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 · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 14
HOS-133279 · Präparat HOS-097412
Adverse reactions are listed below by system organ class and frequency grouping. Frequencies are
defined as: 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, undesirable effects are presented in order of
decreasing seriousness. Table 7 has been generated using Version 14.1 of the MedDRA.
Post-marketing adverse reactions not seen in clinical studies are also included.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 9fd55622894c9461ecb0fbf30bfe60525d59f376e28e8db98e9b13fabbe4d7ec · Zeichen 1071–1619 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 14
HOS-133280 · Präparat HOS-097412
Table 7:Adverse reactions in patients with multiple myeloma treated with bortezomib in clinical
studies, and all post-marketing adverse reactions regardless of indication#
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage b438e63ef8582a0c62aaef86ac65b68ecd204cff7e35604ea436692f4cd68231 · Zeichen 1621–1804 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 14
HOS-133281 · Präparat HOS-097412
System Organ
Class Incidence Adverse reaction
Infections and Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*,
infestations Herpes simplex*, Fungal infection*
Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis
(inc septic shock)*, Bronchopneumonia, Herpes virus
infection*, Meningoencephalitis herpetic#, Bacteraemia (inc
staphylococcal), Hordeolum, Influenza, Cellulitis, Device
related infection, Skin infection*, Ear infection*,
Staphylococcal infection, Tooth infection*
Rare Meningitis (inc bacterial), Epstein-Barr virus infection,
Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue
syndrome
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage ae1067b7984c8d4d4276fb4d5f9a57996c1c93cb937be8789c9ae84ad2e68650 · Zeichen 1806–2886 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 14–15
HOS-133282 · Präparat HOS-097412
14
System Organ
Class Incidence Adverse reaction
Neoplasms Rare Neoplasm malignant, Leukaemia plasmacytic, Renal cell
benign, malignant carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
and unspecified
(incl cysts and
polyps)
Blood and Very Common Thrombocytopenia*, Neutropenia*, Anaemia*
lymphatic system Common Leukopenia*, Lymphopenia*
disorders Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*,
Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#
Rare Disseminated intravascular coagulation, Thrombocytosis*,
Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic
microangiopathy (inc thrombocytopenic purpura) #, Blood
disorder NOS, Haemorrhagic diathesis, Lymphocytic
infiltration
Immune system Uncommon Angioedema#, Hypersensitivity*
disorders Rare Anaphylactic shock, Amyloidosis, Type III immune complex
mediated reaction
Endocrine Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate
disorders antidiuretic hormone secretion
Rare Hypothyroidism
Metabolism and Very Common Decreased appetite
nutrition disorders Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood
glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Uncommon Tumour lysis syndrome, Failure to thrive*,
Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*,
Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*,
Diabetes mellitus*, Fluid retention
Rare Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid
overload, Hypochloraemia*, Hypovolaemia,
Hyperchloraemia*, Hyperphosphataemia*, Metabolic
disorder, Vitamin B complex deficiency, Vitamin B12
deficiency, Gout, Increased appetite, Alcohol intolerance
Psychiatric Common Mood disorders and disturbances*, Anxiety disorder*, Sleep
disorders disorders and disturbances*
Uncommon Mental disorder*, Hallucination*, Psychotic disorder*,
Confusion*, Restlessness
Rare Suicidal ideation*, Adjustment disorder, Delirium, Libido
decreased
Nervous system Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*,
disorders Neuralgia*
Common Motor neuropathy*, Loss of consciousness (inc syncope),
Dizziness*, Dysgeusia*, Lethargy, Headache*
Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*,
Cerebellar coordination and balance disturbances*, Memory
loss (exc dementia)*, Encephalopathy*, Posterior Reversible
