Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg
- 30mg
- 35mg
- 150mg
tablet, delayed release
- 35mg
Postmenopausal Osteoporosis
Treatment and prevention
5 mg PO once daily or 35 mg PO once weekly or 150 mg PO once monthly
35 mg once-weekly dosing copackaged with calcium carbonate 1250 mg for remaining 6 days of week
Glucocorticoid-Induced Osteoporosis
5 mg/day PO
Paget Disease
30 mg/day PO for 2 months
Monitor serum alkaline phosphatase
Osteoporosis in Men
35 mg PO once weekly
Osteogenesis Imperfecta (Orphan)
Orphan indication sponsor
- Warner Chilcott Pharmaceuticals; 100 Enterprise Drive; Rockaway, NJ 07866
Dosing Modifications
Renal impairment
- CrCl >30 mL/min: No dose adjustment necessary
- CrCl <30 mL/min: Not recommended
Hepatic impairment
- Safety and efficacy not established
- No dose adjustment suggested; drug does not undergo hepatic metabolism
Administration
Immediate release
- Take at least 30 minutes with 6-8 oz water before first food or drink of day
- Swallow with plain water only, not coffee or juice
- Stand or sit upright; do not lie down for 30 minutes after taking to avoid esophageal irritation
Delayed release
- Administer in morning immediately after breakfast; compared with immediate-release risedronate, Atelvia resulted in significantly higher incidence of abdominal pain when administered before breakfast under fasting conditions
- To facilitate delivery to stomach, swallow whole while in upright position and with ≥4 oz plain water
- Tablets should not be chewed, cut, or crushed
- Do not lie down for 30 minutes after taking medication
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- human parathyroid hormone, recombinant
risedronate decreases effects of human parathyroid hormone, recombinant by Other (see comment). Contraindicated. Comment: Coadministration of bisphosphonates with rhPTH leads to reduction in rhPTH's calcium sparing effect, which can interfere with the normalization of serum calcium.
Serious - Use Alternative (4)
- cimetidine
cimetidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate
- famotidine
famotidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate
- ibuprofen/famotidine
ibuprofen/famotidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate
- nizatidine
nizatidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate
Monitor Closely (16)
- aluminum hydroxide
aluminum hydroxide decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- calcium acetate
calcium acetate decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- calcium carbonate
calcium carbonate decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- calcium chloride
calcium chloride decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- calcium citrate
calcium citrate decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- calcium gluconate
calcium gluconate decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- deferasirox
deferasirox, risedronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- magnesium supplement
magnesium supplement will decrease the level or effect of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Formation of a chelate reduces absorption of the drug through intestinal tract; administer magnesium 2hr before or 2hr after the bisphosphonate derivative
- selenium
selenium will decrease the level or effect of risedronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Avoid administering polyvalent cations 2 hr before or 30 min after risedronate.
- sodium bicarbonate
sodium bicarbonate decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- sodium citrate/citric acid
sodium citrate/citric acid decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of risedronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of risedronate by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium zirconium cyclosilicate
sodium zirconium cyclosilicate, risedronate. increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.
- voclosporin
voclosporin, risedronate. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- zinc
zinc will decrease the level or effect of risedronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Multivalent cation-containing products may interfere with absorption of risedronate. Administer risedronate at least 30 min before taking any other oral medications.
Minor (5)
- dexlansoprazole
dexlansoprazole will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies only to delayed release form; increase in pH may enhance the release of the drug from the delayed release formulation and increases availability
- entecavir
risedronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.
- food
food decreases levels of risedronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- foscarnet
foscarnet increases effects of risedronate by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.
