Actonel with Calcium

What Is Actonel with Calcium?

Actonel with Calcium (risedronate sodium with calcium carbonate) is a combination of a bisphosphonate with the mineral calcium used to treat or prevent postmenopausal and steroid-induced osteoporosis. Risedronate is also used to treat Paget's disease of bone. Calcium carbonate is used to prevent and to treat calcium deficiencies. The brand name Actonel with Calcium is discontinued, but generic versions may be available.

What Are Side Effects of Actonel with Calcium?

Common side effects of Actonel with Calcium (risedronate sodium with calcium carbonate) include:

• upset stomach
• nausea
• heartburn
• constipation
• gas
• diarrhea
• bloating
• headache
• muscle or joint pain
• back pain
• pain or burning with urination
• skin rash, or
• depressed mood

Dosage for Actonel with Calcium

The dose of Actonel is one 35 mg Actonel tablet orally, taken once-a-week (Day 1 of the 7-day treatment cycle), and one 1250 mg calcium carbonate tablet (500 mg elemental calcium) orally, taken with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle).

What Drugs, Substances, or Supplements Interact with Actonel with Calcium?

Actonel with Calcium may interact with levothyroxine, diuretics, steroids, antibiotics, or aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications and supplements you use.

Actonel with Calcium During Pregnancy or Breastfeeding

Caution is advised if you are pregnant or planning to become pregnant in the future. Risedronate may stay in your body for many years. Its effects on a fetus are unknown. Discuss the risks and benefits with your doctor before starting treatment. It is unknown if risedronate passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Actonel with Calcium (risedronate sodium with calcium carbonate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Actonel with Calcium Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop using risedronate and call your doctor at once if you have:

• chest pain, new or worsening heartburn;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

• heartburn, diarrhea, indigestion;
• stomach pain;
• back pain, joint pain, muscle pain; or
• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Actonel with Calcium (Risedronate Sodium with Calcium Carbonate)

 

Actonel with Calcium Professional Information

SIDE EFFECTS

Actonel

Osteoporosis

Actonel 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 Actonel 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 Actonel 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 Actonel 5 mg groups, respectively. Table 4 lists adverse events from the Phase 3 osteoporosis trials reported in ≥ 2% of patients and in more Actonel-treated patients than placebo-treated patients. Adverse events are shown without attribution of causality.

Table 4 : Adverse Events Occurring at a Frequency ≥ 2% and in More Actonel-Treated Patients than Placebo-Treated Patients Combined Phase 3 Osteoporosis Trials

Body System	Placebo % (N = 1914)	Actonel 5 mg % (N = 1916)
Body as a Whole
Infection	29.7	29.9
Back Pain	23.6	26.1
Pain	13.1	13.6
Abdominal Pain	9.4	11.6
Neck Pain	4.5	5.3
Asthenia	4.3	5.1
Chest Pain	4.9	5.0
Neoplasm	3.0	3.3
Hernia	2.5	2.9
Cardiovascular
Hypertension	9.0	10.0
Cardiovascular Disorder	1.7	2.5
Angina Pectoris	2.4	2.5
Digestive
Nausea	10.7	10.9
Diarrhea	9.6	10.6
Flatulence	4.2	4.6
Gastritis	2.3	2.5
Gastrointestinal Disorder	2.1	2.3
Rectal Disorder	1.9	2.2
Tooth Disorder	2.0	2.1
Hemic and Lymphatic
Ecchymosis	4.0	4.3
Anemia	1.9	2.4
Musculoskeletal
Arthralgia	21.1	23.7
Joint Disorder	5.4	6.8
Myalgia	6.3	6.6
Bone Pain	4.3	4.6
Bone Disorder	3.2	4.0
Leg Cramps	2.6	3.5
Bursitis	2.9	3.0
Tendon Disorder	2.5	3.0
Nervous
Depression	6.2	6.8
Dizziness	5.4	6.4
Insomnia	4.5	4.7
Anxiety	3.0	4.3
Neuralgia	3.5	3.8
Vertigo	3.2	3.3
Hypertonia	2.1	2.2
Paresthesia	1.8	2.1
Respiratory
Pharyngitis	5.0	5.8
Rhinitis	5.0	5.7
Dyspnea	3.2	3.8
Pneumonia	2.6	3.1
Skin and Appendages
Rash	7.2	7.7
Pruritus	2.2	3.0
Skin Carcinoma	1.8	2.0
Special Senses
Cataract	5.4	5.9
Conjunctivitis	2.8	3.1
Otitis Media	2.4	2.5
Urogenital
Urinary Tract Infection	9.7	10.9
Cystitis	3.5	4.1

