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.
Wechselwirkungen · Reyataz
REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 17–18
HOS-112095 · Präparat HOS-093615
17
Medicinal products by Interaction Recommendations concerning co-
therapeutic area administration
Dabigatran Potential for increased dabigatran Co-administration of dabigatran
concentrations which can result in a higher and REYATAZ with ritonavir is
risk of bleeding. The mechanism of not recommended.
interaction is P-gp inhibition.
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): dabigatran (HOS-112096) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage 1da67caa2ea4887c739b1c8f8555e8036b416a130ad1df429cf9e622b24583fd · Zeichen 40456–41008 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules · Abschnitt 4.5 · PDF-Seite 24–25
HOS-112119 · Präparat HOS-093615
24
In case of withdrawal of ritonavir from the recommended atazanavir-boosted regimen
(see section 4.4)
The same recommendations for drug interactions would apply except:
that co-administration is not recommended with tenofovir, proton pump inhibitors, and
buprenorphine and contraindicated with carbamazepine, phenytoin and phenobarbital.
that co-administration with famotidine is not recommended but if required, atazanavir without
ritonavir should be administered either 2 hours after famotidine or 12 hours before. No single
dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not
exceed 40 mg.
the need to consider that:
co-administration of apixaban, dabigatran, or rivaroxaban and REYATAZ without
ritonavir may affect apixaban, dabigatran, or rivaroxaban concentrations
co-administration of voriconazole and REYATAZ without ritonavir may affect atazanavir
concentrations
co-administration of fluticasone and REYATAZ without ritonavir may increase
fluticasone concentrations relative to fluticasone given alone
if an oral contraceptive is administered with REYATAZ without ritonavir, it is
recommended that the oral contraceptive contain no more than 30 μg of ethinyloestradiol
no dose adjustment of lamotrigine is required
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): tenofovir (HOS-088083) lamotrigine (HOS-086242) fluticasone (HOS-108914) phenobarbital (HOS-085617) carbamazepine (HOS-085618) famotidine (HOS-112087) dabigatran (HOS-112096) buprenorphine (HOS-086193) rivaroxaban (HOS-086236) voriconazole (HOS-084524) apixaban (HOS-112091) ritonavir (HOS-084521) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage e782985711b73a21e78ab499d92e8fece89fe8ca127ddbacf1a99dce682dcc07 · Zeichen 75495–76934 im Abschnitt
Wechselwirkungen · Reyataz
REYATAZ 50 mg oral powder · Abschnitt 4.5 · PDF-Seite 53
HOS-112186 · Präparat HOS-093615
REYATAZ is an inhibitor of CYP3A4. The
potential inhibition of P-gp by REYATAZ
is unknown and cannot be excluded.
Dabigatran Potential for increased dabigatran Co-administration of
concentrations which can result in a higher dabigatran and REYATAZ
risk of bleeding. The mechanism of with ritonavir is not
interaction is P-gp inhibition. recommended.
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): dabigatran (HOS-112096) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-06-29T13:00:00Z · SHA-256 ff5481974bd7c752b73fa0c147cf3e96fc892edc735359fa71817833db471beb · Passage c940401e8d9aba45346c6c621af29b79b9337e9fc9276b80a2674797821bd8c9 · Zeichen 41317–41891 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 15–16
HOS-116363 · Präparat HOS-094447
15
ANTIBIOTIC
Clarithromycin clarithromycin AUC ↑ 57% Caution should be exercised when
500 mg twice daily
clarithromycin Cmin ↑ 174% clarithromycin is combined with
clarithromycin Cmax ↑ 26% boosted PREZISTA.
#
darunavir AUC ↓ 13%
#
darunavir Cmin ↑ 1% For patients with renal impairment
# the Summary of Product
darunavir Cmax ↓ 17%
Characteristics for clarithromycin
14-OH-clarithromycin concentrations
should be consulted for the
were not detectable when combined with
recommended dose.
PREZISTA/ritonavir.
