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Commonly reported side effects of zoledronic acid 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 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:
Incidence not known
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:
For Healthcare Professionals
Applies to zoledronic acid: intravenous powder for injection, intravenous solutionGeneral
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 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 hypotensionDermatologic
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 urticariaGastrointestinal
Very common (10% or more): Nausea (29.1% to 46%), vomiting (14% to 32%), constipation (26.7% to 31%), diarrhea (17.4% to 24%), abdominal pain (14% to 16.3%), dyspepsia (10%)
Common (1% to 10%): Stomatitis, sore throat, dysphagia
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, esophagitis, toothache, gastritis
Postmarketing reports: Dry mouthGenitourinary
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%): LeukopeniaMetabolic
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
Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).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, tremorOther
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%): ConfusionRenal
The following factors have been associated with an increased risk: Pre-existing renal dysfunction, dehydration, multiple cycles of zoledronic acid 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, hypernatremiaRespiratory
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 exacerbationsOcular
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 edemaHypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reaction including bronchoconstriction, urticaria, angioedema, anaphylactic reaction/shockLocal
Uncommon (0.1% to 1%): Injection site reactions (including pain, irritation, swelling, induration)
Postmarketing reports: Itching and pain at the injection siteImmunologic
Rare (less than 0.1%): Angioneurotic edemaOncologic
Frequency not reported: Aggravation of malignant neoplasm and progression of cancer
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