Encephalopathy Syndrome#, Neurotoxicity, Seizure
disorders*, Post herpetic neuralgia, Speech disorder*,
Restless legs syndrome, Migraine, Sciatica, Disturbance in
attention, Reflexes abnormal*, Parosmia
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 0ec6e55379e1828856392f71a6475a5d2ca12be863d7dc5047df0eed89c02aa9 · Zeichen 2940–6752 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 15–16
HOS-133283 · Präparat HOS-097412
15
System Organ
Class Incidence Adverse reaction
Rare Cerebral haemorrhage*, Haemorrhage intracranial (inc
subarachnoid)*, Brain oedema, Transient ischaemic attack,
Coma, Autonomic nervous system imbalance, Autonomic
neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope,
Brain stem syndrome, Cerebrovascular disorder, Nerve root
lesion, Psychomotor hyperactivity, Spinal cord compression,
Cognitive disorder NOS, Motor dysfunction, Nervous system
disorder NOS, Radiculitis, Drooling, Hypotonia, Guillain-
Barré syndrome#, Demyelinating polyneuropathy#
Eye disorders Common Eye swelling*, Vision abnormal*, Conjunctivitis*
Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion# ,
Blepharitis# , Eye inflammation*, Diplopia, Dry eye*, Eye
irritation*, Eye pain, Lacrimation increased, Eye discharge
Rare Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye
disorder (inc. eyelid) NOS, Dacryoadenitis acquired,
Photophobia, Photopsia, Optic neuropathy#, Different degrees
of visual impairment (up to blindness)*
Ear and labyrinth Common Vertigo*
disorders Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc
deafness), Ear discomfort*
Rare Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS
Cardiac disorders Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac
fibrillation (inc atrial), Cardiac failure (inc left and right
ventricular)*, Arrhythmia*, Tachycardia*, Palpitations,
Angina pectoris, Pericarditis (inc pericardial effusion)*,
Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Rare Atrial flutter, Myocardial infarction*, Atrioventricular block*,
Cardiovascular disorder (inc cardiogenic shock), Torsade de
pointes, Angina unstable, Cardiac valve disorders*, Coronary
artery insufficiency, Sinus arrest
Vascular disorders Common Hypotension*, Orthostatic hypotension, Hypertension*
Uncommon Cerebrovascular accident#, Deep vein thrombosis*,
Haemorrhage*, Thrombophlebitis (inc superficial),
Circulatory collapse (inc hypovolaemic shock), Phlebitis,
Flushing*, Haematoma (inc perirenal)*, Poor peripheral
circulation*, Vasculitis, Hyperaemia (inc ocular)*
Rare Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia,
Vasodilatation, Vein discolouration, Venous insufficiency
Respiratory, Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract
thoracic and infection*, Cough*
mediastinal Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema
disorders (inc acute), Pulmonary alveolar haemorrhage#,
Bronchospasm, Chronic obstructive pulmonary disease*,
Hypoxaemia*, Respiratory tract congestion*, Hypoxia,
Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Rare Respiratory failure, Acute respiratory distress syndrome,
Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension,
Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis,
Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis,
Bronchial disorder*, Hypocapnia*, Interstitial lung disease,
Lung infiltration, Throat tightness, Dry throat, Increased
upper airway secretion, Throat irritation, Upper-airway cough
syndrome
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 38b30c4c28ffc439b1134e275ba19978ce02b223b1d6062b858671824b19131e · Zeichen 6801–11526 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 16–17
HOS-133284 · Präparat HOS-097412
16
System Organ
Class Incidence Adverse reaction
Gastrointestinal Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation
disorders Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia,
Stomatitis*, Abdominal distension, Oropharyngeal pain*,
Abdominal pain (inc gastrointestinal and splenic pain)*, Oral
disorder*, Flatulence
Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*,
Gastrointestinal obstruction (inc small intestinal obstruction,
ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*,
Gastritis*, Gingival bleeding, Gastrooesophageal reflux
disease*, Colitis (inc clostridium difficile)*, Colitis
