Actonel Side Effects

Generic name: risedronate

Note: This document contains side effect information about risedronate. Some of the dosage forms listed on this page may not apply to the brand name Actonel.

Some side effects of Actonel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to risedronate: oral delayed release tablet, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking risedronate (the active ingredient contained in Actonel) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using risedronate and call your doctor at once if you have a serious side effect such as:

• chest pain;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• new or worsening heartburn;

• severe or ongoing indigestion;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip; or

• jaw pain, numbness, or swelling.

Less serious side effects of risedronate may include:

• mild stomach pain or upset stomach;

• flu symptoms, muscle pain;

• diarrhea, constipation;

• mild joint or back pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to risedronate: oral delayed release tablet, oral tablet

General

Adverse effects reported with risedronate (the active ingredient contained in Actonel) have been mild to moderate and have seldom required discontinuation of therapy. General body symptoms have included flu-like symptoms (10%) and asthenia (5%).

There were no deaths in a 1 year, double-blind, placebo-controlled study of risedronate 35 mg once a week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on risedronate experienced arthralgia (risedronate 13.9%; placebo 7.8%), myalgia (risedronate 5.1%; placebo 2.1%), and nausea (risedronate 7.3%; placebo 4.3%) than subjects on placebo.

Gastrointestinal

During phase 3 clinical studies, patients with a history of upper gastrointestinal (GI) disease or abnormalities were not excluded. Severe upper GI side effects were not noted. Patients using NSAIDs or aspirin were also included in phase 3 clinical studies. GI side effects in patient using concomitant NSAIDs or aspirin were higher than in non users.

Gastrointestinal side effects have included diarrhea (20%), nausea (10%), abdominal pain (12%), constipation (6%), belching or colitis (3%). Dyspepsia, diarrhea, gastrointestinal disorder, flatulence, gastroenteritis, vomiting, and dry mouth have also been reported.

Nervous system

Nervous system side effects have included headache (18%), dizziness (7%), and tinnitus (3%). Dizziness, anxiety, depression, and vertigo have also been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgias (33%), bone pain (5%), and leg cramps or myasthenia (3%). Postmarketing experience has included reports of bone, joint, or muscle pain, rarely described as severe or incapacitating. Myalgia, arthritis, bursitis, and traumatic bone fracture have also been reported. Additional postmarketing experience has included cases of osteonecrosis (primarily involving the jaw), predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Data suggest a greater frequency of reports of ONJ in certain cancers, such as advanced breast cancer and multiple myeloma. The majority of the reported cases are in cancer patients following invasive dental procedures, such as tooth extraction.

Dermatologic

Dermatologic side effects have included rash and pruritus.

Cardiovascular

Cardiovascular side effects have included peripheral edema (8%) and chest pain (7%). Hypertension, syncope, and vasodilation have also been reported.

Respiratory

Respiratory side effects have included bronchitis (3%) and sinusitis (5%). Sinusitis, pharyngitis, increased cough, pneumonia, and rhinitis have also been reported.

Ocular

Iritis occurred in 3 patients in one supportive study. Treatment with topical steroids was effective in all cases. Iritis has not been observed in other clinical studies.

Ocular side effects have included amblyopia or dry eyes (3%) and iritis. Cataracts have also been reported.

Oncologic

Oncologic side effects have included neoplasms, which have occurred in 3% of patients receiving risedronate (the active ingredient contained in Actonel) therapy.

Hypersensitivity

Hypersensitivity side effects have included angioedema, generalized rash, and bullous skin reactions.

Genitourinary

Genitourinary side effects have included urinary tract infections.

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