Risedronate

Pronunciation: ris-ED-roe-nate.

Generic name
risedronate sodium
Drug class
Pyridinyl bisphosphonate (osteoclast-mediated bone resorption inhibitor)
Form
Film-coated tablet (5 mg, 30 mg, 35 mg, 75 mg, 150 mg depending on market/regimen); delayed-release tablet (US)
Route
Oral
Legal status
Prescription-only

Supply Rules Vary

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Actonel (4) · Full directory

What risedronate sodium is and how it works

Risedronate is a prescription-only oral bisphosphonate used to treat and prevent osteoporosis after menopause, to treat osteoporosis in men, to treat and prevent osteoporosis caused by long-term glucocorticoid (steroid) medicines, and (in some markets) to treat Paget's disease of bone. It works by slowing the activity of osteoclasts, the cells that break down bone tissue, which helps preserve bone density and reduce fracture risk. (1) (2)

Risedronate does not carry a boxed warning -- the FDA's strongest category of safety warning -- on any of the regulator labels checked for this page. It does require a very specific way of taking it (an empty stomach, plain water only, staying upright for 30 minutes) to avoid irritating the oesophagus, and carries less common but serious risks such as jaw bone problems (osteonecrosis of the jaw) and unusual thigh-bone fractures with long-term use. Your prescriber will discuss whether risedronate is right for you and how to take it safely.

Mechanism of action: how risedronate sodium works

Risedronate is a third-generation pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption, reducing bone turnover toward premenopausal levels while increasing bone mineral density and biomechanical strength. (3) (5)

What risedronate sodium is used for

Postmenopausal osteoporosis (treatment)

Approved to treat osteoporosis in postmenopausal women, reducing the risk of vertebral and hip fractures and increasing bone mineral density. (1) (2) (3) (5)

Postmenopausal osteoporosis (prevention)

Approved (US) to prevent postmenopausal osteoporosis in women at increased risk. (1)

Osteoporosis in men

Approved to increase bone mass in men with osteoporosis. (1) (2) (5)

Glucocorticoid-induced osteoporosis

Approved (US, New Zealand) to treat and/or prevent osteoporosis caused by long-term glucocorticoid (steroid) treatment. (1) (5)

Paget's disease of bone (United States)

Approved in the US for treatment of Paget's disease of bone, using a different regimen (30 mg once daily for 2 months) than the osteoporosis indications. (1)

Before taking risedronate sodium

Do not take / not appropriate for

  • Do not take risedronate if you have had an allergic reaction to it or any of its ingredients. (all confirmed markets) (1) (2) (3)
  • Do not take risedronate if you have hypocalcaemia (low blood calcium) -- this must be corrected before starting treatment. (all confirmed markets) (1) (2) (5)
  • Do not take risedronate if you are unable to stand or sit upright for at least 30 minutes. (all confirmed markets) (1) (2) (5)
  • Do not take risedronate if you have oesophagus problems that delay emptying, such as stricture or achalasia. (United States, United Kingdom) (1) (2)
  • Do not take risedronate if you have severe kidney impairment (creatinine clearance below 30 mL/min). (all confirmed markets) (1) (2) (5)
  • Do not take risedronate if you are pregnant or breastfeeding. (United Kingdom, New Zealand) (2) (5)

Tell your clinician about

  • Any history of oesophagus problems, heartburn, or difficulty swallowing.
  • Any planned dental work or history of poor oral hygiene, cancer treatment, or corticosteroid use -- these increase the risk of jaw bone problems.
  • Any thigh, hip, or groin pain, which can be an early sign of an unusual bone fracture with long-term bisphosphonate use.
  • Kidney problems.
  • Whether you are pregnant, planning pregnancy, or breastfeeding.
  • All other medicines and supplements you take, especially calcium, antacids, or products containing magnesium, aluminium, or iron.
(1) (2) (3) (5)

