csDMARDComprimé oralPfizer

Salazopyrine®

DCI : Sulfasalazine

Sulfamide-salicylé. 2-3 g/j en 2-3 prises. Souvent en triple thérapie classique avec MTX + HCQ.

Pharmacovigilance — Top effets indésirables

75 260 rapports FAERS

Inefficacité du traitement29 192 (16%)
Polyarthrite rhumatoïde19 424 (10%)
Douleur15 915 (8%)
DRUG INTOLERANCE13 770 (7%)
Arthralgies13 369 (7%)
Fatigue13 306 (7%)
JOINT SWELLING12 734 (7%)
Utilisation hors AMM11 094 (6%)
Rash cutané10 903 (6%)
ABDOMINAL DISCOMFORT10 053 (5%)
CONTRAINDICATED PRODUCT ADMINISTERED9 661 (5%)
Aggravation de la pathologie9 562 (5%)
Alopécie9 473 (5%)
SYNOVITIS9 218 (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-994-2014
Class II
Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.
20130702 · Terminated
D-648-2014
Class II
Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014.
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.