Risedronate

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate inhibits osteoclasts.

• Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2).ICD-10: M81.0

• Risedronate sodium delayed-release tablets contraindicated in patients with the following conditions: 1. Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] 2.contraindicated

One 35 mg delayed-release tablet once-a-week (2.1) Instruct patients to: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast with at least 4 ounces of plain water (2.2) • Avoid lying down for 30 minutes after taking risedronate sodium delayed-release tablets (2.2) • Take supplemental calcium and vitamin D if dietary intake is inadequate (2.3) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1) ] The recommended regimen is: • one 35 mg delayed-release tablet orally, taken once-a-week [see Indications and Usage (1.1)] 2.2 Important Administration Instructions Instruct patients to do the following: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast. Risedronate sodium delayed-release tablets should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting. • Swallow risedronate sodium delayed-release tablets whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication [ see Warnings and Precautions (5.2) ]. • Do not chew, cut, or crush risedronate sodium delayed-release tablets.

• Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with risedronate sodium delayed-release tablets (5.1) • Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur (5.2) • Hypocalcemia may worsen and must be corrected prior to use (5.3) • Osteonecrosis of the Jaw has been reported (5.4) • Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop (5.5, 6.2) • Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture (5.6) 5.1 Drug Products with the Same Active Ingredient Risedronate sodium delayed-release tablets contain the same active ingredient found in Actonel ® . A patient being treated with Actonel should not receive risedronate sodium delayed-release tablets. 5.2 Upper Gastrointestinal Adverse Reactions Risedronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when risedronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [ see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17) ].

Most common adverse reactions (greater than 5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain (6.1) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Once-a-Week Dosing with Risedronate Sodium Delayed-Release tablets The safety of risedronate sodium delayed-release 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing risedronate sodium delayed-release 35 mg once-a-week to risedronate sodium immediate-release 5 mg daily in postmenopausal women 50 years of age or older. Risedronate sodium delayed-release was administered either at least 30 minutes before (N = 308) or immediately following (N = 307) breakfast, and risedronate sodium immediate-release 5 mg daily (N = 307) was administered at least 30 minutes before breakfast.

• Pregnancy: Discontinue when pregnancy is recognized (8.1) • Risedronate sodium is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) (5.6, 8.6, 12.3) • Risedronate sodium is not indicated for use in pediatric patients (8.4) 8.1 Pregnancy Risk Summary Available data on use of risedronate sodium in pregnant women are insufficient to inform drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate sodium when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ), the dose indicated for treatment of Paget’s disease. A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 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.

Metabolism

Absorption The mean absolute oral bioavailability of the 30 mg risedronate sodium immediate-release tablet taken 4 hours prior to a meal is 0.63% (90% confidence interval [CI]: 0.54% to 0.75%) and is similar to an oral solution. The time to peak concentration (T max ) for risedronate sodium delayed-release tablet is approximately 3 hours when administered in the morning 4 hours prior to a meal.

Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. While milk or antacids containing calcium may be given to bind risedronate sodium immediate-release and reduce absorption of the drug, the impact of this intervention for risedronate sodium delayed-release tablets has not been evaluated. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia. Lethality after single oral doses of risedronate was seen in female rats at 903 mg/kg and male rats at 1703 mg/kg. The minimum lethal dose in mice and rabbits was 4000 mg/kg and 1000 mg/kg, respectively. These values represent 320 to 620 times the human Paget’s disease dose of 30 mg/day based on surface area (mg/m 2 ).

• Mar 27, 1998NDANDA020835Apil
• Oct 5, 2007ANDAANDA077132Teva Pharms Usa
• Oct 8, 2010NDANDA022560Apil
• Jun 10, 2014ANDAANDA090877Apotex
• Jun 10, 2014ANDAANDA090886Sun Pharm
• Nov 30, 2015ANDAANDA200296Aurobindo Pharma Ltd
• Dec 9, 2015ANDAANDA203533Macleods Pharms Ltd
• Oct 21, 2016ANDAANDA206768Aurobindo Pharma

1. 1Arthralgia3,80812%
2. 2Pain3,70212%
3. 3Drug Ineffective3,66912%
4. 4Nausea3,0299.9%
5. 5Fatigue2,9709.7%
6. 6Dyspnoea2,9169.6%
7. 7Off Label Use2,8779.4%
8. 8Vomiting2,8329.3%
9. 9Diarrhoea2,7309.0%
10. 10Pneumonia2,5128.2%
11. 11Drug Hypersensitivity2,5088.2%
12. 12Headache2,3757.8%
13. 13Malaise2,3707.8%
14. 14Rheumatoid Arthritis2,3637.8%
15. 15Pain In Extremity2,1597.1%