(↑ clarithromycin from CYP3A inhibition
and possible P-gp inhibition)
ANTICOAGULANT/PLATELET AGGREGATION INHIBITOR
Apixaban Not studied. Co-administration of The use of boosted PREZISTA
Rivaroxaban boosted PREZISTA with these with a direct oral anticoagulant
anticoagulants may increase (DOAC) that is metabolised by
concentrations of the anticoagulant. CYP3A4 and transported by P-gp
(CYP3A and/or P-gp inhibition) is not recommended as this may
lead to an increased bleeding risk.
Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir:
Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose
dose: reduction of the DOAC should be
dabigatran AUC ↑ 72% considered when a DOAC
dabigatran Cmax ↑ 64% transported by P-gp but not
metabolised by CYP3A4,
darunavir/ritonavir 800/100 mg once including dabigatran etexilate and
daily: edoxaban, is co-administered with
dabigatran AUC ↑ 18% PREZISTA/rtv.
dabigatran Cmax ↑ 22%
Darunavir/cobicistat:
darunavir/cobicistat 800/150 mg single Clinical monitoring and dose
dose: reduction is required when a
dabigatran AUC ↑ 164% DOAC transported by P-gp but not
dabigatran Cmax ↑ 164% metabolised by CYP3A4,
including dabigatran etexilate and
darunavir/cobicistat 800/150 mg once edoxaban, is co-administered with
daily: PREZISTA/cobi.
dabigatran AUC ↑ 88%
dabigatran Cmax ↑ 99%
Ticagrelor Concomitant administration of
Based on theoretical considerations,
boosted PREZISTA with ticagrelor
co-administration of boosted PREZISTA
is contraindicated (see section 4.3).
with ticagrelor may increase
concentrations of ticagrelor (CYP3A
and/or P-glycoprotein inhibition).
Clopidogrel Co-administration of clopidogrel
Not studied. Co-administration of
with boosted PREZISTA is not
clopidogrel with boosted PREZISTA is
recommended. Use of other
expected to decrease clopidogrel active
antiplatelets not affected by CYP
metabolite plasma concentration, which
inhibition or induction (e.g.
may reduce the antiplatelet activity of
prasugrel) is recommended.
clopidogrel.
Warfarin Not studied. Warfarin concentrations may It is recommended that the
be affected when co-administered with international normalised ratio
boosted PREZISTA. (INR) be monitored when warfarin
is combined with boosted
PREZISTA.
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): ticagrelor (HOS-112065) cobicistat (HOS-088111) dabigatran (HOS-112096) rivaroxaban (HOS-086236) lead (HOS-085592) clopidogrel (HOS-087927) clarithromycin (HOS-084517) edoxaban (HOS-086234) apixaban (HOS-112091) prasugrel (HOS-112066) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage c517feec8afcc30d3aa41f1410083f5273e19d3aef8a7a29cc68426909e25762 · Zeichen 29322–34850 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 57–58
HOS-116518 · Präparat HOS-094447
57
Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir:
Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose
dose: reduction of the DOAC should be
dabigatran AUC ↑ 72% considered when a DOAC
dabigatran Cmax ↑ 64% transported by P-gp but not
metabolised by CYP3A4,
darunavir/ritonavir 800/100 mg once including dabigatran etexilate and
daily: edoxaban, is co-administered with
dabigatran AUC ↑ 18% PREZISTA/rtv.
dabigatran Cmax ↑ 22%
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): dabigatran (HOS-112096) edoxaban (HOS-086234) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 27db9f0bf7d3eff8fc751958b0898ab6c1c88cc80ae072e5e8522c23a9e450e5 · Zeichen 24652–25546 im Abschnitt
Wechselwirkungen · Prezista
PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 97–98
HOS-116609 · Präparat HOS-094447
97
Dabigatran etexilate dabigatran etexilate (150 mg): Darunavir/ritonavir:
Edoxaban darunavir/ritonavir 800/100 mg single Clinical monitoring and/or dose
dose: reduction of the DOAC should be
dabigatran AUC ↑ 72% considered when a DOAC
dabigatran Cmax ↑ 64% transported by P-gp but not
metabolised by CYP3A4,
darunavir/ritonavir 800/100 mg once including dabigatran etexilate and
daily: edoxaban, is co-administered with
dabigatran AUC ↑ 18% PREZISTA/rtv.
