Prescription medication · Bisphosphonate
risedronate
Also sold as Actonel. This medicine treats osteoporosis in women after menopause.
Data updated 2026-05-15
- 30,089
- FDA reportsModerately reported
- 2
- InteractionsFew interactions
- 73% less
- Generic vs brandBig savings
- $81.74
- Brand price (NADAC)
What the data shows
risedronate (Actonel) is a prescription Bisphosphonate, reported at a middle-of-the-pack volume (30,089 FDA reports), whose generic runs roughly half the brand price or less (73% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
risedronate (Actonel) is a prescription Bisphosphonate. This medicine treats osteoporosis in women after menopause.
Risedronate sodium delayed-release tablets help treat osteoporosis after menopause. It helps to make your bones stronger and less likely to break.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$81.74/unit
Generic Price
$21.97/unit
Generic Savings
73%
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats osteoporosis in women after menopause.
Common side effects
Diarrhea, Flu-like symptoms, Joint pain
Key warnings
Risedronate can cause problems with your esophagus.
The sections below are summarized in plain English from risedronate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Risedronate belongs to a class of drugs called bisphosphonates. It works by slowing down the breakdown of bone. This helps to increase bone density and reduce the risk of fractures.
Side Effects (from patient reports)
Based on 30,089 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for risedronate, by number of reports
- Arthralgia
Arthralgia
3,730 reports
- Pain
Pain
3,613 reports
- Nausea
Nausea
2,991 reports
- Fatigue
Fatigue
2,911 reports
- Dyspnoea
Dyspnoea
2,802 reports
- Vomiting
Vomiting
2,735 reports
- Diarrhoea
Diarrhoea
2,685 reports
- Pneumonia
Pneumonia
2,434 reports
- Drug Hypersensitivity
Drug Hypersensitivity
2,417 reports
- Headache
Headache
2,327 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for risedronate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where risedronate sits
risedronate has more FDA adverse-event reports than 64% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is risedronate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 30,089 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
30,089
Reports Mentioning Death
2,696
9.0% of reports — not proof of cause
Hospitalization Reports
12,023
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ARTHRALGIA | 3,730 |
| 3 | PAIN | 3,613 |
| 4 | NAUSEA | 2,991 |
| 5 | FATIGUE | 2,911 |
| 7 | DYSPNOEA | 2,802 |
| 8 | VOMITING | 2,735 |
| 9 | DIARRHOEA | 2,685 |
| 10 | PNEUMONIA | 2,434 |
| 11 | DRUG HYPERSENSITIVITY | 2,417 |
| 12 | HEADACHE | 2,327 |
| 13 | RHEUMATOID ARTHRITIS | 2,319 |
| 14 | MALAISE | 2,297 |
| 15 | PAIN IN EXTREMITY | 2,136 |
| 16 | FALL | 1,987 |
| 17 | JOINT SWELLING | 1,957 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Risedronate can cause problems with your esophagus. Follow the directions carefully and stay upright for 30 minutes after taking it. It can also cause bone, joint, or muscle pain. Tell your doctor right away if you have new pain in your thigh or groin.
Known Drug Interactions
7.4 Aspirin/Nonsteroidal Anti-Inflammatory Drugs In the Phase 3 study comparing risedronate sodium 35 mg once-a-week immediately following breakfast and risedronate sodium 5 mg daily, 18% of NSAID users (any use) in both groups developed upper gastrointestinal adverse reactions.
Mechanism: Both of these drugs can be tough on the stomach lining, and taking them together increases the chance of having stomach pain or irritation.
Co-administration of risedronate sodium with the PPI, esomeprazole, increased risedronate bioavailability.
Mechanism: This acid-reducing medicine can cause your body to absorb a larger amount of the bone medication than it normally would.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take risedronate with food?
What if I have trouble swallowing pills?
Can I take calcium supplements at the same time?
How long should I take this medicine?
What should I do if I get heartburn?
Can I lie down right after taking the pill?
What if I have kidney problems?
Can men take this medication?
What if I am already taking Actonel?
Can I take antacids with risedronate?
What are the common side effects of risedronate?
Does risedronate interact with other medications?
What drug class is risedronate?
Is there a generic version of risedronate?
What pregnancy or breastfeeding source fields are listed for risedronate?
Related Medications in Bisphosphonate
Other drugs grouped near risedronate - same-class peers and common alternatives.
abaloparatide
Tymlos
Tymlos is a medicine to treat osteoporosis.
Compare with risedronate →
alendronate
Fosamax
Binosto is a medicine that helps make your bones stronger.
Compare with risedronate →
calcitonin
Miacalcin, Fortical
Calcitonin is a medicine that helps manage calcium levels in your body.
Compare with risedronate →
denosumab
Prolia, Xgeva
Stoboclo is a medicine that helps to treat osteoporosis and increase bone mass.
Compare with risedronate →
ibandronate
Boniva
Ibandronate (Boniva) is a medicine that helps treat and prevent bone loss in women after menopause.
Compare with risedronate →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for risedronate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 30,089.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.96%.
- clomipramine Δ 0.03 pts · 4,403 reports · Tricyclic Antidepressant (TCA) 8.93%death share
- adenosine Δ 0.04 pts · 1,547 reports · Endogenous Nucleoside (Antiarrhythmic) 8.92%death share
- simvastatin Δ 0.04 pts · 245,754 reports · HMG-CoA Reductase Inhibitor (Statin) 8.92%death share
- valproate Δ 0.05 pts · 19,772 reports · Anticonvulsant / Mood Stabilizer 9.01%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on risedronate
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What the FDA Data Shows for risedronate
The FDA label for risedronate (sold under brand names such as Actonel) classifies it as a prescription-only medication in the Bisphosphonate class. This medicine treats osteoporosis in women after menopause. Official labeling lists 5 commonly reported side effects, including Diarrhea, Flu-like symptoms, Joint pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 30,089 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $21.97 versus $81.74 for the brand - a 73% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 9, 2020
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages