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

108 082 rapports FAERS

Inefficacité du traitement33 131 (15%)
Polyarthrite rhumatoïde21 850 (10%)
Utilisation hors AMM20 306 (9%)
Douleur17 595 (8%)
Fatigue15 019 (7%)
DRUG INTOLERANCE14 552 (7%)
Arthralgies14 378 (7%)
JOINT SWELLING13 376 (6%)
Rash cutané12 072 (6%)
CONTRAINDICATED PRODUCT ADMINISTERED11 019 (5%)
Alopécie10 786 (5%)
ABDOMINAL DISCOMFORT10 735 (5%)
Aggravation de la pathologie10 475 (5%)
SYSTEMIC LUPUS ERYTHEMATOSUS10 360 (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.