dabigatran Cmax ↑ 22%
Darunavir/cobicistat:
darunavir/cobicistat 800/150 mg single Clinical monitoring and dose
dose: reduction is required when a
dabigatran AUC ↑ 164% DOAC transported by P-gp but not
dabigatran Cmax ↑ 164% metabolised by CYP3A4,
including dabigatran etexilate and
darunavir/cobicistat 800/150 mg once edoxaban, is co-administered with
daily: PREZISTA/cobi.
dabigatran AUC ↑ 88%
dabigatran Cmax ↑ 99%
Ticagrelor Based on theoretical considerations, Concomitant administration of
co-administration of boosted PREZISTA boosted PREZISTA with ticagrelor
with ticagrelor may increase is contraindicated (see section 4.3).
concentrations of ticagrelor (CYP3A
and/or P-glycoprotein inhibition).
Clopidogrel Not studied. Co-administration of Co-administration of clopidogrel
clopidogrel with boosted PREZISTA is with boosted PREZISTA is not
expected to decrease clopidogrel active recommended. Use of other
metabolite plasma concentration, which antiplatelets not affected by CYP
may reduce the antiplatelet activity of inhibition or induction (e.g.
clopidogrel prasugrel) is recommended.
Warfarin Not studied. Warfarin concentrations may It is recommended that the
be affected when co-administered with international normalised ratio
boosted PREZISTA. (INR) be monitored when warfarin
is combined with boosted
PREZISTA.
ANTICONVULSANTS
Phenobarbital Not studied. Phenobarbital and phenytoin PREZISTA co-administered with
Phenytoin are expected to decrease plasma low dose ritonavir should not be
concentrations of darunavir and its used in combination with these
pharmacoenhancer. medicines.
(induction of CYP450 enzymes)
The use of these medicines with
PREZISTA/cobicistat 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): ticagrelor (HOS-112065) phenobarbital (HOS-085617) cobicistat (HOS-088111) dabigatran (HOS-112096) clopidogrel (HOS-087927) edoxaban (HOS-086234) prasugrel (HOS-112066) ritonavir (HOS-084521) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2024-07-26T09:44:00Z · SHA-256 457dafbe8b3b9cee45b9ca7b46919ded598e0d0cd16715525d161e54f80b9117 · Passage 39d7135aa5b8b1dfa56535d5e896900efac27586a70d7bbd090683d83951a637 · Zeichen 31232–35170 im Abschnitt
Wechselwirkungen · Torisel
Torisel 30 mg concentrate and solvent for solution for infusion · Abschnitt 4.5 · PDF-Seite 10
HOS-208985 · Präparat HOS-154221
In an in vitro study, temsirolimus inhibited the transport of P-glycoprotein (P-gp) substrates with an
IC50 value of 2 µM. In vivo, the effect of P-gp inhibition has not been investigated in a clinical
drug-drug interaction study, however, recent preliminary data from a Phase 1 study of combined
lenalidomide (dose of 25 mg) and temsirolimus (dose of 20 mg) seem to support the in vitro findings
and suggest an increased risk of adverse events. Therefore, when temsirolimus is co-administered with
medicinal products which are P-gp substrates (e.g. digoxin, vincristine, colchicine, dabigatran,
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): digoxin (HOS-086172) vincristine (HOS-086219) lenalidomide (HOS-117069) dabigatran (HOS-112096) colchicine (HOS-086147)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-03-03T15:46:00Z · SHA-256 f3c5550dfcb830d2de46566ba2243d0ebed5a8365e91770a67e6d6f36e348415 · Passage 51846b71a6e4566be828cca0ba3ff7694190759e2a9b770c396a8869ffca40bc · Zeichen 4730–5325 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11
HOS-118627 · Präparat HOS-094855
Dabigatran etexilate is a substrate for the efflux transporter P-gp. Concomitant administration of P-gp
inhibitors (see table 7) is expected to result in increased dabigatran plasma concentrations.
