Risedronate (risedronate sodium)

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Risedronate sodium is administered orally.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Oral Bisphosphonates/Oral Multivalent Cations

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Multivalent cations may bind to and inhibit the absorption of oral bisphosphonates.(1-6)

CLINICAL EFFECTS: Simultaneous administration of products containing multivalent cations may result in decreased levels of and clinical effects from oral bisphosphonates.(1-6)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Instruct patients to separate the administration times of products containing multivalent cations and oral bisphosphonates. Manufacturer recommendations regarding the separation of administration times of oral bisphosphonates and multivalent cations vary. Do NOT give multivalent cation-containing products: - until at least 30 minutes after taking alendronate(1) - within 2 hours of etidronate(2) - until at least 1 hour after taking ibandronate(3) - until at least 30 minutes after taking risedronate(4) - within 2 hours of tiludronate(5)

DISCUSSION: Multivalent cations may bind to and inhibit the absorption of oral bisphosphonates, resulting in decreased levels of and clinical effects from these agents.(1-6) Administration of aluminum- or magnesium-containing antacids 1 hour before tiludronate decreased the bioavailability of tiludronate by 60%.(5)

Hypocalcemia, known hypersensitivity to risedronate or any ingredient in the formulation, inability to stand or sit upright for at least 30 minutes, or abnormalities of the esophagus that delay esophageal emptying (e.g., stricture, achalasia).

• Achalasia of esophagus
• Aseptic necrosis of jaw bone
• Hypocalcemia
• Stricture of esophagus

• Atypical femoral fracture
• Barrett's esophagus
• Bed-ridden
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Duodenitis
• Dysphagia
• Esophageal dysmotility
• Esophageal obstruction
• Esophageal ulcer
• Esophagitis
• Gastritis
• Invasive dental procedure
• Peptic ulcer
• Periodontitis

• Arthralgia
• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Myalgia

Adverse effects occurring in more than 5% of patients receiving daily risedronate therapy include back, chest or abdominal pain, pain (unspecified), hypertension, flu-like syndrome, peripheral edema, nausea, diarrhea, constipation, arthralgia, joint disorder, depression, headache, dizziness, myalgia, rash, cataract, pharyngitis, rhinitis, urinary tract infection, and infection (unspecified). Adverse effects occurring in more than 5% of patients receiving once-weekly risedronate include back or abdominal pain, pain (unspecified), hypertension, flu syndrome, infection (unspecified), accidental injury, overdose, nausea, constipation, dyspepsia, arthralgia, traumatic bone fracture, myalgia, headache, asthenia, and urinary tract infection.

More Frequent

• Abdominal pain with cramps
• Skin rash

Less Frequent

• Bone pain
• Hypertension
• Urinary tract infection

Rare or Very Rare

• Abnormal hepatic function tests
• Angioedema
• Aseptic necrosis of bone in orofacial region
• Aseptic necrosis of jaw bone
• Asthma exacerbation
• Atypical femoral fracture
• Benign prostatic hyperplasia
• Bullous dermatitis
• Cardiac arrhythmia
• Cataracts
• Duodenitis
• Esophageal perforation
• Esophageal ulcer
• Esophagitis
• Gastrointestinal ulcer
• Hypersensitivity drug reaction
• Iritis
• Kidney stone
• Myalgia
• Stevens-johnson syndrome
• Toxic epidermal necrolysis
• Uveitis

More Frequent

• Arthralgia
• Back pain
• Diarrhea
• Dyspepsia
• Headache disorder
• Nausea

Less Frequent

• Arthritis
• Chest pain
• Constipation
• Depression
• Dizziness
• Flu-like symptoms
• Gastritis
• General weakness
• Hypocalcemia
• Neck pain
• Peripheral edema
• Pharyngitis
• Rhinitis
• Vomiting

Rare or Very Rare

• Dysphagia
• Glossitis
• Insomnia

No enhanced messaging available.

Risedronate is not indicated for use in pediatric patients. Efficacy and safety of the drug in pediatric patients were evaluated in a 1-year, randomized, double-blind, placebo-controlled study in 143 pediatric patients 4 to less than 16 years of age with osteogenesis imperfecta. Although risedronate was effective in increasing lumbar spine bone mineral density (BMD) compared with placebo, therapy with the drug was not associated with a reduction in fracture risk. Adverse effects reported in the pediatric patients evaluated in this study generally were similar to those reported in adults with osteoporosis; however, an increased risk of vomiting relative to placebo was observed with risedronate.

Category C. (See Users Guide.)

Risedronate is distributed into milk in rats; it is not known whether the drug is distributed into human milk. Because of the potential for serious adverse effects from risedronate in nursing infants, a decision should be made whether to discontinue nursing or the drug.

No substantial differences in safety and efficacy have been observed in geriatric patients relative to younger adults.