Warnings

Risedronate Sodium

Medically Reviewed by Dr. Harshi Dhingra, M.D.

Last Reviewed: Feb 24, 2025

Warnings

Risedronate Sodium (Actonel) Risks, Warnings, and Complications

Risedronate sodium may cause or worsen health problems in some people. Talk to your doctor or pharmacist about other treatment options for osteoporosis or Paget’s disease if you are at an increased risk of adverse events from this drug. Some of the risks of taking risedronate sodium include:

OTHER DRUGS WITH THE SAME ACTIVE INGREDIENT: Brand name products Actonel and Atelvia contain the same active ingredient, risedronate sodium. A person receiving one of these drugs should not take the other, as it can result in an overdose.
UPPER GASTROINTESTINAL ADVERSE EFFECTS: Risedronate sodium and other oral bisphosphonates can cause local irritation of the lining of the upper gastrointestinal tract. There are reports of adverse reactions involving the esophagus in patients treated with risedronate sodium, including esophagitis, esophageal ulcers, erosions, bleeding, and rarely, esophageal stricture or perforation. These complications can be severe and may require hospitalization.
Oral bisphosphonates should therefore be used with caution in people with active upper gastrointestinal problems, such as dysphagia (difficulty swallowing), Barrett’s esophagus (damage to the esophagus from stomach acid), other esophageal conditions, inflammation of the stomach or intestines (gastritis, duodenitis), or ulcers.
To lower the risk of severe esophageal damage, do not lie down after taking risedronate sodium. Make sure you swallow the medicine with a full glass of water.
Stop taking risedronate sodium and seek emergency medical attention if you develop signs or symptoms of possible esophageal problems, such as pain with swallowing, trouble swallowing, new or worsening heartburn, or chest pain.
MINERAL METABOLISM: There are reports of hypocalcemia (low calcium levels) in patients treated with risedronate sodium. Your healthcare provider will check calcium levels and treat hypocalcemia, if present, before starting risedronate sodium therapy. You may also need to take vitamin D and calcium supplements.
OSTEONECROSIS OF THE JAW: Osteonecrosis of the jaw (ONJ) is a rare complication in which bone cells in the jaw bone die due to a lack of blood supply. This serious complication can develop spontaneously or in association with tooth extractions and/or local infections with poor healing in patients taking bisphosphonates, including risedronate sodium. Risk factors for jaw osteonecrosis include:
Poor oral hygiene
Invasive dental surgery (for example, tooth extraction, dental implants, or bone surgery)
Other treatments (for example, corticosteroids, chemotherapy, or angiogenesis inhibitors)
Other disorders (for example, periodontal (gum) disease, other dental diseases, coagulopathies, anemia, infections, poorly fitted dentures)
Cancer Diagnosis
The risk of severe jaw problems increases with a longer duration of treatment with bisphosphonates. Your doctor may ask you to discontinue risedronate sodium treatment prior to any invasive dental procedures to lower the risk of ONJ.
If you develop jaw osteonecrosis while on a bisphosphonate, you may need specialized treatment by an oral surgeon.
MUSCULOSKELETAL PAIN: There are postmarketing reports of severe bone, joint, or muscle pain in patients treated with bisphosphonates. These problems can occur within a day to several months after starting therapy. Stopping the bisphosphonate relieves symptoms in most people. Some patients have a recurrence of musculoskeletal symptoms if they restart treatment even with a different bisphosphonate.
FEMUR FRACTURES: There are reports of atypical femur fractures (fractures of the thigh bone) in association with minimal to no trauma in patients treated with bisphosphonate. These fractures can be located anywhere along the femoral shaft in one or both legs. A direct causal relationship has not been established because atypical femur fractures also occur in osteoporotic patients who have not received bisphosphonates. In many cases, patients who developed atypical femur fractures were on steroid drug therapy (treatment with medications such as prednisone).
Seek immediate medical care for a dull or aching pain in the thigh, hip, or groin. This pain can be present for weeks or even months before the femur fractures completely.
KIDNEY DISEASE: Risedronate sodium is not recommended in patients with severe renal impairment (creatinine clearance below 30 mL/min).
STEROID-INDUCED OSTEOPOROSIS: If you are prescribed risedronate sodium for glucocorticoid-induced osteoporosis, your doctor will check sex steroid hormone status before starting treatment.
INTERACTIONS WITH LABORATORY TESTS: Bisphosphonates can interfere with agents used during bone imaging studies. Tell all your healthcare providers and laboratory personnel you are on risedronate sodium before any evaluations.

Precautions Before Starting Risedronate Sodium (Actonel)

Tell your healthcare professional if you have ever had an allergic reaction to risedronate sodium, any of the active or inactive ingredients in risedronate sodium tablets, other bisphosphonate drugs, or any other drugs. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of all your medications, including prescription medications, over-the-counter medicines, vitamins, supplements, and herbal products. This can help avoid possible interactions.

Give your doctor a complete medical history. Risedronate sodium may not be safe for people with certain medical conditions such as low calcium, stomach or esophagus problems, stomach trouble like ulcers, anemia, cancer, infections, mouth or jaw problems, dental issues, inability to stay upright for at least 30 minutes, radiation therapy, cancer treatment, dysphagia (difficulty swallowing), acid reflux or heartburn, blood clotting problems, or kidney disease.

Your doctor will recommend having a dental exam and all necessary dental treatments, including cleaning, fixing ill-fitting dentures, or tooth extractions, before you start taking risedronate sodium.

Tell your doctor if you are pregnant, could be pregnant, or are planning a pregnancy at any time in the future. Risedronate sodium can stay in your body for many years after you stop taking it. Also, tell your healthcare provider if you are nursing an infant with breast milk.

Precautions During Use of Risedronate Sodium (Actonel)

Keep all your medical and lab appointments while taking risedronate sodium.

Take risedronate sodium on an empty stomach, first thing in the morning, before your first food or drink, after you get out of bed. Take Actonel (risedronate sodium) with a full glass of plain water. Do not take any other oral medications or dietary supplements (vitamins, calcium, antacids) before and for at least 30 minutes after your dose of risedronate sodium. Remain upright for at least 30 minutes after you take this medicine. Follow these dosing instructions carefully to avoid mouth and esophagus problems.

Practice good oral hygiene and brush your teeth twice a day. Tell your dentist you are on risedronate sodium before any dental treatments.

Risedronate sodium can cause severe bone, joint, or muscle pain at any time during treatment. Tell your doctor immediately if you experience any new or unusual pain while on risedronate sodium therapy. You may need to stop taking the medicine. The musculoskeletal pain usually goes away when treatment is discontinued.

Talk to your doctor about other ways to prevent osteoporosis or prevent it getting worse. Discuss hormone replacement therapy with your provider. You should avoid smoking and heavy drinking. Your provider will recommend regular weight-bearing exercise and a diet rich in calcium and vitamin D. They may recommend taking vitamin D and calcium supplements.

Risedronate Sodium (Actonel) Drug Interactions

Taking risedronate sodium with certain other medications can affect how it works. Drug interactions with other medicines can also increase the risk of severe adverse events. Some of the medications that can interact with risedronate sodium include:

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil) and naproxen sodium (Naprosyn, Aleve)
Proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), esomeprazole (Nexium), and rabeprazole (AcipHex)
H2 blockers such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac)

The above list may not describe all the potential interactions of risedronate sodium. Give your doctor or pharmacist a complete list of your other medicines, including prescription medications, over-the-counter medications, dietary supplements, and herbal products. Also, tell your healthcare professional if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.

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