Side effects of reclast

Contents

What is Zolendronic acid (Reclast®)?

Zolendronic acid is used to treat or prevent osteoporosis. Osteoporosis is a disease which causes bones to become thin. You are at risk for osteoporosis if you are:

Thin Do not exercise
Smoke Drink alcohol often
Caucasian Do not get enough calcium or vitamin D
Going through or past menopause Have a family history of osteoporosis
Take or have taken bone thinning medications like prednisone

How do I take it?

Zolendronic acid is given as an infusion (through a vein in your arm) lasting 15 minutes. You should drink 2 glasses of fluid at least one hour before receiving your infusion. You may eat normally before your infusion. Zolendronic acid infusions are once a year. The infusion must be administered by a health care professional.
You should not take Zolendronic acid if you are pregnant, breast feeding, have kidney problems, or have low blood calcium.

What about side effects?

The most common side effects with the injection are bone, muscle and joint pains, flu like illness and headache. The flu like symptoms generally disappears after 24-48 hours and usually occurs only after the first injection. The most common side effects with the pill are diarrhea, pain in the extremities, and upset stomach. Less common side effects may be pain or trouble swallowing, heartburn and stomach ulcers.

Rarely patients have reported severe bone, joint and muscle pain that begins from 1 day to one month after starting any bisphosphonate, including Zolendronic acid. Most patients report relief from these symptoms after stopping the medication.

In rare cases some patients have experienced jaw problems when taking bisphosphonates including Zolendronic acid. This included delayed healing and infection.

What about other medications?

Some medicines may cause low blood calcium levels or may harm your kidneys if taken with Zolendronic acids. Tell your doctor if you are taking Zometa, a diuretic or “water pill”, or an antibiotic. Take your calcium and vitamin D as recommended by your doctor.

What else should I know?

Your doctor may order bone density tests to follow your osteoporosis. Contact your doctor if you have any questions about this or any of your medications. Contact your doctor if you experience any troubling side effects.

Once a year I receive an infusion of Reclast. How safe is this and how does it compare to taking the pill?

Reclast is one of eight FDA approved bisphosphonates. Bisphosphonates are a type of drug commonly used for osteoporosis treatment and prevention. While pills may be taken daily, weekly or monthly, Reclast requires an annual infusion. Therefore, those who dislike taking medication often may prefer an annual infusion. While there is no defined optimal duration of use, the FDA asks patients at low risk for fracture to consider discontinuing bisphosphonates after 3-5 years. This recommendation was based off studies indicating that taking bisphosphonates for more than six years may do more harm than good. The FDA expressed additional safety concerns for both pills and infusions. Clinical trials indicated that bisphosphonates may come with a variety of health problems such as severe heartburn, renal impairment, cancer, ulcers, and jaw tissue damage. According to the FDA, one study “found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over 3 years” for bisphosphonate pills. For an in-depth account of bisphosphonate pills, you can review the FDA reports of FOSAMAX, Didronel, Actonel and Skelid. There are many drugs on the market for the treatment and prevention of osteoporosis. Therefore, it’s important to discuss these options with your healthcare provider to ensure your decision reflects the most safe and effective treatment.

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images and information, contained on or available through this web site is for general information purposes only.

Reclast

Generic Name: zoledronic acid (ZOE le DRON ik AS id)
Brand Names: Reclast, Zometa

Medically reviewed by Drugs.com. Last updated on Dec 23, 2019.

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What is Reclast?

Reclast (zoledronic acid) (sometimes called zoledronate) is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Reclast is used to treat or prevent osteoporosis caused by menopause, steroid use, or gonadal failure. This medicine is for use when you have a high risk of bone fracture due to osteoporosis.

Reclast is also used to increase bone mass in men who have osteoporosis, and to treat Paget’s disease of bone in men and women.

Zometa is another brand of zoledronic acid used to treat high blood levels of calcium caused by cancer and multiple myeloma.

You should not use Reclast and Zometa at the same time.

Important information

Reclast may harm an unborn baby. Avoid getting pregnant while using this medicine and tell your doctor if you become pregnant.

Reclast can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Reclast have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Before taking this medicine

You should not be treated with Reclast if you are allergic to zoledronic acid.

You also should not receive Reclast if you have:

  • low levels of calcium in your blood (hypocalcemia); or

  • severe kidney disease.

You should not be treated with this medicine if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).

To make sure Reclast is safe for you, tell your doctor if you have ever had:

  • kidney disease;

  • hypocalcemia;

  • thyroid or parathyroid surgery;

  • surgery to remove part of your intestine;

  • asthma caused by taking aspirin;

  • any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or

  • a dental problem (you may need a dental exam before you receive Reclast).

Reclast can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Reclast, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Zoledronic acid may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant. You may also need to use birth control for several weeks after you last received Reclast. This medicine can have long-lasting effects on your body.

Zoledronic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How is Reclast given?

Reclast is injected into a vein through an IV. A healthcare provider will give you this injection.

Reclast is sometimes given as a single dose only one time. It may also be given once every 1 or 2 years. How often you receive Reclast will depend on why you are using this medicine. Follow your doctor’s instructions.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

You may need frequent medical tests to help your doctor determine how long to treat you with Reclast. Your kidney function may also need to be checked.

Pay special attention to your dental hygiene while using Reclast. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using zoledronic acid.

Reclast is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.

Your doctor will determine how long to treat you with this medicine. Reclast is often given for only 3 to 5 years.

Reclast dosing information

Usual Adult Dose for Paget’s Disease:

5 mg IV infusion, at a constant infusion rate, over no less than 15 minutes
Calcium and vitamin D supplementation:
-Calcium: 750 mg elemental calcium orally twice a day, or 500 mg orally three times a day
-Vitamin D: 800 international units orally daily, especially in the 2 weeks following drug administration
Comments: Retreatment may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase or failure to achieve normalization of serum alkaline phosphatase.
Uses: Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of age- specific normal reference range

Usual Adult Dose for Osteoporosis:

5 mg IV infusion over no less than 15 minutes, once a year
Comments: An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.
Uses:
-Osteoporosis in postmenopausal women, diagnosed by bone mineral density or prevalent vertebral fracture (this drug reduces the incidence of fractures).
-To increase bone mass in men with osteoporosis.
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Usual Adult Dose for Prevention of Osteoporosis:

5 mg IV infusion over no less than 15 minutes, every 2 years
Uses:
-Prevention of osteoporosis in postmenopausal women.
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Reclast injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Reclast?

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Reclast side effects

Get emergency medical help if you have signs of an allergic reaction to Reclast: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or unusual pain in your thigh or hip;

  • jaw pain, numbness, or swelling;

  • kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

  • 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).

Serious side effects on the kidneys may be more likely in older adults.

Common Reclast side effects may include:

  • nausea, vomiting, diarrhea, constipation;

  • bone pain, muscle or joint pain;

  • fever or other flu symptoms;

  • pain in your arms or legs;

  • red or puffy eyes;

  • headache, tiredness; or

  • trouble breathing.

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 other drugs will affect Reclast?

Zoledronic acid can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Reclast only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 16.02.

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Related treatment guides

  • Osteoporosis
  • Hypercalcemia of Malignancy
  • Osteolytic Bone Lesions of Multiple Myeloma
  • Osteolytic Bone Metastases of Solid Tumors
  • Paget’s Disease
  • Prevention of Osteoporosis

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Treatment Of Osteoporosis In Postmenopausal Women

The safety of Reclast in the treatment of postmenopausal osteoporosis was assessed in Study 1, a large, randomized, double-blind, placebo-controlled, multinational study of 7736 postmenopausal women aged 65 to 89 years with osteoporosis, diagnosed by bone mineral density or the presence of a prevalent vertebral fracture. The duration of the trial was three years with 3862 patients exposed to Reclast and 3852 patients exposed to placebo administered once annually as a single 5 mg dose in 100 mL solution infused over at least 15 minutes, for a total of three doses. All women received 1000 to 1500 mg of elemental calcium plus 400 to 1200 international units of vitamin D supplementation per day.

The incidence of all-cause mortality was similar between groups: 3.4% in the Reclast group and 2.9% in the placebo group. The incidence of serious adverse events was 29.2% in the Reclast group and 30.1% in the placebo group. The percentage of patients who withdrew from the study due to adverse events was 5.4% and 4.8% for the Reclast and placebo groups, respectively.

The safety of Reclast in the treatment of osteoporosis patients with a recent (within 90 days) low-trauma hip fracture was assessed in Study 2, a randomized, double-blind, placebo-controlled, multinational endpoint-driven study of 2127 men and women aged 50 to 95 years; 1065 patients were randomized to Reclast and 1062 patients were randomized to placebo. Reclast was administered once annually as a single 5 mg dose in 100 mL solution infused over at least 15 minutes. The study continued until at least 211 patients had a confirmed clinical fracture in the study population who were followed for an average of approximately 2 years on study drug. Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 international units orally or IM) was given to patients and they were started on 1000 to 1500 mg of elemental calcium plus 800 to 1200 international units of vitamin D supplementation per day for at least 14 days prior to the study drug infusions.

The incidence of all-cause mortality was 9.6% in the Reclast group and 13.3% in the placebo group. The incidence of serious adverse events was 38.3% in the Reclast group and 41.3% in the placebo group. The percentage of patients who withdrew from the study due to adverse events was 5.3% and 4.7% for the Reclast and placebo groups, respectively.

Adverse reactions reported in at least 2% of patients with osteoporosis and more frequently in the Reclast-treated patients than placebo-treated patients in either osteoporosis trial are shown below in Table 1.

Table 1: Adverse Reactions Occurring in greater than or equal to 2.0% of Patients with Osteoporosis and More Frequently than in Placebo-Treated Patients

Renal Impairment

Treatment with intravenous bisphosphonates, including zoledronic acid, has been associated with renal impairment manifested as deterioration in renal function (i.e., increased serum creatinine) and in rare cases, acute renal failure. In the clinical trial for postmenopausal osteoporosis, patients with baseline creatinine clearance less than 30 mL/min (based on actual body weight), urine dipstick greater than or equal to 2+ protein or increase in serum creatinine of greater than 0.5 mg/dL during the screening visits were excluded. The change in creatinine clearance (measured annually prior to dosing) and the incidence of renal failure and impairment was comparable for both the Reclast and placebo treatment groups over 3 years, including patients with creatinine clearance between 30-60 mL/min at baseline. Overall, there was a transient increase in serum creatinine observed within 10 days of dosing in 1.8% of Reclast-treated patients versus 0.8% of placebo-treated patients which resolved without specific therapy .

Acute Phase Reaction

The signs and symptoms of acute phase reaction occurred in Study 1 following Reclast infusion including fever (18%), myalgia (9%), flu-like symptoms (8%), headache (7%), and arthralgia (7%). The majority of these symptoms occurred within the first 3 days following the dose of Reclast and usually resolved within 3 days of onset but resolution could take up to 7-14 days. In Study 2, patients without a contraindication to acetaminophen were provided with a standard oral dose at the time of the IV infusion and instructed to use additional acetaminophen at home for the next 72 hours as needed. Reclast was associated with fewer signs and symptoms of a transient acute phase reaction in this trial: fever (7%) and arthralgia (3%). The incidence of these symptoms decreased with subsequent doses of Reclast.

