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 · 871 Präparate · 48256 Quellenpassagen · 124 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Gegenanzeigen · Viagra
VIAGRA 25 mg film-coated tablets VIAGRA 50 mg film-coated tablets VIAGRA 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3–4
HOS-088776 · Präparat HOS-083727
3
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage 514cc64ce37e263f485f6b2f45b7111a3d36cb54fd009b79d8c7cd281fe5cd15 · Zeichen 469–682 im Abschnitt
Gegenanzeigen · Viagra
VIAGRA 50 mg orodispersible tablets · Abschnitt 4.3 · PDF-Seite 17
HOS-088836 · Präparat HOS-083727
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage 8f544c13b61bef2b6bc6eeae57ce7b53ff1b75095b32b53e2a06ade095001471 · Zeichen 413–623 im Abschnitt
Gegenanzeigen · Viagra
VIAGRA 50 mg orodispersible films · Abschnitt 4.3 · PDF-Seite 31
HOS-088887 · Präparat HOS-083727
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see
section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage abbea2eded8461c7f0476e1851671e3ba4ac296dfea68a7ea0ff323410b31eaf · Zeichen 413–623 im Abschnitt
Wechselwirkungen · Viagra
VIAGRA 25 mg film-coated tablets VIAGRA 50 mg film-coated tablets VIAGRA 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 7
HOS-088798 · Präparat HOS-083727
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 5051–5498 im Abschnitt
Wechselwirkungen · Viagra
VIAGRA 50 mg orodispersible tablets · Abschnitt 4.5 · PDF-Seite 20–21
HOS-088855 · Präparat HOS-083727
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
20
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to
symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours
post sildenafil dosing (see sections 4.2 and 4.4). In three specific drug-drug interaction studies, the
alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered
simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In
these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg,
9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg,
11/4 mmHg, and 4/5 mmHg, respectively, were observed. When sildenafil and doxazosin were
administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports
of patients who experienced symptomatic postural hypotension. These reports included dizziness and
light-headedness, but not syncope.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592) doxazosin (HOS-088800)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage b828f8947fcc03e3016c59c4b438ec2d0048266fb83b7e546a68a4e887ecc849 · Zeichen 5054–6570 im Abschnitt
Wechselwirkungen · Viagra
VIAGRA 50 mg orodispersible films · Abschnitt 4.5 · PDF-Seite 34
HOS-088905 · Präparat HOS-083727
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T10:49:00Z · SHA-256 6ad3c46b09a0a4a504f9373ab6370260a3b70fd305f7a7b80959175ca84b454e · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 5052–5499 im Abschnitt
Gegenanzeigen · Revatio
Revatio 20 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3
HOS-114920 · Präparat HOS-094193
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir)
(see section 4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592) ketoconazole (HOS-084513) itraconazole (HOS-084516) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage 459ad0687f3737f4f970b1b61385ed61356a294143302bfb2cadf8e89c4466b6 · Zeichen 246–577 im Abschnitt
Gegenanzeigen · Revatio
Revatio 0.8 mg/ml solution for injection · Abschnitt 4.3 · PDF-Seite 23
HOS-114980 · Präparat HOS-094193
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage 8f544c13b61bef2b6bc6eeae57ce7b53ff1b75095b32b53e2a06ade095001471 · Zeichen 246–456 im Abschnitt
Gegenanzeigen · Revatio
Revatio 10 mg/ml powder for oral suspension · Abschnitt 4.3 · PDF-Seite 41–42
HOS-115040 · Präparat HOS-094193
41
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lead (HOS-085592) riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage 177e7758111a4d0eb1cfc5fc32bb8f50fd7e95d7332f5fff618e734bf60a4cac · Zeichen 300–514 im Abschnitt
Wechselwirkungen · Revatio
Revatio 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8
HOS-114956 · Präparat HOS-094193
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 9926–10373 im Abschnitt
Wechselwirkungen · Revatio
Revatio 0.8 mg/ml solution for injection · Abschnitt 4.5 · PDF-Seite 28
HOS-115019 · Präparat HOS-094193
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 10769–11216 im Abschnitt
Wechselwirkungen · Revatio
Revatio 10 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 46
HOS-115077 · Präparat HOS-094193
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-10-13T14:12:00Z · SHA-256 38afb4f2877b63c9a3d5213ff8cb4458ff9d43618600f9ce01caed1bd5a4764f · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 9929–10376 im Abschnitt
Gegenanzeigen · Sildenafil ratiopharm
Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 3
HOS-121653 · Präparat HOS-095413
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators,
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
4.5).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293) lead (HOS-085592)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2022-06-24T11:00:00Z · SHA-256 c808d2606faf49a55ff479538c23c7b32973eab6a82cf87d69b7ee7085cb369e · Passage 8f544c13b61bef2b6bc6eeae57ce7b53ff1b75095b32b53e2a06ade095001471 · Zeichen 413–623 im Abschnitt
Wechselwirkungen · Sildenafil ratiopharm
Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 6
HOS-121695 · Präparat HOS-095413
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5
inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the
hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the
combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including
sildenafil, is contraindicated (see section 4.3).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): riociguat (HOS-086293)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2022-06-24T11:00:00Z · SHA-256 c808d2606faf49a55ff479538c23c7b32973eab6a82cf87d69b7ee7085cb369e · Passage fb207357e01f6963af8ef0ba3724a31dffe7034c79512e41a6f13722046d8352 · Zeichen 5054–5501 im Abschnitt
Gegenanzeigen · Adempas
Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets · Abschnitt 4.3 · PDF-Seite 6
HOS-129020 · Präparat HOS-096659
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see
sections 4.2 and 4.5).
- Severe hepatic impairment (Child Pugh C).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see sections 4.4; 4.5 and 4.6).