- teriparatide
teriparatide, risedronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
Adverse Effects
>10%
Arthralgia (7-33%)
Diarrhea (5-20%)
Headache (3-18%)
Nausea (4-13%)
Constipation (3-13%)
Rash (8-12%)
Abdominal pain (2-12%)
Hypertension (11%)
Dyspepsia (4-11%)
1-10%
Flulike syndrome (10%)
Depression (7%)
Chest pain (5-7%)
Dizziness (3-7%)
Pharyngitis (6%)
Rhinitis (6%)
Prostatic hyperplasia (5%)
Hypocalcemia (<5%)
Dyspnea (4%)
Gastritis (3%)
Nephrolithiasis (3%)
Hypophosphatemia (<3%)
Arrhythmia (2%)
<1%
Diaphyseal femur
Dysphagia
Esophageal cancer
Esophageal ulcer
Femur fracture
Gastric and duodenal ulcer
Osteonecrosis
Postmarketing Reports
Hypersensitivity reactions including angioedema, generalized rash and bullous skin reactions, some severe
Gastrointestinal: Esophagitis, flatulence, bloating, esophageal or gastric ulcers
Musculoskeletal pain: Bone, joint, or muscle pain, described as severe or incapacitating, have been reported rarely
Eye inflammation: Iritis, uveitis
Jaw osteonecrosis
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Pulmonary: Asthma exacerbations
Warnings
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 (eg, stricture, achalasia) that delay esophageal emptying
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 (eg, 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 jaw may increase with duration of exposure to bisphosphonates
Food decreases bioavailability
Not recommended in severe renal impairment (CrCl <30 mL/min)
Risk of severe joint, muscle, or bone pain
Possible increased risk of atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >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 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 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 full glass of water)
- Ongoing review of data from published studies to evaluate whether use of oral bisphosphonates is associated with increased risk of cancer of esophagus is currently being conducted by FDA
- FDA has not concluded that taking oral bisphosphonates increases 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 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 & Lactation
Pregnancy
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 recognized
Animal data
In animal reproduction studies, daily oral administration to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5-26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m2)
A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to 30 mg human daily dose; delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose
Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose
-
Effects of bisphosphonates on bones
- Bisphosphonates are incorporated into bone matrix, from which they are gradually released over a period of years; the amount of bisphosphonate incorporated into adult bone and available for release into systemic circulation is directly related to dose and duration of bisphosphonate use
- Based on mechanism of action of bisphosphonates, there is 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 breastfed infant, or on milk production; a small degree of lacteal transfer occurred in nursing rats
Concentration of the drug in animal milk does not necessarily predict the concentration of drug in human milk; however, when a drug is present in animal milk, it is likely that the drug will be present in human milk
Developmental and health benefits of breast-feeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption
Absorption
Bioavailability: 0.54-0.75%
Peak plasma time: 1-3 hr
Distribution
Protein bound: 24%
Vd: 13.8 L/kg
Metabolism
Not metabolized
Elimination
Half-life: Initial, 1.5 hr; terminal, 480 hr
Renal clearance: 105 mL/min
Total body clearance: 122 mL/min
Excretion: Urine (up to 85%), feces (unabsorbed drug)
Administration
Instructions
Immediate release
- Take at least 30 minutes with 6-8 oz water before first food or drink of day
- Swallow with plain water only, not coffee or juice
- Stand or sit upright; do not lie down for 30 minutes after taking to avoid esophageal irritation
Delayed release
- Administer in morning immediately after breakfast; compared with immediate-release risedronate, Atelvia resulted in significantly higher incidence of abdominal pain when administered before breakfast under fasting conditions
- To facilitate delivery to stomach, swallow whole while in upright position and with ≥4 oz plain water
- Tablets should not be chewed, cut, or crushed
- Do not lie down for 30 minutes after taking medication
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 150 mg tablet |  | |
| risedronate oral - | 150 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 150 mg tablet |  | |
| risedronate oral - | 5 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 30 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 35 mg tablet |  | |
| risedronate oral - | 150 mg tablet |  | |
| Actonel oral - | 35 mg tablet | | |
| Actonel oral - | 5 mg tablet |  | |
| Actonel oral - | 150 mg tablet |  | |
| Actonel oral - | 150 mg tablet |  | |
| Atelvia oral - | 35 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
risedronate oral
RISEDRONATE - ORAL
(RIS-e-DROE-nate)
COMMON BRAND NAME(S): Actonel
USES: Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for long periods of time.This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Risedronate belongs to a class of medications called bisphosphonates.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using risedronate and each time you get a refill. Follow the instructions very closely to make sure you absorb as much of the drug as possible and reduce the risk of injury to your esophagus. Consult your doctor or pharmacist if you have any questions.Take this medication by mouth as directed by your doctor, usually once a day. Take it after getting up for the day and before taking your first food, beverage or other medication. Do not take it at bedtime or while you are still in bed.Take this medication with a full glass of plain water (6 to 8 ounces or 180 to 240 milliliters). Do not take it with any other beverage. Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright (sitting, standing or walking) for at least 30 minutes, and do not lie down until after your first food of the day. Wait at least 30 minutes after taking risedronate before you eat or drink anything other than plain water and before taking any other medication by mouth.Calcium or iron supplements, vitamins with minerals, antacids containing calcium/magnesium/aluminum, dairy products (such as milk, yogurt), and calcium-enriched juice may interfere with absorption of risedronate. Medications such as quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), sucralfate, and bismuth subsalicylate may also interfere with absorption. Do not take these products for at least 30 minutes after taking risedronate.Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each morning. Talk to your doctor about the risks and benefits of long-term use of this medication.
SIDE EFFECTS: Upset stomach may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, eye/vision problems.This medication may rarely cause irritation and ulcers in your stomach or esophagus. Get medical help right away if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: esophagus problems (such as esophageal stricture, achalasia), difficult or painful swallowing, low blood calcium levels (hypocalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease, stomach/intestinal disorders (such as ulcers).Some people taking risedronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking risedronate before your surgery. Ask for specific instructions about stopping or starting this medication.Tell your doctor if you are pregnant or plan to become pregnant. Risedronate may stay in your body for many years. You should not become pregnant while using risedronate. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may affect the results of certain lab tests (bone-imaging agents). Be sure to tell your doctor or laboratory personnel that you are taking this medication.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.Lab and/or medical tests (x-rays, height, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose. Do not take it later in the day. Take your next dose at the regular time the following day. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised January 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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