Risedronate

Risedronate is a prescription medication used for the treatment of osteoporosis of different types and Paget disease.

• Risedronate is available under the following different brand names: Actonel, Atelvia, Actonel with Calcium

Adult dosage

Tablet

• 5mg
• 30mg
• 35mg
• 150mg

Tablet, delayed release

• 35mg

Postmenopausal Osteoporosis

Adult dosage

• 5 mg orally once daily or 35 mg orally once weekly or 150 mg orally once monthly
• 35 mg once-weekly dosing copackaged with calcium carbonate 1250 mg for remaining 6 days of weeks

Glucocorticoid-Induced Osteoporosis

Adult dosage

• 5 mg/day orally

Paget Disease

Adult dosage

• 30 mg/day orally for 2 months

Osteoporosis in Men

Adult dosage

• 35 mg orally once weekly

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Risedronate include:

• heartburn,
• diarrhea,
• indigestion,
• stomach pain,
• back pain,
• joint pain,
• muscle pain, and
• flu-like symptoms.

Serious side effects of Risedronate include:

• chest pain,
• new or worsening heartburn,
• difficulty or pain when swallowing,
• pain or burning under the ribs or in the back,
• severe heartburn,
• burning in the upper stomach,
• coughing up blood,
• new or unusual pain in the thigh or hip,
• jaw pain,
• numbness,
• swelling,
• severe joint, bone, or muscle pain,
• muscle spasms or contractions, and
• numbness or tingly feeling (around the mouth, or in your fingers and toes).

Rare side effects of Risedronate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Risedronate has severe interactions with the following drug:
  • human parathyroid hormone, recombinant
• Risedronate has serious interactions with the following drugs:
  • cimetidine
  • famotidine
  • ibuprofen/famotidine
  • nizatidine
• Risedronate has moderate interactions with at least 16 other drugs.
• Risedronate has minor interactions with the following drugs:
  • dexlansoprazole
  • entecavir
  • food
  • foscarnet
  • teriparatide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity; angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported
• Hypocalcemia
• Hypercalcemia from any cause including, but not limited to, hyperparathyroidism, hypercalcemia of malignancy, or sarcoidosis
• Inability to stand or sit upright for at least 30 minutes
• Esophagus abnormalities (e.g., stricture, achalasia) that delay esophageal emptying

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Risedronate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Risedronate?”

Cautions

• Ensure adequate intake of calcium and vitamin D; correct hypocalcemia, if present, before initiating therapy
• Avoid concomitant polyvalent cation-containing medications
• May cause upper GI disorders (e.g., dysphagia, esophagitis, esophageal or gastric ulcer); instruct patients to follow dosing instructions; discontinue use if new or worsening symptoms occur
• Severe irritation of upper GI mucosa; discontinue if new or worsening symptoms occur in patients with active upper GI disease
• Osteonecrosis of the jaw can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates
• Food decreases bioavailability
• Not recommended in severe renal impairment (CrCl less than 30 mL/min)
• Risk of severe joint, muscle, or bone pain
• e increased risk of atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of the need for continued bisphosphonate therapy, particularly if the treatment lasts for more than 5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture
• Consider appropriate hormone replacement therapy if necessary
• Administration of calcium has been associated with a slight increase in the risk of kidney stones; in patients with a history of kidney stones or hypercalciuria, metabolic assessment to seek treatable causes of these conditions is warranted; if administration of calcium tablets is necessary monitor urinary calcium excretion periodically; patients with achlorhydria may have decreased absorption of calcium; taking calcium with food enhances absorption; concomitant use of calcium-containing antacids should be monitored to avoid excessive intake of calcium
• Esophageal cancer risk (July 21, 2011, FDA safety communication)
  • Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
  • Esophagitis and other esophageal events have been reported, particularly in patients who do not follow specific directions for use of oral bisphosphonates (eg, sitting up or standing after administration, taking with a full glass of water)
  • Ongoing review of data from published studies to evaluate whether the use of oral bisphosphonates is associated with increased risk of cancer of the esophagus is currently being conducted by FDA
  • FDA has not concluded that taking oral bisphosphonates increases the risk of esophageal cancer
  • Data are insufficient to recommend endoscopic screening of asymptomatic patients
  • FDA will continue to evaluate all available data supporting safety and effectiveness of bisphosphonates and will update the public when more information becomes available
  • Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)

Pregnancy and Lactation

• Available data on use in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue therapy when pregnancy is recognized.
• Effects of bisphosphonates on bones
• Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over years; the amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use
• Based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy; the impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied
• Females and males of reproductive potential
• There are no data available in humans; female and male fertility may be impaired based on animal studies demonstrating adverse effects on fertility parameters
• Lactation
  • There are no data on presence in human milk, effects on the breastfed infant, or milk production; a small degree of lacteal transfer occurred in nursing rats
  • The concentration of the drug in animal milk does not necessarily predict the concentration of the drug in human milk; however, when a drug is present in animal milk, the drug will likely be present in human milk
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breast-fed child from the drug or the underlying maternal condition