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.
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HOS-121038 · 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-121039 · 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-121040 · 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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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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HOS-121042 · 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-121043 · 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-121044 · Präparat HOS-095257
Description of selected adverse reactions
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HOS-121045 · 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-121046 · 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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HOS-121047 · 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-121048 · Präparat HOS-095257
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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-121049 · 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-121050 · 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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Nebenwirkungen · Simponi
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HOS-121051 · Präparat HOS-095257
In the controlled and uncontrolled periods of pivotal trials with a median follow-up of up to 3 years,
non-melanoma skin cancer was diagnosed in 5 placebo-treated, 10 golimumab 50 mg-treated and 31
golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of
0.36 (0.26, 0.49) for combined golimumab and 0.87 (0.28, 2.04) for placebo.
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Nebenwirkungen · Simponi
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HOS-121052 · Präparat HOS-095257
In the controlled and uncontrolled period of pivotal trials with a median follow-up of up to 3 years,
malignancies besides melanoma, non-melanoma skin cancer and lymphoma were diagnosed in 5
placebo-treated, 21 golimumab 50 mg-treated and 34 golimumab 100 mg-treated subjects with an
incidence (95% CI) per 100 subject-years of follow-up of 0.48 (0.36, 0.62) for combined golimumab
and 0.87 (0.28, 2.04) for placebo (see section 4.4).
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Nebenwirkungen · Simponi
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HOS-121053 · Präparat HOS-095257
Cases reported in clinical studies in asthma
In an exploratory clinical study, patients with severe persistent asthma received a golimumab loading
dose (150% of the assigned treatment dose) subcutaneously at week 0 followed by golimumab
200 mg, golimumab 100 mg or golimumab 50 mg every 4 weeks subcutaneously through week 52.
Eight malignancies in the combined golimumab treatment group (n = 230) and none in the placebo
treatment group (n = 79) were reported. Lymphoma was reported in 1 patient, non-melanoma skin
cancer in 2 patients, and other malignancies in 5 patients. There was no specific clustering of any type
of malignancy.
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Nebenwirkungen · Simponi
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HOS-121054 · Präparat HOS-095257
During the placebo-controlled portion of the study, the incidence (95% CI) of all malignancies per
100 subject-years of follow-up was 3.19 (1.38, 6.28) in the golimumab group. In this study, the
incidence (95% CI) per 100 subject-years of follow-up in golimumab-treated subjects was 0.40 (0.01,
2.20) for lymphoma, 0.79 (0.10, 2.86) for non-melanoma skin cancers, and 1.99 (0.64, 4.63) for other
malignancies. For placebo subjects, the incidence (95% CI) per 100 subject-years of follow-up of
these malignancies was 0.00 (0.00, 2.94). The significance of this finding is unknown.
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HOS-121055 · Präparat HOS-095257
Neurological events
In the controlled and uncontrolled periods of the pivotal trials with a median follow-up of up to
3 years, a greater incidence of demyelination was observed in patients receiving golimumab 100 mg
compared with patients receiving golimumab 50 mg (see section 4.4).
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HOS-121056 · Präparat HOS-095257
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Liver enzyme elevations
In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit
of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and
PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more
golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations. In the
controlled and uncontrolled periods of the RA and PsA pivotal trials, with a median follow-up of
approximately 5 years, the incidence of mild ALT elevations was similar in golimumab-treated and
control patients in RA and PsA studies. In the controlled period of the UC pivotal trials of golimumab
induction, mild ALT elevations (> 1 and < 3 x ULN) occurred in similar proportions of
golimumab-treated and control patients (8.0% to 6.9%, respectively). In controlled and uncontrolled
periods of the UC pivotal trials with a median follow-up of approximately 2 years, the proportion of
patients with mild ALT elevations was 24.7% in patients receiving golimumab during the maintenance
portion of the UC study.
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 2026-01-30T15:08:00Z · SHA-256 9c07aa0af39af47a872fdf98b4749f232dd8d93a2e23d0c5c99feea1d99b8bfd · Passage 1b7124344173d238f67eb0db033b8398a3d60a680f831f42e858b1e32e082281 · Zeichen 13609–14723 im Abschnitt
Nebenwirkungen · Simponi
Simponi 45 mg/0.45 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 14
HOS-121057 · Präparat HOS-095257
In the controlled period of RA and AS pivotal trials, ALT elevations ≥ 5 x ULN were uncommon and
seen in more golimumab-treated patients (0.4% to 0.9%) than control patients (0.0%). This trend was
not observed in the PsA population. In the controlled and uncontrolled periods of RA, PsA and AS
pivotal trials, with a median follow-up of 5 years, the incidence of ALT elevations ≥ 5 x ULN was
similar in both golimumab-treated and control patients. In general these elevations were asymptomatic
and the abnormalities decreased or resolved with either continuation or discontinuation of golimumab
or modification of concomitant medicinal products. No cases were reported in the controlled and
uncontrolled periods of the nr-Axial SpA study (up to 1 year). In the controlled periods of the pivotal
UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of
golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively). In the
controlled and uncontrolled periods of the pivotal UC trials with a median follow-up of approximately
2 years, the proportion of patients with ALT elevations ≥ 5 x ULN was 0.8% in patients receiving
golimumab during the maintenance portion of the UC study.
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 2026-01-30T15:08:00Z · SHA-256 9c07aa0af39af47a872fdf98b4749f232dd8d93a2e23d0c5c99feea1d99b8bfd · Passage c413876a8151f5e776c9e34e98af7204c5a0575c0857a087b6643506373a1c53 · Zeichen 14725–15972 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.