Laboratory Findings

In Study 1, in women with postmenopausal osteoporosis, approximately 0.2% of patients had notable declines of serum calcium levels (less than 7.5 mg/dL) following Reclast administration. No symptomatic cases of hypocalcemia were observed. In Study 2, following pre-treatment with vitamin D, no patients had treatment emergent serum calcium levels below 7.5 mg/dL.

Injection Site Reactions

In the osteoporosis trials, local reactions at the infusion site such as itching, redness and/or pain have been reported in 0% to 0.7% of patients following the administration of Reclast and 0% to 0.5% of patients following administration of placebo.

Osteonecrosis Of The Jaw

In the postmenopausal osteoporosis trial, Study 1, in 7736 patients, after initiation of therapy, symptoms consistent with ONJ occurred in one patient treated with placebo and one patient treated with Reclast. Both cases resolved after appropriate treatment . No reports of osteonecrosis of the jaw were reported in either treatment group in Study 2.

Atrial Fibrillation

In the postmenopausal osteoporosis trial, Study 1, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid treatment group occurred in 1.3% of patients (50 out of 3862) compared to 0.4% (17 out of 3852) in the placebo group. The overall incidence of all atrial fibrillation adverse events in the zoledronic acid treatment group was reported in 2.5% of patients (96 out of 3862) in the Reclast group vs. 1.9% of patients (75 out of 3852) in the placebo group. Over 90% of these events in both treatment groups occurred more than a month after the infusion. In an ECG sub-study, ECG measurements were performed on a subset of 559 patients before and 9 to 11 days after treatment. There was no difference in the incidence of atrial fibrillation between treatment groups suggesting these events were not related to the acute infusions. In Study 2, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid treatment group occurred in 1.0% of patients (11 out of 1054) compared to 1.2% (13 out of 1057) in the placebo group demonstrating no difference between treatment groups.

Ocular Adverse Events

Cases of iritis/uveitis/episcleritis/conjunctivitis have been reported in patients treated with bisphosphonates, including zoledronic acid. In the osteoporosis trials, 1 (less than 0.1%) to 9 (0.2%) patients treated with Reclast and 0 (0%) to 1 (less than 0.1%) patient treated with placebo developed iritis/uveitis/episcleritis.

Prevention Of Osteoporosis In Postmenopausal Women

The safety of Reclast in postmenopausal women with osteopenia (low bone mass) was assessed in a 2-year randomized, multi-center, double-blind, placebo-controlled study of 581 postmenopausal women aged greater than or equal to 45 years. Patients were randomized to one of three treatment groups: (1) Reclast given at randomization and Month 12 (n=198); (2) Reclast given at randomization and placebo at Month 12 (n=181); and (3) placebo given at randomization and Month 12 (n=202). Reclast was administered as a single 5 mg dose in 100 mL solution infused over at least 15 minutes. All women received 500 to 1200 mg elemental calcium plus 400 to 800 international units vitamin D supplementation per day.

The incidence of serious adverse events was similar for subjects given (1) Reclast at randomization and at Month 12 (10.6%), (2) Reclast at randomization and placebo given at Month 12 (9.4%), and (3) placebo at randomization and at Month 12 (11.4%). The percentages of patients who withdrew from the study due to adverse events were 7.1%, 7.2%, and 3.0% in the two Reclast groups and placebo group, respectively. Adverse reactions reported in at least 2% of patients with osteopenia and more frequently in the Reclast-treated patients than placebo-treated patients are shown in Table 2.

Table 2: Adverse Reactions Occurring in greater than or equal to 2% of Patients with Osteopenia and More Frequently than in Placebo-Treated Patients

Cases of iritis/uveitis/episcleritis/conjunctivitis have been reported in patients treated with bisphosphonates, including zoledronic acid. In the osteoporosis prevention trial, 4 (1.1%) patients treated with Reclast and 0 (0%) patients treated with placebo developed iritis/uveitis.

Osteoporosis In Men

The safety of Reclast in men with osteoporosis or osteoporosis secondary to hypogonadism was assessed in a two year randomized, multicenter, double-blind, active controlled group study of 302 men aged 25 to 86 years. One hundred fifty three (153) patients were exposed to Reclast administered once annually with a 5 mg dose in 100 mL infused over 15 minutes for up to a total of two doses, and 148 patients were exposed to a commercially-available oral weekly bisphosphonate (active control) for up to two years. All participants received 1000 mg of elemental calcium plus 800 to 1000 international units of vitamin D supplementation per day.

The incidence of all-cause mortality (one in each group) and serious adverse events were similar between the Reclast and active control treatment groups. The percentage of patients experiencing at least one adverse event was comparable between the Reclast and active control groups, with the exception of a higher incidence of post-dose symptoms in the Reclast group that occurred within 3 days after infusion. The overall safety and tolerability of Reclast was similar to the active control.

Adverse reactions reported in at least 2% of men with osteoporosis and more frequently in the Reclast-treated patients than the active control-treated patients and either (1) not reported in the postmenopausal osteoporosis treatment trial or (2) reported more frequently in the trial of osteoporosis in men are presented in Table 3. Therefore, Table 3 should be viewed in conjunction with Table 1.

