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 · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-143234 · Präparat HOS-098954
a. See section 4.5
b. Hyperuricaemia includes hyperuricaemia and blood uric acid increased
c. (CLEAR Outcomes study) Weight decrease was observed only in patients with a baseline body mass index (BMI) of
≥30 kg/m2, with a mean body weight reduction of -2.28 kg at month 36. Mean reduction in body weight was ≤0.5 kg in
patients with a baseline BMI of 25 to <30 kg/m2. Bempedoic acid was not associated with a mean change in body
weight in patients with a baseline BMI of < 25 kg/m2
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 2f5ef1c7769a22f8e18a22b156f9087613076a11351e4abddecb167371564c5f · Zeichen 2770–3272 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-143235 · Präparat HOS-098954
Description of selected adverse reactions
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 3274–3315 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-143236 · Präparat HOS-098954
Hepatic enzyme elevations
Increases in serum transaminases (AST and/or ALT) have been reported with bempedoic acid. In the
phase 3 primary hyperlipidaemia studies, the incidence of elevations (≥ 3× ULN) in hepatic
transaminase levels was 0.7% for patients treated with bempedoic acid and 0.3% for placebo. In the
CLEAR Outcomes study, the incidence of elevations > 3× ULN in hepatic transaminase levels also
occurred more frequently in bempedoic acid-treated patients (1.6%) than in placebo-treated patients
(1.0%). These elevations in transaminases were not associated with other evidence of liver dysfunction
(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 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 086dba18c5ae43314fe542229d5c71779b6720761ea7f435d70e5968dda57184 · Zeichen 3317–3946 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7
HOS-143237 · Präparat HOS-098954
Increased serum uric acid
Increases in serum uric acid were observed in clinical trials with bempedoic acid possibly related to
inhibition of renal tubular OAT2 (see section 4.5). In the phase 3 primary hyperlipidemia studies, a
mean increase of 47.6 micromole/L (0.8 mg/dL) in uric acid compared to baseline was observed with
bempedoic acid at week 12. The elevations in serum uric acid usually occurred within the first 4 weeks
of treatment and returned to baseline following discontinuation of treatment. In the phase 3 primary
hyperlipidemia studies, gout was reported in 1.4% of patients treated with bempedoic acid and 0.4% of
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 45b7fe140f0431ac65bf138460d4f84968edd26eab3f545974d1e7468445d6c4 · Zeichen 3948–4580 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7–8
HOS-143238 · Präparat HOS-098954
7
patients treated with placebo (see section 4.4). In the CLEAR Outcomes study, a mean increase of
47.6 micromole/L (0.8 mg/dL) in uric acid compared to baseline was observed in bempedoic acid-
treated patients at month 3, and gout was also reported more frequently in bempedoic acid-treated
patients (3.1%) than placebo-treated patients (2.1%). In both treatment groups, patients who reported
gout were more likely to have a medical history of gout and/or baseline levels of uric acid above the
ULN. An increase in the incidence of hyperuricaemia was observed in patients treated concomitantly
with bempedoic acid and a fibrate. In the CLEAR Outcomes study, hyperuricaemia was reported more
frequently in bempedoic acid-treated patients taking a fibrate at baseline (19.5%) compared to patients
not taking a fibrate (10.4%), see section 4.5. There was no increase in the incidence of gout in
bempedoic acid-treated patients taking a fibrate at baseline (1.1%) compared to patients not taking a
fibrate (3.2%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 84642602cb238eae0d72faaba3b1f889313959b5f4e1051570c189fbf77f21f4 · Zeichen 4641–5652 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-143239 · Präparat HOS-098954
Effects on serum creatinine and blood urea nitrogen
Bempedoic acid has been shown to increase serum creatinine and blood urea nitrogen (BUN). In the
phase 3 primary hyperlipidemia studies, a mean increase of 4.4 micromole/L (0.05 mg/dL) in serum
creatinine and a mean increase of 0.61 mmol/L (1.7 mg/dL) in BUN compared to baseline was
observed with bempedoic acid at week 12. The elevations in serum creatinine and BUN usually
