[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule


Consumer Drug Information Sheet

Actonel
Brand Name: Actonel
Active Ingredient:   risedronate sodium
Strength(s): 5mg, 30mg, & 35 mg
Dosage Form(s):   Tablet
Company Name:    Procter and Gamble Pharmaceuticals
Availability:         Prescription only
*Date Approved by the FDA:   March 27, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Actonel used for?

Actonel is used to treat Paget’s disease of the bone.

Actonel is also used to prevent and treat:

  • postmenopausal osteoporosis

  • glucocorticoid-induced osteoporosis in men and women

 Who should not take Actonel?

 You should not take Actonel if you:

  • have low calcium levels in the blood

  • have bone or mineral problems that have not been treated by your health care provider

  • have severe kidney problems

  • are unable to stand or sit up for at least 30 minutes.

 General Precautions with Actonel:

Tell your doctor if you have a history of stomach problems because Actonel can cause difficulty swallowing, inflammation of the esophagus, esophageal ulcer, and stomach ulcer.

If you have a bone-imaging test, tell your doctor or technician you are taking Actonel because it can interfere with the test.

What should I tell my doctor or health care provider:

Tell your doctor or health car provider if you are:

  • taking aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS), because taken togetherwith Actonel, aspirin and NSAIDS can increase the probability of stomach irritation.

  • trying to become pregnant, are already pregnant, or are breast-feeding.

What are some possible side effects of Actonel? (This is not a complete list of side effects reported with Actonel.  Your health care provider can discuss with you a more complete list of side effects.)

Side effects of Actonel are generally mild to moderate and do not require stopping the treatment.

The following is a listing of the most common side effects:

  • flu syndrome

  • chest pain

  • diarrhea

  • abdominal

  • pain  nausea

  • constipation

  • swelling

  • joint pain

  • headache

  • dizziness rash

For more detailed information about Actonel, ask your health care provider.

Actonel’s Approved  Labeling and Patient Information

Back to Top     Other Consumer Drug Information Sheets

Date created: March 30, 2004

Updated:  February 2005

horizonal rule