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 · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17
HOS-089895 · Präparat HOS-083941
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal
oedema and severe bronchospasm, and seizure have been associated with Remicade administration
(see section 4.4).
Cases of transient visual loss occurring during or within 2 hours of Remicade infusion have been
reported. Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported,
some in close temporal association with infusion of infliximab; cerebrovascular accidents have also
been reported in close temporal association with infusion of infliximab.
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 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 4bd0733d3bc11edaa183532b855edca6794c957106fd97378334129b9c0ceeb6 · Zeichen 12194–12775 im Abschnitt
Nebenwirkungen · Remicade
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HOS-089896 · Präparat HOS-083941
Infusion reactions following re-administration of Remicade
A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and
safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade
(maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare. Patients did not receive
any concomitant immunosuppressant therapy. In the re-treatment arm, 4% (8/219) of patients
experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy. The majority of
serious infusion reactions occurred during the second infusion at week 2. The interval between the last
maintenance dose and the first re-induction dose ranged from 35-231 days. Symptoms included, but
were not limited to, dyspnoea, urticaria, facial oedema, and hypotension. In all cases, Remicade
treatment was discontinued and/or other treatment instituted with complete resolution of signs and
symptoms.
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 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage a0eb75da9eb6c0e3b57c698bd75798240ef1810b6aefdaea9a3315e82d29e7cb · Zeichen 12777–13736 im Abschnitt
Nebenwirkungen · Remicade
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HOS-089897 · Präparat HOS-083941
17
Delayed hypersensitivity
In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after
Remicade-free intervals of less than 1 year. In the psoriasis studies, delayed hypersensitivity reactions
occurred early in the treatment course. Signs and symptoms included myalgia and/or arthralgia with
fever and/or rash, with some patients experiencing pruritus, facial, hand or lip oedema, dysphagia,
urticaria, sore throat and headache.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089898 · Präparat HOS-083941
There are insufficient data on the incidence of delayed hypersensitivity reactions after Remicade-free
intervals of more than 1 year but limited data from clinical studies suggest an increased risk for
delayed hypersensitivity with increasing Remicade-free interval (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 · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089899 · Präparat HOS-083941
In a 1-year clinical study with repeated infusions in patients with Crohn’s disease (ACCENT I study),
the incidence of serum sickness-like reactions was 2.4%.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 5d1eed18a62dbd7578839870b9098dc9073c5f823dbc171ff9e7bd8d82da2c9b · Zeichen 14557–14715 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089900 · Präparat HOS-083941
Immunogenicity
Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop
infusion-related reactions. Use of concomitant immunosuppressant agents appeared to reduce the
frequency of infusion-related reactions.
In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies
to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24%
of patients without immunosuppressant therapy. In rheumatoid arthritis patients who received the
recommended repeated treatment dose regimens with methotrexate, 8% of patients developed
antibodies to infliximab. In psoriatic arthritis patients who received 5 mg/kg with and without
methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients
receiving methotrexate and in 26% of patients not receiving methotrexate at baseline). In Crohn’s
disease patients who received maintenance treatment, antibodies to infliximab occurred overall in
3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving
immunosuppressants. The antibody incidence was 2-3 fold higher for patients treated episodically.
Due to methodological limitations, a negative assay did not exclude the presence of antibodies to
infliximab. Some patients who developed high titres of antibodies to infliximab had evidence of
reduced efficacy. In psoriasis patients treated with infliximab as a maintenance regimen in the absence
of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see
section 4.4: “Infusion reactions and hypersensitivity”).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 0bb56213fe476b93cbda116ac077cba5fc01c9ee1dddcd472b6b514da8518ae4 · Zeichen 14717–16371 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089901 · Präparat HOS-083941
Infections
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other
opportunistic infections have been observed in patients receiving Remicade. Some of these infections
have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5%
include pneumocystosis, candidiasis, listeriosis and aspergillosis (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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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 7a3815f8bedc9280f1ab69fbeeaca7f7eff70c89c5b6116b51dab2f750b3b1b9 · Zeichen 16373–16773 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089902 · Präparat HOS-083941
In clinical studies 36% of infliximab-treated patients were treated for infections compared with 25% of
placebo-treated patients.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089903 · Präparat HOS-083941
In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was
higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at
doses of 6 mg/kg or greater (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 · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089904 · Präparat HOS-083941
In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Some of the cases have resulted in a fatal outcome. Nearly 50% of reported deaths have been
associated with infection. Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and
tuberculosis with extra-pulmonary location have been reported (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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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 76f2091fb2314ab8deeed555f3eab506c828e49fa44d54323a0936e88c5daa28 · Zeichen 17159–17531 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 18
HOS-089905 · Präparat HOS-083941
Malignancies and lymphoproliferative disorders
