ACTONEL (risedronate sodium)

There are 0 contraindications.

Drug contraindication overview.

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).

Adverse reaction overview.

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.

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None