Risedronic acid

ATC code

M05BA07

Therapeutic class

Agente que afecta la estructura ósea y la mineralización · Bisfosfonato

Forms

oral tablet

Brand names

Actonel (US) · Risedronato Normon (ES)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA FT:79140 (https://cima.aemps.es/cima/dochtml/ft/79140/FT_79140.html)
Professional Clinical Knowledge
AEMPS CIMA · nº registro 79140 ↗
RxNorm rxcui 55685 ↗

Approved indications

Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures.
Treatment of established postmenopausal osteoporosis to reduce the risk of hip fractures.
Treatment of osteoporosis in men at high risk of fractures.

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients.
Hypocalcemia.
Pregnancy and lactation.
Severe renal impairment (creatinine clearance < 30 ml/min).

Clinical warnings

Major warning · Upper gastrointestinal adverse reactions, such as esophagitis, esophageal ulcers, and esophageal erosions. It is crucial to follow dosing instructions to minimize risk. — AEMPS CIMA
Major warning · Osteonecrosis of the jaw has been reported, generally associated with tooth extraction and/or local infection. A dental examination is recommended before starting treatment. — AEMPS CIMA
Major warning · Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy. — AEMPS CIMA

Drug interactions

HighCationes polivalentes (Calcio, Magnesio, Hierro, Aluminio)
Mechanism: Concomitant intake of medications containing polyvalent cations (e.g., calcium, magnesium, aluminum, and iron) interferes with the absorption of risedronate by forming non-absorbable chelates in the GI tract.
Recommendation: Administer risedronate at least 30 minutes before (ideally several hours before) calcium supplements, antacids, or other medications containing polyvalent cations.
AEMPS CIMA FT:79140

Adverse events

Common (≥1%)

cefalea · dispepsia · dolor abdominal · náuseas · estreñimiento · diarrea · dolor musculoesquelético

Rare but serious

osteonecrosis de la mandíbula · fracturas femorales atípicas · reacciones de hipersensibilidad cutánea · iritis · uveítis · reacciones anafilácticas

Pregnancy and lactation

FDA category: X

Contraindicated during pregnancy and lactation. There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.