In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient
years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no
lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing
941 patient years.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage d92652f50a7e077f0ce9a52e59f889506269fa3f353cc7431d4351fd694a2ab7 · Zeichen 17533–17881 im Abschnitt
Nebenwirkungen · Remicade
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HOS-089906 · Präparat HOS-083941
18
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing
6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma
malignancies were reported.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 5dcb88e66709a81b663b9b68e01329badd60fe4710fcb2bfddece0ab6cd4b3c4 · Zeichen 17935–18151 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089907 · Präparat HOS-083941
Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting
(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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Version 2025-12-15T13:59:00Z · SHA-256 3fe5ec643ebd8b47f3d2adf8a19ade1224c614e70c07c2d563b0cf68054693ab · Passage 3b07a10fe0707c8cea96973e07eff92924ed4994b77eaf96918a0e6f72a5272b · Zeichen 18153–18268 im Abschnitt
Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089908 · Präparat HOS-083941
In an exploratory clinical study involving patients with moderate to severe COPD who were either
current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to
those used in rheumatoid arthritis and Crohn’s disease. Nine of these patients developed malignancies,
including 1 lymphoma. The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI
2.65%-10.6%]. There was one reported malignancy amongst 77 control patients (median duration of
follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]). The majority of the malignancies
developed in the lung or head and neck.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089909 · Präparat HOS-083941
A population-based retrospective cohort study found an increased incidence of cervical cancer in
women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the
general population, including those over 60 years of age (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 · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089910 · Präparat HOS-083941
In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients
treated with Remicade with the vast majority of cases occurring in Crohn’s disease and ulcerative
colitis, and most of whom were adolescent or young adult males (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 · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089911 · Präparat HOS-083941
Heart failure
In a Phase II study aimed at evaluating Remicade in CHF, higher incidence of mortality due to
worsening of heart failure were seen in patients treated with Remicade, especially those treated with
the higher dose of 10 mg/kg (i.e. twice the maximum approved dose). In this study 150 patients with
NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of
Remicade 5 mg/kg, 10 mg/kg, or placebo over 6 weeks. At 38 weeks, 9 of 101 patients treated with
Remicade (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on
placebo.
There have been post-marketing reports of worsening heart failure, with and without identifiable
precipitating factors, in patients taking Remicade. There have also been post-marketing reports of new
onset heart failure, including heart failure in patients without known pre-existing cardiovascular
disease. Some of these patients have been under 50 years of age.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Remicade
Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 19
HOS-089912 · Präparat HOS-083941
Hepatobiliary events
In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients
receiving Remicade without progression to severe hepatic injury. Elevations of ALT ≥ 5 x Upper
Limit of Normal (ULN) have been observed (see Table 2). Elevations of aminotransferases were
observed (ALT more common than AST) in a greater proportion of patients receiving Remicade than
in controls, both when Remicade was given as monotherapy and when it was used in combination with
other immunosuppressive agents. Most aminotransferase abnormalities were transient; however, a
small number of patients experienced more prolonged elevations. In general, patients who developed
ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either
continuation or discontinuation of Remicade, or modification of concomitant therapy. In
post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune
hepatitis, have been reported in patients receiving Remicade (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 · Remicade
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HOS-089913 · Präparat HOS-083941
19
Table 2
Proportion of patients with increased ALT activity in clinical studies
Indication Number of patients3 Median follow-up ≥ 3 x ULN ≥ 5 x ULN
(wks)4
placeb infliximab placebo infliximab placebo infliximab placebo infliximab
o
Rheumatoid 375 1,087 58.1 58.3 3.2% 3.9% 0.8% 0.9%
arthritis1
Crohn’s 324 1034 53.7 54.0 2.2% 4.9% 0.0% 1.5%
disease2
Paediatric N/A 139 N/A 53.0 N/A 4.4% N/A 1.5%
Crohn’s
disease
Ulcerative 242 482 30.1 30.8 1.2% 2.5% 0.4% 0.6%
colitis
Paediatric N/A 60 N/A 49.4 N/A 6.7% N/A 1.7%
Ulcerative
colitis
Ankylosing 76 275 24.1 101.9 0.0% 9.5% 0.0% 3.6%
spondylitis
Psoriatic 98 191 18.1 39.1 0.0% 6.8% 0.0% 2.1%
arthritis
Plaque 281 1,175 16.1 50.1 0.4% 7.7% 0.0% 3.4%
psoriasis
1
Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
2
Placebo patients in the 2 Phase III studies in Crohn’s disease, ACCENT I and ACCENT II, received an initial dose of
5 mg/kg infliximab at study start and were on placebo in the maintenance phase. Patients who were randomised to the
placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT
analysis. In the Phase IIIb trial in Crohn’s disease, SONIC, placebo patients received AZA 2.5 mg/kg/day as active
control in addition to placebo infliximab infusions.
3
Number of patients evaluated for ALT.
4
Median follow-up is based on patients treated.
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Nebenwirkungen · Remicade
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HOS-089914 · Präparat HOS-083941
Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Approximately half of infliximab-treated patients in clinical studies who were ANA negative at
baseline developed a positive ANA during the study compared with approximately one fifth of
placebo-treated patients. Anti-dsDNA antibodies were newly detected in approximately 17% of
infliximab-treated patients compared with 0% of placebo-treated patients. At the last evaluation, 57%
of infliximab-treated patients remained anti-dsDNA positive. Reports of lupus and lupus-like
syndromes, however, remain uncommon (see section 4.4).
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