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): dabigatran (HOS-112096)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 3e6d26d9f974e738234ba37b2f2d0e2960c832469f531c76ee7e19608d05625d · Zeichen 26–223 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11
HOS-118628 · Präparat HOS-094855
If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or
anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors. Dose reductions
may be required in combination with some P-gp inhibitors (see sections 4.2, 4.3, 4.4 and 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): dabigatran (HOS-112096)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 2ed66e046c4c48b35b40866bf59cbb5444acfb442c8356d12ba331fd78603396 · Zeichen 225–523 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11
HOS-118632 · Präparat HOS-094855
Ketoconazole Ketoconazole increased total dabigatran AUC0-∞ and Cmax values by 2.38-fold and
2.35-fold, respectively, after a single oral dose of 400 mg, and by 2.53-fold and
2.49-fold, respectively, after multiple oral dosing of 400 mg ketoconazole once
daily.
Dronedarone When dabigatran etexilate and dronedarone were given at the same time total
dabigatran AUC0-∞ and Cmax values increased by about 2.4-fold and 2.3-fold,
respectively, after multiple dosing of 400 mg dronedarone bid, and about 2.1-fold
and 1.9-fold, respectively, after a single dose of 400 mg.
Itraconazole, Based on in vitro results a similar effect as with ketoconazole may be expected.
cyclosporine
Glecaprevir / The concomitant use of dabigatran etexilate with the fixed-dose combination of
pibrentasvir the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure
of dabigatran and may increase the risk of bleeding.
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): dronedarone (HOS-086144) ketoconazole (HOS-084513) pibrentasvir (HOS-086298) glecaprevir (HOS-086297) dabigatran (HOS-112096) itraconazole (HOS-084516) cyclosporine (HOS-084512)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage b497c2d17a671eadd6d3621f31894d932a018ff0cc8853d598c918ee52245e3c · Zeichen 637–1725 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12
HOS-118636 · Präparat HOS-094855
Verapamil When dabigatran etexilate (150 mg) was co-administered with oral verapamil,
the Cmax and AUC of dabigatran were increased but the magnitude of this change
differs depending on timing of administration and formulation of verapamil (see
sections 4.2 and 4.4).
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): dabigatran (HOS-112096) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 20aee27b01311018027650be35932bd07e016f0fef7b00e831c44c6bfb49a1be · Zeichen 2384–2713 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12
HOS-118637 · Präparat HOS-094855
The greatest elevation of dabigatran exposure was observed with the first dose of
an immediate release formulation of verapamil administered one hour prior to the
dabigatran etexilate intake (increase of Cmax by about 2.8-fold and AUC by about
2.5-fold). The effect was progressively decreased with administration of an
extended release formulation (increase of Cmax by about 1.9-fold and AUC by
about 1.7-fold) or administration of multiple doses of verapamil (increase of Cmax
by about 1.6-fold and AUC by about 1.5-fold).
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): dabigatran (HOS-112096) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage d77e67bd8c1e57a8424c897a3ee0ff3fac36c116c84a0d16522bc6e146adbcf7 · Zeichen 2733–3365 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12
HOS-118638 · Präparat HOS-094855
There was no meaningful interaction observed when verapamil was given
2 hours after dabigatran etexilate (increase of Cmax by about 1.1-fold and AUC by
about 1.2-fold). This is explained by completed dabigatran absorption after
2 hours.
