Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-27 · 1381 Präparate · 72104 Quellenpassagen · 204 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Simponi
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HOS-121058 · Präparat HOS-095257
Within the RA, PsA, AS, and nr-Axial SpA pivotal trials, one patient in an RA trial with pre-existing
liver abnormalities and confounding medicinal products treated with golimumab developed
non-infectious fatal hepatitis with jaundice. The role of golimumab as a contributing or aggravation
factor cannot be excluded.
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Nebenwirkungen · Simponi
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HOS-121059 · Präparat HOS-095257
Injection site reactions
In the controlled periods of pivotal trials, 5.4% of golimumab-treated patients had injection site
reactions compared with 2.0% in control patients. The presence of antibodies to golimumab may
increase the risk of injection site reactions. The majority of the injection site reactions were mild and
moderate and the most frequent manifestation was injection site erythema. Injection site reactions
generally did not necessitate discontinuation of the medicinal product.
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Nebenwirkungen · Simponi
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HOS-121060 · Präparat HOS-095257
In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and
Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
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Nebenwirkungen · Simponi
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HOS-121061 · Präparat HOS-095257
Autoimmune antibodies
In the controlled and uncontrolled periods of pivotal trials through 1 year of follow-up, 3.5% of
golimumab-treated patients and 2.3% of control patients were newly ANA-positive (at titres of 1:160
or greater). The frequency of anti-dsDNA antibodies at 1 year of follow-up in patients anti-dsDNA
negative at baseline was 1.1%.
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Nebenwirkungen · Simponi
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HOS-121062 · Präparat HOS-095257
Paediatric population
Polyarticular juvenile idiopathic arthritis
The safety of golimumab has been studied in a Phase III study of 173 pJIA patients from 2 to 17 years
of age. The average follow-up was approximately two years. In this study, the type and frequency of
adverse events reported were generally similar to those seen in adult RA studies.
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Nebenwirkungen · Simponi
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HOS-121063 · Präparat HOS-095257
14
Ulcerative colitis
The safety of golimumab has been studied in a Phase III study of 69 patients from 4 to 17 years of age
with moderately to severely active ulcerative colitis. In this study, adverse reactions observed were
consistent with the established safety profile of golimumab in adult patients with UC.
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Nebenwirkungen · Simponi
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HOS-121064 · Präparat HOS-095257
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
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Nebenwirkungen · Simponi
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HOS-121073 · Präparat HOS-095257
Summary of the safety profile
In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory
tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated
patients compared with 11.0% of control patients. The most serious ARs that have been reported for
golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and
opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes
(lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including
anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4).
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Nebenwirkungen · Simponi
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HOS-121074 · Präparat HOS-095257
Tabulated list of adverse reactions
ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are
listed in Table 2. Within the designated system organ classes, the ARs are listed under headings of
frequency and using the following convention: 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.
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Nebenwirkungen · Simponi
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HOS-121075 · Präparat HOS-095257
Table 2
Tabulated list of ARs
Infections and infestations
Very common: Upper respiratory tract infection (nasopharyngitis,
pharyngitis, laryngitis and rhinitis)
Common: Bacterial infections (such as cellulitis), lower respiratory tract
infection (such as pneumonia), viral infections (such as
influenza and herpes), bronchitis, sinusitis, superficial fungal
infections, abscess
Uncommon: Sepsis including septic shock, pyelonephritis
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HOS-121076 · Präparat HOS-095257
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Rare: Tuberculosis, opportunistic infections (such as invasive
fungal infections [histoplasmosis, coccidioidomycosis,
pneumocytosis], bacterial, atypical mycobacterial infection
and protozoal), hepatitis B reactivation, bacterial arthritis,
infective bursitis
Neoplasms, benign, malignant and
unspecified
Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma
and melanocytic naevus)
Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma
Not known: Hepatosplenic T-cell lymphoma*, Kaposi’s sarcoma
Blood and lymphatic system
disorders
Common: Leukopenia (including neutropenia), anaemia
Uncommon: Thrombocytopenia, pancytopenia
Rare: Aplastic anaemia, agranulocytosis
Immune system disorders
Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria),
autoantibody positive
Rare: Serious systemic hypersensitivity reactions (including
anaphylactic reaction), vasculitis (systemic), sarcoidosis
Endocrine disorders
Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism
and goitre)
Metabolism and nutrition disorders
Uncommon: Blood glucose increased, lipids increased
Psychiatric disorders
Common: Depression, insomnia
Nervous system disorders
Common: Dizziness, headache, paraesthesia
Uncommon: Balance disorders
Rare: Demyelinating disorders (central and peripheral), dysgeusia
Eye disorders
Uncommon: Visual disorders (such as blurred vision and decreased visual
acuity), conjunctivitis, eye allergy (such as pruritus and
irritation)
Cardiac disorders
Uncommon: Arrhythmia, ischaemic coronary artery disorders
Rare: Congestive heart failure (new onset or worsening)
Vascular disorders
Common: Hypertension
Uncommon: Thrombosis (such as deep venous and aortic), flushing
Rare: Raynaud’s phenomenon
Respiratory, thoracic and
mediastinal disorders
Common: Asthma and related symptoms (such as wheezing and
bronchial hyperactivity)
Uncommon: Interstitial lung disease
Gastrointestinal disorders
Common: Dyspepsia, gastrointestinal and abdominal pain, nausea,
gastrointestinal inflammatory disorders (such as gastritis and
colitis), stomatitis
Uncommon: Constipation, gastro-oesophageal reflux disease
Hepatobiliary disorders
Common: Alanine aminotransferase increased, aspartate
aminotransferase increased
Uncommon: Cholelithiasis, hepatic disorders
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Nebenwirkungen · Simponi
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HOS-121077 · Präparat HOS-095257
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Skin and subcutaneous tissue
disorders
Common: Pruritus, rash, alopecia, dermatitis
Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of
pre-existing psoriasis, palmar/plantar and pustular), urticaria
Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous)
Not known: Worsening of symptoms of dermatomyositis
Musculoskeletal and connective
tissue disorders
Rare: Lupus-like syndrome
Renal and urinary disorders
Rare: Bladder disorders, renal disorders
Reproductive system and breast
disorders
Uncommon: Breast disorders, menstrual disorders
General disorders and
administration site conditions
Common: Pyrexia, asthenia, injection site reaction (such as injection site
erythema, urticaria, induration, pain, bruising, pruritus,
irritation and paraesthesia), chest discomfort
Rare: Impaired healing
Injury, poisoning and procedural
complications
Common: Bone fractures
* Observed with other TNF-blocking agents.
