Risedronate Side Effects

Brand Names: Actonel

Please note - some side effects for Risedronate 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 Risedronate - for the Consumer

Risedronate

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 Risedronate:

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.

Risedronate Side Effects - for the Professional

Risedronate

Daily Dosing

Risedronate has been studied in over 5700 patients enrolled in the Phase 3 glucocorticoid-induced osteoporosis clinical trials and in postmenopausal osteoporosis trials of up to 3 years duration. The overall adverse event profile of Risedronate sodium tablets 5 mg in these studies was similar to that of placebo. Most adverse events were either mild or moderate and did not lead to discontinuation from the study. The incidence of serious adverse events in the placebo group was 24.9% and in the Risedronate sodium tablets 5 mg group was 26.3%. The percentage of patients who withdrew from the study due to adverse events was 14.4% and 13.5% for the placebo and Risedronate sodium tablets 5 mg groups, respectively. Table 5 lists adverse events from the Phase 3 osteoporosis trials reported in ≥ 2% of patients and in more Risedronate-treated patients than placebo-treated patients. Adverse events are shown without attribution of causality.

Duodenitis and glossitis have been reported uncommonly (0.1% to 1%). There have been rare reports (< 0.1%) of abnormal liver function tests.

Throughout the Phase 3 studies, transient decreases from baseline in serum calcium (< 1%) and serum phosphate (< 3%) and compensatory increases in serum PTH levels (< 30%) were observed within 6 months in patients in osteoporosis clinical trials treated with Risedronate sodium tablets 5 mg once daily. There were no significant differences in serum calcium, phosphate, or PTH levels between Risedronate sodium tablets 5 mg once daily and placebo at 3 years. Serum calcium levels below 8 mg/dL were observed in 18 patients, 9 (0.5%) in each treatment arm (Risedronate sodium tablets 5 mg once daily and placebo). Serum phosphorus levels below 2 mg/dL were observed in 14 patients, 11 (0.6%) treated with Risedronate sodium tablets 5 mg once daily and 3 (0.2%) treated with placebo.

Risedronate clinical studies enrolled over 5700 patients, many with preexisting gastrointestinal disease and concomitant use of NSAIDs or aspirin. Investigators were encouraged to perform endoscopies in any patients with moderate-to-severe gastrointestinal complaints, while maintaining the blind. These endoscopies were ultimately performed on equal numbers of patients between the treated and placebo groups [75 (14.5%) placebo; 75 (11.9%) Risedronate]. Across treatment groups, the percentage of patients with normal esophageal, gastric, and duodenal mucosa on endoscopy was similar (20% placebo, 21% Risedronate). The number of patients who withdrew from the studies due to the event prompting endoscopy was similar across treatment groups. Positive findings on endoscopy were also generally comparable across treatment groups. There was a higher number of reports of mild duodenitis in the Risedronate group, however there were more duodenal ulcers in the placebo group. Clinically important findings (perforations, ulcers, or bleeding) among this symptomatic population were similar between groups (51% placebo; 39% Risedronate).

Once-A-Week Dosing

In a 1 year, double-blind, multicenter study comparing Risedronate sodium tablets 5 mg daily and Risedronate sodium tablets 35 mg once a week in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar. Table 6 lists the adverse events in ≥ 2% of patients from this trial. Events are shown without attribution of causality.

In a 1 year study comparing daily versus weekly oral dosing regimens of Risedronate sodium tablets in postmenopausal women, the mean percent changes from baseline at 12 months were similar between the Risedronate sodium tablets 5 mg daily and Risedronate sodium tablets 35 mg once a week groups, respectively, for serum calcium (0.4% and 0.7%), phosphate (- 3.8% and - 2.6%) and PTH (6.4% and 4.2%).

Paget's Disease

Risedronate has been studied in 392 patients with Paget's disease of bone. As in trials of Risedronate for other indications, the adverse experiences reported in the Paget's disease trials have generally been mild or moderate, have not required discontinuation of treatment, and have not appeared to be related to patient age, gender, or race.

In a double-blind, active-controlled study, the adverse event profile was similar for Risedronate and etidronate disodium: 6.6% (4/61) of patients treated with Risedronate sodium tablets 30 mg daily for 2 months discontinued treatment due to adverse events, compared to 8.2% (5/61) of patients treated with etidronate disodium tablets 400 mg daily for 6 months.

Three patients who received Risedronate sodium tablets 30 mg daily experienced acute iritis in 1 supportive study. All 3 patients recovered from their events; however, in 1 of these patients, the event recurred during Risedronate treatment and again during treatment with pamidronate. All patients were effectively treated with topical steroids.

Postmarketing Experience

Very rare hypersensitivity and skin reactions have been reported, including angioedema, generalized rash and bullous skin reactions, some severe.

Musculoskeletal: bone, joint, or muscle pain, rarely described as severe or incapacitating.

Very rare reactions of eye inflammation including iritis and uveitis have been reported.

Osteonecrosis of the jaw has been reported very rarely.

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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