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 · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 12–13
HOS-153874 · Präparat HOS-101064
12
MedDRA system organ
Frequency Adverse Reaction
class
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 Common: Asthma and related symptoms (such as wheezing and
mediastinal disorders 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,
gastrooesophageal reflux disease.
Hepatobiliary disorders Common: Alanine aminotransferase increased,
aspartate aminotransferase increased.
Uncommon: Cholelithiasis,
hepatic disorders.
Skin and subcutaneous Common: Pruritus,
tissue disorders 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 Rare: Lupus-like syndrome.
connective tissue
disorders
Renal and urinary Rare: Bladder disorders,
disorders renal disorders.
Reproductive system and Uncommon: Breast disorders,
breast disorders menstrual disorders.
General disorders and Common: Pyrexia,
administration site asthenia,
conditions injection site reaction (such as injection site
erythema, urticaria, induration, pain, bruising,
pruritus, irritation and paraesthesia),
chest discomfort.
Rare: Impaired healing.
Injury, poisoning and Common: Bone fractures.
procedural complications
* Observed with other TNF-blocking agents.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 13
HOS-153875 · Präparat HOS-101064
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
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 13–14
HOS-153876 · Präparat HOS-101064
13
varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may
have switched between doses.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14
HOS-153877 · Präparat HOS-101064
Description of selected adverse reactions
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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14
HOS-153878 · Präparat HOS-101064
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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14
HOS-153879 · Präparat HOS-101064
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 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.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14
HOS-153880 · Präparat HOS-101064
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).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14
HOS-153881 · Präparat HOS-101064
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 · Gotenfia
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HOS-153882 · Präparat HOS-101064
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 · Gotenfia
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HOS-153883 · Präparat HOS-101064
14
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 · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15
HOS-153884 · Präparat HOS-101064
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 · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15
HOS-153885 · Präparat HOS-101064
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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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15
HOS-153886 · Präparat HOS-101064
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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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15
HOS-153887 · Präparat HOS-101064
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.
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Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15
HOS-153888 · Präparat HOS-101064
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.
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Nebenwirkungen · Gotenfia
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HOS-153889 · Präparat HOS-101064
15
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 · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16
HOS-153890 · Präparat HOS-101064
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 · Gotenfia
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HOS-153891 · Präparat HOS-101064
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 · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16
HOS-153892 · Präparat HOS-101064
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%.
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 2026-07-01T14:34:00Z · SHA-256 9ed339171b0daaef4c95efe77e333a813f5a2e0f8a3934c14714714e9cc0cd6e · Passage 126700931816c2348527988372212adfebdd5fdf39e57514cfa1f26e5a3cf02e · Zeichen 19329–19677 im Abschnitt
Nebenwirkungen · Gotenfia
Gotenfia 50 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16
HOS-153893 · Präparat HOS-101064
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.
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 2026-07-01T14:34:00Z · SHA-256 9ed339171b0daaef4c95efe77e333a813f5a2e0f8a3934c14714714e9cc0cd6e · Passage f6a094306dba6853753801c99a6d2f27b67a36e9c54eb373eabaa1476750248d · Zeichen 19679–20028 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.