Actonel with Calcium Side Effects

Generic name: calcium carbonate / risedronate

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

Some side effects of Actonel with Calcium 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 calcium carbonate / risedronate: oral kit

Get emergency medical help if you have any of these signs of an allergic reaction while taking calcium carbonate / risedronate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication 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 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 calcium carbonate / risedronate may include:

• mild heartburn, nausea, or stomach upset;

• diarrhea, gas, or constipation;

• muscle, joint, or back pain;

• pain or burning with urination;

• mild skin rash; or

• headache or depressed mood.

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 calcium carbonate / risedronate: oral kit

Cardiovascular

Cardiovascular side effects of risedronate have included hypertension, cardiovascular disorders, and angina pectoris.

Dermatologic

Dermatologic side effects of risedronate have included rash, pruritus, and skin cancer.

Gastrointestinal

Gastrointestinal side effects of risedronate have included diarrhea, nausea, flatulence, gastrointestinal disorder, constipation, rectal disorder and tooth disorder.

Gastrointestinal side effects of calcium carbonate have included rebound hyperacidity, constipation (6% to 37%) and gallstones (rarely).

During phase 3 clinical studies of risedronate, 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.

Rebound hyperacidity has been associated with calcium salt antacids. This side effect does not appear to be due to the acid buffering capacity of calcium carbonate, but is a consequence of a specific action of calcium on the parietal cell. Rare cases of calcium carbonate gallstones have been reported in the pediatric literature.

General

General body side effects of risedronate have included infection, back pain, pain, abdominal pain, chest pain, hernia, otitis media, and asthenia.

Hypersensitivity

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

Musculoskeletal

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.

Musculoskeletal side effects of risedronate have included arthralgias, bone pain, joint disorder, myalgia, bone pain, bone disorder, bursitis, hypertonia, tendon disorder, and leg cramps.

Nervous system

Nervous system side effects of risedronate have included headache, dizziness, depression, insomnia, anxiety, neuralgia, vertigo, hypertonia, paresthesia and tinnitus.

Ocular

Ocular side effects have of risedronate included cataracts and conjunctivitis.

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.

Oncologic

Oncologic side effects of risedronate have included neoplasms which have occurred in 3% of patients receiving risedronate therapy.

Respiratory

Respiratory side effects of risedronate have included bronchitis and sinusitis.

Metabolic

Prolonged ingestion of large amounts of calcium carbonate and other sources of exogenous calcium can rarely result in the "milk alkali syndrome" and calcinosis. The milk alkali syndrome is characterized by the triad of hypercalcemia, metabolic alkalosis, and renal insufficiency.

Metabolic side effects of calcium carbonate have rarely included hypercalcemia and hypophosphatemia. Other metabolic side effects have rarely included "mild alkali syndrome", calcinosis, and irreversible renal damage.

Genitourinary

Genitourinary side effects of risedronate have included urinary tract infection and cystitis.

Hematologic

Hematologic side effects of risedronate have included ecchymosis and anemia.

Renal

Renal side effects of calcium carbonate have included renal failure, formation of renal calcium, and a single case report of a calcium carbonate and calcium phosphate-filled renal cyst.

The renal failure that accompanies hypercalcemia and alkalosis in the milk alkali syndrome is usually transient.

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