ischaemic#, Gastrointestinal inflammation*, Dysphagia,
Irritable bowel syndrome, Gastrointestinal disorder NOS,
Tongue coated, Gastrointestinal motility disorder*, Salivary
gland disorder*
Rare Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites,
Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter
atony, Faecaloma*, Gastrointestinal ulceration and
perforation*, Gingival hypertrophy, Megacolon, Rectal
discharge, Oropharyngeal blistering*, Lip pain, Periodontitis,
Anal fissure, Change of bowel habit, Proctalgia, Abnormal
faeces
Hepatobiliary Common Hepatic enzyme abnormality*
disorders Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis
Rare Hepatic failure, Hepatomegaly, Budd-Chiari syndrome,
Cytomegalovirus hepatitis, Hepatic haemorrhage,
Cholelithiasis
Skin and Common Rash*, Pruritus*, Erythema, Dry skin
subcutaneous Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic
tissue disorders dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#,
Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*,
Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*,
Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#,
Acne*, Blister*, Pigmentation disorder*
Rare Skin reaction, Jessner's lymphocytic infiltration, Palmar-
plantar erythrodysaesthesia syndrome, Haemorrhage
subcutaneous, Livedo reticularis, Skin induration, Papule,
Photosensitivity reaction, Seborrhoea, Cold sweat, Skin
disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Musculoskeletal Very Common Musculoskeletal pain*
and connective Common Muscle spasms*, Pain in extremity, Muscular weakness
tissue disorders Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness,
Myopathies*,Sensation of heaviness
Rare Rhabdomyolysis, Temporomandibular joint syndrome,
Fistula, Joint effusion, Pain in jaw, Bone disorder,
Musculoskeletal and connective tissue infections and
inflammations*, Synovial cyst
Renal and urinary Common Renal impairment*
disorders Uncommon Renal failure acute, Renal failure chronic*, Urinary tract
infection*, Urinary tract signs and symptoms*, Haematuria*,
Urinary retention, Micturition disorder*, Proteinuria,
Azotaemia, Oliguria*, Pollakisuria
Rare Bladder irritation
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 8cee92981afd9b72b27768e2232e4f25d3727de341a2c6fd9740a4b3a4f3fe07 · Zeichen 11575–15978 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 17–18
HOS-133285 · Präparat HOS-097412
17
System Organ
Class Incidence Adverse reaction
Reproductive Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction,
system and breast Rare Testicular disorder*, Prostatitis, Breast disorder female,
disorders Epididymal tenderness, Epididymitis, Pelvic pain, Vulval
ulceration
Congenital, Rare Aplasia, Gastrointestinal malformation, Ichthyosis
familial and
genetic disorders
General disorders Very Common Pyrexia*, Fatigue, Asthenia
and administration Common Oedema (inc peripheral), Chills, Pain*, Malaise*
site conditions Uncommon General physical health deterioration*, Face oedema*,
Injection site reaction*, Mucosal disorder*, Chest pain, Gait
disturbance, Feeling cold, Extravasation*, Catheter related
complication*, Change in thirst*, Chest discomfort, Feeling
of body temperature change*, Injection site pain*
Rare Death (inc sudden), Multi-organ failure, Injection site
haemorrhage*, Hernia(inc hiatus)*, Impaired healing*,
Inflammation, Injection site phlebitis*, Tenderness, Ulcer,
Irritability, Non-cardiac chest pain, Catheter site pain,
Sensation of foreign body
Investigations Common Weight decreased
Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight
increased, Blood test abnormal*,C-reactive protein increased
Rare Blood gases abnormal*, Electrocardiogram abnormalities (inc
QT prolongation)*, International normalised ratio abnormal*,
Gastric pH decreased, Platelet aggregation increased,
Troponin I increased, Virus identification and serology*,
Urine analysis abnormal*
Injury, poisoning Uncommon Fall, Contusion
and procedural Rare Transfusion reaction, Fractures*, Rigors*, Face injury, Joint
complications injury*, Burns, Laceration, Procedural pain, Radiation
injuries*
Surgical and Rare Macrophage activation
medical
procedures
NOS=not otherwise specified
* Grouping of more than one MedDRA preferred term.
