Zoledronic acid Side Effects

Brand Names: Reclast, Zometa

Please note - some side effects for Zoledronic acid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Zoledronic acid - for the Consumer

Zoledronic Acid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zoledronic Acid:

Diarrhea; dizziness; headache; mild back, joint, or muscle pain; mild flu-like symptoms (eg, mild fever, muscle aches); mild itching, pain, or redness at the injection site; nausea; stomach pain or upset; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; eye pain, redness, or swelling; fever, chills, or persistent sore throat; irregular heartbeat; jaw pain or swelling; mental or mood changes (eg, depression); muscle cramps or spasms; numbness or tingling (especially around the mouth); severe bone, joint, or muscle pain (especially in the hip, groin, or thigh); severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

In general, side effects have been mild and transient and similar to other bisphosphonates. Postmarketing reports have included weight gain.

Metabolic

Metabolic side effects have included hypomagnesemia (10.5%), hypokalemia (11.6%), hypophosphatemia (12.8%), and dehydration and hypocalcemia have been reported in 5% to 10% of patients. Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).

Renal

Renal side effects have included renal toxicity (deterioration of renal function or renal failure). Grade 3 increases (more than 3 times upper limit of normal) in serum creatinine have been reported in 2.3% of patients. Postmarketing reports have included hematuria, proteinuria, hyperkalemia, and hypernatremia.

Hematologic

Hematologic side effects have included anemia (22.1% to 33%) and neutropenia (12%). Granulocytopenia, thrombocytopenia, and pancytopenia have been reported in 5% to 10% of patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (46% to 29.1%), vomiting (14% to 32%), constipation (26.7% to 31%), diarrhea (17.4% to 24%), abdominal pain (14% to 16.3%), dyspepsia (10%), anorexia (9.3%), stomatitis (8%), sore throat (8%), and dysphagia (5% to 10%). Postmarketing reports have included reports of dry mouth.

Ocular

Ocular side effects have included conjunctivitis. Cases of uveitis and episcleritis have been reported during post approval use. Postmarketing reports have included blurred vision. Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.

Cardiovascular

Cardiovascular side effects have included hypotension (10.5%). Postmarketing reports have included atrial fibrillation, hypertension, bradycardia, and hypotension.

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.

Musculoskeletal

Musculoskeletal side effects have included bone pain (55%), myalgia (23%0, arthralgia (21%), back pain (15%), and limb pain (14%). Postmarketing reports have included muscle cramps. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with bisphosphonate use. Cases of osteonecrosis (primarily involving the jaws) have been reported predominantly in cancer patients treated with intravenous bisphosphonates including zoledronic acid

Nervous system

Nervous system side effects have included headache (19%), dizziness (18%), insomnia (15.1%), paresthesia (15%), anxiety (14%), confusion (12.8%), agitation (12.8%), hypoesthesia (12%), and somnolence (5% to 10%). Postmarketing reports have included taste disturbance, hyperesthesia, tremor, and vertigo.

Respiratory

Respiratory side effects have included dyspnea (27% to 22.1%), coughing (22% to 11.6%), upper respiratory infection (10%), and pleural effusion (5% to 10%). Postmarketing reports have included bronchoconstriction.

Genitourinary

Genitourinary side effects have included urinary tract infection (14%).

Oncologic

Oncologic side effects have included aggravation of malignant neoplasm and progression of cancer.

Other

Other side effects have included fever (44.2%) and moniliasis (11.6%). Nonspecific infections, asthenia, chest pain, leg edema, and mucositis have been reported in 5% to 10% of patients. Flu-like syndromes have also been reported.

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.

Local

Local side effects have infrequently included redness or swelling at the injection site. Postmarketing reports have included itching and pain at the injection site.

Dermatologic

Dermatologic side effects have included alopecia (12%) and dermatitis (11%). Rash and pruritus have been reported rarely. Postmarketing reports have included increased sweating and urticaria.

Psychiatric

Psychiatric side effects have included depression (14%), anxiety (11%), and confusion (7%).

Hypersensitivity

Hypersensitivity side effects have included rare cases of urticaria and angioedema and very rare cases of anaphylactic shock.

Other

Other side effects have included postmarketing reports of pyrexia, asthenia, fatigue, or malaise persisting for greater than 30 days.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.