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: tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking calcium carbonate / risedronate:
Constipation; diarrhea; dizziness; gas; mild back, joint, or muscle pain; mild flu-like symptoms (eg, fever, headache, muscle aches, tiredness); mild stomach pain or upset; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or persistent heartburn; painful or difficult urination; severe back pain; severe bone, muscle, or joint pain (especially in the hip, groin, or thigh); severe headache, dizziness, or blurred vision; severe or persistent sore throat or stomach pain; swelling or pain in your jaw; symptoms of low blood calcium (eg, spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers or toes, or around your mouth); unusual eye pain, swelling, redness, or sensitivity to light.
For Healthcare Professionals
Applies to calcium carbonate / risedronate: oral kit
Cardiovascular side effects of risedronate have included hypertension, cardiovascular disorders, and angina pectoris.
Dermatologic side effects of risedronate have included rash, pruritus, and skin cancer.
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 body side effects of risedronate have included infection, back pain, pain, abdominal pain, chest pain, hernia, otitis media, and asthenia.
Hypersensitivity side effects of risedronate have included angioedema, generalized rash, and bullous skin reactions.
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 side effects of risedronate have included headache, dizziness, depression, insomnia, anxiety, neuralgia, vertigo, hypertonia, paresthesia and tinnitus.
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 side effects of risedronate have included neoplasms which have occurred in 3% of patients receiving risedronate therapy.
Respiratory side effects of risedronate have included bronchitis and sinusitis. Postmarketing side effects have included exacerbations of asthma.
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 side effects of risedronate have included urinary tract infection and cystitis.
Hematologic side effects of risedronate have included ecchymosis and anemia.
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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