How to take risedronate sodium

  • Take risedronate first thing in the morning, at least 30 minutes before the first food, drink (other than plain water), or other medication of the day.
  • Swallow the tablet whole with 6-8 ounces (about 120 mL or more) of plain water -- do not chew, suck, or crush it.
  • Stay in an upright position (sitting or standing) while taking risedronate and for at least 30 minutes afterward -- do not lie down.
  • Do not use mineral water or water from areas with high natural calcium content -- use plain tap or bottled drinking water.
  • Do not take calcium, antacids, or supplements containing magnesium, aluminium, or iron within 30 minutes of your risedronate dose -- these interfere with absorption.
  • Take supplemental calcium and vitamin D if your prescriber advises it and your dietary intake is inadequate.
  • Do not change your dose or stop taking risedronate without talking to your prescriber first.
(1) (3) (5)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

For weekly or monthly regimens, if you miss a dose, take it the morning after you remember, then return to your original schedule -- unless it is close to your next scheduled dose, in which case skip the missed dose (never take two doses in the same week, or more than one 150 mg dose within 7 days). Contact your prescriber if you are unsure which rule applies to your specific regimen.

Overdose

Seek urgent medical attention or contact a poison control centre if too much risedronate may have been taken. Low blood calcium can occur after a substantial overdose. Milk or calcium/magnesium/aluminium-containing antacids may be given to bind the drug and reduce absorption if given promptly; do not attempt to manage a suspected overdose yourself. (3) (5)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Back pain, joint pain (arthralgia) -- common.

What to notice: Back pain, joint pain (arthralgia) -- common.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (5)

Abdominal pain, dyspepsia (indigestion), nausea, constipation, diarrhoea -- common.

What to notice: Abdominal pain, dyspepsia (indigestion), nausea, constipation, diarrhoea -- common.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3) (5)

Headache, dizziness -- common.

What to notice: Headache, dizziness -- common.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2) (5)

Serious warnings

Signs of oesophagus (upper digestive tract) irritation or injury — high caution

Symptoms: Difficulty or pain swallowing, new or worsening heartburn, or pain behind the breastbone.

Action: Seek medical attention promptly and tell your prescriber -- they will decide whether you should stop risedronate. Risk is higher if the administration instructions (upright position, plain water, staying upright afterward) are not followed exactly. (1) (2) (3)

Signs of osteonecrosis of the jaw — moderate caution

Symptoms: Jaw pain, swelling, numbness, a feeling of heaviness, loose teeth, or exposed bone in the mouth that is slow to heal, especially after a dental procedure.

Action: Tell your prescriber and dentist promptly. Maintain good oral hygiene and have a dental check-up before starting risedronate, particularly if you have cancer, are undergoing chemotherapy, take corticosteroids, or have poor oral health. (1) (2) (3)

Signs of an atypical (unusual) thigh-bone fracture — moderate caution

Symptoms: New or unusual dull, aching pain in the thigh, hip, or groin, which can occur weeks to months before a complete fracture, sometimes in both legs.

Action: Tell your prescriber promptly. You may be assessed for an incomplete fracture in both legs, and continuing risedronate will be reassessed based on your individual risks and benefits. (1) (2) (3) (5)

Signs of low blood calcium (hypocalcaemia) — moderate caution

Symptoms: Muscle cramps or spasms, tingling in the fingers or around the mouth.

Action: Tell your prescriber. Hypocalcaemia must be corrected before starting risedronate and monitored during treatment, particularly if you have risk factors such as vitamin D deficiency or kidney problems. (1) (3)

Severe eye inflammation — moderate caution

Symptoms: Eye pain, redness, or vision changes (possible iritis, uveitis, episcleritis, or scleritis).

Action: See an eye specialist promptly. Treatment may need to be stopped if inflammatory eye symptoms occur. (3) (5)

Severe allergic or skin reactions — high caution

Symptoms: Swelling of the face, lips, tongue, or throat; widespread rash; blistering or peeling skin.

Action: Seek emergency medical attention immediately -- rare but serious reactions including angioedema, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported after marketing. (3) (5)

Severe bone, joint, or muscle pain — moderate caution

Symptoms: Severe or incapacitating pain in bones, joints, or muscles, which can start anywhere from one day to several months after starting treatment.