# Post-marketing adverse reaction regardless of indication
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage a752d24deca51def314a0c73aaf5563c34b25a3f5930097b8ba617eaffaaae53 · Zeichen 16027–19108 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 18
HOS-133286 · Präparat HOS-097412
Mantle cell lymphoma (MCL)
The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in
combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP) versus
242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
[R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main
differences described below. Additional adverse drug reactions identified associated with the use of
the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia
(1.3%). The similar incidences of these events in both treatment arms, indicated that these adverse
drug reactions are not attributable to bortezomib alone. Notable differences in the MCL patient
population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of
the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia,
lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair
disorders.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the
BzR-CAP arm and with at least a possible or probable causal relationship to the components of the
BzR-CAP arm, are listed in Table 8 below. Also included are adverse drug reactions identified in the
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 46819c93fbcdc22d0bde8794f2c35363402ddbba3b75cf968ad95287800ac808 · Zeichen 19110–20502 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 18–19
HOS-133287 · Präparat HOS-097412
18
BzR-CAP arm that were considered by investigators to have at least a possible or probable causal
relationship to bortezomib based on historical data in the multiple myeloma studies.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage c6103f0000b84a746f4d6c244a93a7d9db9c696e0609d54a1a4b67d78cdb1520 · Zeichen 20566–20751 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 19
HOS-133288 · Präparat HOS-097412
Adverse reactions are listed below by system organ class and frequency grouping. Frequencies are
defined as: 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, undesirable effects are presented in order of
decreasing seriousness. Table 8 has been generated using Version 16 of the MedDRA.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage cfe3ec76c71b3f0fde5556861757062eb388d3067f3f55994d848894c5c61e15 · Zeichen 20753–21218 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 19
HOS-133289 · Präparat HOS-097412
Table 8 Adverse reactions in patients with mantle cell lymphoma treated with BzR-CAP in a
clinical study
System Organ
Class Incidence Adverse reaction
Infections and Very Common Pneumonia*
infestations Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &
ophthalmic), Herpes virus infection*, Bacterial infections*,
Upper/lower respiratory tract infection*, Fungal infection*,
Herpes simplex*
Uncommon Hepatitis B, Infection*, Bronchopneumonia
Blood and Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
lymphatic system Leukopenia*, Anaemia*, Lymphopenia*
disorders Uncommon Pancytopenia*
Immune system Common Hypersensitivity*
disorders Uncommon Anaphylactic reaction
Metabolism and Very Common Decreased appetite
nutrition disorders Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*,
Diabetes mellitus*, Fluid retention
Uncommon Tumour lysis syndrome
Psychiatric Common Sleep disorders and disturbances*
disorders
Nervous system Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
disorders Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc
syncope), Encephalopathy*, Peripheral sensorimotor
neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Uncommon Autonomic nervous system imbalance
Eye disorders Common Vision abnormal*
Ear and labyrinth Common Dysacusis (inc tinnitus)*
disorders Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Cardiac disorders Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure
(inc left and right ventricular)*, Myocardial ischaemia,
Ventricular dysfunction*
Uncommon Cardiovascular disorder (inc cardiogenic shock)
Vascular disorders Common Hypertension*, Hypotension*, Orthostatic hypotension
Respiratory, Common Dyspnoea*, Cough*, Hiccups
thoracic and Uncommon Acute respiratory distress syndrome, Pulmonary embolism,
mediastinal Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc
disorders acute)
Gastrointestinal Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*,
disorders Constipation
Common Gastrointestinal haemorrhage (inc mucosal)*, Abdominal
distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral
ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal
inflammation*, Abdominal pain (inc gastrointestinal and splenic
pain)*, Oral disorder*
Uncommon Colitis (inc clostridium difficile)*
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage e181dd2c68249262f13871be69707a0cee9f398bb03590941a45b2e0bf6566a1 · Zeichen 21220–24674 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 19–20
HOS-133290 · Präparat HOS-097412
19
System Organ
Class Incidence Adverse reaction
Hepatobiliary Common Hepatotoxicity (inc liver disorder)
disorders Uncommon Hepatic failure
