Fosamax® / génériques
DCI : Alendronate
Bisphosphonate de référence. 70 mg / semaine, à jeun avec eau, debout 30 min. Standard de soin ostéoporose post-ménopausique.
Pharmacovigilance — Top effets indésirables
54 935 rapports FAERS- Douleur7 877 (9%)
- Fatigue7 741 (9%)
- Inefficacité du traitement7 309 (9%)
- Arthralgies7 038 (8%)
- Polyarthrite rhumatoïde5 916 (7%)
- Rash cutané5 761 (7%)
- Utilisation hors AMM5 569 (7%)
- ABDOMINAL DISCOMFORT5 534 (7%)
- Alopécie5 496 (7%)
- FEMUR FRACTURE5 444 (7%)
- Dyspnée5 174 (6%)
- ARTHROPATHY5 042 (6%)
- SYSTEMIC LUPUS ERYTHEMATOSUS4 945 (6%)
- PEMPHIGUS4 845 (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-0526-2026
Class IIThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
20260407 · Ongoing
D-0735-2016
Class IIFailed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
20160211 · Terminated
Avis HAS — Commission de la Transparence
Source HAS via Google News RSS · avis SMR/ASMR officiels.