Aclasta Side Effects

Generic name: zoledronic acid

Medically reviewed by Drugs.com. Last updated on Jun 5, 2024.

Note: This document provides detailed information about Aclasta.

Applies to zoledronic acid: intravenous powder for solution, intravenous solution Side Effects associated with zoledronic acid. Some dosage forms listed on this page may not apply specifically to the brand name Aclasta.

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

Precautions

It is very important that your doctor check your progress at regular visits after you have received zoledronic acid (the active ingredient contained in Aclasta) injection. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed. You will need a yearly dose of this medicine if you are being treated for postmenopausal osteoporosis, so check with your doctor regularly.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

You should not use other medicines that also contain zoledronic acid, such as Reclast® or Zometa®. Using these medicines together may increase your chance for more serious side effects.

This medicine may rarely cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

This medicine may cause hypocalcemia (low calcium in the blood). Low blood calcium must be corrected before you receive this medicine. Check with your doctor immediately if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.

Tell your doctor right away if you have agitation, blood in the urine, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness. These could be symptoms of serious kidney problems.

Your doctor will need to know if you have a history of problems with your mouth or teeth (eg, gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine, such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®) in the past.

It is important that you tell all of your doctors that you are receiving zoledronic acid injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, other medicines that also contain zoledronic acid) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Aclasta

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:

Other side effects of Aclasta

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 solution.

General adverse events

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.^[Ref]

Cardiovascular

• 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^[Ref]

In the postmenopausal osteoporosis trial, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid (the active ingredient contained in Aclasta) 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.^[Ref]

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^[Ref]

Gastrointestinal

• 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 mouth^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (14%)^[Ref]

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^[Ref]

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^[Ref]

Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).^[Ref]

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).^[Ref]

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).^[Ref]

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^[Ref]

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).^[Ref]

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.^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (15.1%), anxiety (14%), depression (14%), agitation (12.8%)
• Common (1% to 10%): Confusion^[Ref]

Renal

• 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^[Ref]

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.^[Ref]

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^[Ref]

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^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reaction including bronchoconstriction, urticaria, angioedema, anaphylactic reaction/shock^[Ref]

Local

• Uncommon (0.1% to 1%): Injection site reactions (including pain, irritation, swelling, induration)
• Postmarketing reports: Itching and pain at the injection site^[Ref]

Immunologic

• Rare (less than 0.1%): Angioneurotic edema^[Ref]

Oncologic

• Frequency not reported: Aggravation of malignant neoplasm and progression of cancer^[Ref]

See also:

Further information

Aclasta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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