Skin and Very Common Hair disorder*
subcutaneous Common Pruritus*, Dermatitis*, Rash*
tissue disorders
Musculoskeletal Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity
and connective
tissue disorders
Renal and urinary Common Urinary tract infection*
disorders
General disorders Very Common Pyrexia*, Fatigue, Asthenia
and administration Common Oedema (inc peripheral), Chills, Injection site reaction*,
site conditions Malaise*
Investigations Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight
decreased, Weight increased
* Grouping of more than one MedDRA preferred term.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 4de08f6a1c2a54fbdadad6863dcc791283fce3a09a155479ed9ddf08a2ba7796 · Zeichen 24727–25652 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20
HOS-133291 · Präparat HOS-097412
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 25654–25695 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20
HOS-133292 · Präparat HOS-097412
Herpes zoster virus reactivation
Multiple myeloma
Antiviral prophylaxis was administered to 26% of the patients in the Bz+M+P arm. The incidence of
herpes zoster among patients in the Bz+M+P treatment group was 17% for patients not administered
antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage d88fe937463bbd5d2c0a83f3a1774e6944ef347d6159d2f190412906d0994ed9 · Zeichen 25697–26027 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20
HOS-133293 · Präparat HOS-097412
Mantle cell lymphoma
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm. The
incidence of herpes zoster among patients in the BzR-CAP arm was 10.7% for patients not
administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis
(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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage f75a94dc8483a33c34940a02250b44f08604a9d22ce9c0a792e767dce6322366 · Zeichen 26029–26348 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20
HOS-133294 · Präparat HOS-097412
Hepatitis B virus (HBV) reactivation and infection
Mantle cell lymphoma
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib
treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP)
and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide,
doxorubicin, and prednisone (BzR-CAP). The overall incidence of hepatitis B infections was similar
in patients treated with BzR-CAP or with R-CHOP (0.8% vs 1.2% 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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage f1d2d3551cadc6786dc24991d5b571e2b68cf545ed83ebbbfc8ccf76e4700524 · Zeichen 26350–26881 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20
HOS-133295 · Präparat HOS-097412
Peripheral neuropathy in combination regimens
Multiple myeloma
In studies in which bortezomib was administered as induction treatment in combination with
dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the
incidence of peripheral neuropathy in the combination regimens is presented in the table below:
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage ffcfa0d21d688c9c36283b0775d43e5c05974b3d52f393fe2bb604f0e3187565 · Zeichen 26883–27219 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 20–21
HOS-133296 · Präparat HOS-097412
20
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment
discontinuation due to peripheral neuropathy
IFM-2005-01 MMY-3010
VDDx BzDx TDx BzTDx
(N=239) (N=239) (N=126) (N=130)
Incidence of PN (%)
All GradePN 3 15 12 45
Grade 2 PN 1 10 2 31
Grade 3 PN <1 5 0 5
Discontinuation due to PN (%) <1 2 1 5
VDDx=vincristine, doxorubicin, dexamethasone; BzDx= bortezomib, dexamethasone; TDx=thalidomide, dexamethasone;
BzTDx= bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy
Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral
sensory neuropathy, and polyneuropathy.
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 04358cf7e65e0c7f9e2d851b41e836f6063b44e30c5e92dc9c54cac6583efca3 · Zeichen 27277–28463 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 21
HOS-133297 · Präparat HOS-097412
Mantle cell lymphoma
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide,
doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination
regimens is presented in the table below:
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage f4f2c5c4f0f31bfd12e255d56cde60e09ec6c164415cc8b26db7cdb4bf5ec3a6 · Zeichen 28465–28711 im Abschnitt
Nebenwirkungen · Bortezomib Accord
Bortezomib Accord 2.5 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 21
HOS-133298 · Präparat HOS-097412
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment
discontinuation due to peripheral neuropathy
BzR-CAP R-CHOP
(N=240) (N=242)
Incidence of PN (%)
All GradePN 30 29
Grade 2 PN 18 9
Grade 3 PN 8 4
Discontinuation due to PN (%) 2 <1
BzR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy
Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral
motor neuropathy, and peripheral sensorimotor neuropathy
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 2026-03-25T15:00:00Z · SHA-256 95954b33292c291c1f0b9499f65ea0d9efd1266892e12a142f48541fdf5605bb · Passage 672abd964b256df558e3e460c2b0128fcdcc802d935d4899f0e90508227b7f8a · Zeichen 28713–29686 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.