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risedronate

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Brand names: Actonel

Bisphosphonate Rx

Risedronate sodium delayed-release tablets help treat osteoporosis after menopause. It helps to make your bones stronger and less likely to break.

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.

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.

How to Take It

Take one 35 mg tablet once a week. Take it in the morning right after you finish breakfast with at least 4 ounces of plain water. Do not lie down for at least 30 minutes after taking the tablet. If you don't get enough calcium and vitamin D from food, take supplements.

Pregnancy & Breastfeeding

Stop taking risedronate if you become pregnant. This medicine can affect the baby's bones. It is not known if risedronate passes into breast milk.

Missed Dose

If you miss your weekly dose, take it the next morning after you remember. Then, go back to your regular weekly schedule. Do not take two tablets on the same day.

Storage

Store at room temperature between 68°F and 77°F.

Side Effects (from patient reports)

Based on 30,337 FDA adverse event reports.

Joint pain
3,730
The medicine is not working
3,620
Pain
3,614
Feeling sick to your stomach
2,990
Feeling tired
2,911
Using the medicine for something it's not approved for
2,817
Difficulty breathing
2,802
Throwing up
2,735
Loose stools
2,684
Lung infection
2,434

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

Death-Related Reports

2,696

Hospitalization Reports

12,023

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 23,730 (85%)
Male 3,957 (14%)

Age Distribution

0–17 91
18–44 2,041
45–64 6,555
65–74 5,861
75+ 5,775

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 ARTHRALGIA 3,730
2 DRUG INEFFECTIVE 3,621
3 PAIN 3,613
4 NAUSEA 2,991
5 FATIGUE 2,911
6 OFF LABEL USE 2,817
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

Reactions in Death Reports

DEATH 572
PAIN 547
VOMITING 544
DIARRHOEA 543
FATIGUE 515
GENERAL PHYSICAL HEALTH DETERIORATION 511
ARTHRALGIA 505
CONFUSIONAL STATE 505
OFF LABEL USE 501
JOINT SWELLING 500

Reactions in Hospitalization Reports

PAIN 1,849
ARTHRALGIA 1,775
FATIGUE 1,643
DIARRHOEA 1,641
NAUSEA 1,627
DRUG INEFFECTIVE 1,606
OFF LABEL USE 1,439
FALL 1,406
VOMITING 1,356
DYSPNOEA 1,315

Source: FDA FAERS (Adverse Event Reporting System) 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

minor aspirin

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.

What to do: If you take aspirin often, let your doctor know so they can monitor you for any stomach problems or discomfort.

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.

What to do: Your doctor may need to monitor you more closely for side effects since more of the drug is entering your system.

Common Questions

Can I take risedronate with food?
Yes, take it immediately after breakfast.
What if I have trouble swallowing pills?
Swallow the tablet whole with water. Do not chew, cut, or crush it.
Can I take calcium supplements at the same time?
No, take calcium supplements at a different time of day.
How long should I take this medicine?
Your doctor will decide how long you need to take it. They may stop it after 3-5 years.
What should I do if I get heartburn?
Stop taking risedronate and call your doctor if you get new or worsening heartburn.
Can I lie down right after taking the pill?
No, stay upright for at least 30 minutes after taking the pill.
What if I have kidney problems?
Risedronate is not recommended if you have severe kidney problems.
Can men take this medication?
This medication is specifically indicated for postmenopausal women.
What if I am already taking Actonel?
Do not take risedronate sodium delayed-release tablets if you are already taking Actonel.
Can I take antacids with risedronate?
No, take antacids at a different time of day.
What are the common side effects of risedronate?
The most commonly reported side effects of risedronate include Diarrhea, Flu-like symptoms, Joint pain, Back pain, Abdominal pain. Based on 30,337 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does risedronate interact with other medications?
Yes, risedronate has 2 known drug interactions. Notable interactions include aspirin, esomeprazole. Always inform your doctor about all medications you are taking.
What drug class is risedronate?
risedronate belongs to the Bisphosphonate drug class. It requires a prescription (Rx). This medicine treats osteoporosis in women after menopause.
Is there a generic version of risedronate?
Yes, generic risedronate is available from 8 manufacturers. The generic costs $21.97 per unit compared to $81.74 for the brand version, saving approximately 73%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is risedronate safe during pregnancy?
Stop taking risedronate if you become pregnant. This medicine can affect the baby's bones. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Bisphosphonate

Other drugs grouped near risedronate — same-class peers and common alternatives.

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Medication Guides

Related Health & Safety Data

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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 30,337 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: September 9, 2020

All federal data sources used on this page