ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026

Risedronate

Active ingredient

GB MHRACA Health Canada

Drug class: -
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 27

Overview

Risedronate is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	23	May 15, 2026
CA Canada	Health Canada	4	August 21, 2025

GBUnited Kingdom· MHRA

23 products

Uses

GBOfficial regulatory label· revised May 15, 2026[1]

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. 1). 1).

How to take

CACanada· Health Canada

4 products

Uses

CAOfficial regulatory label· revised August 21, 2025[2]

RISEDRONATE (Risedronate Sodium Tablets) is indicated for: • the treatment and prevention of osteoporosis in postmenopausal women • the treatment of osteoporosis in men, to improve bone mineral density Postmenopausal Osteoporosis: In the treatment of osteoporosis in postmenopausal women at risk of fracture, risedronate sodium prevent vertebral and nonvertebral osteoporosis-related (fragility) fractures and increase bone mineral density (BMD) at all measured skeletal sites of clinical importance for osteoporotic fractures, including spine, hip, and wrist.
, at least 2 standard deviation [SD] below the premenopausal mean). For the prevention of osteoporosis in postmenopausal women who are at risk of developing osteoporosis, risedronate sodium preserves or increases BMD at sites of clinical importance.
RISEDRONATE may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture. Factors such as family history of osteoporosis (particularly maternal history), age, previous fracture, smoking, moderately low BMD, high bone turnover, thin body frame, Caucasian or Asian race, and early menopause are associated with an increased risk of developing osteoporosis and fractures.

Sources & citations

[1]MHRA (UK) · PL200751069 · revised May 15, 2026
[2]Health Canada (DPD) · 02370255 · revised August 21, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Risedronate: Uses, Side Effects, Dosage - Drugvu

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 15, 2026[1]

Risedronate sodium has been studied in phase III clinical trials involving more than 15,000 patients. The majority of undesirable effects observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy.
Adverse experiences reported in phase III clinical trials in postmenopausal women with osteoporosis treated for up to 36 months with risedronate sodium 5 mg/day (n=5020) or placebo (n=5048) and considered possibly or probably related to risedronate sodium are listed below using the following convention (incidences versus placebo are shown in brackets): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
8% vs. 0% vs. 5% vs. 3% vs. 5% vs. 0% vs. 9% vs. 9% vs. 4% vs. 2% vs. 2% vs. 1% vs. 1% vs. 1% vs. 9%) Investigations Rare: abnormal liver function tests* * No relevant incidences from Phase III osteoporosis studies; frequency based on adverse event/laboratory/rechallenge findings in earlier clinical trials.
In a one-year, double-blind, multicentre study comparing risedronate sodium 5 mg daily (n=480) and risedronate sodium 35 mg weekly (n=485) in postmenopausal women with osteoporosis, the overall safety and tolerability profiles were similar.
6% vs. 2% vs. 8%). In a 2-year study in men with osteoporosis, the overall safety and tolerability were similar between the treatment and the placebo groups. Adverse experiences were consistent with those previously observed in women. Laboratory findings Early, transient, asymptomatic and mild decreases in serum calcium and phosphate levels have been observed in some patients.
The following additional adverse reactions have been reported during post-marketing experience: Immune system disorders Not known: anaphylactic reaction Eye disorders Not known: iritis, uveitis Hepatobiliary disorders Not known: serious hepatic disorders.
In most of the reported cases the patients were also treated with other products known to cause hepatic disorders. Skin and subcutaneous tissue disorders Not known: hypersensitivity and skin reactions, including angioedema, generalised rash, urticaria and bullous skin reactions, some severe including isolated reports of Stevens-Johnson syndrome toxic epidermal necrolysis and leukocytoclastic vasculitis, hair loss Musculoskeletal and connective tissues disorders Not known: osteonecrosis of the jaw Rare: atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) Very rare: osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 15, 2026[1]

5). 2). Efficacy of bisphosphonates in the treatment of osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture. High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.
1). Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. g. stricture or achalasia. • In patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet.
• If risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems (including known Barrett’s oesophagus). Prescribers should emphasise to patients the importance of paying attention to the dosing instructions and be alert to any signs and symptoms of possible oesophageal reaction.
The patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn. Hypocalcaemia should be treated before starting Risedronate Sodium Accord Once a Week 35 mg film-coated tablets therapy.
e. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Risedronate Sodium Accord Once a Week 35 mg film-coated tablets therapy. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised August 21, 2025[2]