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form
including recreational drugs called ‘poppers’ (see section 4.5).
- Concomitant use with other soluble guanylate cyclase stimulators.
- Treatment initiation for
o children aged 6 to < 12 years with systolic blood pressure < 90 mmHg,
o patients ≥ 12 years with systolic blood pressure < 95 mmHg.
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-
IIP) (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): nitric oxide (HOS-088773) amyl nitrite (HOS-088775) sildenafil (HOS-086162) tadalafil (HOS-086316) vardenafil (HOS-086163)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-05-22T01:00:00Z · SHA-256 3d1a5306a1e99b336747bac1f508fcb4f4b6128739940b8414bff8db32c20c38 · Passage 00331715dc784e84ddd70cd7949f822340b123bb82eedce2d853740e2f7681e7 · Zeichen 0–872 im Abschnitt
Gegenanzeigen · Adempas
Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.3 · PDF-Seite 29
HOS-129069 · Präparat HOS-096659
- Co-administration with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) (see
sections 4.2 and 4.5).
- Severe hepatic impairment (Child Pugh C).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see sections 4.4; 4.5 and 4.6).
- Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form
including recreational drugs called ‘poppers’ (see section 4.5).
- Concomitant use with other soluble guanylate cyclase stimulators.
- Treatment initiation for
o children aged 6 to < 12 years with systolic blood pressure < 90 mmHg,
o patients ≥ 12 to < 18 years with systolic blood pressure < 95 mmHg.
- Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-
IIP) (see section 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sildenafil (HOS-086162) tadalafil (HOS-086316) vardenafil (HOS-086163) nitric oxide (HOS-088773) amyl nitrite (HOS-088775)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-05-22T01:00:00Z · SHA-256 3d1a5306a1e99b336747bac1f508fcb4f4b6128739940b8414bff8db32c20c38 · Passage 6efff0eb19700d01422cf4a13c7b36dbf4bb71c0578af25da3e0a6f8d6c90475 · Zeichen 0–880 im Abschnitt
Wechselwirkungen · Adempas
Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8
HOS-129030 · Präparat HOS-096659
PDE5 inhibitors
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when
riociguat was combined with either sildenafil or vardenafil. With increased doses, over additive effects
on systemic blood pressure were observed in some cases.
In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg
3 times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive
haemodynamic effects. Doses above 1 mg riociguat were not investigated in this study.
A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg 3 times
daily) and riociguat (1.0 mg to 2.5 mg 3 times daily) compared to sildenafil alone was performed. In
the long term extension part of this study (non controlled) the concomitant use of sildenafil and
riociguat resulted in a high rate of discontinuation, predominately due to hypotension. There was no
evidence of a favourable clinical effect of the combination in the population studied.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is
contraindicated (see sections 4.2 and 4.3).
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to
riociguat, in 61 adult PAH patients on stable PDE5 inhibitors. All patients were WHO Functional
Class III and 82% received background therapy with an endothelin receptor antagonist (ERA). For the
transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and
for tadalafil 3 days. Overall, the safety profile observed in the study was comparable with that
observed in the pivotal trials, with no serious adverse reactions reported during the transition period.
Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to
study drug. Changes from baseline suggested beneficial effects in selected patients, e.g. improvement
in 6MWD (+31 m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels
(-347 pg/mL), percent distribution of WHO FC I/II/III/IV (2% / 52% / 46% / 0%), and cardiac index
(+0.3 L/min/m2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sildenafil (HOS-086162) vardenafil (HOS-086163) tadalafil (HOS-086316)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-05-22T01:00:00Z · SHA-256 3d1a5306a1e99b336747bac1f508fcb4f4b6128739940b8414bff8db32c20c38 · Passage f2b7cfea8dec36ad69c76a802a67a1c0a6d4703dac7be3863930485fd346a484 · Zeichen 775–2943 im Abschnitt
Wechselwirkungen · Adempas
Adempas 0.15 mg/mL granules for oral suspension · Abschnitt 4.5 · PDF-Seite 30–31
HOS-129073 · Präparat HOS-096659
30
PDE5 inhibitors
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when
riociguat was combined with either sildenafil or vardenafil. With increased doses, over additive effects
on systemic blood pressure were observed in some cases.
In an exploratory interaction study in 7 patients with PAH on stable sildenafil treatment (20 mg
3 times daily) single doses of riociguat (0.5 mg and 1 mg sequentially) showed additive
haemodynamic effects. Doses above 1 mg riociguat were not investigated in this study.
A 12 week combination study in 18 patients with PAH on stable sildenafil treatment (20 mg 3 times
daily) and riociguat (1.0 mg to 2.5 mg 3 times daily) compared to sildenafil alone was performed. In
the long term extension part of this study (non controlled) the concomitant use of sildenafil and
riociguat resulted in a high rate of discontinuation, predominately due to hypotension. There was no
evidence of a favourable clinical effect of the combination in the population studied.
Concomitant use of riociguat with PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil) is
contraindicated (see sections 4.2 and 4.3).
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to
riociguat, in 61 adult PAH patients on stable PDE5 inhibitors. All patients were WHO Functional
Class III and 82% received background therapy with an endothelin receptor antagonist (ERA). For the
transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and
for tadalafil 3 days. Overall, the safety profile observed in the study was comparable with that
observed in the pivotal trials, with no serious adverse reactions reported during the transition period.
Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to
study drug. Changes from baseline suggested beneficial effects in selected patients, e.g. improvement
in 6MWD (+31 m), N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels
(-347 pg/mL), percent distribution of WHO FC I/II/III/IV (2% / 52% / 46% / 0%), and cardiac index
(+0.3 L/min/m2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sildenafil (HOS-086162) vardenafil (HOS-086163) tadalafil (HOS-086316)
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