Amiodarone When dabigatran etexilate was co-administered with a single oral dose of 600 mg
amiodarone, the extent and rate of absorption of amiodarone and its active
metabolite DEA were essentially unchanged. The dabigatran AUC and Cmax were
increased by about 1.6-fold and 1.5-fold, respectively. In view of the long
half-life of amiodarone the potential for an interaction may exist for weeks after
discontinuation of amiodarone (see sections 4.2 and 4.4).
Quinidine Quinidine was given as 200 mg dose every 2nd hour up to a total dose of
1 000 mg. Dabigatran etexilate was given twice daily over 3 consecutive days, on
the 3rd day either with or without quinidine. Dabigatran AUCτ,ss and Cmax,ss were
increased on average by 1.53-fold and 1.56-fold, respectively with concomitant
quinidine (see sections 4.2 and 4.4).
Clarithromycin When clarithromycin (500 mg twice daily) was administered together with
dabigatran etexilate in healthy volunteers, increase of AUC by about 1.19-fold
and Cmax by about 1.15-fold was observed.
Ticagrelor When a single dose of 75 mg dabigatran etexilate was coadministered
simultaneously with a loading dose of 180 mg ticagrelor, the dabigatran AUC
and Cmax were increased by 1.73-fold and 1.95-fold, respectively. After multiple
doses of ticagrelor 90 mg b.i.d. the increase of dabigatran exposure is 1.56-fold
and 1.46-fold for Cmax and AUC, respectively.
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): ticagrelor (HOS-112065) quinidine (HOS-085593) dabigatran (HOS-112096) clarithromycin (HOS-084517) amiodarone (HOS-085596) verapamil (HOS-090602)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage f116df601c50f4f32f2fd36d8bc3a9439cdd0a0e7e55d2f7ca9f4bc9db279c31 · Zeichen 3385–5363 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12
HOS-118639 · Präparat HOS-094855
Concomitant administration of a loading dose of 180 mg ticagrelor and 110 mg
dabigatran etexilate (in steady state) increased the dabigatran AUCτ,ss and Cmax,ss
by 1.49-fold and 1.65-fold, respectively, compared with dabigatran etexilate
given alone. When a loading dose of 180 mg ticagrelor was given 2 hours after
110 mg dabigatran etexilate (in steady state), the increase of dabigatran AUCτ,ss
and Cmax,ss was reduced to 1.27-fold and 1.23-fold, respectively, compared with
dabigatran etexilate given alone. This staggered intake is the recommended
administration for start of ticagrelor with a loading dose.
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): ticagrelor (HOS-112065) dabigatran (HOS-112096)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage df838b72b33ea00260c132801d8349fab4dfff70c30a801486844f300e7008dc · Zeichen 5383–6121 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 12–13
HOS-118640 · Präparat HOS-094855
12
Concomitant administration of 90 mg ticagrelor b.i.d. (maintenance dose) with
110 mg dabigatran etexilate increased the adjusted dabigatran AUCτ,ss and Cmax,ss
1.26-fold and 1.29-fold, respectively, compared with dabigatran etexilate given
alone.
Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically
studied. Caution should be exercised when dabigatran etexilate is co-
administered with posaconazole.
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): ticagrelor (HOS-112065) dabigatran (HOS-112096) posaconazole (HOS-085622)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 6e97d07200fcbf44595bf112e7395a533d9747cd31fb49d4057fa0941e139ebf · Zeichen 6172–6746 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13
HOS-118643 · Präparat HOS-094855
e.g. rifampicin, Concomitant administration is expected to result in decreased dabigatran
St. John´s wort concentrations.
(Hypericum
perforatum), Pre-dosing of the probe inducer rifampicin at a dose of 600 mg once daily for
carbamazepine, 7 days decreased total dabigatran peak and total exposure by 65.5 % and 67 %,
or phenytoin respectively. The inducing effect was diminished resulting in dabigatran
exposure close to the reference by day 7 after cessation of rifampicin treatment.
No further increase in bioavailability was observed after another 7 days.