Action: Tell your prescriber -- discontinuing risedronate may be considered if symptoms are severe. (1) (3)

Interactions

  • Calcium supplements, antacids, or other medicines/supplements containing calcium, magnesium, aluminium, or iron: significantly reduce absorption of risedronate. Take these at a different time of day, at least 30 minutes apart from risedronate. (1) (2) (5)
  • NSAIDs and aspirin: no clinically significant increase in upper GI adverse events was seen in clinical trials with concomitant use of 3 or more days per week, but caution is still advised given the shared potential for GI irritation. (5)
  • Hormone replacement therapy or the contraceptive pill: no interaction identified; may be used concomitantly. (5)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Risedronate is contraindicated in pregnancy (UK, New Zealand labels) or not intended for use in pregnancy (Canada, US, no adequate human data). Animal studies have shown reproductive toxicity at high doses. (1) (2) (3) (4) (5) (6)

Breastfeeding

Contraindicated (UK, New Zealand) or not intended for use (Canada, US) in breastfeeding women; a small degree of transfer into breast milk has been shown in animal studies and human data are not available. (1) (2) (3) (4) (5) (6)

Children

Not authorised for use in patients under 18 in any of the markets reviewed -- Health Canada and Medsafe both state no data are available to support paediatric use. (1) (2) (3) (4) (5) (6)

Elderly

No dose adjustment is necessary based on age alone; no overall differences in efficacy or safety were observed between elderly and younger patients in osteoporosis studies, though greater sensitivity in some individuals cannot be ruled out. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Risedronate is not metabolised by the liver, so a dosage adjustment is not expected to be necessary; no dedicated hepatic-impairment dosing studies were identified. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dose adjustment is necessary for mild-to-moderate renal impairment (creatinine clearance 30-60 mL/min or above). Not recommended for severe renal impairment (creatinine clearance below 30 mL/min). (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-RISEDRONATE-2026,UK-EMC-RISEDRONATE-35MG-2026,CA-HEALTHCANADA-RISEDRONATE-2023,NZ-MEDSAFE-RISEDRONATE-SANDOZ-2025 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Correction of hypocalcaemia and other bone/mineral metabolism disturbances
  • Dental examination, particularly if cancer, chemotherapy, corticosteroid use, or poor oral hygiene are present
  • Kidney function assessment
  • Confirmation the patient can remain upright for at least 30 minutes after dosing

During treatment

  • Monitoring for oesophageal/upper GI symptoms.
  • Routine dental check-ups and prompt reporting of any oral symptoms.
  • Monitoring for thigh, hip, or groin pain that could indicate an atypical fracture.
  • Periodic reassessment of the need for continued therapy -- the optimal duration of bisphosphonate treatment has not been established, and discontinuation after 3-5 years may be considered in lower-risk patients.
(1) (3)

Storage

Store at room temperature, away from moisture, out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US, UK, Canadian, Australian, and New Zealand labels reviewed; verify against the current full label before prescribing, and note the real regimen differences described above.

United States

Indication: Postmenopausal osteoporosis (treatment and prevention); osteoporosis in men; glucocorticoid-induced osteoporosis (treatment and prevention); Paget's disease of bone

Dose summary: 5 mg daily, 35 mg weekly, or 75 mg on 2 consecutive days monthly (osteoporosis); 30 mg daily x2 months (Paget's disease).

Renal context: No adjustment for CrCl >=30 mL/min; not recommended below 30 mL/min. (1)

Canada

Indication: Treatment of osteoporosis in postmenopausal women

Dose summary: 150 mg once monthly, same calendar day each month.

Renal context: No adjustment for CrCl >=30 mL/min; not recommended below 30 mL/min. (3)

United Kingdom / New Zealand

Indication: Postmenopausal osteoporosis (vertebral/hip fracture risk reduction); osteoporosis in men

Dose summary: 35 mg once weekly, same day each week.

Renal context: No adjustment for mild-to-moderate impairment; contraindicated/not recommended in severe impairment (CrCl <30 mL/min). (2) (5)

Mechanism of action

Hepatic guidance

Not metabolised hepatically; dosage adjustment not expected to be necessary.

Overdose note

Manage supportively; milk or calcium/magnesium/aluminium-containing antacids may be given to bind unabsorbed drug; gastric lavage may be considered if performed promptly after ingestion; monitor and correct hypocalcaemia. (3) (5)

Frequently asked questions

Does risedronate carry a boxed warning?