Recent PubMed references pinned to Risedronate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• In silico and in vitro evaluation of risedronate as a DKK1 antagonist: Implications for neuroprotection through DKK1-LRP6 modulation.
  European journal of pharmacology · 2026 · Manandhar S, Govindula A, Atchou K, et al.
  PMID 42134757DOI 10.1016/j.ejphar.2026.178971
• DoE-based Development of Transdermal Risedronate-laden Cubosomes: In Vitro Characterization, Drug Deposition, and In Vivo Permeation in Rats.
  AAPS PharmSciTech · 2026 · Gautam AJ, Wairkar S
  PMID 41781691DOI 10.1208/s12249-026-03371-0
• Enhancement of oral bioavailability of risedronate through xyloglucan rafts.
  Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025 · Namazi NI, Bafail R, Alanezi AA, et al.
  PMID 41574228DOI 10.3389/jpps.2025.15525
• Risedronate attenuates renal fibrosis by targeting prenylation-dependent RhoA/ROCK1 and ERK/NF-κB signaling.
  Naunyn-Schmiedeberg's archives of pharmacology · 2026 · Bhadange R, Gaikwad AB
  PMID 41343045DOI 10.1007/s00210-025-04870-w
• Transdermal delivery of risedronate via spanlastics for osteoporosis: formulation optimization, skin deposition, and pharmacokinetic assessment.
  Naunyn-Schmiedeberg's archives of pharmacology · 2026 · Gautam AJ, Wairkar S
  PMID 41313443DOI 10.1007/s00210-025-04786-5
• Engineering a BMP2-risedronate complex with sustained release for osteoporosis therapy.
  Archives of pharmacal research · 2025 · Jeon SO, Lamichhane S, Oh DH, et al.
  PMID 40987998DOI 10.1007/s12272-025-01568-8
• The efficacy and safety of denosumab, risedronate, alendronate and teriparatide to treat male osteoporosis: a systematic review and bayesian network meta-analysis.
  Frontiers in endocrinology · 2025 · Chai SJ, Yu T, Wang GR, et al.
  PMID 40612431DOI 10.3389/fendo.2025.1579101
• Synthesis and Biological Evaluation of (131)I-Risedronate with Bone Targeting Activity.
  Molecular pharmaceutics · 2025 · Lin Z, Hai W, Pan P, et al.
  PMID 40308157DOI 10.1021/acs.molpharmaceut.5c00300

The 10 most recently updated of 112 ClinicalTrials.gov registrations naming Risedronate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effects of Bisphosphonates on OI-Related Hearing Loss
  Recruiting · Phase 4 · Interventional · 100 enrolled · Hospital for Special Surgery, New York
  NCT04152551updated 2026-04-28
• Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mechanisms and Efficacy
  Active not recruiting · Phase 2 · Interventional · 30 enrolled · Harbin Medical University
  NCT07471815updated 2026-03-13
• Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
  Recruiting · Phase 3 · Interventional · 200 enrolled · Wake Forest University Health Sciences
  NCT04922333updated 2026-02-19
• Rise & Renew: Supporting Well-Being in Black Women After the Loss of a Loved One
  Active not recruiting · Interventional · 40 enrolled · Lillian Haley, PhD
  NCT07009795updated 2025-12-30
• Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis
  Recruiting · Interventional · 40 enrolled · Khyber Medical University Peshawar
  NCT07242612updated 2025-11-21
• Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
  Completed · Phase 4 · Interventional · 149 enrolled · Dong-A ST Co., Ltd.
  NCT05630768updated 2025-08-24
• Denosumab Safety Assessment in Multiple Observational Databases
  Completed · Observational · 517,991 enrolled · Amgen
  NCT02520362updated 2024-11-04
• A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
  Completed · Phase 3 · Interventional · 1,053 enrolled · Organon and Co
  NCT00092014updated 2024-08-14
• A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)
  Completed · Phase 3 · Interventional · 936 enrolled · Organon and Co
  NCT00092040updated 2024-08-14
• Prevention of Osteoporosis in Breast Cancer Survivors
  Completed · Interventional · 249 enrolled · University of Nebraska
  NCT00567606updated 2023-11-30

CPIC-curated drug–gene pairs for Risedronate. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• FDPSCPIC D (provisional)

Frequently asked questions

How does Risedronate work?

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate inhibits osteoclasts.

What is Risedronate used for?

According to FDA labeling, Risedronate carries indications including: Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Risedronate?

Risedronate is classified as Bone Surface Interactions, Bone Resorption Inhibition.

What are the brand names for Risedronate?

Risedronate is marketed under brand names including Actonel.

What are the contraindications for Risedronate?

Risedronate labeling lists contraindications including: Risedronate sodium delayed-release tablets contraindicated in patients with the following conditions: 1. Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] 2.. Always consult the full prescribing information and a clinician.