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

Laboratory Test Findings

Asymptomatic and small decreases were observed in serum calcium and phosphorus levels. Overall, mean decreases of 0.8% in serum calcium and of 2.7% in phosphorus were observed at 6 months in patients receiving Actonel. Throughout the Phase 3 studies, serum calcium levels below 8 mg/dL were observed in 18 patients, 9 (0.5%) in each treatment arm (Actonel and placebo). Serum phosphorus levels below 2 mg/dL were observed in 14 patients, 11 (0.6%) treated with Actonel and 3 (0.2%) treated with placebo.

Endoscopic Findings

Actonel clinical studies enrolled over 5700 patients, many with pre-existing 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%) Actonel]. Across treatment groups, the percentage of patients with normal esophageal, gastric, and duodenal mucosa on endoscopy was similar (20% placebo; 21% Actonel). 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 Actonel 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% Actonel).

Once-a-week Dosing

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

Table 5: Adverse Events Occurring in ≥ 2% of Patients of Either Treatment Group in the Daily vs. Weekly Osteoporosis Treatment Study in Postmenopausal Women

Body System	5 mg Daily Actonel % (N = 480)	35 mg Weekly Actonel % (N = 485)
Body as a Whole
Infection	19.0	20.6
Accidental Injury	10.6	10.7
Pain	7.7	9.9
Back Pain	9.2	8.7
Flu Syndrome	7.1	8.5
Abdominal Pain	7.3	7.6
Headache	7.3	7.2
Overdose	6.9	6.8
Asthenia	3.5	5.4
Chest Pain	2.3	2.7
Allergic Reaction	1.9	2.5
Neoplasm	0.8	2.1
Neck Pain	2.7	1.2
Cardiovascular System
Hypertension	5.8	4.9
Syncope	0.6	2.1
Vasodilatation	2.3	1.4
Digestive System
Constipation	12.5	12.2
Dyspepsia	6.9	7.6
Nausea	8.5	6.2
Diarrhea	6.3	4.9
Gastroenteritis	3.8	3.5
Flatulence	3.3	3.1
Colitis	0.8	2.5
Gastrointestinal Disorder	1.9	2.5
Vomiting	1.9	2.5
Dry Mouth	2.5	1.4
Metabolic and Nutritional Disorders
Peripheral Edema	4.2	1.6
Musculoskeletal System
Arthralgia	11.5	14.2
Traumatic Bone Fracture	5.0	6.4
Myalgia	4.6	6.2
Arthritis	4.8	4.1
Bursitis	1.3	2.5
Bone Pain	2.9	1.4
Nervous System
Dizziness	5.8	4.9
Anxiety	0.6	2.7
Depression	2.3	2.3
Vertigo	2.1	1.6
Respiratory System
Bronchitis	2.3	4.9
Sinusitis	4.6	4.5
Pharyngitis	4.6	2.9
Cough Increased	3.1	2.5
Pneumonia	0.8	2.5
Rhinitis	2.3	2.1
Skin and Appendages
Rash	3.1	4.1
Pruritus	1.9	2.3
Special Senses
Cataract	2.9	1.9
Urogenital System
Urinary Tract Infection	2.9	5.2

Osteoporosis Prevention

There were no deaths in a 1-year, double-blind, placebo-controlled study of Actonel 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.

Post-marketing 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 (see PRECAUTIONS, Musculoskeletal Pain).

Very rare reactions of eye inflammation including iritis and uveitis have been reported. Osteonecrosis of the jaw has been reported very rarely (see PRECAUTIONS, General).

Calcium

Calcium carbonate may cause gastrointestinal adverse effects such as constipation, flatulence, nausea, abdominal pain, and bloating. Administration of calcium may increase the risk of kidney stones, particularly in patients with a history of this condition (see PRECAUTIONS).

Read the entire FDA prescribing information for Actonel with Calcium (Risedronate Sodium with Calcium Carbonate)