Table 3: Adverse Reactions Occurring in greater than or equal to 2% of Men with Osteoporosis and More Frequently in the Reclast-Treated Patients than the Active Control-Treated Patients and either (1) Not Reported in the Postmenopausal Osteoporosis Treatment Trial or (2) Reported More Frequently in this Trial

System Organ Class 5 mg IV Reclast once per year %
(N=153)
Active Control once weekly %
(N=148)
Nervous System Disorders
Headache 15.0 6.1
Lethargy 3.3 1.4
Eye Disorders
Eye pain 2.0 0.0
Cardiac Disorders
Atrial fibrillation 3.3 2.0
Palpitations 2.6 0.0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 6.5 4.7
Abdominal pain* 7.9 4.1
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 2.6 2.0
Musculoskeletal, Connective Tissue and BoneDisorders
Myalgia 19.6 6.8
Musculoskeletal pain** 12.4 10.8
Musculoskeletal stiffness 4.6 0.0
Renal and Urinary Disorders
Blood creatinine increased 2.0 0.7
General Disorders and Administrative Site Conditions
Fatigue 17.6 6.1
Pain 11.8 4.1
Chills 9.8 2.7
Influenza-like illness 9.2 2.0
Malaise 7.2 0.7
Acute phase reaction 3.9 0.0
Investigations
C-reactive protein increased 4.6 1.4
* Combined abdominal pain, abdominal pain upper, and abdominal pain lower as one ADR
** Combined musculoskeletal pain and musculoskeletal chest pain as one ADR

Creatinine clearance was measured annually prior to dosing and changes in long-term renal function over 24 months were comparable in the Reclast and active control groups .

The incidence of all atrial fibrillation adverse events in the Reclast treatment group was 3.3% (5 out of 153) compared to 2.0% (3 out of 148) in the active control group. However, there were no patients with adjudicated serious adverse events of atrial fibrillation in the Reclast treatment group.

There were no patients who had treatment emergent serum calcium levels below 7.5 mg/dL.

There were 4 patients (2.6%) on Reclast vs. 2 patients (1.4%) on active control with local site reactions.

In this trial there were no cases of osteonecrosis of the jaw .

Glucocorticoid-Induced Osteoporosis

The safety of Reclast in men and women in the treatment and prevention of glucocorticoid-induced osteoporosis was assessed in a randomized, multicenter, double-blind, active controlled, stratified study of 833 men and women aged 18 to 85 years treated with greater than or equal to 7.5 mg/day oral prednisone (or equivalent). Patients were stratified according to the duration of their pre-study corticosteroid therapy: less than or equal to 3 months prior to randomization (prevention subpopulation), and greater than 3 months prior to randomization (treatment subpopulation).

The duration of the trial was one year with 416 patients exposed to Reclast administered once as a single 5 mg dose in 100 mL infused over 15 minutes, and 417 patients exposed to a commercially-available oral daily bisphosphonate (active control) for one year. All participants received 1000 mg of elemental calcium plus 400 to 1000 international units of vitamin D supplementation per day.

The incidence of all-cause mortality was similar between treatment groups: 0.9% in the Reclast group and 0.7% in the active control group. The incidence of serious adverse events was similar between the Reclast treatment and prevention groups, 18.4% and 18.1%, respectively, and the active control treatment and prevention groups, 19.8% and 16.0%, respectively. The percentage of subjects who withdrew from the study due to adverse events was 2.2% in the Reclast group vs. 1.4% in the active control group. The overall safety and tolerability were similar between Reclast and active control groups with the exception of a higher incidence of post-dose symptoms in the Reclast group that occurred within 3 days after infusion. The overall safety and tolerability profile of Reclast in glucocorticoid-induced osteoporosis was similar to the adverse events reported in the Reclast postmenopausal osteoporosis clinical trial.

Adverse reactions reported in at least 2% of patients that were either not reported in the postmenopausal osteoporosis treatment trial or reported more frequently in the treatment and prevention of glucocorticoid-induced osteoporosis trial included the following: abdominal pain (Reclast 7.5%; active control 5.0%), and musculoskeletal pain (Reclast 3.1%; active control 1.7%). Other musculoskeletal events included back pain (Reclast 4.3%, active control 6.2%), bone pain (Reclast 3.1%, active control 2.2%), and pain in the extremity (Reclast 3.1%, active control 1.2%). In addition, the following adverse events occurred more frequently than in the postmenopausal osteoporosis trial: nausea (Reclast 9.6%; active control 8.4%), and dyspepsia (Reclast 5.5%; active control 4.3%).

Renal function measured prior to dosing and at the end of the 12 month study was comparable in the Reclast and active control groups .

Reclast was associated with signs and symptoms of a transient acute phase reaction that was similar to that seen in the Reclast postmenopausal osteoporosis clinical trial.

The incidence of atrial fibrillation adverse events was 0.7% (3 of 416) in the Reclast group compared to no adverse events in the active control group. All subjects had a prior history of atrial fibrillation and no cases were adjudicated as serious adverse events. One patient had atrial flutter in the active control group.

There were no patients who had treatment emergent serum calcium levels below 7.5 mg/dL.

There were no local reactions at the infusion site.

In this trial there were no cases of osteonecrosis of the jaw .

Paget’s Disease Of Bone

In the Paget’s disease trials, two 6-month, double-blind, comparative, multinational studies of 349 men and women aged greater than 30 years with moderate to severe disease and with confirmed Paget’s disease of bone, 177 patients were exposed to Reclast and 172 patients exposed to risedronate. Reclast was administered once as a single 5 mg dose in 100 mL solution infused over at least 15 minutes. Risedronate was given as an oral daily dose of 30 mg for 2 months.

The incidence of serious adverse events was 5.1% in the Reclast group and 6.4% in the risedronate group. The percentage of patients who withdrew from the study due to adverse events was 1.7% and 1.2% for the Reclast and risedronate groups, respectively.

