Actonel Side Effects

Generic Name: risedronate

Please note - some side effects for Actonel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Actonel - for the Consumer

Actonel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actonel:

Back pain; constipation; diarrhea; dizziness; gas; headache; joint pain; mild stomach pain or upset; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; painful or difficult urination; sensitivity to light; severe bone, muscle, or joint pain; severe or persistent sore throat or stomach pain; swelling of the arms or legs; swelling or pain in your jaw; unusual eye pain or redness; vision changes.

Actonel with Calcium

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actonel with Calcium:

Back pain; bloating; constipation; diarrhea; dizziness; gas; headache; joint pain; mild stomach pain or upset; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; painful or difficult urination; sensitivity to light; severe bone, muscle, or joint pain; severe or persistent lower back pain; severe or persistent sore throat or stomach pain; swelling of the arms or legs; swelling or pain in your jaw; unusual eye pain or redness; vision changes.

Actonel Side Effects - for the Professional

Actonel

Most common adverse reactions reported in >10% of patients treated with Actonel and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia (6.1).

Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely (6.2).

Side Effects by Body System

General

Adverse effects reported with risedronate 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.

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 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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