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): carbamazepine (HOS-085618) dabigatran (HOS-112096) phenytoin (HOS-084531)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage cb6528b627b8a76912f17916d6a29ac20c123d716fed8d78a5cf924576a8afb6 · Zeichen 6803–7434 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13
HOS-118646 · Präparat HOS-094855
e.g. ritonavir These affect P-gp (either as inhibitor or as inducer). They have not been studied
and its and are therefore not recommended for concomitant treatment with dabigatran
combinations etexilate.
with other
protease
inhibitors
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): protease (HOS-085623) dabigatran (HOS-112096) ritonavir (HOS-084521)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage ab84b6d4840a20f0c784969add7643c942e83d84d13b6175beddb59b7b04a2ed · Zeichen 7512–7776 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 13
HOS-118648 · Präparat HOS-094855
Digoxin In a study performed with 24 healthy subjects, when dabigatran etexilate was
co-administered with digoxin, no changes on digoxin and no clinically relevant
changes on dabigatran exposure have been observed.
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): digoxin (HOS-086172) dabigatran (HOS-112096)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage e0d32e8baac14b2e566129bda90dcaf766ab5fd280f5ee87effd87da75941825 · Zeichen 7796–8064 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 14
HOS-118657 · Präparat HOS-094855
NSAIDs NSAIDs given for short-term analgesia have been shown not to be associated with
increased bleeding risk when given in conjunction with dabigatran etexilate. With
chronic use in a phase III clinical trial comparing dabigatran to warfarin for stroke
prevention in atrial fibrillation patients (RE-LY), NSAIDs increased the risk of
bleeding by approximately 50 % on both dabigatran etexilate and warfarin.
Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran
etexilate and clopidogrel resulted in no further prolongation of capillary bleeding
times compared to clopidogrel monotherapy. In addition, dabigatran AUCτ,ss and
Cmax,ss and the coagulation measures for dabigatran effect or the inhibition of platelet
aggregation as measure of clopidogrel effect remained essentially unchanged
comparing combined treatment and the respective mono-treatments. With a loading
dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased
by about 30-40 % (see section 4.4).
ASA Co-administration of ASA and 150 mg dabigatran etexilate twice daily may increase
the risk for any bleeding from 12 % to 18 % and 24 % with 81 mg and 325 mg ASA,
respectively (see section 4.4).
LMWH The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not
been specifically investigated. After switching from 3-day treatment of once daily
40 mg enoxaparin s.c., 24 hours after the last dose of enoxaparin the exposure to
dabigatran was slightly lower than that after administration of dabigatran etexilate
(single dose of 220 mg) alone. A higher anti-FXa/FIIa activity was observed after
dabigatran etexilate administration with enoxaparin pre-treatment compared to that
after treatment with dabigatran etexilate alone. This is considered to be due to the
carry-over effect of enoxaparin treatment, and regarded as not clinically relevant.
Other dabigatran related anti-coagulation tests were not changed significantly by the
pre-treatment of enoxaparin.
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): dabigatran (HOS-112096) clopidogrel (HOS-087927) enoxaparin (HOS-118623) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 0a19359480c6a0c248c94155bba1861177ff79423de391a6a6b273c2558ac642 · Zeichen 9052–11373 im Abschnitt
Wechselwirkungen · Pradaxa
Pradaxa 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 14
HOS-118661 · Präparat HOS-094855
SSRIs, SNRIs SSRIs and SNRIs increased the risk of bleeding in all treatment groups of a
phase III clinical trial comparing dabigatran to warfarin for stroke prevention in
atrial fibrillation patients (RE-LY).
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): dabigatran (HOS-112096) warfarin (HOS-085950)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-24T16:05:00Z · SHA-256 6fdebd4ffab4d65c0f88f2d9fedf86e816358c723b5b8edac8e90f1c47487499 · Passage 33151e399e7bbce93d3ec8f7d3abe43d2490cbeb221c38b3d576c244c1c067f1 · Zeichen 11550–11808 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.