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Actonel with Calcium

"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any sp"...

Actonel with Calcium

Actonel with Calcium Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 of this medication is discontinued, but generic versions may be available. Common side effects include upset stomach, nausea, constipation, gas, bloating, or headache.

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). 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. 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.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Actonel with Calcium in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Actonel with Calcium Overview - Patient Information: Side Effects

SIDE EFFECTS: Upset stomach, nausea, constipation, gas, or bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw pain, eye/vision problems.

Risedronate may infrequently cause irritation and ulcers in your stomach or esophagus. Get medical help right away if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Actonel with Calcium (Risedronate Sodium with Calcium Carbonate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Actonel with Calcium FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Actonel with Calcium - User Reviews

Actonel with Calcium User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Actonel with Calcium sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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