Hypouricémiant — inhibiteur xanthine oxydaseComprimé oral quotidienMulti-laboratoires

Zyloric® / génériques

DCI : Allopurinol

Première ligne traitement de fond goutte. 100-300 mg/j. Cible uricémie < 60 mg/L (< 360 µmol/L).

Pharmacovigilance — Top effets indésirables

160 466 rapports FAERS

Diarrhée8 932 (10%)
Fatigue8 494 (9%)
Dyspnée8 147 (9%)
Nausées7 513 (8%)
Décès7 011 (8%)
ACUTE KIDNEY INJURY6 897 (7%)
Utilisation hors AMM6 762 (7%)
Fièvre6 306 (7%)
Pneumopathie5 840 (6%)
Asthénie5 777 (6%)
ANAEMIA5 593 (6%)
Inefficacité du traitement5 301 (6%)
DIZZINESS5 294 (6%)
RENAL FAILURE4 910 (5%)

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

⚠️ Rappels (recalls) FDA

D-0168-2023
Class II
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
20230112 · Terminated
D-0173-2023
Class II
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
20230116 · Terminated
D-1405-2015
Class III
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
20150720 · Terminated
D-0583-2024
Class II
Presence of foreign substance.
20240607 · Terminated
D-515-2014
Class II
Labeling: Label Mixup; ALLOPURINOL Tablet, 300 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD52993_25, EXP: 5/20/2014.
20130702 · Terminated

Avis HAS — Commission de la Transparence

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

Avis HAS CNEDiMTS — Dispositifs / Numérique

Ressources patient & prescripteur

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