1 Adverse Reaction Overview RISEDRONATE Product Monograph Page 11 of 42 Protected B / Protégé B Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis, esophageal ulcer and gastric ulcer. It is therefore important to follow the recommended dosing instructions.
4 Administration. Musculoskeletal pain, rarely severe, has been reported as a common adverse event in patients who received risedronate sodium for all indications. In risedronate sodium osteoporosis studies, the most commonly reported adverse reactions were abdominal pain, dyspepsia and nausea.
In addition, diarrhea was the most commonly reported adverse reaction for the highest risedronate sodium monthly dose. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Treatment and Prevention of Postmenopausal Osteoporosis:
Risedronate sodium 5 mg daily has been studied for up to 3 years in over 5000 women enrolled in Phase III clinical trials for treatment or prevention of postmenopausal osteoporosis. Most adverse events reported in these trials were either mild or moderate in severity, and did not lead to discontinuation from the study.
The distribution of severe adverse events was similar across treatment groups. In addition, the overall incidence of adverse events (AEs) was found to be comparable amongst risedronate sodium- and placebo-treated patients. Table 2 lists adverse events considered possibly or probably drug-related, reported in ≥1% of risedronate sodium 5 mg daily-treated patients, in Phase III postmenopausal osteoporosis trials.
0% of patients treated with placebo. 5 * Considered to be possibly or probably causally related by clinical study Investigators Weekly Dosing: In the 1-year, double-blind, multicentre study comparing risedronate sodium 35 mg Once-a-Week to risedronate sodium 5 mg daily for the treatment of osteoporosis in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar.
The proportion of patients who experienced an upper gastrointestinal adverse event and the pattern of those events were found to be similar between the risedronate sodium 35 mg Once- a-Week and risedronate sodium 5 mg daily-treated groups.
3%) was reported in ≥ 1% of patients and in more risedronate sodium 35 mg weekly treated patients than in risedronate sodium 5 mg daily treated patients. In the 1-year, double-blind, multicentre study comparing risedronate sodium 35 mg Once-a- Week to placebo for the prevention of osteoporosis in postmenopausal women, the overall safety and tolerability profiles of the two groups were comparable with the exception of arthralgia.
7% of placebo patients. The overall safety profile observed in this study showed no substantive difference from that observed in the risedronate sodium 5 mg daily versus risedronate sodium 35 mg Once-a-Week treatment study. Monthly Dosing: (Once-a-Month) – In a 1-year, double-blind, multicentre study for the treatment of osteoporosis in postmenopausal women comparing risedronate sodium 150 mg Once-a- Month to risedronate sodium 5 mg daily, the overall safety profiles of the dosing regimens were similar.
The proportion of patients who experienced an upper gastrointestinal adverse event and the pattern of those events were found to be similar between the risedronate sodium 150 mg Once-a-Month and the risedronate sodium 5 mg daily treated groups.
3%) were reported in ≥1% of patients and in more risedronate RISEDRONATE Product Monograph Page 13 of 42 Protected B / Protégé B sodium 150 mg treated patients than in risedronate sodium 5 mg daily treated patients. Symptoms consistent with acute phase reactions have been reported.
1% in the risedronate sodium 5 mg daily group. 2% of patients in […]

CAOfficial regulatory label· Warnings and precautions· revised August 21, 2025[2]

1 Dosing Considerations • Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. See 7 WARNINGS AND PRECAUTIONS. 2 Recommended Dose and Dosage Adjustment • For all indications and doses: The patient should be informed to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions.
• Treatment of Postmenopausal Osteoporosis: The recommended regimen is 35 mg once-a-week, taken orally. • Prevention of Postmenopausal Osteoporosis: The recommended regimen is 35 mg once-a-week, taken orally. • Treatment of Osteoporosis in Men, to Improve Bone Mineral Density: The recommended regimen is 35 mg once-a-week, taken orally.
• Renal Impairment: No dosage adjustment is necessary in patients with a creatinine clearance ≥ 30 mL/min or in the elderly. Not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min). • Pediatrics (<18 years of age): Health Canada has not authorized an indication for pediatric use.
RISEDRONATE Product Monograph Page 6 of 42 Protected B / Protégé B • Geriatrics:
No dosage adjustment is necessary in elderly patients. 2 Geriatrics. 4 Administration • RISEDRONATE should be taken on an empty stomach at least 30 minutes before consuming the first food, drink (other than plain water) and/or any other medication of the day.
Food, medication or drink (other than plain water) can interfere with the absorption of risedronate sodium. 2 Recommended Dose and Dosage Adjustment and 9 DRUG INTERACTIONS). • Each RISEDRONATE tablet should be swallowed whole while the patient is in an upright position and with sufficient plain water (≥ 120 mL) to facilitate delivery to the stomach.
• Patients taking RISEDRONATE should not lie down for at least 30 minutes after taking the medication. See 7 WARNINGS AND PRECAUTIONS. • RISEDRONATE tablets should not be chewed, cut, or crushed. See 7 WARNINGS AND PRECAUTIONS. g. calcium, magnesium, aluminum, and iron) can interfere with the absorption of risedronate sodium.
These medications should be administered at a different time of the day than RISEDRONATE. • The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of RISEDRONATE on an individual patient basis.

This is not medical advice. Consult a qualified healthcare professional.