Adverse reactions occurring in at least 2% of the Paget’s patients receiving Reclast (single 5 mg intravenous infusion) or risedronate (30 mg oral daily dose for 2 months) over a 6-month study period are listed by system organ class in Table 4.

Table 4: Adverse Reactions Reported in at Least 2% of Paget’s Patients Receiving Reclast (Single 5 mg intravenous Infusion) or Risedronate (Oral 30 mg Daily for 2 Months) Over a 6-Month Follow-Up Period

System Organ Class 5 mg IV Reclast %
(N = 177)
30 mg/day x 2 Months risedronate %
(N = 172)
Infections and Infestations
Influenza 7 5
Metabolism and Nutrition Disorders
Hypocalcemia 3 1
Anorexia 2 2
Nervous System Disorders
Headache 11 10
Dizziness 9 4
Lethargy 5 1
Paresthesia 2 0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 5 1
Gastrointestinal Disorders
Nausea 9 6
Diarrhea 6 6
Constipation 6 5
Dyspepsia 5 4
Abdominal Distension 2 1
Abdominal Pain 2 2
Vomiting 2 2
Abdominal Pain Upper 1 2
Skin and Subcutaneous Tissue Disorders
Rash 3 2
Musculoskeletal, Connective Tissue and Bone Disorders
Arthralgia 9 11
Bone Pain 9 5
Myalgia 7 4
Back Pain 4 7
Musculoskeletal Stiffness 2 1
General Disorders and Administrative Site Conditions
Influenza-like Illness 11 6
Pyrexia 9 2
Fatigue 8 4
Rigors 8 1
Pain 5 4
Peripheral Edema 3 1
Asthenia 2 1

In the Paget’s disease trials, early, transient decreases in serum calcium and phosphate levels were observed. Approximately 21% of patients had serum calcium levels less than 8.4 mg/dL 9-11 days following Reclast administration.

In clinical trials in Paget’s disease there were no cases of renal deterioration following a single 5 mg 15-minute infusion .

The signs and symptoms of acute phase reaction (influenza-like illness, pyrexia, myalgia, arthralgia, and bone pain) were reported in 25% of patients in the Reclast-treated group compared to 8% in the risedronate-treated group. Symptoms usually occur within the first 3 days following Reclast administration. The majority of these symptoms resolved within 4 days of onset.

Osteonecrosis of the jaw has been reported with zoledronic acid .

Post-Marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post approval use of Reclast:

Acute Phase Reactions

Fever, headache, flu-like symptoms, nausea, vomiting, diarrhea, arthralgia, and myalgia. Symptoms may be significant and lead to dehydration.

Acute Renal Failure

Acute renal failure requiring hospitalization and/or dialysis or with a fatal outcome have been rarely reported. Increased serum creatinine was reported in patients with 1) underlying renal disease, 2) dehydration secondary to fever, sepsis, gastrointestinal losses, or diuretic therapy, or 3) other risk factors such as advanced age, or concomitant nephrotoxic drugs in the post-infusion period. Transient rise in serum creatinine can be correctable with intravenous fluids.

Allergic Reactions

Allergic reactions with intravenous zoledronic acid including anaphylactic reaction/shock, urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bronchoconstriction have been reported.

Asthma Exacerbations

Asthma exacerbations have been reported.

Hypocalcemia

Hypocalcemia has been reported.

Hypophosphatemia

Hypophosphatemia has been reported.

Osteonecrosis of the jaw has been reported.

Osteonecrosis Of Other Bones

Cases of osteonecrosis of other bones (including femur, hip, knee, ankle, wrist and humerus) have been reported; causality has not been determined in the population treated with Reclast.

Cases of the following events have been reported: conjunctivitis, iritis, iridocyclitis, uveitis, episcleritis, scleritis and orbital inflammation/edema.

Hypotension in patients with underlying risk factors has been reported.

Read the entire FDA prescribing information for Reclast (Zoledronic Acid Injection)

Osteoporosis drugs: Which one is right for you?

There’s no one-size-fits-all answer. Understanding your options begins with knowing what’s available.

Published: June, 2014

Throughout our lives, our bones undergo constant renovation. In a process called bone turnover, cells called osteoclasts break down and remove old bone, and then cells called osteoblasts lay down new bone. After menopause, the rate of bone removal speeds up, and bone formation doesn’t always keep pace. The net result can be bone loss and ultimately the weakened, brittle bones of osteoporosis.

Even if you’ve been diagnosed with osteoporosis, a fracture isn’t inevitable. Many drugs available today can slow the rate of bone loss—and can rebuild bone strength.

Your doctor will determine whether you have osteoporosis by measuring your bone density—usually at the hip and spine—using dual energy x-ray absorptiometry (DEXA). The result, expressed as a number called a T-score, compares your bone density with that of a healthy 30-year-old woman.

The doctor will likely recommend medicine if you have

  • a T-score of –2.5 or lower—the definition of osteoporosis

  • a history of hip or vertebral (spinal) fracture caused by a fall while standing (in contrast to a fall from a height)

  • a T-score between –1.0 and –2.5 (called osteopenia) and a high risk of hip or osteoporosis-related fracture in the next 10 years according to a fracture risk calculator.

Osteoporosis treatment: Where to start

To slow bone breakdown, many doctors first turn to one particular class of drugs. “If someone has a very low T-score, we’ll typically start with the bisphosphonates,” says Dr. David Slovik, associate professor of medicine at Harvard Medical School and endocrinologist at Massachusetts General Hospital.

