Prescription medicine
Risedronate Brand names: Actonel, Atelvia
Risedronate (Actonel) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $12.91 per risedronate sodium 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the risedronate FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals, Inc.); the NDA 20835 record on Drugs@FDA; every risedronate label on DailyMed.
Highlights of the record
FDA label of February 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRisedronate Sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined.
Forms and strengths
- 5 mg
- 30 mg
- 35 mg
- 75 mg
- 150 mg
- 30.1 mg / 4.9 mg
- 129 mg / 21 mg
Film-coated tablet; delayed-release tablet.
On the market
- Earliest approval on file
- March 27, 1998 Actonel, Apil; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first October 5, 2007; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 8 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 9, 2028 Atelvia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $12.91 per tablet Risedronate sodium 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2016 0 Class I among all firms' recalls; latest March 10, 2022
- FAERS reports
- 30,906 through July 30, 2026
What is risedronate used for?
From the label: indications and usageRisedronate Sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) 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. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate Sodium is indicated for the treatment and prevention of osteoporosis in postmenopausal women. […]
Conditions named in the indications of risedronate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Bisphosphonate.
Source: FDA drug label (Risedronate Sodium), NDA020835 (Apil), as published by Mylan Pharmaceuticals, Inc., effective February 12, 2026 (SPL set f715718a-407d-4e2a-9834-74a8f1361d03), via openFDA; the full label on DailyMed
What does the patient leaflet for risedronate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Risedronate Sodium?Risedronate Sodium can cause serious side effects including: Esophagus problems Low calcium levels in your blood (hypocalcemia) Severe jaw bone problems (osteonecrosis) Bone, joint, or muscle pain Unusual breaks in thigh and other bones 1. Esophagus problems. Some people who take Risedronate Sodium may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed. It is important that you take Risedronate Sodium exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take Risedronate Sodium ?”) Stop taking Risedronate Sodium and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 2. Low calcium levels in your blood (hypocalcemia). Risedronate Sodium may lower the calcium levels in your blood. If you have low blood calcium before you start taking Risedronate Sodium, it may get worse during treatment. Your low blood calcium must be treated before you take Risedronate Sodium. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: Spasms, twitches, or cramps in your muscles Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Risedronate Sodium. Take calcium and vitamin D as your doctor tells you to. 3. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Risedronate Sodium. Your doctor should examine your mouth before you start Risedronate Sodium. […]
From the patient leaflet: How should I store Risedronate Sodium ?Store Risedronate Sodium at room temperature, 68° F to 77° F (20° C to 25° C). Safely throw away medicine that is out of date or no longer needed. Keep Risedronate Sodium and all medicines out of the reach of children.
Source: FDA drug label (Risedronate Sodium), NDA020835 (Apil), as published by Mylan Pharmaceuticals, Inc., effective February 12, 2026 (SPL set f715718a-407d-4e2a-9834-74a8f1361d03), via openFDA; the full label on DailyMed
Is there a generic for risedronate (Actonel)?
The FDA approved the first generic risedronate on October 5, 2007. 14 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists risedronate from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Actonel tablets; a patent listed only for Atelvia tablets runs to January 9, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1998 earliest approval on file
- 2007 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for risedronate (Actonel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12.91 per Risedronate sodium 150 mg tablet, down 27% from $17.66 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Risedronate sodium 150 mg tablet (generic)
- Atelvia DR 35 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Risedronate sod DR 35 mg tablet | Generic | $30.68 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $920.32 | +28% |
| Risedronate sodium 150 mg tablet | Generic | $12.91 per tablet | $387.22 | -27% |
| Risedronate sodium 35 mg tablet | Generic | $1.60 per tablet | $47.94 | -28% |
| Risedronate sodium 35 mg tablet | Generic | $1.60 per tablet | $47.94 | -28% |
| Risedronate sodium 5 mg tablet | Generic | $1.52 per tablet | $45.45 | -7% |
| Actonel 35 mg tablet | Brand | $81.86 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,455.66 | +0.4% |
| Atelvia DR 35 mg tablet | Brand | $63.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,914.24 | +0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has risedronate been recalled?
The FDA's Enforcement Report lists 3 recalls naming risedronate since 2016: 0 Class I (the most serious), 0 Class II, 3 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 10, 2022 | Class III | Macleods Pharma Usa Inc | FAILED CONTENT UNIFORMITY SPECIFICATIONS |
| February 17, 2017 | Class III | Teva Pharmaceuticals USA | Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. |
| December 1, 2016 | Class III | Teva Pharmaceuticals USA | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the risedronate label say about other medicines?
The risedronate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Of over 5700 patients enrolled in the Risedronate Sodium Phase 3 osteoporosis studies, aspirin use was reported by 31% of patients, 24% of whom were regular users (3 or more days per week). |
| Esomeprazole | drug interactions | Co-administration of Risedronate sodium delayed-release with the PPI, esomeprazole, increased risedronate bioavailability. |
Source: FDA drug label (Risedronate Sodium), NDA020835 (Apil), as published by Mylan Pharmaceuticals, Inc., effective February 12, 2026 (SPL set f715718a-407d-4e2a-9834-74a8f1361d03), via openFDA; the full label on DailyMed
What do FAERS reports show for risedronate?
The FDA Adverse Event Reporting System holds 30,906 reports that list risedronate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,904 are coded as a death and 12,402 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as risedronate?
5 other medicines are given the same way (oral) and in the same FDA class as risedronate or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Alendronate | Osteoporosis | 16 labelers | $0.256 per tablet 70 mg tablet | No current entry |
| Ibandronate | Osteoporosis | 6 labelers | $2.68 per tablet 150 mg tablet | No current entry |
| Alendronate and cholecalciferol | Osteoporosis | none listed | $52.51 per unit 70 mg-5600 unit | No current entry |
| Raloxifene | Osteoporosis | 17 labelers | $0.223 per tablet 60 mg tablet | No current entry |
| Bazedoxifene and estrogens conjugated | Osteoporosis | none listed | $6.48 per tablet 0.45-20 mg tablet | No current entry |
Every medicine labeled for the same conditions as risedronate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does risedronate compare with medicines for the same use?
1 side-by-side page set risedronate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to risedronate
- 5 medicines for the same use
- Other bisphosphonates
- the pharmacologic class, with prices and generics
- Risedronate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other