
2066 (43%) patients after a median time of 239 [95% CI 201, 288] days after starting treatment with
capecitabine. In all studies combined, the following covariates were statistically significantly
associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram),
decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six
weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female
gender, and good ECOG performance status at baseline (0 versus ≥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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 63585a8b2c889405be7ff9791b712c51c604534057608adb599e1192e046b601 · Zeichen 18879–19736 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17
HOS-125534 · Präparat HOS-096081
Diarrhoea (see section 4.4)
Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 86b38bf8154c42fea1037217552eaa4ff99ef641033e7fb36f9f61fae3b9e01c · Zeichen 19738–19868 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17–18
HOS-125535 · Präparat HOS-096081
17
The results of a meta-analysis of 14 clinical trials with data from over 4700 patients treated with
capecitabine showed that in all studies combined, the following covariates were statistically
significantly associated with an increased risk of developing diarrhoea: increasing capecitabine
starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year
increments), and female gender. The following covariates were statistically significantly associated
with a decreased risk of developing diarrhoea: increasing cumulative capecitabine dose (0.1*kg) and
increasing relative dose intensity in the first six weeks.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage d752f0ee5a4faa004071be565b93750f9e0de1ba6dd48e854bd09ec01a9aad63 · Zeichen 19924–20575 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 18
HOS-125536 · Präparat HOS-096081
Cardiotoxicity (see section 4.4)
In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than
0.1% were associated with the use of capecitabine monotherapy based on a pooled analysis from
clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials
in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden
death, and ventricular extrasystoles.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage ebb71da392bbffd19fccd8bd41d67bc99ce48bdfeb0685ce12b18134ea84029c · Zeichen 20577–21058 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 18
HOS-125537 · Präparat HOS-096081
Encephalopathy
In addition to the ADRs described in tables 4 and 5, and based on the above pooled analysis from
clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of
capecitabine monotherapy with an incidence of less than 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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 04e23b27370f40fa787337b4f91788b4a9ba261354735c2e8d928e137efeb16b · Zeichen 21060–21329 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 18
HOS-125538 · Präparat HOS-096081
Exposure to crushed or cut capecitabine tablets:
In the instance of exposure to crushed or cut capecitabine tablets, the following adverse drug reactions
have been reported: eye irritation, eye swelling, skin rash, headache, paresthesia, diarrhea, nausea,
gastric irritation, and vomiting.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage aeb4482029376d1199fff723cb915d39e91158c2674448f3ebc323d9c8985a71 · Zeichen 21331–21620 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 18
HOS-125539 · Präparat HOS-096081
Special populations
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage aff3e9efab65f7283de9c5cbb6a63f191f8aa790437b98aa9413380c55f2c310 · Zeichen 21622–21641 im Abschnitt
Nebenwirkungen · Capecitabine Accord
Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 18
HOS-125540 · Präparat HOS-096081
Elderly patients (see section 4.2)
An analysis of safety data in patients ≥ 60 years of age treated with capecitabine monotherapy and an
analysis of patients treated with capecitabine plus docetaxel combination therapy showed an increase
in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious
adverse reactions compared to patients < 60 years of age. Patients ≥ 60 years of age treated with
capecitabine plus docetaxel also had more early withdrawals from treatment due to adverse reactions
compared to patients < 60 years of age.
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 2025-05-05T15:07:00Z · SHA-256 31136a37a67bcc7d3d37a3db0a926c5402c9346bcaefe911a69ae0fa32bf9225 · Passage 4516ac5266358a6e986275677c8823f5f5aea5198f52336628f9b7aadea862c2 · Zeichen 21643–22218 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.