There are several bisphosphonates to choose from:

  • pills, such as alendronate (Fosamax), ibandronate (Boniva), or risedronate (Actonel, Atelvia), taken daily, weekly, or monthly

  • injections of ibandronate (Boniva), given once every three months

  • intravenous infusion of zoledronic acid (Reclast), given once a year.

“I like starting with alendronate because it’s been around the longest, it has shown a good therapeutic response, and it comes in a generic version, which can save patients money,” Dr. Slovik says.

Your doctor will also consider where your bone loss is centered. Alendronate, risedronate, and ibandronate have all been shown effective for reducing spine fractures. For women with a history of hip or nonspinal fractures, alendronate and risedronate are better options than ibandronate.

If you have gastrointestinal problems like reflux, or if you can’t sit or stand upright for the full 30 to 60 minutes required after taking an oral bisphosphonate, then your doctor may put you on an injection or infusion of these drugs, which works about as well as the oral versions.

You might have read about risks associated with bisphosphonate drugs—particularly fractures of the thighbone (femur) and osteonecrosis (bone death) in the jaw. Though these concerns are real, they are more common in people taking intravenous bisphosphonates to treat cancer that has spread to the bones, or in women who are on long-term, high-dose bisphosphonates.

Doctors acknowledge that the risk of these side effects also increases with long-term use of bisphosphonates, so most women take these drugs for about five years. The good news is that the bone-protective benefits continue even after you stop taking bisphosphonates.

Other drug options

For postmenopausal women who aren’t starting with a bisphosphonate, or those who’ve already been on one for five years, here are a few other options.

Raloxifene (Evista), a selective estrogen receptor modulator (SERM), is perhaps best known for its role in breast cancer prevention and treatment, but it serves double duty in treating osteoporosis, too. It works by binding with estrogen receptors around the body to produce estrogen-like effects, one of which is to decrease bone turnover. “For people with osteoporosis of the spine, raloxifene reduces the risk of vertebral fractures,” Dr. Slovik says. The main side effects are hot flashes, muscle pain, and an increased risk of blood clots in the leg (deep-vein thrombosis).

Teriparatide (Forteo) is a synthetic version of parathyroid hormone that increases bone density and strength. It can reduce the risk of fractures significantly in the spine and other bones. “If someone has very low bone density and vertebral fractures, I often consider treatment with teriparatide,” Dr. Slovik says. Doctors usually limit teriparatide treatment to two years, because it hasn’t been tested for longer than that. After two years, your doctor may switch you to a bisphosphonate to help you maintain bone density. Women on teriparatide need to give themselves a daily injection.

Denosumab (Prolia) is given as a twice-yearly injection. It prevents bone-dissolving osteoclast cells from forming. Denosumab may be an option if a woman cannot tolerate bisphosphonates.

Calcitonin (Miacalcin, Fortical) has been around since the 1980s, making it the oldest osteoporosis drug. It’s a hormone that binds to osteoclasts to prevent bone loss. When taken as a daily nasal spray or by injection, calcitonin can reduce spinal fractures, but it hasn’t been shown effective for preventing other types of fractures and is not a first-line treatment for most women.

A number of other osteoporosis drugs are in development, including a new monoclonal antibody (romosozumab) and drugs that block sclerostin, a protein that inhibits bone formation. However, Dr. Slovik doesn’t think we’re going to see any of these new drugs approved within the next year. For now, the best ways to strengthen bone are with the existing osteoporosis drugs.

Osteoporosis drugs compared

Class

Drug

Dosing

How it works

Risks/side effects

bisphosphonates

  • alendronate (Fosamax, Binosto)

  • daily or weekly tablet or weekly effervescent tablet that you dissolve in water

  • strengthens bones by slowing the rate at which osteoclasts remove bone

  • gastrointestinal problems, such as trouble swallowing, inflammation of the esophagus, and ulcers

  • osteonecrosis (death of bone tissue) in the jaw (rare)

  • ibandronate (Boniva)

  • monthly tablet or injection every three months

  • strengthens bones by slowing the rate at which osteoclasts remove bone

  • fracture of the thighbone (femur) with more than five years of use (rare)

  • risedronate (Actonel, Atelvia)

  • daily, weekly, or monthly tablet

  • strengthens bones by slowing the rate at which osteoclasts remove bone

  • irritation at the injection site

  • flu-like symptoms—headache, muscle aches, fever

  • fracture of the thighbone (rare)

  • osteonecrosis of the jaw (rare)

  • zoledronic acid (Reclast)

  • yearly intravenous infusion

  • strengthens bones by slowing the rate at which osteoclasts remove bone

  • allergic reactions

  • small increase in cancer risk

calcitonin

  • calcitonin (Miacalcin, Fortical)

  • daily nasal spray or injection

  • inhibits bone removal by osteoclasts, and increases the rate of new bone formation by osteoblasts

allergic reactions

  • small increase in cancer risk

parathyroid hormone

  • teriparatide (Forteo)

  • daily injection

  • increases the number of bone-forming osteoblasts

  • leg cramps

  • nausea

  • dizziness

monoclonal antibody

  • denosumab (Prolia)

  • injection given by a health care provider twice a year

  • prevents the development of bone-removing osteoclasts

  • low blood calcium

  • skin infections and rash

  • osteonecrosis of the jaw (rare)

  • fracture of the thighbone (rare)

Disclaimer:
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Reclast Side Effects

Generic Name: zoledronic acid

Medically reviewed by Drugs.com. Last updated on Feb 17, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
  • Interactions
  • More

Note: This document contains side effect information about zoledronic acid. Some of the dosage forms listed on this page may not apply to the brand name Reclast.

