HypouricémiantComprimé oral quotidienMenarini / Ipsen

Adénuric®

DCI : Febuxostat

Inhibiteur xanthine oxydase non purinique. Alternative à l'allopurinol en cas d'intolérance ou inefficacité. Surveillance cardio-vasculaire (alerte CARES 2018).

Pharmacovigilance — Top effets indésirables

10 321 rapports FAERS

ACUTE KIDNEY INJURY604 (10%)
Utilisation hors AMM550 (9%)
Diarrhée546 (9%)
ANAEMIA511 (8%)
Nausées500 (8%)
RENAL IMPAIRMENT451 (7%)
Fièvre435 (7%)
Dyspnée420 (7%)
Rash cutané410 (6%)
CARDIAC FAILURE402 (6%)
Pneumopathie380 (6%)
Inefficacité du traitement379 (6%)
Céphalées371 (6%)
DECREASED APPETITE360 (6%)

Source : OpenFDA / FAERS (FDA Adverse Event Reporting System). Termes MedDRA traduits FR. Les rapports incluent des attributions causales non confirmées.

⚠️ Rappels (recalls) FDA

D-0314-2024
Class II
CGMP Deviations
20240125 · Terminated
D-698-2014
Class II
Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014; tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014; SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014.
20130702 · Terminated
D-0369-2024
Class II
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
20240304 · Ongoing
D-0368-2024
Class II
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
20240304 · Ongoing
D-0265-2024
Class II
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
20240118 · Completed

Avis HAS — Commission de la Transparence

Source HAS via Google News RSS · avis SMR/ASMR officiels.

Avis HAS CNEDiMTS — Dispositifs / Numérique

Untitled

Ressources patient & prescripteur

Sources : OpenFDA (FAERS), HAS Commission de la Transparence, base ANSM. Ne se substitue pas au RCP.