occurred within the first 4 weeks of treatment, remained stable, and returned to baseline following
discontinuation of treatment. Similar mean increases in serum creatinine (5.8 micromole/L (0.066
mg/dL)) and BUN (0.82 mmol/L (2.3 mg/dL)) were observed with bempedoic acid in the CLEAR
Outcomes study.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 435f4baaf6d84e7e17dbd506a0d648208d8c963b88c25c8bb9452b14007b78e9 · Zeichen 5654–6383 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-143240 · Präparat HOS-098954
The observed elevations in serum creatinine may be associated with bempedoic acid inhibition of
OAT2-dependent renal tubular secretion of creatinine (see section 4.5), representing a drug-
endogenous substrate interaction and does not appear to indicate worsening renal function. This effect
should be considered when interpreting changes in estimated creatinine clearance in patients on
Nilemdo therapy, particularly in patients with medical conditions or receiving medicinal products that
require monitoring of estimated creatinine clearance.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage b25bb3606c6b67ce28235658b8bef1748bfa79789754e34b4109299982587b18 · Zeichen 6385–6929 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-143241 · Präparat HOS-098954
Decreased haemoglobin
Decreases in haemoglobin were observed in clinical trials with bempedoic acid. In the phase 3 primary
hyperlipidaemia studies, a decrease in haemoglobin from baseline of ≥ 20 g/L and < lower limit of
normal (LLN) was observed in 4.6% of patients in the bempedoic acid group compared with 1.9% of
patients on placebo. Greater than 50 g/L and < LLN decreases in haemoglobin were reported at similar
rates in bempedoic acid and placebo groups (0.2% versus 0.2%, respectively). The decreases in
haemoglobin usually occurred within the first 4 weeks of treatment and returned to baseline following
discontinuation of treatment. Among patients who had normal haemoglobin values at baseline, 1.4%
in the bempedoic acid group and 0.4% in the placebo group experienced haemoglobin values below
LLN while on treatment. In the phase 3 primary hyperlipidemia studies, anaemia was reported in 2.5%
of patients treated with bempedoic acid and 1.6% of patients treated with placebo. In the CLEAR
Outcomes study, similar decreases in haemoglobin were observed, and anaemia was also reported
more frequently in bempedoic acid-treated patients (4.7%) compared to placebo-treated patients
(3.9%). An increase in the incidence of anaemia was observed in patients treated concomitantly with
bempedoic acid and a fibrate. In the CLEAR outcomes study, anaemia was reported more frequently
in bempedoic acid-treated patients taking a fibrate at baseline (9.6%) compared to patients not taking a
fibrate (4.5%).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage a4edf20a2079c684387fb4027061b93b3513d63b2c4d437f3189651873abfbe0 · Zeichen 6931–8439 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-143242 · Präparat HOS-098954
Elderly population
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 8571b0aac270958cb543d4b756ce10d59148bf7a884d9606f752ee17cd1279fb · Zeichen 8441–8459 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-143243 · Präparat HOS-098954
Of the 3 621 patients treated with bempedoic acid in the phase 3 primary hyperlipidemia studies, 2 098
(58%) were > 65 years old. In the CLEAR Outcomes study, 4 141 patients (59%) treated with
bempedoic acid were ≥65 years of age and 1 066 patients (15%) treated with bempedoic acid were ≥75
years of age. No overall difference in safety was observed between elderly and the younger
population.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage ecb82f3e6dcdf1430cf4110687e7d8bf4c95d87961e8a0c772979f153e1a7b8f · Zeichen 8461–8855 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8–9
HOS-143244 · Präparat HOS-098954
8
Reporting of suspected adverse reactions
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 7f42b4aa963e8bf128e7dadb6d180d89ac9c01d3091e08114b0674c9b2bb1ff9 · Zeichen 8911–8954 im Abschnitt
Nebenwirkungen · Nilemdo
Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-143245 · Präparat HOS-098954
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2026-02-27T17:50:00Z · SHA-256 e22c45bda49313040ac4a284f068b61ba66ef21d794753c9c1627e320bff57f6 · Passage 591ce3aa6d6555db7032d0551da929e990b92080da2928085827a75c666ec353 · Zeichen 8956–9270 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.