In Summary

Common side effects of Reclast include: hypophosphatemia, hypokalemia, and hypomagnesemia. Other side effects include: hypocalcemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zoledronic acid: intravenous powder for solution, intravenous solution

Along with its needed effects, zoledronic acid (the active ingredient contained in Reclast) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking zoledronic acid:

More common

  • Agitation
  • black, tarry stools
  • blurred vision
  • chest pain
  • chills
  • confusion
  • convulsions
  • cough
  • depression
  • difficult or labored breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • irregular heartbeat
  • irritability
  • lack or loss of strength
  • lethargy
  • lower back or side pain
  • muscle pain or cramps
  • muscle trembling or twitching
  • nausea or vomiting
  • numbness and tingling around the mouth, fingertips, or feet
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • seizures
  • shaking of the hands, arms, feet, legs, or face
  • skin rash, cracks in the skin at the corners of the mouth, or soreness or redness around the fingernails and toenails
  • sore throat
  • sores, ulcers, or white spots on the lips or mouth
  • stupor
  • sudden sweating
  • swollen glands
  • tightness in the chest
  • trouble breathing with exercise
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Feeling of constant movement of self or surroundings
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle spasms
  • neck pain
  • pounding in the ears
  • rapid breathing
  • sensation of spinning
  • slow or fast heartbeat
  • sunken eyes
  • tingling of the hands or feet
  • tremor

Incidence not known

  • Blurred vision or other change in vision
  • decreased frequency or amount of urine
  • decreased vision
  • eye pain
  • eye tenderness
  • heavy jaw feeling
  • increased blood pressure
  • increased tearing
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loosening of a tooth
  • pain, swelling, or numbness in the mouth or jaw
  • redness of the eye
  • sensitivity of the eye to light
  • severe eye pain
  • swelling of the face, hands, fingers, lower legs, or ankles
  • weight gain

Some side effects of zoledronic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Abdominal or stomach pain
  • back pain
  • bad, unusual, or unpleasant (after) taste
  • bladder pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • bone pain
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • change in taste
  • constipation
  • cracked lips
  • cracked, dry, or scaly skin
  • diarrhea
  • difficulty with swallowing
  • discouragement
  • dry mouth
  • ear congestion
  • feeling sad or empty
  • frequent urge to urinate
  • hair loss or thinning hair
  • headache
  • hyperventilation
  • joint pain or swollen joints
  • loss of appetite
  • loss of interest or pleasure
  • loss of voice
  • muscle stiffness or difficulty with moving
  • nasal congestion or runny nose
  • pain, swelling, or redness in the joints
  • partial loss of feeling
  • seeing, hearing, or feeling things that are not there
  • sleepiness or unusual drowsiness
  • swelling or inflammation of the mouth
  • thirst
  • trouble concentrating
  • trouble sleeping
  • unusually cold, shivering
  • vomiting
  • weight loss

Less common

  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • red streaks on the skin
  • stomach discomfort or upset
  • swelling, tenderness, or pain at the injection site
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • wrinkled skin

Rare

  • Burning, dry, or itching eyes
  • discharge or excessive tearing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • throbbing pain

For Healthcare Professionals

Applies to zoledronic acid: intravenous powder for injection, intravenous solution

General

In general, side effects have been mild and transient and similar to other bisphosphonates.

Acute phase reactions have occurred within three days after administration of this drug with symptoms of pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness. Symptoms usually resolve within three days of onset, but resolution can take up to 7 to 14 days, and some symptoms have persisted for a longer duration.

Cardiovascular

In the postmenopausal osteoporosis trial, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid (the active ingredient contained in Reclast) treatment group occurred in 1.3% of patients (50 out of 3862) compared to 0.4% (17 out of 3852) in the placebo group. The overall incidence of all atrial fibrillation adverse events in the zoledronic acid treatment group was, reported in 2.5% of patients (96 out of 3862) in the Reclast group vs. 1.9% of patients (75 out of 3852) in the placebo group.

Very common (10% or more): Hypotension (10.5%)

Common (1% to 10%): Atrial fibrillation

Uncommon (0.1% to 1%): Palpitations, flushing, hypotension, hypotension leading to syncope or circulatory collapse

Rare (less than 0.1%): Bradycardia

Very rare (less than 0.01%): Cardiac arrhythmia (secondary to hypocalcemia)

Postmarketing reports: Atrial fibrillation, hypertension, bradycardia, and hypotension

Dermatologic

Very common (10% or more): Alopecia (12%) and dermatitis (11%)

Uncommon (0.1% to 1%): Pruritus, hyperhidrosis, rash (including erythematous and macular rash), increased sweating

Frequency not reported: Stevens-Johnson syndrome, epidermal necrolysis

Postmarketing reports: Increased sweating and urticaria

Gastrointestinal

Common (1% to 10%): Stomatitis, sore throat, dysphagia

Uncommon (0.1% to 1%): Gastroesophageal reflux disease, esophagitis, toothache, gastritis

Postmarketing reports: Dry mouth

Genitourinary

Very common (10% or more): Urinary tract infection (14%)

Hematologic

Very common (10% or more): Anemia (22.1% to 33%) and neutropenia (12%)

Common (1% to 10%): Granulocytopenia, thrombocytopenia and pancytopenia

Uncommon (0.1% to 1%): Leukopenia

Metabolic

Very common (10% or more): Hypophosphatemia (12.8%), hypokalemia (11.6%), hypomagnesemia (10.5%),

Common (1% to 10%): Dehydration, hypocalcemia

Uncommon (0.1% to 1%): Anorexia, decrease appetite

Rare (less than 0.1%): Hyperkalemia, hypernatremia

Musculoskeletal

Very common (10% or more): Bone pain (55%), myalgia (23%), arthralgia (21%), back pain (15%), and limb pain (14%)

Common (1% to 10%): Myalgia, arthralgia, generalized pain, pain in extremity

Uncommon (0.1% to 1%): Muscle cramps, osteonecrosis of the jaw (ONJ), neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness

Rare (less than 0.1%): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)

Postmarketing reports: Muscle cramps; osteonecrosis of the jaw, hip, and femur have been reported predominantly in cancer patients treated with intravenous bisphosphonates (many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ).

