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csDMARD — antipaludéenComprimé oral quotidienSanofi

Plaquenil®

DCI : Hydroxychloroquine

Antipaludéen utilisé comme immunomodulateur. Pierre angulaire du lupus. Surveillance ophtalmo annuelle (rétinopathie cumul-dose).

Pharmacovigilance — Top effets indésirables

109 825 rapports FAERS
  • Inefficacité du traitement33 385 (15%)
  • Polyarthrite rhumatoïde22 057 (10%)
  • Utilisation hors AMM20 575 (9%)
  • Douleur17 778 (8%)
  • Fatigue15 225 (7%)
  • DRUG INTOLERANCE14 688 (7%)
  • Arthralgies14 567 (7%)
  • JOINT SWELLING13 509 (6%)
  • Rash cutané12 266 (6%)
  • CONTRAINDICATED PRODUCT ADMINISTERED11 125 (5%)
  • Alopécie10 910 (5%)
  • ABDOMINAL DISCOMFORT10 855 (5%)
  • Aggravation de la pathologie10 627 (5%)
  • SYSTEMIC LUPUS ERYTHEMATOSUS10 563 (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-677-2014

    Class II

    Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.

    20130702 · Terminated

  • D-66373-001

    Class III

    Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

    20130925 · 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.