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Nebenwirkungen · Simponi
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HOS-121078 · Präparat HOS-095257
Throughout this section, median duration of follow-up (approximately 4 years) is generally presented
for all golimumab use. Where golimumab use is described by dose, the median duration of follow-up
varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may
have switched between doses.
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Nebenwirkungen · Simponi
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HOS-121079 · Präparat HOS-095257
Description of selected adverse reactions
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Nebenwirkungen · Simponi
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HOS-121080 · Präparat HOS-095257
Infections
In the controlled period of pivotal trials, upper respiratory tract infection was the most common
adverse reaction reported in 12.6% of golimumab-treated patients (incidence per 100 subject-years:
60.8; 95% CI: 55.0, 67.1) compared with 11.0% of control patients (incidence per 100 subject-years:
54.5; 95% CI: 46.1, 64.0). In controlled and uncontrolled portions of the studies with a median
follow-up of approximately 4 years, the incidence per 100 subject-years of upper respiratory tract
infections was 34.9 events; 95% CI: 33.8, 36.0 for golimumab treated patients.
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Nebenwirkungen · Simponi
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HOS-121081 · Präparat HOS-095257
In the controlled period of pivotal trials, infections were observed in 23.0% of golimumab-treated
patients (incidence per 100 subject-years: 132.0; 95% CI: 123.3, 141.1) compared with 20.2% of
control patients (incidence per 100 subject-years: 122.3; 95% CI: 109.5, 136.2). In controlled and
uncontrolled portions of the trials with a median follow-up of approximately 4 years, the incidence per
100 subject-years of infections was 81.1 events; 95% CI: 79.5, 82.8 for golimumab treated patients.
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Nebenwirkungen · Simponi
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HOS-121082 · Präparat HOS-095257
In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in
1.2% of golimumab-treated patients and 1.2% of control-treated patients. The incidence of serious
infections per 100 subject-years of follow-up in the controlled period of RA, PsA, AS, and nr-Axial
SpA trials was 7.3; 95% CI: 4.6, 11.1 for the golimumab 100 mg group, 2.9; 95% CI: 1.2, 6.0 for the
golimumab 50 mg group and 3.6; 95% CI: 1.5, 7.0 for the placebo group. In the controlled period of
UC trials of golimumab induction, serious infections were observed in 0.8% of golimumab-treated
patients compared with 1.5% of control-treated patients. Serious infections observed in
golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia,
invasive fungal infections and other opportunistic infections. Some of these infections have been fatal.
In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of up to
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Nebenwirkungen · Simponi
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HOS-121083 · Präparat HOS-095257
39
3 years, there was a greater incidence of serious infections, including opportunistic infections and TB
in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. The
incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients
receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
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Nebenwirkungen · Simponi
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HOS-121084 · Präparat HOS-095257
Malignancies
Lymphoma
The incidence of lymphoma in golimumab-treated patients during the pivotal trials was higher than
expected in the general population. In the controlled and uncontrolled portions of these trials with a
median follow-up of up to 3 years, a greater incidence of lymphoma was observed in patients
receiving golimumab 100 mg compared with patients receiving golimumab 50 mg. Lymphoma was
diagnosed in 11 subjects (1 in the golimumab 50 mg treatment groups and 10 in the golimumab
100 mg treatment groups) with an incidence (95% CI) per 100 subject-years of follow-up of 0.03
(0.00, 0.15) and 0.13 (0.06, 0.24) events for golimumab 50 mg and 100 mg respectively and 0.00
(0.00, 0.57) events for the placebo. The majority of lymphomas occurred in study GO-AFTER, which
enrolled patients previously exposed to anti-TNF agents who had longer disease duration and more
refractory disease (see section 4.4).
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HOS-121085 · Präparat HOS-095257
Malignancies other than lymphoma
In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the
incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between
the golimumab and the control groups. Through approximately 4 years of follow-up, the incidence of
non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general
population.
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Version 2026-01-30T15:08:00Z · SHA-256 9c07aa0af39af47a872fdf98b4749f232dd8d93a2e23d0c5c99feea1d99b8bfd · Passage bb69f076d545fd5da188cb1dcdc62cb6f8bf1f64e5fedf34550cdb7cce70dceb · Zeichen 10778–11203 im Abschnitt
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