Cases of osteonecrosis (primarily of the jaws) have been reported, predominantly in cancer patients taking this drug. Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries. Osteonecrosis of the jaws has multiple documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anemia, coagulopathies, infection, pre-existing oral disease).

Nervous system

Very common (10% or more): Headache (19%), dizziness (18%), paresthesia (15%), hypoesthesia (12%)

Common (1% to 10%): Somnolence

Uncommon (0.1% to 1%): Paraesthesia, taste disturbance, hyperesthesia, tremor, somnolence, syncope, dysgeusia, lethargy

Very rare (less than 0.01%): Seizures, numbness and tetany (secondary to hypocalcemia)

Frequency not reported: Neurological events due to hypokalemia (e.g., seizures, numbness, tetany)

Postmarketing reports: Taste disturbance, hyperesthesia, tremor

Other

Very common (10% or more): Fever (44.2%), moniliasis (11.6%)

Common (1% to 10%): Nonspecific infections, asthenia, mucositis, chest pain, leg edema

Uncommon (0.1% to 1%): Vertigo

Postmarketing reports: Flu-like syndrome, pyrexia, fatigue, malaise; osteonecrosis of the external auditory canal have been reported predominantly in cancer patients treated with intravenous bisphosphonates (many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ).

Fever is the most common adverse effect associated with zoledronic acid infusion.

Flu-like syndromes including fever, chills, bone pain, and/or arthralgias and myalgias have also occasionally been reported. These symptoms generally did not require treatment and resolved within 24 to 48 hours.

Psychiatric

Very common (10% or more): Insomnia (15.1%), anxiety (14%), depression (14%), agitation (12.8%)

Common (1% to 10%): Confusion

Renal

The following factors have been associated with an increased risk: Pre-existing renal dysfunction, dehydration, multiple cycles of zoledronic acid (the active ingredient contained in Reclast) or other bisphosphonates, concomitant use of nephrotoxic medicines and use of a shorter infusion time than what is recommended.

The frequency of renal impairment adverse events suspected to be related to this drug was as follows: Multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumors (3.2%). Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.

Very common (10% or more): Renal toxicity (deterioration of renal function or renal failure),

Common (1% to 10%): Grade 3 increases (more than 3 times upper limit of normal) in serum creatinine in 2.3% of patients, blood urea increased

Uncommon (0.1% to 1%): Acute renal failure, hematuria, proteinuria, pollakiuria

Postmarketing reports: Hematuria, proteinuria, hyperkalemia, hypernatremia

Respiratory

Very common (10% or more): Dyspnea (22.1% to 27%), coughing (11.6% to 22%), upper respiratory infection (10%)

Uncommon (0.1% to 1%): Pleural effusion

Rare (less than 0.1%): Interstitial lung disease

Postmarketing reports: Bronchoconstriction and asthma exacerbations

Ocular

Common (1% to 10%): Conjunctivitis, ocular hyperemia

Uncommon (0.1% to 1%): Blurred vision, scleritis, orbital inflammation, eye pain

Very rare (less than 0.01%): Uveitis, episcleritis, iritis

Frequency not reported: Scleritis

Postmarketing reports: Uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema

Hypersensitivity

Local

Uncommon (0.1% to 1%): Injection site reactions (including pain, irritation, swelling, induration)

Postmarketing reports: Itching and pain at the injection site

Immunologic

Rare (less than 0.1%): Angioneurotic edema

Oncologic

Frequency not reported: Aggravation of malignant neoplasm and progression of cancer

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. “Product Information. Zometa (zoledronic acid).” Novartis Pharmaceuticals, East Hanover, NJ.

4. Cerner Multum, Inc. “Australian Product Information.” O 0

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

  • What medications are available to treat osteoporosis?

Medical Disclaimer

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Patient Tips
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 86 Reviews
  • Generic Availability
  • Drug class: bisphosphonates
  • FDA Alerts (3)
  • FDA Approval History
  • Reclast
  • Reclast (Advanced Reading)

Other brands: Zometa, Aclasta

  • Reclast (FDA)
  • … +1 more
  • Osteoporosis
  • Hypercalcemia of Malignancy
  • Osteolytic Bone Lesions of Multiple Myeloma
  • Osteolytic Bone Metastases of Solid Tumors
  • Paget’s Disease
  • Prevention of Osteoporosis

Zoledronic acid is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is also approved to increase bone mass in men with osteoporosis and for the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture. In 2009, it was approved for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women as a result of long-term use of steroid medicines (examples are prednisone and cortisone).

Zoledronic acid is given once a year as an intravenous (IV) infusion to treat osteoporosis. It is also given every two years as an IV infusion to prevent osteoporosis. Zoledronic acid increases bone density and reduces the incidence of the spine and non-spine fractures, including hip fractures.

A healthcare provider gives zoledronic acid as an intravenous (IV) dose of 5 mg in a doctor’s office or other outpatient setting. It takes at least 15 minutes for the yearly infusion. Patients need to have a blood test to check creatinine and creatinine clearance prior to each IV dose to make sure the kidney function is normal. A routine oral exam is also done before each dose.

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