No. None of the six regulator sources checked for this page (US FDA/DailyMed, UK emc, Health Canada, Australia TGA, New Zealand Medsafe, and an EU EMA referral document) show a boxed warning or equivalent 'Serious Warnings and Precautions' box for risedronate. It does carry real, non-boxed warnings -- particularly about how it must be taken to avoid oesophagus irritation, and less common risks of jaw bone problems and unusual thigh-bone fractures with long-term use. (1) (2) (3) (5)

Why do I have to stay upright after taking risedronate?

Staying upright (sitting or standing) for at least 30 minutes after taking risedronate, along with taking it with a full glass of plain water on an empty stomach, helps the tablet pass quickly into the stomach and reduces the risk of it irritating or injuring your oesophagus (the tube connecting your mouth to your stomach). If you cannot stay upright for at least 30 minutes, risedronate should not be taken. (1) (2) (5)

Is risedronate dosed the same way everywhere?

No. The regimen depends on your indication and country -- for example, US labelling describes 5 mg daily, 35 mg weekly, or 75 mg on two consecutive days a month for osteoporosis, while Canadian labelling for one product describes 150 mg once monthly, and UK/New Zealand labelling for osteoporosis in men describes 35 mg once weekly. Always follow your own prescriber's and pharmacist's instructions for your specific product. (1) (3) (2)

Is risedronate authorised the same way across the European Union?

Not centrally. Unlike some other medicines that hold a single EU-wide EMA marketing authorisation, risedronate-containing products are authorised nationally in individual EU member states, sometimes via mutual-recognition procedures. A real EMA referral document shows a risedronate/calcium/vitamin D3 combination product's authorisation moving from Sweden to Italy through this national process, not through a centralised EU-wide approval. (6)

What is the mechanism of action of risedronate sodium?

Risedronate is a third-generation pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption, reducing bone turnover toward premenopausal levels while increasing bone mineral density and biomechanical strength. (3) (5)

What is the generic name of Risedronate?

The generic name is risedronate sodium. (1) (4)

What class of drug is risedronate sodium?

Risedronate is classed as: Pyridinyl bisphosphonate (osteoclast-mediated bone resorption inhibitor). (1) (4)

References

  1. RISEDRONATE SODIUM tablet, film coated -- full prescribing informationU.S. Food and Drug Administration (via DailyMed) · United States · dated 2024 · accessed 2026-07-31 · source 1
  2. Risedronate sodium 35 mg film-coated tablets -- Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · accessed 2026-07-31 · source 2
  3. RISEDRONATE (risedronate sodium hemi-pentahydrate) tablets, 150 mg -- Product Monograph (Sanis Health Inc.)Health Canada · Canada · dated 2023-09-19 · accessed 2026-07-31 · source 3
  4. ACTONEL 5mg risedronate sodium 5mg tablet blister pack -- ARTG 74135Therapeutic Goods Administration · Australia · dated 2000-08-14 · accessed 2026-07-31 · source 4
  5. Risedronate Sandoz (risedronate sodium) film-coated tablets -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · dated 2025-01-23 · accessed 2026-07-31 · source 5
  6. Questions and answers on Fortipan Combi D and associated names (risedronate sodium 35 mg tablets / calcium plus colecalciferol effervescent granules) -- outcome of an Article 29 referral procedureEuropean Medicines Agency · European Union · dated 2010-10-05 · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient risedronate sodium names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Risedronate sodium (generic; originator Actonel) (1)current regulator label · 5 mg, 35 mg, 150 mg · See current FDA/DailyMed listing (multiple generic manufacturers)

United Kingdom

  • Risedronate sodium (generic; originator Actonel) (2)current licensed product · 5 mg, 30 mg, 35 mg · See current emc SmPC listing

Canada

  • ACTONEL
  • ACTONEL DR

Australia

  • Actonel (4)current register product example · 5 mg · See current ARTG entry

New Zealand

  • Risedronate Sandoz (5)current data sheet · 35 mg · Sandoz
View brands in additional countries.

This page provides general reference information about risedronate and is not a substitute for advice from the prescriber managing your treatment. All dosing, administration technique, and treatment decisions should be made with your prescriber, especially given the real country- and regimen-specific differences described above.

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